[NCEZID] Traveler-based Genomic Surveillance

Forms and Documents

Document Name	Status
Traveler-based Genomic Surveillance Questionnaire Form	Modified
RSV question justification v2.docx Justification for No Material/Nonsubstantive Change	2023-08-11
Attachment 6-Human Subjects Determination.pdf Supplementary Document	2023-03-09
Attachment 5-Privacy Impact Assessment.pdf Supplementary Document	2023-03-09
Attachment 4B - Recruitment Script.docx Supplementary Document	2023-03-09
Attachment 4A - Consent.docx Supplementary Document	2023-03-09
Attachment 2 - 60-day FRN.pdf Supplementary Document	2023-03-09
Attachment 1D - Authorizing Legislation - Section 311.pdf Supplementary Document	2023-03-09
Attachment 1C - Authorizing Legislation - Section 301.pdf Supplementary Document	2023-03-09
Attachment 1B - Authorizing Legislation - 42 CFR 71.pdf Supplementary Document	2023-03-09
Attachment 1A - Authorizing Legislation - 42 CFR 70.pdf Supplementary Document	2023-03-09
2. Supporting Statement B.docx Supporting Statement B	2023-03-09
1. Supporting Statement A_final.docx Supporting Statement A	2023-03-09

IC Document Collections

IC ID	Document Title	Status
259028	Traveler-based Genomic Surveillance Questionnaire Form	Modified

ICR Details

OMB Control No: 0920-1406	ICR Reference No: 202308-0920-006
Status: Active	Previous ICR Reference No: 202302-0920-019
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1406-23HP
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: 08/14/2023
	Date Received in OIRA: 08/14/2023
Terms of Clearance:

	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)	46,250	0	46,250
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of the study is to monitor importation of SARS-COV-2 variants among international travelers at select US airports. Participants recruited will fill out a consent form (digital or paper), a short questionnaire (digital or paper), and will provide two self-collected nasal swab samples. Samples are pooled with other swabs from travelers from the same travel origin country. Samples will be tested using RT-PCR for pathogens including SARS-CoV-2. Positive results will be sequenced.

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Authorizing Statute(s): US Code: 42 USC 71 Name of Law: Foreign Quarantine
   US Code: 42 USC 301 and 311 Name of Law: PHSA
   US Code: 42 USC 70 Name of Law: Interstate Quarantine
  

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

IC Title	Form No.	Form Name
Traveler-based Genomic Surveillance Questionnaire	n/a	Information Collection Instrument

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ICR Summary 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)	46,250	46,250	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: 08/14/2023

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