ADR Petitions

Enter the information required in the Petition Details section.

Petition Details section – Fields

Item	Description
Initiated Date	Read-only date entered by OPA when creating the petition.
Filing Status	Read-only; set by OPA when creating the petition.
Covered Entity 340B IDs	List the 340B ID A unique identification number assigned by OPA to each covered entity parent or child site (e.g., child site, subdivisions, or sub-grantees).(s) from the submitted petition
Manufacturer Name and Labeler Codes	List the Labeler Code(s) from the submitted petition
Date of Alleged Violation	Enter the date of alleged violation from the petition
Summary of Petition	Enter a summary of the information in the Petition.

You can view and update the Petitioner organization and contact information in the Contacts section.

For entering a new Petitioner Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the petitioner.

In this section, the petitioner can upload the supporting documents to the petition.

As a petitioner, you can upload documents to the following folder only:

• Petitioner

• Good Faith Efforts

• Reconsideration – Petitioner

You can only view documents uploaded by the Opposing to the following document folders:

• Opposing

• Reconsideration – Opposing

Select the Upload button on the appropriate folder to add the relevant attachments. In the Upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button if you need to remove the uploaded file before saving the petition.

After reviewing the document information, click on Submit from the Review and Submit section to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder. The following table shows the fields displayed on the View Folder section.

View Folder – Fields

Item	Description
Uploaded Date	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Remove	Click on Remove to delete the comment. Remove is not available after saving the comment.
Edit	Click on Edit to edit the comment. Edit is not available after saving the comment.

In the NDC A unique 11-digit, 3-segment code numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment (4 or 5 digits) is assigned by the Food and Drug Administration (FDA). The second segment (3 or 4 digits) identifies a specific strength, dosage form, and formulation for a particular firm. The third segment (1 or 2 digits) identifies package forms and sizes. Details section, you can enter the NDCs in question which belong to the labeler codes specified in the petition.

Click on Manage to enter one or more NDCs separated by commas, or each one on a new line.

The system validates if the entered NDC is not in the correct format; specifically, NDCs should be entered as 11 digits with no hyphens that includes leading zeros, e.g., 00777310502.

You can view and update the Opposing organization and contact information in the Contacts section.

For entering a new Opposing Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the Opposing.

In this section, the opposing can upload the supporting documents to the petition.

As a petitioner, you can upload documents to the following folder only:

• Opposing

• Good Faith Efforts

• Reconsideration – Opposing

You can only view documents uploaded by the Opposing to the following document folders:

• Petitioner

• Reconsideration – Petitioner

Select the Upload button on the appropriate folder to add the relevant attachments. In the Upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button if you need to remove the uploaded file before saving the petition.

After reviewing the document information, click on Submit from the Review and Submit section to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder. The following table shows the fields displayed on the View Folder section.

View Folder – Fields

Item	Description
Uploaded Date	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Remove	Click on Remove to delete the comment. Remove is not available after saving the comment.
Edit	Click on Edit to edit the comment. Edit is not available after saving the comment.

Enter the information required in the Petition Details section.

MFR Petition Details section – Fields

Item	Description
Initiated Date	Read-only date represents the when petitioner submitted the petition.
Filing Status	Read-only; set by OPA when creating the petition.
Manufacturer Name and Labeler Codes	List the Labeler Code(s) from the submitted petition
Covered Entity 340B IDs	List the 340B ID(s) from the submitted petition
Date of Alleged Violation	Enter the date of alleged violation from the petition
Summary of Petition	Enter a summary of the information in the Petition.

You can view and update the Petitioner organization and contact information in the Contacts section.

For entering a new Petitioner Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the petitioner.

In this section, the petitioner can upload the supporting documents to the petition.

As a petitioner, you can upload documents to the following folder only:

• Petitioner

• Good Faith Efforts

• Reconsideration – Petitioner

You can only view documents uploaded by the Opposing to the following document folders:

• Opposing

• Reconsideration – Petitioner

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button if you need to remove the uploaded file before saving the petition.

After reviewing the document information, click on Submit from the Review and Submit section to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder. The following table shows the fields displayed on the View Folder section.

