Notice2023-03960
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
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Published
February 27, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 38 (Monday, February 27, 2023)</title>
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[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12358-12361]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03960]
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="/cdn-cgi/l/email-protection#2e6f7c6260716a667f7e6e4d4a4d00494158"><span class="__cf_email__" data-cfemail="5110031d1f0e15190001113235327f363e27">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#c9818880889b89aaadaae7aea6bf"><span class="__cf_email__" data-cfemail="de969f979f8c9ebdbabdf0b9b1a8">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#6021322c2e200304034e070f16"><span class="__cf_email__" data-cfemail="4e0f1c02000e2d2a2d60292138">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#09485b45475668656c7b7d496a6d6a276e667f"><span class="__cf_email__" data-cfemail="b5f4e7f9fbead4d9d0c7c1f5d6d1d69bd2dac3">[email protected]</span></a> 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
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