Non-Substantive Change Request 21MAY2021

Non-Substantive Change Request Memo

Phased Approach to the Resumption of

Cruise Ship Passenger Operations

(OMB Control No. 0920-1335)

Program Contact

Jeffrey M. Zirger

HEALTH SCIENTIST

Information Collection Review Office

Office of Scientific Integrity

Office of Science

Centers for Disease Control and Prevention

1600 Clifton Road, NE MS D-74

Atlanta, GA 30333

Telephone: (404) 639-7118

Mobile: (470) 217-8909

Fax: (404) 639-3249

Email: [email protected]

Submission Date: May 20, 2021

The Centers for Disease Control and Prevention (CDC) requests a nonmaterial/non-substantive change of the currently approved Information Collection Request: “Phased Approach to the Resumption of

Cruise Ship Passenger Operations”

This change request is to add the following form “Attestation by A Cruise Ship Operator

In Lieu Of A Simulated Voyage”

This change allows the cruise ship operators to Attest that:

• Restricted passenger voyages will only operate with 95%1 of crew who are fully vaccinated.2

• A clear and specific vaccination plan and timeline to limit cruise ship sailings to 95% of

• passengers who will be confirmed as fully vaccinated prior to sailing has been submitted to

• CDC.

CDC will discontinue the use of the following form “Attestation for Commercial Transportation of Disembarking Crew for Cruise Ship Operators During the Initial Phases of

CDC’s Framework for Conditional Sailing Order (CSO)”

Additionally, CDC has added the following changes to the “Enhanced Data Collection (EDC) During COVID-19 Pandemic” form:

• Changed the reporting time to 1200ET

• Clarified and added that the longitude and latitude, must be reported as “(in Decimal Degrees [DD])

• Added that crew ships can report “Percentage of travelers fully vaccinated† for COVID-19”

• Added in” FOR ASYMPTOMATIC TESTING ONLY (i.e., not testing for symptomatic persons): confirmatory testing for a positive antigen test should take place as soon as possible after the antigen test, and not longer than 48 hours after the initial antigen testing. If more than 48 hours separate the two specimen collections, or if there have been opportunities for new exposures, a NAAT should be considered a separate test – not a confirmation of the earlier test.”, “Ships that choose to use antigen tests should follow CDC”

• Clarified that End of newly embarking quarantine screening testing and disembarking testing only applies to not fully vaccinated crew

• Clarified and updated that Viral testing is not only restricted to “ reverse transcription polymerase chain reaction (RT-PCR), reverse transcription loop-mediated isothermal amplification (RT-LAMP), transcription-mediated amplification (TMA), nicking enzyme amplification reaction (NEAR), and helicase-dependent amplification (HAD)”

• Clarified and added that “ disembarkation testing for “NOT FULLY VACCINATED TRAVELERS (Please report final screening test results only [e.g., if an asymptomatic person is antigen-positive then tests NAAT-negative on the same day, do not report the initial antigen-positive result to EDC]”

• Added the word “viral” in lines 39-54

• Added the words “viral test collected within 24 hours before” in lines 55-62

• Added in the following sentences as clarification

  • All overnight contractors/visitors/vendors should be identified as crew for all CDC reporting requirements [i.e., day contractor/visitors/vendors can be excluded]

  • ‡ A febrile person in the presence of a more likely diagnosis (e.g., cellulitis, urinary tract infection, tooth abscess) does not represent CLI and should not be reported via EDC.

  • § Examples of available NAATs for SARS-CoV-2 include but are not restricted to: reverse transcription polymerase chain reaction (RT-PCR), reverse transcription loop-mediated isothermal amplification (RT-LAMP), transcription-mediated amplification (TMA), nicking enzyme amplification reaction (NEAR), and helicase-dependent amplification (HDA).

  • ‖ Please refer to CDC’s antigen testing guidance.

  • ¶ If an alternate infectious etiology is identified through laboratory testing, routine infection control precautions recommended for the diagnosis should be followed.

  • ¶¶ Embarkation day testing applies to all passengers on back-to-back sailings prior to the ship sailing on the next voyage, regardless of vaccination status.

This Non-Substantive Change Request results in no additional changes to currently approved information collection instruments and no change in burden hours.