Non-research determination

NCEZID Tracking Number:

030117CD

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Waiver of Inadmissibility Under the Immigration and Nationality Act
Primary contact Chris de la Motte Hurst

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 provide CDC with adequate information to fulfill its responsibilities with regard to
the processing of applications for waivers of inadmissibility on health related grounds for prospective immigrants.
CDC assists DHS/USCIS in determining whether or not a prospective immigrant with a Class A mental health
disorders with associated harmful behavior may be admitted into the United States. The information collection is
authorized and required under US immigration law and regulation. As an activity authorized by law to prevent
harm to residents and immigrants, this activity is consistent with non-research public health intervention. This
activity is not designed to contribute to generalizable knowledge.
Additional considerations

This determination refers to data collection OMB Control No. 0920-0006.

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: _________________________________

03/01/2017
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: 2017.03.01 10:25:28 -05'00'