Research Determination

STARS Tracking Number: 0900f3eb82336101

NCEZID Tracking Number:

031524CB

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Importation Regulations (42 CFR 71 Subpart F) - Revision 0920-1383

Primary contact

Colleen Brouillette

Division/Branch

DGMH/ODP

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 disease among dogs imported into the United States.
Those who wish to import dogs into the United States will be required to complete required forms
and certifications to ensure that disease is not being imported. Results will be used directly to
perform duties required by law. As this activity involves the collection of data by a public health
authority to monitor and mitigate a public health threat, 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: 2024.03.15 18:08:53 -04'00'

Title

Human Subjects Advisor

Date 3/15/2024