FDA 5005 Pre RFD - Supplemental

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

PRE-REQUEST FOR DESIGNATION (PRE-RFD)
If you want to update or supplement your initial Pre-RFD submission to address OCP’s questions, you may submit your revised Pre-RFD or
responses here.

Pre-RFD Number
What is the Pre-RFD number you are following up on? (This is an eight digit number that may contain leading zeroes.)
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Upload Additional Information
* You must upload a file to continue with the submission.
You may submit your request as a common electronic format, such as a Portable Document Format (PDF) or a Word Document. Only one
electronic submission is necessary.
Note: Multiple Files can be uploaded using the below upload files button. Individual File Size should not exceed 10MB. Only files with
extensions .pdf, .doc, .jpeg, .tif, .png, .txt should be uploaded. You must provide a Pre-RFD number before you can select files.
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Designer note: This form will be made
as a “508 compliant” Adobe LiveCycle
PDF with entry fields after FDA (along
with OMB, if applicable) gives final
approval to this “layout design” version.

FORM FDA 5005 (09/20)

Page 1

PSC Publishing Services (301) 443-6740

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