Will 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.

Will users be able to submit on behalf of another company (sponsor) and how will 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?

ESG NextGen will be migrating over all Non-Repudiation Letters (NRL) and Authorization Letters.

For the Authorization Letters, the ESG NextGen team is working on parsing out the name of the authorizing company (sponsor). There is the possibility that users will have to provide the company/sponsor name for their Authorization 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 will support 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 will have 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.

Will Sponsors be 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 will allow 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.

Will user account information and role assignment migrate over from ESG to ESG NextGen?

Yes, active legacy ESG user's information will be migrated over into ESG NextGen. Active legacy ESG users will have to step through a simplified ESG NextGen registration process to update their multi-factor authentication option and other information.

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

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

Please make any adjustments to user roles in legacy ESG prior to ESG NextGen go live to ensure the correct role is assigned to users within ESG NextGen.

Will Non-Repudiation Letters be transferred over from ESG to ESG NextGen?

Yes. All Non-Repudiation Letters currently in ESG will be migrated over to ESG NextGen.

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

In ESG NextGen, the Power User will have 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.

Current documentation pertaining to Non-Repudiation Letters can be found here: https://www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement

What user roles will be 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?

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 will have the ability to promote a Submitter to a Power User. This functionality will be managed under User Management.

Power Users will be able to see all submissions for a company regardless of the Power User uploading the submission. If a user is deactivated, the Power Users for a company will be 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.

Will a test submission be required prior to a production account being approved?

Legacy ESG users will be migrated over to a production account in ESG NextGen.

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 will be able register within ESG NextGen at which time a NRL can be uploaded.

Once the account is created, the authorizing company will be 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 will be an option to register as an Agency/Consultant/CRO. Detailed instructions will be available in the user guide.

For companies migrated over from legacy ESG to ESG NextGen:
Companies will be identified as being an Agency by having Authorization Letters. ESG NextGen will migrate over all Authorization Letters from legacy ESG to ESG NextGen.

For further guidance around Authorization Letters: https://www.fda.gov/industry/about-esg/appendix-k-sample-authorization-letter

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

No. ESG NextGen will migration over the Non-Repudiation Letters and Authorization Letters associated with the AS2 users. If an AS2 user wanted to view submission details or history within ESG NextGen Unified Submission Portal (USP), then yes, the AS2 user would need to complete the registration process in USP.

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 be required to 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 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?

In Release 1, Power Users for the company will have the ability to review and manage other user accounts (make Submitter a Power User) within their company and submit files and see submissions for the entire company.

How will Acknowledgements be delivered?

ESG NextGen will deliver Acknowledgement responses via email.

If the submission was submitted via API, there will be an API call which will allow the user to retrieve the Acknowledgements for a submission.

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

Where will Acknowledgements be available/accessible within the platform?

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

What Acknowledgements will be supported?

The same Acknowledgements which legacy ESG supports today will be supported within ESG NextGen.

Will Acknowledgements be able to be received via API?

Yes, for API submissions, there will be 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?

Acknowledgements will be sent via email. They will also be available within ESG NextGen Unified Submission Portal.

For AS2 users, Acknowledgements will be sent back via AS2. ESG NextGen will support 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.

What are the benefits of ESG NextGen over legacy ESG?

The following page gives an overview of the benefits of ESG NextGen over legacy ESG: https://www.fda.gov/industry/esg-next-generation/comparison-current-esg-esg-nextgen

How will the industry be notified of ESG NextGen go live date and what materials will be available to prepare the industry?

Go live dates, trainings sessions, training materials and user guides will be communicated with the industry via email and the FDA's ESG NextGen website, well in advance of ESG NextGen's go live date.

Will all centers migrate to utilize ESG NextGen at the same time?

Yes. When ESG NextGen goes live, all Centers will be migrated at the same time.

When will industry testing begin?

3Q FY24 - 4Q FY24 (April '24 - Sept '24)

When will ESG NextGen be live (Release 1) for the industry and centers to use and what is included?

The production release of ESG NextGen is planned to occur in Q4 FY24 to Q1 FY25.

When ESG NextGen goes live, ESG NextGen will replace all legacy ESG functionality. ESG NextGen will be used for user account management, submissions uploads, viewing submission history, and obtaining API keys.

How do I sign up to participate in the industry testing phase?

Please send an email to ESGNGSupport@fda.hhs.gov stating your interest in participating in the industry testing. All volunteers are welcome.

Is ESG NextGen replacing ESG WebTrader?

