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 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 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 SizeTest (T) SizeTest (T) GWTEST_7GB HC Transaction Transaction HC_Transaction MWP MWP_Report (A, NGP) MWP_REPORT OC SPL SPL OC_REGLIST_SPL OCAC OCAC AERS_PSTMKT_OCAC OOPD HUD_Designation_Requests (T) HUD_Designation_Requests (T) OOPD_HUD_DESIGNATIONS Orphan_drug_Designation_Requests (T) Orphan_drug_Designation_Requests (T) OOPD_ORPHAN_DRUG_DESIGNATIONS OPQ 704a4_Pharma_Inspection_Records (W) ORA Document_Requests (W) 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
- Center Name-
- FdaSubmissionType: Abbreviated New Drug (add submission type information)