Research Determination

Print Date: 2/27/25

Title:

Emergency Cruise Ship Outbreak Investigations (CSOIs)

Project Id:

0900f3eb81d9a780

Accession #:

NCEH-VSPT-8/9/21-9a780

Project Contact:

Stefanie B White

Organization:

NCEH/ATSDR/DEHSP/WFEHSB/VSPT

Status:

Project In Progress : PRA Revision

Intended Use:

Project Determination

Estimated Start Date:

03/31/2021

Estimated Completion Date:

03/31/2022

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations

0020-1255

Determination

Justification

Completed

Entered By & Role

11/5/24

Ding_Yan (Shirley) (yad6) CIO HSC

11/5/24

Ding_Yan (Shirley) (yad6) CIO OMB / PRA

11/6/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Non-Epi Aids Investigations

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 3/18/22
OMB Expiration date: 3/31/25

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

12/14/21

Description:

This is an extension information collection request for the #Emergency Cruise Ship Outbreak Investigations (CSOIs)# (OMB Control
Number 0920-1255; expiration date 03/31/2022). The purpose of this ICR is to allow CDC to conduct CSOIs of AGE outbreaks or
when unusual AGE illness clusters occur. The VSP conducts CSOIs to assist cruise industry partners as they respond to AGE
outbreaks or events on their vessels. Data collection instruments and methods must be rapidly created and implemented to direct
appropriate public health action. Under this generic clearance, CDC will seek emergency PRA clearance for each CSOI within 24hours of submission to OMB. The data collection period for each CSOI will not exceed 30 days.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal of the emergency cruise ship outbreak investigations (CSOIs) is to rapidly determine unknown agents, source, risk factors,
and/or mode of transmission for acute gastroenteritis (AGE) illness outbreaks on cruise ships in the U.S. jurisdiction.

Objective:

Data will be used to identify AGE outbreak cause and provide public health recommendations for prevention and control. This
project addresses Objective 1 of the DEHSP Science Agenda: Identify and develop environmental health data sets, methodologies,
and tools to assess exposures, health outcomes, and public health actions (Category 1: High impact, low effort).

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Cruise ship passengers and crew

Tags/Keywords:

Outbreak investigation ; cruise ; Gastroenteritis

CDC's Role:

CDC employees or agents will obtain data by intervening or interacting with participants

Method Categories:

Outbreak Investigation

Methods:

Methods used include retrospective cohort or case control design, health questionnaire, and personal interview.

Collection of Info, Data or Biospecimen:

health and exposure questionnaires

Expected Use of Findings/Results and their impact:

VSP will analyze data using frequencies, proportions, measures of association (e.g., chi-square), odds ratios, and relative risk
ratios.

Could Individuals potentially be identified based on
Information Collected?

Funding

No

Funding Type

Funding Title

Other-

Staff Time Only

Funding #

Original Budget Yr

HSC Attributes
Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers

Budget Amount
0.00

HSC Review

Non-Epi Aids Investigations

# Years Award

Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPAA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions

Will you be working with an outside Organization or Institution? Yes
Institution

FWA #

FWA Exp Date

Centers for Disease Control & Prevention

FWA00001413

05/30/29

Institution

Funding Restriction Percentage

Funding

Funding Restriction Reason

Funding Restriction Amount

Funding Restriction has been Lifted

Centers for Disease Control & Prevention

Institution

Institution Role(s)

Institution Project Title

Institution Project Tracking #

Prime Institution

Centers for Disease Control & Prevention

Institution

Regulatory Coverage

IRB Review Status

Centers for Disease Control & Prevention

Institution
Centers for Disease Control & Prevention

Registered IRB

IRB Registration Exp. Date

IRB Approval Status

Institution

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

Centers for Disease Control & Prevention

Staff
Staff
Member

Leigh Ellyn
Preston

SIQT
Exp.
Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

n/a

n/a

n/a

n/a

n/a

Staff Role

Email

CoInvestigator

poe2@cdc.
gov

Phone

Organization

Centers for
Disease Control &
Prevention

Data
DMP
Proposed Data Collection Start Date:

4/1/22

Proposed Data Collection End Date:

3/31/25

Proposed Public Access Level:

Non-Public, Restricted

Non-Public Details:
Reason For Not Releasing Data:

CIO conducting this project does not fund or own the data and is not responsible for making it available

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:
Data Use Contact:
Public Access Justification:

Voyage information and individual level data will not be made available to the public. Data is owned by the cruise company. Only
cumulative gastroenteritis case counts for passengers and crew is available for restricted sharing.

