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  1. About ESG

Submission Times

The following transaction times are generated quarterly based on PDUFA submissions. Your company submission times may be above or below these transaction averages, sometimes by a significant amount. There are a number of factors that affect submission upload and processing times. Below are some of these factors:

  • Internet connection bandwidth: The bandwidth your Internet Service Provider (ISP) provides to your company
  • Internet connection bandwidth consumption: The amount of available bandwidth is currently in use by the company. Upload speed can be determined by going to: http://beta.speedtest.net
  • Geographic proximity to FDA (Washington DC): The farther your location from FDA, the more network hops are required for your connection to reach FDA. The more hops your connection takes to get to FDA, the longer your submission will take to get to FDA
  • Data compression ratio (for multi-file submissions) and submission composition:  The number of files and folders/directories and the type of data you are sending will affect the speed at which the submission makes it to FDA
  • End client/user infrastructure: Capacity of end user's machine (processor and memory), network storage performance, and shared vs dedicated machine might also affect the speed of signing the submission and upload
  • Uploading a submission during  infrastructure maintenance (end user's and/or FDA)
  • Submission traffic during the specific period:  Multiple, very large submissions (e.g., over 10 GB) being received concurrently, then the ACK times will vary.

     

    Business Hours Submissions
                     
    Application Type Submission Size Range Avg Submission Size (compressed) Upload Duration (Avg; Target: 6 Hrs) Deliver Receipt to User (Avg; Target: 2 Hrs) Delivery to Centers (Avg; Target: 2 Hrs 55 Mins) Delivery Ack2 to User (Avg; Target: 5 Mins) Delivery Ack3 to User (Avg; Target: 1 Hrs) Total Duration (Avg; Target: 12 Hrs)
    BLA Up to 1 GB 0.02 GB 17 sec 2 sec 1 sec 10 mins 49 mins 60 mins
    1 GB to 5 GB 2.35 GB 43 mins 2 mins 1 mins 9 mins 12 mins 1 hrs
    5 GB to 10 GB 7.12 GB 1 hrs 7 mins 3 mins 19 mins 13 mins 2.3 hrs
    10 GB to 20 GB 18.51 GB 1 hrs 37 mins 14 mins 36 mins 2.8 hrs 5.4 hrs
    20 GB to 30 GB No Data Available
    30 GB to 40 GB
    DMF Up to 1 GB 0.03 GB 2 mins 3 sec 2 sec 8 mins 22 mins 32 mins
    1 GB to 5 GB 1.12 GB 8 mins 1 mins 30 sec 6 mins 5 mins 21 mins
    5 GB to 10 GB No Data Available
    10 GB to 20 GB
    20 GB to 30 GB
    30 GB to 40 GB
    NDA Up to 1 GB 0.03 GB 1 mins 7 sec 2 sec 7 mins 21 mins 30 mins
    1 GB to 5 GB 1.83 GB 59 mins 2 mins 1 mins 8 mins 49 mins 2 hrs
    5 GB to 10 GB 6.75 GB 3 hrs 5 mins 4 mins 12 mins 8 mins 3.5 hrs
    10 GB to 20 GB 13.58 GB 1.83 hrs 21 mins 14 mins 59 mins 23 mins 3.8 hrs
    20 GB to 30 GB No Data Available
    30 GB to 40 GB
    40 GB to 100 GB 61.67 GB 4.2 hrs 1.8 hrs 1.3 hrs 5.8 hrs 7 hrs 19.3 hrs
    100 GB and Above 118 GB 8.75 hrs 18.3 hrs 2.3 hrs 1.2 hrs 9.1 hrs 39.4 hrs
                     
    Non-Business Hours Submissions
                     
    Application Type Submission Size Range Avg Submission Size (compressed) Upload Duration (Avg; Target: 6 Hrs) Deliver Receipt to User (Avg; Target: 2 Hrs) Delivery to Centers (Avg; Target: 2 Hrs 55 Mins) Delivery Ack2 to User (Avg; Target: 5 Mins) Delivery Ack3 to User (Avg; Target: 1 Hrs) Total Duration (Avg; Target: 12 Hrs)
    BLA Up to 1 GB 0.02 GB 24 sec 39 sec 1 sec 8 mins 2.4 hrs 2.6 hrs
    1 GB to 5 GB 3.08 GB 36 mins 3 mins 2 mins 12 mins 8 mins 1 hrs
    5 GB to 10 GB 5.25 GB 57 mins 5 mins 2 mins 12 mins 3.3 hrs 4.6 hrs
    10 GB to 20 GB 18.80 GB 61 mins 30.5 mins 16 mins 34.4 mins 42 mins 184.2 mins
    20 GB to 30 GB No Data Available
    30 GB to 40 GB
    DMF Up to 1 GB 0.04 GB 7 mins 3 mins 2 sec 6 mins 1.1 hrs 1.4 hrs
    1 GB to 5 GB 1.16 GB 1.3 hrs 41 sec 31 sec 7 mins 6 mins 1.6 hrs
    5 GB to 10 GB No Data Available
    10 GB to 20 GB
    20 GB to 30 GB
    30 GB to 40 GB
    NDA Up to 1 GB 0.04 GB 3 mins 2 mins 2 sec 6 mins 56 mins 1.1 hrs
    1 GB to 5 GB 2.16 GB 2 hrs 2 mins 1 mins 9 mins 1.1 hrs 3.7 hrs
    5 GB to 10 GB 8.45 GB 1.1 hrs 17 mins 4 mins 4.5 hrs 5.2 hrs 11.2 hrs
    10 GB to 20 GB No Data Available
    20 GB to 30 GB 23.36 GB 1.7 hrs 40 mins 17 mins 46 mins 2.9 hrs 6.3 hrs
    30 GB to 40 GB No Data Available

     

    Terminology

    • Upload Submission Duration:  How long does it take to upload a submission from my computer
    • Deliver Receipt to User:  When should I expect a receipt
    • Delivery to Centers:  How long does it take to deliver to Center CFT inboxes
    • Delivery Ack2 to User:  Time it takes to unpackage submission, generate Ack2, and send Ack 2 back
    • Delivery Ack3 to User:  Time it takes to validate, generate Ack3, and send Ack 3 back
    • N/A: Data not available
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