ESG NextGen Frequently Asked Questions

Account Management

Does ESG NextGen allow the creation of one user account that all users for the company can use?

No, using someone else's login information would be in violation of the FDA's security policies.

Are users able to submit on behalf of another company (sponsor) and how does that work?

Yes. The user will have their own account within ESG NextGen and be required to upload an Authorization Letter from the sponsoring company. The Authorization Letter will allow the user (agent/consulting company) to submit on behalf of their sponsor.

Will Non-Repudiation Letters and Authorization Letters need to be re-uploaded to ESG Next Gen?

No, the Non-Repudiation Letters and Authorization Letters are on file within the FDA. At go-live, these letters are not accessible within ESG NextGen. ESG NextGen will recognize these letters are on file and not require the user to re-upload the letters.

Can an Agent/Consultant be able to utilize API submissions on behalf of their clients?

Yes, as long as the agent/consultant's company has an Authorization Letter on file for the company they are submitting for via an API.

Where will Non-Repudiation Letters and Authorization Letters be uploaded?

ESG NextGen supports the upload of Non-Repudiation Letters (NRL) and Authorization Letters in two places in the platform: 
1) During registration, NRLs and Authorization Letters can be uploaded. 
2) In User/Company management, a Power User has the ability to upload additional NRLs and Authorization Letters for their company. 

Please note the following: 
1) During registration, Authorization Letters can only be uploaded by the person who is creating/registering the company. All following users for the company, when registering, will not have the option to upload Authorization Letters. 
2) Users are only allowed to upload NRLs for their own company.

Are Sponsors able to delegate to CROs?

The CRO will have their own account under the company they work for in ESG NextGen and will be required to upload an Authorization Letter from the sponsoring company. The Authorization Letter allows the CRO to submit on behalf of their sponsor.

Does the FEIN replace the DUNS and is the EIN or FEIN field required during Company registration?

FEIN (also referred to as EIN) is the Federal Employer Identification Number the U.S. Internal Revenue Service (IRS) utilizes. The DUNS is a unique 9-digit business identifier assigned by the company Dun & Bradstreet. The FEIN does not replace the DUNS. 

FEIN is an optional field. It is not required to create a new company within ESG NextGen.

Has user account information and role assignment been migrated over from legacy ESG to ESG NextGen?

Yes, active legacy ESG user's information has been migrated over into ESG NextGen. Active legacy ESG users will step through a simplified ESG NextGen registration process to finalize the set-up of their account. 

Any legacy ESG user designated as a Power User or Power User Plus has been migrated over as a Power User. 
Any legacy ESG user designated as a WebTrader User has been migrated over as a Submitter. 

Users migrated from legacy ESG are registered under the same company in ESG NextGen. 
 

Has Non-Repudiation Letters been transferred over from legacy ESG to ESG NextGen?

The Non-Repudiation Letters and Authorization Letters are on file within the FDA. At go-live, these letters are not accessible within ESG NextGen. ESG NextGen will recognize these letters are on file and not require the user to re-upload the letters.

Will a Power User be able to update a Non-Repudiation Letter on behalf of a standard user?

In ESG NextGen, the Power User has the ability to upload a Non-Repudiation Letter which covers the entire company. If the company does not have a company wide Non-Repudiation Letter, then each individual user for the company will have to upload a Non-Repudiation Letter which covers the individual.

What user roles are available in ESG NextGen?

ESG NextGen will support two roles. 

1) Power User: These users will have the ability to review and manage other user accounts within their company, review and manage (upload/remove) Non-Repudiation Letters and Authorization Letters, submit files and see submissions for the entire company, including the Acknowledgements. It is required for each company to have a minimum of one Power User, and it is recommended to have at least two Power Users. There is not a limit on the number of Power Users a company may have. 

2) Submitter: These users will have the ability to review and manage their own account, submit files and see their own submissions, including the Acknowledgements. There is not a limit on the number of Submitters a company may have. 

The registration process is only available within ESG NextGen Unified Submission Portal and is the same regardless of role selected.

How many Power Users are allowed in ESG NextGen per company?

ESG NextGen requires at least one Power User per company. The first person to register with a company will, by default, be a Power User. 

There is no limit on the number of Power Users allowed. It is recommended to have a minimum of two Power Users per company.

What happens when a Power User leaves the company?

