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: 200307-0910-005
Status: Historical Active	Previous ICR Reference No: 200004-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Electronic Records; Electronic Signatures
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/04/2003
	Date Received in OIRA: 07/25/2003
Terms of Clearance: This collection is approved for 18 months. In the next submission for OMB approval, FDA will report on the progress of revising Part 11 requirements to reduce burden.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2005	07/31/2005	10/31/2003
Responses	4,500	0	4,500
Time Burden (Hours)	270,000	0	270,000
Cost Burden (Dollars)	0	0	0

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