Agency Forms Undergoing Paperwork Reduction Act Review, 3912-3914 [2020-01046]
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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
Dated: January 21, 2020.
Sarah L. Stewart,
Deputy General Counsel.
[FR Doc. 2020–01168 Filed 1–21–20; 4:15 pm]
BILLING CODE 6735–01–P
GENERAL SERVICES
ADMINISTRATION
[Notice–QQE–2020–01; Docket No. 2020–
0002; Sequence No. 1]
Publication of Website Standards
Technology Transformation
Services (TTS), Federal Acquisition
Service (FAS), General Services
Administration (GSA).
ACTION: Notice.
AGENCY:
The 21st Century Integrated
Digital Experience Act requires any
public website of an executive agency to
comply with GSA’s website standards.
GSA publishes the standards at https://
designsystem.digital.gov/websitestandards. To notify agencies of
revisions to the website standards, GSA
will periodically update the U.S. Web
Design System website and publish
notices in the Federal Register.
DATES: The website standards were first
published on January 22, 2020. They
were last revised on January 22, 2020.
FOR FURTHER INFORMATION CONTACT: For
clarification of content, contact Mr.
Jacob Parcell, Director, Innovation
Portfolio, Technology Transformation
Services, at 202–208–7139, or by email
at uswds@support.digitalgov.gov.
Please cite Notice of website
Standards.
SUMMARY:
Dated: January 16, 2020.
Anil Cheriyan,
Deputy Commissioner, Federal Acquisition
Service and Director, Technology
Transformation Services.
[FR Doc. 2020–01068 Filed 1–22–20; 8:45 am]
BILLING CODE 4733–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19AYV]
Proposed Project
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:13 Jan 22, 2020
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 July 5th,
2019 to obtain comments from the
public and affected agencies. CDC
received one comment from the public.
This notice serves to allow an additional
30 days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. 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.
Jkt 250001
Public Health Laboratory Testing for
Emerging Antibiotic Resistance and
Fungal Threats—Existing Collection in
Use without an OMB Control Number—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
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Background and Brief Description
This state and local laboratory testing
capacity study 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 (i.e. all fifty states, four
large cities, and Puerto Rico). These
public health laboratories will be
equipped to detect and characterize
isolates of carbapenem-resistant
Enterobacteriaceae (CRE), carbapenemresistant 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 matrixassisted laser desorption ionization/
E:\FR\FM\23JAN1.SGM
23JAN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
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.
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 (1) provide data for state and
local infection prevention programs, (2)
identify new types of antibiotic resistant
organisms, (3) identify new resistance
mechanisms in targeted organisms, (4)
describe the spread of targeted
resistance mechanisms, and (5) identify
geographical distribution of antibiotic
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
VerDate Sep<11>2014
17:13 Jan 22, 2020
Jkt 250001
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’’)
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 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
PO 00000
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Fmt 4703
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3913
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
elements of these messages will include
the unique public health laboratory
specimen ID and a summary of
specimen testing results to date.
The estimated annualized burden
hours were determined as follows.
There are 55 public health laboratories
within this framework. A ‘‘respondent’’
refers to a single participating testing
public health laboratory. A ‘‘response’’
is defined as the data collection/
processing associated with an
individual specimen from an individual
patient.
The average burden per response for
the Annual Summary of testing methods
was evaluated to be approximately six
minutes.
The average burden per response for
the Annual Evaluation and Performance
Measurement Report was evaluated to
be 4 hours per report.
Based on previous laboratory
experience in analyzing carbapenemresistant isolates and specimens, the
estimated time for each participating
public health laboratory for Monthly
Testing Results Report is four hours per
response. Because of the need to add
more data collection points as new
drugs are developed, new susceptibility
testing methods are made available, new
resistance mechanisms emerge, and new
pathogens are prioritized as threats, the
Monthly Data Report includes some
placeholder elements in expectation of
evolving needs. For Candida
identification, elements to include are
fairly minimal (specimen ID, submitting
laboratory ID, etc.) and the estimated
time for each participating laboratory for
E:\FR\FM\23JAN1.SGM
23JAN1
3914
Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
the Candida Monthly Data Report is two
hours.
The use of ARLN Alerts encompass
targeted AR threats that include new
and rare plasmid-mediated (‘‘jumping’’)
carbapenemase genes, isolates that are
non-susceptible to all drugs tested, and
detection of novel resistance
mechanisms. These alerts must be sent
within one working day of detection.
The elements of these messages include
the unique public health laboratory
specimen ID and a summary of
specimen testing results generated to
date. With the conversion to HL7
messaging of these data will be
transmitted in real-time, thus
eliminating the need to send alerts.
Until that time, REDCap will be utilized
to communicate alerts. CDC estimates
that public health laboratories send an
average of 34 ARLN Alerts per lab each
year, with an estimated burden per
response of 0.1 hours. The estimated
burden of response for Candida
identification is also 0.1 hours, though
far fewer alerts are reported yearly
(estimated to be approximately 700 total
per year including all 55 jurisdictions,
averaging to 13 per each jurisdiction).
The total estimated annualized
burden across all AR Lab Network labs
and activities for DHQP is 4555 hours.
Public Health laboratories receive
federal funds through CDC’s
Epidemiology and Laboratory Capacity
for Infectious Diseases (ELC) mechanism
to participate in this project.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Public
Public
Public
Public
Public
Health
Health
Health
Health
Health
Laboratories
Laboratories
Laboratories
Laboratories
Laboratories
.....
.....
.....
.....
