Configure eSubmissions

You must complete the following procedures to properly configure Activator to use eSubmissions. These are:

1. Getting started with eSubmissions
2. Add an application pickup
3. Add partner-specific collaboration settings
4. Complete the FDA partner
5. Import root certificate for SSL

You must complete all of the above tasks before you can you send messages to the FDA.

The following topics explain each procedure in detail.

Related topics

• Getting started with eSubmissions
• Add an application pickup
• Add partner-specific collaboration settings
• Complete the FDA partner
• Import root certificate for SSL

Getting started with eSubmissions

Use this procedure to apply for an electronic submissions account and gather information to provide to the FDA about your community.

One of the first tasks in using eSubmissions is to contact the FDA to apply for an electronic submissions account. Go to the FDA web site http://www.fda.gov/esg/ for details. While waiting for the FDA to send information, you can partially perform the configuration for Activator. Once the FDA responds, you can complete the configuration.

To use eSubmissions, you must add a community as you would in establishing any e-commerce relationship. The community must have a certificate for encrypting messages and a delivery exchange for receiving messages via the AS2 message protocol. The transport must be HTTPS, but without client authentication. You can use an embedded HTTPS server, but you must add an SSL certificate.

You must manually add a partner for the FDA. The FDA does not send you a partner profile file to import to Activator. You can add the partner right away with a minimum of information (for example, partner name only). Later you can complete the partner information when the FDA sends you SSL and message encryption certificates, the URL to send messages via HTTPS, and other information.

When registering for an AS2 electronic submissions account with the FDA, be prepared to provide the following information about your community:

1. Company name. This must be a unique name not also used by your company for any other FDA electronic submissions account.
2. Community routing ID.
3. Name, phone number and email address of primary and alternate contact persons for your company.
4. A file containing the community’s encryption certificate and public key. See Export a certificate to a file.
5. A file containing the SSL certificate and public key for your HTTPS server. If you are using an embedded server, open the server’s maintenance page to add an SSL certificate or export it to a file (see HTTP (embedded) fields).
6. If applicable, the user name and password required for the FDA to connect to your HTTPS server.
7. The external URL the FDA must use to connect to your server. The host, port and path may be different than the values in the local URL. If your network uses a load balancer or firewall, contact your network administrator for the correct value. This URL should include the fully qualified host name or IP address, port number and path where a partner must connect to send messages.

Related topics

• Add an application pickup
• Add partner-specific collaboration settings
• Complete the FDA partner
• Import root certificate for SSL

Add an application pickup

Use this procedure to configure an application pickup needed for eSubmissions. This is a pluggable transport named Directory file system consumer.

To configure an application pickup for eSubmissions:

1. If you have not done so already, add a community in Activator user interface. See Add a community.
2. Change the pluggabletransports.xml file to support the eSubmissions. There are several ways to do this.
3. If no pluggable transports are in use, copy pluggabletransports.xml from <install directory>\util\fda to <install directory>\conf. This file, which has the configuration for the eSubmissions transport, replaces the pluggabletransports.xml file already in the conf directory. Do this only if the pre-existing conf file was not configured earlier for other pluggable transports.
4. If other pluggable transports are in use, edit the pluggabletransports.xml file in the conf directory to add the configuration for the eSubmissions transport. Copy the block below from util\fda\pluggabletransports.xml to conf\pluggabletransports.xml:

5. <TransportDefinition name="Directory file system consumer" description="Pluggable transport which consumes directory  messages from the file system." available="true"> <Class>com.cyclonecommerce.custom.fda.  PluggableArchiveSubmissionClient</Class> <Usages>   <Consume>    <Integration/>   <Consume> </Usages> <SettingDefinitions>  <SettingDefinition name="Directory" description="Directory from which  directories/files will be consumed." type="string" required="true"   encrypt="false" mask="false"/> </SettingDefinitions> </TransportDefinition>

3. In the user interface, click Application pickup in the navigation graphic at the top of the community summary page.
4. Click the Add an application pickup task at the bottom of the page to open the wizard.
5. On the From address page, select one of these options:
   
