Agency Forms Undergoing Paperwork Reduction Act Review, 12358-12361 [2023-03960]
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ddrumheller on DSK120RN23PROD with NOTICES
12358
Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
Suite 100 (02–2), Boston, MA 02109–
3912, telephone number: (617) 918–
1403, email address:
greendlinger.stacy@epa.gov.
SUPPLEMENTARY INFORMATION: Notice of
this proposed settlement agreement is
made in accordance with section 122(i)
of the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA), 42 U.S.C. 9622(i). This
administrative settlement agreement is
made in accordance with sections 104,
106, 107(a), and 122 of CERCLA, and
includes a compromise of EPA response
costs, under CERCLA sections 107(a)
and the authority of the Attorney
General of the United States to
compromise and settle claims of the
United States with the Settling Party,
City of Salem, concerning the Mansell
Field Site. The proposed settlement,
which involves a mixed work and
funding agreement with the Settling
Party, includes a compromise of up to
$1.841 million in direct and indirect
EPA costs associated with EPA’s
contribution to the implementation of a
removal action at the Site. The
settlement agreement includes a
covenant not to sue pursuant to sections
106 (for the work) and 107(a) (for future
response costs and EPA costs to perform
the work up to the amount of $1.841
million) of CERCLA, 42 U.S.C. 9606 and
9607(a), relating to the Site, and
protection from contribution actions or
claims as provided by sections 113(f)(2)
and 1229h)(4) of CERCLA. Pursuant to
the terms of the proposed settlement,
EPA has reserved its right to recover any
costs incurred to perform the removal
action that are above the amount of
$1.841 million, as well as EPA’s past
costs. The settlement has been approved
by the Environmental and Natural
Resources Division of the United States
Department of Justice.
For 30 days following the date of
publication of this notice, the Agency
will receive written comments relating
solely to the cost compromise
component of the settlement under
CERCLA section 107(a) (the compromise
of up to $1.841 million in direct and
indirect EPA costs associated with
EPA’s contribution to the
implementation of a removal action at
the Site). Section XIV (Payment of
Response Costs) of the settlement
agreement will become effective when
EPA notifies Salem that the public
comment period has closed and that
such comments, if any, do not require
that EPA modify or withdraw from
consent to section XIV (Payment of
Response Costs) of this agreement. The
United States will consider all
comments received and may seek to
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modify or withdraw consent from the
cost compromise contained in the
proposed settlement if comments
received disclose facts or considerations
which indicate that the cost
compromise contained in the settlement
is inappropriate, improper, or
inadequate. The Agency’s response to
any comments received will be available
for public inspection at the
Environmental Protection Agency—
Region I, 5 Post Office Square, Suite
100, Boston, MA 02109–3912.
Meghan Cassidy,
Deputy Director, Superfund and Emergency
Management Division.
[FR Doc. 2023–03988 Filed 2–24–23; 8:45 am]
BILLING CODE 6560–50–P
EXPORT-IMPORT BANK
Sunshine Act Meetings
Notice of Open Meeting of the SubSaharan Africa Advisory Committee of
the Export-Import Bank of the United
States (EXIM)
TIME AND DATE: Thursday, March 23rd,
2023 from 2:00pm–3:30 p.m. ET.
PLACE: The meeting will be held
virtually.
STATUS: Public Participation: The
meeting will be open to public
participation and time will be allotted
for questions or comments submitted
online. Members of the public may also
file written statements before or after the
meeting to external@exim.gov.
Interested parties may register for the
meeting at: https://
events.teams.microsoft.com/event/
c2e2631d-2807-40d1-ab1f7bd067f41d4a@b953013c-c791-4d32996f-518390854527.
MATTERS TO BE CONSIDERED: Discussion
of EXIM policies and programs designed
to support the expansion of financing
support for U.S. manufactured goods
and services in Sub-Saharan Africa.
