Notice2024-22958
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 4, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 89 Issue 193 (Friday, October 4, 2024)</title>
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[Federal Register Volume 89, Number 193 (Friday, October 4, 2024)]
[Notices]
[Pages 80900-80903]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-1310]
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 June 17, 2024 to obtain comments from the
public and affected agencies. CDC did not receive comments related to
the previous notice. 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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding
[[Page 80901]]
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 (0920-1310, Exp. 5/31/2026)--Revision--National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Antimicrobial resistance has the potential to impact all Americans
at every stage of life and the Centers for Disease Control and
Prevention (CDC) is working to drive aggressive action and empower the
nation to comprehensively respond to these threats. The National Action
Plan Sub-Objective 2.1.1 describes creation of ``a regional public
health laboratory network that uses standardized testing platforms to
expand the availability of reference testing services'', and
facilitation of ``rapid data analysis and dissemination of
information.'' The CDC has created this public health laboratory
network and named it the Antimicrobial Resistance Laboratory Network
(AR Lab Network). The mission of the AR Lab Network is to offer
validated high-quality laboratory testing through funding support of
state and regional labs so these labs can build the capacity and the
capability to locally improve detection and laboratory diagnostics.
Building strength nationally through public health laboratories thereby
increases the capacity of state and local health departments for rapid
detection and faster response to outbreaks and emerging antimicrobial
resistance among bacterial and fungal pathogens (<a href="https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf">https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf</a>).
This state and local public health 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, the National Strategy of
September 2014 and to implement the National Action Plan of October
2020 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 CDC's AR Lab Network supports nationwide lab capacity to
rapidly detect antimicrobial resistance and inform local public health
responses to prevent spread and protect people. It closes the gap
between local laboratory capabilities and the data needed to combat
antimicrobial resistance by providing comprehensive lab capacity and
infrastructure for detecting antimicrobial-resistant pathogens (germs),
advanced 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 antimicrobial-resistant threats in healthcare,
food, and the community, mount a comprehensive local response, and
better understand these deadly threats to quickly contain them.
The AR Lab Network is a network of jurisdictional public health
laboratories currently including those of all 50 states, District of
Columbia, Los Angeles County, Houston, New York City, Philadelphia,
Guam, and Puerto Rico. Laboratories are financially supported through
the Epidemiology and Laboratory Capacity for Prevention and Control of
Emerging Infectious Diseases (ELC) Cooperative agreement (CDC-RFA-CK-
24-0002) to perform testing, support workforce, and laboratory
infrastructure. Laboratory capacity supported through the AR Lab
Network fall into the following categories: (1) core testing, support
for important antimicrobial resistant pathogens that are traditionally
healthcare-associated, including carbapenem-resistant
Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas aeruginosa
(CRPA), carbapenem-resistant Acinetobacter baumannii (CRAB), and
Candida species, including C. auris; (2) jurisdictional testing
capacity that supports Neisseria gonorrhoeae surveillance; (3) testing
of colonization screening samples to support local public health
response; and (4) enhanced testing capacity at the regional
laboratories (currently seven).
CDC is requesting a three-year approval for revisions made to OMB
Control No. 0920-1310 for the Public Health Laboratory Testing for
Emerging Antibiotic Resistance and Fungal Threats which supports the
data collected through the Antimicrobial Resistance Laboratory Network
(AR Lab Network). A Revision is being submitted to: (1) add new data
elements to the data collection forms: (2) ensure that the burden of
generating electronic messages for data transmission are accounted for;
and (3) accommodate changes to the Performance Measures (PMs) used to
monitor the performance of the AR Lab Network. For this Revision, the
total estimated annual burden is 57,872 hours. There are no costs to
respondents other than their time.
