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  1. About ESG

Submission Times

The following transaction times were generated based on PDUFA submissions starting August 1, 2018. Your company submission times may be above or below these averages, sometimes by a significant amount of time. There are a number of factors that affect upload and processing times. Below are some of the factors that determine submission upload and processing times:

  • 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 disclaimer iconhttp://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.

 

Application Type Submission 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 Original 5GB+ 6.65 GB 1.5 hrs 8 mins 9 mins 4.4 hrs 4.3 hrs 10.5 hrs
1GB to 5GB 2.014 GB 1.6 hrs 2 mins 2 mins 8 mins 4.8 hrs 6.6 hrs
up to 1GB 35.48 MB 24 sec 3 sec 43 sec 24 mins 2.8 hrs 3.2 hrs
Amendment 5GB+ 9.01 GB 36 mins 20 mins 20 mins 58 mins N/A 2.2 hrs
1GB to 5GB 2.37 GB 8 mins 3 mins 2 mins 18 mins 15 hrs 15.5 hrs
up to 1GB 15.35 MB 18 sec 2 sec 1 mins 25 mins 5 hrs 5.4 hrs
Supplement
 
5GB+ 7.36 GB 56 mins 6 mins 5 mins 18 mins 3.7 hrs 5.2 hrs
1GB to 5GB 1.78 GB 18 mins 2 mins 2 mins 19 mins 8.5 hrs 9.2 hrs
up to 1GB 29.67 MB 24 sec 3 sec 33 sec 22 mins 2.9 hrs 3.3 hrs
DMF Original 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 1.74 GB 22 mins 3 mins 56 sec 8 mins N/A 34 mins
up to 1GB 42.35 MB 8 mins 4 sec 32 sec 20 mins 3.2 hrs 3.6 hrs
Amendment 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB N/A N/A N/A N/A N/A N/A N/A
up to 1GB 8.13 MB 16 sec 2 sec 1 mins 15 mins 8 mins 25 mins
Supplement 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB N/A N/A N/A N/A N/A N/A N/A
up to 1GB 89.12 MB 2 mins 7 sec 27 sec 5 mins 5.1 hrs 5.2 hrs
NDA Original 5GB + 8.92 GB 2 hrs 13 mins 8 mins 44 mins 5 hrs 8.1 hrs
1GB to 5GB 1.90 GB 1.3 hrs 2 mins 2 mins 18 mins 3.5 hrs 5.2 hrs
up to 1GB 51.45 GB 2 mins 5 sec 36 sec 18 mins 3.2 hrs 3.6 hrs
Amendment 5GB+ 26.67 GB 1.2 hrs 3 mins 34 mins 4.5 hrs 4 mins 6.4 hrs
1GB to 5GB 2.33  GB 2.7 hrs 2 mins 2 mins 13 mins 18 mins 3.2 hrs
up to 1GB 14.65 MB 7 sec 2 sec 1 mins 36 mins 15.7 hrs 16.4 hrs
Supplement 5GB+ 5.94 GB 23 mins 5 mins 5 mins 42 mins 12.1 hrs 13.4 hrs
1GB to 5GB 2.13 GB 27 mins 2 mins 2 mins 21 mins 4.7 hrs 5.6 hrs
up to 1GB 22.71 MB 1 mins 3 sec 32 sec 16 mins 2.9 hrs 3.1 hrs

 

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