[NCEZID] Traveler-based Genomic Surveillance

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1406 TGS Updated Digital Collection + Double Collection Questionnaire - Revised 14AUG2025	Form and Instruction	Modified	Available
Form 0920-1406 TGS Updated Digital Collection + Double Collection Questionnaire - Revised 22JUL2025	Form	Modified	Available
Form 0920-1406 TGS Updated Digital Collection + Double Collection Questionnaire	Form	Modified	Available
TGS Questionnaire Change Request Justifications_20250811.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-08-14	Available
TGS Questionnaire Change Request Justifications_20250718.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-07-22	Available
0920-1406 Non-Sub Change Request -DGMH - TGS.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-03-06	Available
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	Available
RSV question justification v2.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-08-11	Available
Attachment 6-Human Subjects Determination.pdf	Supplementary Document	Uploaded 2023-03-09	Available
Attachment 5-Privacy Impact Assessment.pdf	Supplementary Document	Uploaded 2023-03-09	Available
Attachment 4B - Recruitment Script.docx	Supplementary Document	Uploaded 2023-03-09	Available
Attachment 4A - Consent.docx	Supplementary Document	Uploaded 2023-03-09	Available
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	Available
Attachment 1C - Authorizing Legislation - Section 301.pdf	Supplementary Document	Uploaded 2023-03-09	Available
Attachment 1B - Authorizing Legislation - 42 CFR 71.pdf	Supplementary Document	Uploaded 2023-03-09	Available
Attachment 1A - Authorizing Legislation - 42 CFR 70.pdf	Supplementary Document	Uploaded 2023-03-09	Available
2. Supporting Statement B.docx	Supporting Statement B	Uploaded 2023-03-09	Available
1. Supporting Statement A_final_030425.docx	Supporting Statement A	Uploaded 2025-03-06	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
259028	[NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ)	Form and Instruction	Modified	TGS Updated Digital Collection + Double Collection Questionnaire - Revised 14AUG2025
259028	[NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ)	Form	Modified	TGS Updated Digital Collection + Double Collection Questionnaire - Revised 22JUL2025
259028	[NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ)	Form	Modified	TGS Updated Digital Collection + Double Collection Questionnaire
259028	[NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ)	Other-WORD	Modified

ICR Details

OMB Control No: 0920-1406	ICR Reference No: 202508-0920-004
Status: Active	Previous ICR Reference No: 202507-0920-016
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25-0158
Title: [NCEZID] Traveler-based Genomic Surveillance
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/15/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/15/2025
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	06/30/2026	06/30/2026
Responses	555,000	0	555,000
Time Burden (Hours)	37,000	0	37,000
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 27155	05/06/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 15030	03/10/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
[NCEZID] Traveler-based Genomic Surveillance Questionnaire (24EQ)	0920-1406, 0920-1406, 0920-1406	TGS Updated Digital Collection + Double Collection Questionnaire ,   TGS Updated Digital Collection + Double Collection Questionnaire - Revised 22JUL2025 ,   TGS Updated Digital Collection + Double Collection Questionnaire - Revised 14AUG2025

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	37,000	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $20,687,244

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 08/15/2025

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