Att L_Determination of Non-applicability of Human Subjects

NCEZID Tracking Number: 021815SM

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

Primary contact

Emerging Infections Program healthcare-associated infections and antimicrobial use prevalence
survey

Shelley Magill, MD, PhD

Division/Branch DHQP/ERIB

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
This project is Phase IV of DHQP's HAI point prevalence survey. Phase I was determined to be research, as it was
designed to establish new methodology for HAI surveillance. Phases II and III applied the knowledge that was
generated from Phase I to implement a regional point prevalence survey (II) and then a national point-prevalence
survey (III) through the Emerging Infections Program. The national survey has always been intended to be repeated
at 3-5 year intervals to monitor the frequency and occurrence of HAI and to assess antimicrobial use and prescribing
practices in the context of existing CDC recommendations. Phase IV represents the first follow-up to the nation-wide
survey. The objectives remain consistent with non-research surveillance and evaluation objectives as described in
current CDC policy, as they are designed to monitor the frequency and occurrence of HAI and to evaluate adherence
to public health recommendations. Findings will inform ongoing HAI program and policy recommendations.

Additional considerations
Previous determination/protocol tracking numbers: Phase I (research) -- 5566; Phase II (non-research) -- RD-5375;
Phase III (non-research) -- 012411SM

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, MPH, CIP

Laura
Youngblood -S

Digitally signed by Laura Youngblood -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001704097
, cn=Laura Youngblood -S
Date: 2015.02.18 15:09:27 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
2/18/15

Date: _______________