.....
Public Health Laboratories .....
Public Health Laboratories .....
Annual Report of Testing Methods ........................................
Annual Evaluation and Performance Measurement Report ..
Monthly Testing Results Reports ...........................................
ARLN Alerts ............................................................................
Annual Evaluation and Performance .....................................
Measurement Report (Candida identification) .......................
Monthly Testing Results Reports—Candida identification .....
AR Lab Network Alerts—Candida auris .................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–01046 Filed 1–22–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19BQB]
jbell on DSKJLSW7X2PROD with NOTICES
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
Accreditation Board (PHAB):
Assessment of Processes and Outcomes
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 September 25, 2019 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.
CDC will accept all comments for this
proposed information collection project.
VerDate Sep<11>2014
Number of
respondents
Form name
17:13 Jan 22, 2020
Jkt 250001
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 or
send an email to omb@cdc.gov. 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)
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
55
55
55
55
55
1
1
12
34
1
6/60
4
4
6/60
2
55
55
12
13
2
6/60
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Public Health Accreditation Board
(PHAB): Assessment of Processes and
Outcomes—New—Center for State,
Tribal, Local and Territorial Support
(CSTLTS), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) works to protect
America from health, safety and security
threats, both foreign and in the U.S.
CDC strives to fulfill this mission, in
part, by supporting state, tribal, local,
and territorial (STLT) health
departments. One mechanism for
supporting STLT health departments is
through CDC’s support of a national,
voluntary accreditation program.
CDC supports the Public Health
Accreditation Board (PHAB), a nonprofit organization that serves as the
independent accrediting body. PHAB,
with considerable input from national,
state, tribal, and local public health
professionals, developed a consensus
set of standards to assess the capacity of
state, tribal, local, and territorial health
departments. The first health
departments were accredited by PHAB
in early 2013; as of August 2019, a total
of 268 health departments (36 state,
three Tribal and 229 local) as well as
one statewide integrated local public
health department system have been
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3912-3914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01046]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-19AYV]
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 July 5th, 2019 to obtain comments from the
public and affected agencies. CDC received one comment from the public.
This notice serves to allow an additional 30 days for public and
affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. 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--Existing Collection in Use without an OMB Control
Number--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 study 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 (i.e. all fifty
states, four 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/
[[Page 3913]]
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.
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 (1) provide
data for state and local infection prevention programs, (2) identify
new types of antibiotic resistant organisms, (3) identify new
resistance mechanisms in targeted organisms, (4) describe the spread of
targeted resistance mechanisms, and (5) identify geographical
distribution of antibiotic 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 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 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. 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.
The estimated annualized burden hours were determined as follows.
There are 55 public health laboratories within this framework. A
``respondent'' refers to a single participating testing public health
laboratory. A ``response'' is defined as the data collection/processing
associated with an individual specimen from an individual patient.
The average burden per response for the Annual Summary of testing
methods was evaluated to be approximately six minutes.
The average burden per response for the Annual Evaluation and
Performance Measurement Report was evaluated to be 4 hours per report.
Based on previous laboratory experience in analyzing carbapenem-
resistant isolates and specimens, the estimated time for each
participating public health laboratory for Monthly Testing Results
Report is four hours per response. Because of the need to add more data
collection points as new drugs are developed, new susceptibility
testing methods are made available, new resistance mechanisms emerge,
and new pathogens are prioritized as threats, the Monthly Data Report
includes some placeholder elements in expectation of evolving needs.
For Candida identification, elements to include are fairly minimal
(specimen ID, submitting laboratory ID, etc.) and the estimated time
for each participating laboratory for
[[Page 3914]]
the Candida Monthly Data Report is two hours.
The use of ARLN Alerts encompass targeted AR threats that include
new and rare plasmid-mediated (``jumping'') carbapenemase genes,
isolates that are non-susceptible to all drugs tested, and detection of
novel resistance mechanisms. These alerts must be sent within one
working day of detection. The elements of these messages include the
unique public health laboratory specimen ID and a summary of specimen
testing results generated to date. With the conversion to HL7 messaging
of these data will be transmitted in real-time, thus eliminating the
need to send alerts. Until that time, REDCap will be utilized to
communicate alerts. CDC estimates that public health laboratories send
an average of 34 ARLN Alerts per lab each year, with an estimated
burden per response of 0.1 hours. The estimated burden of response for
Candida identification is also 0.1 hours, though far fewer alerts are
reported yearly (estimated to be approximately 700 total per year
including all 55 jurisdictions, averaging to 13 per each jurisdiction).
The total estimated annualized burden across all AR Lab Network
labs and activities for DHQP is 4555 hours. Public Health laboratories
receive federal funds through CDC's Epidemiology and Laboratory
Capacity for Infectious Diseases (ELC) mechanism to participate in this
project.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories......... Annual Report of Testing 55 1 6/60
Methods.
Public Health Laboratories......... Annual Evaluation and 55 1 4
Performance Measurement
Report.
Public Health Laboratories......... Monthly Testing Results 55 12 4
Reports.
Public Health Laboratories......... ARLN Alerts................ 55 34 6/60
Public Health Laboratories......... Annual Evaluation and 55 1 2
Performance.
Measurement Report (Candida
identification).
Public Health Laboratories......... Monthly Testing Results 55 12 2
Reports--Candida
identification.
Public Health Laboratories......... AR Lab Network Alerts-- 55 13 6/60
Candida auris.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-01046 Filed 1-22-20; 8:45 am]
BILLING CODE 4163-18-P
