Research Determination

STARS Tracking Number: 0900f3eb82326358

NCEZID Tracking Number:

030824AV

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Investigation of Burkholderia multivorans infections in acute care hospital settings following

potential exposure to nonsterile ice and water from ice machines, United States, 2022-2024

Primary contact

Axel Vazquez-Deida

Division/Branch

DHQP/PRB

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.
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 project is to identify the national scope of B. multivorans infections among hospitalized
patients throughout the US. Between 2020-2024, there have been 46 patients identified to have B.
multivorans. In an effort to assess the burden of disease for the US, CDC would like to solicit case reports
on Epi-X from public health authorities from January 1st, 2022 to present. In addition, informal interviews will
be performed with hospital staff to better assess risk factors for transmission. Results will be used to inform
infection prevention and control measures and recommendations. Results may also be published. As this
activity involves the collection of data by a public health authority to assess a public health threat and related
risk factors, it is consistent with non-research public health surveillance.
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: 2024.03.08 13:36:07 -05'00'

Title

Human Subjects Advisor

Date 3/8/2024