Transaction Partners

Apply for a Test Account. Organizations that wish to submit electronically to the FDA must apply for an account to establish themselves as Transaction Partners. The term Transaction Partner refers to... 

Application for a test account must be initially requested for the FDA ESG. This is done to enable Transaction Partners to send a test submission to the FDA ESG. 

Applying for an account involves information-sharing activities between the Transaction Partner and the FDA to set up transmission, receipt, and identification parameters. This ensures the correct identification of the Transaction Partner to the FDA. Digital certificate information is provided to the FDA as part of the application. 

Test Account Setup and Approval. The account application is reviewed by the FDA ESG Administrator. The Administrator verifies that a letter of nonrepudiation agreement is on file, that the digital certificate conforms to the X.509 version 3 standard, and that all data fields in the Issuer and Subject fields are completed (see Appendix A, Digital Certificates for more information). The Administrator will also communicate with the Transaction Partner to confirm the application information. If these conditions are met, a test account is set up, and connections to the FDA ESG test system are established before the submitting organization is approved as a Transaction Partner. 

Send a Test Submission. By sending a test submission, the Transaction Partner ensures the following conditions are met. 

During the testing process, Transaction Partners who will be sending submissions larger than 1GB 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. Send 7.5-GB test submissions to the GW TEST Center and select SIZE TEST as the submission type. 

Send Submissions to the Production System. After completion of these steps, the Transaction Partner is enabled and approved to send submissions to the FDA ESG. The Production System Account allows the Transaction Partner to send any of the supported submission types to the FDA. However, the FDA... 

NOTE 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. 

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 1.4 lists the maximum transmission rates for a variety of network connections and the optimal time it would take to send a 1-GB submission. 

Transaction partner considerations FDA ESG Web Interface AS Gateway-to-Gateway AS2 Gateway-to-Gateway... 

Technical Issues with Submissions after becoming a Production System Transaction Partner... 

The Welcome to the WebTrader registration wizard page is displayed. This wizard guides the Transaction Partner through the remainder of the application process. 

This page is used to specify the user ID, password, and contact information selected by the Transaction Partner. After registration is complete, this user ID and password will be used by the Transaction Partner to log on to the FDA ESG Web Interface. 

Test Account Setup and Approval. After a successful Test Account setup, the FDA sends an e-mail to the e-mail address provided for the contact, indicating approval as a Transaction Partner and authorization to send a test submission. Typically, the approval notification is sent on the next business day. 

Send a Test Submission. After Test Account Setup and Transaction Partner approval, a test submission must be sent to ensure that the submission conduit is working properly from end to end. To do this, follow the steps below. 

Tracking Submissions. Once a submission has been sent by using the FDA ESG Web Interface, the Transaction Partner can track the submission to ensure that it was received by the FDA ESG and the Center. 

A problem that cannot be avoided by the signature scheme is that someone swamps other users outside the system, e.g., courts, with so much work that they can no longer perform the necessary work. However, as an explicit command from each transaction partner is needed in every transaction, no attack of this kind can happen inside the system. 

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