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View ICR - OIRA Conclusion

OMB Control No: 0910-0885	ICR Reference No: 202104-0910-001
Status: Historical Active	Previous ICR Reference No: 202007-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Study of Oncology Indications in Direct-to-Consumer Television 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 with change	Conclusion Date: 05/18/2021
	Date Received in OIRA: 04/05/2021
Terms of Clearance: "Other" is not an approved race response category and must be removed as a response option.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023	02/28/2023
Responses	4,704	0	3,622
Time Burden (Hours)	657	0	641
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,704	3,622	1,082
Annual Time Burden (Hours)	657	641	16
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Based on cognitive interviews and pretesting, we made several revisions to the study materials and updated the burden chart to reflect the actual pretest burden and the revised estimated burden for the main studies.

Annual Cost to Federal Government: $652,824

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

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