SSA Emergency Clearance - 2024 Marburg Airport Entry Questions

SSA Emergency Clearance - 2024 Marburg Airport Entry Questions.docx

[NCEZID] 2024 Marburg Airport Entry Questionnaires

OMB: 0920-1443

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2024 Marburg Airport Entry Questionnaires


Request for OMB approval of a New Information Collection


October 8, 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 3

3. Use of Improved Information Technology and Burden Reduction 3

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

5. Impact on Small Businesses or Other Small Entities 4

6. Consequences of Collecting the Information Less Frequently 4

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 4

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 4

9. Explanation of Any Payment or Gift to Respondents 4

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents 5

11. Institutional Review Board (IRB) and Justification for Sensitive Questions 5

12. Estimates of Annualized Burden Hours and Costs 5

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 6

14. Annualized Cost to the Government 6

15. Explanation for Program Changes or Adjustments 6

16. Plans for Tabulation and Publication and Project Time Schedule 6

17. Reason(s) Display of OMB Expiration Date is Inappropriate 7

18. Exceptions to Certification for Paperwork Reduction Act Submissions 7

Attachments 7





Shape1

  • Goal of the study: The goal of this information collection is to accurately assess risk for infection or exposure to Marburg in travelers coming to the United States from Rwanda where a Marburg outbreak is occurring.

  • Intended use of the resulting data: The information will be used to determine if individuals meet risk thresholds for further medical evaluation, travel restrictions, or public health follow-up according to guidance developed by the CDC, and to assist health departments in facilitating public health follow-up, if needed.

  • Methods to be used to collect: Travelers will answer questions on screening and risk assessment tools developed by CDC.

  • The subpopulation to be studied: The respondent universe for this information collection request is travelers originating in Rwanda.

  • 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 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 statutory and regulatory authority related to conducting public health screening of travelers upon arrival to the United States and assessing individual travelers for public health risk following a report of illness from a conveyance.

CDC has been tasked with conducting public health assessments at U.S. airports of travelers coming from areas experiencing an outbreak of Marburg virus disease (MVD) originating in Rwanda. The purpose is to detect ill travelers or travelers at high-risk of becoming ill with MVD from regions affected by the outbreak. As the response evolves, CDC may be tasked with performing this action for additional travelers in the future. This information will help CDC determine if illness investigations and medical care is needed, or if CDC should inform state and local health departments of travelers.

Additionally, 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 fields 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 may retain the information 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.

CDC relies on its federal partners in the DHS to assist in the screening process because of their presence at the ports of entry. DHS will refer travelers that have been to MVD outbreak areas to another location at the airport where CDC will ask initial health screening questions to determine if a more in-depth public health risk assessment is necessary. CDC develops the tools and training to facilitate this screening process and works to ensure that any individual who is identified by DHS as being from the outbreak area is further evaluated. This may involve medical evaluation by CDC followed by transport to a healthcare facility if somebody is identified as being ill; a location for quarantine at or near that location; and/or communication via phone with CDC or state and local health departments to see if the travelers develop symptoms after arrival.



  1. Purpose and Use of Information Collection

The purpose of this information collection is to determine the public health risk that travelers from originating in Rwanda, where a Marburg outbreak is occurring, may pose. This information will be used to 1) determine if travelers have symptoms consistent with MVD and should be isolated and medically evaluated upon arrival in the US; and 2) assist state and local health departments with understanding which travelers from the region may be at higher risk of becoming ill with MVD and should be prioritized for taking certain public health protection measures, such as quarantine.

CDC collects international travelers’ contact information under authorities in the Interim Final Rule: Control of Communicable Diseases: Foreign Quarantine and 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 Information.2,3 Traveler contact information is sent to CDC though an existing data-sharing infrastructure in place between the United States Department of Homeland Security (DHS) and HHS/CDC and approved in OMB Control Number 0920-1354. Contact information for travelers who have been to an area affected by the outbreak during the 21 days prior to arrival will be confirmed at the port of entry. CDC will share contact information for travelers for whom monitoring is recommended with state and local health departments so that they can do possible public health follow up, including public health assessment of exposure risk and monitoring for MVD symptoms, and education to travelers. These public health interventions will help state and local health departments determine the appropriate level of follow needed based on the traveler’s level of risk and rapidly identify any travelers with symptoms that could which travelers may need to be prioritized for more targeted public health measures, such as quarantine, due to a higher risk of exposure to MVD.

To implement the 2024 Marburg Airport Entry Questionnaires information collection, CDC will first require all travelers from designated areas affected by the 2024 outbreak of MVD originating in Rwanda, to undergo an initial MVD screening to determine if CDC needs to do further public health risk assessment or illness response at the airport.

