[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51345-51348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-1310; Docket No. CDC-2024-0051]


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.

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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 proposed and/or 
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 Antimicrobial Resistance and Fungal Threats. This data 
collection is designed to allow CDC to test and characterize, 
antimicrobial resistant bacteria and fungal isolates.

DATES: CDC must receive written comments on or before August 16, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0051 by either 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 Antimicrobial 
Resistance and Fungal Threats (OMB Control No. 0920-1310, Exp. 5/31/
2026)--Revision--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    State and Local laboratory testing capacity is 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 the National Action Plan of October 2020 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 Antimicrobial 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 as 
described. Carbapenemase-producing organisms: equipped to detect and 
characterize carbapenem-resistant Enterobacterales (CRE), carbapenem-
resistant Pseudomonas aeruginosa (CRPA), and carbapenem-resistant 
Acinetobacter baumannii (CRAB) isolates and detect carbapenemase-
producing organisms (CPOs) from screening swabs. Characterization of 
these resistant bacteria, which are typically identified in clinical 
laboratories, is often limited despite the fact they are becoming more 
prevalent, particularly in healthcare settings. The proposed laboratory 
testing will allow for additional testing and characterization, 
including use of validated high-quality 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 (e.g., whole genome sequencing 
[WGS]) to identify the resistance mechanism(s). Screening swabs will 
undergo molecular testing to identify carbapenemase genes 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, participating jurisdictional public health 
laboratories will also participate in reference

[[Page 51346]]

identification of Candida spp. A subset of these laboratories will also 
conduct testing on Candida isolates and screening swabs, and 
Aspergillus fumigatus. The capacity to test for fungal pathogens at 
local clinical and public health laboratories is limited, and therefore 
the proposed laboratory testing will truly build infrastructure and 
ensure that validated high-quality methodologies are used. Fungal 
isolate characterization includes identification, antifungal testing to 
determine susceptibility to new drugs of therapeutic and 
epidemiological importance. Screening swabs will undergo the same 
series of validated tests, after Candida spp. are grown from the swab. 
Results from this laboratory testing will be used locally to: (1) 
support infection control, efforts; (2) monitor resistance; (3) 
characterize geographical distribution of resistance; and (5) provide 
data that informs state and local public health surveillance and 
prevention activities and priorities.
    A subset of jurisdictions will perform routine antimicrobial 
susceptibility testing for N. gonorrhoeae. Also, a subset of local and 
state public health laboratories in the AR Lab Network will be using 
validated agar dilution and/or gradient strip diffusion assays to 
assess the levels of susceptibility in gonococcal isolates to 10 
different antimicrobial agents. Several identified resistance isolates 
will undergo high-quality whole genome sequencing. AST and WGS data are 
critical for public health actions and for gonorrhea control efforts 
including gonococcal antimicrobial resistance surveillance, and to 
curtail the spread of antimicrobial-resistant N. gonorrhoeae.
    In addition to the testing that is done throughout the AR Lab 
Network, performance measures are collected from each laboratory, to 
ensure that participating laboratories are making progress. The purpose 
of collecting performance measures is to facilitate informed decision-
making for the AR Lab Network, to improve the technical assistance 
provided to the participating AR Lab Network partners, and to measure 
progress across the AR Lab Network.
    CDC's AR Lab Network supports nationwide lab capacity to rapidly 
detect antimicrobial resistance and inform local public health 
responses to prevent spread and protect people. It closes the gap 
between local laboratory capabilities and the data needed to combat 
antimicrobial resistance by providing comprehensive lab capacity and 
infrastructure for detecting antimicrobial-resistant pathogens (germs), 
advanced 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 antimicrobial-resistant threats in healthcare, 
food, 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 Division of Healthcare Quality Promotion 
(DHQP) Program Office at CDC about carbapenemase-producing organisms:
    1. Annually, participating laboratories will submit a summary 
report describing testing methods and volume. These reports will be 
submitted through REDCap. And are to be used by 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 Performance 
Measures data through the Epidemiology and Laboratory Capacity 
performance measures portal. 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 antimicrobial resistant organisms; (3) identify new 
resistance mechanisms in targeted organisms; (4) describe the spread of 
targeted resistance mechanisms; and (5) identify geographical 
distribution of antimicrobial 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 Division of Foodborne, Waterborne, and 
Environmental Diseases (DFWED) Mycotics Program Office at CDC:
    1. Annually, participating laboratories will provide Performance 
Measures data through the Epidemiology and Laboratory Capacity 
performance measures portal. 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.
    Sites participating in detection and characterization of AR 
Neisseria gonorrhoeae, including antimicrobial

[[Page 51347]]

susceptibility testing of Neisseria gonorrhoeae will provide the 
following to the Division of STD Prevention (DSTDP), STD Laboratory 
Reference and Research Branch (SLRRB) at CDC:
    1. Annually, participating laboratories will provide Performance 
Measures data through the Epidemiology and Laboratory Capacity 
performance measures portal. 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'' 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 antimicrobial resistant pathogens and 
emerging patterns of resistance; and (2) aid public health departments 
and healthcare facilities in timely responding to antimicrobial 
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 a Revision to the data collection that with an 
increase in burden due to the building and maintaining of HL7 and CSV 
data feeds. Additionally, there has been a significant increase of AR 
threats identified through the AR Lab Network, and the addition of 
laboratories testing and taking on screening testing are reflected in 
this submission. OMB approval is requested for an estimated 57,993 
annual burden hours of data collection. There are no costs to 
respondents other than their time to participate.

