IRB determination

STARS Tracking Number: NCEZID-BDBEEA-4/18/22-f34d6

NCEZID Tracking Number:

042822JB

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Assessing the capacity of vector management programs in the US to provide comprehensive

community-level tick management services

Primary contact

James Burtis

Division/Branch

DVBD/BDB

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

This project will assess current tick management capacity in federally funded vector management
programs US regions with endemic tickborne disease. The objective is to identify gaps in current
services and barriers to implementation of comprehensive tick control/management programs.
Findings will be used to inform ongoing DVBD funding decisions to address these gaps and barriers
and support development of comprehensive tick control and management programs. This project is
consistent with the attributes of non-research program evaluation.

Additional considerations

This project also does not involve human subjects, as respondents will be asked only about practices
at their organizations, rather than questions about themselves. Participating in this project is
voluntary, and respondents will be provided sufficient information to make a voluntary and informed
decision about whether or not to participate.
Additional requirements

None.

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

Laura Youngblood

Laura Youngblood Signature S

Digitally signed by Laura
Youngblood -S
Date: 2022.04.28 11:37:15 -04'00'

Title

Human Subjects Advisor

Date 4/28/22