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

Forms and Documents

Document	Type	Status	Availability
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	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
258566	AR Lab Network Form for Phylogenetic Tree-level Mycotics Reporting (C. auris Whole Genome Sequencing)	Form and Instruction	New
258565	AR Lab Network Form for Isolate/Specimen-level Mycotics Testing (C. auris Whole Genome Sequencing)	Form and Instruction	New
258564	Annual Evaluation and Performance Measurement Report (C. auris Whole Genome Sequencing)	Form and Instruction	New
258563	AR Lab Network Alert and Monthly Data Report Form for Neisseria gonorrhoeae	Form and Instruction	New
258562	Annual Evaluation and Performance Measurement Report (Neisseria gonorrhoeae)	Form and Instruction	New
239439	AR Lab network Alert Report Form for C auris	Form and Instruction	Modified
239438	Monthly Data Report Form Candida	Form and Instruction	Modified
239437	Annual evaluation and Performance Measurement Report (Candida)	Form and Instruction	Modified
239436	AR Lab network Alert Report Form for Bacterial Specimen Testing	Form and Instruction	Modified
239435	Monthly Data Report Form for Bacterial Specimen Testing	Form and Instruction	Modified
239434	Annual Eval and Performance Measurement Report for Bacterial Specimen Testing	Form and Instruction	Modified
239433	Annual Report of Bacterial Specimen Testing Methods	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1310	ICR Reference No: 202302-0920-008
Status: Historical Active	Previous ICR Reference No: 201912-0920-013
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/23/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2026	36 Months From Approved	12/31/2023
Responses	6,272	0	4,070
Time Burden (Hours)	4,950	0	4,555
Cost Burden (Dollars)	0	0	0

---

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

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 61329	10/11/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 12358	02/27/2023
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 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

---

ICR Summary of Burden

	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

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: 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.

---

Annual Cost to Federal Government: $6,515,008

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

---

Common Form ICR:  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:

(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: 02/28/2023

---