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Request an Industry Account Manager (IAM) for CTP Portal

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What Is an Industry Account Manager (IAM)?

The Industry Account Manager (IAM) is an individual designated by the authorized representative of an organization and acts as an administrator (“admin”) for the organization’s CTP Portal user accounts. Once the IAM account is created by CTP, the IAM is given an “admin” role, and can create, manage, and set roles for all of the organization’s employees’ CTP Portal user accounts*, including user accounts for non-employee attorneys or agents.

*Note about CTP Portal accounts: Accounts in CTP Portal will only exist for tobacco manufacturers as defined under sections 900(7) and 900(20) of the Family Smoking Prevention and Tobacco Control Act (Public Law 111–31), not for companies that may represent them.

What Does the IAM for My Organization Do, and What Information Do They Have Access to?

The IAM is granted a “CTP Portal User Admin” role in the CTP Portal. Only an individual with the “CTP Portal User Admin” privilege can perform the following actions:

  • Create user accounts
  • Manage user accounts
  • Deactivate user accounts
  • Reset user accounts
  • Unlock user accounts

Additionally, IAMs are able to view submission-related information, view and reply to messages, and upload eSubmitter files through CTP Portal.

The IAM has full access to all information in the organization’s CTP Portal account, the user accounts, and full privileges, including the ability to manage user accounts and upload submissions to FDA.

Note: These permissions can be changed or revoked by other IAM user accounts.

Who Can Request an IAM Account for My Organization?

Only an authorized representative for your organization can request that FDA create an IAM account for your organization. The IAM Request Form must be completed by an authorized representative who is a direct employee of the organization. The authorized representative can designate themself or another employee of the organization to be the IAM for your organization’s CTP Portal account.

Who Can Be the Authorized Representative for My Organization?

The authorized representative is an individual who is a corporate or executive officer with signatory powers, a general partner, or proprietor that has the authority to sign contracts, permits, applications, and other documents in the company's name. The IAM Request Form must be signed by an authorized representative who is a direct employee of the organization. The person who signs the IAM Request Form should be on file at FDA as an authorized representative for your organization (if you have an authorized representative on file).

Can the Designated IAM Also Be the Authorized Representative?

Yes, the designated IAM may be the same individual as the authorized representative. There is no requirement that they be different individuals. However, the person who signs the IAM Request Form should be on file at FDA as your organization’s authorized representative (if one is on file).

Can an Attorney or Agent Request an IAM Account for My Organization?

FDA does not accept IAM requests designating non-employee attorneys or agents to be the IAM. Attorneys that are direct employees of the organization may be designated as IAM. If an organization would like a non-employee attorney or agent to be an IAM for their organization, they should first submit an IAM request designating an employee of the organization to be the IAM. Then, that individual will be able to create a secondary (additional) IAM account for the non-employee attorney or agent.

How Do I, the Authorized Representative, Request an IAM Account for My Organization?

As an authorized representative, to designate a primary (initial) IAM for your organization:

  • Visit the IAM Request Form and Rules of Behavior (ROB) homepage.
  • On that page, click the "Request an IAM Account” button to access the IAM Request Form and ROB.
  • Ensure the forms are fully completed and appropriately signed.
    Note: Please confirm the email address for the designated IAM is correct, as a unique link and instructions for account set-up will be sent to this email address. The link in the email will expire after 24 hours.
  • Submit the signed forms to CTP.

Tips for filling out the IAM Request Form:

  • Include the full legal name of the organization (this should exactly match the organization name as listed in Dun & Bradstreet and be linked to the organization’s DUNS number).
    • Do not use or include a DBA.
    • Do not write “self-employed” or use your own name as the organization name, unless that is the legally registered name of the organization.
  • Include the full legal address of the organization.
    • Do not include personal addresses.
  • Confirm the email address is the correct email address for your organization before submitting.
    • Do not use your personal email address.

How Do I Complete My IAM Account Setup?

FDA will notify the designated IAM via the email address provided on the IAM Request Form once CTP Portal account is created. An IAM request can take 10 or more business days to process, so this email may arrive 10 or more business days after completing an IAM request. The email will include a link and instructions for the IAM to complete the account set-up. The IAM is responsible for monitoring the email address provided on the IAM Request Form. The link to complete account set-up in the email is only valid for 24 hours.

