Determination Letter

20146-01 HSR Determination FDA CTP.pdf

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

Determination Letter

OMB: 0910-0697

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September 9, 2020
Everly Macario, Sc.D, MS, Ed.M
IQ Solutions, Inc.
11300 Rockville Pike, Suite 901
Rockville, MD 20852
RE:

2020 FDA CTP Emails Survey Audience Analysis Study
E&I ID# 20146

Dear Dr. Macario:
Using a Determination of Research with Human Subjects assessment process, the E&I
administrative review team has reviewed your submission. We have determined that your
project is not "research". No formal IRB review is required at this time. Please keep this
determination document with your project records.

E&I Assigned Study ID:
Date of Certification:

20146 - 01
September 1, 2020

Conditions: There is no expiration date. The determination does not render any opinion about
the ethical conduct of the activities. The determination is for the described activities only. If
there is a question about the determination, please call.
Please remember to submit any desired modification to your project for further assessment
and consideration prior to carrying out such changes.
Thank you for choosing E&I and please feel free to contact us anytime, we are here to help.
Sincerely,

Teresa Majors, CIP
Organizational Official
cc: Sarah Byrnes, sbyrnes@iqsolutions.com

E&I
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