Non-Research Determination

NCEZID Tracking Number: 040919ML

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

Primary contact

Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant
Campylobacter infections traced to contact with pet store puppies

Mark Laughlin, MPH, DVM

Division/Branch

DFWED/EDEB

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 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 enhanced surveillance for to detect a antimicrobial resistant
Campylobacter strain which emerged in an outbreak associated with puppies at a pet store chain.
Though the outbreak investigation ended in January of 2018, it is likely cases are still occurring as the
source could not be eliminated. Surveillance sequence data will be analyzed to detect additional
cases which will be will have follow up interviews to determine contact with puppies. As the purpose of
this activity is to collect and test information to assess signals and risk factors of a condition of public
health importance, it is consistent with public health surveillance per 45 CFR 46.102(l)(2).
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
Digitally signed by James M.

James M. Peterson -S Peterson -S

Date: 2019.04.09 09:43:11 -04'00'
Signature: _________________________________________

Title

Human Subjects Advisor

4/9/2019

Date: _______________