SSA - Emergency Clearance 2024 Marburg Traveler Symptom Monitoring & Feedback

SSA - Emergency Clearance 2024 Marburg Traveler Symptom Monitoring & Feedback.docx

[NCEZID] 2024 Marburg Traveler Symptom Monitoring & Feedback

OMB: 0920-1451

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2024 Marburg Traveler Symptom Monitoring & Feedback


Request for OMB approval of a New Information Collection


November 18, 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



1. Circumstances Making the Collection of Information Necessary 3

2. Purpose and Use of Information Collection 5

3. Use of Improved Information Technology and Burden Reduction 5

4. Efforts to Identify Duplication and Use of Similar Information 6

5. Impact on Small Businesses or Other Small Entities 6

6. Consequences of Collecting the Information Less Frequently 6

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 6

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 6

9. Explanation of Any Payment or Gift to Respondents 6

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 7

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 7

12. Estimates of Annualized Burden Hours and Costs 8

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 9

14. Annualized Cost to the Government 9

15. Explanation for Program Changes or Adjustments 10

16. Plans for Tabulation and Publication and Project Time Schedule 10

17. Reason(s) Display of OMB Expiration Date is Inappropriate 10

18. Exceptions to Certification for Paperwork Reduction Act Submissions 10

Attachments 10





Shape1

  • Goal of the study: The purpose of this information collection is to conduct post-arrival symptom monitoring of travelers who have been in the outbreak area and evaluate the impact of rerouting and public health entry screening on travelers.

  • Intended use of the resulting data: This information will be used to 1) conduct post-arrival symptom monitoring of travelers in accordance with CDC recommendations; 2) assess the quality of contact information provided by travelers; 3) update and inform the development of guidance and recommendations for post-arrival traveler management, and 4) update public health messaging to more efficiently reach travelers and provide information about Marburg, public health entry screening, and post-arrival monitoring.

  • Methods to be used to collect: CDC will utilize text messages and web surveys.

  • The subpopulation to be studied: The respondent universe for this information collection request is travelers arriving in the United States who have been in Rwanda in the previous 21 days.

  • How data will be analyzed: No statistical methods will be used.


  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 The Department of Homeland Security has instructed airlines to redirect flights carrying persons who have recently traveled from or were otherwise present within Rwanda to land at designated U.S. airports.4 CDC is conducting public health entry screening at these designated U.S. airports of travelers coming from 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 approved under OMB Control Number 0920-1443.   

CDC will utilize information collected during public health entry screening (approved under OMB Control Number 0920-1443) to determine which travelers should be monitored for Marburg symptoms in accordance with CDC’s interim recommendations for post-arrival public health management of travelers from Rwanda.5 Monitoring of travelers will be done via text message and web survey and will take place over a period of 21 days from the traveler’s last documented Marburg exposure. Text messages and web survey will be available in English with a translated Kinyarwanda version as well. The information collected will allow CDC to identify the level of follow up necessary based on the level of risk of exposure to Marburg and determine additional if additional risk assessment and/or targeted public health measures are needed. Information collected from travelers during symptom monitoring will be shared with state and local health departments through existing secure data-sharing infrastructure. This information collection is necessary to facilitate post-arrival public health management of travelers as specified in CDC interim recommendations for management of U.S.-based healthcare personnel who have been in Rwanda6 and interim recommendations for post-arrival public health management of travelers from Rwanda5.  At the end of the 21-day monitoring period, CDC will send a final survey to travelers intended to evaluate the impact of rerouting and public health entry screening on travelers. The results of this final survey will allow CDC to identify the most efficient channels for reaching travelers and refine public health messaging for travelers coming from the outbreak area.



  1. Purpose and Use of Information Collection

The purpose of this information collection is to conduct post-arrival symptom monitoring of travelers who have been in the outbreak area and evaluate the impact of rerouting and public health entry screening on travelers. This information will be used to 1) conduct post-arrival symptom monitoring of travelers in accordance with CDC recommendations; 2) assess the quality of contact information provided by travelers; 3) inform the development of future guidance and recommendations for post-arrival traveler management, and 4) update public health messaging to more efficiently reach travelers and provide information about Marburg, public health entry screening, and post-arrival monitoring.

