Determination of Non-applicability of Human Subjects Regulations

STARS Tracking Number: 0900f3eb82275f1c

NCEZID Tracking Number:

112123SE

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

Primary contact

Waiver of Inadmissibility Under the Immigration and Nationality Act
Soda Elizabeth

Division/Branch

DGMH/IRHB

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 project involves the collection of adequate information from those entering the country to fulfill
responsibilities with regard to the processing of applications for waivers of inadmissibility on
health-related grounds. This will involve CDC form 4.422-1 which is completed by an applicant's
sponsor through a chosen medical facility or specialist. This project is determined to be non-research
programmatic standard practice activities. This is not a systematic investigation.

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

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2023.11.21 15:51:03 -05'00'

Title

Human Subjects Advisor

Date 11/21/2023