Research Determination

Print Date: 1/20/23

Title:

Airport-based COVID-19 surveillance among international travelers

Project Id:

0900f3eb81d54b5e

Accession #:

NCEZID-SET-6/11/21-54b5e

Project Contact:

Teresa C Smith

Organization:

NCEZID/DGMQ/TH/SET

Status:

Project In Progress : Amendment

Intended Use:

Project Determination

Estimated Start Date:

07/01/2021

Estimated Completion Date:

06/30/2022

CDC/ATSDR HRPO/IRB Protocol #:
No OMB Control Number issued

OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance
45 CFR 46.102(l)(2)

Qualifies for a statutory waiver:

21st Century Cures Act - Sec. 3087 (Public Health
Emergency)

Completed

Entered By & Role

12/20/22

Peterson_James M. (iyr1) CIO HSC

PRA:
PRA Applies

ICRO:
PRA Applies

Justification: PRA applies but is waived by
the COVID-19 PHE Waiver. Waiver
element updates: Burden: For those
participating in 2A, the time estimate to
participate in this surveillance activity is
five minutes per person. With an estimate
of 5,000 persons participating per week,
it is estimated that 417 person-hours per
week will contribute to this activity. Over
the course of a year, this results in
21,667 person-hours. Instruments: There
is a new, shorter questionnaire that will
be moved to a digital format. It is in the
protocol appendix.

OMB Approval date: 1/4/23
OMB Expiration date: 12/31/99

12/20/22

Daymude_Thomas (qkh7) OMB /
PRA

1/4/23

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Urgent

Date Needed:

06/25/2021

Priority Justification:

To respond to risk of spread of the SARS-CoV-2 variant Delta, circulating widely in India, among travelers through enhanced
surveillance.

Determination Start Date:

02/10/22

Description:

This project will implement enhanced SARS-CoV-2 surveillance among international travelers at selected ports of entry. Pooled
PCR tests will be conducted in at least 5 airports. Through the locations where PCR tests are used, the program will enable the
near-real-time (NRT) detection of existing and novel SARS-CoV-2 variants entering the United States through its airports by testing
passengers and sequencing all positive cases. This project will leverage a variety of testing technologies, including individual
testing, pooled testing, and whole genome sequencing.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

Yes

IMS Activation Name:

2019 Novel Coronavirus Response

Primary Priority of the Project:

COVID-19 disease detection, burden, and impact

Secondary Priority(s) of the Project:

Prevention, mitigation, and intervention strategies

Task Force Associated with the Response:

Global Migration

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

Implement enhanced surveillance via testing of inbound international travelers combined with sequencing of positive samples to
inform implementation of appropriate prevention and mitigation measures for arriving international travelers before widespread
transmission of new and consequential variants can occur in communities where travelers visit and live.

Objective:

1. Identify COVID cases and rates for populations arriving to US airports, with particular focus on travel routes from geographies
with high positivity rates and higher risk for new variants to emerge. Although the initial focus for sequencing will be on flights from
India, in light of the current health crisis, it may shift over time based on response priorities. 2. Measure SARS-CoV-2 positivity rates
3-5 days after arrival for vaccinated and unvaccinated passengers arriving into the US from foreign destinations to evaluate current
CDC recommendations. 3. Identify variants of interests, concern, and high consequence among the positive cases captured in Point
1. 4. Share the raw data collected with the CDC and public databases. Data include consensus sequences and lineage reports. 5.
Combine the raw data from sequencing with travel-related information and publicly available data to prepare epidemiological
analyses and reports.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Yes

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Programmatic Work

Target Populations to be Included/Represented:

General US Population ; International

Tags/Keywords:

Genomics ; Travel ; Public Health Surveillance

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Genetic Sequencing; Surveillance Support

Methods:

Phase 1A: Pooled tests for flights from India; genomic sequencing of positive pools Phase 1B: Arriving international passengers
from India pick up an at-home RT-PCR kit at the airport, take the test 3-5 days later; sequencing for positive cases Phase 1C:
Arriving international passengers pick up an at-home Ellume antigen test kit at the airport or have the kit sent to them on arrival day;
take test 3-5 days later Phase 2A: Arriving international passengers participate in double collection pooled testing and receive a free

at-home antigen test to take home. Pooled tests use RT-PCR and positives are sequenced for lineage determination Phase 2B:
Aircraft wastewater SARS-CoV-2 testing and sequencing.

