Non-Research Determination

NCEZID Tracking Number: 020816RE

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

Primary contact

CDC survey of county-level surveillance records of Aedes aegypti and Aedes albopictus from 2000 to
present

Rebecca Eisen, PhD

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. 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 activity is to gather mosquito surveillance records from across the US to map the known
distribution of Aedes aegypti and Ae. albopictus. Mosquito maps will identify areas at increased risk for local
transmission of arboviruses, including Zika, in the US. Maps will also identify areas where mosquito surveillance is
lacking. This activity will inform the allocation of surveillance and prevention resources. As an activity designed to
map the presence of mosquito vectors in the US, in the context of a large outbreak of Zika virus in Brazil and recent
introduction of Zika into the Americas, this activity is consistent with the attributes of non-research surveillance and
public health response, as described in current CDC policy. This activity is not designed to develop or contribute to
generalizable knowledge.

Additional considerations
In addition, information is to be collected at the county level only. No information about living individuals will be
requested.

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, 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: 2016.02.08 08:48:57 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
2/8/2016

Date: _______________