Non-research determination

NCEZID Tracking Number: 030215KB

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

Primary contact

Enhanced surveillance of Coccidioidomycosis in low- and non-endemic states

Kaitlyn Benedict, MPH

Division/Branch DFWED/MDB

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. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.
Rationale
The purpose of this project is to characterize the burden of Valley Fever in areas that have historically been
considered low- or non-endemic, and to assess and evaluate current coccidioidomycosis surveillance practices and
methods in these settings. As an effort designed to describe the frequency and occurrence of Valley Fever in a
specific setting, and to provide feedback to improve existing public health practice, this activity is consistent with the
attributes of both non-research surveillance and non-research program evaluation, as described in current CDC
policy.

Additional considerations
This project involves brief telephone interviews with identified cases; verbal informed consent will be obtained from all
respondents prior to initiating the interview.

Additional requirements
The program has consulted with Amy McMillen regarding PRA applicability. An OMB submission package will be
initiated following receipt of this determination.

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, MPH, CIP

Laura
Youngblood -S

Digitally signed by Laura Youngblood -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001704097
, cn=Laura Youngblood -S
Date: 2015.03.02 10:10:28 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
3/2/15

Date: _______________