OMB control number

[NCEZID] Traveler-based Genomic Surveillance

OMB 0920-1406 · HHS/CDC.

OMB 0920-1406

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 replace the existing instruction “list all connections” with the more explicit follow-up question: “Did you have any other connecting flights?” to allow data collection would flow more smoothly and result in higher quality, more consistent data collection. There is no change to the approved burden hours.

The latest form for [NCEZID] Traveler-based Genomic Surveillance expires 2026-07-31 and is listed under ICR 202508-0920-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 0920-26-0225 TGS Participant QuestionnaireForm and Instruction
Attachment 2B public comments from 60-day FRN & responses.docxPublic Comments
Attachment 6 - TGS non-research project determination.pdfSupplementary Document
Attachment 5-Privacy Impact Assessment waiver.pdfSupplementary Document
Attachment 4B - Recruitment Script.docxSupplementary Document
Attachment 4A - Consent.docxSupplementary Document
Attachment 2A - 60-day FRN.pdfSupplementary Document
Attachment 1D - Authorizing Legislation - Section 311.pdfSupplementary Document
Attachment 1C - Authorizing Legislation - Section 301.pdfSupplementary Document
Attachment 1B - Authorizing Legislation - 42 CFR 71.pdfSupplementary Document
Attachment 1A - Authorizing Legislation - 42 CFR 70.pdfSupplementary Document
TGS Questionnaire Change Request Justifications_20250811.docxJustification for No Material/Nonsubstantive Change
TGS Questionnaire Change Request Justifications_20250718.docxJustification for No Material/Nonsubstantive Change
0920-1406 Non-Sub Change Request -DGMH - TGS.docxJustification for No Material/Nonsubstantive Change
Change Request Memo.docxJustification for No Material/Nonsubstantive Change
Change Request Memo.docxJustification for No Material/Nonsubstantive Change
RSV question justification v2.docxJustification for No Material/Nonsubstantive Change
Attachment 6-Human Subjects Determination.pdfSupplementary Document
Attachment 5-Privacy Impact Assessment.pdfSupplementary Document
Attachment 4B - Recruitment Script.docxSupplementary Document
Attachment 4A - Consent.docxSupplementary Document
Attachment 2 - 60-day FRN.pdfSupplementary Document
Attachment 1D - Authorizing Legislation - Section 311.pdfSupplementary Document
Attachment 1C - Authorizing Legislation - Section 301.pdfSupplementary Document
Attachment 1B - Authorizing Legislation - 42 CFR 71.pdfSupplementary Document
Attachment 1A - Authorizing Legislation - 42 CFR 70.pdfSupplementary Document
Supporting Statement B_TGS 30-Day PRA package_2026.docxSupporting Statement B
Supporting Statement A_June2026.docxSupporting Statement A
[NCEZID] Traveler-based Genomic Surveillance Questionnaire Form and Instruction