Proposed Data Collection Submitted for Public Comment and Recommendations, 61329-61331 [2022-22027]
Download as PDF
61329
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Potential LA-PrEP users or Clients ................
Client Screening Survey & Consent Form .....
C4P Client DCE Survey .................................
Provider Screening Survey & Consent Form
8,050
1,610
1,150
1
1
1
10/60
25/60
10/60
C4P Provider DCE Survey .............................
230
1
20/60
Clinical providers who prescribe PrEP, in the
United States.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–22025 Filed 10–7–22; 8:45 am]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
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 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
Antibiotic Resistance and Fungal
Threats. This collection will allow CDC
to partner with public health
laboratories and will help equip them to
detect and characterize isolates.
DATES: CDC must receive written
comments on or before December 12,
2022.
SUMMARY:
You may submit comments,
identified by Docket No. CDC–2022–
0119 by any 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
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
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;
FOR FURTHER INFORMATION CONTACT:
[60Day–23–1310; Docket No. CDC–2022–
0119]
ADDRESSES:
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondent
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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 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 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 (Attachment 1a),
the National Strategy of September 2014
(Attachment 1b) and to implement subobjective 2.1.1 of the National Action
Plan of March 2015 for Combating
Antibiotic Resistant Bacteria
(Attachment 1c). 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 (i.e., 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
E:\FR\FM\11OCN1.SGM
11OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
61330
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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
resistance by providing comprehensive
lab capacity and infrastructure for
detecting antibiotic-resistant pathogens,
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. 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
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
information to the Program Office at
CDC’s 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 DHQP
Program Office 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 an 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. Participating laboratories will
utilize secure public health messaging
protocols to transfer 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 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’’)
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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 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 testing results to CDC,
requested at least monthly, by REDCap
or HL7 using an online web-portal
transmission. This information will be
used to: (a) identify and track antifungal
resistance and emerging fungal
pathogens; and (b) 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.
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. 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
E:\FR\FM\11OCN1.SGM
11OCN1
61331
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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 HL7 using an online webportal transmission. This information
will be used to: (a) identify and track
antibiotic resistant pathogens and
emerging patterns of resistance; and (b)
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 4,705 annualized 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 ................
Annual Report of Bacterial Specimen Testing Methods.
Annual Evaluation and Performance
Measurement Report for Bacterial
Specimen Testing.
Monthly Testing Results Reports—
Bacterial Specimen Testing.
AR Lab Network Alerts—Bacterial
Specimen Testing.
Annual Evaluation and Performance
Measurement Report (Candida
identification).
Monthly Testing Results Reports—
Candida identification.
AR Lab Network Alerts—Candida
auris.
Annual Evaluation and Performance
Measurement Report (Neisseria
gonorrhoeae).
Monthly Testing Results Reports—
Neisseria gonorrhoeae.
AR Lab Network Alerts—Neisseria
gonorrhoeae.
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 ................
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–22027 Filed 10–7–22; 8:45 am]
6/60
6
56
1
4
224
56
12
4
2688
56
34
6/60
190
Up to 56
1
2
112
Up to 56
12
2
1344
Up to 56
13
6/60
73
Up to 56
1
1
56
Up to 56
1
6/60
6
Up to 56
1
6/60
6
........................
........................
........................
4705
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
khammond on DSKJM1Z7X2PROD with NOTICES
Medicare Program; Virtual Meeting of
the Medicare Evidence Development
and Coverage Advisory Committee—
December 7, 2022
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
AGENCY:
Jkt 259001
PO 00000
Frm 00056
Fmt 4703
Total burden
(in hours)
1
[CMS–3431–N]
17:37 Oct 07, 2022
Average
burden per
response
(in hours)
56
BILLING CODE 4163–18–P
VerDate Sep<11>2014
Number of
responses per
respondent
Sfmt 4703
ACTION:
Notice.
This notice announces a
virtual public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MEDCAC)
(‘‘Committee’’) will be held on
Wednesday, December 7, 2022. National
Coverage Determinations resulting in
coverage with evidence development
(CED) can expedite earlier Medicare
beneficiary access to innovative
technology while ensuring that
systematic patient safeguards are in
place to reduce the risks inherent to
new technologies, or to new
SUMMARY:
E:\FR\FM\11OCN1.SGM
11OCN1
Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61329-61331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22027]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1310; Docket No. CDC-2022-0119]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Public Health Laboratory Testing for Emerging Antibiotic
Resistance and Fungal Threats. This collection will allow CDC to
partner with public health laboratories and will help equip them to
detect and characterize isolates.
DATES: CDC must receive written comments on or before December 12,
2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0119 by any 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 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 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 (Attachment 1a), the
National Strategy of September 2014 (Attachment 1b) and to implement
sub-objective 2.1.1 of the National Action Plan of March 2015 for
Combating Antibiotic Resistant Bacteria (Attachment 1c). 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 (i.e., 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
[[Page 61330]]
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, 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. 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's 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 DHQP Program Office 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 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.
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.
Participating laboratories will utilize secure public health messaging
protocols to transfer 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 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 testing results to
CDC, requested at least monthly, by REDCap or HL7 using an online web-
portal transmission. This information will be used to: (a) identify and
track antifungal resistance and emerging fungal pathogens; and (b) 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. 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. 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
[[Page 61331]]
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 HL7 using an
online web-portal transmission. This information will be used to: (a)
identify and track antibiotic resistant pathogens and emerging patterns
of resistance; and (b) 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 4,705 annualized burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories.... Annual Report of 56 1 6/60 6
Bacterial
Specimen
Testing Methods.
Public Health Laboratories.... Annual 56 1 4 224
Evaluation and
Performance
Measurement
Report for
Bacterial
Specimen
Testing.
Public Health Laboratories.... Monthly Testing 56 12 4 2688
Results
Reports--Bacter
ial Specimen
Testing.
Public Health Laboratories.... AR Lab Network 56 34 6/60 190
Alerts--Bacteri
al Specimen
Testing.
Public Health Laboratories.... Annual Up to 56 1 2 112
Evaluation and
Performance
Measurement
Report (Candida
identification).
Public Health Laboratories.... Monthly Testing Up to 56 12 2 1344
Results
Reports--Candid
a
identification.
Public Health Laboratories.... AR Lab Network Up to 56 13 6/60 73
Alerts--Candida
auris.
Public Health Laboratories.... Annual Up to 56 1 1 56
Evaluation and
Performance
Measurement
Report
(Neisseria
gonorrhoeae).
Public Health Laboratories.... Monthly Testing Up to 56 1 6/60 6
Results
Reports--Neisse
ria gonorrhoeae.
Public Health Laboratories.... AR Lab Network Up to 56 1 6/60 6
Alerts--Neisser
ia gonorrhoeae.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 4705
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-22027 Filed 10-7-22; 8:45 am]
BILLING CODE 4163-18-P