SSA Emergency Clearance 2022 Ebola Traveler Follow Up Evaluation_10.26.2022

Goal of the study: The goal of this information collection is to determine the proportion of travelers coming from areas affected by an Ebola outbreak originating in Uganda that are enrolled by jurisdictions into monitoring and the proportion of travelers that completed monitoring.
Intended use of the resulting data: The information will be used to inform CDC and interagency decision makers on state/local health department travel monitoring activities related to travelers coming from areas affected by an Ebola outbreak originating in Uganda.
Methods to be used to collect: State and local health officials will complete a traveler follow up evaluation developed by CDC via REDCap.
The subpopulation to be studied: The respondent universe for this information collection request is state and local health officials conducting monitoring and follow up activities related to travelers coming from areas affected by an Ebola outbreak originating in Uganda.
How data will be analyzed: Data will be analyzed using standard statistical methods to help CDC assess health departments’ efforts in traveler outreach, communication, and monitoring.

Supporting Statement A

CDC is requesting an emergency clearance for this information collection for 180 days.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ) requests an emergency 180-day approval for a new information collection.

Section 361 of the Public Health Service (PHS) Act (42 USC 264) (Attachment A1) authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the United States. Under its delegated authority, DGMQ works to fulfill this responsibility through a variety of activities, including the operation of Quarantine Stations at ports of entry and administration of foreign quarantine regulations; 42 Code of Federal Regulation part 71 (Attachment A2), specifically 42 CFR 71.20 Public health prevention measures to detect communicable disease. This information collection concerns CDC’s responsibility to ensure the successful implementation of traveler monitoring to prevent the transmission or spread of communicable diseases into the United States.

On February 21, 2020, CDC issued an interim final rule (IFR)¹ to amend its Foreign Quarantine regulations, to enable CDC to require airlines to collect, and provide to CDC, certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including travel restrictions. CDC’s authority for collecting data for travelers arriving in the United States is contained in 42 CFR 71.4.

Under this IFR, airlines must transmit these data to CDC within 24 hours of an order. The order Requirement for Airlines and Operators to Collect and Transmit Designated Information for Passengers and Crew Arriving Into the United States; Requirement for Passengers to Provide Designated Information² requiring the collection of this information was issued on October 25, 2021 and went into effect on November 8, 2021. Under this order, airlines may transmit the required information using the existing data-sharing infrastructure in place between the United States Department of Homeland Security (DHS) and HHS/CDC or they must retain the information for a minimum of 30 days and transmit it to CDC within 24 hours upon request. This information collection for contact information is already approved under OMB Control 0920-1354.

In September 2022, an outbreak of Ebola virus disease caused by the Sudan ebolavirus was detected in the Republic of Uganda.³ CDC is currently conducting public health assessments at designated U.S. airports of travelers coming from areas experiencing an outbreak of Ebola originating in Uganda. The purpose is to detect ill travelers or travelers arriving from regions affected by the outbreak who are at risk of becoming ill with Ebola to facilitate post-arrival management. This information collection is approved under OMB Control 0920-1375.

CDC is currently sharing contact information and initial public health assessment of exposure risk to Ebola for travelers who have been in areas affected by the outbreak during the 21 days before their arrival in the United States with state and local health departments through existing data-sharing infrastructure. State and local health departments utilize the contact information provided by CDC to prioritize and identify the level of follow up needed based on the level of risk of exposure to Ebola and determine additional if additional risk assessment and/or targeted public health measures are necessary. This coordination is necessary to facilitate post-arrival public health management as specified in CDC interim guidance.⁴

2. Purpose and Use of Information Collection

The purpose of this information collection is to inform CDC and interagency decision makers on state/local health department activities related to travelers coming from areas affected by an Ebola outbreak originating in Uganda. This information will be used to 1) gather feedback from state and local health department partners on CDC’s interim guidance and post-arrival management of travelers; 2) assess the quality of contact information provided to states by determining the proportion of travelers that state and local health departments were able to contact for recommended assessment and monitoring; and 3) inform the development of future guidance and recommendations for post-arrival traveler management during Ebola outbreaks abroad.

CDC is currently sharing contact information and public health assessment of exposure risk to Ebola for travelers with state and local health departments through existing data-sharing infrastructure. State and local health departments utilize the contact information provided by CDC to prioritize and identify the level of follow up needed based on the level of risk of exposure to Ebola and determine additional if additional targeted public health measures are necessary.

State/local health department partners are contacting travelers in order to determine if they are symptomatic and require additional screening for possible Ebola. The purpose of this evaluation will be to gather feedback from state and local health departments regarding traveler monitoring activities and determine the usability of contact information and public health risk assessment information shared by CDC.

3. Use of Improved Information Technology and Burden Reduction

State and local health officials will be asked to submit data electronically on a weekly basis to CDC via REDCap⁵, a CDC-approved secure web application.

Depending on the length of the outbreak, the use of other data collection platforms may be considered if a timely and accurate method of providing information to CDC can be identified and determined to be feasible and cost effective.

4. Efforts to Identify Duplication and Use of Similar Information

CDC has the regulatory authority for performing quarantine-related public health risk assessment and evaluation activities at U.S. ports of entry (42 Part 71). As a result, CDC is the only agency collecting illness or death reports related to the introduction and transmission of communicable diseases at ports of entry. CDC works in collaboration with its international, federal, state, and local partners at ports of entry and through multi-state contact investigations to ensure all illness responses and public health follow-up and travel restrictions are done in a coordinated manner.

5. Impact on Small Businesses or Other Small Entities

CDC does not anticipate the respondents to be small businesses.

