Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

June 17, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

Abstract

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.

Full Text

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<title>Federal Register, Volume 89 Issue 117 (Monday, June 17, 2024)</title>
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[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51345-51348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#ea858788aa898e89c48d859c"><span class="__cf_email__" data-cfemail="e986848ba98a8d8ac78e869f">[email&#160;protected]</span></a>.

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.
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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

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