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In this section: Create an ESG Account

Setting up an AS2 Account Checklist

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Request an AS2 account
	1. Send an email to ESGHelpDesk@fda.hhs.gov requesting an AS2 test account. Please make the subject of the email “New AS2 Test Account Registration”. Provide the following information: Company name First and Last Name Phone Number Submission Method: (AS2) Attach a Letter of Non Repudiation
Preparatory activities
	2. Send an electronic copy of your Letter of Non-Repudiation Agreement to the ESG Help Desk at ESGHelpDesk@fda.hhs.gov. Users are no longer required to submit a physical copy to the FDA. Submitting a physical copy is now optional. Click here for more information on Non-Repudiation Letters. Click here for additional steps pertaining to CROs, US Agents and Consultants.
	3. Obtain a personal digital certificate. Click here for more information on certificates.
	4. Prepare a guidance compliant test submission. Each FDA Center has published guidance on the preparation of electronic submissions. Refer to the specific center web site for information about guidance compliant submissions.
	5. Prepare a load test submission. Each FDA Center may have different load test requirements. Refer to the load test web site for information about load test submissions.
	6. Read the User Guide and tutorials on the FDA ESG web site.
Register Your Test Account
Wait for email with information on how to register online for an AS2 test account. (The reply email from Step 1)
	7. Review the steps to Register for an AS2 test account in the reply email (generated from step 1). You will need the public key for your personal digital certificate to complete this step. Note: The Primary Contact must be a real person; the "Company Name" is actually an account name and must be unique throughout the entire ESG test system. In the event that your company has multiple AS2 accounts, we recommend appending the user's initials to your company name.
Wait for the AS2 test account activation email. Account activation may take up to 48 hours.
Setup your machine for AS2 usage
	8. After you have received the activation email, configure your firewall and ports and install the FDA public Test certificate (activation email will contain the details). The FDA Gateway does not allow SSL 3.0.
Send Test Submissions
	9. Send a test submission via AS2: *If your company does NOT* currently have a Production AS2 account and you intend to send to FDA: Send a guidance compliant test submission to the appropriate FDA center with the appropriate submission type. Each FDA Center has published guidance on the preparation of electronic submissions. Refer to the specific center web site for information about guidance compliant submissions. If your company has at least one Production AS2 account and you intend to send to FDA: To ensure your AS2 account works properly, send a test submission to the Center labeled "GWTEST" and the Submission Type labeled "ConnectTest". The FDA ESG team will review your test submission, migrate your account to production, and notify you within 24 hours. If you intend to send submissions via AS2 to HC (Health Canada): Health Canada requires a guidance compliance test submission only for new ESG Health Canada AS2 accounts. Refer to Guidance Document - Preparation of Regulatory Activities in eCTD Format** for guidance instructions. The AS2 center and submission type for the compliance test submission are "HC" and "Transaction", respectively. The AS2 guidance compliance test submissions are not manually reviewed.
	10. Send a Load Test submission to Routing ID “GWTEST_7GB” or Center as GWTEST and submission type as SizeTest. The type of test submission will be based on the type of files you plan to send to the Gateway. Refer to the load test web site for *information about load test submissions*.
The FDA will review your guidance compliant test submission, which may take up to 1 week. You will receive an email from ESG Helpdesk regarding submission status.
Production Account Approval
	11. Once your test submissions have been approved, the ESG HelpDesk will send instructions on how to Register for an AS2 Production account.
Wait for the AS2 Production account activation email. Account activation may take up to 48 hours.
	12. After you have received the activation email, configure your firewall and ports and install the FDA public Production certificate (activation email will contain the details).
You are now ready to send electronic submissions to FDA using the ESG system.