Collection of Info, Data or Biospecimen:

Phase 1A: self-collected nasal swabs Phase 1B: self-collected saliva samples Phase 1C: self-collected nasal swabs Phase 2A: selfcollected nasal swabs Phase 2B: aircraft wastewater collected via device developed by contractor and collection done by airport
grounds crew. Demographic information will be collected on paper or electronic form.

Expected Use of Findings/Results and their impact:

This information will help with implementation of appropriate prevention and mitigation measures for arriving international travelers
before widespread transmission of new and consequential variants can occur in communities where travelers visit and live.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Contract

Traveler-based SARS-CoV-2 Genomic Surveillance Program

75D30122C14933

2022

1

CDC Contract

Airport-based COVID-19 Surveillance Among International Travelers

PR57344

2021

Budget Amount

HSC Review

Additional Ethical Considerations
testing under this program is voluntary and will only be performed with consent or parent/guardian permission; this program targets travelers from India because of the high prevalence of the
Delta variant in India.

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office
Estimated number of study participants

No

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

No Selection

Other method

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

XPresCheck

PR57344

Concentric by Gingko

PR57344

Staff

Staff
Member

SIQT
Exp.
Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff
Role

Email

Phone

Organization

11/30/2025

06/29/2023

Program
Lead

[email protected]

4702250073

QUARANTINE AND BORDER
HEALTH SERVICES BRANCH

Program
Official

[email protected]

4046396097

TRAVELERS HEALTH BRANCH

Program
Official

[email protected]

3055262910

QB ROIC

Program
Official

[email protected]

4043752812

EPI FIELD TEAM

Alida Gertz

03/17
/2025

Allison
Taylor

09/28
/2025

Andrew
Klevos

07/29
/2022

Anna
Shaum

06/14
/2025

Cindy
Friedman

11/28
/2025

Program
Official

[email protected]

4046391430

DIVISION OF GLOBAL
MIGRATION AND QUARANTINE

Clive
Brown

12/30
/2024

Program
Official

[email protected]

4046393952

DIVISION OF GLOBAL
MIGRATION AND QUARANTINE

Erin
Rothney

03/04
/2022

Program
Official

[email protected]

7345023191

QB ROIC

Ezra Ernst

04/23
/2023

Program
Lead

[email protected]

XPresCheck

Gabrielle
Woronoff

04/23
/2023

Program
Lead

gworonoff@ginkgobioworks.
com

Concentric by Gingko

John
Shufeldt

04/23
/2023

Program
Official

jshufeldt@shufeldtconsulting.
com

XPresCheck

Leah
Moriarty

12/06
/2024

Program
Lead

[email protected]

Marcelo
Venegas

04/23
/2023

Program
Official

[email protected]

Matthew

02/22

Program

03/20/2022

12/20/2021

02/27/2023

11/26/2024

01/02/2022

02/28/2023

4047184831

404-

SURVEILLANCE AND
EPIDEMIOLOGY TEAM

DIVISION OF GLOBAL

Palo

/2023

Official

[email protected]

Renee
Wegryzn

04/23
/2023

Program
Official

rwegrzyn@ginkgobioworks.
com

Concentric by Gingko

Robert
Morfino

04/23
/2023

Program
Official

rmorfino@ginkgobioworks.
com

Concentric by Gingko

Robin
Rinker

11/04
/2025

Program
Official

[email protected]

4044981467

TRAVELERS HEALTH BRANCH

Tai-ho
Chen

10/06
/2025

Program
Official

[email protected]

6502727452

INACTIVE

11/24/2024

12/21/2021

05/03/2022

7185484

MIGRATION AND QUARANTINE

Data
DMP
Proposed Data Collection Start Date:

7/1/21

Proposed Data Collection End Date:

6/30/22

Proposed Public Access Level:

Public

Public Access Justification:

De-identified data from this project will be made accessible to the public to inform public health programs and policies.

How Access Will Be Provided for Data:

All data will be de-identified before sharing. Following dissemination of findings, the following data elements will be publicly shared:
test results, age range, gender, vaccination status, and state. Sequencing data will be uploaded into public sharing platforms such
as GISAID.