Estimated Annualized Burden Hours
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Average number Average burden
Type of respondents Form name Number of of responses per response
respondents per respondent (in hours)
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Public Health Laboratories........... I.1--ROUTINE TESTING BY 57 1 10/60
GENERAL IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.2--EXPANDED DRUG 7 1 10/60
SUSCEPTIBILITY TESTING
(ExAST) IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.3--CANDIDA SPECIES 57 1 10/60
IDENTIFICATION IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.4--HAIAR WHOLE GENOME Up to 57 1 10/60
SEQUENCING (WGS) OF
GRAM-NEGATIVE AR
THREATS IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
[[Page 80902]]
1.5--C. AURIS Up to 57 1 10/60
COLONIZATION SCREENING
IN JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.6--CARBAPENEMASE-PRODU Up to 57 1 10/60
CING ORGANISM (CPO)
SCREENING IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.7--AZOLE RESISTANCE IN 2 1 20/60
CLINICAL ASPERGILLUS
FUMIGATUS ISOLATES--
Annual Evaluation and
Performance Measurement
Report.
1.8--N. GONORRHOEAE 4 1 10/60
WHOLE GENOME SEQUENCING
(WGS)--Annual
Evaluation and
Performance Measurement
Report.
1.9--GONOCOCCAL (GC) 4 1 20/60
ANTIMICROBIAL
SUSCEPTIBILITY TESTING
(AST) IN JURISDICTION--
Annual Evaluation and
Performance Measurement
Report.
1.10--WHOLE GENOME 2 1 20/60
SEQUENCING (WGS) OF S.
PNEUMONAIE--Annual
Evaluation and
Performance Measurement
Report.
1.11--CLOSTRIDIOIDES 2 1 20/60
DIFFICILE (C. DIFFICLE)
TESTING IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.12--ANTIFUNGAL 3 1 20/60
RESISTANT TINEA
DERMATOPHYTES--Annual
Evaluation and
Performance Measurement
Report.
1.13--ANTIMICROBIAL 2 1 20/60
SUSCEPTIBILITY TESTING
(AST) OF INVASIVE
HAEMOPHILUS INFLUENZAE
(H. INFLUENZAE) IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.14--MYCOPLASMA 4 1 20/60
GENTALIUM (MG)--Annual
Evaluation and
Performance Measurement
Report.
1.15--MOLECULAR Mtb Up to 20 1 10/60
TESTING--Annual
Evaluation and
Performance Measurement
Report.
1.16--C. AURIS WHOLE Up to 57 1 10/60
GENOME SEQUENCING (WGS)
IN JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.17--MONITORING CRE Up to 2 1 20/60
CRPA IN COMPANION
ANIMALS TO FROM HUMANS--
Annual Evaluation and
Performance Measurement
Report.
1.18--HEALTHCARE Up to 2 1 20/60
WASTEWATER-BASED
SURVEILLANCE--Annual
Evaluation and
Performance Measurement
Report.
1.19--COMMUNICATION AND 57 1 10/60
COORDINATION OF
ACTIONABLE EPI LAB DATA
IN JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.20--CHARACTERIZATION 57 1 10/60
OF THE CLINICAL
LABORATORY NETWORK IN
JURISDICTION--Annual
Evaluation and
Performance Measurement
Report.
1.21 NEISSERIA 17 1 20/60
GONORRHOEAE ETEST FOR
SHARP.
AR Lab Network Annual 57 1 2
Report of Testing
Methods for
Carbapenemase-producing
Organisms.
AR Lab Network Monthly 57 1302 20/60
Data Report Form for
Carbapenemase-producing
Organisms.
AR Lab Network Alert 57 214 3/60
Report Form for
Carbapenemase-producing
Organisms.
AR Lab Network Alert and Up to 57 1671 20/60
Monthly Data Report
Form for Candida.
AR Lab Network Form for Up to 57 30 6/60
Phylogenetic Tree-level
Mycotics Reporting.
AR Lab Network Alert and 17 93 6/60
Monthly Data Report
Form for Neisseria
gonorrhoeae.
AR Lab Network DAART 4 50 10/60
data elements for
Neisseria gonorrhoeae.
HL7 Messages updates--IT 32 4 20/60
Maintenance.
[[Page 80903]]
Implementation of new 11 4 3
HL7 messages--IT
Initial Set up.
CSV files updates for 24 1 1
Carbapenemase-producing
organisms--IT
Maintenance.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-22958 Filed 10-3-24; 8:45 am]
BILLING CODE 4163-18-P
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