It is recommended to always have two Power Users in your company. If one Power User leaves, the other Power User has the ability to promote a Submitter to a Power User. This functionality is managed under User Management. 

Power Users are able to see all submissions for a company regardless of who uploaded the submission. If a user is deactivated, the Power Users for a company is able to see/monitor all of the deactivated users' submissions. 

ESG NextGen Support will also be available to assist if a user needs to be promoted to a Power User.

Is a test submission required prior to a production account being approved?

Legacy ESG users migrated over to ESG NextGen will have an active production account and will not need to upload a test submission prior to uploading a production submission. 

A user who has never submitted to the FDA through legacy ESG is referred to as a “net new” user. If a user is a net new user to ESG NextGen, the user may be required to upload a test submission prior to gaining access to all production Center/Submission Types. This test submission is only required for the Center/Submission Types which require a test submission prior to allowing a net new ESG NextGen user to submit a production submission. Please refer to Center Submission Types to identify which Center/Submission types require a test submission for a net new user.

If a company utilizes an agency/consulting/CRO to upload on their behalf, do we still have to submit a Non-Repudiation Letter for ourselves/company?

Yes, a Non-Repudiation Letter (NRL) is required for any signature within the submission or on the submission itself. 

An authorizing company is able register within ESG NextGen at which time a NRL can be uploaded. 

Once the account is created, the authorizing company is able to view the submission details for the submissions their agency/consulting/CRO has uploaded on their behalf.

How do you register as an Agency/Consultant/CRO?

For a company registering their company for the first time in ESG NextGen: 
During the registration process, there is an option to indicate the company as an Agency/Consultant/CRO. 
This designation can also be updated in User Management by a Power User of the company. 

For companies migrated over from legacy ESG to ESG NextGen: 
Companies have been identified as being an Agency by having Authorization Letters on file.

Do AS2 users need to create an account in ESG NextGen?

No, having a USP account is not required for AS2 users. If an AS2 user wants to view submission details or history within ESG NextGen Unified Submission Portal (USP) or they need to provide the FDA with updated Non-Repudiation Letters/Authorization Letters, then yes, the AS2 user would need to complete the registration process in USP. Once the USP registration is complete, please email ESGNGSupport@fda.hhs.gov so the AS2 account and the USP account can be linked within ESG NextGen.

How do Agency companies select the Sponsor Company in the dropdown?

If the sponsoring company is not already in ESG NextGen, when uploading the Authorization Letter, the Power User for the Agency will enter the sponsoring company's name. This entry will populate the drop down for the Agency users when doing a submission via ESG NextGen Unified Submission Portal. 

Please refer to sections 5.6 and 5.7 of the USP Guide for further guidance. 
Please note: The agency itself will also appear in the company dropdown when selecting a company to submit for.

As a Power User, can I assign the Power User role to a colleague?

Yes, a Power User for a company is able to change a Submitter for their company to a Power User.

Acknowledgements

How are Acknowledgements delivered?

ESG NextGen delivers Acknowledgement responses via email for USP and API submissions. 

If the submission was submitted via AS2, the Acknowledgements is sent back via AS2. 

For API submissions, there is an API call which allows the user to retrieve the Acknowledgements for a submission. 
In User Management, users do have the option to Opt Out of email Acknowledgements.

Where are Acknowledgements available/accessible within the platform?

Acknowledgements are accessible within the Unified Submission Portal (USP). Submission acknowledgments are available to view and download via the Submission History in the USP.

What Acknowledgements are supported?

The same Acknowledgements which legacy ESG supported are supported within ESG NextGen.

Can Acknowledgements be received via API?

Yes, for API submissions, there is an API call which can be made to retrieve the Acknowledgement messages for a submission.

Will AS2 continue to support gateway-to-gateway communication for the Acknowledgements?

Yes, Acknowledgements will be sent back via AS2. ESG NextGen supports sending AS2 based Acknowledgements via in-flight HTTPS/SSL if your Acknowledgement receipt endpoint is configured for it.

Can a shared email inbox be utilized to send Acknowledgement to?

No, the Acknowledgement will be sent to the submitters email address.

Submissions

What is API, who can utilize submitting via API, and what is the format?

API (Application Programming Interface) is a modernized RESTful interface over HTTPS which can be used to automate submissions to ESG NextGen. 