6. Consequences of Collecting the Information Less Frequently

Failure to collect this information from state and local health departments could lead to an increased risk of ill travelers coming in contact with the general public.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

Frequency of data collection is inconsistent with the guidelines, as discussed in Section A6. The frequency of data collection will be weekly. Over time the frequency of data collection may decrease depending upon the frequency of travelers coming from the outbreak areas, and by the frequency of ill travelers identified at the U.S. airports where these travelers enter the United States.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A. Because this is a request for an emergency clearance, CDC asks that the 60-day comment period be waived. However, a 60-day Federal Register notice will be submitted to make the public aware of this investigation (Attachment B).

B. CDC is the primary authority with responsibility to prevent the introduction and spread of communicable disease in the U.S. through air, land and sea ports of entry and interstate. No other entity collects the type and quantity of information from ill travelers or from individuals under federal public health orders.

9. Explanations of Any Payment or Gift to Respondents

No monetary incentives or gifts are provided to respondents.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

This information collection request has been reviewed by the National Center for Emerging and Zoonotic Infectious Diseases and it has been determined that the Privacy Act does not apply to this information collection request.

Aggregate data not containing personal identifiers will be retained indefinitely for statistical and historical documentation purposes. Electronic media will be protected by adequate physical, administrative, and procedural safeguards to ensure the security of the data. Access will be restricted to agency employees with a bona fide “need to know” in order to carry out the duties of their positions or to accomplish the purposes for which the data were collected. When information is deleted, a special “certified” process will be used to completely overwrite tapes on the mainframe or overwriting (not merely deleting) microcomputer files. Source documents, printouts and thumb drives will be safeguarded by storing them in locked cabinets in locked offices when not in use.

Information collection tools in this request do not ask for personally identifiable information. Individuals may make a request for their available information collected through a Privacy Act request. (https://www.hhs.gov/foia/privacy/how-make-privacy-act-request.html)

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

IRB Determination

CDC’s National Center for Emerging and Zoonotic Infectious Diseases has determined that this project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required (Attachment D).

Justification for Sensitive Questions

This information collection request does not contain personally identifying information of travelers. This information is necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States.

12. Estimates of Annualized Burden Hours and Costs

Below are the estimates of the Annualized Burden Hours that CDC is requesting for this emergency request.

The total annual burden requested for this revision is 350 respondents, state and local health officials conducting traveler monitoring with approximately 4,550 burden hours.

This estimate is based on the following assumptions:

CDC is conducting initial screening and public health risk assessments of travelers arriving from areas affected by the Ebola outbreak originating in Uganda. When indicated, CDC shares contact information and public health risk assessment of travelers with state/local health departments for additional follow up and public health monitoring. CDC is still evaluating the impact of the outbreak on global travel and has provided the best estimate given the current information.

An annual estimate of staff from 350 state and local health departments may be required to answer questions on the Risk Assessment and Post-Arrival Monitoring Outcome REDCap Reporting (Attachment C) regarding traveler monitoring activities. CDC estimates these questions will take approximately 15 minutes.

12 A. Estimates of Annualized Burden Hours

Respondent

Information Collection Tool

Number of Respondents

Number of Responses per

Respondent

Average Burden per Response

(in minutes)

Total Burden Hours

State/local health department

Risk Assessment and Post-Arrival Monitoring Outcome REDCap Reporting

350

15/60

‬ 4,550‬‬‬‬‬‬‬

Total

‬ 4,550‬

12 B. Estimates of Annualized Cost

There will be no anticipated costs to respondents other than time. Wages for travelers were gathered from BLS category 00-0000 “All Occupations” (http://www.bls.gov/oes/current/oes_nat.htm#00-0000). The estimated total cost is $127,446.

Respondent	Information Collection Tool	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State/local health department	Risk Assessment and Post-Arrival Monitoring Outcome REDCap Reporting	‬4,550‬	$28.01	$127,446
Total		4,550		$127,446

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There are no costs to respondents other than the time necessary to respond to the information collection

14. Annualized Cost to the Government

The estimated annual cost for these activities to the federal government is approximately $2,135,790 for CDC staff to create and electronically distribute the traveler follow up evaluation tool and perform statistical analyses of the data. This number may change depending on the volume of data submitted to CDC from state and local health departments.

15. Explanation for Program Changes or Adjustments

This is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

CDC may report aggregate numbers of travelers contacted for monitoring and illness or death investigations as well as methods of contact.

Publication of the results of any lessons learned, may be published to inform future public health interventions and to contribute to the body of knowledge concerning public health monitoring and risk communication. No personally identifiable information will be published.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

Display of the expiration date is appropriate. No exemption is requested.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

List of Attachments

Attachment A1 - Section 361 of the Public Health Service (PHS) Act (42 USC 264)

Attachment A2 - 42 Code of Federal Regulations part 71

Attachment B - 60-day Federal Register Notice

Attachment C - Risk Assessment and Post-Arrival Monitoring Outcome REDCap Reporting

Attachment D - IRB Non-Research Determination

1 https://www.federalregister.gov/documents/2020/02/12/2020-02731/control-of-communicable-diseases-foreign-quarantine

2 https://www.cdc.gov/quarantine/order-collect-contact-info.html

3 https://www.cdc.gov/vhf/ebola/outbreaks/uganda/2022-sep.html

4 https://www.cdc.gov/quarantine/interim-guidance-risk-assessment-ebola.html

5 https://www.project-redcap.org/

File Type	application/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title	Foreign Quarantine Regulations (42 CFR 71)
Author	Stolp, Amber (CDC/DDID/NCEZID/DGMQ)
File Modified	0000-00-00
File Created	2023-08-27

SSA Emergency Clearance 2022 Ebola Traveler Follow Up Evaluation_10.26.2022