AS2_Header_Attributes

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:

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

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:

Table G-1: Allowable Center Attribute Values
Center Destination	Allowed Attribute Values
CBER	AERS AERS_Attachments EBLA ECTD EIDE EIND eDMF H1N1_Lot_Release Promotional_Material Lot_Distribution_Data
CDER	AERS AERS_Attachements EANDA EBLA ECTD ENDA EIND
CDRH	Adverse_Events Electronic_Submissions
CFSAN	BNFs Color_Master_File Food_Contact_Notification Food_Master_File GRAS Notice New_Protein_Consultation Petitions PNC Threshold_of_Regulation
CVM	Adverse_Events_Reports Electronic_Submissions
OOPD	Orphan-drug_Designation_Requests HUD_Designation_Requests
GWTEST	ConnectTest SizeTest
OC	SPL
CTP	Electronic Submission

Appendix G. AS2 Header Attributes