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View ICR - OIRA Conclusion

OMB Control No: 0910-0297	ICR Reference No: 202008-0910-002
Status: Historical Active	Previous ICR Reference No: 201902-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug User Fee Program
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/05/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/03/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	03/31/2022	03/31/2022
Responses	445	0	262
Time Burden (Hours)	2,761	0	131
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	445	262	183
Annual Time Burden (Hours)	2,761	131	2,630
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: We are consolidating related information collection activity pertaining to prescription drug user fees for efficiency of agency operations. Upon approval we plan to discontinue control no. 0910-0693.

Annual Cost to Federal Government: $14,934

Does this IC contain surveys, censuses, or employ statistical methods? No

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. No

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? No

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov