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Submission Acknowledgements

 

The FDA ESG sends Acknowledgements (Acks) to ESG users as part of processing ESG submissions. Different submission types receive certain Acks. The table below illustrates the type of Acks for each submission type. The table also details the file format and identifies the environment: production and pre-production.

 

  Production   

Pre-Production  
Center

Submission Type

ACK2 (file format/ extension) ACK3 (file format/ extension) ACK4 (file format/ extension) Notes ACK2 (file format/ extension) ACK3 (file format/ extension) ACK4 (file format/ extension) Notes
CBER
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AERS N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly. N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
AERS_Attachments N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly. N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
NDA Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
EBLA Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
EIDE Y (.txt)   N   Y (.txt) N N  
EIND Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
EUA Y (.txt)   N   Y (.txt) N N  
Promotional_Materials Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
510K Y (.txt)   N   Y (.txt) N N  
CDISC Y (.txt)   N   Y (.txt) N N  
eDMF Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
SPL_LDD Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
VAERS Y (.txt) Y (.xml) N   Y (.txt) Y (.xml) N  
PMA Y (.txt)   N   Y (.txt) N N  
QSUBS Y (.txt)   N   Y (.txt) N N  
Pre_IND Y (.txt) Y (.pdf) N only eCTD format submissions receive ACK3 Y (.txt) N N  
Lot_Release_Protocol Y (.txt)   N   Y (.txt) N N  
CDER
 
 
 
 
 
 
 
 
 
AERS N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly. N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
AERS_Attachments N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly. N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
AERS_IND** N/A N/A N/A   N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
AERS_Attachments_IND** N/A N/A N/A   N Y (.ack) N ACK's are not generated for Invalid file extensions and files which are not encoded properly.
Voluntary_Direct_AEs N   N   N   N  
ACA6004_Drug_Samples Y (.txt)   N   Y (.txt)   N  
ECTD Y (.txt) Y (.PDF) N Majority of the ACK3 are delivered automatically except a few that are manually processed by EDR staff Y (.txt) Y (.PDF) N In test/pre-prod, ACK3 are NOT sent to industry. They are limited only to coordinated UAT when applicable.
EIND Y (.txt) Y (.PDF) N Majority of the ACK3 are delivered automatically except a few that are manually processed by EDR staff Y (.txt) Y (.PDF) N In test/pre-prod, ACK3 are NOT sent to industry. They are limited only to coordinated UAT when applicable.
PFC Y (.txt) Y (.PDF) N ACK3 for all PFC submissions are processed manually by EDR Staff Y (.txt) Y (.PDF) N In test/pre-prod, ACK3 are NOT sent to industry. They are limited only to coordinated UAT when applicable.
GDUFA_Facility_Registration Y (.txt) Y (.xml or .ack) N ".xml - if the submission fails validation
.ack - if the submission passes validation"
Y (.txt)   N  
CDRH
 
 
Adverse_Events Y (.txt) Y (.html and .xml) N   Y (.txt) Y (.html and .xml) N  
Electronic_Submissions Y (.txt) Y (.zip and .html and .xml) N The Zip files contain PDFs or combination of html, xml and PDF files Y (.txt) Y (.zip and .html and .xml) N The Zip files contain PDFs or combination of html, xml and PDF files
GUDID Y (.txt) Y (.html and .xml) N   Y (.txt) Y (.html and .xml) N  
CFSAN
 
 
 
 
 
 
 
 
 
Form 3480A Y (.txt) N N   Y (.txt) N N  
Form 3480 Y (.txt) N N   Y (.txt) N N  
Form 3503 Y (.txt) N N   Y (.txt) N N  
Form 3665 Y (.txt) N N   Y (.txt) N N  
Form 3667 Y (.txt) N N   Y (.txt) N N  
Form 3666 Y (.txt) N N   Y (.txt) N N  
Threshold_of_Regulation Y (.txt) N N   Y (.txt) N N  
NDI Y (.txt) N N   Y (.txt) N N  
EON_Payload_Files* Y (.txt) N N   Y (.txt) N N  
Food_Pilot_Listing Y (.txt) N N   Y (.txt) N N  
CTP Electronic_Submission Y (.txt) N N   Y (.txt) N N  
CVM
 
 
eSubmitter Y (.txt) Y (.zip) Y (.zip) These are zip files of PDFs Y (.txt) Y (.zip) Y (.zip) These are zip files of PDFs
Adverse_Events_Reports Y (.txt) Y (.cvm) N These are text files but use .cvm as the file extension Y (.txt) Y (.cvm)   These are text files but use .cvm as the file extension
Electronic_Submissions Y (.txt) Y (.pdf or .zip) N "PDF is sent for single file transactions; ZIP(containing PDFs) is sent for multiple file (or folder) transactions" Y (.txt) Y (.pdf or .zip)   "PDF is sent for single file transactions; ZIP(containing PDFs) is sent for multiple file (or folder) transactions"
OC SPL Y (.txt) Y (.xml or .ack) N ".xml - if the submission fails validation
.ack - if the submission passes validation"
Y (.txt) N N  
HC
 
ECTD Y (.html) Y (.txt) N   Y (.html) Y (.txt) N  
REP Y (.html) Y (.txt) Y (.zip)   Y (.html) Y (.txt) Y (.zip)  
OPQ 704a4_Pharma_Inspection_Records Y (.txt) N N   Y (.txt) N N  
OOPD**
 
HUD_Designation_Requests N/A N/A N/A   Y (.txt) N N  
Orphan-drug_Designation_Requests N/A N/A N/A   Y (.txt) N N  
ORA** Gamma_Rays_Analysis N/A N/A N/A   Y (.txt) N N  
GWTEST**
 
ConnectTest N/A N/A N/A   Y (.txt) N N  
SizeTest N/A N/A N/A   Y (.txt) N N  

 

 

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** not available in production