   • Address must be determined by either message attribute configuration or by protocol address only.
   • Specify the address. Always use a fixed address.
   • Specifies that Activator should always use a fixed address for the sender or receiver. You can click Pick party to launch a wizard that helps you locate the community or partner you want. The “from” or “to” party must be set up as a community or partner in the user interface.
   • Use the protocol address but if protocol address is missing, parse the document for the address.
   • If you select this option, you must configure the address parsing rule. See Address parsing rule options below.
   • Always parse for the address. Regardless of whether the message protocol provides the address, always parse the document for the address.
   • Select this option to specify that Activator should always parse the message for the sender or receiver address.
   • For messages from partners, however, Activator still checks the protocol header for the sender and receiver. A message with an unknown sender or receiver in the header is rejected. The always parse option for inbound messages is for finding the identity of true senders or true receivers.
   • For messages picked up from applications, the always parse option tells Activator to find the sender or receiver in the message body. Messages from integration do not have protocol headers.
   • If you select this option, you must configure the address parsing rule. See Address parsing rule options below.
   • Address parsing rule options:
     
     • If the document is EDI, parse for the address – If an EDI document is picked up, use the “to” and “from” addresses specified within it. Properly formatted EDI documents contain this information.
       
       • Perform enhanced EDI parsing to match partner messaging IDs – This setting applies to X12, EDIFACT, and TRADACOMS. If selected, Activator performs additional parsing of the header information to create routing IDs with a colon separator between values. For example, information from an EDIFACT file would be parsed in the following format:
       • ID:interchange ID:internal ID:sub-internal ID
       • When this parsing option is elected, communities and partners must have matching routing IDs in the same format. For example, if the “from” address in a parsed message is ID:interchange ID:value3:value4, the partner must have the same routing ID.
       • When this option is not selected, “to” and “from” addresses in messages are parsed only for Activator ID and ID values. For example, 1:partner is parsed as the sender and rendered as partner1 in the user interface.
       • Note that TRADACOMS only has two optional values that can be parsed. They must match one of the following patterns:
         
         • A:
         • :B
         • A:B
     • If the document is XML, use XPaths to locate the address – If an XML document is picked up, use the “to” and “from” addresses specified by the XPaths within it. XML Path Language or XPath is a language for addressing parts of an XML document.
       
       • Document type – For XML, select a document type from the available list for the From XPath or To XPath fields. These fields are for specifying the XPaths of the message sender or receiver. If you use a document type not listed, click XPath and use the wizard to specify the XPaths using your example of the XML document. You can use the XPath wizard for the “from” or “to” address or both. Using the XPath wizard requires knowledge of XML.
         If you want to select multiple document types from the list, you must cut the XPath from the top field and paste it in a lower field. Otherwise, the value in the top field is replaced when you select another document type.
6. On the To address page, do the same as for the From address in step 5.
7. On the Choose transport protocol page, select Directory file system consumer.
8. On the Enter transport settings page, type the path of a directory. This is the directory Activator polls for messages to consume, package and send to the FDA.
9. You can use any path and name you want for the directory. If the directory does not exist, Activator creates it for you. Do not use spaces in the path or directory name. For example, on Windows the path could be C:\FDA_Reports\out.
9. To name the delivery, click Next. Otherwise click Finish.

Related topics

• Getting started with eSubmissions
• Add partner-specific collaboration settings
• Complete the FDA partner
• Import root certificate for SSL

Add partner-specific collaboration settings

Use this procedure to add partner-specific AS2 collaboration settings for your community and the FDA. These rules affect how your community sends messages to the FDA.

