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: 0910-0014	ICR Reference No: 201105-0910-011
Status: Historical Active	Previous ICR Reference No: 200905-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Investigational New Drug Regulations
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: 04/16/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/31/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. Following approval of this ICR, FDA will discontinue the following control numbers: 0910-0651 and 0910-0653. In the future, the agency should consider collapsing the ICs into categories (e.g., recordkeeping, reporting) and should provide meaningful titles to each IC in ROCIS to make the information provided to the public clearer. It is not appropriate to use only a provision number as a title for an IC. The agency is also reminded that failure to properly identify and explain the information contained in the ICR can be the basis for an improper submission. Regulatory citations must be correct in both the supporting statement and ROCIS and fully described in the supporting statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved	04/30/2012
Responses	2,685,772	0	2,744,640
Time Burden (Hours)	141,870,849	0	141,492,162
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	2,685,772	2,744,640	-41	-58,827
Annual Time Burden (Hours)	141,870,849	141,492,162	-940	379,627
Annual Cost Burden (Dollars)	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The hour changes for this ICR are the result of burden hours associated with new rulemaking that have been added to this extension. These new burden hours are indicated in the following "21 CFR sections" of Table 1: 312.2(e); 312.8; 312.10; 312.120; 312.310(b) & 312.305(b); 312.310(d); 312.315(c) & 312.305(b); and 312.320.