[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
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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