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  1. Electronic Submissions Gateway

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+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 2.31 GB 18 mins 2 mins 2 mins 29 mins 2 hrs 2.8 hrs
up to 1GB 12 MB 11 sec 1.9 sec 2.45 sec 8 mins 2.3 hrs 2.4 hrs
Amendment 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 1.28 GB 23 mins 58 mins 2 mins 21 mins N/A 1.7 hrs
up to 1GB 15.79 MB 15 sec 2 sec 2 sec 9 mins 45 mins 55 mins
Supplement
 
5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 1.15 GB 3 mins 29 sec 49 sec 20 mins 18 mins 42 mins
up to 1GB 29.38 MB 54.76 sec 28.25 sec 3.32 sec 1.5 hrs 1.4 hrs 2.9 hrs
DMF Original 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 26.63 MB 4 mins 6 sec 3 sec 8 mins 2.7 hrs 2.9 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 22.17MB 2 mins 4.9 sec 3 sec 9 mins 1.2 hrs 1.4 hrs
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 N/A N/A N/A N/A N/A N/A N/A
NDA Original 5GB + 5.94 GB 1.3 hrs 6 mins 4 mins 1.4 hrs 42.5 hrs 45.3 hrs
1GB to 5GB 2.14 GB 33 mins 2 mins 2 mins 21 mins 2.4 hrs 3.4 hrs
up to 1GB 22.17 MB 21 sec 2.23 sec 3 sec 7 mins 2.3 hrs 2.4 hrs
Amendment 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 1.43 GB 5 mins 8 sec 32 mins 1 min 19 mins 57 mins
up to 1GB 13.33 MB 11 sec 56 sec 3 sec 9 mins 1.3 hrs 1.4 hrs
Supplement 5GB+ N/A N/A N/A N/A N/A N/A N/A
1GB to 5GB 2.31 GB 28 mins 2 mins 2 mins 32 mins 60 mins 2.1 hrs
up to 1GB 16.61 MB 17 sec 2 sec 3 sec 7 mins 1.8 hrs 2 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