FDA CVM eSubmitter ADMS Book Electronic Submission Software User Guide

CVM eSubmitter
Animal Drug and Manufacturing (ADMS) Book
Quick Guide

Introduction

This guide outlines the functions associated with viewing and managing establishment information and supply chains in the Animal Drugs and Manufacturing System, or  ADMS, database. The ADM’s establishments list is a tool used to manage the overall information on each establishment. There is a separate ADMS Supply Chain, which is used to designate the role of each establishment. Reusing data makes building a submission more efficient, as well as ensures data entry consistency.

ADMS Establishments Book

A. Access from the Tools Menu
Direct access to the book is available at any time from the Tools option in the menu bar.

Accessing the establishment book from the Tools menu allows you to see all of the currently entered establishments.

The Establishment List displays all the ADMS Establishments matching the search criteria, or all ADM’s Establishments available when no search criteria are provided. The list contains the Establishment Name, DUNS, FEI, Country, State/Territory, and the date the information was last updated. The listing title contains a count of the establishments currently included within the list. In addition, internal sponsor comments are displayed for the selected establishment.

The following options are available:

• View: Displays all details related to the selected establishment.
• New: Allows for new establishments to be added to the list.
• Edit: This allows for details on the selected establishment to be updated.
• Delete: This allows for the selected establishment to be permanently deleted from the list.

B. Search/Sort Criteria
The Search capability allows for searching across all ADM Establishments contained within the ADMS Establishment List. The fields available for searching include establishment Name, DUNS, and FEI. Specifically, the search locates all establishments matching all criteria provided.

The Establishment Name search allows for up to five keywords to be entered. Each keyword is separated by a space. The search matches all establishment names that contain words beginning with the keywords provided. The order of the keywords is not relevant to the search results. For example: providing ‘co ab’ as the search text would match ‘ABC Company’.

The DUNS and FEI searches are based on locating all establishments that begin with the digits entered. For example, providing ‘123’ as the search text for FEI would match an FEI of ‘123456789’.
When no search text is provided, all establishments are listed. A Clear option is provided to clear the search text and reset the establishment list.
The Sort capability controls the ordering of establishments within the list. The sort orders available include Establishment Name, DUNS, FEI, and Country. Specifically, the
establishment list will be reordered whenever a sort order is selected. The default sort order is Establishment Name. The sort order will reset to the default when the Clear option is selected

C. New Establishments
To add a new establishment, select the “New…” button at the bottom of the page. You are presented with a window with three tabs. The first tab, “Establishment”; this section collects information on the establishment name, reference identifiers (i.e., FEI and DUNS), address, phone numbers, and internal sponsor comments.
It is possible to have two establishments with the same name, however, the DUNS number must be unique. It is important to make sure the FEI and DUNS numbers are accurate. The DUNS number is required for all establishments in a submission. While the FEI number is not required at the time of submission, the absence of this information may hinder the timeline for the assessment of establishment information.

In addition, the following capabilities are provided:

• Copy from Establishment Book (Only Add Mode): This allows for establishment information to be selected and copied from the general eSubmitter Establishment Book.
• Check D&B D-U-N-S Number: This allows for the entered DUNS number to be checked against the ADMS Establishment List to determine if it is unique prior to the entering of the remaining information. If a unique number is used, the form will confirm the acceptability of the information. If the same number is found in the database, the check will notify the user that the establishment cannot be added.
• Establishment Comments: Adding internal comments allows you to capture additional information for overall management and identification of establishment information. This information is not transmitted to CVM.

D. Inspection Information
Add information about the GMP status of the establishment and date of last inspection on this tab.

The additional information section allows for the entry of any information about an inspection that has been scheduled, currently taking place, or completed but not yet classified.
Note: For information regarding the current inspectional status on a facility, see https://datadashboard.fda.gov/ora/cd/inspections.htm. If an inspection is scheduled, currently taking place, or completed but not yet classified you should select the status of the previous inspection.

