Non-Research Determination

De La Motte Hurst, Christopher (CDC/OID/NCEZID) (CTR)
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Youngblood, Laura (CDC/OID/NCEZID)
Wednesday, December 03, 2014 11:16 AM
De La Motte Hurst, Christopher (CDC/OID/NCEZID) (CTR); McMillen, Amy
(CDC/OID/NCEZID)
NCEZIDHumanStudies (CDC)
#082114CB: 0900 Contact Investigation Revision
0920-0900 Supporting Statement B - 11262014.docx; 30_Day_FRN Revision
0920-0900.docx; 0920-0900 Supporting Statement A - 11262014.docx; Attachment U
Script_Introduction and Confirmation.docx; Attachment A1 Section 361 of the Public
Health Service Act (42 USC 264)..pdf; Attachment A2 42 CFR part 70.pdf; Attachment A3
42 CFR part 71.pdf; Attachment B 60 Day FRN 0920-0900 Revision.docx; Attachment C General Contact Investigation Outcome Reporting Form - Air.docx; Attachment D General Contact Investigation Outcome Reporting Form - Maritime.docx; Attachment E
- General Contact Investigation Outcome Reporting Form - Maritime.xlsx; Attachment F
- General Contact Investigation Outcome Reporting Form - Land.docx; Attachment G TB Contact Investigation Outcome Reporting Form - Air 2.docx; Attachment H - TB
Contact Investigation Outcome Reporting Form - Maritime 2.docx; Attachment I - TB
Contact Investigation Outcome Reporting Form - Maritime.xlsx; Attachment J - Measels
Contact Investigation Outcome Reporting From - Air.docx; Attachment K - Measles
Contact Investigation Outcome Reporting Form - Maritime.docx; Attachment L Measles Contact Investigation Form - Maritime.xlsx; Attachment M - Rubella Contact
Investigation Outcome Reporting Form - Air.docx; Attachment N - Rubella Contact
Investigation Outcome Reporting Form - Maritime.docx; Attachment O - Rubella
Contact Investigation Outcome Reporting From - Maritime.xlsx; Attachment P
ExposureQuestionnaire_Passengers.docx; Attachment Q
ExposureQuestionnaire_FlightCrew.docx; Attachment R
ExposureQuestionnaire_CleaningCrew.docx; Attachment S
ExposureQuestionnaire_AirportStaff.docx; Attachment T
ExposureQuestionnaire_OtherCommercialConveyance.docx; 082114CB-signed.pdf

Dear Chris,
I have reviewed attachments P-U related to OMB package #0920-0900. The proposed changes do not impact the
original determination (#082114CB) that the Ebola contact tracing activities do not meet the definition of research.
Further, I confirm that all other documents included in this package pertain to activities that are within the scope of
DGMQ’s statutory authority to monitor/prevent the introduction of infectious diseases into the US, and to
monitor/prevent the spread of infectious diseases between states. These activities are routine public health practice,
and they do not meet the regulatory definition of research.
Thanks,
Laura
Laura Youngblood, MPH, CIP | Human Subjects Advisor | National Center for Emerging and Zoonotic Infectious Diseases |
Centers for Disease Control and Prevention | [email protected] | MW: (404) 639-6394 | TThF: (404) 510-0093

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