Investigation of a Cluster of Extensively Drug Resistant Shigellosis Associated with a Cruise Ship

Forms and Documents

Document Name	Status
Survey 2 - Confirmed Shigellosis Cases (Group 3) Form and Instruction	New
Survey 1 - Confirmed Shigellosis Cases (Group 2) Form and Instruction	New
Survey 1 - Cruise Ship Pssengers (Group 1) Form and Instruction	New
NonResearchDetermination.pdf Supplementary Document	2020-03-17
NonResearchDetermination.pdf Supplementary Document	2020-03-17
SSA_ShigellaCruise_3.16.2020.docx Supporting Statement A	2020-03-17
SSB_ShigellaCruise_3.16.2020.docx Supporting Statement B	2020-03-16
Appendix A. Email Invitation3.5.2020.docx Supplementary Document	2020-03-16
20181228 EIWS PIA.pdf Supplementary Document	2020-03-16
Emergency Review Request Memo Shigella_RFK.pdf Supplementary Document	2020-03-16

IC Document Collections

IC ID	Document Title	Status
240760	Survey 2 - Confirmed Shigellosis Cases (Group 3) Form and Instruction	New
240759	Survey 1 - Confirmed Shigellosis Cases (Group 2) Form and Instruction	New
240758	Survey 1 - Cruise Ship Pssengers (Group 1) Form and Instruction	New

ICR Details

OMB Control No: 0920-1288	ICR Reference No: 202003-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20LI
Title: Investigation of a Cluster of Extensively Drug Resistant Shigellosis Associated with a Cruise Ship
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: 03/17/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/17/2020
	Date Received in OIRA: 03/17/2020
Terms of Clearance: Approved consistent with the understanding the CDC will work with its desk officer to determine the appropriate pathway forward should the agency want to revise or extend this collection. The OMB control number, expiration date, and PRA statement will be clearly displayed on all materials.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2020	3 Months From Approved
Responses	4,217	0	0
Time Burden (Hours)	704	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: On February 13, 2020 CDC was notified by Australian public health authorities of three cases of infection with extensively drug-resistant (XDR) Shigella associated with Cruise X. On February 20, 2020, CDC notified state and local enteric disease epidemiologists of these cases, and asked states to notify CDC of any patients with Shigella infection who reported taking a cruise matching the characteristics of Cruise X. As a result of preliminary case finding, a total of 9 U.S. cases were identified as associated with Cruise X. This investigation is submitted to identify additional cases and better characterize cases of acute gastroenteritis (AGE) and shigellosis associated with Cruise X. This will inform strategies to prevent introduction and transmission of XDR Shigella within the United States, and to identify future prevention strategies.

Emergency Justfication: CDC cannot reasonably comply with the normal clearance because the initial investigation suggests it is critical to rapidly begin collection of patient data from multiple states in order to identify individuals with infections and prevent transmission of this highly resistant organism within the U.S. Because the collection of patient data is projected to begin on March 13, 2020, accelerated OMB review is requested.

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Authorizing Statute(s): US Code: 42 USC 231 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: 3

IC Title	Form No.	Form Name
Survey 1 - Cruise Ship Pssengers (Group 1)	NA	Appendix B - Survey Instrument 1
Survey 1 - Confirmed Shigellosis Cases (Group 2)	NA	Appendix B - Survey Instrument 1
Survey 2 - Confirmed Shigellosis Cases (Group 3)	NA	Appendix C - Survey Instrument 2

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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	4,217	0	0	4,217	0	0
Annual Time Burden (Hours)	704	0	0	704	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 is a New Emergency ICR

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Annual Cost to Federal Government: $12,742

Does this IC contain surveys, censuses, or employ statistical methods? No

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.     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? 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: 03/17/2020

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