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ESG Appendix F: AS2 Header Attributes

ESG User Guide - Table of Contents

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-

        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.

        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 F-1: Allowable Center Attribute Values

        Center Destination Allowed Attribute Values Test Production

        CBER

        510K Yes Yes
        AERS Yes Yes
        AERS_Attachments Yes Yes
        CDISC Yes Yes
        EBLA Yes Yes
        EIDE Yes Yes
        EIND Yes Yes
        eDMF Yes Yes
        EUA Yes Yes
        H1N1_Lot_Release Yes Yes
        Lot_Release_Protocol Yes Yes
        NDA Yes Yes
        Pre_IND Yes Yes
        Promotional_Material Yes Yes
        PMA Yes Yes
        QSUBS Yes Yes
        SEND_PILOT Yes No
        SPL_LDD Yes Yes
        VAERS Yes Yes

        CDER

        ACA6004_Drug_Samples Yes Yes
        AERS Yes Yes
        AERS_Attachments Yes Yes
        AERS IND Yes No
        AERS Attachment IND Yes No
        AERS_PREMKT Yes No
        AERS_Attachments_PREMKT Yes No
        ECTD Yes Yes
        EIND Yes Yes
        GDUFA_Facility_Registration Yes Yes
        PFC Yes Yes
        Voluntary_Direct_AEs (WebTrader Submission ONLY) N/A N/A

        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-Payload-Files Yes Yes
        Food_Pilot_Listing Yes Yes

        CVM

        Adverse_Events_Reports Yes Yes
        Electronic_Submissions Yes Yes
        eSubmitter Yes Yes

        OOPD

        Orphan-drug_Designation_Requests Yes No
        HUD_Designation_Requests Yes No

        GWTEST

        ConnectTest Yes No
        SizeTest Yes No
        OC SPL Yes Yes

        CTP

        Electronic_Submissions Yes Yes
        Adverse_Events Yes No
        HC Transaction Yes Yes

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        • FdaCenter: CDER (add Center information)
        • X-Cyclone-Metadata-FdaSubmissionType: ENDA
        • X-Cyclone-Metadata-FdaCenter: CDER
        • 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

 

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