Determination of Non-applicability of Human Subjects

STARS Tracking Number: NCEZID-AREP-2/22/22-9b5ce

NCEZID Tracking Number:

030122MW

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

Primary contact

HAIAR Program MDRO Prevention and Response Needs Assessment
Maroya Walters

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.
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 is a needs assessment, designed to gather feedback from jurisdictions receiving ELC funds to support
MDRO prevention. CDC interim guidance on MDRO prevention is expected in 2022. This assessment will
identify capacity and infrastructure needs to support awardee jurisdictions in the development and
implementation of MDRO prevention plans. This assessment will inform allocation of ELC funding. This is
consistent with the attributes of non-research formative program evaluation. The activity is not designed to
develop or contribute to generalizable knowledge; rather, it is designed to inform allocation of funding under
a large cooperative agreement focused on improving jurisdictional epi and lab capacity.
Additional considerations

ELC is a long-running, cross-cutting non-research cooperative agreement that provides funding to 64
state, territorial, county, and municipal health departments. Funds support epidemiology and
laboratory capacity for public health programs.

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: 2022.03.01 08:49:02 -05'00'

Title

Human Subjects Advisor

Date 3/1/22