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 Department of Health and Human Services Centers for Disease Control and Prevention [30Day-24-1310]
 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 
                    ( print 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
Type of
                             respondents
Form name
Number of
                             respondents
Average
                             number of 
                             responses per 
                             respondent
Average
                             burden per 
                             response 
                             (in hours)Public Health Laboratories
I.1—ROUTINE TESTING BY GENERAL IN JURISDICTION—Annual Evaluation and Performance Measurement Report
57
1
10/601.2—EXPANDED DRUG SUSCEPTIBILITY TESTING (ExAST) IN JURISDICTION—Annual Evaluation and Performance Measurement Report
7
1
10/601.3—CANDIDA SPECIES IDENTIFICATION IN JURISDICTION—Annual Evaluation and Performance Measurement Report
57
1
10/601.4—HAIAR WHOLE GENOME SEQUENCING (WGS) OF GRAM-NEGATIVE AR THREATS IN JURISDICTION—Annual Evaluation and Performance Measurement Report
Up to 57
1
10/60( print page 80902)1.5—C. AURIS COLONIZATION SCREENING IN JURISDICTION—Annual Evaluation and Performance Measurement Report
Up to 57
1
10/601.6—CARBAPENEMASE-PRODUCING ORGANISM (CPO) SCREENING IN JURISDICTION—Annual Evaluation and Performance Measurement Report
Up to 57
1
10/601.7—AZOLE RESISTANCE IN CLINICAL ASPERGILLUS FUMIGATUS ISOLATES—Annual Evaluation and Performance Measurement Report
2
1
20/601.8—N. GONORRHOEAE WHOLE GENOME SEQUENCING (WGS)—Annual Evaluation and Performance Measurement Report
4
1
10/601.9—GONOCOCCAL (GC) ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) IN JURISDICTION—Annual Evaluation and Performance Measurement Report
4
1
20/601.10—WHOLE GENOME SEQUENCING (WGS) OF S. PNEUMONAIE—Annual Evaluation and Performance Measurement Report
2
1
20/601.11—CLOSTRIDIOIDES DIFFICILE (C. DIFFICLE) TESTING IN JURISDICTION—Annual Evaluation and Performance Measurement Report
2
1
20/601.12—ANTIFUNGAL RESISTANT TINEA DERMATOPHYTES—Annual Evaluation and Performance Measurement Report
3
1
20/601.13—ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) OF INVASIVE HAEMOPHILUS INFLUENZAE (H. INFLUENZAE) IN JURISDICTION—Annual Evaluation and Performance Measurement Report
2
1
20/601.14—MYCOPLASMA GENTALIUM (MG)—Annual Evaluation and Performance Measurement Report
4
1
20/601.15—MOLECULAR Mtb TESTING—Annual Evaluation and Performance Measurement Report
Up to 20
1
10/601.16—C. AURIS WHOLE GENOME SEQUENCING (WGS) IN JURISDICTION—Annual Evaluation and Performance Measurement Report
Up to 57
1
10/601.17—MONITORING CRE CRPA IN COMPANION ANIMALS TO FROM HUMANS—Annual Evaluation and Performance Measurement Report
Up to 2
1
20/601.18—HEALTHCARE WASTEWATER-BASED SURVEILLANCE—Annual Evaluation and Performance Measurement Report
Up to 2
1
20/601.19—COMMUNICATION AND COORDINATION OF ACTIONABLE EPI LAB DATA IN JURISDICTION—Annual Evaluation and Performance Measurement Report
57
1
10/601.20—CHARACTERIZATION OF THE CLINICAL LABORATORY NETWORK IN JURISDICTION—Annual Evaluation and Performance Measurement Report
57
1
10/601.21 NEISSERIA GONORRHOEAE ETEST FOR SHARP
17
1
20/60AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms
57
1
2AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms
57
1302
20/60AR Lab Network Alert Report Form for Carbapenemase-producing Organisms
57
214
3/60AR Lab Network Alert and Monthly Data Report Form for 
                            *Candida*
Up to 57
1671
20/60AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting
Up to 57
30
6/60AR Lab Network Alert and Monthly Data Report Form for 
                            *Neisseria gonorrhoeae*
17
93
6/60AR Lab Network DAART data elements for 
                            *Neisseria gonorrhoeae*
4
50
10/60HL7 Messages updates—IT Maintenance
32
4
20/60( print page 80903)Implementation of new HL7 messages—IT Initial Set up
11
4
3CSV files updates for Carbapenemase-producing organisms—IT Maintenance
24
1
1
 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