Human Subjects Determination

STARS Tracking Number: 0900f3eb823074ac

NCEZID Tracking Number:

022924HE

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

Primary contact

Formative Communications Assessment on Antimicrobial Resistance
Heather Ewing

Division/Branch

DHQP/OAR

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.
Select, if applicable

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 focus groups with stakeholders to test standard public
health messaging and inform future development of messaging. The evaluation will consist of a
series of focus groups with professionals. CDC will oversee the focus groups and provide technical
assistance. Results will be used to amend drafting messaging materials and inform future develop of
messaging materials. Results may be presented or published. As this project involves the evaluation
of a standard public health programmatic activity, it is consistent with non-research program
evaluation. This activity is not designed to contribute to generalizable information.
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: 2024.02.29 15:53:45 -05'00'

Title

Human Subjects Advisor

Date 2/29/2024