[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.
----------------------------------------------------------------------------------------------------------------


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