Appendix G.    AS2 Header Attributes

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:

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

AERS

AERS_Attachments

EBLA

ECTD

EIDE

EIND

eDMF

H1N1_Lot_Release

Promotional_Material

Lot_Distribution_Data

510K

Pilot_Lot_Release

CDISC

SPL_LLD

Pre_IND

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

CDER

AERS

AERS_Attachements

EANDA

EBLA

ECTD

ENDA

EIND

ACA6004_Drug_Samples

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

CDRH

Adverse_Events

Electronic_Submissions

Yes

Yes

Yes

Yes

CFSAN

BNFs

Color_Master_File

Food_Contact_Notification

Food_Master_File

GRAS Notice

New_Protein_Consultation

Petitions

PNC

Threshold_of_Regulation

NDI

EON-Payload-Files

Food_Pilot_Listing

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

CVM

Adverse_Events_Reports

Electronic_Submissions

eSubmitter

Yes

Yes

Yes

Yes

Yes

No

OOPD

Orphan-drug_Designation_Requests

HUD_Designation_Requests

Yes

Yes

Yes

Yes

GWTEST

ConnectTest

SizeTest

Yes

Yes

No

No

OC

SPL

Yes

Yes

CTP

Electronic Submission

Adverse_Events

Yes

Yes

Yes

Yes