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ESG Chapter 3 Preparatory Activities

ESG User Guide - Table of Contents

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.

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

Center Submission Type Notes
CBER





 
510K Medical Device Premarket Notification
AERS Adverse Event Reports (AERS)
AERS_Attachments AERS Attachments
CDISC Clinical Data Interchange Standards Consortium (CDISC)
EBLA BLA – Biologics License Application (eBLA format)
eDMF DMF – Drug Master File (eDMF format)
EIDE IDE – Investigational Device Exemption (eIDE format)
EIND IND – Investigational New Drug Application (eIND format)
EUA Emergency Use Authorization (EUA)
Lot_Release_Protocol  
NDA New Drug Application
PMA Premarket Approval Application (PMA)
Pre_IND Pre Investigational New Drug Application
Promotional_Materials Promotional Materials
QSUBS Q-Submissions
SPL_LDD Structured Product Labeling (SPL) Lot Distribution Database (LDD)
VAERS Vaccine Adverse Event Reporting System (VAERS)
CDER ACA6004_Drug_Samples ACA6004_Drug_Samples
AERS Adverse Event Reports (AERS)
AERS_Attachments AERS Attachments
AERS_IND** AERS for Investigational New Drug Application
AERS_Attachments_IND **AERS Attachments for Investigational New Drug Application
AERS_PREMKT AERS Pre-Market
AERS_Attachments_PREMKT AERS Pre-Market Attachment
ECTD Select ECTD submission type for the following filings:
eCTD – Electronic Common Technical Document (includes DMF - Drug Master File and EUA – Emergency Use Authorization)
BLA – Biologics License Application (eCTD and eBLA format)
ANDA – Abbreviated New Drug Application (eANDA format)
NDA – New Drug Application (eCTD and eNDA format)
EIND IND – Investigational New Drug Application (eIND format)
GDUFA_Facility_Registration Generic Drug User Fee Amendments (GDUFA) Facility Registration
PFC PFC - Pre-Submission Facility Correspondence
Voluntary_Direct_AEs  
CDRH Adverse_Events Adverse Events
Electronic_Submissions Electronic Submissions
GUDID Global Unique Device Identification Database (GUDID)
CFSAN Form 3480 Food Contact Notification (Form 3480)
Food Master File for FCS (Form 3480)
Pre-notification Consultation (Form 3480)
Form 3480A Food Contact Notification Amendment (Form 3480A)
Form 3503 Color Additive Petition (Form 3503)
Color Master File (Form 3503)
Food Master File (Form 3503)
Food Additive Petition (Form 3503)
Form 3665 Biotechnology Final Consultation (Form 3665)
Form 3666 New Protein Consultation (Form 3666)
Form 3667 Generally Recognized As Safe Notice (Form 3667)
Threshold_of_Regulation  
NDI New Dietary Ingredients
EON_Payload_Files*  
Food_Pilot_Listing  
CTP Adverse_Events Adverse Events
Electronic_Submission Electronic Submission
CVM Adverse_Events_Reports Adverse Events Reports
Electronic_Submissions Electronic Submissions
eSubmitter  
OC SPL SPL - Structured Product Labeling (includes NDC Labeler Code Request, Establishment Registration and Drug Listing)
HC Transaction

Frequently Asked Questions - Common Electronic Submissions Gateway

Foires aux questions - Portail commun de demandes électroniques

OPQ 704a4_Pharma_Inspection_Records  
OOPD** HUD_Designation_Requests  
Orphan-drug_Designation_Requests  
ORA** Gamma_Rays_Analysis  
GWTEST** ConnectTest To test the connectivity for submissions and receipts / notifications. Not more than 1GB to 50GB submissions.
SizeTest To test the size of submissions.

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

3.4  Naming Conventions

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

3.5  Determine Submission Method

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

  FDA ESG Web Interface AS2
Gateway-to-Gateway
Cost None High setup and support costs
Setup Minimal Need to install and configure Gateway
User-friendly web interface Yes No
Submission types supported All, including AERS reports All, including AERS reports
Long-term support by FDA Yes Yes
Preparation of multi-file submissions * Occurs automatically Multi-file submissions need to be archived and compressed using a tar and gzip utility prior to submission
Custom attributes for submission routing ** Automatically adds custom attributes to the AS2 header Need to add custom attributes to the AS2 header
Routing IDs *** N/A

Need to add routing IDs to the AS2 header

Integration to backend systems No

Can be automated

Tracking of submission activity by Transaction Partner

Manual tracking Can be automated
Automation of submission process No Yes

* 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

Network Connection Max. Transmission Rate (Mbps) Time (min)
T1 1.54 83
T2 6.31 21
T3 44.7

3

OC1 51.8 2.5
OC3 155.4 0.8
T4 274.8 0.5
OC12 621.6 0.2

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

For FDA ESG Web Interface users, submissions may be viewed from most systems that have Internet access. In order to send submissions, a system must have the following:

  • An Operating System of Windows 7 or above.
  • Any of the following browsers: Internet Explorer 11 or above, Mozilla Firefox, or Google Chrome. For Internet Explorer, Compatibility Mode may be set by going to Internet Options, selecting Compatibility View Settings and adding fda.gov. Organizations that have an IT staff may also use Enterprise Mode if accessing WebTrader with Internet Explorer 11.
  • Note: FDA has tested the new WebTrader with Windows 2007 R2, IE 11 (11.0.9600.18665), Firefox (53.0.2), Chrome (58.0.3029.110)
  • Hard disk: space of at least three times the size of the submission.
  • A high-speed internet connection.

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.

Table 5: Submission Process Aspects and Help and Information Contacts

Submission Process Aspect Contact

ESG Account Registration

Email: ESGHelpDesk@fda.hhs.gov
Technical Issues with Submissions after becoming a Production System Transaction Partner Email: ESGHelpDesk@fda.hhs.gov
Center-specific Submission Guidance Reference Section 3.3, Understand Submission Guidelines.

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