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View ICR - OIRA Conclusion

OMB Control No: 0910-0191	ICR Reference No: 202305-0910-007
Status: Historical Active	Previous ICR Reference No: 202005-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Administrative Practices and Procedures; Formal Hearings
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2023
	Date Received in OIRA: 06/30/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	07/31/2023
Responses	4,215	0	1,096
Time Burden (Hours)	6,360	0	9,720
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,215	1,096	3,119
Annual Time Burden (Hours)	6,360	9,720	-3,360
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: The information collection reflects nominal adjustments to individual activities that correspond to the applicable provisions. We have also added 3,900 responses and 663 hours, annually, to reflect burden we believe is associated with requests to FDA for speaker participation at an external agency events. As a result of these adjustments, the information collection reflects an annual increase in responses of 3,119 and an annual decrease in hours of 3,360.

Annual Cost to Federal Government: $469,972

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. 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? No

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

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