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  5. Center Submission Types
  1. Getting Started with ESG NextGen

Center Submission Types

Column Definitions: 
Test Submission Available: Indicates which Center/Submission Types allow test submissions. 
Production Submission Available: Indicates which Center/Submission Types allow production submissions 
File Size Threshold (GB): Provides the Center’s guidance on the Center/Submission Type file size supported. While ESG NextGen supports submissions up to 1TB, Center’s have set their own file size thresholds.  
Test Submission Required for New ESG NextGen Users: Indicates which Center/Submission Types require a test submission prior to allowing a new user to submit a production submission. If a test submission is not required by a Center/Submission Type, upon approval of the new users account, the new user will be able to submit both test and production submissions for that Center/Submission Type. This applies to submitters creating an account with ESG for the very first time.  

Notes

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’. CDRH Premarket submission should be sent via the CDRH Customer Collaboration Portal. 

 
CenterSubmission TypeTest (T) / Production (P) / Both (B) Submission AvailableFile Size Threshold (GB)Test Submission Required for New ESG NextGen Users
CBER510KB200Y
AERSB0.2Y
AERS AttachmentsB0.2Y
AERS_PREMKT_CBERB0.2Y
AERS_ATTACHMENTS_PREMKT_CBERB0.2Y
EBLAB200Y
eDMFB200Y
EIDEB200Y
EINDB200Y
EUAB200Y
Lot_Release_ProtocolB200N
NDAB200N
PMAB200Y
Pre_INDB200Y
Promotional_MaterialsB200N
QSUBSB200Y
SEND_PILOT T200N
SPL_LDDB200Y
VAERSB200Y
CDERACA6004_Drug_SamplesB2N
AERSB0.2Y
AERS AttachmentsB0.2Y
AERS IND T0.2N
AERS Attachment IND T0.2N
AERS_PREMKT T0.2N
AERS_Attachments_PREMKT T0.2N
AERS_PREMKT_CDERB0.2Y
AERS_ATTACHMENTS_PREMKT_CDERB0.2N
ECTDB300N
ECTD WAIVEDB300N
EDMF TYPEIIIB100N
EINDB100N
FFU-PILOT T100N
GDUFA_Facility_RegistrationB0.005N
PFCB100N
POR Large Molecule DocumentsB100N
Voluntary_Direct_Aes B0.2N
CDRHAdverse EventsB100N
Electronic_Submissions B100Y
GUDIDB100Y
HFP (formerly CFSAN)DSR_Adverse_EventsB0.3N
EON-Payload-Files P0.3N
Food_Pilot_Listing P0.3N
Form3479B0.3Y
Form3480B0.3Y
Form3480AB0.3Y
Form3503B0.3Y
Form3665B0.3Y
Form3666B0.3Y
Form3667B0.3Y
NDI P0.3N
Threshold_of_RegulationB0.3Y
CTPAdverse_EventsB100Y
Electronic_SubmissionB100Y
CVMAdverse_Events_ReportsB1N
eSubmitterB1N
GWTESTConnectTest T100N
SizeTest T100N
HealthCanadaTransactionB10N
OCSPLB100N
OCACB0.2Y
OOPDHUD_Designation_Requests T100N
Orphan_drug_Designation_Requests T100N
OPQ704a4_Pharma_Inspection_RecordsB100N
OIIDocument_RequestsB100N
POR Small Molecule DocumentsB100N
Column Definitions: 
USP and API Submission Type: Provides the submission types supported by USP and API submissions.   
AS2 Submission Type and AS2 Routing ID: Provides the header information needed when submitting via AS2. If the AS2 Submission Type and AS2 Routing ID columns are blank, then these Center/Submission Types are not supported by AS2.  
