BILLING CODE: 4163-18-P
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.
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 [INSERT DATE 60 DAYS AFTER
PUBLICATION DATE IN THE FEDERAL REGISTER].
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; E-mail:
omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management
and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the
PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each new proposed collection, each proposed
extension of existing collection of information, and each reinstatement of previously approved
information collection before submitting the collection to the OMB for approval. To comply with
this requirement, we are publishing this notice of a proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the information will have
practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions used;
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 carbapenemaseproducing 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 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 decisionmaking 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 antimicrobialresistant 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 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

Type of
Respondents

Public Health
Laboratories

Public Health
Laboratories

Form Name

Average
Average
Burden
Number of
Number of
Per
Responses
Respondents
Response
per
(in
Respondent
hours)

Total
Burden
(in
hours)

I.1 – ROUTINE
TESTING BY
GENERA IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.2- EXPANDED
DRUG
SUSCEPTIBILITY
TESTING (ExAST)
IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

I.3- CANDIDA
SPECIES
IDENTIFICATION
IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.4- HAIAR
WHOLE GENOME
SEQUENCING
(WGS) OF GRAMNEGATIVE AR
THREATS IN
56
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

6/60

I.5- C. AURIS
COLONIZATION
SCREENING IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.6CARBAPENEMAS
E-PRODUCING
ORGANISM (CPO)
SCREENING IN
56
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

6/60

I.7- AZOLE
RESISTANCE IN
CLINICAL
ASPERGILLUS

6/60

56

FUMIGATUS
ISOLATESAnnual Evaluation
and Performance
Measurement
Report
Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

I.8- N.
GONORRHOEAE
WHOLE GENOME
SEQUENCING
(WGS)- Annual
56
Evaluation and
Performance
Measurement
Report

6/60

I.9GONOCOCCAL
(GC)
ANTIMICROBIAL
SUSCEPTIBILITY
TESTING (AST)
IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.10- WHOLE
GENOME
SEQUENCING
(WGS) OF S.
PNEUMONAIE Annual Evaluation
and Performance
Measurement
Report

1

6/60

I.11CLOSTRIDIOIDES
DIFFICILE (C.
56
DIFFICLE)
TESTING IN
JURISDICTION-

6/60

Annual Evaluation
and Performance
Measurement
Report
Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

I.12ANTIFUNGAL
RESISTANT
TINEA
DERMATOPHYTE
56
S -Annual
Evaluation and
Performance
Measurement
Report

6/60

I.13ANTIMICROBIAL
SUSCEPTIBILITY
TESTING (AST)
OF INVASIVE
HAEMOPHILUS
INFLUENZAE (H.
INFLUENZAE) IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.14MYCOPLASMA
GENTALIUM
(MG)- Annual
Evaluation and
Performance
Measurement
Report

1

6/60

I.15MOLECULAR Mtb
TESTING- Annual
Evaluation and
56
Performance
Measurement
Report

6/60

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

I.16- C. AURIS
WHOLE GENOME
SEQUENCING
(WGS) IN
JURISDICTION56
Annual Evaluation
and Performance
Measurement
Report

6/60

I.17MONITORIING
CRE CRPA IN
COMPANION
ANIMALS TO
FROM HUMANSAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.18HEALTHCARE
WASTEWATERBASED
SURVEILLANCE - 56
Annual Evaluation
and Performance
Measurement
Report

6/60

I.19COMMUNICATIO
N AND
COORDINATION
OFACTIONABLE
EPI LAB DATA IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report

1

6/60

I.20CHARACTERIZA
TION OF THE

1

6/60

CLINICAL
LABORATORY
NETWORK IN
JURISDICTIONAnnual Evaluation
and Performance
Measurement
Report
Public Health
Laboratories

Annual Report of
Bacterial Specimen
Testing Methods for
56
Carbapenemaseproducing
Organisms

2

Monthly Data
Report Form for
Carbapenemaseproducing
Organisms

1302

20/60

24,304

Public Health
Laboratories

Carbapenemaseproducing
Organisms Alert
Form

214

3/60

Public Health
Laboratories

Alert and Monthly
Data Report Form
for Candida

Up to 56

20/60

31,192

Public Health
Laboratories

AR Lab Network
Form for
Phylogenetic Treelevel Mycotics
Reporting

Up to 56

6/60

AR Lab Network
Form for
Isolate/Specimenlevel Mycotics
Testing

Up to 56

6/60

AR Lab Network
Alert and Monthly
Data Report Form

Up to 56

6/60

Public Health
Laboratories

Public Health
Laboratories

Public Health
Laboratories

for Neisseria
gonorrhoeae
Public Health
Laboratories

HL7 Messages
updates-IT
Maintenance

4

20/60

Public Health
Laboratories

Implementation of
new HL7
messages—IT
Initial Set up

4

132

Public Health
Laboratories

CSV files updates
for Carbapenemaseproducing
organisms-IT
Maintenance

1

24

Total

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: 6/14/2024 8:45 am; Publication Date: 6/17/2024]

57,993