Question: Our company uses a business partner to manage our Gateway-to-Gateway EDI connections. Can this vendor continue to submit on our behalf? If so, should they be credentialed as a company user or should they utilize one of their own certifications?

Answer: A vendor / business partner can continue to submit on behalf of your company. Our paradigm will allow you to credential the vendor as a company user but we would prefer to have them utilize one of their own certifications.

Question: For existing E2B AERS submitters, is a certificate and profile exchange necessary to become an AS2 transaction partner with the FDA ESG?

Answer: Instead of a profile exchange, the online registration system will allow companies to provide all the profile information needed to setup an account with the FDA ESG. The certificate will be transferred to FDA using the online registration system. Once the account has been created, FDA will notify the responsible individual that the account has been activated and initiate testing.

Question: Will submitters of ICSR messages receive three acknowledgements from the FDA ESG, instead of the two acknowledgements currently sent from the ESTRI Gateway?

Answer: Submitters of ICSR messages will not receive three acknowledgements. Submitters of ICSR messages will continue to receive the same two acknowledgements from the FDA ESG that they currently receive from the ESTRI Gateway. Only submitters of other guidance compliant electronic submission types, such as NDAs, BLAs, or INDs, will receive three acknowledgements.

Question: How do you add custom attributes to an AS2 header?

Answer: Appendix G of the User Guide provides guidance on how to add two AS2 Header Attributes, one for Center Name, the other for Submission type. These are mandatory attributes that must be added for every submission that uses the AS2 Gateway-to-Gateway communication protocol. Typically, these attributes have to be added through custom coding. Refer to the documentation for your Gateway product to determine how to add custom attributes tan AS2 header. Cyclone Commerce has updated Cyclone Interchange (version 5.3.2) and Cyclone Activator (version 5.3.2) so that custom attributes can be added to the AS2 header using configuration parameters.

Question: How do you cancel a submission using the FDA ESG web interface once a transmission has begun?

A. When the upload progress window appears, press Cancel and this will cease the uploading of that submission.

Question: Are there any special requirements for digital certificates?

Answer: All digital certificates 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 of the User Guide for more information on digital certificates. Carefully review the "Issuer" and "Subject" fields to be sure that all data fields are completed (i.e., for each data element such as "CN", there is a value that follows the equals sign). Certificates must be valid for 1 to 3 years. Certificates that do not conform to these requirements will be rejected by the FDA ESG System Administrator.

Question: Our company currently uses a certificate that is valid for ten years is this acceptable with the new FDA ESG?

Answer: FDA policy is to accept an X509ver.3 certificate that is valid for only one to three years. It is the Transaction Partners responsibility to ensure that the validity period is acceptable and correct.

Question: Where are digital certificates purchased?

Answer: Listed below are the websites of some of the companies that sell digital certificates. Digital certificates issued by other authorities can also be used.

• Comodo: https://secure.instantssl.com/products/frontpage?area=SecureEmailCertificate
• GlobalSign: https://www.globalsign.com/en/
• Exostar: http://www.myexostar.com/Digital-Certificate-Service-Overview

Question: Can there be more than one digital certificate associated with a single account?

Answer: Only one digital certificate can be associated with an account. The certificate can be replaced when it expires, without creating a new account.

Question: When registering for another account, an error is received that says "Company name already exists". How can this error be addressed?

Answer: The error indicates that there is already a company registered with exactly the same name. Company names cannot be identical for different registered accounts. For example, "ABCDrugs" can be used for only one account registration. The name must be changed in some way for other registrations. An example would be to use "ABCDrugsAS2" for the AS2 protocol registration and "ABCDrugsWT" for the WebTrader protocol registration. Other examples would be to use "ABCDrugs" for one account and "BBBDrugs" for another or "ABCDrugs.1" and ABCDrugs.2".

Question: What is the character limit on the Company name?

Answer: There is a character limit of 255 characters.

Question: Is the non-repudiation letter solely for use during the testing period or is it carried forward to the production system environment?

Answer: The non-repudiation letter is necessary to enable your corporation to submit electronic submissions to the FDA. It is mandated by 21 Code of Federal Regulations (CFR) 11 and specifically referenced in 21 CFR 11.100 (c) (2). A copy of the non-repudiation letter sent to the Office of Regional Operations (ORO) shall be provided to the FDA ESG Staff. The use of the non-repudiation letter applies to electronic submissions submitted both through the FDA ESG production system and via the mail.

Question: Is it possible for a company to use both the FDA ESG web interface and the Gateway-to-Gateway exchange with the FDA ESG? For example, a company may want to send ISCR reports via the Gateway-to-Gateway exchange and other submissions via the FDA ESG web interface.

Answer: Yes. The scenario described above is acceptable. Registration can be for any number of AS2 or FDA ESG WebTrader accounts. For example, there can be three AS2 accounts registered in addition to eight WebTrader accounts.

Question: Is there a way to change a registration if a mistake is made? For example, registering for the FDA ESG web interface when the intention was to actually register for the AS2?

Answer: There is no way for users to change and/or retract a registration. In the scenario described above, the solution would be to register for the AS2 communication protocol option as originally intended. Contact FDA ESG staff using [email protected] to change contact information for a registration or to retract a registration.

Question: Is there a recommended time of day to send submissions?

Answer: Submissions can be transmitted anytime via the FDA ESG. We recommend that you send large submissions via the FDA ESG after 4:30 PM EST. This should enable your submission to be received, processed and delivered to the Center overnight. Delivery and processing time is dependent upon the overall size of your submission; larger submissions will take longer to be delivered and processed. You will be sent an acknowledgement from the receiving Center with the date and time your submission arrived. The Center acknowledgement will contain the business rules used to determine the official receipt date of your submission.

Question: How do CROs, U.S. Agents and Consultants apply for an account for themselves and their clients?

Answer: If you are a CRO, U.S. Agent or Consultant, please use the following steps to create an ESG account:

1. Register for a single ESG account (WebTrader or AS2). Using a single account, you may submit for all of your clients.
2. Your must obtain and submit a Letter of Authorization to FDA. Please make sure the Letter of Authorization lists your company name.
3. Your company must submit a Letter of Non-Repudiation to FDA.