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: 0910-0303	ICR Reference No: 201107-0910-009
Status: Historical Active	Previous ICR Reference No: 200807-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Electronic Records: Electronic Signatures
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/31/2011
	Date Received in OIRA: 07/19/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2014	36 Months From Approved	10/31/2011
Responses	4,500	0	4,500
Time Burden (Hours)	284,500	0	270,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,500	4,500	0
Annual Time Burden (Hours)	284,500	270,000	14,500
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The burden for this collection of information is expected to increase by 4,500 reporting hours, and 10,000 recordkeeping hours, due to the addition of certification reporting under section 11.100 and an expected increase in the number of recordkeepers (250) for closed and open systems under sections 11.10 and 11.30. This is a total increase of 14,500 burden hours. These additions to burden were based on the actual number of certifications received and consultations among FDA staff familiar with the types of SOPs needed to meet the requirements of this collection.

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.