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View Generic ICR - OIRA Conclusion

OMB Control No: 0910-0876	ICR Reference No: 202510-0910-001
Status: Active	Previous ICR Reference No: 202203-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/14/2026
	Date Received in OIRA: 02/19/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved
Responses	12,468	0	0
Time Burden (Hours)	1,833	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	12,468	-27,000	39,468
Annual Time Burden (Hours)	1,833	-3,003	4,836
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Since our initial request for continued approval, we have reevaluated actual usage of individual clearance requests. We have reduced our estimate for the number of responses for "Self-Administered Surveys-Study Screener" from 30,000 to 7,500 responses (a drop of 1877.5 hours from 2,500 to 622.5 hours). We have also reduced our estimate for "Self-Administered Surveys" from 6,000 to 1,500 responses (a reduction of 1,125 hours from 1,500 to 375 hours). These estimates were made based on our past experience with conducting these collections of information. The total reduction, therefore, has been 27,000 responses and 3,002.5 hours.

Annual Cost to Federal Government: $900,000

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

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