OMB control number

[NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats

OMB 0920-1310 · HHS/CDC.

OMB 0920-1310

Antibiotic resistance has the potential to impact all Americans at every stage of life and CDC is working to drive aggressive action and empower the nation to comprehensively respond to these threats. The goal of this study is to establish a network of public health laboratories to improve detection and characterization of urgent antibiotic resistant threats in healthcare-associated infections, carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Pseudomonas aeruginosa (CRPA), carbapenem-resistant Acinetobacter baumannii (CRAB), and Candida species, including C. auris. The proposed changes are for: 1) wording changes to enhance clarity of two existing data collection forms related to antimicrobial testing, including a monthly report form and a form used to signal alerts; and 2) removal of questions that are no longer relevant. This Change Request results in a net decrease of the overall burden.

The latest form for [NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats expires 2027-12-31 and is listed under ICR 202602-0920-013.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form I21 Neisseria Ghonorrhoeae	Form and Instruction
Form I20 Characterization of the Clinical Laboratory Network in Jurisdiction	Form and Instruction
Form I19 Communication and Coordination of Actionable Lab Data in Jurisdiction	Form and Instruction
Form I17 Monitoring CRE/CRPA in Companion Animals to/from Humans	Form and Instruction
Form I16 C. Auris Whole Genome Sequencing (WGS) in Jurisdiction (document unavailable)	Form and Instruction
Form I15 Molecular Mtb Testing	Form and Instruction
Form I13 Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction	Form and Instruction
Form I12 Antifungal Resistant Tinea/Dermatophytes (document unavailable)	Form and Instruction
Form I11 Clostridioides Difficile (C. Difficile) Testing in Jurisdiction	Form and Instruction
Form I10 Whole Genome Sequencing (WGS) of S. Pneumonaie	Form and Instruction
Form I9 Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction	Form and Instruction
Form I8 N. Gonorrhoeae Whole Genome Sequencing (WGS)	Form and Instruction
Form I7 Azole Resistance in Clinical Aspergillus Fumigatus Isolates	Form and Instruction
Form I6 Carbapenemase-Producing Organism (CPO) Screening in Jurisdiction	Form and Instruction
Form I5 C. Auris Colonization Screening in Jurisdiction	Form and Instruction
Form I4 Whole Genome Sequencing (WGS) of Carbapenemase-Producing AR Threats in Jurisdiction	Form and Instruction
Form I3 Candida Enhanced Yeast Surveillance for Species Identification (document unavailable)	Form and Instruction
Form I2 Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction	Form and Instruction
Form I1 Routine Testing by Genus in Jurisdiction (document unavailable)	Form and Instruction
AR Lab Network DAART data elements for Neisseria gonorrhoeae	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae (SHARP)	Form and Instruction
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting (C. auris Whole Genome Sequencing)	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Candida	Form and Instruction
Form 0920-1310 AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	Form and Instruction
Form 0920-1310 Monthly Data Report Form for Carbapenemase-producing Organisms	Form and Instruction
Monthly Data Report Form for Carbapenemase-producing Organisms	Form and Instruction
Annual Report of Method Tracking	Form and Instruction
Change Request 0920-1310_022326.docx	Justification for No Material/Nonsubstantive Change
Change Request 0920-1310_12.11.25_final.docx	Justification for No Material/Nonsubstantive Change
Attachment 11 SURRG Project Non-Research Determination.pdf	Supplementary Document
Attachment 10 GC SHARP Project Non-Research Determination.pdf	Supplementary Document
Attachment 9C-Privacy Impact Assessment.pdf	Supplementary Document
Attachment 9B Privacy Impact Assessment.pdf	Supplementary Document
Attachment 9A Privacy Impact Assessment.pdf	Supplementary Document
Attachment 8 AR Lab Network Non-research Determination.pdf (document unavailable)	Supplementary Document
Attachment 7 Summary of Candida Reporting by States.docx	Supplementary Document
Attachment 6 ELC AR Lab Network State Testing Activities.pdf	Supplementary Document
Attachment 5 Summary of CRE, CRPA, and CRAB Reporting by States.docx	Supplementary Document
Attachment 4_Published 60-day FRN.pdf (document unavailable)	Supplementary Document
Attachment 1d Public Health Service Act.pdf	Supplementary Document
Attachment 1c_The National Strategy for Combating Antibiotic_Resistant Bacteria.pdf	Supplementary Document
Attachment 1b_National_action_plan_for_combating_antibotic-resistant_bacteria.pdf	Supplementary Document
Attachment 1a_Executive Order 13676.pdf	Supplementary Document
Supporting Statement B_final.docx	Supporting Statement B
Supporting Statement A_final_updated10.3_FINAL_final_OIRA 12.11.24_MS_snb_clean.docx	Supporting Statement A
Updates to HL7 reporting including additional testing , or LIMS re-validation	Instruction
CSV files updates for Carbapenemase-producing organisms-IT Maintenance	Other-OMB Header and Burden Statement
Implementation of new HL7 messages-IT Initial Set up	Other-OMB Header and Burden Statement
HL7 Messages updates-IT Maintenance	Other-OMB Header and Burden Statement
Neisseria Ghonorrhoeae Etest for SHARP	Form and Instruction
Neisseria Ghonorrhoeae Etest for SHARP	Form and Instruction
Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report	Form and Instruction
Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report	Form and Instruction
C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report	Form and Instruction
Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report	Form and Instruction
Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report	Form and Instruction
Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report	Form and Instruction
Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report	Form and Instruction
Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report	Form and Instruction
Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report	Form and Instruction
N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report	Form and Instruction
Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report	Form and Instruction
Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report	Form and Instruction
Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report	Form and Instruction
C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report	Form and Instruction
C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report	Form and Instruction
HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report	Form and Instruction
AR Lab Network DAART data elements for Neisseria gonorrhoeae	Form and Instruction
AR Lab Network DAART data elements for Neisseria gonorrhoeae	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae	Form and Instruction
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting	Form and Instruction
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Candida	Form and Instruction
AR Lab Network Alert and Monthly Data Report Form for Candida	Form and Instruction
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms	Form and Instruction
AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms	Form and Instruction

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202602-0920-013	No material or nonsubstantive change to a currently approved collection	2026-02-27	Approved without change
202512-0920-010	No material or nonsubstantive change to a currently approved collection	2026-01-06	Approved without change
202409-0920-016	Revision of a currently approved collection	2024-10-10
202302-0920-008	Revision of a currently approved collection	2023-02-28	Approved without change
201912-0920-013	Existing collection in use without an OMB Control Number	2020-01-27	Approved with change

OMB Details

AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms

Federal Enterprise Architecture: Health - Public Health Monitoring

Information collection instruments
Form	Name	Electronic access	Type
Form n/a	Annual Report of Method Tracking	Fillable Fileable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.