Verona Integron-Encoded Metallo-β-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico

Forms and Documents

Document Name	Status
SURVEY: Verona Integron-Encoded Metallo--Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico Form and Instruction	New
Attachment 3 - Non research determination Tijuana.pdf Supplementary Document	2019-03-14
Emergency Review Request Memo Tijuana CRPA.docx Supplementary Document	2019-03-14
Emergency SSB Tijana CRPA.docx Supporting Statement B	2019-03-14
Emergency SSA Tijuana rev.docx Supporting Statement A	2019-03-14

IC Document Collections

IC ID	Document Title	Status
235350	SURVEY: Verona Integron-Encoded Metallo--Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico Form and Instruction	New

ICR Details

OMB Control No: 0920-1253	ICR Reference No: 201903-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19AEG
Title: Verona Integron-Encoded Metallo-β-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/18/2019
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/15/2019
	Date Received in OIRA: 03/14/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	6 Months From Approved
Responses	197	0	0
Time Burden (Hours)	66	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Verona integron-encoded metallo-β-lactamase–producing carbapenem-resistant Pseudomonas aeruginosa (VIM-CRPA) and other carbapenemase-producing organisms are an emerging U.S. public health threat due to their high levels of antibiotic resistance and potential for rapid spread in healthcare. Beginning in September 2018, CDC received reports of VIM-CRPA from multiple states through the Antibiotic Resistance Laboratory Network (AR Lab Network). The purpose of this collection is to identify infections among individuals in the U.S. who had surgery at Facility 1 in order to prevent spread of resistance in the U.S. Data will be used to prevent spread of resistance in the U.S. and improve messaging to stem the flow of U.S. patients to Facility 1.

Emergency Justfication: CDC cannot reasonably comply with the normal clearance procedures due to the public harm that is reasonably likely to result if routine processing of this request is required, specifically life-threatening infections in patients exposed to Facility 1, with the potential for further spread and outbreaks in U.S. hospitals where they seek treatment.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
SURVEY: Verona Integron-Encoded Metallo--Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico	NA	Survey - Verona Integron-Encoded Metallo-β-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico

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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	197	0	0	197	0	0
Annual Time Burden (Hours)	66	0	0	66	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: Submission of 0920-19AEG - Verona Integron-Encoded Metallo-β-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico is a NEW Emergency Request that is submitted to identify infections among individuals in the U.S. who had surgery at Facility 1 in order to prevent spread of resistance in the U.S.

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Annual Cost to Federal Government: $11,814

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.     Yes

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.     Yes

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? Uncollected

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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: 03/14/2019

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