Research Determination

Vice, Rudith (CDC/DDID/NCEZID/OD)
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Youngblood, Laura (CDC/DDID/NCEZID/OD)
Thursday, September 21, 2023 10:11 AM
Vice, Rudith (CDC/DDID/NCEZID/OD)
NCEZIDHumanStudies (CDC)
Non-research: NCEZID-Extension-30-day-0920-1307-Shigella Hypothesis Generating
Questionnaire; NCEZID #103019AG

Thanks, Rudith.
There have been no changes to this project. The original non-research determination stands:

CDC has developed a Shigella hypothesis generating questionnaire (SHGQ) to use in Shigella
infection clusters and outbreaks. CDC will be providing the SHGQ to states for use in multistate and single-state clusters and coordinate surveillance of Shigella clusters with states.
Results of the surveys will be used to inform local public health response and may be
published in peer-reviewed journals. As the purpose of this activity is to collect information
by a public health authority and limited to that necessary to identify, monitor, and
investigate onsets of disease, it is consistent with non-research public health surveillance as
defined by 45 CFR 46.102(l)(2).

Laura
Laura Youngblood, MPH, CIP
Human Subjects Advisor | NCEZID Information Collections & Human Studies Team | [email protected] | Office: (404) 6396394 | Mobile: (404) 510-0093

From: Vice, Rudith (CDC/DDID/NCEZID/OD)
Sent: Thursday, September 21, 2023 10:03 AM
To: Youngblood, Laura (CDC/DDID/NCEZID/OD)
Subject: NCEZID-Extension-30-day-0920-1307-Shigella Hypothesis Generating Questionnaire
Good morning Laura,
Please find attached the OMB Extension package for Shigella Hypothesis Generating Questionnaire, currently approved
under OMB Control # 0920-1307. As discussed, there are no changes to this project since the last OMB approval. The
attached Supporting Statement A includes all the details about this package. Also attached is the most recent human
subjects determination and data collection instruments. Please let me know whether the original non-research
determination still stands.
STARS Tracking Number: 0900f3eb81a2970e.
Thanks,
Rudith Vice, MPH
NCEZID PRA Contact
NCEZID Information Collections & Human Studies Team
[email protected]
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404-718-7292

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