DHS will refer travelers that have been to designated areas to another location of the airport where CDC will ask initial MVD screening questions. DHS will also provide the contact information they have received to CDC electronically as part of the information collection under OMB Control Number 0920-1354. CDC will escort travelers to the area of the initial MVD screening and confirm with the traveler that the contact information on file is correct. CDC will inform DHS if there are any necessary corrections needed to the contact information.

In this initial MVD screening setting, CDC will ask basic questions about signs or symptoms of illness (e.g. fever, rash, diarrhea, etc.) or possible exposure (e.g. contact with a person sick with MVD, attendance at a funeral, etc.) as well as observe travelers to determine if the traveler is experiencing any overt signs and symptoms of disease, and measure their temperature with a noncontact thermometer.

If a traveler answers “Yes” to any of these initial screening questions, is visibly ill, or has a fever, the traveler will then be referred to another area of the airport for a public health risk assessment by CDC. The public health risk assessment will help CDC investigate further to determine if the traveler could be sick with MVD or to get more information about a possible exposure to the Marburg virus to determine if the traveler is high-risk.



  1. Use of Improved Information Technology and Burden Reduction

The initial MVD screening will be a script of questions that a CDC staff member will ask the traveler. If the traveler answers “Yes” to any of these questions, the interviewer will undergo a more detailed public health risk assessment by CDC at the airport using the hard copy or an electronic version of the CDC Initial Screening – Marburg form.



Because of the rapid implementation required by the development of the outbreak, the questions asked by the CDC staff member in the public health risk assessment will be recorded in a hard copy format by the CDC staff member or entered into an electronic version of the form.

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



  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

CDC does not anticipate the respondents to be small businesses.



  1. Consequences of Collecting the Information Less Frequently

Failure to collect this information for airport public health risk assessments or from individuals under orders 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 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.



  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. 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.

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, such as flight number, to ensure accurate identification of travelers. The presence of symptoms and history of exposures to disease 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 F). IRB approval is not required.

Justification for Sensitive Questions

This information collection requests certain personally identifying information of and travelers. Some personally identifying information will be collected during the proposed risk assessments in order to identify ill travelers. Some travelers might find these questions sensitive in nature, but this information is necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States.



  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 for this revision is 43,800 respondents, travelers arriving on commercial flights, with approximately 5,110 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 from affected areas may be required to answer questions on the initial screening assessment (Attachment C). These questions will assess whether the traveler is coming from high-risk area or whether they have symptoms and may be asked additional travel and exposure questions info if they are not immediately referred for further evaluation. CDC estimates these questions will take approximately 5 minutes.

    • CDC estimates approximately 3,650 hours will be incurred as this portion of the entry risk assessment program.

  • CDC estimates that approximately 10% of the travelers from affected areas may be required to answer the more specific contact, travel history, and symptom questions on the POE Public Health Risk Assessment Form - CDC Marburg Response (Attachment D). Enhanced entry screening conducted in 2014 following an imported Ebola case in the U.S. indicated that 10% of travelers required further screening by CDC.4



Type of Respondent

Form Name

No. of Respondents

No. Responses per Respondent

Avg. Burden per response (in hrs.)

Total Burden (in hrs.)

Traveler

CDC Initial Screening – Marburg


(Attachment C)

43,800

1

5/60

3,650

Traveler

POE Public Health Risk Assessment Form - CDC Marburg Response


(Attachment D)

4,380

1

20/60

1,460

Total


5,110

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 $160,863.

Type of Respondent

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

Traveler

CDC Initial Screening – Marburg


(Attachment C)

3,650

$31.48

$114,902

Traveler

POE Public Health Risk Assessment Form - CDC Marburg Response


(Attachment D)

1,460

$31.48

$45,961

Total


$160,863



  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 $8,871,147 ($5,598,902 for CDC staff at the three airports and $3,272,245 for supplies). This may be an overestimate since the supply estimation is based on supplies used in the 2014-2015 Ebola response. This number also may change depending on the volume of travelers, location of CDC public health risk assessments, and volume of contact investigations initiated in response to confirmed cases.



  1. Explanation for Program Changes or Adjustments

This is a new information collection.



  1. Plans for Tabulation and Publication and Project Time Schedule

CDC and CBP may report aggregate totals of number of people screened, number of positives, and number of aircraft contacts publicly, as appropriate. Similarly, aggregate numbers of illness or death investigations may be reported.

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



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

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



  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 C – CDC Initial Screening Form_Marburg_10 08 2024

  5. Attachment D - POE Public Health Risk Assessment Form - CDC Marburg Response

  6. Attachment E – QARS PIA

  7. Attachment F – IRB Non-Research Determination

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