[Federal Register Volume 89, Number 193 (Friday, October 4, 2024)]
[Notices]
[Pages 80900-80903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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 (https://www.cdc.gov/antimicrobial-resistance/media/pdfs/2019-ar-threats-report-508.pdf). 
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
----------------------------------------------------------------------------------------------------------------
                                                                                  Average number  Average burden
         Type of respondents                   Form name            Number of      of responses    per response
                                                                   respondents    per respondent    (in hours)
----------------------------------------------------------------------------------------------------------------
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