Temporary Deferment - Resumption of Action

July 18, 2000

The replacement of CBER's database and tracking system for license applications has been completed. Routine handling of submissions to License Application files has been resumed. CBER appreciates your patience during this difficult period.

A new Submission Tracking Number (STN) system will be used in place of reference numbers. Each Biologics License Application (BLA) file will have a unique STN. This will facilitate identification and tracking of each piece of correspondence pertaining to a file that is received in CBER.

The STN is a three level numbering system that appears as ###### / ###### . ######.

  • The first level number is given to the original application and will be associated with all other submissions related to the original application.

      • Example:

      • The STN for the original BLA for a new product might be 123456 / 0 . 0

  • The second level number is associated with submissions to the approved original BLA, such as supplements, annual reports, post-marketing commitment submissions, etc.

      • Example:

      • The STN for the first supplement to the approved original BLA 123456 would be 123456 / 1.0
      • The STN for the second supplement to that BLA would be 123456 / 2.0

  • The third level number is associated with submissions to pending files, i.e., amendments to original applications or supplements, etc.

      • Example:

      • The STN for the first amendment to the pending original BLA 123456 would be 123456 / 0.1
      • The STN for the first amendment to the pending first supplement to BLA 123456 would be 123456 / 1.1

A list of STNs for approved products will be made available on CBER's web site at a later date. When this list is available, please include the first level STN number on the FDA form 356h that accompanies your submission to the BLA.

  • If you are submitting a new original BLA, a unique STN will be generated by the system and will be included in the acknowledgment letter you receive. Please use that STN for all further communications pertaining to that BLA.
  • For submissions to currently pending files, please use the reference number that was originally assigned to your license application or supplement. Reference numbers and STNs can be cross-referenced in the new system. Our first correspondence to you concerning your pending file will contain the appropriate STN for that application or supplement.

If you have questions, you may contact CBER's Manufacturers Assistance and Technical Training Branch at 301-827-2000, or by email to matt@cber.fda.gov.

FEDERAL REGISTER: Temporary Deferment of Activities Relating to Certain Biological Submissions - 6/22/2000 - (PDF, 123 KB)

Notice of Temporary Deferment of Action on Certain Submissions

 
Updated: January 23, 2001