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  6. Prior Notice System Interface (PNSI) Step-by-Step Instructions: Accessing PNSI
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Prior Notice System Interface (PNSI) Step-by-Step Instructions: Accessing PNSI

Screens, descriptions, and examples are subject to change as enhancements are made to the system. They are not intended to take the place of the written regulations found in the Final Rule (Nov. 7, 2008).

Instructions

Navigate to the FDA Industry Systems Access page (www.access.fda.gov).

On the FDA Industry Access page, choose the Login button.

On the Login page (Figure 1), enter your FDA Industry Systems Account ID and Password.

If you do not have a user account, create a user account by choosing "Create New Account" under the New Users section. (See the FURLS documentation for information on creating a user account.)

Confirm that you understand the consequences of 18 U.S.C. 1001 by choosing I understand.

Choose the Login button.

Figure 1:

Accessing PNSI Instructions: Figure 1 Login

The FDA Industry Systems Welcome page displays (Figure 2), listing the menu of systems that are available, depending on your access level.

Scroll down and choose the Prior Notice System Interface button.

Figure 2:

Accessing PNSI Instructions: Figure 2 System Welcome Screen

The Welcome to the Prior Notice System Interface page displays (Figure 3), listing the options to which you have access on the left side.

  • Get Started opens a Help module that explains how to submit a Prior Notice.
  • Learn New Features opens a Help module describing New Features available in this Version of the Prior Notice System Interface.
  • Create New Web Entry guides you to the first step in creating a Prior Notice.
  • Find Existing Web Entry allows you to find a Web Entry that you or your company has already created.
  • Find Existing Prior Notice allows you to find a Prior Notice that you or your company has already created.

Choose the Create New Web Entry button to display the Web Entry (Create) page.

Figure 3:

Accessing PNSI Instructions: Figure 3 Prior Notice Welcome