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

ICR 202409-0920-016

OMB: 0920-1310

Federal Form Document

Forms and Documents

Document Name	Status
Form I21 Neisseria Ghonorrhoeae Etest for SHARP Form and Instruction	New
Form I20 Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I19 Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I18 Healthcare Wastewater-based Surveillance - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I17 Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I16 C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I15 Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I14 Mycoplasm Gentalium (MG)- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I13 Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I12 Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I11 Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I10 Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I9 Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I8 N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I7 Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I6 Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I5 C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I4 HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I3 Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I2 Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
Form I1 Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
AR Lab Network DAART data elements for Neisseria gonorrhoeae Form and Instruction	New
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae Form and Instruction	Modified
Form Form 11 AR Lab Network Form for Isolate/Specimen-level Mycotics Testing (C. auris Whole Genome Sequencing) Form and Instruction	Removed
Form Form 10 Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing) Form and Instruction	Removed
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting Form and Instruction	Modified
Form Form 8 Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae) Form and Instruction	Removed
Form Form 7 AR Lab network Alert Report Form for C auris Form and Instruction	Removed
AR Lab Network Alert and Monthly Data Report Form for Candida Form and Instruction	Modified
Form Form 5 Annual evaluation and Performance Measurement Report (Candida) Form and Instruction	Removed
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms Form and Instruction	Modified
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms Form and Instruction	Modified
Form Form 2 Annual Eval and Performance Measurement Report for Bacterial Specimen Testing Form and Instruction	Removed
AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms Form and Instruction	Modified
Attachment 11 SURRG Project Non-Research Determination.pdf Supplementary Document	2024-10-07
Attachment 10 GC SHARP Project Non-Research Determination.pdf Supplementary Document	2024-10-07
Attachment 9C-Privacy Impact Assessment.pdf Supplementary Document	2024-10-07
Attachment 9B Privacy Impact Assessment.pdf Supplementary Document	2024-10-07
Attachment 9A Privacy Impact Assessment.pdf Supplementary Document	2024-10-07
Attachment 8 AR Lab Network Non-research Determination.pdf Supplementary Document	2024-10-07
Attachment 7 Summary of Candida Reporting by States.docx Supplementary Document	2024-10-07
Attachment 6 ELC AR Lab Network State Testing Activities.pdf Supplementary Document	2024-10-07
Attachment 5 Summary of CRE, CRPA, and CRAB Reporting by States.docx Supplementary Document	2024-10-07
Attachment 4_Published 60-day FRN.pdf Supplementary Document	2024-10-07
Attachment 1d Public Health Service Act.pdf Supplementary Document	2024-10-07
Attachment 1c_The National Strategy for Combating Antibiotic_Resistant Bacteria.pdf Supplementary Document	2024-10-07
Attachment 1b_National_action_plan_for_combating_antibotic-resistant_bacteria.pdf Supplementary Document	2024-10-07
Attachment 1a_Executive Order 13676.pdf Supplementary Document	2024-10-07
Supporting Statement B_final.docx Supporting Statement B	2024-10-07
Supporting Statement A_final_updated10.3_FINAL_final.docx Supporting Statement A	2024-10-07

IC Document Collections

IC ID	Document Title	Status
271468	CSV files updates for Carbapenemase-producing organisms-IT Maintenance Other-OMB Header and Burden Statement	New
271467	Implementation of new HL7 messages-IT Initial Set up Other-OMB Header and Burden Statement	New
271464	HL7 Messages updates-IT Maintenance Other-OMB Header and Burden Statement	New
271463	Neisseria Ghonorrhoeae Etest for SHARP Form and Instruction	New
271462	Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271461	Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271460	Healthcare Wastewater-based Surveillance - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271458	Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271456	C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271455	Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271454	Mycoplasm Gentalium (MG)- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271453	Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271452	Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271447	Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271446	Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271445	Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271444	N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271443	Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271442	Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report Form and Instruction	New
271440	C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report Form and Instruction	New
271436	HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271435	Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271434	Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271433	Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report Form and Instruction	New
271432	AR Lab Network DAART data elements for Neisseria gonorrhoeae Form and Instruction	New
258566	AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae Form and Instruction	Modified
258565	AR Lab Network Form for Isolate/Specimen-level Mycotics Testing (C. auris Whole Genome Sequencing) Form and Instruction	Removed
258564	Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing) Form and Instruction	Removed
258563	AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting Form and Instruction	Modified
258562	Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae) Form and Instruction	Removed
239439	AR Lab network Alert Report Form for C auris Form and Instruction	Removed
239438	AR Lab Network Alert and Monthly Data Report Form for Candida Form and Instruction	Modified
239437	Annual evaluation and Performance Measurement Report (Candida) Form and Instruction	Removed
239436	AR Lab Network Alert Report Form for Carbapenemase-producing Organisms Form and Instruction	Modified
239435	AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms Form and Instruction	Modified
239434	Annual Eval and Performance Measurement Report for Bacterial Specimen Testing Form and Instruction	Removed
239433	AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms Form and Instruction	Modified