Research Determination

NCEZID Tracking Number: 112414AM

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

Primary contact

Quarantine station illness response forms: airline, maritime, and land/border crossing

Amy McMillen

Division/Branch DGMQ

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 proposed revisions to an existing information collection request pertain to ongoing activities conducted by the
Quarantine stations within the scope of their regulatory authority to prevent the introduction, transmission and spread
of communicable diseases from foreign countries into the US. These activities are non-research public health
practice, consistent with current CDC policy. The addition of Ebola screening forms and an Ebola monitoring survey
remains within the scope of DGMQ's statutory authority, and within the scope of public health practice.

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 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: 2014.11.24 11:36:25 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
11/24/14

Date: _______________