CONTACT PERSON FOR MORE INFORMATION:
For further information, contact India
Walker, External Engagement Specialist
at 202–480–0062.
Joyce B. Stone,
Assistant Corporate Secretary.
[FR Doc. 2023–04095 Filed 2–23–23; 4:15 pm]
BILLING CODE 6690–01–P
EXPORT-IMPORT BANK
Sunshine Act Meetings
Notice of Open Meeting of the
Advisory Committee of the ExportImport Bank of the United States (EXIM)
PO 00000
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Tuesday, March 21st,
2023 from 2:00–3:30 p.m. EDT.
PLACE: The meeting will be held
virtually.
STATUS:
Public Participation: The meeting will
be open to public participation and time
will be allotted for questions or
comments submitted online. Members
of the public may also file written
statements before or after the meeting to
external@exim.gov. Interested parties
may register below for the meeting:
https://events.teams.microsoft.com/
event/28f38ed0-c047-4b0f-915978f185d1fd88@b953013c-c791-4d32996f-518390854527.
MATTERS TO BE CONSIDERED: Discussion
of EXIM policies and programs to
provide competitive financing to
expand United States exports and
comments for inclusion in EXIM’s
Report to the U.S. Congress on Global
Export Credit Competition.
CONTACT PERSON FOR MORE INFORMATION:
For further information, contact India
Walker, External Engagement Specialist,
at 202–480–0062 or at india.walker@
exim.gov.
TIME AND DATE:
Joyce B. Stone,
Assistant Corporate Secretary.
[FR Doc. 2023–04093 Filed 2–23–23; 4:15 pm]
BILLING CODE 6690–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–1310]
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 ‘‘Public Health
Laboratory Testing for Emerging
Antibiotic Resistance and Fungal
Threats’’ 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 October
11, 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
E:\FR\FM\27FEN1.SGM
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES
Proposed Project
Public Health Laboratory Testing for
Emerging Antibiotic Resistance and
Fungal Threats (OMB Control No. 0920–
1310, Exp. 12/31/2023)—Revision—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
This collection related to state and
local laboratory testing capacity is being
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 sub-
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20:06 Feb 24, 2023
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objective 2.1.1 of the National Action
Plan of March 2015 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 Antibiotic Resistance Laboratory
Network (AR Lab Network) is made up
of jurisdictional public health
laboratories in all 50 states, five large
cities, and Puerto Rico. These public
health laboratories will be equipped to
detect and characterize isolates of
carbapenem-resistant Enterobacteriaceae
(CRE), carbapenem-resistant
Pseudomonas aeruginosa (CRPA), and
carbapenem-resistant Acinetobacter
baumannii (CRAB), as well as
carbapenemase-positive organisms
(CPOs) from colonization screening
swabs. These resistant bacteria are
becoming more and more prevalent,
particularly in healthcare settings, and
are typically identified in clinical
laboratories, but characterization is
often limited. The laboratory testing will
allow for additional testing and
characterization, including use of goldstandard 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 to
identify the resistance mechanism(s).
Screening swabs will undergo molecular
testing to identify whether
carbapenemase-producing organisms are
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, some
jurisdictions will participate in
reference identification of Candida spp.
to aid in these pursuits using matrixassisted laser desorption ionization/
time-of-flight (MALDI–TOF) mass
spectrometry or deoxyribonucleic acid
(DNA) based sequencing.
CDC’s AR Lab Network supports
nationwide lab capacity to rapidly
detect antibiotic resistance and inform
local public health responses to prevent
spread and protect people. It closes the
gap between local capabilities and the
data needed to combat antibiotic
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12359
resistance by providing comprehensive
lab capacity and infrastructure for
detecting antibiotic-resistant pathogens
(germs), cutting-edge 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 antibiotic-resistant
threats in healthcare and the
community, mount a comprehensive
local response, and better understand
these deadly threats to quickly contain
them. Additionally, a subset of
jurisdictions will participate in
detection and characterization of AR
Neisseria gonorrhoeae, including
antimicrobial susceptibility testing of
Neisseria gonorrhoeae.