E. Contact Details
This section collects information on the establishment’s contact name, address, and phone number.

In addition, the following capabilities are provided:

• Copy from Contact Book (Only Add Mode): This allows for contact information to be selected and copied from the general eSubmitter Contact Book.
• Copy from Establishment Address: This allows for the contact address to be copied from the establishment-related details section.

F. Missing Information
Users may select OK at any point in the establishment entry process, even with incomplete information. A confirmation message will be displayed that provides details on which fields have not been filled out.

Note: For an ADM’s Establishment to be included within a submission, all required responses must be provided.

G. Add Another Establishment
After completing an establishment entry and selecting OK, if you have additional establishments to add, select the Add Another Establishment button. Making this selection
will clear the form to enable the entry of the next establishment.

H. Edit ADMS Establishment
Allows for details on the selected establishment to be updated. Establishment information can be edited by first selecting the desired establishment from the ADMS  establishment List, and then selecting Edit. Alternatively, you can double-click the establishment name in the list to open the same window. On this screen, the establishment information on each tab can be edited. To save any edits, simply select OK when finished.

I. Delete ADMS Establishment
To delete a facility, select the desired facility from the ADMS Establishment List, and select Delete at the bottom of the form. A warning message will appear to confirm the deletion, which after doing so, will remove the establishment from the list.

If an establishment is associated with a supply chain item, you will not be able to delete it without either redirecting the associated supply chain items to other establishments or
deleting the supply chain items.

J. View ADMS Establishments Report
Users have the option of viewing the establishment report for a selected establishment, or for all establishments within the list. Select the View button after selecting the desired
facility. The dialog box which opens gives the option to select which establishments to output.

Only a single establishment or all establishments can be selected; multiple establishments cannot be selected using “Ctrl” or “Shift”. After selecting which sections should be included in the report, the file will open in your default html viewer.

ADMS Supply Chains

A. Access from the Tools Menu
The ADMS Supply Chains book can be accessed in two ways. Direct access to the books is available at any time from the Tools option in the menu bar.

Accessing the ADMS Supply Chain book from the Tools menu allows you to see all of the currently entered supply chain items.

The ADMS Supply Chain List displays all the ADMS supply chain items for the selected File/Application and/or Establishment. The list contains the Document and establishment references, Role/Entity/Qualifier, CVM Operational Status, Sponsor New Operational Status, Approved Submission ID, Use Code, Substance, Master File reference, and the date the information was last updated. The list title contains a count of the supply chain items currently included within the list. In addition, internal sponsor comments are displayed for the selected supply chain item.

The following options are available:

• Copy/Move To Allows for copying selected supply chain items to another file/application or establishment.
  o If the current search criteria are based on a File/Application then the option supports copying or moving to another File/Application.
  o If the current search criteria are based on an Establishment then the option supports copying or moving to another Establishment.
  o The Supply Chain list supports singular and multi-selection for identifying the items to be copied or moved.

• View: Displays all details related to the selected supply chain item(s) in the list.

• New: Allows for new supply chain items to be added to the list.

• Edit: This allows for details on the selected supply chain item to be updated.

• Delete: This allows for the selected supply chain item(s) to be permanently deleted from the list.

Note: New supply chain items cannot be added until a File/Application and/or Establishment has been selected. Without preselecting a File/Application or Establishment one cannot view which supply chain items already exists before adding new supply chain items.

1. Select a File/Application (Document)
   Click on the Select button to open the Product Description Selection dialog containing the stored File/Application information from the Product Book.

2. Select an Establishment
   Click on the Select button to open the ADMS Select Establishment dialog containing the stored establishments from the ADMS Establishment book.

B. Search/Sort Criteria
The Search capability allows for filtering ADM’s supply chain items within the supply chain list by File/Application (Document) and/or Establishment. The supply chain list is initially empty until a File/Application or Establishment is selected. View options are available to display details of the selected File/Application or Establishment. A Clear option is provided to clear the search selections and the list.
The Sort capability controls the ordering of supply chain items within the list. The sort orders available include Document, Establishment, Role/Entity/Qualifier, CVM Operational Status, New Operational Status, Substance, and Master File Document. The supply chain list will be reordered whenever a sort order is selected. The default sort order is Establishment when a File/Application is selected and Document when an Establishment is selected.

