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: 0925-0586	ICR Reference No: 200803-0925-002
Status: Historical Active	Previous ICR Reference No: 200402-0910-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
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: 03/10/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/10/2008
Terms of Clearance: Approved as amended by FDA in its revised supporting statement with appropriate changes to the burden accounting.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2011	36 Months From Approved
Responses	43,499	0	38,514
Time Burden (Hours)	200,839	0	177,165
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	43,499	38,514	745	4,240
Annual Time Burden (Hours)	200,839	177,165	4,172	19,502
Annual Cost Burden (Dollars)	0	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: We believe the previous burden estimate of 177,165 hours per year underestimated the burden. The new estimate of 196,668 hours per year more accurately reflects the burden. The addition of CMS's estimated burden hours has increased the total.