Non-Research Determination

STARS Tracking Number: NCEZID-TERMT-7/2/24-d9965

NCEZID Tracking Number:

071724SG

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Contact Investigation Outcome Reporting Forms - Request for OMB approval of revised

information collection

Primary contact

Shannon Gearhart

Division/Branch

DGMH/TRAM

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 ongoing activity is to collect data from travelers involved with exposure or
contraction of disease when traveling. CDC will use standard case investigation forms to collect this
data to assess and monitor for communicable disease threats in or entering the United States.
Results will be used to inform response and mitigation efforts against identified public health threats.
As this activity involves the collection of data by a public health authority to monitor and respond to
public health threats, 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.
Reviewed by

James Peterson, PhD

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.07.17 16:11:56 -04'00'

Title

Human Subjects Advisor

Date 7/17/2024