[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]


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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 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