Research Determination

STARS Tracking Number: 0900f3eb82315cc1

NCEZID Tracking Number:

062124AB

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

Primary contact

National Surveillance for C. auris Cases
Anna Baker

Division/Branch

DFWED/MDB

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 conduct surveillance for C. auris infections within the United States.
C. auris infections are nationally notifiable and reportable in many jurisdictions. CDC will be receiving
standardized case information from local jurisdictions into a REDCap database. Data will be used to
monitor and assess trends and patterns in C. auris infections within the United States. Results may
be published and presented but will be primarily used to inform public health response and mitigation
efforts. As such, this activity 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

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.06.21 17:23:55 -04'00'

Title

Human Subjects Advisor

Date 6/21/2024