Yes, the ESG NextGen Unified Submission Portal replaces WebTrader for all submission types used in legacy ESG.

What happens to submissions where the user is waiting on Acknowledgement feedback when ESG NextGen goes live?

When ESG NextGen goes live, for submissions uploaded in legacy ESG, ESG NextGen will pick up with Acknowledgement 3.

Will there be a support desk available with ESG NextGen?

Yes, there will be a support help desk for ESG NextGen.

Is Multi-Factor Authentication mandatory? If so, what method will be available?

Multi-factor Authentication (MFA) is mandatory for logging into ESG NextGen.

Currently, MFA allows the user to use email to receive and submit a one time password (OTP, i.e., PIN). The ESG NextGen team is still in the development process so the final MFA methods may change.

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. API submissions will be available when ESG NextGen goes live in 2024.

API is recommended for high volume industry partners. Any industry partner may choose to submit via API or they may choose to submit via the Unified Submission Portal (USP), which is the WebTrader replacement.

Industry partners will be responsible for implementing the APIs on their side. Sample proof-of-concept code will be provided for the API but exact implementation will be left to the technical expertise of the submitting companies.

Draft API specifications may be obtained by emailing the ESG NextGen support team at ESGNGSupport@fda.hhs.gov

When will draft API specifications be available and will sample API code be provided?

Draft API specifications may be obtained by emailing the ESG NextGen support team at ESGNGSupport@fda.hhs.gov

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

The ESG NextGen team has tested up to 1TB via API.
The number of calls will be determined prior to go-live.

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.

Will the API interface support both synchronous and asynchronous calls?

Synchronous calls are currently supported via API. If the file uploaded is large, the API could switch to asynchronous.

Will sequences be able to 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.

What is ESG NextGen replacing?

ESG NextGen is replacing legacy ESG which includes: WebTrader, AS2 (B2BI / AxWay), and the ESG Account Management Portal. With ESG NextGen, users will be able to utilize the Unified Submission Portal (WebTrader and ESG Account Management Portal replacement) and API submissions (AS2 replacement).

AS2 will be supported for post ESG NextGen go live. However, the goal is to modernize technologies utilized at the FDA. At some point in the future, the FDA will decide to replace the AS2 protocol with APIs. The Industry will be provided ample time to prepare for the transition.

ESG NextGen is not replacing any Center specific portals and there are no current plans to merge Center portals with ESG NextGen.

Will eSubmitter remain available to prepare submissions once ESG NextGen goes live?

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

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

The current ESG Submission History will be migrated over to ESG NextGen and will be available within the Unified Submission Portal.

The submission history will be 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.
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 will just need a web browser.

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

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

No, 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.

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 in 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 will support receiving submissions via:

1) The web-based Unified Submission Portal

2) APIs

3) AS2

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

A certificate maintained by the FDA will handle encryption. Consequently, industry users will 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.

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

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

What can be submitted via ESG Next Gen?

Any Center which currently accepts submissions through legacy ESG, and any submission types supported in legacy ESG will continue to be supported in ESG NextGen. Additionally, any bundling and submission type formats currently supported in legacy ESG will continue to be supported in ESG NextGen.

Will ESG NextGen support Health Canada?

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

Will the upload of a digital signature be supported with ESG NextGen, or will 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 will be signed via an explicit API call which uploads a signature image.

Other types of digital signatures (adobe, etc) are not accepted.

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.

Will ESG NextGen support test submissions?

ESG NextGen will support test submissions.

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

An ESG NextGen user will be 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 will be available to everyone.

Individuals will be 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.

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?

Neither legacy ESG nor ESG NextGen 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?

AS2 will remain available in ESG NextGen at go live for industry partners currently registered and using AS2 in legacy ESG. Current file naming conventions and digital certificates will continue to be utilized when submitting via AS2 in ESG NextGen.

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. Instructions on how to do this will be provided.

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

If you are currently in the process of setting up an AS2 connection, a cutoff date to have the AS2 connection established has not been set yet.

RESTful API is the long-term replacement for AS2. The date to decommission AS2 is to be determined. The industry will be given ample notice when a date has been set.

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.

Will the Unified Submission Portal be accessible from all countries?

Yes. ESG NextGen Unified Submission Portal will be accessible globally.

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

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

The only information available within ESG NextGen regarding a submission, is the 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 will be supported by ESG NextGen?

All major web browsers will be supported (i.e., Firefox, Chrome, Edge, Safari).

Will 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.

Will submitters be 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.

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

Yes, AS2 submission details will be viewable within ESG NextGen USP.

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.