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  1. About ESG

Center Submission Types

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 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
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

 

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