Funded state and local public health
laboratories will provide the following
information to the Program Office at
CDC—Division of Healthcare Quality
Promotion (DHQP):
1. Annually, participating laboratories
will submit a summary report
describing testing methods and volume.
These reports will be submitted by
email to ARLN_DHQP@cdc.gov. These
measures are to be used by the Program
Office (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 Evaluation and
Performance Measurement Report to
CDC via email to HAIAR@cdc.gov. 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: (a) provide data for state and
local infection prevention programs; (b)
identify new types of antibiotic resistant
organisms; (c) identify new resistance
mechanisms in targeted organisms; (d)
describe the spread of targeted
resistance mechanisms; and (e) identify
geographical distribution of antibiotic
resistance or other epidemiological
trends.
4. 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
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES
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.
5. 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 and C. auris whole
genome sequencing (WGS) will also
provide the following to the Mycotics
Program Office at CDC—Division of
Foodborne, Waterborne, and
Environmental Diseases (DFWED):
1. Annually, participating laboratories
will provide an Evaluation and
Performance Measurement Report to
CDC via email to ARLN@cdc.gov. Data
will be used to indicate progress made
toward program objectives and
challenges encountered.
2. Participating laboratories will
report all candida identification 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.
3. Participating laboratories will
report all C. auris WGS testing results to
CDC by REDCap or Health Level 7 (HL7)
using online web-portal transmission.
This information will be used to (1)
support outbreak investigations (i.e.,
helping to identify new introductions
and ongoing or undetected
transmission), (2) monitor circulating
clades and strains, and (3) learn more
about mechanisms of antifungal
resistance. Participating laboratories
will utilize secure public health
messaging protocols to transfer results
data to CDC and coordinating
epidemiologists. For messaging to CDC,
these messaging protocols will be based
in REDCap or the AIMS platform.
4. For those resistant organisms 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 C. auris, which is
rapidly emerging in healthcare settings.
These alerts must be sent within one
working day of detection. Participating
laboratories will utilize REDCap and/or
email to ARLN_alert@cdc.gov 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.
Sites participating in detection and
characterization of AR Neisseria
gonorrhoeae, including antimicrobial
susceptibility testing of Neisseria
gonorrhoeae will provide the following
to the STD Laboratory Reference and
Research Branch (SLRRB) at CDC—
Division of STD Prevention (DSTDP):
1. Annually, participating laboratories
will provide an Evaluation and
Performance Measure Report. 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’’ MIC
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 antibiotic resistant pathogens
and emerging patterns of resistance, and
(2) aid public health departments and
healthcare facilities in timely
responding to antibiotic 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 OMB approval for an
estimated 4,950 annual burden hours.
There is no cost to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Laboratories ...................
3a. Annual Report of Bacterial Specimen Testing
Methods.
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Average
number of
responses per
respondent
1
Average
burden per
response
(in hours)
6/60
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Federal Register / Vol. 88, No. 38 / Monday, February 27, 2023 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Public Health Laboratories ...................
3b. Annual Evaluation and Performance Measurement Report for Bacterial Specimen Testing.
3c. Monthly Data Report Form for Bacterial Specimen Testing.
3d. AR Lab Network Alerts—Bacterial Specimen
Testing.
3e. Annual Evaluation and Performance Measurement Report (Candida identification).
3f. Monthly Data Report Form for Candida identification.
3g. AR Lab Network Alerts Report Form for
Candida auris.
3h. Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae).
3i. AR Lab Network Alert and Monthly Data Report
Form for Neisseria gonorrhoeae.
3j. Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing).
3k. AR Lab Network Form for Isolate/Specimenlevel Mycotics Testing (C. auris Whole Genome
Sequencing).
3l. AR Lab Network Form for Phylogenetic Treelevel Mycotics Reporting (C. auris Whole Genome Sequencing).
