Determination of Non-applicability

STARS Tracking Number: 0900f3eb823b55a9

NCEZID Tracking Number:

060724CC

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

Primary contact

Creative Concept Testing on Antimicrobial Resistance
Catherine Carnes

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 group discussions with experts on the topic of
antibiotic resistance communications and media to inform their development and deployment. The
focus groups will be conducted by KRC Research and will ask healthcare professionals and
consumers on their opinion and usefulness of drafted materials. Results will be used to develop the
public health messaging. As this activity involves evaluating the acceptance of a standard public
health programmatic activity by the intended audience, it is consistent with non-research program
evaluation. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

Participants will provide written consent before taking part in the focus groups.

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: 2024.06.07 15:07:00 -04'00'

Title

Human Subjects Advisor

Date 6/7/2024