Any industry partner may choose to submit via API, or they may choose to submit via the Unified Submission Portal (USP). 

Industry partners will be responsible for implementing the APIs on their side. 

The ESG NextGen API Guide and API Specification can be located under User Guides.

Are there any limitations with API? Size, number of calls, etc

ESG NextGen API currently can support upload size of up to 1TB. There is no set limitation on number of calls. However, the throughput of API submissions are dependent on overall system load and submission sizes.

When submitting an eCTD through the API, should the submission be compressed (tar.gz) prior to submitting or can the uncompressed folder structure be utilized?

The API allows for uploading one file at a time irrespective of the folder structure. 

If a folder structure needs to be maintained in the submission, it is recommended that the entire package be pre-compressed into a single archive which can be uploaded via API or AS2.

Where are API credentials generated and when do they expire?

To obtain API credentials, users will log into the ESG NextGen Unified Submission Portal (USP) to access API Management to generate their API credentials. The API credentials (secret key) will be specific to the user who generated them. 

API credentials will not expire. 

If API credentials need to be re-generated, the user will access API Management in the USP to generate new credentials.

Does the API interface support both synchronous and asynchronous calls?

All calls are synchronous with the exception of submitPayload which is synchronous for smaller files and automatically switches to asynchronous mode for larger files. The response message will indicate which scenario the current call ran under.

Can sequences be submitted?

Current submission formats will not be changing with ESG NextGen.

If ESG NextGen Unified Submission Portal (USP) is down, will API submissions still work?

Yes, given the user has completed their API credentialing, API submissions will still work if the Unified Submission Portal is down.

With API submissions, what checks will be performed on the submission and what notifications will be received?

API submissions will go through the ESG NextGen submission validations checks and the standard Acknowledgement messages will follow.

Is eSubmitter available to prepare submissions with ESG NextGen?

Yes, users who currently use eSubmitter may continue to use eSubmitter with ESG NextGen.

Are historical submissions with acknowledgements be available in ESG NextGen and who is able to access them?

Legacy ESG Submission History has been migrated over to ESG NextGen and is available within the Unified Submission Portal. 

Submission history is company specific. 

Your user role (i.e., Power User or Submitter) will determine the submission history you are able to review. 
A Power User for the company will be able to see all submissions for their company. 
A Submitter for the company will be able to see any submission they initiated.

Do users need to install anything on their PC to use the transfer agent for file/folder uploads?

To access ESG NextGen Unified Submission Portal (USP), you just need a web browser. 

The first time uploading a submission via USP, USP automatically prompts the user for installation of the transfer agent which is available for Mac, Linux, and Windows. 

Please note: The transfer agent is not supported in Safari

Does your browser window need to remain open until the file upload is complete?

Once an upload has been initiated, the submitter can proceed to sign the submission and then close the browser window. 

Uploads will continue via the transfer agent in the background until complete as long as the users computer is on and connected to the internet.

Are there any helpful tips to be aware of before uploading a new submission via the Unified Submission Portal?

When uploading via the USP, local or network drives can be utilized. Network drives must be mapped to a drive letter within Windows for the network drive to be accessed to upload files via USP. 

An uncompressed folder can be directly selected for upload via USP or individual files may be selected. 

Pre-zipping the folder is supported but not required. 

Up to 1TB of data has been tested for upload via USP. 

The format and naming convention of the submissions has not changing.

Does the Unified Submission Portal replace eSTAR?

No, users who currently use eSTAR will continue to use eSTAR with ESG NextGen.

What are all the ways files may be submitted to ESG NextGen?

ESG NextGen supports receiving submissions via: 

1) The web-based Unified Submission Portal 

2) APIs 

3) AS2

Since a digital certificate is no longer required to transfer submissions, is the submission still encrypted during transfer?

A certificate maintained by the FDA handles the encryption. Consequently, industry users do not have to attain their own digital certificate to do submissions, either via the Unified Submission Portal or via the API. AS2 users will need to obtain their own digital certificate to submit via AS2.

Do existing PFX submission key work for the ESG NextGen portal?

PFX/SSL certificates are used for signing AS2 submissions but are not required or supported for API or Unified Submission Portal submissions.

Does ESG NextGen support Health Canada?

Yes, Health Canada submissions are supported with ESG NextGen. Submissions may be sent to the FDA via the Unified Submission Portal, API, or AS2.

