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 Submission Type 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

Legend:
(A)	denotes AS2 only.
(W)	denotes WebTrader only.
(P)	denotes Production environment only.
(T)	denotes Test environment only.
(NGP)	denotes Not for General Public.
(*)	CDRH's only eligible submission categories via the FDA ESG CDRH "Electronic_Submissions" submission type are "Recall Reports of Corrections and Removals" and "Radiological Health Reports and Correspondence". Further, CDRH Premarket submissions should be sent via the CDRH Customer Collaboration Portal.
*Note:* If a WebTrader Display Name or an AS2 Submission Type does not have either the (P) or (T) annotation, then it is allowed in both Production and Test.
*Note:* If an item does not have the (W) or (A) annotation, then it is allowed in both WebTrader and AS2.

Center	WebTrader Display Name	AS2 Submission Type	Allowed Attribute Values (AS2 Routing ID)
CBER	510K	510K	CBER_510K
	AERS	AERS	FDA_AERS
	AERS Attachments	AERS_ATTACHMENTS	FDA_AERS_ATTACHMENTS
	AERS_PREMKT_CBER	AERS_PREMKT_CBER	FDA_AERS_PREMKT_CBER
	AERS_ATTACHMENTS_PREMKT_CBER	AERS_ATTACHMENTS_PREMKT_CBER	FDA_AERS_ATTACHMENTS_PREMKT_CBER
	BEST	BEST	CBER_BEST
	CDISC	CDISC	CBER_CDISC
	EBLA	EBLA	CBER_EBLA
	eDMF	eDMF	CBER_EDMF
	EIDE	EIDE	CBER_EIDE
	EIND	EIND	CBER_EIND
	EUA	EUA	CBER_EUA
		H1N1_Lot_Release ^(A)	CBER_H1N1_LOT_RELEASE
	Lot_Release_Protocol	Lot_Release_Protocol	CBER_LOT_RELEASE_PROTOCOL
	NDA	NDA	CBER_NDA
	PMA	PMA	CBER_PMA
	Pre_IND	PRE_IND	CBER_PRE_IND
	Promotional_Materials	Promotional_Materials	CBER_PROMOTIONAL_MATERIAL
	QSUBS	QSUBS	CBER_QSUBS
	SEND_PILOT ^(T)	SEND_PILOT ^(T)	CBER_SEND_PILOT
	SPL_LDD	SPL_LDD	CBER_SPLLD
	VAERS	VAERS	CBER_VAERS
CDER	ACA6004_Drug_Samples	ACA6004_Drug_Samples	CDER_ACA6004
	AERS	AERS	FDA_AERS
	AERS Attachments	AERS_ATTACHMENTS	FDA_AERS_ATTACHMENTS
	AERS IND ^(T)	AERS_IND ^(T)	AERS_IND
	AERS Attachment IND ^(T)	AERS_ATTACHMENTS_IND ^(T)	AERS_ATTACHMENTS_IND
	AERS_PREMKT ^(T)	AERS_PREMKT ^(T)	FDA_AERS_PREMKT
	AERS_Attachments_PREMKT ^(T)	AERS_Attachments_PREMKT ^(T)	FDA_AERS_ATTACHMENTS_PREMKT
	AERS_PREMKT_CDER	AERS_PREMKT_CDER	FDA_AERS_PREMKT_CDER
	AERS_ATTACHMENTS_PREMKT_CDER	AERS_ATTACHMENTS_PREMKT_CDER	FDA_AERS_ATTACHMENTS_PREMKT_CDER
	ECTD	ECTD	CDER_ECTD
	ECTD WAIVED	ECTD_WAIVED	CDER_ECTD_WAIVED
	EDMF TYPEIII	EDMF_TYPEIII	CDER_EDMF_TYPEIII
	EIND	EIND	CDER_EIND
	FFU-PILOT ^(T)	FFU-PILOT ^(T)	CDER_FFU-PILOT
	GDUFA_Facility_Registration	GDUFA_Facility_Registration	CDER_GDUFA_FACILITY_REGISTRATION
	PFC	PFC	CDER_PFC
	POR Large Molecule Documents	POR_Large_Molecule_Docs	CDER_POR_Large_Molecule_Docs
	Voluntary_Direct_AEs ^(W)
CDRH	Adverse Events	Adverse_Events	CDRH_AERS
	Electronic_Submissions ^(*)	Electronic_Submissions ^(*)	CDRH_ESUBS
	GUDID	GUDID	CDRH_GUDID
HFP (formerly CFSAN)		DSR_Adverse_Events ^(A)	CFSAN_DSR_ADVERSE_EVENTS
	EON-Payload-Files ^(P)	EON-Payload-Files ^(P)	CFSAN_EON_PAYLOAD_FILES
	Food_Pilot_Listing ^(P)	Food_Pilot_Listing ^(P)	CFSAN_FOOD_PILOT_LISTING
	Form3479	Form3479	CFSAN_Form3479
	Form3480	Form3480	CFSAN_FORM3480
	Form3480A	Form3480A	CFSAN_FORM3480A
	Form3503	Form3503	CFSAN_FORM3503
	Form3665	Form3665	CFSAN_FORM3665
	Form3666	Form3666	CFSAN_FORM3666
	Form3667	Form3667	CFSAN_FORM3667
	NDI ^(P)	NDI ^(P)	CFSAN_NDI
	Threshold_of_Regulation	Threshold_of_Regulation	CFSAN_TRESHOLD_OF_REGULATION
CTP		Adverse_Events ^(A)	CTP_AE
CTP	Electronic_Submission	Electronic_Submission	CTP_ESUB
CVM	Adverse_Events_Reports	Adverse_Events_Reports	CVM_AERS
	eSubmitter	eSubmitter	CVM_ESUBMITTER
	Manage Form	Electronic_Submissions	CVM_ESUBS
CVM-VDD	eSubmitter ^(T)	eSubmitter ^(T)	CVMVDD_eSubmitter
GWTEST	ConnectTest ^(T)	ConnectTest ^(T)	GWTEST_CONNECTION
GWTEST	SizeTest ^(T)	SizeTest ^(T)	GWTEST_7GB
HC	Transaction	Transaction	HC_Transaction
MWP		MWP_Report ^{(A, NGP)}	MWP_REPORT
OC	SPL	SPL	OC_REGLIST_SPL
OC	OCAC	OCAC	AERS_PSTMKT_OCAC
OOPD	HUD_Designation_Requests ^(T)	HUD_Designation_Requests ^(T)	OOPD_HUD_DESIGNATIONS
OOPD	Orphan_drug_Designation_Requests ^(T)	Orphan_drug_Designation_Requests ^(T)	OOPD_ORPHAN_DRUG_DESIGNATIONS
OPQ	704a4_Pharma_Inspection_Records ^(W)
ORA	Document_Requests ^(W)
ORA	POR Small Molecule Documents	POR_Small_Molecule_Docs	ORA_POR_Small_Molecule_Docs

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