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: 201503-0910-002
Status: Historical Active	Previous ICR Reference No: 201105-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
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 with change	Conclusion Date: 02/23/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/11/2015
Terms of Clearance: In this submission, FDA significantly reorganized the way estimates are provided. OMB welcomes public input on this or future submissions with respect to the accuracy and helpfulness of this reorganization.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved	02/29/2016
Responses	160,927	0	2,685,772
Time Burden (Hours)	22,800,811	0	141,870,849
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	160,927	2,685,772	-343,360	-2,181,485
Annual Time Burden (Hours)	22,800,811	141,870,849	-23,140,841	-95,929,197
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This ICR contains significant estimate adjustments due to agency discretion. The CDER 2015 total hours is 22,800,811. The CDER 2011 total hours is 141,870,849. Overall, there is a cumulative decrease of 119,070,038 burden hours. The reason for these large estimate adjustments is because the data used for the 2015 extension was generated by CDER's Office of Strategic Programs using their Document Archiving, Reporting & Regulatory Tracking System (DARRTS). This system was not availabile to us for 2011 request for extension and therefore we relied on data estimates derived from the IND Review Divisions. Going forward, we plan to use the same DARRTS tracking system for future extensions so that there will be more consistency. In addition, we plan to use the data from this extension as the baseline for new data, and any fluctuations will be investigated and revised to ensure consistency. Details on the two largest decreases are as follows: The largest decrease may be found within the CDER program in administering 21 CFR 312.55 (sponsor reports to investigators on new observations, especially adverse reactions and safe use) reflecting a drop in burden hours from [109,027,680] in 2011 to [99,216] in 2015, a difference of [108,928,464]; and a corresponding drop in respondents from [985] to [590], a difference of [395] (approximately a 40% drop). The next largest reduction can be found in the annual recordkeeping estimate for CDER where, under 21 CFR 312.62(a) (disposition of drug) and (b) (case histories), the number of recordkeepers dropped collectively by over 90 percent, resulting in a decrease of 9,837,244 burden hours. Finally, we have revised the IC list found at www.reginfo.gov by consolidating the previously itemized regulatory provisions by their corresponding subpart in the CFR. We believe this will assist the reader by more easily identifying the summary of fluctuations for this collection. Readers may still view burden associated with individual provisions by referring to the tables found in tiem 12.: "Estimates of Annualized Burden Hours and Costs" found in this document.