                                                            Estimated Annualized Burden Hours
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                                                                                                          Average number  Average burden
              Type of respondents                               Form name                    Number of     of responses    per response    Total burden
                                                                                            respondents   per respondent    (in hours)      (in hours)
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Public Health Laboratories.....................  I.1--ROUTINE TESTING BY GENERA IN                    56               1            6/60               6
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.2--EXPANDED DRUG SUSCEPTIBILITY                    56               1            6/60               6
                                                  TESTING (ExAST) IN JURISDICTION--
                                                  Annual Evaluation and Performance
                                                  Measurement Report.
Public Health Laboratories.....................  I.3--CANDIDA SPECIES IDENTIFICATION IN               56               1            6/60               6
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.4--HAIAR WHOLE GENOME SEQUENCING                   56               1            6/60               6
                                                  (WGS) OF GRAM-NEGATIVE AR THREATS IN
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.5--C. AURIS COLONIZATION SCREENING IN              56               1            6/60               6
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.6--CARBAPENEMASE-PRODUCING ORGANISM                56               1            6/60               6
                                                  (CPO) SCREENING IN JURISDICTION--
                                                  Annual Evaluation and Performance
                                                  Measurement Report.
Public Health Laboratories.....................  I.7--AZOLE RESISTANCE IN CLINICAL                    56               1            6/60               6
                                                  ASPERGILLUS FUMIGATUS ISOLATES--Annual
                                                  Evaluation and Performance Measurement
                                                  Report.
Public Health Laboratories.....................  I.8--N. GONORRHOEAE WHOLE GENOME                     56               1            6/60               6
                                                  SEQUENCING (WGS)--Annual Evaluation
                                                  and Performance Measurement Report.
Public Health Laboratories.....................  I.9--GONOCOCCAL (GC) ANTIMICROBIAL                   56               1            6/60               6
                                                  SUSCEPTIBILITY TESTING (AST) IN
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.10--WHOLE GENOME SEQUENCING (WGS) OF               56               1            6/60               6
                                                  S. PNEUMONAIE--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.11--CLOSTRIDIOIDES DIFFICILE (C.                   56               1            6/60               6
                                                  DIFFICILE) TESTING IN JURISDICTION--
                                                  Annual Evaluation and Performance
                                                  Measurement Report.
Public Health Laboratories.....................  I.12--ANTIFUNGAL RESISTANT TINEA                     56               1            6/60               6
                                                  DERMATOPHYTES--Annual Evaluation and
                                                  Performance Measurement Report.

[[Page 51348]]

 
Public Health Laboratories.....................  I.13--ANTIMICROBIAL SUSCEPTIBILITY                   56               1            6/60               6
                                                  TESTING (AST) OF INVASIVE HAEMOPHILUS
                                                  INFLUENZAE (H. INFLUENZAE) IN
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.14--MYCOPLASMA GENTALIUM (MG)--Annual              56               1            6/60               6
                                                  Evaluation and Performance Measurement
                                                  Report.
Public Health Laboratories.....................  I.15--MOLECULAR Mtb TESTING--Annual                  56               1            6/60               6
                                                  Evaluation and Performance Measurement
                                                  Report.
Public Health Laboratories.....................  I.16--C. AURIS WHOLE GENOME SEQUENCING               56               1            6/60               6
                                                  (WGS) IN JURISDICTION--Annual
                                                  Evaluation and Performance Measurement
                                                  Report.
Public Health Laboratories.....................  I.17--MONITORIING CRE CRPA IN COMPANION              56               1            6/60               6
                                                  ANIMALS TO FROM HUMANS--Annual
                                                  Evaluation and Performance Measurement
                                                  Report.
Public Health Laboratories.....................  I.18--HEALTHCARE WASTEWATER-BASED                    56               1            6/60               6
                                                  SURVEILLANCE--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.19--COMMUNICATION AND COORDINATION OF              56               1            6/60               6
                                                  ACTIONABLE EPI LAB DATA IN
                                                  JURISDICTION--Annual Evaluation and
                                                  Performance Measurement Report.
Public Health Laboratories.....................  I.20--CHARACTERIZATION OF THE CLINICAL               56               1            6/60               6
                                                  LABORATORY NETWORK IN JURISDICTION--
                                                  Annual Evaluation and Performance
                                                  Measurement Report.
Public Health Laboratories.....................  Annual Report of Bacterial Specimen                  56               1               2             112
                                                  Testing Methods for Carbapenemase-
                                                  producing Organisms.
Public Health Laboratories.....................  Monthly Data Report Form for                         56           1,302           20/60          24,304
                                                  Carbapenemase-producing Organisms.
Public Health Laboratories.....................  Carbapenemase-producing Organisms Alert              56             214            3/60             599
                                                  Form.
Public Health Laboratories.....................  Alert and Monthly Data Report Form for         Up to 56           1,671           20/60          31,192
                                                  Candida.
Public Health Laboratories.....................  AR Lab Network Form for Phylogenetic           Up to 56              30            6/60             168
                                                  Tree-level Mycotics Reporting.
Public Health Laboratories.....................  AR Lab Network Form for Isolate/               Up to 56              30            6/60             168
                                                  Specimen-level Mycotics Testing.
Public Health Laboratories.....................  AR Lab Network Alert and Monthly Data          Up to 56             202            6/60           1,131
                                                  Report Form for Neisseria gonorrhoeae.
Public Health Laboratories.....................  HL7 Messages updates--IT Maintenance...              32               4           20/60              43
Public Health Laboratories.....................  Implementation of new HL7 messages--IT               11               4               3             132
                                                  Initial Set up.
Public Health Laboratories.....................  CSV files updates for Carbapenemase-                 24               1               1              24
                                                  producing organisms--IT Maintenance.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          57,993
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-13227 Filed 6-14-24; 8:45 am]
BILLING CODE 4163-18-P