Notice2022-22027
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
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Published
October 11, 2022
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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 195 (Tuesday, October 11, 2022)</title>
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[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61329-61331]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22027]
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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.
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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 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:
<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#c1aeaca381a2a5a2efa6aeb7"><span class="__cf_email__" data-cfemail="b9d6d4dbf9daddda97ded6cf">[email 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 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 <a href="/cdn-cgi/l/email-protection#1657445a5849525e47465675727538717960"><span class="__cf_email__" data-cfemail="4706150b0918030f16170724232469202831">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#09414840485b496a6d6a276e667f"><span class="__cf_email__" data-cfemail="3d757c747c6f7d5e595e135a524b">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#a6e7f4eae8e6c5c2c588c1c9d0"><span class="__cf_email__" data-cfemail="d796859b9997b4b3b4f9b0b8a1">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#eaabb8a6a4b58b868f989eaa898e89c48d859c"><span class="__cf_email__" data-cfemail="2b6a796765744a474e595f6b484f48054c445d">[email protected]</span></a> 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
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Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
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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.
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Total..................... ................ .............. .............. .............. 4705
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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
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