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:
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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 = robert.gray@vaccineshot.com
o Contact Fax = 314-555-1122
Product Information
o Product Name = good vaccine 123
Regulated Product Submissions R2 Test Case
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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 = mary.regulator@regulator.gov
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.)