CHANGE REQUEST (June 2023) Streamlined reporting for Acute Respiratory Illness at the end of the PHE for COVID-19

Non-Substantive Change Request Memo

Phased Approach to the Resumption of

Cruise Ship Passenger Operations

(OMB Control No. 0920-1335, exp. 1/31/2026)

June 6, 2023

Program Contact

Thomas Daymude

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: 404.718.7103

Email: [email protected]

Effective Date of Proposed Changes: Immediately upon receipt of OMB approval

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

Cruise Ship Passenger Operations,” OMB Control No. 0920-1335.

During the COVID-19 Public Health Emergency (PHE), CDC used the “Enhanced Data Collection (EDC) During COVID-19 Pandemic” Form to collect aggregate case count and testing information about travelers with confirmed or suspected infection with the virus that causes COVID-19, as well as limited information about travelers with other acute respiratory infections (ARI). The “EDC” form was submitted to CDC daily by the cruise ship physician.

With the end of the COVID-19 PHE, CDC proposes a number of changes that will reduce burden and align reporting with revised guidance for cruise ships. The revised “EDC” form will be shorter and allow consolidated reporting of multiple conditions, and will be renamed to reflect a change in focus from COVID-19 to ARI more generally. In addition, the frequency of reporting will be reduced from daily to once per voyage. An itemized justification of each proposed change is provided below.

1. Update Enhanced Data Collection (EDC) Form:

1. Change: Updated title of form

FROM “Enhanced Data Collection (EDC) During COVID 19 Pandemic”

TO “Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form”

Rationale: To reflect cumulative reporting of any acute respiratory illness (ARI) into one form (for COVID-19, influenza, & Respiratory Syncytial Virus and unspecified ARI).

1. Change: Updated to show changing reporting frequency to once per voyage (previously

daily)

Rationale: CDC now only requests cumulative reports once per voyage, instead of every day.

2. Change: Added footnote

Rationale: To clarify to ships with multiple US ports in same voyage (e.g., Alaska) that

reporting only has to be done at the last port of a voyage.

3. Change: Updated hyperlink and title of webpage

Rationale: Items reflect new cruise webpage guidance for acute viral respiratory pathogens (e.g., COVID-19, influenza, RSV).

4. Change: Updated to “Next U.S. Seaport (City and State/Territory)” from “Closest seaport at time of submission (City and Country)”

Rationale: Aligns with the Maritime Illness/Death Reporting form.

5. Change: Removed request for GPS coordinates

Rationale: This information is no longer necessary because cruise ships will be reporting once per voyage rather than every day.

6. Change: Added definition of acute respiratory illness (ARI), clarifying language, and link to guidance

Rationale: Including this language/guidance allows the reporting of any acute respiratory illness (ARI), instead of solely COVID-19.

7. Change: Re-ordered the points in the bulleted listed for emphasis

Rationale: This change was made to prioritize reporting of illnesses of public health concern.

8. Change: The language in this section was updated from “COVID-19-like Illness (CLI)” to “Acute Respiratory Illness (ARI)”

Rationale: Updated to allow the reporting of other acute respiratory illness, instead of solely COVID-19.

9. Change: The definition used for this section was updated from “CLI clinical criteria/definition” to “ARI clinical criteria/definition”

Rationale: Updated to allow the reporting of other acute respiratory illness, instead of solely COVID-19.

10. Change: Removed five questions from this section

Rationale: By updating this section to account for ARI instead of COVID-19 specifically,

these questions are no longer necessary.

11. Change: Added clarifying footnote

Rationale: Added to address continued confusion for what constitutes a medical evacuation.

12. Change: The questions in this section were reworded

Rationale: These questions were reworded to provide greater clarity to the cruise ship clinicians completing the form and elicit more accurate responses.

13. Change: Seventeen questions were removed from this section

Rationale: To simplify and align with the fact that screening is no longer required,

Annual Burden

Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form: The ARI Reporting Form is a simplified, updated version of the prior EDC Form. These changes are necessary to remain in alignment with current CDC guidance (which is now more flexible) following the conclusion of the COVID-19 public health emergency. CDC estimates that the burden for reporting (particularly because we are no longer requiring daily reports) will decrease from 15,817 hours to 1,000 hours annually.

• The number of respondents has decreased from 130 to 100 as some cruise ships no longer port in the US because other countries opened up their ports.

• The estimated number of times each respondent would need to respond will decrease from 365 to 60, because CDC is now only requesting one report per voyage, instead of one report each day. CDC used 2019 estimates of cumulative influenza-like illness reports to estimate the number of times a cruise ship may report per year.

• With the number of questions being reduced by 66%, and the revisions not requiring any additional information needing to be collected by cruise ship operators, CDC now estimates it will take respondents 10 minutes to fill this out, instead of 20.

The total estimated annualized burden for the revised form will change from 15,817 hours to 1,000 hours (-14,817 hours).

The total estimated annualized burden for the Information Collection Request will change from 17,532 hours to 2,715 hours.

Previous approval (burden table excerpt):

Type of Respondent	Form or Information Collection Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
Cruise ship physician	Enhanced Data Collection (EDC) During COVID-19 Pandemic Form (Daily)	130	365	20/60	15,817
	ICR Total				17,532

Effects of changes requested in this Change Request (burden table excerpt):

Type of Respondent	Form or Information Collection Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
Cruise ship physician	Cruise Ship Cumulative Acute Respiratory Illness (ARI) Reporting Form	100	60	10/60	1,000
	ICR Total (Revised)				2,715

The revised form is provided as Attachment H_06022023_clean.

To facilitate review of changes, see Attachment H_06022023_tracked.

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