1. If you have not done so already, add a partner for the FDA. Minimally, add a partner with the partner name and a placeholder value for the contact name. Select Partners > Add a partner and choose Manually create a new partner.
2. You only need to partially configure the partner now. This enables you to set up partner-specific collaboration settings in the next step. If you have not yet received information from the FDA about the contact name, routing ID, certificates and the URL to send messages, you can add that later.
2. Click Collaboration settings in the navigation graphic on the community summary page.
3. Click Specialize collaboration settings for a partner. Pick the FDA partner and click Add.
4. Click the FDA partner name to open the Configure community endpoint to partner specific collaboration settings page. The community should be identified as your community and the partner as the FDA.
5. Select Set sending rules for the AS2 message protocol.
6. Scroll down the page until the AS2 settings are displayed.
7. Select Request receipts be sent over an asynchronous connection. Enter a Disposition notification URL.
8. Commonly, the URL to use is the URL used by partners for the HTTP or HTTPS delivery exchange your community has for receiving messages from partners. To get this value, click Application delivery on the navigation graphic at the top of the community summary page to open the Application delivery page. Copy the URL from the Location column for the desired transport. Return to the collaboration settings page and paste the URL in the Disposition notification URL field.
8. For message compression select MIME/GZIP.
9. Select Specify message attributes to be packaged with message.
10. This option is available only if your software license supports allowCustomMetadataInMessageHeaders. Select Help > License information in the user interface to check whether this license key is enabled.
10. Use the Add new and Add buttons to add the following as selected attributes:
    
    • FdaCenter
    • FdaSubmissionType
11. Click Save changes.

Related topics

• Getting started with eSubmissions
• Add an application pickup
• Complete the FDA partner
• Import root certificate for SSL

Complete the FDA partner

Use this procedure to complete the partner for the FDA. You can do this after the FDA approves your electronic submission account and sends you information including:

• The URL for connecting to the FDA’s HTTPS server
• The FDA’s routing ID
• A certificate and public key for encrypting outbound messages

1. Open the FDA partner in the user interface.
2. Add the routing ID for the FDA. On the partner summary page, click Routing IDs on the navigation graphic at the top of the page.
3. Add the contact information for the FDA. On the partner summary page, click Contact on the navigation graphic at the top of the page.
4. Import the encryption certificate and public key provided by the FDA. On the partner summary page, click Certificates on the navigation graphic at the top of the page. Then click Add a certificate. Make sure to trust the certificate for trading and SSL.
5. Add a delivery for sending messages to the FDA.
   1. Select the Add a delivery task at the bottom of the partner summary page to open the wizard.
   2. On the Choose message protocol page select EDIINT AS2.
   3. Type the URL the FDA provided for connecting to its HTTPS server.
   4. Select Clients must use SSL to connect to this server. But do not select Enable host name verification.
   5. Select This server requires a user name and password only if the FDA sent a user name and password to use.
   6. Click Next to optionally name the delivery. Otherwise, click Finish.
6. Complete the delivery configuration.
   1. On the partner summary page, click Partner delivery on the navigation graphic at the top of the page. Then click the transport added in step 5 to open its maintenance page.
   2. Click the Advanced tab.
   3. Make sure each of the following fields has a value of 300 seconds (5 minutes). These intervals are needed to accommodate the FDA’s busy network.
      • Connect timeout
      • Read timeout
      • Response timeout
   4. Select Enable HTTP chunking.
   5. Click Save changes.

Related topics

• Getting started with eSubmissions
• Add an application pickup
• Add partner-specific collaboration settings
• Import root certificate for SSL

Import root certificate for SSL

Use this procedure to add a trusted root certificate to your community after the FDA has sent you a root certificate for SSL.

1. On the community summary page, click Certificates in the navigation graphic at the top of the page.
2. Click the Add a trusted root certificate for SSL servers task at the bottom of the Certificates page.
3. Select Import a certificate from a file and click Next.
4. Click Browse and locate the SSL root certificate file the FDA sent you. Click Open and Next.
5. Click Finish.

Related topics

• Getting started with eSubmissions
• Add an application pickup
• Add partner-specific collaboration settings
• Complete the FDA partner
• eSubmissions
• Overview of eSubmissions
• Send messages to the FDA
• Manage unlimited strength JCE policy download issues