Emergency Cruise Ship Outbreak Investigations (CSOIs)

Forms and Documents

Document Name	Status
AttL. CSOI Research Determination.pdf Supplementary Document	2025-03-10
AttM. VSP_Copy_of_Privacy_Impact_Assessment_PIA_7.24.2026.pdf Supplementary Document	2025-03-10
AttB. 60D FRN CDC 0920-1255.pdf Supplementary Document	2025-03-10
AttM.VSP_PIA 20180323.pdf Supplementary Document	2022-01-18
AttL.CSOI Research Determination 2021.pdf Supplementary Document	2022-01-18
AttK2_CDC SpecmnSubmssnForm 50.34 0920-1309.pdf Supplementary Document	2022-01-18
AttK1_ViralGastroenteritisOutbreakSubmission Form 0920-0004.docx Supplementary Document	2022-01-18
AttJ Consent Forms Sample 20211215.docx Supplementary Document	2022-01-18
AttI CSOI Burden Memo 20211215.docx Supplementary Document	2022-01-18
AttH Request for Emergency CSOI 20211215.docx Supplementary Document	2022-01-18
AttG CSOI Advance Notification Email 20211215.docx Supplementary Document	2022-01-18
AttF Steps for Conducting a CSOI 20211215.docx Supplementary Document	2022-01-18
AttE4 Example Questionnaire for Undetermined Exp Risk Factor 20211215.pdf Supplementary Document	2022-01-18
AttE3 Example Questionnaire for Undetermined Agent 20211215.pdf Supplementary Document	2022-01-18
AttE2 Semi-structured Interview Guide Example 20211215.docx Supplementary Document	2022-01-18
AttE1 AGE Example Questionnaire 20211215.docx Supplementary Document	2022-01-18
AttD.VSP2018OperationsManual.pdf Supplementary Document	2022-01-18
AttC2. 1987Memo_VSPfromDGMQtoNCEH.pdf Supplementary Document	2022-01-18
AttC1.1985FRN_VSPinDGMQ.pdf Supplementary Document	2022-01-18
AttB.60D FRN CSOI 2021.pdf Supplementary Document	2022-01-18
AttA3. 42CFRPart71.pdf Supplementary Document	2022-01-18
AttA2.42USCSection269.pdf Supplementary Document	2022-01-18
AttA1. 42USCSection264.pdf Supplementary Document	2022-01-18
0 - SSB_VSP CSOIs GnrcClrnce Revision 2 11 2025.docx Supporting Statement B	2025-03-10
0 - SSA_VSP CSOIs GnrcClrnce Revision_2 11 2025.docx Supporting Statement A	2025-03-10

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0920-1255	ICR Reference No: 202503-0920-010
Status: Received in OIRA	Previous ICR Reference No: 202201-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1255
Title: Emergency Cruise Ship Outbreak Investigations (CSOIs)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/25/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	39,000	0
Time Burden (Hours)	12,189	0
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this data collection is to allow CDC to conduct emergency cruise ship outbreak investigations (CSOIs) of acute gastroenteritis (AGE) outbreaks or when unusual AGE illness clusters occur. The Vessel Sanitation Program (VSP) deploys to the field and conducts CSOIs to assist cruise industry partners as they respond to AGE outbreaks or events on their vessels. Under this generic clearance, CDC will seek emergency PRA clearance for each CSOI within 24-hours of submission to OMB. The data collection period for each CSOI will not exceed 30 days. Data will be gathered by NCEH's VSP. Submission of Revision ICR for 0920-1255 is submitted for approval of Generic mechanism for an additional three years and a reduction in burden hours (4,063 annually) due to the refinement in estimated number of CSOIs conducted annually in response to cruise ship AGE outbreaks.

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Authorizing Statute(s): US Code: 42 USC 269 Name of Law: Quarantine and Inspection - Bills of Health
   US Code: 42 USC Part 71 Name of Law: Foreign Quarantine Regulations
   US Code: 42 USC 264 Name of Law: Quarantine and Inspection-Regulations to Control Communicable Diseases
  

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:
	89 FR 92937	11/25/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 24618	06/11/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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ICR Summary of Burden

	Total Request	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	39,000	0	0	-117,702	0	156,702
Annual Time Burden (Hours)	12,189	0	0	-26,991	0	39,180
Annual Cost Burden (Dollars)	0	0	0	-1,115,824	0	1,115,824

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Revision of 0920-1255 results in a decrease in burden hours (4,063 annually) due to the refinement in estimated number of CSOIs conducted annually in response to cruise ship AGE outbreaks.

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Annual Cost to Federal Government: $0

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.     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: 06/25/2025

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