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

California

San Francisco County

United States

New York

New York

United States

New Jersey

Essex

United States

California

Los Angeles

United States

Colorado

Denver

United States

Georgia

Fulton

United States

Massachusetts

Suffolk

United States

Virginia

Loudoun

United States

Florida

Miami-Dade County

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and Role
Zirger_Jeffrey
(wtj5)
ICRO Reviewer

Smith_Teresa
(pvy2)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

01/04/2023

Amendment to activity approved
under the PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval COVID.docx

12/14/2022

CLEAN protocol including
appendices with new program
documents including consent,
questionnaire and recruiting
materials

Protocol

TGS_Protocol Amendment_TS_Dec92022_clean.docx

12/14/2022

TRACKED protocol including
appendices with new program
documents including consent,
questionnaire and recruiting
materials

Protocol

TGS_Protocol Amendment_TS_Dec92022.docx

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

02/16/2022

Amendment to activity previously
approved/conducted under PHE
PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Appiah_Grace
(ydg3)
Project Contact

02/10/2022

Tracked changes version of the
protocol

Protocol

XPresCheck_Protocol Amendment_Tracked Changes.
docx

Appiah_Grace
(ydg3)
Project Contact

02/10/2022

Clean version of the updated
protocol

Protocol

XPresCheck_Protocol Amendment_Clean.docx

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

09/15/2021

Amendment to activity approved
under PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Moriarty_Leah F
(wvp4)
Branch Approver
Projects

09/15/2021

Updated version of the 3-5 day
data collection tool for at-home
testers.

Data Collection Form

Test Taker Data Capture_Sept 14.docx

Moriarty_Leah F
(wvp4)
Branch Approver
Projects

09/15/2021

PDF of brochure given to
participants upon arrival.

Data Collection Form

21-2507 XpresCheck_CDC_TestingBrochure_v15.pdf

Moriarty_Leah F
(wvp4)
Project Contact

09/08/2021

Text of the previous formatted
brochure for ease of review

Data Collection Form

XpresCheck_CDC_Brochure_v13_TEXT_9.3.21.docx

Moriarty_Leah F
(wvp4)
Project Contact

09/08/2021

Questionnaire being given to
volunteers participating in the
testing 3-5 days after arrival.
Questions will be captured on a
secure, electronic platform.

Data Collection Form

Test Taker Data Capture_Sept 2.docx

Moriarty_Leah F
(wvp4)
Project Contact

09/08/2021

PDF formatted brochure for phase
1A

Data Collection Form

21-2507 XpresCheck_CDC_TestingBrochure_v13.pdf

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

07/29/2021

Amendment to activity previously
approved under PHE PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Smith_Teresa
(pvy2)
Project Contact

Cohen_Nicole J.
(hei1)
Division ADS

07/20/2021

Screening, consent, initial survey
instrument

Consent Form

Initial Survey for Post Arrival Test Project 1c_July 20
2021.docx

Cohen_Nicole J.
(hei1)
Division ADS

07/20/2021

Post-test data collection

Data Collection Form

Test Results Reporting Survey for Post Arrival Test
Project 1c_July 20 2021.docx

Cohen_Nicole J.
(hei1)
Division ADS

07/20/2021

Templates for emails to
participants (generated by
Redcap)

Other

Emails recieved by user for Post Arrival Test Project
1c_July 20 2021.docx

Moriarty_Leah F
(wvp4)
Project Contact

07/12/2021

Data collection form to collect
results of the Ellume test kit

Data Collection Form

TestResults_PostArrivalTesting (9).pdf

Moriarty_Leah F
(wvp4)
Project Contact

07/12/2021

Initial data collection form for 1C

Data Collection Form

VoluntaryCDCPostArrivalTesting (5).pdf

Moriarty_Leah F
(wvp4)
Project Contact

07/12/2021

Email text to participants

Other

Appendices 1c - Emails Text.pdf

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

06/23/2021

Activity conducted under the PHE
PRA Waiver.

Notice of Action

PHE PRA Waiver Approval.docx

Youngblood_Laura
L. (zfk9)
CIO HSC

06/15/2021

NCEZID non-research
determination

HS Research Determination Memo

061521LM-NR-PHS.pdf

Moriarty_Leah F
(wvp4)
Project Contact

06/11/2021

Data collection & consent forms for
Phase 1C

Consent Form

Post arrival testing project 1-C Appendices.docx

Moriarty_Leah F
(wvp4)
Project Contact

06/11/2021

Project protocol

Protocol

XPresCheck_Protocol_V3_Clean.docx

Moriarty_Leah F
(wvp4)
Project Contact

06/11/2021

Consent form for sections 1A and
1B

Consent Form

Appendix 1 - 060821_CDC Post Travel Testing
Pilot_Consent Draft_v3_Clean.docx

Moriarty_Leah F
(wvp4)
Project Contact

06/11/2021

SOP for pooled testing (Phase 1A)

Other-Standard Operating
Procedure

Appendix2 - Concentric - Pooled Test SOP.pdf