Att K_Determination of Non-applicability of Human Submects Regulations

NCEZID Tracking Number: RD-091214RT

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

CDC Burden of Canine Brucellosis Survey
Division/Branch

Rita Traxler

DHCPP/BSPB

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 objective of this project is to determine the public health importance of human Brucella canis
infections by estimating the disease burden in dogs to assess the potential for zoonotic transmission and
determine the need for future human studies. The proposal describes the administration of a web-based
questionnaire to 86 State Veterinary Diagnostic Laboratories, which include State Universities and State
Animal Health laboratories. The data requested are not about the respondents, but rather veterinary
laboratory data and laboratory policies, and no identifying information will collected beyond the laboratory
name. Since no identifiable data will be collected about humans for the purpose of the study, this project
does not involve human subjects.

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 Wendy Carr, PhD

Wendy L. Carr -S

Title Human Subjects Advisor, NCEZID
Digitally signed by Wendy L. Carr -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Wendy L. Carr -S,
0.9.2342.19200300.100.1.1=1000545351
Date: 2014.09.12 09:36:41 -04'00'

Signature: _________________________________

09/12/2014

Date: _______________
Page 1 of 1