1. Home
  2. For Industry
  3. Electronic Submissions Gateway Next Generation (ESG NextGen)
  4. Resources
  5. Submission Times
  1. Resources

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: https://www.speedtest.net/
  • 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.

  • The targets for each processing phase are based on a 30 GB submission. View the targets in the column headings below.

     

Business Hours Submissions
Application TypeSubmission Size RangeAvg 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)
BLAUp to 1 GB0.04 GB3 mins3 mins1 min0.1 min43 mins51 mins
1 GB to 5 GB1.95 GB12 mins5 mins5 mins0.1 min52 mins1.2 hrs
5 GB to 10 GB6.52 GB21 mins13 mins16 mins0.1 min14 mins1 hr
10 GB to 20 GB13.57 GB26 mins20 mins27 mins0.1 min14 mins1.4 hrs
20 GB to 30 GB20.51 GB1 hr28 mins1.2 hrs0.1 min26 mins3.2 hrs

30 GB to 40 GB

No Data Available

40 GB to 100 GB

100 GB and Above
DMFUp to 1 GB0.04 GB4 mins4 mins0.4 min0.1 min1.3 hrs1.4 hrs
1 GB to 5 GB1.37 GB13 mins7 mins3 mins0.1 min16 mins40 mins
5 GB to 10 GBNo Data Available
10 GB to 20 GB
20 GB to 30 GB
30 GB to 40 GB
NDAUp to 1 GB0.03 GB3 mins3 mins1 min0.1 min30 mins38 mins
1 GB to 5 GB1.84 GB10 mins4 mins5 mins0.1 min56 mins1.2 hrs
5 GB to 10 GB6.22 GB15 mins9 mins17 mins0.1 min1.3 hrs1.9 hrs
10 GB to 20 GB15.70 GB41 mins1.3 hrs23 mins0.1 min19 mins2.6 hrs
20 GB to 30 GB20.07 GB2.4 hrs38 mins49 mins0.1 min19 mins4.2 hrs
30 GB to 40 GBNo Data Available
40 GB to 50 GB41.23 GB41 mins1 hr1.5 hrs0.1 min19 mins3.5 hrs
50 GB and Above97.65 GB1 hr1 hr3 hrs0.1 min21 mins5.8 hrs
         
Non-Business Hours Submissions
Application TypeSubmission Size RangeAvg 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)
BLAUp to 1 GB0.04 GB3 mins2 mins2 mins0.1 min29 mins36 mins
1 GB to 5 GB1.88 GB16 mins3 mins7 mins0.1 min42 mins1 hr
5 GB to 10 GB6.13 GB11 mins1 min49 mins0.1 min10 mins1 hr
10 GB to 20 GB15.78 GB32 mins1 min7 hrs0.1 min24 mins8.7 hrs
20 GB to 30 GB24.65 GB20 mins16 mins22 mins0.1 min20 mins1.3 hrs
30 GB to 40 GBNo Data Available

40 GB to 100 GB

100 GB and Above168.62 GB12 hrs1 hr14 hrs0.1 min53 mins29 hrs
DMFUp to 1 GB0.03 GB5 mins3 mins0.4 min0.1 min2.4 hrs2.6 hrs
1 GB to 5 GB1.33 GB16 mins4 mins4 mins0.1 min2 hrs2.5 hrs
5 GB to 10 GB

No Data Available

10 GB to 20 GB
20 GB to 30 GB
30 GB to 40 GB
NDAUp to 1 GB0.04 GB2 mins1 min2 mins0.1 min24 mins30 mins
1 GB to 5 GB2.06 GB5 mins2 mins6 mins0.2 min26 mins39 mins
5 GB to 10 GB5.22 GB11 mins3 mins29 mins0.2 min13 mins57 mins
10 GB to 20 GB13.48 GB28 mins18 mins1.3 hrs0.2 min17 mins2.4 hrs
20 GB to 30 GBNo Data Available
30 GB to 40 GB30.53 GB29 mins35 mins1.3 hrs0.1 min5 hrs7.4 hrs

40 GB to 100 GB

No Data Available

100 GB and Above

 

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
Back to Top