CenterUSP and API Submission TypeAS2 Submission TypeAS2 Routing ID
CBER510K510KCBER_510K
AERSAERSFDA_AERS
AERS AttachmentsAERS_ATTACHMENTSFDA_AERS_ATTACHMENTS
AERS_PREMKT_CBERAERS_PREMKT_CBERFDA_AERS_PREMKT_CBER
AERS_ATTACHMENTS_PREMKT_CBERAERS_ATTACHMENTS_PREMKT_CBERFDA_AERS_ATTACHMENTS_PREMKT_CBER
EBLAEBLACBER_EBLA
eDMFeDMFCBER_EDMF
EIDEEIDECBER_EIDE
EINDEINDCBER_EIND
EUAEUACBER_EUA
Lot_Release_ProtocolLot_Release_ProtocolCBER_LOT_RELEASE_PROTOCOL
NDANDACBER_NDA
PMAPMACBER_PMA
Pre_INDPRE_INDCBER_PRE_IND
Promotional_MaterialsPromotional_MaterialsCBER_PROMOTIONAL_MATERIAL
QSUBSQSUBSCBER_QSUBS
SEND_PILOT SEND_PILOT CBER_SEND_PILOT
SPL_LDDSPL_LDDCBER_SPLLD
VAERSVAERSCBER_VAERS
CDERACA6004_Drug_SamplesACA6004_Drug_SamplesCDER_ACA6004
AERSAERSFDA_AERS
AERS AttachmentsAERS_ATTACHMENTSFDA_AERS_ATTACHMENTS
AERS IND AERS_IND AERS_IND
AERS Attachment IND AERS_ATTACHMENTS_IND AERS_ATTACHMENTS_IND
AERS_PREMKT AERS_PREMKT FDA_AERS_PREMKT
AERS_Attachments_PREMKT AERS_Attachments_PREMKT FDA_AERS_ATTACHMENTS_PREMKT
AERS_PREMKT_CDERAERS_PREMKT_CDERFDA_AERS_PREMKT_CDER
AERS_ATTACHMENTS_PREMKT_CDERAERS_ATTACHMENTS_PREMKT_CDERFDA_AERS_ATTACHMENTS_PREMKT_CDER
ECTDECTDCDER_ECTD
ECTD WAIVEDECTD_WAIVEDCDER_ECTD_WAIVED
EDMF TYPEIIIEDMF_TYPEIIICDER_EDMF_TYPEIII
EINDEINDCDER_EIND
FFU-PILOT FFU-PILOT CDER_FFU-PILOT
GDUFA_Facility_RegistrationGDUFA_Facility_RegistrationCDER_GDUFA_FACILITY_REGISTRATION
PFCPFCCDER_PFC
POR Large Molecule DocumentsPOR_Large_Molecule_DocsCDER_POR_Large_Molecule_Docs
Voluntary_Direct_Aes   
CDRHAdverse EventsAdverse_EventsCDRH_AERS
Electronic_Submissions Electronic_SubmissionsCDRH_ESUBS
GUDIDGUDIDCDRH_GUDID
HFP (formerly CFSAN)DSR_Adverse_EventsDSR_Adverse_Events CFSAN_DRG_ADVERSE_EVENTS
EON-Payload-Files EON-Payload-Files CFSAN_EON_PAYLOAD_FILES
Food_Pilot_Listing Food_Pilot_Listing CFSAN_FOOD_PILOT_LISTING
Form3479Form3479CFSAN_Form3479
Form3480Form3480CFSAN_FORM3480
Form3480AForm3480ACFSAN_FORM3480A
Form3503Form3503CFSAN_FORM3503
Form3665Form3665CFSAN_FORM3665
Form3666Form3666CFSAN_FORM3666
Form3667Form3667CFSAN_FORM3667
NDI NDI CFSAN_NDI
Threshold_of_RegulationThreshold_of_RegulationCFSAN_THRESHOLD_OF_REGULATION
CTPAdverse_EventsAdverse_Events CTP_AE
Electronic_SubmissionElectronic_SubmissionCTP_ESUB
CVMAdverse_Events_ReportsAdverse_Events_ReportsCVM_AERS
eSubmittereSubmitterCVM_ESUBMITTER
GWTESTConnectTest ConnectTest GWTEST_CONNECTION
SizeTest SizeTest GWTEST_7GB
HealthCanadaTransactionTransactionHC_Transaction
OCSPLSPLOC_REGLIST_SPL
OCACOCACAERS_PSTMKT_OCAC
OOPDHUD_Designation_Requests HUD_Designation_Requests OOPD_HUD_DESIGNATIONS
Orphan_drug_Designation_Requests Orphan_drug_Designation_Requests OOPD_ORPHAN_DRUG_DESIGNATIONS
OPQ704a4_Pharma_Inspection_Records  
OIIDocument_Requests  
POR Small Molecule DocumentsPOR_Small_Molecule_DocsORA_POR_Small_Molecule_Docs

 

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