Non-research determination Letter

NCEZID Tracking Number:

102915CD

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Airline and Maritime Conveyance Manifest Orders
Primary contact Chris De La Motte Hurst, MPH

Division/Branch DGMQ/OD

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 collect data on airline passengers in response to an exposure to prevent and
control a possible outbreak. The collection of airline passenger manifest data is done specifically under the
authority provided by 42 CFR 71.32(b) and 42 CFR 70.2 to CDC. As this information collection is to respond to a
possible outbreak, this activity is consistent with the attributes of non-research public health outbreak response,
as described in current CDC policy. This activity is not designed to develop or contribute to generalizable
knowledge.
Additional considerations

None.

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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

James M.
Peterson -S
Signature: _________________________________

10/29/2015
Date: _______________

Digitally signed by James M. Peterson -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=0014247152,
cn=James M. Peterson -S
Date: 2015.10.29 14:25:20 -04'00'