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View ICR - OIRA Conclusion

OMB Control No: 0910-0872	ICR Reference No: 202204-0910-010
Status: Historical Active	Previous ICR Reference No: 201908-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER/OPDP
Title: Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
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: 05/18/2022
	Date Received in OIRA: 04/08/2022
Terms of Clearance: Any updates made to the collection as a result of the pretest(s) will need to be submitted for review prior to fielding the main study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2025	36 Months From Approved
Responses	25,410	0	0
Time Burden (Hours)	2,335	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	25,410	22,354	3,056
Annual Time Burden (Hours)	2,335	1,932	403
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: Although the proposed study does not duplicate, it builds upon previous research conducted under this control number and we are therefore submitting our request as a reinstatement with change. We explain this more fully in our justification at Question 1 of our Supporting Statement Part A.

Annual Cost to Federal Government: $270,000

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. 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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