Non-Research Determination - 2026 Ebola Attestation

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STARS Tracking Number: 0900f3eb82709bb7

NCEZID Tracking Number: 082426NC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

PRA package for Attestation Order

Primary contact Nicole Cohen

Division/Branch DGMH/OD

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]
Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.

✔ Project is deemed not to be research under the following provision. IRB review is not required.
Public health surveillance activities, 45 CFR 46.102(l)(2)

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

This activity involves collecting the attestation of airline passengers arriving to the United States that
they have not been in certain areas where there is risk of Ebola exposure. These attestations will be
collected in order to help prevent possible Ebola's introduction to the United States from those
countries currently suffering the ongoing outbreak. As this activity involves a public health authority
collecting information in order to mitigate or respond to a public health threat, it is consistent with
non-research public health surveillance.

Additional considerations

Additional requirements

Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

JAMES M.
Signature PETERSON -S

Date 08/24/2026

Digitally signed by JAMES M.
PETERSON -S
Date: 2026.08.24 13:32:27 -04'00'