Research Determination

STARS Tracking Number: 0900f3eb820a62fd

NCEZID Tracking Number:

020623DS

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

Primary contact

FungiSurv
Dallas Smith

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 monitor for fungal diseases in the US. Cases will be identified by
state, local, and territorial reportable disease systems and assorted networks. Case report forms will
be completed by state or local health departments and submitted to the central platform. This is an
initial pilot of the surveillance system limited to fewer than 10 states. Results will be used to monitor
for fungal diseases and evaluate the usefulness of the surveillance system. As the purpose of this
activity is for a public health authority to collect data to monitor for disease, 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

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2023.02.06 17:23:53 -05'00'

Title

Human Subjects Advisor

Date 2/6/2023