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View Generic ICR - OIRA Conclusion

OMB Control No: 0910-0796	ICR Reference No: 201805-0910-001
Status: Historical Active	Previous ICR Reference No: 201411-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
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: 07/31/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/17/2018
Terms of Clearance: FDA will submit a mini-supporting statement for each individual Gen IC submission. The mini-supporting statement must describe the specific purpose of the collection, including the way that the resulting data will be used (i.e., identify the activity that the developmental work will inform, and broader purpose of the activity that is being informed by the developmental work being conducted in the particular Gen IC). When incentives are used, FDA will provide a justification.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2021	36 Months From Approved	07/31/2018
Responses	11,589	0	24,050
Time Burden (Hours)	9,293	0	29,059
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	11,589	24,050	-12,461
Annual Time Burden (Hours)	9,293	29,059	-19,766
Annual Cost Burden (Dollars)	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: FDA has updated the existing burden from 6,184 to an estimated 9,293 hours. This is based on our experience the last three years and forecasting the generics to be submitted during the next approval. Additionally, we have also updated the cost burden estimate and the cost to the Federal government based on current salary figures. FDA is also noting that the burden figures in ROCIS (24,050 responses and 29,059 hours) are incorrect. An error was made after approval and the updated burden was not entered into ROCIS. The burden should have been updated to 14,800 responses and 6,184 hours.

Annual Cost to Federal Government: $1,026,460

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov