[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3912-3914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-20-19AYV]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Public Health Laboratory Testing for Emerging
Antibiotic Resistance and Fungal Threats to the Office of Management
and Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on July 5th, 2019 to obtain comments from the
public and affected agencies. CDC received one comment from the public.
This notice serves to allow an additional 30 days for public and
affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Public Health Laboratory Testing for Emerging Antibiotic Resistance
and Fungal Threats--Existing Collection in Use without an OMB Control
Number--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 study 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, the National Strategy of
September 2014 and to implement sub-objective 2.1.1 of the National
Action Plan of March 2015 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 Antibiotic Resistance Laboratory Network (AR Lab Network) is
made up of jurisdictional public health laboratories (i.e. all fifty
states, four 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
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/
[[Page 3913]]
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 (germs), 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.
Funded state and local public health laboratories will provide the
following information to the Program Office at CDC--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 Program Office (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 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 (1) provide
data for state and local infection prevention programs, (2) identify
new types of antibiotic resistant organisms, (3) identify new
resistance mechanisms in targeted organisms, (4) describe the spread of
targeted resistance mechanisms, and (5) identify geographical
distribution of antibiotic 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 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 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.
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 elements of these messages will include the unique
public health laboratory specimen ID and a summary of specimen testing
results to date.
The estimated annualized burden hours were determined as follows.
There are 55 public health laboratories within this framework. A
``respondent'' refers to a single participating testing public health
laboratory. A ``response'' is defined as the data collection/processing
associated with an individual specimen from an individual patient.
The average burden per response for the Annual Summary of testing
methods was evaluated to be approximately six minutes.
The average burden per response for the Annual Evaluation and
Performance Measurement Report was evaluated to be 4 hours per report.
Based on previous laboratory experience in analyzing carbapenem-
resistant isolates and specimens, the estimated time for each
participating public health laboratory for Monthly Testing Results
Report is four hours per response. Because of the need to add more data
collection points as new drugs are developed, new susceptibility
testing methods are made available, new resistance mechanisms emerge,
and new pathogens are prioritized as threats, the Monthly Data Report
includes some placeholder elements in expectation of evolving needs.
For Candida identification, elements to include are fairly minimal
(specimen ID, submitting laboratory ID, etc.) and the estimated time
for each participating laboratory for
[[Page 3914]]
the Candida Monthly Data Report is two hours.
The use of ARLN Alerts encompass targeted AR threats that include
new and rare plasmid-mediated (``jumping'') carbapenemase genes,
isolates that are non-susceptible to all drugs tested, and detection of
novel resistance mechanisms. These alerts must be sent within one
working day of detection. The elements of these messages include the
unique public health laboratory specimen ID and a summary of specimen
testing results generated to date. With the conversion to HL7 messaging
of these data will be transmitted in real-time, thus eliminating the
need to send alerts. Until that time, REDCap will be utilized to
communicate alerts. CDC estimates that public health laboratories send
an average of 34 ARLN Alerts per lab each year, with an estimated
burden per response of 0.1 hours. The estimated burden of response for
Candida identification is also 0.1 hours, though far fewer alerts are
reported yearly (estimated to be approximately 700 total per year
including all 55 jurisdictions, averaging to 13 per each jurisdiction).
The total estimated annualized burden across all AR Lab Network
labs and activities for DHQP is 4555 hours. Public Health laboratories
receive federal funds through CDC's Epidemiology and Laboratory
Capacity for Infectious Diseases (ELC) mechanism to participate in this
project.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories......... Annual Report of Testing 55 1 6/60
Methods.
Public Health Laboratories......... Annual Evaluation and 55 1 4
Performance Measurement
Report.
Public Health Laboratories......... Monthly Testing Results 55 12 4
Reports.
Public Health Laboratories......... ARLN Alerts................ 55 34 6/60
Public Health Laboratories......... Annual Evaluation and 55 1 2
Performance.
Measurement Report (Candida
identification).
Public Health Laboratories......... Monthly Testing Results 55 12 2
Reports--Candida
identification.
Public Health Laboratories......... AR Lab Network Alerts-- 55 13 6/60
Candida auris.
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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. 2020-01046 Filed 1-22-20; 8:45 am]
BILLING CODE 4163-18-P