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.
• 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 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	13 sec	47 sec	10 sec	7 mins	8 mins	10 mins
	1 GB to 5 GB	2.8 GB	8 mins	15 mins	22 mins	12 mins	17 mins	1.1 hrs
	5 GB to 10 GB	8.92 GB	16 mins	37 mins	1.1 hrs	19 mins	10 mins	2.8 hrs
	10 GB to 20 GB	11 GB	24 mins	34 mins	1.2 hrs	17 mins	6 mins	2.9 hrs
	20 GB to 30 GB	18 GB	32 mins	39 mins	1.4 hrs	17 mins	6 mins	3 hrs
	30 GB to 40 GB	No Data Available
DMF	Up to 1 GB	0.06 GB	24 sec	56 sec	1 min	9 mins	11 mins	22 mins
	1 GB to 5 GB	2.3 GB	7 mins	9 mins	15 mins	9 mins	12 mins	52 mins
	5 GB to 10 GB	7.28 GB	34 mins	33 mins	53 mins	13 mins	7 mins	2.2 hrs
	10 GB to 20 GB	No Data Available
	20 GB to 30 GB
	30 GB to 40 GB
NDA	Up to 1 GB	0.06 GB	21 sec	55 sec	1 min	7 mins	12 mins	21 mins
	1 GB to 5 GB	2.07 GB	4 mins	9 mins	15 mins	10 mins	6 mins	54 hrs
	5 GB to 10 GB	7.28 GB	34 mins	33 mins	53 mins	13 mins	7 mins	2.2 hrs
	10 GB to 20 GB	14.32 GB	1.2 hrs	58 mins	1.3 hrs	1.3 hrs	25 mins	4.5 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	118.0 GB	8.8 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	0.03 GB	17 sec	22 sec	29 sec	7 mins	16 mins	24 mins
	1 GB to 5 GB	5 GB	12 mins	22 mins	37 mins	17 mins	11 mins	2.1 hrs
	5 GB to 10 GB	9.67 GB	17 mins	36 mins	1.1 hrs	25 mins	8 mins	2.9 hrs
	10 GB to 20 GB	12 GB	29 mins	1.1 hrs	1.2 hrs	30 mins	10 mins	3.6 hrs
	20 GB to 30 GB	26.0 GB	7.2 hrs	48 mins	24 mins	45 mins	16 mins	9.6 hrs
	30 GB to 40 GB	No Data Available
DMF	Up to 1 GB	0.04 GB	45 sec	3 sec	4 sec	8 mins	17 mins	26 mins
	1 GB to 5 GB	1.67 GB	7 mins	4 mins	2 mins	9 mins	9 mins	31 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	0.01 GB	22 sec	35 sec	55 sec	7 mins	13 mins	21 mins
	1 GB to 5 GB	2.21 GB	6 mins	10 mins	15 mins	10 mins	5 mins	56 mins
	5 GB to 10 GB	7.6 GB	14 mins	16 mins	44 mins	11 mins	4 mins	1.6 hrs
	10 GB to 20 GB	12.45 GB	8.2 hrs	15 mins	16 mins	50 mins	15 mins	9.8 hrs
	20 GB to 30 GB	23.03 GB	2.4 hrs	28 mins	30 mins	1.8 hrs	23 mins	5.5 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