View Information Collection Request (ICR) Package

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View Generic ICR - OIRA Conclusion

OMB Control No: 0910-0847	ICR Reference No: 202602-0910-002
Status: Active	Previous ICR Reference No: 202311-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
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: 05/21/2026
	Date Received in OIRA: 02/20/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	05/31/2026
Responses	126,770	0	109,470
Time Burden (Hours)	31,693	0	27,368
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	126,770	109,470	17,300
Annual Time Burden (Hours)	31,693	27,368	4,325
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: Our estimated burden for the information collection reflects an overall increase of 4,325 hours based on a corresponding increase of 17,300 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Annual Cost to Federal Government: $2,520,970

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? No

Agency Contact: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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