[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61329-61331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22027]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-1310; Docket No. CDC-2022-0119]


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 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 Antibiotic 
Resistance and Fungal Threats. This collection will allow CDC to 
partner with public health laboratories and will help equip them to 
detect and characterize isolates.

DATES: CDC must receive written comments on or before December 12, 
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0119 by any 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 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 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 (Attachment 1a), the 
National Strategy of September 2014 (Attachment 1b) and to implement 
sub-objective 2.1.1 of the National Action Plan of March 2015 for 
Combating Antibiotic Resistant Bacteria (Attachment 1c). 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 (i.e., 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

[[Page 61330]]

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, 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. 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's 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 DHQP Program Office 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 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.
    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. 
Participating laboratories will utilize secure public health messaging 
protocols to transfer 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 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 testing results to 
CDC, requested at least monthly, by REDCap or HL7 using an online web-
portal transmission. This information will be used to: (a) identify and 
track antifungal resistance and emerging fungal pathogens; and (b) 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. 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. 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

[[Page 61331]]

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 HL7 using an 
online web-portal transmission. This information will be used to: (a) 
identify and track antibiotic resistant pathogens and emerging patterns 
of resistance; and (b) 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 4,705 annualized burden 
hours. There is no cost to respondents other than their time to 
participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories....  Annual Report of              56               1            6/60               6
                                 Bacterial
                                 Specimen
                                 Testing Methods.
Public Health Laboratories....  Annual                        56               1               4             224
                                 Evaluation and
                                 Performance
                                 Measurement
                                 Report for
                                 Bacterial
                                 Specimen
                                 Testing.
Public Health Laboratories....  Monthly Testing               56              12               4            2688
                                 Results
                                 Reports--Bacter
                                 ial Specimen
                                 Testing.
Public Health Laboratories....  AR Lab Network                56              34            6/60             190
                                 Alerts--Bacteri
                                 al Specimen
                                 Testing.
Public Health Laboratories....  Annual                  Up to 56               1               2             112
                                 Evaluation and
                                 Performance
                                 Measurement
                                 Report (Candida
                                 identification).
Public Health Laboratories....  Monthly Testing         Up to 56              12               2            1344
                                 Results
                                 Reports--Candid
                                 a
                                 identification.
Public Health Laboratories....  AR Lab Network          Up to 56              13            6/60              73
                                 Alerts--Candida
                                 auris.
Public Health Laboratories....  Annual                  Up to 56               1               1              56
                                 Evaluation and
                                 Performance
                                 Measurement
                                 Report
                                 (Neisseria
                                 gonorrhoeae).
Public Health Laboratories....  Monthly Testing         Up to 56               1            6/60               6
                                 Results
                                 Reports--Neisse
                                 ria gonorrhoeae.
Public Health Laboratories....  AR Lab Network          Up to 56               1            6/60               6
                                 Alerts--Neisser
                                 ia gonorrhoeae.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............            4705
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-22027 Filed 10-7-22; 8:45 am]
BILLING CODE 4163-18-P