Research Determination

STARS Tracking Number: 0900f3eb81b47849

NCEZID Tracking Number:

051520MM

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

Primary contact

SARS-CoV-2 animal testing surveillance questionniare
Matt Mauldin, PhD

Division/Branch

DHCPP/PRB

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 collect additional data on COVID-19 testing among animals. While
positive cases of COVID-19 among animals are being reported, more extensive data on animals
tested has not. CDC will send questionnaires bi-weekly to state officials on all animal COVID-19
testing to monitor trends. Results will be used to inform response to COVID-19 by assessing and
monitoring animal reservoirs and relation to human cases. As the purpose of this activity is to assess
and monitor a public health concern to inform response, 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: 2020.05.15 10:33:54 -04'00'

Title

Human Subjects Advisor

Date 5/15/2020