SSA Emergency Clearance 2024 Marburg Traveler Monitoring Assessment

2024 Marburg Traveler Monitoring Assessment

Request for OMB approval of a New Information Collection

October 9, 2024

Supporting Statement A

Contact:

Rudith Vice

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404) 718-7292

Email: [email protected]

Table of Contents

Request for OMB approval of a New Information Collection 1

1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 4

3. Use of Improved Information Technology and Burden Reduction 4

4. Efforts to Identify Duplication and Use of Similar Information 5

5. Impact on Small Businesses or Other Small Entities 5

6. Consequences of Collecting the Information Less Frequently 5

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

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 5

9. Explanation of Any Payment or Gift to Respondents 5

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 6

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 6

12. Estimates of Annualized Burden Hours and Costs 6

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 7

14. Annualized Cost to the Government 7

15. Explanation for Program Changes or Adjustments 7

16. Plans for Tabulation and Publication and Project Time Schedule 7

17. Reason(s) Display of OMB Expiration Date is Inappropriate 8

18. Exceptions to Certification for Paperwork Reduction Act Submissions 8

Attachments 8

• Goal of the study: The goal of this information collection is to determine the number of travelers coming to the United States from Rwanda, where a Marburg outbreak is occurring, that are enrolled by jurisdictions into monitoring, if recommended, and the proportion of travelers that completed monitoring. A one-time survey at the end of the response will collect information related to resources needed by health department for this response.

• 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 a Marburg outbreak originating in Rwanda.

• Methods to be used to collect: State and local health officials will complete a survey developed by CDC via REDCap and RREDI.

• 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 a Marburg outbreak originating in Rwanda.

• 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.

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 Health (DGMH) 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, DGMH works to fulfill this responsibility through a variety of activities, including the operation of Port Health 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.

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 Number 0920-1354.

In September 2024, an outbreak of Marburg virus was detected in the Republic of Rwanda.³ CDC plans to conduct public health entry screening at designated U.S. airports of travelers coming from areas experiencing an outbreak of Marburg originating in Rwanda. The purpose of public health entry screening is to detect ill travelers or travelers arriving from regions affected by the outbreak who are at risk of becoming ill with Marburg to facilitate post-arrival management. This information collection has been submitted to OMB and is pending approval.

CDC will share contact information and public health assessment of exposure risk to Marburg for travelers who have been in Rwanda during the 21 days before their arrival in the United States, and for whom post-arrival monitoring is recommended based on activities in Rwanda, with state and local health departments through existing secure 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 Marburg 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 recommendations for management of U.S.-based healthcare personnel who have been in Rwanda and additional interim recommendations for other travelers that are under development within CDC.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 a Marburg outbreak originating in Rwanda. 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 viral hemorrhagic fever outbreaks abroad.

CDC will share contact information and public health assessment of exposure risk to Marburg for travelers for whom post-arrival monitoring is recommended 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 Marburg and determine 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 Marburg. 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 twice weekly to CDC via REDCap⁵ initially and later RREDI (both CDC-approved secure web applications). CDC has minimized the data collected to reduce burden to participating health departments.

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

This data collection will not involve 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

This request fully complies with the regulation 5 CFR 1320.5.

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 seaports 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. Explanation 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 (Attachment E).

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.

Data will be kept private to the extent allowed by law.

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

Institutional Review Board (IRB)

NCEZID’s Human Subjects Advisor has determined that information collection is not research involving human subjects. IRB approval is not required (Attachment F).

Justification for Sensitive Questions

This information collection does not contain sensitive questions.

12. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

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

The total annual burden requested for this request is 70 respondents, state and local health officials conducting traveler monitoring with approximately 607 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 Marburg outbreak originating in Rwanda. 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 estimate of 1 staff member from 70 state and local health departments may be required to answer questions on the CDC - Marburg Virus Disease Healthcare Worker Monitoring 2024 (Attachment C) regarding traveler monitoring activities. State and local health departments will be asked to answer questions twice a week. CDC estimates these questions will take approximately 5 minutes.

• An estimate of 1 staff member from 70 state and local health departments may be required to answer questions on the MVD Final Survey_10.08.2024 (Attachment D) regarding traveler monitoring activities. State and local health departments will be asked to answer questions once at the end of this response. CDC estimates these questions will take approximately 20 minutes.

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
State/Local Health Department	CDC - Marburg Virus Disease Healthcare Worker Monitoring 2024	70	104	5/60	607
State/Local Health Department	MVD Final Survey_10.08.2024	70	1	20/60	23
Total					630

B. Estimated Annualized Burden Costs

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 $19,098.

Type of Respondent	Form Name	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State/Local Health Department	CDC - Marburg Virus Disease Healthcare Worker Monitoring 2024	607	$ 31.48	$19,108
State/Local Health Department	MVD Final Survey_10.08.2024	23	$ 31.48	$724
Total				$19,832

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

There are no costs to respondents other than their time to participate.

14. Annualized Cost to the Government

The estimated annual cost for these activities to the federal government is approximately $1,240,610 for CDC staff to create and electronically distribute the traveler monitoring 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

The display of the OMB Expiration date is not inappropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

Attachments

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

2. Attachment A2 - 42 Code of Federal Regulations part 71

3. Attachment B - 60-day Federal Register Notice

4. Attachment C – CDC - Marburg Virus Disease Healthcare Worker Monitoring 2024

5. Attachment D - MVD Final Survey_10.08.2024

6. Attachment E—Privacy Impact Assessment

7. Attachment F – 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/port-health/legal-authorities/order-collect-contact-info.html?CDC_AAref_Val=https://www.cdc.gov/quarantine/order-collect-contact-info.html

3 https://www.cdc.gov/media/releases/2024/s0929-marburg-cases-rwanda.html

4 https://www.cdc.gov/viral-hemorrhagic-fevers/php/public-health-strategy/management-of-US-based-healthcare-personnel-2024-marburg-outbreak.html

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

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