Attachment S_Not Research Determination

STARS Tracking Number: 0900f3eb81c61e7a

NCEZID Tracking Number:

122320SW

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

Primary contact

COVID-19 Conditional Sailing Certificate
Stefanie White

Division/Branch

DGMQ/QBHSB

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. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]

✔ Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.
Project is deemed not to be research under the following provision. IRB review is not required.
Select, if applicable

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

This determination request is issued for purposes of supporting the OMB/PRA application. This is an
information collection for purposes issuing Conditional Sailing Certificates to vessels operating in US
waterways. This is a programmatic activity under CDC’s statutory and regulatory authority related to
preventing the spread of communicable disease from maritime vessels into the US.
This programmatic activity is neither a systematic investigation, nor an effort to develop or contribute
to generalizable knowledge. As such, it does not meet the definition of research.
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.
Reviewed by

Laura Youngblood

Laura Youngblood Signature S

Digitally signed by Laura
Youngblood -S
Date: 2020.12.23 14:43:40 -05'00'

Title

Human Subjects Advisor

Date 12/23/20