Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats

Forms and Documents

Document Name	Status
Form 0920-19AYV AR Lab network Alert Report Form for C auris Form and Instruction	New
Form 0920-19AYV Monthly Data Report Form Candida Form and Instruction	New
Form 0920-19AYV Annual evaluation and Performance Measurement Report (Candida) Form and Instruction	New
Form 0920-19AYV AR Lab network Alert Report Form for Bacterial Specimen Testing Form and Instruction	New
Form 0920-19AYV Monthly Data Report Form for Bacterial Specimen Testing Form and Instruction	New
Form 0920-19AYV Annual Eval and Performance Measurement Report for Bacterial Specimen Testing Form and Instruction	New
Form 0920-19AYV Annual Report of Bacterial Specimen Testing Methods Form and Instruction	New
Privacy Impact Assessment (Signed PIA).pdf Supplementary Document	2020-01-24
Attachment 7 Human Subjects Exemption (Umbrella Protocol Number 7218).pdf Supplementary Document	2020-01-24
Attachment 6 Summary of Candida Reporting by States.docx Supplementary Document	2020-01-24
Attachment 5 ELC ARLN State Testing Activities.pdf Supplementary Document	2020-01-24
Attachment 4 Summary of CRE, CRPA, and CRAB Reporting by States.docx Supplementary Document	2020-01-24
Attachment 2 Published 60-Day FRN.pdf Supplementary Document	2020-01-24
Attachment 1d Public Health Service Act.pdf Supplementary Document	2020-01-24
Attachment 1c National_action_plan_for_combating_antibotic-resistant_bacteria.pdf Supplementary Document	2020-01-24
Attachment 1b The National Strategy for Combating Antibiotic Resistant Bacteria.pdf Supplementary Document	2020-01-24
Attachment 1a Executive Order 13676.pdf Supplementary Document	2020-01-24
Supporting Statement B final.docx Supporting Statement B	2020-01-24
Supporting Statement A v2 final.docx Supporting Statement A	2020-01-24

IC Document Collections

IC ID	Document Title	Status
239439	AR Lab network Alert Report Form for C auris Form and Instruction	New
239438	Monthly Data Report Form Candida Form and Instruction	New
239437	Annual evaluation and Performance Measurement Report (Candida) Form and Instruction	New
239436	AR Lab network Alert Report Form for Bacterial Specimen Testing Form and Instruction	New
239435	Monthly Data Report Form for Bacterial Specimen Testing Form and Instruction	New
239434	Annual Eval and Performance Measurement Report for Bacterial Specimen Testing Form and Instruction	New
239433	Annual Report of Bacterial Specimen Testing Methods Form and Instruction	New

ICR Details

OMB Control No: 0920-1310	ICR Reference No: 201912-0920-013
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19AYV
Title: Public Health Laboratory Testing for Emerging Antibiotic Resistance and Fungal Threats
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/03/2020
	Date Received in OIRA: 01/27/2020
Terms of Clearance:

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

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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:
	84 FR 32182	07/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 3912	01/23/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Annual Report of Bacterial Specimen Testing Methods	0920-19AYV	Annual Report of Bacterial Specimen Testing Methods
Annual Eval and Performance Measurement Report for Bacterial Specimen Testing	0920-19AYV	Annual Evaluation and Performance Measurement Report for Bacterial Specimen Testing
Monthly Data Report Form for Bacterial Specimen Testing	0920-19AYV	Monthly Data Report Form for Bacterial Specimen Testing
AR Lab network Alert Report Form for Bacterial Specimen Testing	0920-19AYV	AR Lab Network Alert Report Form for Bacterial Specimen Testing
Annual evaluation and Performance Measurement Report (Candida)	0920-19AYV	Annual Eval and Performance Measurement Report (Candida)
Monthly Data Report Form Candida	0920-19AYV	Monthly Data Report Form Candida
AR Lab network Alert Report Form for C auris	0920-19AYV	AR Lab Network Alert Report Form for C auris

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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	4,070	0	0	0	0	4,070
Annual Time Burden (Hours)	4,555	0	0	0	0	4,555
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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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

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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: 01/27/2020

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