CDC determination: Non-research activity

NCEZID Tracking Number:

021617CD

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Requirements for the Importation of Nonhuman Primates into the United States
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 for CDC to collect information from non-human primate importers by authority of 42
CFR part 71 for the purpose of ensuring safe import of non-human primates. The information enables CDC to
evaluate compliance with pre-arrival of shipment notification requirements, investigate the number and species of
imported nonhuman primates, and to determine if adequate measures are taken for the prevention of exposure
to persons and animals during importation. As this collection of information is directly related to specific
regulations for surveillance, this activity is consistent with non-research public health surveillance per CDC policy.
This activity is not designed to contribute to generalizable knowledge.
Additional considerations

This determination pertains to the information collection with OMB Control No. 0920-0263.

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: _________________________________

02/16/2017
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: 2017.02.16 11:43:38 -05'00'