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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

    AERSYesYes
    AERS_AttachmentsYesYes
    EBLAYesYes
    EIDEYesYes
    EINDYesYes
    eDMFYesYes
    H1N1_Lot_ReleaseYesYes
    Promotional_MaterialYesYes
    Lot_Distribution_DataYesYes
    510KYesYes
    Pilot_Lot_ReleaseYesYes
    CDISCYesYes
    SPL_LDDYesYes
    Pre_INDYesYes
    VAERSYesYes

    CDER

    AERSYesYes
    AERS_AttachmentsYesYes
    EANDAYesYes
    EBLAYesYes
    ECTDYesYes
    ENDAYesYes
    EINDYesYes
    ACA6004_Drug_SamplesYesYes
    GDUFA_Facility_RegistrationYesYes

    CDRH

    Adverse_EventsYesYes
    Electronic_SubmissionsYesYes
    GUDIDYesYes

    CFSAN

    Form 3665YesYes
    Form 3503YesYes
    Form 3480YesYes
    Form 3480AYesYes
    Form 3667YesYes
    Form 3666YesYes
    Threshold_of_RegulationYesYes
    NDIYesYes
    EON-Payload-FilesYesYes
    Food_Pilot_ListingYesYes

    CVM

    Adverse_Events_ReportsYesYes
    Electronic_SubmissionsYesYes
    eSubmitterYesYes

    OOPD

    Orphan-drug_Designation_RequestsYesNo
    HUD_Designation_RequestsYesNo

    GWTEST

    ConnectTestYesNo
    SizeTestYesNo
    OCSPLYesYes

    CTP

    Electronic_SubmissionsYesYes
    Adverse_EventsYesNo
    HCECTDYesYes

     

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