Emergency Cruise Ship Outbreak Investigations (CSOIs)

Forms and Documents

Document Name	Status
AttM.PIA.pdf Supplementary Document	2019-02-21
AttL.CSOI Research Determination.pdf Supplementary Document	2019-02-21
AttK2_CDC Specimen Submission Form.pdf Supplementary Document	2019-02-21
AttK1.National Calicivirus Laboratory Form.pdf Supplementary Document	2019-02-21
AttJ Consent Forms Sample.docx Supplementary Document	2019-02-21
AttI CSOI Burden Memo.docx Supplementary Document	2019-02-21
AttH Request for Emergency CSOI.docx Supplementary Document	2019-02-21
AttG CSOI Advance Notification Email.docx Supplementary Document	2019-02-21
AttF Steps for Conducting a CSOI.docx Supplementary Document	2019-02-21
AttE4.Example Questionnaire for Undetermined Exposure and Undetermined Risk Factor.pdf Supplementary Document	2019-02-21
AttE3.Example Questionnaire for Undetermined Agent.pdf Supplementary Document	2019-02-21
AttE2 Semi-structured Interview Guide Example.docx Supplementary Document	2019-02-21
AttE1 AGE Example Questionnaire.docx Supplementary Document	2019-02-21
AttD.VSP2018OperationsManual.pdf Supplementary Document	2019-02-21
AttC2. 1987FRN_VSPfromDGMQtoNCEH.pdf Supplementary Document	2019-02-21
AttC1.1985FRN_VSPinDGMQ.pdf Supplementary Document	2019-02-21
AttB.60dayFRN.pdf Supplementary Document	2019-02-21
AttA3. 42CFRPart71.pdf Supplementary Document	2019-02-21
AttA2.42USCSection269.pdf Supplementary Document	2019-02-21
AttA1. 42USCSection264.pdf Supplementary Document	2019-02-21
SSB_VSP CSOIs Generic Clearance.docx Supporting Statement B	2019-02-21
SSA_VSP CSOIs Generic Clearance.docx Supporting Statement A	2019-02-21

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0920-1255	ICR Reference No: 201902-0920-015
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19BN
Title: Emergency Cruise Ship Outbreak Investigations (CSOIs)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/29/2019
	Date Received in OIRA: 03/04/2019
Terms of Clearance: OMB approves this collection for a period of three years, consistent with the understanding that CDC will use this generic specifically for acute gastroenteritis (AGE) outbreaks or unusual AGE illness clusters on cruise ships that are urgent in nature. This would not be the vehicle to submit ICRs for gathering data primarily for programmatic purposes, including but not limited to program evaluations, surveillance, needs assessment, or research. 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 insturment used during the investigation; 2) Notify the OIRA desk officer via email when a new IC is submitted to ROCIS to ensure prompt attention.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved
Responses	75,000	0	0
Time Burden (Hours)	18,750	0	0
Cost Burden (Dollars)	339,750	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.

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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:
	83 FR 60868	11/27/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 7377	03/04/2019
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 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	75,000	0	0	75,000	0	0
Annual Time Burden (Hours)	18,750	0	0	18,750	0	0
Annual Cost Burden (Dollars)	339,750	0	0	339,750	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 is a generic clearance request for an existing collection without an OMB number.

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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? 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: 03/04/2019

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