3      Preparatory Activities

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.

3.1      Submit Letter of Non-Repudiation Agreement

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.

3.2      Obtain Digital Certificate

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.

3.3      Understand Submission Guidelines

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.

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.

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

3.4      Naming Conventions

A special consideration applies to the naming convention for files and directories. The following characters are not recommended for use when naming submission files and directories:

/ - forward slash

\ - backslash

: - colon

? - question mark

" - quotation marks

< - less than sign

> - greater than sign

| - vertical bar,

space - If you need to use a space, use_an_underscore_instead or SeparateWordsWithCapitalLetters.

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

3.5      Determine Submission Method

There are three 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.

* 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.

Mbps = Megabits per sec.

1 GB (Gigabyte) = 8,590 Megabits

Actual times will be greater than those listed in the table due to factors such as network configuration and the amount of traffic coming in and going out through the line. For example, submissions sent in the middle of the day typically take 1.5 – 2 times longer to send than those sent after business hours.  Pilot testing with selected Industry Transaction Partners has shown that it takes approximately 24 hrs for submissions 15 GB to 25 GB in total size to be transmitted and processed by the FDA ESG.  These companies had T3 network connections or better.  FDA recommends that submissions of this size be sent overnight, starting at 4:30 PM EST, in order for the submission to be received by the target Center before the end of the next business day. 

During the testing process, Transaction Partners who will be sending submissions larger than 1 GB in total size will be asked to send a 7.5 GB test submission.  This test will allow Transaction Partners to identify and resolve network limitations that will impact the speed of delivery. 

3.6 Connection Requirements

FDA ESG Web Interface users need the following:

• A high-speed internet connection.
• A web browser: Internet Explorer 6, 7, 8 or Firefox 2.0.x.
• Hard disk space of at least three times the size of the submission. For instance, if the submission is 1MB in size, then at least 3MB of hard disk space is required.
• Sun’s Java Runtime Edition (JRE) 1.5.0_18, for the browser plug-in files.

Reference Appendix D., Java Runtime Edition Installation for more information on obtaining and installing JRE.

Gateway functionality is optimized with JRE version 1.5.0_18 installed.  It is recommended that the automatic Java update option on the computer be disabled to avoid the automatic installation of a different version of JRE.  The steps to do this are as follows:

1. Select Control Panel from the Start menu.
2. Double click on the Java (or Java Plug-In) icon.
3. Click on the "Update" tab.
4. Uncheck the "Check for Updates Automatically" checkbox.
5. Click OK.

Gateway-to-Gateway users need the following:

• A high-speed internet connection,
• An AS2 compliant Gateway product,
• Hard disk space of at least three times the size of the submission.

3.7 Help and Information

There are resources that can be contacted if you need assistance with various aspects of the submission process. These are provided in the table below.