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 Laboratories ...................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2023–03960 Filed 2–24–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–22FS]
Agency Forms Undergoing Paperwork
Reduction Act Review
ddrumheller on DSK120RN23PROD with NOTICES
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Artificial
Stone Countertops: Exposures, Controls,
Surveillance, & Translation’’ 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 June 02, 2022 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
VerDate Sep<11>2014
20:06 Feb 24, 2023
Jkt 259001
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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Average
number of
responses per
respondent
Average
burden per
response
(in hours)
56
1
4
56
12
4
56
34
6/60
56
1
2
56
12
2
56
13
6/60
56
1
1
56
12
6/60
56
1
1
56
12
6/60
56
12
6/60
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
Artificial Stone Countertops:
Exposures, Controls, Surveillance, &
Translation—New—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As a recently introduced technology
in the United States, the Artificial Stone
(AS) Countertop industry is not well
defined; the obligation to monitor
workers’ health might not be known,
considered, or understood; and
education on potential hazard and
health risks related to respirable
crystalline silica (RCS) is limited.
Exposure is associated with the
development of silicosis, an irreversible,
sometimes fatal, but preventable lung
disease. Twenty-four cases of silicosis,
E:\FR\FM\27FEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12358-12361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03960]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-1310]
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 ``Public Health Laboratory Testing for
Emerging Antibiotic Resistance and Fungal Threats'' 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 October 11, 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
[[Page 12359]]
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
Public Health Laboratory Testing for Emerging Antibiotic Resistance
and Fungal Threats (OMB Control No. 0920-1310, Exp. 12/31/2023)--
Revision--National Center for Emerging and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This collection related to state and local laboratory testing
capacity is being 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 sub-objective
2.1.1 of the National Action Plan of March 2015 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 Antibiotic Resistance Laboratory Network (AR Lab Network) is
made up of jurisdictional public health laboratories in all 50 states,
five large cities, and Puerto Rico. These public health laboratories
will be equipped to detect and characterize isolates of carbapenem-
resistant Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas
aeruginosa (CRPA), and carbapenem-resistant Acinetobacter baumannii
(CRAB), as well as carbapenemase-positive organisms (CPOs) from
colonization screening swabs. These resistant bacteria are becoming
more and more prevalent, particularly in healthcare settings, and are
typically identified in clinical laboratories, but characterization is
often limited. The laboratory testing will allow for additional testing
and characterization, including use of gold-standard 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 to identify the resistance
mechanism(s). Screening swabs will undergo molecular testing to
identify whether carbapenemase-producing organisms are 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, some jurisdictions will participate in reference
identification of Candida spp. to aid in these pursuits using matrix-
assisted laser desorption ionization/time-of-flight (MALDI-TOF) mass
spectrometry or deoxyribonucleic acid (DNA) based sequencing.
CDC's AR Lab Network supports nationwide lab capacity to rapidly
detect antibiotic resistance and inform local public health responses
to prevent spread and protect people. It closes the gap between local
capabilities and the data needed to combat antibiotic resistance by
providing comprehensive lab capacity and infrastructure for detecting
antibiotic-resistant pathogens (germs), cutting-edge 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 antibiotic-
resistant threats in healthcare and the community, mount a
comprehensive local response, and better understand these deadly
threats to quickly contain them. Additionally, a subset of
jurisdictions will participate in detection and characterization of AR
Neisseria gonorrhoeae, including antimicrobial susceptibility testing
of Neisseria gonorrhoeae.
Funded state and local public health laboratories will provide the
following information to the Program Office at CDC--Division of
Healthcare Quality Promotion (DHQP):
1. Annually, participating laboratories will submit a summary
report describing testing methods and volume. These reports will be
submitted by email to [email protected]. These measures are to be used
by the Program Office (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 Evaluation and
Performance Measurement Report to CDC via email to [email protected]. 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: (a) provide
data for state and local infection prevention programs; (b) identify
new types of antibiotic resistant organisms; (c) identify new
resistance mechanisms in targeted organisms; (d) describe the spread of
targeted resistance mechanisms; and (e) identify geographical
distribution of antibiotic resistance or other epidemiological trends.