C. New Supply Chain Role
You may add a supply chain role association between an establishment and application/file. To add a supply chain role, either the File/application or Establishment must be selected first. You must also have an entry in the Product Book. If the file/application does not exist with the product book, you cannot enter the File/Application Reference to a supply chain role.
Once both a file/application and the establishment reference are selected, fill out the supply chain information section.
Master files can be associated with a supply chain role by selecting yes there is an associated mater file. Click on the select button to open the Select Master File dialog that contains information from the Master File book. Select the appropriate master file from the list by double clicking on the entry in the list or highlighting it and clicking Select.

If you select Drug Substance as the entity, the Substance Reference field is activated. When referencing a substance, click on select next to Substance, and a pop-up window will appear for substance selection. To enter the substance information from the FDA substance registration system you can perform a keyword search using either by name or UNII code. The link to the FDA Substance Registration System (SRS) is also provided on this screen. The other option is to enter a substance manually by activating the manual entry button.
Adding internal Supply Chain Role comments allows you to capture additional information for overall management and identification of supply chain information. This information is not transmitted to CVM.

D. Missing Information
Users may select OK at any point in the supply chain entry process after the required fields are entered, even with incomplete information. A confirmation message will be displayed that provides details on which fields have not been filled out.
Note: For an ADMS Supply Chain to be included within a submission, all required responses must be provided.
E. Add Another Supply Chain
After completing a supply chain entry and selecting OK, if you have additional supply chains to add, select the Add Another Supply Chain button. Making this selection will clear the form to enable the entry of the next supply chain entry.
F. Edit Supply Chain
Allows for details on the selected supply chain to be updated. Supply chain information can be edited by first selecting the desired supply chain from the list, and then selecting Edit. Alternatively, you can double-click the establishment name in the list to open the same window. On this screen, the establishment information on each tab can be edited. To save any edits, simply select OK when finished.
G. Delete Supply Chain
To delete a supply chain entry, select the desired item from the list, and select Delete at the bottom of the form. A warning message will appear to confirm the deletion, which after doing so, will remove the supply chain from the list.
H. View ADMS Supply Chain Listing Report
Users have the option of viewing the ADMS Supply Chain Listing report for a selected establishment, or for all establishments within the list. Select the View button after selecting the desired supply chain. The dialog box which opens gives the option to select which supply chains to output.
Only a single supply chain in the list or all supply chains in the list can be selected; multiple supply chains cannot be selected using “Ctrl” or “Shift”. The file will open in your default HTML viewer.

Including ADMS Establishment Information within a Submission

Previously, establishment information was collected in various locations within the chemistry, manufacturing, and controls sections of submission based on the submission
type (e.g., drug substance, drug product). Now, all establishment information is collected within a single section, under the ADMS Establishment Information tab, regardless of the submission type. In addition, establishment information is no longer entered directly into the submission, but selected from the ADM’s book to ensure consistency of information across submissions, as well as to make building a submission more efficient.
Note: In preparation for submission, ADMS information should be added to the ADM’s books so that it can be easily selected for inclusion within a submission. Also, the document type and number should be specified within section 1.0 “Document Information” of the CVM ONADE Submissions tab.

The following options are available:

• Add: Displays the ADM’s book, allowing for the selection of ADMS information to be included within the submission list.
• Delete: Deletes the selected ADMS item from the submission list.
• Delete All: Deletes all ADM items from the submission list.
• View: Displays a detailed report of all ADM’s items included within the submission list for review.
• Edit Establishment: Supports editing of the Establishment information for the selected ADMS within the submission list. Note: Any changes made will also be reflected within the ADM’s book.
• Edit Supply Chain: Supports the editing of the Supply Chain information for the selected ADMS item within the submission list. Note: Any changes made will also be reflected within the ADM’s book.
• Refresh: Refreshes the contents of the list. This can be useful when making changes directly within the ADMS book and reflecting the updates to items included within the
  submission list.

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