There are a number of preparatory activities that need to be completed before beginning the registration process. This section describes these preparatory activities and presents system and protocol issues for FDA ESG users to consider.

A letter of Non-Repudiation Agreement must be submitted to the FDA. Reference Appendix H, Sample Letters of Non-Repudiation Agreement, for letter examples.

The non-repudiation agreement allows the FDA to receive electronically signed submissions in compliance with 21 Code of Federal Regulations (CFR) Part 11.100.

A digital certificate must be obtained.

Digital certificates ensure private and secure submission of electronic documents. The digital certificate binds together the owner’s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents.

Digital certificates can be obtained from either a public or private Certificate Authority (CA). It must be an X.509 version 3 certificate and all data fields in the Issuer and Subject fields must be completed. Reference Appendix C., Digital Certificates for more information on digital certificates.

Each FDA Center has specific guidelines that must be followed for successful submission. Table 1: FDA Links to Submission Preparation Guidelines below contains links to Center-specific preparation guidelines and contacts. Table 2: Electronic Submissions Supported by the FDA ESG lists electronic submissions supported by the FDA ESG. Important information on the use of digital/electronic signatures on FDA forms can be found in Appendix J., Digital Signatures.

Table 1: FDA Links to Submission Preparation Guidelines

NOTE: Meeting the requirements for using the FDA ESG to route submissions does not mean that these submissions automatically meet FDA Center-specific submission requirements.

For each test submission type, a test submission must be validated by the Center before sending submissions to the Production System.

It is the responsibility of the Transaction Partner to consult the appropriate FDA Center for information on formats, deadlines, and other information or procedures for submissions.

The submission acronyms or names listed in Table 2 below are not to be used as attributes in the submission header. See Table G-1 in Appendix G., AS2 Header Attributes, for a list of allowed attributes for the different submission types.

Table 2: Electronic Submissions Supported by the FDA ESG

* These submission types are only supported in the Test environment and are intended solely for testing.

ESG recommends using only letters, numbers, spaces, and underscores when naming files, directories and digital certificates. The following characters are not recommended when naming files, directories and digital certificates:  forward/back slash, colon, question mark, quotation marks, less/greater than sign, vertical bar, and pound/hash sign.

Note: Directories and sub-directories cannot begin with the "." (dot) character

There are two options for sending FDA ESG submissions:

1. FDA ESG Web Interface – The FDA ESG Web Interface sends submissions via Hyper Text Transfer Protocol Secure (HTTPS) through a web browser according to Applicability Statement 2 (AS2) standards.
2. Applicability Statement 2 (AS2) Gateway-to-Gateway – An electronic submission protocol that uses HTTP/HTTPS for communications.

Determining the best of these options for your organization will be influenced by the types of submissions to be transmitted, infrastructure capabilities, and business requirements.

One or more of these options can be selected to submit electronic documents to the FDA. However, a separate registration will be required for each option selected.

Considerations for each option are shown in Table 3 below.

Table 3: Considerations for Submission Protocol Choice

* See Appendix B., Creating .tar Files and Compressing Files for Submission

** See Appendix G., AS2 Header Attributes

*** See Appendix K., AS2 Routing IDs

A factor that determines how quickly a submission can be sent to the FDA ESG is the Transaction Partner’s network connection to the Internet. Table 4 lists the maximum transmission rates for a variety of network connections and the optimal time it would take to send a 1 GB submission.

Table 4: Transmission Rates for Network Connections and Optimal Times for Transmission

3.6  Connection Requirements

3.7  Help and Information