4. 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
[[Page 12360]]
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.
5. 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 and C. auris
whole genome sequencing (WGS) will also provide the following to the
Mycotics Program Office at CDC--Division of Foodborne, Waterborne, and
Environmental Diseases (DFWED):
1. Annually, participating laboratories will provide an Evaluation
and Performance Measurement Report to CDC via email to [email protected].
Data will be used to indicate progress made toward program objectives
and challenges encountered.
2. Participating laboratories will report all candida
identification 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.
3. Participating laboratories will report all C. auris WGS testing
results to CDC by REDCap or Health Level 7 (HL7) using online web-
portal transmission. This information will be used to (1) support
outbreak investigations (i.e., helping to identify new introductions
and ongoing or undetected transmission), (2) monitor circulating clades
and strains, and (3) learn more about mechanisms of antifungal
resistance. Participating laboratories will utilize secure public
health messaging protocols to transfer results data to CDC and
coordinating epidemiologists. For messaging to CDC, these messaging
protocols will be based in REDCap or the AIMS platform.
4. For those resistant organisms 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 C. auris,
which is rapidly emerging in healthcare settings. These alerts must be
sent within one working day of detection. Participating laboratories
will utilize REDCap and/or email to [email protected] 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.
Sites participating in detection and characterization of AR
Neisseria gonorrhoeae, including antimicrobial susceptibility testing
of Neisseria gonorrhoeae will provide the following to the STD
Laboratory Reference and Research Branch (SLRRB) at CDC--Division of
STD Prevention (DSTDP):
1. Annually, participating laboratories will provide an Evaluation
and Performance Measure Report. 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'' MIC 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 antibiotic resistant pathogens and
emerging patterns of resistance, and (2) aid public health departments
and healthcare facilities in timely responding to antibiotic 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 OMB approval for an estimated 4,950 annual burden
hours. There is no cost 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
respondents per respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories......... 3a. Annual Report of 56 1 6/60
Bacterial Specimen Testing
Methods.
[[Page 12361]]
Public Health Laboratories......... 3b. Annual Evaluation and 56 1 4
Performance Measurement
Report for Bacterial
Specimen Testing.
Public Health Laboratories......... 3c. Monthly Data Report 56 12 4
Form for Bacterial
Specimen Testing.
Public Health Laboratories......... 3d. AR Lab Network Alerts-- 56 34 6/60
Bacterial Specimen Testing.
Public Health Laboratories......... 3e. Annual Evaluation and 56 1 2
Performance Measurement
Report (Candida
identification).
Public Health Laboratories......... 3f. Monthly Data Report 56 12 2
Form for Candida
identification.
Public Health Laboratories......... 3g. AR Lab Network Alerts 56 13 6/60
Report Form for Candida
auris.
Public Health Laboratories......... 3h. Annual Evaluation and 56 1 1
Performance Measurement
Report (Neisseria
gonorrhoeae).
Public Health Laboratories......... 3i. AR Lab Network Alert 56 12 6/60
and Monthly Data Report
Form for Neisseria
gonorrhoeae.
Public Health Laboratories......... 3j. Annual Evaluation and 56 1 1
Performance Measurement
Report (C. auris Whole
Genome Sequencing).
Public Health Laboratories......... 3k. AR Lab Network Form for 56 12 6/60
Isolate/Specimen-level
Mycotics Testing (C. auris
Whole Genome Sequencing).
Public Health Laboratories......... 3l. AR Lab Network Form for 56 12 6/60
Phylogenetic Tree-level
Mycotics Reporting (C.
auris Whole Genome
Sequencing).
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2023-03960 Filed 2-24-23; 8:45 am]
BILLING CODE 4163-18-P