How Access Will Be Provided for Data:

Deidentified Excel worksheet

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

11/06/2024

NOA 0920-1255 (2022)

Notice of Action

NOA 0920-1255_2022.pdf

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

60-day FRN Publication Request
Form

Other, 0.1260 Request to End
Review of Human Research
Studies

0 - 60-day FRN Publication Request Form VSP CSOI 1029-2024.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN

Other, 0.1260 Request to End
Review of Human Research
Studies

0 - 60-day_FRN_CDC_Template_VSP CSOI 10-24-2024.
docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Sample Consent

Consent Form, 0.1260 Request to
End Review of Human Research
Studies

Consent Forms Sample.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Example Questionnaire

Data Collection Form, 0.1260
Request to End Review of Human
Research Studies

AGE Example Questionnaire.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Semi-structures Interview
Guide Example

Data Collection Form, 0.1260
Request to End Review of Human
Research Studies

Semi-structured Interview Guide Example.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

60-day FRN Publication Request
Form

Other, 0.1260 Request to End
Review of Human Research
Studies

0 - 60-day FRN Publication Request Form VSP CSOI 1029-2024.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN

Other, 0.1260 Request to End
Review of Human Research
Studies

0 - 60-day_FRN_CDC_Template_VSP CSOI 10-24-2024.
docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Sample Consent

Consent Form, 0.1260 Request to
End Review of Human Research
Studies

Consent Forms Sample.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Example Questionnaire

Data Collection Form, 0.1260
Request to End Review of Human
Research Studies

AGE Example Questionnaire.docx

Current

White_Stefanie
B. (ixy3)
Project Contact

10/29/2024

FRN: Semi-structures Interview
Guide Example

Data Collection Form, 0.1260
Request to End Review of Human
Research Studies

Semi-structured Interview Guide Example.docx

Zirger_Jeffrey

(wtj5)
ICRO Reviewer

12/22/2021

NOA 0920-1255 (2019)

Notice of Action

NOA 0920-1255.pdf

Foster_Stephanie
L. (sob4)
Division Approver
Projects

12/20/2021

Adding zip package per discussion
with Stephanie Davis. Please note
an additional comment to
Pt1Wksht_CSOIs 2022 20211215.
pdf that I added regarding PII
following discussion and
confirmation with the program.

Other

0920-1255 2022 CSOI Rev 20211215 to ICRO_v2.zip

Jenkins_Keisha
A. (brn0)
Project Contact

12/14/2021

30-day ICR Zip file

Paperwork Reduction Act Form

0920-1255 2022 CSOI Revision draft 20211119.zip

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/22/2021

NOA 0920-1255 (2019)

Notice of Action

NOA 0920-1255.pdf

Davis_Stephanie
I. (sgd8)
CIO OMB / PRA

09/21/2021

60-day FRN publication request
package

Paperwork Reduction Act Form

CSOI 60D 2021 to ICRO.zip

Jenkins_Keisha
A. (brn0)
Project Contact

09/21/2021

60-day Package

Other

CSOI 60D 2021 rev OS_kj.zip

Davis_Stephanie
I. (sgd8)
CIO HSC

09/16/2021

60-day package with OS edits

Paperwork Reduction Act Form

CSOI 60D 2021 rev OS.zip

Jenkins_Keisha
A. (brn0)
Project Contact

08/09/2021

Folder includes attachments

Other-ICR Package

CSOI ICR package_2021.zip