Information Collection Request

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

ICR 202302-0920-008 · OMB 0920-1310 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form Form 12 AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting (C. auris Whole Genome Sequencing) Form and Instruction New Repair queued
Form Form 11 AR Lab Network Form for Isolate/Specimen-level Mycotics Testing (C. auris Whole Genome Sequencing) Form and Instruction New Repair queued
Form Form 10 Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing) Form and Instruction New Repair queued
Form Form 9 AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae Form and Instruction New Repair queued
Form Form 8 Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae) Form and Instruction New Missing upstream
Form Form 7 AR Lab network Alert Report Form for C auris Form and Instruction Modified Missing upstream
Form Form 6 Monthly Data Report Form Candida Form and Instruction Modified Repair queued
Form Form 5 Annual evaluation and Performance Measurement Report (Candida) Form and Instruction Modified Repair queued
Form Form 4 AR Lab network Alert Report Form for Bacterial Specimen Testing Form and Instruction Modified Repair queued
Form Form 3 Monthly Data Report Form for Bacterial Specimen Testing Form and Instruction Modified Missing upstream
Form Form 2 Annual Eval and Performance Measurement Report for Bacterial Specimen Testing Form and Instruction Modified Repair queued
Form Form 1 Annual Report of Bacterial Specimen Testing Methods Form and Instruction Modified Repair queued
Attachment 9 Privacy Impact Assessment.pdf Supplementary Document Uploaded 2023-02-15 Repair queued
Attachment 8 Human Subjects Exemption.pdf Supplementary Document Uploaded 2023-02-15 Repair queued
Attachment 7 Summary of Candida Reporting by States.docx Supplementary Document Uploaded 2023-02-15 Repair queued
Attachment 6 ELC ARLN State Testing Activities.pdf Supplementary Document Uploaded 2023-02-15 Repair queued
Attachment 5 Summary of CRE, CRPA, and CRAB Reporting by States.docx Supplementary Document Uploaded 2023-02-15 Repair queued
Attachment 2 60-day Federal Register.pdf Supplementary Document Uploaded 2023-02-14 Repair queued
Attachment 1d Public Health Service Act.pdf Supplementary Document Uploaded 2023-02-14 Repair queued
Attachment 1c National_action_plan_for_combating_antibotic-resistant_bacteria.pdf Supplementary Document Uploaded 2023-02-14 Repair queued
Attachment 1b The National Strategy for Combating Antibiotic Resistant Bacteria.pdf Supplementary Document Uploaded 2023-02-14 Repair queued
Attachment 1a Executive Order 13676.pdf Supplementary Document Uploaded 2023-02-14 Repair queued
2. Supporting Statement B_final.docx Supporting Statement B Uploaded 2023-02-14 Repair queued
1. Supporting Statement A_final.docx Supporting Statement A Uploaded 2023-02-14 Missing upstream
ICR Details
0920-1310 202302-0920-008
Historical Active 201912-0920-013
HHS/CDC 0920-1310
[NCEZID] Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats
Revision of a currently approved collection   No
Regular
Approved without change 05/23/2023
Retrieve Notice of Action (NOA) 02/28/2023
  Inventory as of this Action Requested Previously Approved
05/31/2026 36 Months From Approved 12/31/2023
6,272 0 4,070
4,950 0 4,555
0 0 0

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 of five instruments and one additional site. These changes increase the overall burden.

EO: EO 13676 Name/Subject of EO: Combating Antibiotic-Resistant Bacteria
   US Code: 42 USC 241 Name of Law: PHSA
  
None

Not associated with rulemaking

  87 FR 61329 10/11/2022
88 FR 12358 02/27/2023
Yes

12
IC Title Form No. Form Name
AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae Form 9 AR Lab Network Alert and Monthly Data Report Form 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 (C. auris Whole Genome Sequencing) Form 12 AR Lab Network Alert and Monthly Data Report Form for Phylogentic Tree-level Mycotics Reporting (C. auris WGS)
AR Lab network Alert Report Form for Bacterial Specimen Testing Form 4 AR Lab Network Alert Report Form for Bacterial Specimen Testing
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 Report of Bacterial Specimen Testing Methods Form 1 Annual Report of Bacterial Specimen Testing Methods
Annual evaluation and Performance Measurement Report (Candida) Form 5 Annual Eval and Performance Measurement Report (Candida)
Monthly Data Report Form Candida Form 6 Monthly Data Report Form Candida
Monthly Data Report Form for Bacterial Specimen Testing Form 3 Monthly Data Report Form for Bacterial Specimen Testing

  Total Approved 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 6,272 4,070 0 2,202 0 0
Annual Time Burden (Hours) 4,950 4,555 0 395 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
There are 5 new data collections instruments and the jurisdictions have increased by 1 from 55 to 56 ( i.e., state and local public health laboratories). With these forms, we have estimated an additional 395 burden hours.

$6,515,008
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Kevin Joyce 404 639-1944 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/28/2023