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

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

ICR Details

OMB Control No: 0920-1310	ICR Reference No: 202409-0920-016
Status: Received in OIRA	Previous ICR Reference No: 202302-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1310
Title: [NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/10/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2026
Responses	185,930	6,272
Time Burden (Hours)	57,872	4,950
Cost Burden (Dollars)	0	0

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Abstract: 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. This Revision includes addition and removal of instruments along with other changes. These changes increase the overall burden.

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Authorizing Statute(s): EO: EO 13676 Name/Subject of EO: Combating Antibiotic-Resistant Bacteria
   US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 51345	06/17/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 80900	10/04/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 31

IC Title	Form No.	Form Name
AR Lab Network Alert Report Form for Carbapenemase-producing Organisms	n/a	AR Lab Network Alert Report Form for Carbapenemase-producing Organisms
AR Lab Network Alert and Monthly Data Report Form for Candida	n/a	AR Lab Network Alert and Monthly Data Report Form for Candida
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae	n/a	AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae (SHARP)
AR Lab Network Annual Report of Testing Methods for Carbapenemase-producing Organisms	n/a	Annual Report of Method Tracking
AR Lab Network DAART data elements for Neisseria gonorrhoeae	n/a	AR Lab Network DAART data elements for Neisseria gonorrhoeae
AR Lab Network Form for Isolate/Specimen-level Mycotics Testing (C. auris Whole Genome Sequencing)	Form 11	AR Lab Network Alert and Monthly Data Report Form for isolate and Specimen-level Mycotics Testing (C. auris WGS)
AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting	n/a	AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting (C. auris Whole Genome Sequencing)
AR Lab Network Monthly Data Report Form for Carbapenemase-producing Organisms	n/a	Monthly Data Report Form for Carbapenemase-producing Organisms
AR Lab network Alert Report Form for C auris	Form 7	AR Lab Network Alert Report Form for C auris
Annual Eval and Performance Measurement Report for Bacterial Specimen Testing	Form 2	Annual Evaluation and Performance Measurement Report for Bacterial Specimen Testing
Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing)	Form 10	Annual Evaluation and Performance Measurement Report (C.auris WGS)
Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae)	Form 8	Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoere)
Annual evaluation and Performance Measurement Report (Candida)	Form 5	Annual Eval and Performance Measurement Report (Candida)
Antifungal Resistant Tinea Dermatophytes - Annual Evaluation and Performance Measurement Report	I12	Antifungal Resistant Tinea/Dermatophytes
Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction - Annual Evaluation and Performance Measurement Report	I13	Antimicrobial Susceptibility Testing (AST) of Invasive Haemophilus Influenzae (H. Influenzae) in Jurisdiction
Azole Resistance in Clinical Aspergillus Fumigatus Isolates - Annual Evaluation and Performance Measurement Report	I7	Azole Resistance in Clinical Aspergillus Fumigatus Isolates
C. Auris Colonization Screening in Jurisdiction-Annual Evaluation and Performance Measurement Report	I5	C. Auris Colonization Screening in Jurisdiction
C. Auris Whole Genome Sequencing (WGS) in Jurisdiction- Annual Evaluation and Performance Measurement Report	I16	C. Auris Whole Genome Sequencing (WGS) in Jurisdiction
CSV files updates for Carbapenemase-producing organisms-IT Maintenance
Candida Species Identification in Jurisdiction- Annual Evaluation and Performance Measurement Report	I3	Candida Enhanced Yeast Surveillance for Species Identification
Carbapenemase-Producing Orgranism (CPO) Screening in Jurisdiction - Annual Evaluation and Performance Measurement Report	I6	Carbapenemase-Producing Organism (CPO) Screening in Jurisdiction
Characterization of the Clinical Laboratory Network in Jurisdiction - Annual Evaluation and Performance Measurement Report	I20	Characterization of the Clinical Laboratory Network in Jurisdiction
Clostridioides Difficile (C. Difficile) Testing in Jurisdiction - Annual Evaluation and Performance Measurement Report	I11	Clostridioides Difficile (C. Difficile) Testing in Jurisdiction
Communication and Coordination of Actionable Epi Lab Data in Jurisdiction - Annual Evaluation and Performance Measurement Report	I19	Communication and Coordination of Actionable Lab Data in Jurisdiction
Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction- Annual Evaluation and Performance Measurement Report	I2	Expanded Drug Susceptibility Testing (ExAST) in Jurisdiction
Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction - Annual Evaluation and Performance Measurement Report	I9	Gonococcal (GC) Antimicrobial Susceptibility Testing (AST) in Jurisdiction
HAIAR Whole Genome Sequencing (WGS) of Gram-negative AR Threats in Jurisdiction- Annual Evaluation and Performance Measurement Report	I4	Whole Genome Sequencing (WGS) of Carbapenemase-Producing AR Threats in Jurisdiction
HL7 Messages updates-IT Maintenance
Healthcare Wastewater-based Surveillance - Annual Evaluation and Performance Measurement Report	I18	Healthcare Wasterwater-based Surveillance
Implementation of new HL7 messages-IT Initial Set up
Molecular Mtb Testing- Annual Evaluation and Performance Measurement Report	I15	Molecular Mtb Testing
Monitoring CRE CRPA in Companion Animals to from Humans - Annual Evaluation and Performance Measurement Report	I17	Monitoring CRE/CRPA in Companion Animals to/from Humans
Mycoplasm Gentalium (MG)- Annual Evaluation and Performance Measurement Report	I14	Mycoplasma Gentalium (MG)
N. Gonorrhoeae Whole Genome Sequencing (WGS)- Annual Evaluation and Performance Measurement Report	I8	N. Gonorrhoeae Whole Genome Sequencing (WGS)
Neisseria Ghonorrhoeae Etest for SHARP	I21	Neisseria Ghonorrhoeae
Routine Testing by Genera in Jurisdiction- Annual Evaluation and Performance Measurement Report	I1	Routine Testing by Genus in Jurisdiction
Whole Genome Sequencing (WGS) of S. Pneumonaie - Annual Evaluation and Performance Measurement Report	I10	Whole Genome Sequencing (WGS) of S. Pneumonaie

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	185,930	6,272	0	181,282	-1,624	0
Annual Time Burden (Hours)	57,872	4,950	0	53,510	-588	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden adjustments are due to the addition and deletion of instruments.

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Annual Cost to Federal Government: $12,583,265

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/10/2024

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