Is the upload of a digital signature be supported with ESG NextGen, or does the submitter have to sign each submission (when submitting via the Unified Submission Portal)?

Users uploading submissions via the Unified Submission Portal must apply their signature for each submission. 

Digital certificates will continue to be required to sign AS2 submissions. 

API submissions are signed via an explicit API call which uploads a signature image. 
 

Do e-signatures on submissions have to match the e-signature on the Non-Repudiation Letter?

The user uploading the submission must be covered in the Non-Repudiation Letter.

Does ESG NextGen support test submissions?

Yes, ESG NextGen supports test submissions.

Can a user submit via the Unified Submission Portal, API, and/or AS2?

An ESG NextGen user is able to submit via any of the methods ESG NextGen supports. 

AS2 will only be available for those who already have an active AS2 account within legacy ESG. 

Uploading via the Unified Submission Portal or via API is available to everyone. 

Individuals are able to upload submissions via any of the methods accessible to them.

What if the submission is over 1 Terabyte (TB)?

ESG NextGen has been tested to support submissions up to 1TB. If a submission is greater than 1TB, the user will need to divide the submission up. 

Please refer to the Center Submission Types page to understand any Center/Submission Type file size thresholds which are in place. 
Support for submissions over 1TB is part of Release 2.

Since ESG NextGen will be preforming a virus scan on all submissions, is the virus scan letter requirement still in place?

ESG NextGen does not have have inherent antivirus cover letter requirements. Please continue to follow downstream Center guidance if a virus scan letter is required.

What needs to be done to continue to submit via AS2?

ESG NextGen has migrated all legacy ESG Pre-Prod and Prod AS2 accounts over to ESG NextGen. This includes digital certificates. 

If your company uses a username and password to secure your AS2 protocol for receiving Acknowledgements, the username and password will need to be re-entered for ESG NextGen. 

The AS2 connections will need to be pointed to the ESG NextGen AS2 endpoint. 

Please refer to the AS2 Guide for Industry Users for complete details. 
 

Does the submitter have to be listed within the reports uploaded for ESG NextGen to accept the submission?

No, ESG NextGen validates the submitter/company with their Non-Repudiation Letter prior to accepting the submission.

Can one person, who is not an agent, submit for multiple companies?

Only if the company authorizes the person to have a company email and the person is covered under the company's Non-Repudiation Letter.

If a company has to submit reports which span multiple Centers, does selecting a single Center hinder this distribution?

Similar to legacy ESG, in ESG NextGen, a Center/Submission Type must be selected and ESG NextGen will determine routing to the centers based on the Submission Type.

Unified Submission Portal

Is the Unified Submission Portal accessible from all countries?

Yes. ESG NextGen Unified Submission Portal is accessible globally.

Who is able to see submission history/packages and what is available to view?

Legacy ESG Submission History has been migrated over to ESG NextGen and is available within the Unified Submission Portal. The submission history is company specific. Your user role (i.e., Power User or Submitter) determines the submission history you are able to view. 

The only information available within ESG NextGen regarding a submission, is information about the submission: 
Center/Submission Type 
Date/Time of Submission 
Submitter 
Acknowledgements 

Users will not be able to access/retrieve the actual files uploaded to ESG NextGen.

What web browsers are supported by ESG NextGen?

Major web browsers are supported (i.e., Firefox, Chrome, Edge).

Are Centers be able to communicate with submitters via the Unified Submission Portal (USP)?

Bi-directional communication is not in scope for Release 1 and 2.

Are submitters able to view or download the files they have submitted within ESG NextGen Unified Submission Portal?

No. Submitted files cannot be downloaded from ESG NextGen from outside the FDA. It is a one-way portal for data transfer.

Are submissions uploaded via AS2 available within the ESG NextGen Unified Submission Portal (USP)?

Yes, AS2 submission details are viewable within ESG NextGen USP. The AS2 user will have to create a USP account and then notify ESGNGSupport@fda.hhs.gov to link their AS2 and USP accounts.

Submission details include: 
Center/Submission Type 
Date/Time of Submission 
Submitter 
Acknowledgements 

Users will not be able to access/retrieve the actual files uploaded to ESG NextGen.

To provide feedback, please email ESGNGSupport@fda.hhs.gov