CDC will share contact information, public health entry screening information, and post-arrival symptom monitoring information with state and local health departments through existing data-sharing infrastructure. State and local health departments utilize the information provided by CDC to prioritize and identify the level of follow up needed for travelers based on the level of risk of exposure to Marburg and determine if additional targeted public health measures are necessary.



  1. Use of Improved Information Technology and Burden Reduction

All responses will be collected electronically. Consistent with CDC’s 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 Information7, airlines transmit traveler contact information to DHS. DHS then transmits traveler contact information to CDC using the existing data-sharing infrastructure in place between the agencies. CDC will then confirm traveler contact information during public health entry screening at designated U.S. airports of travelers coming from Rwanda.

Traveler phone numbers are then electronically routed to the Data Collation and Integration for Public Health Event Responses (DCIPHER) system. DCIPHER is a web-based data integration and management platform for use across CDC programs to collate, link, manage, analyze, visualize, and share data from multiple sources to inform public health responses. All DCIPHER users must authenticate via CDC’s Digital Support Office – Secure Access Management System (SAMS). Text messages will be sent to travelers using a module within DCIPHER. Depending on whether self-monitoring or intermittent monitoring by public health officials is recommended, travelers will receive either static health messages or interactive symptom monitoring messages (Attachment C1 & Attachment C2). Travelers will have the option to select a language preference, either English or Kinyarwanda.

If travelers respond to text messages indicating they are experiencing Marburg symptoms, they will be directed to a webform where they will be asked for additional details regarding their symptoms (Attachment C3). This webform will be hosted on Response Ready Enterprise Data Integration (RREDI), which is a module hosted within the DCIPHER platform. Travelers will be able to access the webform on mobile devices.



  1. 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.



  1. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.



  1. Consequences of Collecting the Information Less Frequently

Failure to collect this information from travelers that have been in Rwanda in the previous 21 days could lead to an increased risk of ill travelers coming in contact with the general public.



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

This request fully complies with the regulation 5 CFR 1320.5.



  1. 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 consulted on numerous occasions with state and local health departments on the development of information collection instruments and workflows and their feedback was incorporated.



  1. Explanation of Any Payment or Gift to Respondents

No monetary incentives or gifts are provided to respondents.



  1. 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 apply to some aspects of this information collection request (Attachment E). The applicable System of Records Notice is 09-20-0171, Quarantine- and Traveler-Related Activities, including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71 (Attachment F).

Information about travelers with illness investigations or public health risk assessments will be entered into a computer system for analysis and later retrieved if necessary. Data containing personal identifiers and source documents will be retained until the event prompting the collection of data has concluded in accordance with DGMH’s records retention schedule. 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 ask for personally identifiable information, to include name, contact information, and travel related information, to ensure accurate identification of travelers. The presence of symptoms is also collected to assist CDC in making a risk assessment and determine if further public health measures are needed. 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).

Information is being collected that may have an impact on an individual if the information was disclosed. CDC will only share the information without the consent of the traveler as outlined in System of Records Notice is 09-20-0171, Quarantine- and Traveler-Related Activities, including Records for Contact Tracing Investigation and Notification under 42 CFR Parts 70 and 71. These purposes are primarily to ensure appropriate follow-up in the event medical care of additional public health response is necessary and recipients of the information will generally be public health departments and medical providers.

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



  1. 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 (Attachment G). IRB approval is not required.

Justification for Sensitive Questions

No sensitive questions are included in this information collection.



  1. Estimates of Annualized Burden Hours and Costs

A. Estimated Annualized Burden Hours

Below are the Annualized Burden Hours that CDC is estimating for this emergency request.

The total annual burden requested is 4,380 respondents, travelers from Rwanda arriving on commercial flights in the U.S., with approximately 2,833 burden hours.

This estimate is based on the following assumptions:

An average of 120 international air passengers from Rwanda arrive in the U.S. daily. CDC is still evaluating the impact of the outbreak on global travel and has provided the best estimate given the current information.

  • Using the daily average estimate, 43,800 travelers annually from affected areas may be required to participate in public health entry screening upon arrival in the U.S. (OMB Control Number 0920-1443). During public health entry screening, traveler contact information will be confirmed, and CDC staff will determine if the traveler is coming from high-risk area, if they have symptoms consistent with Marburg, and if they have any additional high-risk exposures.