Note: If the IAM fails to complete account set-up within the 24-hour window, please do not submit another IAM Request Form. This will further delay accessing your account. Instead, request an account reset by sending an email to the CTP eSub Help Desk at CTPeSub@fda.hhs.gov. For faster assistance, please include the organization name when requesting an account reset.

How Long Will It Take to Process My IAM Request?

With a properly completed IAM Request Form and ROB, most IAM requests can be fulfilled within 10 business days of receipt. 

However, the processing time can vary, and can increase to 20 or more business days depending on the volume of requests being processed at that time and whether CTP requires additional information or clarification regarding the request. To best ensure your organization gains access to your CTP Portal account in time to meet an FDA-mandated deadline, please submit your IAM request at least six weeks prior to the deadline.

Who Can I Contact To Determine the Status of My IAM Request?

Please wait at least 10 business days from the date of submitting the IAM Request Form/ROB before contacting FDA about the status of your request. FDA will contact the IAM email address listed on the IAM Request Form if there is an issue with the request preventing your CTP Portal account from being created. 

If the designated IAM has not received an email regarding account set-up after 10 business days of the date the request was submitted and FDA has not contacted the IAM, the designated IAM or the authorized representative may email the IAM Request Team at ctp-iam-request@fda.hhs.gov to request the status of the IAM request. Be sure to include the IAM name and the organization the request is for in the email.

Can an Organization Have More Than One IAM?

Yes, an organization can have as many IAM accounts as they wish to designate, however FDA will only create the initial IAM account for a company. All other IAM accounts for a company are then created by the initial IAM.

In fact, FDA highly recommends that an organization maintain at least two IAMs for their CTP Portal account and recommends that at least one of the IAMs is a direct employee of the organization. This will help maintain continuity of access if one of the IAMs leaves or is no longer affiliated with your organization. 

However, FDA will only create the first, primary IAM for an organization. As such, please only submit one initial IAM request for your organization. It is up to your organization to determine the appropriate person to designate as the first, primary IAM. Once the first IAM is created, that individual can create additional accounts as necessary, including IAM accounts for other individuals within your organization.

How Do I Create Additional IAMs?

To create a secondary (additional) IAM, an existing IAM should follow the directions below:

  1. Sign in into your CTP Portal account. If you are an IAM for your organization, you will see the “Admin” button at the top of the screen.
  2. Click the “Admin” button, then click the “Add New User” button.
  3. Fill in the user information.
  4. Under the “Privileges” section, select the appropriate access for the individual, including “CTP Portal User Admin.” The “CTP Portal User Admin” privilege will enable the user to create and manage user accounts for your organization, as an IAM.
  5. Click “Save.”

With “CTP Portal User Admin” privileges, this new IAM user will then have the ability to create additional users for your organization. 

What Do I Do if the IAM Has Left the Organization Without Designating a New IAM?

IMPORTANT: If the organization’s only IAM has left the organization before creating additional IAMs, no one is capable of managing the account and we cannot guarantee an organization will easily regain access to the account. Therefore, it is very important that the organization take the precautionary steps to maintain continuity of access by maintaining at least two IAMs for their CTP Portal account and ensuring that at least one of the IAMs is a direct employee of the organization.

If the current and only IAM has already left the organization without designating a new IAM, the new user should email the IAM Request Team at ctp-iam-request@fda.hhs.gov to explain their case and provide the name, email address, and date of departure of the former IAM, at the minimum. Only if CTP can verify this information will CTP respond and instruct the new user to submit an IAM request.

Tips for ensuring an IAM back-up: 

  • CTP strongly recommends creating a second IAM account for another individual within the organization immediately after setting up the initial IAM account.
  • Ensure your organization has a plan or policy in place for setting up an a second IAM account, and that the IAM implements this policy PRIOR to the IAM’s departure from the organization.
  • If the IAM is temporarily out of office, the organization can still submit documents via CTP Portal if other user accounts have been granted “CTP Portal Upload” permissions. IAM permissions are not required in order to submit documents via CTP Portal.

An IAM of an organization can create a secondary IAM for the organization as a backup by following instructions above.

If you have trouble accessing your account, please contact the CTP Help Desk.

For other questions about requesting an IAM account, please contact the IAM Request Team.

 
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