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: 0910-0530	ICR Reference No: 200702-0910-001
Status: Historical Active	Previous ICR Reference No: 200311-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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: 05/15/2007
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/08/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved	05/31/2007
Responses	14,714	0	9,200
Time Burden (Hours)	3,680	0	52,344
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	14,714	9,200	5,514
Annual Time Burden (Hours)	3,680	52,344	-48,664
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The changes in burden from the final rule are the result of more recent data submissions, and the elimination of one-time costs in the Paperwork Reduction Act section of the final rule.