Determination of Non-applicability of Human Subjects Regulations

STARS Tracking Number: NCEZID-MAPT-8/6/24-089f8

NCEZID Tracking Number:

081324KH

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

Primary contact

Tuberculosis Indicators
Kibrten Hailu

Division/Branch

DGMH/IRHB

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 data collection is to monitor the effectiveness of the CDC Technical Instructions
in diagnosing applicants with tuberculosis. The data collection will be from panel physicians who
must submit Tuberculosis Indicator reports to CDC/DGMH annually. The data involves programmatic
numbers for immigrants or refugees screened and examined. As this data collection is to monitor a
standard public health program, it is consistent with non-research program evaluation. This activity is
not designed to contribute to generalizable knowledge.

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

JAMES M.
Signature PETERSON -S

Digitally signed by JAMES M.
PETERSON -S
Date: 2024.08.13 14:39:45 -04'00'

Title

Human Subjects Advisor

Date 8/13/2024