Information Collection Request

[NCEZID] Traveler-based Genomic Surveillance

ICR 202507-0920-016 · OMB 0920-1406 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1406 [NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ) Form Modified Repair queued
TGS Questionnaire Change Request Justifications_20250718.docx Justification for No Material/Nonsubstantive Change Uploaded 2025-07-22 Repair queued
0920-1406 Non-Sub Change Request -DGMH - TGS.docx Justification for No Material/Nonsubstantive Change Uploaded 2025-03-06 Repair queued
Change Request Memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-04-10 Repair queued
Change Request Memo.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-01-02 Repair queued
RSV question justification v2.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-08-11 Repair queued
Attachment 6-Human Subjects Determination.pdf Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 5-Privacy Impact Assessment.pdf Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 4B - Recruitment Script.docx Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 4A - Consent.docx Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 2 - 60-day FRN.pdf Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 1D - Authorizing Legislation - Section 311.pdf Supplementary Document Uploaded 2023-03-09 Missing upstream
Attachment 1C - Authorizing Legislation - Section 301.pdf Supplementary Document Uploaded 2023-03-09 Repair queued
Attachment 1B - Authorizing Legislation - 42 CFR 71.pdf Supplementary Document Uploaded 2023-03-09 Missing upstream
Attachment 1A - Authorizing Legislation - 42 CFR 70.pdf Supplementary Document Uploaded 2023-03-09 Repair queued
2. Supporting Statement B.docx Supporting Statement B Uploaded 2023-03-09 Repair queued
1. Supporting Statement A_final_030425.docx Supporting Statement A Uploaded 2025-03-06 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
259028 [NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ) Form Modified
ICR Details
0920-1406 202507-0920-016
Received in OIRA 202503-0920-008
HHS/CDC 0920-25-0147
[NCEZID] Traveler-based Genomic Surveillance
No material or nonsubstantive change to a currently approved collection   No
Regular 07/28/2025
  Requested Previously Approved
06/30/2026 06/30/2026
555,000 555,000
37,000 46,250
0 0

The goal of [NCEZID] Traveler-based Genomic Surveillance is to monitor importation of SARS-CoV-2 variants among arriving international air travelers at select U.S. airports. Data will be used to inform early detection of imported SARS-COV-2 variants into the U.S. and for program management purposes. Data is collected from two lower nasal dry self-swabs from participants in airports that are pooled in batches of 5-10 samples. One sample will be pooled with samples from other travelers from the same flight origin country. Pooled samples undergo SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing and whole genome sequencing on positive samples to determine viral lineage. The second will be kept if there is a need to look more closely at a positive pool. Samples may be sent to CDC for further testing. Surveillance may be expanded to test for other pathogens such as influenza. Participants complete a questionnaire with their demographic, clinical, and travel history information and will be given a free antigen test kit for their time. This Non-Substantive Change Request is submitted to modify the existing questionnaire through combining and/or dropping questions, standardizing response choices, limiting areas of confusion and conversation with frontline ground staff, and prioritizing collection of the highest value information. There is a reduction in burden associated with these changes.

US Code: 42 USC 70 Name of Law: Interstate Quarantine
   US Code: 42 USC 71 Name of Law: Foreign Quarantine
   US Code: 42 USC 301 and 311 Name of Law: PHSA
  
None

Not associated with rulemaking

  87 FR 27155 05/06/2022
88 FR 15030 03/10/2023
Yes

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 555,000 555,000 0 0 0 0
Annual Time Burden (Hours) 37,000 46,250 0 -9,250 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
Non-Substantive Change Request submitted for 0920-1406 modifies the existing questionnaire through combining and/or dropping questions, standardizing response choices, limiting areas of confusion and conversation with frontline ground staff, and prioritizing collection of the highest value information. There is a net reduction in burden associated with these changes.

$20,687,244
Yes Part B of Supporting Statement
    No
    No
No
No
No
Yes
Jeffrey Zirger 404 639-7118 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
07/28/2025