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 BEST 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 FFU-PILOT Yes No 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 CVM
Adverse_Events_Reports Yes Yes Electronic_Submissions Yes Yes eSubmitter Yes Yes CVM-VDD 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 ORA Inspection Yes No CTP
Electronic_Submissions Yes Yes Adverse_Events Yes No HC Transaction Yes Yes - 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
- Center Name-
- FdaSubmissionType: Abbreviated New Drug (add submission type information)