Change Request Justification - COVID-19 - April 2020

Request for Nonmaterial/Non-substantive change

Foreign Quarantine Regulations (42 CFR 71)

(OMB Control No. 0920-0134)

Expires 03/31/2022

Program Contact

Amanda Crouse

Office of Policy, Analysis and Strategy

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)

Centers for Disease Control and Prevention

1600 Clifton Road NE, MS H16-5

Atlanta, Georgia 30329-4027

Phone: 404.639.5136

Email: [email protected]

Submission Date: 11/4/2021

Circumstances of Change Request for OMB 0920-0134

The Centers for Disease Control and Prevention (CDC), Division of Global Migration and Quarantine (DGMQ) requests a nonmaterial/non-substantive change of the currently approved Information Collection Request: Foreign Quarantine Regulations (42 CFR 71), OMB Control No. 0920-0134, expiration date: 05/31/2022.

Recent CDC investigations in response to COVID-19 onboard maritime vessels have shown that cruise ship travel markedly increases the risk and impact of the COVID-19 disease outbreak within the United States (U.S.). Due to the CDC Level 3 Travel Health Notice that exists for all cruise ships, the increasing number of countries with widespread ongoing transmission, and the temporary suspension of cruise travel worldwide, the shifting focus in the U.S. is for the safe return of crew members to their home country and the well-being of crew members remaining onboard. During a period of suspended passenger operations, such as the COVID-19 pandemic, it is acknowledged that some crew are essential to maintain basic operations (i.e., Minimum Safe Manning [MSM]) of the ship.

CDC is requesting the addition of a cruise ship reporting form that will solicit data concerning COVID-19 cases or potential COVID-19 cases. This data will be collected from cruise ships originating from, stopping in, or anchored off of the U.S. (i.e., for fuel, provisions, crew disembarkations, or medical assistance). Current CDC reporting forms do not elicit the type of information needed to adequately respond to the outbreaks of the disease, as the current forms do not distinguish between Influenza-like Illness (ILI), Acute Respiratory Illness (ARI), pneumonia, and COVID-19. In lieu of submitting the Maritime Conveyance Cumulative Influenza/Influenza-Like Illness (ILI) Form (Attachment A), the CDC will strongly recommend weekly submission of the Enhanced Data Collection During COVID-19 Pandemic form (Attachment B) during suspended cruise ship operations. Data points for this form include number of crew members currently onboard; case counts and diagnostic testing data for ARI, ILI, and pneumonia among crew; isolation practices; and onboard medical shortages or limitations. This data will greatly increase the transparency of the overall health of the crewmembers remaining onboard and better allow the CDC to manage potential outbreaks and offer recommendations to port partners.

Seaports are denying entry to cruise ships due to their already overburdened health care systems and federal partners are requiring CDC to make determinations about the health status of the ship before it ports in the U.S. At this time, CDC cannot make informed recommendations to our federal and local partners without this information. The Enhanced Data Collection During COVID-19 Pandemic form will allow CDC to track and respond to potential outbreaks on ships and quickly respond to data inquiries. CDC is currently writing Interim Guidance for the Mitigation of COVID-19 Among Crew During Suspended Cruise Ship Operations to assist ships.

CDC is currently investigating several large outbreaks of respiratory illness among cruise ship crew members and is aware of several rumored outbreaks. Unfortunately, current reporting guidelines do not fully capture the information needed to properly respond to the outbreak. From the initial pilot, the first three Enhanced Data Collection During COVID-19 Pandemic forms that were submitted by ships showed possible COVID-19 outbreaks with 30+ cases per ship, of which CDC and port partners were previously unaware.

Description of the changes

The new form, “Enhanced Data Collection During COVID-19 Pandemic”, will solicit information on the number of crew on board, as well as what port is nearest when the report is made. It will then solicit information on the number of cases of illness meeting certain criteria, such as those having ARI, ILI, and pneumonia. It will also ask if any diagnostic testing has been done. Finally, the form asks whether the cruise ship has implemented isolation procedures according to CDC COVID-19 guidelines.

CDC will be providing guidance on the use of the form via multiple channels to ensure broad distribution to the cruise industry. Those channels include distribution via Cruise Lines International Association (CLIA), which is the world’s largest cruise industry trade association; email correspondence from CDC Maritime Activity to cruise line medical directors; and posting guidance to CDC’s maritime industry website, available here: https://www.cdc.gov/quarantine/maritime/recommendations-for-ships.html.

Burden

This form would constitute an additional burden to cruise ship operators. The additional burden to this information collection is 2,167 hours from 250 respondents. The currently approved burden under this ICR is 268,493 hours. With the addition of this new instrument, the new burden will be 270,660 hours.

CDC expects the form to be submitted once a week by any cruise ship originating from, stopping in, or anchored off of the U.S. The number of cruise ships meeting these criteria is currently unknown at this time, but could be up to 250. Cruise ships should already have the information needed to complete the form in their medical logs; based on the pilot, the form should take around 5-10 minutes to complete. For the purposes of estimating burden hours, the upper limit of this range (i.e., 10 minutes) is used.

Respondent	Form	Number of Respondents	Number of Responses per Respondent	Average Burden per Response (in minutes)	Total Burden Hours
Cruise ship operator	Enhanced Data Collection During COVID-19 Pandemic	250	52	10/60	‬2,167‬‬‬‬‬‬‬‬‬
Total					2,167

As the COVID-19 outbreak progresses and the impact on the cruise industry changes, CDC will monitor the burden on cruise ships to see if the number of ships/voyages and market demand declines. Additionally, if the No Sail Order is rescinded and COVID-19 remains in circulation, CDC may consider a change request to incorporate some of the data fields in a revised Cumulative ILI form, or have this new form replace the Cumulative ILI form as a permanent request from the cruise lines, as the requirement will no longer be an option.

Privacy

There is no PII collected as part of this information collection.

4