Maritime Illness Database and Reporting System (MIDRS)
OMB Control No. 0920-1260
Expiration Date 04/30/2022
Extension
Formerly under Foreign Quarantine Regulations (OMB Control No. 0920-0134)
Supporting Statement Part B –
Collections of Information Employing Statistical Methods
Project Officer: Keisha Jenkins, DrPH, MPH
LCDR U.S. Public Health Service
CDC Vessel Sanitation Program
Office: 770.488.3096
Email: [email protected]
Date: January 25, 2022
B.1. Respondent Universe and Sampling Methods 3
B.2. Procedures for the Collection of Information 3
B.3. Methods to Maximize Response Rates and Deal with No Response 4
B.4. Test of Procedures or Methods to be Undertaken 4
B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5
Part B. Collections of Information Employing Statistical Methods
The regulations at 42 CFR part 71 outline the respondent universe, which for this information collection request (ICR) includes a ship’s master, medical staff, or other designated person on a passenger vessel carrying 13 or more passengers and within 15 days of arriving in a U.S. port from a foreign port. The ship’s designated Maritime Illness Database and Reporting System (MIDRS) reporter, usually a medical crewmember, reports the aggregate number of passengers and crewmembers onboard who have experienced acute gastroenteritis (AGE) as defined by federal regulations at any time during the voyage. These aggregate numbers are derived from cruise line/passenger vessel owned medical documentation kept during the normal course of business when treating patients experiencing AGE symptoms (Attachments A1, A2, A3). Individual case information is compiled by the medical staff on an AGE log using a standard format (Attachment 5b).
Additionally, in the event of an outbreak, the respondent universe includes AGE cases, both crew and passengers, who report what they ate, drank, and did in the 72 hours prior to symptom onset to the medical staff (“72 hour food/activity history” template is provided in Attachment 5c). There are no sampling methods employed in this information collection. This work is performed to prevent the introduction, transmission, and spread of communicable diseases from foreign countries into the United States.
This information collection request has been further revised to separate cruise ship crew and cruise ship passengers to more accurately estimate the additional burden on the crew. They are required to complete several additional assessments to document fitness to work (Attachments 5d, 5e, 5f).
This ICR has also been revised to more accurately account for recordkeeping burden on cruise ship medical staff (Attachment 6a) and on cruise ship engineering staff (Attachment 6b). The engineering staff are a new respondent type in this revision.
AGE illnesses are reported to CDC’s Vessel Sanitation Program (VSP) via MIDRS, https://wwwn.cdc.gov/midrs/GILogin.aspx (Attachment 5a1). MIDRS is an electronic reporting and surveillance system that offers a variety of options for submitting reports, including online submission using this common web-based portal, or by email, fax and phone (Attachment 5a2). The Master of the vessel, the medical staff, or other designated staff receives self-reports of AGE illness from passengers and crew members onboard their ship, completes a medical assessment, and determines if that person meets the reportable case definition as outlined in 42 CFR 71.1 (b) ii (B) (Attachment 4a). If the ill person meets the AGE case definition, key data elements are recorded on a standardized AGE log (Attachment 5b; Attachment 4b, §4.1.2.1.3, p.62). AGE cases are asked about what they ate, drank, and did in the 72-hours prior to symptom onset (“72-hr. food/activity history) (no standard form, example template at Attachment 5c, operational requirement can be found in Attachment 4b, §4.1.2.2.1, p.64) in order to identify a likely source of exposure and target response efforts.
When AGE cases exceed the 2-percent alert threshold and the 3-percent outbreak threshold, special reports and updates (Attachment 5a3) are sent by medical staff to VSP until they are four hours from port. These ships must begin sending at least one and up to 12 daily reports in the form of AGE logs (Attachment 5b).
AGE cases reported to MIDRS are totals for the entire voyage 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) (Attachment 6a). VSP reviews these records during operational inspections to confirm they are available if needed, and if there is an AGE outbreak or report of unusual AGE illness for a particular voyage.
Cruise ship medical staff are required to send a total number of AGE illness cases to VSP via MIDRS at the following designated times:
24 to 36 hours before arriving to a U.S. port from a foreign port; this report is required even when there are no cases of gastrointestinal illness (“Routine 24-hr Report”; Attachment 4b, §4.2.1.1.1, p.66)
if the number of passenger or crew AGE reportable cases changes after the initial notification in the bullet above, but before the ship is 4 hours from arrival (“Routine 4-hr Report”; Attachment 4b, §4.2.1.1.2, p.66), and
when 2% or more of the passengers or crew are ill with AGE illness, and then again when 3% or more of the passengers or crew are ill with AGE illness (“Special 2% or 3% Report”; Attachment 4b, §4.2.2.1.1, p.67). This report must be sent at any time the vessel is in the United States or within 15 days of arriving to a U.S. port
The requirements for reporting AGE illness data on passenger vessels in U.S. jurisdiction are codified in regulations in 42 CFR part 71 (Attachment 1C). If passenger vessel personnel fail to submit reports at the appropriate times during their voyage, they will receive a critical violation on their subsequent unannounced sanitation inspection, which affects the ship’s overall inspection score, and which is posted on VSP’s public website for program transparency. CDC requires that AGE illness information be reported at certain times during a foreign to U.S. voyage (42 CFR 71.21). Not responding to this data collection is a violation of regulation.
Data elements that are required to be submitted to MIDRS are documented for the cruise industry in the VSP Operations Manual (Attachment 4b) and have been used for monitoring purposes for several decades. Data elements required in the AGE Log and the 72-hour food/activity history are commonly requested during medical assessments during a normal course of treatment, have been vetted during public meetings with stakeholders, and have been requested by CDC for many years for the purpose of monitoring AGE illness as is mandated by federal quarantine laws.
The electronic system used for this information collection is continually updated and improved for quality of data collection and ease of use for the public, industry, and CDC program administrators.
Data are collaboratively delivered to the VSP by cruise lines. Below are the names, telephone number, and e-mail addresses of VSP staff who will analyze the information for the agency. Drs. Keisha Jenkins and Michtta Jean-Louis at CDC will perform data analysis and prepare reports. No outside consultations have been made in the past three years.
Table 1. Personnel Consulted on Statistical Design
Name |
Title |
Affiliation |
Phone |
|
FEDERAL AGENCY |
||||
Keisha Jenkins, DrPH |
Senior Epidemiologist |
CDC |
(770) 488-3096 |
|
Michtta Jean-Louis, PharmD |
Epidemiologist |
CDC |
(404) 498-4666 |
|
Table 2. Personnel Responsible for Data Analysis of Information
Name |
Title |
Affiliation |
Phone |
|
Keisha Jenkins, DrPH |
Senior Epidemiologist |
CDC |
(770) 488-3096 |
|
Michtta Jean-Louis, PharmD |
Epidemiologist |
CDC |
(404) 498-4666 |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Richardson, Tony (CDC/OD/OADS) |
| File Modified | 0000-00-00 |
| File Created | 2022-04-06 |