[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Pages 32182-32184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-19-19AYV; Docket No. CDC-2019-0048]


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 State and Local Public Health 
Laboratory Antibiotic Resistance Testing. This collection will assist 
public health laboratories to improve detection and characterization of 
two urgent antibiotic resistant threats in healthcare-associated 
infections, carbapenem-resistant Enterobacteriaceae (CRE) and 
carbapenem-resistant Pseudomonas aeruginosa (CRPA).

DATES: CDC must receive written comments on or before September 3, 
2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0048 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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, of the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 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; and
    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.
    5. Assess information collection costs.

Proposed Project

    State and Local Public Health Laboratory Antibiotic Resistance 
Testing--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 collection is 
being implemented by the Department of Health and Human Services (HHS), 
Centers for Disease Control and Prevention (CDC) in response to 
Executive Order 13676, with 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

[[Page 32183]]

301 of the Public Health Service Act (42 U.S.C. 241).
    The Antibiotic Resistance Laboratory Network (AR Lab Network) is 
made up of 56 jurisdictional public health laboratories (i.e., all 50 
states, five large cities, and Puerto Rico). These 56 laboratories will 
be equipped to detect and characterize carbapenem-resistant 
Enterobacteriaceae (CRE) and Pseudomonas aeruginosa (CRPA). These 
resistant bacteria are becoming more and more prevalent, particularly 
in healthcare settings, and are typically identified in clinical 
laboratories. However, characterization is often limited. The 
laboratory testing will allow for additional testing and 
characterization, including use of gold-standard methods. 
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). Results from this laboratory testing will be used to (1) 
identify targets for infection control, (2) detect new types of 
resistance, (2) characterize geographical distribution of resistance, 
(3) determine whether resistance mechanisms are spreading among 
organisms, people, and facilities, and (4) provide data that informs 
state and local public health surveillance and prevention activities 
and priorities.
    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. A summary report describing testing methods and volume. These 
reports will be submitted by email to [email protected].
    2. Evaluation and Performance Measurement Reports to CDC via email 
to [email protected].
    3. A report for all testing results to CDC using an online web-
portal transmission. For messaging to CDC, these messaging protocols 
will be provided by the Association of Public Health Laboratories 
(APHL) Informatics Messaging Services (AIMS) platform.
    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, and an immediate communication to the local healthcare-
associated infection program in the jurisdictional public health 
department and CDC.
    The estimated annualized burden hours were determined as follows. 
There are 56 laboratories within this framework. A ``respondent'' 
refers to a single participating testing laboratory. A ``response'' is 
defined as the data collection/processing and laboratory processing 
associated with an individual isolate 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 four hours per report.
    Based on previous laboratory experience in analyzing CRE/CRPA 
isolates, 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.
    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 total estimated annualized burden across all AR Lab Network 
labs and activities for DHQP is 3108 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
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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....  Annual Report of              56               1            6/60               6
                                 Testing Methods.
Public Health Laboratories....  Annual                        56               1               4             224
                                 Evaluation and
                                 Performance
                                 Measurement
                                 Report.
Public Health Laboratories....  Monthly Testing               56              12               4           2,688
                                 Results Reports.
Public Health Laboratories....  ARLN Alerts.....              56              34            6/60             190
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,108
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[[Page 32184]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-14299 Filed 7-3-19; 8:45 am]
 BILLING CODE 4163-18-P