View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0833	ICR Reference No: 202211-0910-001
Status: Active	Previous ICR Reference No: 202005-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Food and Drug Administration Advisory Committee 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 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	760	0	445
Time Burden (Hours)	190	0	112
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	760	445	315
Annual Time Burden (Hours)	190	112	78
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 have made adjustments to the information collection to reflect a decrease in membership nominations and an increase in submissions of updated information. Our estimated burden for the information collections reflects an increase of 78 total burden hours and a corresponding increase of 315 total annual responses.

Annual Cost to Federal Government: $13,417

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

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