FDA Electronic Submissions Gateway (ESG) User Guide ... - ICON plc

Appendix J. Digital SignaturesFDA does not require submission of a paper copy for electronic submissions submitted using theFDA ESG.FDA forms (e.g., 1571, 356h) and documents require a signature. Accepted signature methods byFDA are:• Scanned signatures• Digital signatures• Flattened digital signatures. A flattened digital signature must include:o the printed name of the signero the date and time when the signature was executedo the reason for signaturePlease use the Adobe Acrobat Self-Sign plug-in to insert your signature on fillable FDA forms.The FDA cannot hold digital signatures to a higher standard than paper signatures. The FDA willnot check the signature on an electronic or paper-based submission unless there is a directedinspection involving that submission. Please maintain the security certificates associated withyour digital signatures in case of a directed inspection.The FDAAs General Counsel (GC) has said that the FDA must be able to determine the origin ofa submission in order to implement fully electronic submissions. The PKI (x.509 version 3 classI) certificate employed by the ESG allows the FDA to determine the origin of the submissionthrough the use of a public/private key exchange.Please use the 1571(http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf) and356h (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf)fillable PDF forms with your electronic submissions to CDER and CBER via the ESG.• If you do not include these forms with your electronic submissions, CBER and CDERwill not be able to leverage their automated loading processes, reducing the process to amanual one. This results in a large increase in the time required by the Centers to makesubmissions available to our review community.• 356h and 1571 Form Field Sizeso For documents sent through the ESG for regulatory review, the most importantform fields from the FDAAs perspective are the application number and thesubmission type.o The current form fields have the maximum number of characters allowed. If aform field is not large enough, please abbreviate the text in the field. Increasingthe size of a form field or otherwise altering a form would require OMB approval.o FDA contractors or administrative reviewers read a submissionns cover letter andselected text to determine the nature and content of the submission. FDAgenerateddata and information is utilized in FDA submission tracking databases.