RPS R2 Test Case: Test Case Title

Regulated Product Submissions R2 Test Case

Modified for BLS

RPS R2 Test Case Title: C.2 Modify Information about a Submission. Example 2: Modify Information about a Submission by Regulatory Authority

Storyboard Content: The RA has received a BL[A]S amendment from BioPharm Co. (RI) for product 123 that is under review, the information provided in the submission indicates that a new supplement should have been submitted. The RA sends an update to the submission unit back to the BioPharm Co. to indicate that the submission number has been changed and reassigned a new submission number and sequence number. FDA NOTE: The example above is most likely a case where the company would need to resubmit and restructure the contents of the submission. The Test Case below describes an example of when the company would not have to resubmit. Note: This storyboard needs to be validated – this is for the simple situations where something can be reclassified without the submission being resubmitted. This would not handle a situation where the company would need to restructure the contents of their submission because the content was not accurate for the new submission type.

Test Case Objective: The ability for the Regulatory Authority (RA) to send a message to the RI containing a submission unit that modifies a submission, a relationship to an initial submission unit unit, a unique correspondence ID and additional metadata.

Test Case Description: The FDA sends a message to RI changing a BLA CBE supplement to a BLA PAS. The message contains a submission unit, a relationship to the initial submission unit, a unique correspondence ID and the following metadata:  Contact information (contact name and title, address, phone, email, fax)  Product information (product name (proper and trade))  RA information (Agency, Center, Office, Division)  Submission information (tracking number (e.g., BLA, NDA), sequence (serial) number, submission unit type (category, subcategory)  Comment field (free text)

Test Case Inputs:

 Original BLA and BLA CBE Supplement  Correspondence ID (system generated)  Letter containing FDA change of supplement classification from CBE to PAS  Contact Information, To; o Contact Type = ‘Regulatory’ o Contact Name = Robert Gray o Contact Address = 101 Bio Ave o Contact Phone = 314-979-0698 o Contact Email = [email protected] o Contact Fax = 314-555-1122  Product Information Regulated Product Submissions R2 Test Case

o Product Name = good vaccine 123  FDA Information o Agency = FDA o Center = CBER o Office = OVRR o Division = DVP  Contact Information, From; o Contact Type = ‘RPM’ o Contact Name = Mary Regulator o Contact Address = 10903 New Hampshire Ave Silver Spring MD 20905 o Contact Phone = 314-979-0698 o Contact Email = [email protected] o Contact Fax = 301-827-1122  Submission information o Application = 15025 o Sequence Number = ?? o Category / Subcategory = Supplement / Reclassification  Submission Status Code = Pending

Data elements RPS Standard

Applicant

Application Identifier Application.Id = 123456

Submission Identifier Submission.Id = 0A0A

Regulatory Activity Submission.Code = CBE

Submission Unit Identifier SubmissionUnit.Id = ABCD

Agency

Application Identifier Application.Id = 123456

Submission Identifier Submission.Id = 0A0A

Regulatory Activity Submission.Code = PAS

Submission Unit Identifier SubmissionUnit.Id = ABCD

Reclassification document ContextOfUse.Id = C2E3 Regulated Product Submissions R2 Test Case

Test Case Variations:

Expected Results: RI receives a message from the RA containing a submission unit that changes the submission (supplement) classification, a relationship to the initial submission unit, a unique correspondence ID and additional metadata.

More than likely, the following fields will contain the same information

Domain Area: Human Pharmaceuticals

Region: United States

Software Tools: (List the vendor, product name and version of the software tool being used to input the changes into the actual message. For example Altova, XML Spy, VS 3.0)

The following fields will be completed during testing

Test Date:

Tester’s Name:

Tester’s Email:

Test Case Deviations: (Describe any unplanned deviations used to continue testing. For example: The test case description instructed you to attach an “approval letter.pdf” to the message but it was not allowed so you attached an “approval letter.doc” to continue testing)

Actual Test Results: (Document whether the test passed or failed based on the Expected Results. For example: “Passed. Actual Results matched Expected Results” or “Failed. See Discrepancies and Issue Number 123456”)

Test Result Discrepancies: (Document any differences between the Actual Results and the Expected Results. For example: The Expected Results stated the Regulated Industry should receive a correspondence containing submission information but submission information did not display in correspondence.)

Issue Number: (Enter the number provided by the issue-tracking software.)