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.
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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. | |
| BEST | Y (.txt) | Y (.txt) | N | Y (.txt) | Y (.txt) | N | |||
| 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 | ||
| SEND_PILOT | N/A | N/A | N/A | N | 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 |
ACA6004_Drug_Samples | Y (.txt) | N | Y (.txt) | N | ||||
| 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. | ||
| AERS_PREMKT | Y (.txt) | N | Y (.txt) | N | |||||
| AERS_Attachments_PREMKT | 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. | |
| FFU-PILOT | N/A | N/A | N/A | Y (.txt) | Y (.txt) | N | |||
| 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 | |||
| 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. | |
| Voluntary_Direct_AEs | N | N | N | 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 | |||
| 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" | ||
| CVM-VDD | 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 |
| 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 |
Transaction | Y (.html) | Y (.txt) | N | Y (.html) | Y (.txt) | N | ||
| 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** | Inspection | 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 for general public |
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** not available in production |