Emergency Cruise Ship Outbreak Investigations (CSOIs)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
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
AttK2_CDC SpecmnSubmssnForm 50.34 0920-1309.pdf	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
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
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	Missing upstream
AttE4 Example Questionnaire for Undetermined Exp Risk Factor 20211215.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttE3 Example Questionnaire for Undetermined Agent 20211215.pdf	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
AttD.VSP2018OperationsManual.pdf	Supplementary Document	Uploaded 2022-01-18	Repair queued
AttC2. 1987Memo_VSPfromDGMQtoNCEH.pdf	Supplementary Document	Uploaded 2022-01-18	Available
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
AttA3. 42CFRPart71.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
0 - SSB_VSP CSOIs GnrcClrnce Revision 20220110 clean_final.docx	Supporting Statement B	Uploaded 2022-01-18	Repair queued
0 - SSA_VSP CSOIs GnrcClrnce Revision 20220110 clean_final.docx	Supporting Statement A	Uploaded 2022-01-18	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: 202201-0920-005
Status: Received in OIRA	Previous ICR Reference No: 201902-0920-015
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1255
Title: Emergency Cruise Ship Outbreak Investigations (CSOIs)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/19/2022

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2022
Responses	156,702	75,000
Time Burden (Hours)	39,180	18,750
Cost Burden (Dollars)	1,115,824	339,750

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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.

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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:
	86 FR 56955	10/13/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 2792	01/19/2022
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 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	156,702	75,000	0	81,702	0	0
Annual Time Burden (Hours)	39,180	18,750	0	20,430	0	0
Annual Cost Burden (Dollars)	1,115,824	339,750	0	776,074	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: This Revision is requesting an increase in a subset of potential respondents for additional information.

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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: 01/19/2022

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