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View ICR - OIRA Conclusion

OMB Control No: 0910-0686	ICR Reference No: 202501-0910-004
Status: Active	Previous ICR Reference No: 202406-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Advertisements and Product Communications
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: 07/29/2025
	Date Received in OIRA: 01/07/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2028	36 Months From Approved	11/30/2026
Responses	204,599	0	240,444
Time Burden (Hours)	29,832,614	0	30,363,915
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	204,599	240,444	-35,845
Annual Time Burden (Hours)	29,832,614	30,363,915	-531,301
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: The information collection includes a program change pertaining to disclosure burden we attribute to agency guidance. Although we have included the disclosure activities within the collection element “IC recommended in FDA guidance” and accounted for attendant burden; we reduced the overall number of respondents from 1181 to 747 based on current information. This results in an overall decrease of 35,845 responses and 531,301 hours annually.

Annual Cost to Federal Government: $5,600,000

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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