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

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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