Emergency Cruise Ship Outbreak Investigations (CSOIs)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CSTE CSOIs Comments 7-11-2025.pdf	Public Comments	Uploaded 2025-07-11	Repair queued
PC_202503-0920-010_071125_054709_1.pdf	Public Comments	Uploaded 2025-07-11	Repair queued
CLIA comments Emergency Cruise Ship Outbreak Investigations_July8.pdf	Public Comments	Uploaded 2025-07-08	Repair queued
AttL. CSOI Research Determination.pdf	Supplementary Document	Uploaded 2025-03-10	Repair queued
AttL. CSOI Research Determination.pdf	Supplementary Document	Uploaded 2025-03-10	Missing upstream
AttM. VSP_Copy_of_Privacy_Impact_Assessment_PIA_7.24.2026.pdf	Supplementary Document	Uploaded 2025-03-10	Repair queued
AttM. VSP_Copy_of_Privacy_Impact_Assessment_PIA_7.24.2026.pdf	Supplementary Document	Uploaded 2025-03-10	Missing upstream
AttB. 60D FRN CDC 0920-1255.pdf	Supplementary Document	Uploaded 2025-03-10	Repair queued
AttB. 60D FRN CDC 0920-1255.pdf	Supplementary Document	Uploaded 2025-03-10	Repair queued
AttM.VSP_PIA 20180323.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttM.VSP_PIA 20180323.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttL.CSOI Research Determination 2021.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttL.CSOI Research Determination 2021.pdf	Supplementary Document	Uploaded 2022-01-18	Missing upstream
AttK2_CDC SpecmnSubmssnForm 50.34 0920-1309.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttK2_CDC SpecmnSubmssnForm 50.34 0920-1309.pdf	Supplementary Document	Uploaded 2022-01-18	Missing upstream
AttK1_ViralGastroenteritisOutbreakSubmission Form 0920-0004.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttK1_ViralGastroenteritisOutbreakSubmission Form 0920-0004.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttJ Consent Forms Sample 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttJ Consent Forms Sample 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttI CSOI Burden Memo 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttI CSOI Burden Memo 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttH Request for Emergency CSOI 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttH Request for Emergency CSOI 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttG CSOI Advance Notification Email 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttG CSOI Advance Notification Email 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttF Steps for Conducting a CSOI 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttF Steps for Conducting a CSOI 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Missing upstream
AttE4 Example Questionnaire for Undetermined Exp Risk Factor 20211215.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE4 Example Questionnaire for Undetermined Exp Risk Factor 20211215.pdf	Supplementary Document	Uploaded 2022-01-18	Missing upstream
AttE3 Example Questionnaire for Undetermined Agent 20211215.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE3 Example Questionnaire for Undetermined Agent 20211215.pdf	Supplementary Document	Uploaded 2022-01-18	Missing upstream
AttE2 Semi-structured Interview Guide Example 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE2 Semi-structured Interview Guide Example 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE1 AGE Example Questionnaire 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE1 AGE Example Questionnaire 20211215.docx	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttD.VSP2018OperationsManual.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttD.VSP2018OperationsManual.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttC2. 1987Memo_VSPfromDGMQtoNCEH.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttC2. 1987Memo_VSPfromDGMQtoNCEH.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttC1.1985FRN_VSPinDGMQ.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttC1.1985FRN_VSPinDGMQ.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttB.60D FRN CSOI 2021.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttB.60D FRN CSOI 2021.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttA3. 42CFRPart71.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttA3. 42CFRPart71.pdf	Supplementary Document	Uploaded 2022-01-18	Available
AttA2.42USCSection269.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttA2.42USCSection269.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttA1. 42USCSection264.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttA1. 42USCSection264.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
0 - SSB_VSP CSOIs GnrcClrnce Revision 2 11 2025.docx	Supporting Statement B	Uploaded 2025-03-10	Repair queued
0 - SSB_VSP CSOIs GnrcClrnce Revision 2 11 2025.docx	Supporting Statement B	Uploaded 2025-03-10	Repair queued
0 - SSA_VSP CSOIs GnrcClrnce Revision_2 11 2025.docx	Supporting Statement A	Uploaded 2025-03-10	Repair queued
0 - SSA_VSP CSOIs GnrcClrnce Revision_2 11 2025.docx	Supporting Statement A	Uploaded 2025-03-10	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form

ICR Details

OMB Control No: 0920-1255	ICR Reference No: 202503-0920-010
Status: Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/22/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/25/2025
Terms of Clearance: Previous Terms of Clearance/Comments continue: To request approval of information collections under this generic approval, CDC must do the following: 1) Individual submissions will include the actual study instruments along with documentation and burden memos for each instrument used during the investigation; 2) Notify the OIRA desk officer via email when a new IC is submitted to ROCIS to ensure prompt attention.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2028	36 Months From Approved
Responses	39,000	0	0
Time Burden (Hours)	12,189	0	0
Cost Burden (Dollars)	0	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 264 Name of Law: Quarantine and Inspection-Regulations to Control Communicable Diseases
   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
  

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

table that charts list 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	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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