Non-research determination

Print Date: 10/14/21

Title:

Emergency Cruise Ship Outbreak Investigations (CSOIs)

Project Id:

0900f3eb81d9a780

Accession #:

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

Project Contact:

Keisha A Jenkins

Organization:

NCEH/ATSDR/DEHSP/WFEHSB/VSPT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

03/31/2021

Estimated Completion Date:

03/31/2022

CDC/ATSDR HRPO/IRB Protocol #:
No OMB Control Number issued

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

9/21/21

Davis_Stephanie I. (sgd8) CIO HSC

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: 9/22/21
OMB Expiration date: 12/31/99

9/21/21

Davis_Stephanie I. (sgd8) CIO OMB / PRA

9/22/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Determination Start Date:

08/09/21

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 deploys to the field and 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 24-hours of submission to OMB. The data collection period for each CSOI will not exceed 30 days.

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

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-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.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

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

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:

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?

No

Funding

Funding Type

Funding Title

Other-

Staff Time Only

HSC Review

HSC Attributes

Funding #

Original Budget Yr

# Years Award

Budget Amount
0.00

Non-Epi Aids Investigations

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research
Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA 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
Name

FWA #

FWA Exp Date

Centers for Disease Control & Prevention

FWA00001413

07/30/26

IRB Title

IRB Exp Date

Funding #

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical Exp.
Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical Practice
Exp. Date

Keisha
Jenkins

n/a

n/a

n/a

n/a

Staff Role

Email

Phone

Program
Official

brn0@cdc.
gov

770-4883096

Organization

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...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date