Process for converting a paper IND to eCTD

Question:

Can you please confirm the process for converting a paper IND to eCTD?

Response:

For transitioning to eCTD format from paper or non-eCTD format, the first submission would be coded according to the currently active regulatory activity. 

If you are transitioning your unapproved original application, you would code the us-regional.xml file as "original-application" as the submission-type for the first submission with a detailed explanation in the cover letter. 

If you are transitioning an approved original application, you would use "other" as the submission-type. If you are transitioning with the submission of a new supplement, you would use the appropriate supplement type (e.g. labeling supplement).

It's recommended that your transitioning eCTD sequence be identified as a general correspondence submission in the cover letter and FDA Form, stating the application will be submitted in eCTD format from this date forward. 

The FDA form should list the submission type as General Correspondence (Other). The bold print on the top of the cover letter should say the correct submission type (General Correspondence, Amendment, etc.). 

In the body or at the end of the cover letter, you could state the following:

"As per the advice received from Office of Business Informatics, this eCTD submission sequence is intentionally being coded as "other" in the us-regional.xml and serves as a first-level submission type in the Electronic Common Technical Document (eCTD) format. This eCTD sequence is intentionally being submitted as "other" to establish the eCTD hierarchal structure and will allow second-level submission types such as amendments and resubmissions to be related to it."  You should adjust the wording in your cover letter to match your specific situation.

If unable to submit a fully completed fillable form with an electronic digital signature, it is possible to submit the complete fillable form (not scanned) without the signature, along with a second 1571 form that uses another method for signatures (e.g., a scanned signature).

When including a second complete 1571 form (it can be scanned), do not include "1571" anywhere in the file name. We recommend that you use a filename such as "signed-form.pdf" or similar.  The filled form should be named "1571.pdf". This will allow our automated systems to correctly find your fillable form, read it, and process your submission appropriately. The project manager will be able to find your signed form near your filled form, in the module 1 forms section of the eCTD.  Both of these forms should be placed in section 1.1.1 for eCTD submissions.