Submission Acknowledgements
Submission Acknowledgements in ESG NextGen
ESG NextGen provides automated acknowledgments (ACKs) to confirm receipt, processing, and routing of electronic submissions. These acknowledgments serve as notifications, helping submitters track the status of their submissions to the FDA.
Types of Acknowledgements in ESG NextGen:
- ACK1: Provides information on the submission and if the submission was uploaded into ESG NextGen.
- ACK2 (if applicable): Provides information on the submission and if the submission was successfully transmitted to the Center.
- ACK3 & ACK4 (if applicable): Provides the Center’s response on the submission.
How to View Acknowledgements: Submissions made via the ESG NextGen Unified Submission Portal (USP) and API will receive email acknowledgements and the acknowledgements can be viewed within Submission History in the USP. Additionally, API submissions have the option to retrieve ACK messages via API. Submissions made via AS2 will be sent back to the submitter via AS2.
| PRODUCTION SUBMISSION | TEST SUBMISSIONS | ||||||||
| 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 | 510K | Y (.txt) | N | Y (.txt) | N | N | |||
| AERS | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | |
| AERS Attachments | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | |
| AERS_PREMKT_CBER | Y (.txt) | N | N | Y (.txt) | N | N | |||
| AERS_ATTACHMENTS_PREMKT_CBER | Y (.txt) | N | N | ||||||
| EBLA | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| eDMF | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| EIDE | Y (.txt) | N | Y (.txt) | N | N | ||||
| EIND | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| EUA | Y (.txt) | N | Y (.txt) | N | N | ||||
| Lot_Release_Protocol | Y (.txt) | N | Y (.txt) | N | N | ||||
| NDA | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| PMA | Y (.txt) | N | Y (.txt) | N | N | ||||
| Pre_IND | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| Promotional_Materials | Y (.txt) | Y (.pdf) | N | Only eCTD format submissions receive ACK3 | Y (.txt) | Y (.pdf) | N | ||
| QSUBS | Y (.txt) | N | 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) | Y (.pdf) | N | ||
| VAERS | Y (.txt) | Y (.xml) | N | Y (.txt) | Y (.xml) | N | |||
| CDER | ACA6004_Drug_Samples | Y (.txt) | N | Y (.txt) | N | ||||
| AERS | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | |
| AERS Attachments | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | |
| AERS IND | N/A | N/A | N/A | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | ||
| AERS Attachment IND | N/A | N/A | N/A | N | Y (.ack) | N | ACKs are not generated for invalid file extensions nor for files which are not encoded properly. | ||
| AERS_PREMKT | Y (.txt) | N | Y (.txt) | N | |||||
| AERS_Attachments_PREMKT | Y (.txt) | N | Y (.txt) | N | |||||
| AERS_PREMKT_CDER | Y (.txt) | N | N | Y (.txt) | N | N | |||
| AERS_ATTACHMENTS_PREMKT_CDER | Y (.txt) | N | N | Y (.txt) | N | N | |||
| ECTD | Y (.txt) | Y (.pdf) | N | Majority of ACK3s are delivered automatically except a few are manually processed by EDR staff | Y (.txt) | Y (.pdf) | N | ACK3s are NOT sent to the Industry for Test Submissions. ACK3s are limited only to coordinated UAT, when applicable. | |
| ECTD WAIVED | Y (.txt) | Y (.txt) | |||||||
| EDMF TYPEIII | Y (.txt) | Y (.txt) | |||||||
| EIND | Y (.txt) | Y (.pdf) | N | Majority of ACK3s are delivered automatically except a few are manually processed by EDR staff | Y (.txt) | Y (.pdf) | N | ACK3s are NOT sent to the Industry for Test Submissions. ACK3s 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 | ACK3s for all PFC submissions are processed manually by the EDR staff | Y (.txt) | Y (.pdf) | N | ACK3s are NOT sent to the Industry for Test Submissions. ACK3s are limited only to coordinated UAT, when applicable. | |
| POR Large Molecule Documents | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Voluntary_Direct_Aes | N | N | N | N | |||||
| CDRH | Adverse Events | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file |
| Electronic_Submissions | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file | |
| GUDID | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file | Y (.txt) | Y (.html) | Y (.xml) | The ACK4 is the previous ACK3 .xml file | |
| HFP (formerly CFSAN) | DSR_Adverse_Events | 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 | |||
| Form3479 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3480 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3480A | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3503 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3665 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3666 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Form3667 | Y (.txt) | N | N | Y (.txt) | N | N | |||
| NDI | Y (.txt) | N | N | Y (.txt) | N | N | |||
| Threshold_of_Regulation | Y (.txt) | N | N | Y (.txt) | N | N | |||
| CTP | Adverse_Events | ||||||||
| Electronic_Submission | Y (.txt) | N | N | Y (.txt) | N | N | |||
| CVM | 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 | |
| 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 | |
| GWTEST | ConnectTest | N/A | N/A | N/A | Y (.txt) | N | N | ||
| SizeTest | N/A | N/A | N/A | Y (.txt) | N | N | |||
| HealthCanada | Transaction | Y (.html) | Y (.txt) | N | Y (.html) | Y (.txt) | N | ||
| 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 | |
| OCAC | 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 | |||
| OPQ | 704a4_Pharma_Inspection_Records | Y (.txt) | N | N | Y (.txt) | N | N | ||
| OII | Document_Requests | ||||||||
| POR Small Molecule Documents | Y (.txt) | N | N | Y (.txt) | N | N | |||