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Title:
Maritime Illness Database and Reporting System (MIDRS)
Project Id:
0900f3eb81d971d8
Accession #:
NCEH-VSPT-8/5/21-971d8
Project Contact:
Keisha A Jenkins
Organization:
NCEH/ATSDR/DEHSP/WFEHSB/VSPT
Status:
Project In Progress
Intended Use:
Project Determination
Estimated Start Date:
04/30/2022
Estimated Completion Date:
04/29/2025
CDC/ATSDR HRPO/IRB Protocol #:
0920-1260
OMB Control #:
Determinations
Determination
Justification
HSC:
Does NOT Require HRPO
Review
Not Research - Public Health Surveillance
PRA:
PRA Applies
Completed
Entered By & Role
9/16/21
Davis_Stephanie I. (sgd8) CIO HSC
9/16/21
Davis_Stephanie I. (sgd8) CIO OMB / PRA
45 CFR 46.102(l)(2)
ICRO:
PRA Applies
OMB Approval date: 4/2/19
OMB Expiration date: 4/30/22
9/16/21
Zirger_Jeffrey (wtj5) ICRO Reviewer
Description & Funding
Description
Priority:
Standard
Determination Start Date:
08/05/21
Description:
OMB #: 0920-1260
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
This is an extension information collection request (ICR) for #Maritime Illness Database and Reporting System (MIDRS)# (OMB
Control No. 0920-1260; expiration date 04/30/2022). The Vessel Sanitation Program (VSP) monitors AGE illness on passenger
ships (#cruise ships#), conducts sanitation inspections and epidemiologic investigations when outbreaks occur, and formulates
public health recommendations to prevent future transmissions and outbreaks. Cruise ships carrying 13 or more passengers and
within 15 days of arriving in the U.S. from a foreign port are required to report the number of cases of AGE through CDC VSP#s
Maritime Illness Database and Reporting System (MIDRS). The number of AGE cases is ascertained from a ship#s medical
records, a line listing of AGE cases onboard (i.e., #AGE Log#) is provided to CDC#s VSP and a 72-hour food/activity history used to
identify potential sources of illness exposure.
Objective:
VSP will analyze data from MIDRS, AGE Logs, and 72-hour food/activity histories using descriptive analysis methods to monitor
AGE outbreaks and identify trends. Results are used to determine sources of exposure, identify clusters, high risk populations
/groups, causative agents of cruise ship AGE outbreaks, inform outbreak management plans and prevention strategies, and
improve cruise industry infection control procedures.
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
Yes
equity science:
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:
General US Population
Tags/Keywords:
Public Health Surveillance ; Gastroenteritis ; Outbreak investigation
CDC's Role:
CDC is recipient of private data/specimens FROM an institution
Method Categories:
Outbreak Investigation
Methods:
The MIDRS data collection system is a syndromic surveillance system that receives AGE case information electronically through a
web-based reporting portal or by email; data can also be submitted by phone, email or fax and entered into MIDRS by VSP. AGE
cases reported to MIDRS are cumulative case counts and do not represent the number of active (symptomatic) AGE cases at any
given port of call or at disembarkation. The AGE log and 72-hour food/activity history are completed and maintained on the ship as
part of the case#s medical record owned by the cruise line; cruise lines decide how they are maintained onboard (e.g., electronic,
paper). VSP reviews these records during operational inspections to confirm availability of records, and proper reporting of AGE
illness cases and occurrence of AGE outbreaks for a particular voyage.
Collection of Info, Data or Biospecimen:
The AGE Log and MIDRS reports are completed and submitted by cruise ship medical staff or other designated personnel who
report AGE cases among passengers or crew aboard cruise ships carrying 13 or more passengers and within 15 days of arriving in
the U.S. from a foreign port. AGE cases provide information for the 72-hour food/activity histories.
Expected Use of Findings/Results:
VSP will analyze data from MIDRS, AGE Logs, and 72-hour food/activity histories using descriptive analysis methods to monitor
AGE outbreaks and identify trends. Results are used to determine sources of exposure, identify clusters, high risk populations
/groups, causative agents of cruise ship AGE outbreaks, inform outbreak management plans and prevention strategies, and
improve cruise industry infection control procedures.
Could Individuals potentially be identified based on
Information Collected?
No
Funding
Funding Type
Funding Title
Funding #
Original Budget Yr
# Years Award
Budget Amount
Other-
Staff Time Only
0.00
HSC Review
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
Keisha
Jenkins
05/12/2024
CITI Biomedical Exp.
Date
CITI Social & Behavioral
Exp. Date
CITI Good Clinical Practice
Exp. Date
Staff Role
Email
Phone
Organization
Program
Official
brn0@cdc.
gov
770-4883096
VSP
Data
DMP
Proposed Data Collection Start Date:
4/30/22
Proposed Data Collection End Date:
4/29/25
Proposed Public Access Level:
Non-Public
Non-Public Details:
Reason For Not Releasing Data:
Country/Jurisdiction owns the data with protections under their laws and regulations
Public Access Justification:
Cruise companies own their data
How Access Will Be Provided for Data:
Confidential
Plans for Archival and Long Term Preservation:
Spatiality
Spatiality (Geographic Locations) yet to be added .....
Spatiality (Geographic Locations) yet to be added .....
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
| File Type | application/pdf |
| File Modified | 0000-00-00 |
| File Created | 2021-10-11 |