  • CDC estimates that approximately 10% of the travelers (4,380) from affected areas will be coming from a high-risk area, have symptoms consistent with Marburg, or if have any additional high-risk exposures. This estimate is based on enhanced entry screening conducted in 2014 following an imported Ebola case in the U.S.8

  • CDC further estimates that approximately 10% of travelers with symptoms or high-risk exposures (438) will require daily symptom monitoring. CDC estimates that responding to text messages will take approximately 1 minute.

    • CDC estimates completing the Web Survey for Symptomatic Travelers will take an additional 5 minutes.

  • CDC further estimates the remaining 90% of travelers with lower risk exposures (3,942) will require weekly symptom monitoring. CDC estimates that responding to text messages will take approximately 1 minute.

    • CDC estimates completing the Web Survey for Symptomatic Travelers will take an additional 5 minutes.

After travelers have completed daily or weekly symptom monitoring, CDC will send an optional survey to assess how travelers received information about public health entry screening. A text message containing a link to the survey webform will be sent to approximately 4,380 travelers.

Type of Respondent

Form Name

No. of Respondents

No. Responses per Respondent

Avg. Burden per response (in hrs.)

Total Burden (in hrs.)

Traveler

2024 Marburg Symptom Monitoring Daily Group


(Attachments C1 or C1a)

438

21

1/60

153


2024 Marburg Symptom Monitoring Daily Group – Web Survey for Symptomatic Travelers


(C3 or C3a)

438

21

5/60

767

Traveler

2024 Marburg Symptom Monitoring Weekly Group


(Attachments C2 or C2a)

3,942

3

1/60

197


2024 Marburg Symptom Monitoring Weekly Group – Web Survey for Symptomatic Travelers


(Attachments C3 or C3a)

3,942

3

5/60

986

Traveler

2024 Marburg Response Survey of Travelers


(Attachments D1 & D2)

4,380

1

10/60

730

Total


2,833



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 to respondents is $78,164.

Type of Respondent

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Traveler

2024 Marburg Symptom Monitoring Daily Group


(Attachments C1 or C1a)

153

$31.48

$4,816


2024 Marburg Symptom Monitoring Daily Group – Web Survey for Symptomatic Travelers


(C3 or C3a)

767

$31.48

$24,145

Traveler

2024 Marburg Symptom Monitoring Weekly Group


(Attachments C2 or C2a)

197

$31.48

$6,202


2024 Marburg Symptom Monitoring Weekly Group – Web Survey for Symptomatic Travelers


(Attachments C3 or C3a)

986

$31.48

$31,039

Traveler

2024 Marburg Response Survey of Travelers


(Attachments D1 & D2)

730

$31.48

$22,980

Total


$89,182



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

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



  1. Annualized Cost to the Government

The estimated annual cost for these activities to the federal government is approximately $1,469,000 for CDC staff to create, develop, and deliver a traveler symptom monitoring tool and send symptom monitoring notifications to travelers from outbreak affected areas. These costs reflect $1,400,000 for staffing and development resources and $69,000 for supplies. This number may change depending on the volume of data submitted to CDC from state and local health departments.



  1. Explanation for Program Changes or Adjustments

This is a new information collection.



  1. Plans for Tabulation and Publication and Project Time Schedule

CDC may report aggregate numbers of travelers contacted for monitoring.

CDC may publish lessons learned 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.



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

The display of the OMB Expiration date is not inappropriate.



  1. 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 C1 – 2024 Marburg Symptom Monitoring Daily Group

  5. Attachment C1a - 2024 Marburg Symptom Monitoring Daily Group_Kinyarwanda

  6. Attachment C2 - 2024 Marburg Symptom Monitoring Weekly Group

  7. Attachment C2a - 2024 Marburg Symptom Monitoring Weekly Group_Kinyarwanda

  8. Attachment C3 - 2024 Marburg Symptom Monitoring Web Survey

  9. Attachment C3a - 2024 Marburg Symptom Monitoring Web Survey_Kinyarwanda

  10. Attachment D1 – 2024 Marburg Response Survey of Travelers

  11. Attachment D2 - 2024 Marburg Response Survey of Travelers_Kinyarwanda

  12. Attachment E – DCIPHER PIA

  13. Attachment F – QARS SORN 09-20-0171

  14. Attachment G – IRB Non-research Determination

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