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View ICR - OIRA Conclusion

OMB Control No: 0910-0929	ICR Reference No: 202411-0910-006
Status: Historical Active	Previous ICR Reference No: 202311-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
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: 01/16/2025
	Date Received in OIRA: 12/02/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2027	06/30/2027	06/30/2027
Responses	4,493	0	2,993
Time Burden (Hours)	1,250	0	1,094
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,493	2,993	1,500
Annual Time Burden (Hours)	1,250	1,094	156
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 anticipated 1,100 participants would respond to the survey from our initial recruitment of 2,993 individuals. However, the response rate was lower than expected due to declining survey response rates seen across Federal surveys, resulting in 480 survey responses. The purpose of this change is to increase the number of respondents to get closer to the previously estimated survey response and therefore increase the power to detect differences among subgroups. We request an additional recruitment of 1,500 individuals, with the intent to yield an additional 214 completed surveys and allow us to detect differences of 14.4 percentage points. Based on the initial recruitment, we are assuming a 15 percent response rate and a 5 percent postage non-deliverable rate for the additional sample.

Annual Cost to Federal Government: $520,000

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. 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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