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ESG Appendix G: AS2 Header Attributes

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In order to communicate the filename to the FDA, the FDA requires the FileName Preserve on all AS2 submissions. 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:

    Table G-1: Allowable Center Attribute Values

     

    Center Destination

    Allowed Attribute Values

    Test

    Production

    CBER

    AERS Yes Yes
    AERS_Attachments Yes Yes
    EBLA Yes Yes
    ECTD Yes Yes
    EIDE Yes Yes
    EIND Yes Yes
    eDMF Yes Yes
    H1N1_Lot_Release Yes Yes
    Promotional_Material Yes Yes
    Lot_Distribution_Data Yes Yes
    510K Yes Yes
    Pilot_Lot_Release Yes Yes
    CDISC Yes Yes
    SPL_LLD Yes Yes
    Pre_IND Yes Yes
    VAERS Yes Yes

    CDER

    AERS Yes Yes
    AERS_Attachments Yes Yes
    EANDA Yes Yes
    EBLA Yes Yes
    ECTD Yes Yes
    ENDA Yes Yes
    EIND Yes Yes
    ACA6004_Drug_Samples Yes Yes
    GDUFA_Facility_Registration Yes Yes

    CDRH

    Adverse_Events Yes Yes
    Electronic_Submissions Yes Yes
    GUDID Yes Yes

    CFSAN

    Form 3665 Yes Yes
    Form 3503 Yes Yes
    Form 3480 Yes Yes
    Form 3480A Yes Yes
    Form 3667 Yes Yes
    Form 3666 Yes Yes
    Threshold_of_Regulation Yes Yes
    NDI Yes Yes
    EON-Notification-Files Yes Yes
    EON-Payload-Files Yes Yes
    Food_Pilot_Listing Yes Yes

    CVM

    Adverse_Events_Reports Yes Yes
    Electronic_Submissions Yes Yes
    eSubmitter Yes No

    OOPD

    Orphan-drug_Designation_Requests Yes Yes
    HUD_Designation_Requests Yes Yes

    GWTEST

    ConnectTest Yes No
    SizeTest Yes No
    OC SPL Yes Yes

    CTP

    Electronic Submission Yes Yes
    Adverse_Events Yes Yes
    HC ECTD Yes Yes

     

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