View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0777	ICR Reference No: 201409-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/17/2014
	Date Received in OIRA: 09/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	36 Months From Approved
Responses	51	0	0
Time Burden (Hours)	226	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	51	51
Annual Time Burden (Hours)	226	226
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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