ESG Appendix G: AS2 Header Attributes

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In addition to tarring/gzipping the actual documents, AS2 submissions must include the following attributes in their AS2 headers. The additional information is comprised of:

• FDA submissions Type
• FdaSubmissionType: Abbreviated New Drug (add submission type information)
• Center Name-
• FdaCenter: CDER (add Center information)

The Mime Headers are to be located in the outermost MIME wrapper and will appear as follows:

• X-Cyclone-Metadata-FdaSubmissionType: ENDA
• X-Cyclone-Metadata-FdaCenter: CDER

The following example represents how the standard AS2 mime header should appear after appending the Center and SubmissionType attributes and upon and presented at the FDA ESG.

• Message-ID: <1115406057162.328983@WIN2K3-ESX6>
• Date: Fri, 06 May 2005 19:00:57 GMT
• From: esx6
• Mime-Version: 1.0
• Content-Type: application/pkcs7-mime; smime-type=enveloped-data;
• name=smime.p7m
• Content-Transfer-Encoding: binary
• Content-Disposition: attachment; filename=smime.p7m
• Disposition-Notification-To: esx6
• Disposition-Notification-Options: signed-receipt-protocol=optional,
• pkcs7-signature; signed-receipt-micalg=optional, sha1
• AS2-Version: 1.1
• AS2-To: db-as2
• AS2-From: esx6-as2
• X-Cyclone-Metadata-FdaSubmissionType: EANDA
• X-Cyclone-Metadata-FdaCenter: CDER
• Content-Length: 3607

This information must be included in the outermost portion of the outermost MIME wrapper.

The table below indicates the allowable attribute values for each FDA Center destination:

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