MFR View Folder section – Fields

Item	Description
Uploaded Date	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

 

In the Audit Details section, enter the Audit Date and the Audit ID of the Manufacturer Audit that should have been conducted on the Opposing entity.

Click on Add Audit Finding to select the finding and enter the other details about the audit finding such as Summary of Finding Details, MFR Proposed Solution and Covered Entity Response Summary.

Audit Details section – Fields

Item	Description
Audit Date	Enter the audit date
Audit ID	Enter the Audit ID for the Manufacturer Audit from Compliance
Finding	Select from “Diversion” or “Duplicate Discount”
Summary of Finding Details	Enter the summary of the finding details
MFR Proposed Solution	Enter the MFR Proposed Solution
Covered Entity Response	Enter the Covered Entity Response
Remove	Click Remove to delete the finding
Edit	Click Edit to update the finding details

You can view and update the Opposing organization and contact information in the Contacts section.

For entering a new Opposing Contact, click Reset and enter the contact email. If it is a new contact then enter the Name, Phone, Title, and Organization of the Opposing.

In this section, the opposing can upload the supporting documents to the petition.

As a petitioner, you can upload documents to the following folder only:

• Opposing

• Good Faith Efforts

• Reconsideration – Opposing

You can only view documents uploaded by the Opposing to the following document folders:.

• Petitioner

• Reconsideration – Petitioner

Select the Upload button on the appropriate folder to add the relevant attachments. In the upload Document dialog box, select the document(s) to be uploaded. You can add an optional comment.

The maximum file size allowed for upload is 100 MB and the allowed file types are .doc,.docx,.pdf,.csv,.wpd,.ppt,.pptx,.txt,.xls,.xlsx,.jpg,.png,.tif,.msg,.eml,.ics". (Word documents, Excel spreadsheets, PowerPoint presentations, PDF, image files, email messages, etc.)

The selected documents are uploaded temporarily and shown in the Documents Pending Upload section. You can select the Remove button if you need to remove the uploaded file before saving the petition.

After reviewing the document information, click on Submit from the Review and Submit section to save the information updated in the Petition. The document count on the appropriate folder will be updated to reflect the uploaded documents.

You can select View Folder to view the individual documents in a folder. The following table shows the fields displayed on the View Folder section.

View Folder section – Fields

Item	Description
Uploaded Date	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

 

You can add comments to the Petition using the Add Comment function from the Comments section.

Enter the text you want to add as Comment and Click on Add.

The text gets saved to the Petition as a Comment. You will be able to Remove or Edit the comment before you click on the petition Save button.

Comments section – Fields

Item	Description
Created On	Displays the date when the document was uploaded. The documents are sorted in descending order by this field.
Uploaded By	Displays the user or the user on whose behalf the document was uploaded
Comment	Displays an optional comment that was added when the document was uploaded
Document Name	Displays the name of the document
Actions	The Download action will allow you to download the document

The Activity tab contains a table that provides a chronological record of activities that occurred on the Petition. The activities are ordered in descending order.

Activity section – Fields

Item	Description
Date Time	Indicates the date and time when the activity occurred
User	Displays the user who performed the activity
Description	Displays a description of the activity. The activity can be adding or updating petition details, uploading attachments, sending email notifications to any of the parties related to the petition, adding, or updating contacts, updating any of the Statuses, adding comments, and adding or updating decision details.

The Documents tab displays the document folders with the petition supporting documents.

Document section – Fields

Item	Description
Folder Name	Petition Document folder name
Last Updated On	Date when an attachment was last uploaded in the folder
Last Updated By	Email address of the user who last uploaded to the folder
Document Count	Number of individual documents in the folder
Actions	View Folder – displays the individual documents in the folder

The Communications tab displays a chronological list of email notifications sent from the petition.

Item	Description
Sent On	Date email sent on.
Sent To	Email Recipient(s).
Sent From	Email sent “From” Address. It is set to “340BADR@hrsa.gov”.
Subject	Displays the email subject.

The comments tab contains a table that provides a chronological record of comments attached to the petition.

The NDC Details tab shows the NDCs in question that have been specified in the petition.