Determination

STARS Tracking Number: NCEZID-DGMH-1/22/25-ec797

NCEZID Tracking Number:

012425NC

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Gen ICR - Traveler Risk Assessment and Management Activities During Disease Outbreaks

Primary contact

Nicole Cohen

Division/Branch

DGMH

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

The purpose of this activity is to have a prepared data collection for instances when a quick response is
needed due to a new disease outbreak. The data collection will cover screening travelers, post-arrival
management, health department follow-up, messaging surveys for travelers, and evaluation of these
activities. These resources will be prepared for as needed use during possible future outbreaks.
Results will be used to perform CDC responsibilities for monitoring and responding to health threats
among travelers. As the purpose of this activity is to prepare resources for the timely monitoring and
response to a public health threat, it is consistent with non-research public health surveillance.
Additional considerations

This determination covers the gen-ICR for the development of and staging of these materials and
does not cover the use of outbreak specific materials that come from the gen-ICR, which would
require a separate determination.

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.
Reviewed by

James Peterson, PhD

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2025.01.24 15:29:11 -05'00'

Title

Human Subjects Advisor

Date 1/24/2025