HS Determination

NCEZID Tracking Number:

020717KF

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Improving outpatient antibiotic use through implementation and evaluation of Core
Elements of Outpatient Antibiotic Stewardship - Baseline period
Primary contact Katherine Fleming-Dutra, MD

Division/Branch DHQP/PRB

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 develop a baseline of data for the development of effective interventions that
improve antibiotic use and prescribing. The baseline objectives are to determine overall antibiotic use per patient
visit, assess the appropriateness of antibiotic use, measure health outcomes associated with antibiotic use, and
assess barriers to appropriate antibiotic prescribing. The results will be used to develop and inform intervention
development. CDC personnel will be providing technical expertise and will not have contact with participants nor
have access to private identifiable information. As such, CDC is not engaged in the conduct of this research per
CDC guidance.
Additional considerations

The University of Utah's IRB has reviewed and approved this activity for research.

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: _________________________________

2/7/2017
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: 2017.02.07 10:11:28 -05'00'