View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0340	ICR Reference No: 202011-0910-003
Status: Historical Active	Previous ICR Reference No: 201911-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Format and Content Requirements for Over-the-Counter Drug Product Labeling
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: 12/08/2020
	Date Received in OIRA: 12/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	12/31/2022	12/31/2022
Responses	7,860	0	7,859
Time Burden (Hours)	94,895	0	94,320
Cost Burden (Dollars)	1,950,000	0	1,950,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute
Annual Number of Responses	7,860	7,859	1
Annual Time Burden (Hours)	94,895	94,320	575
Annual Cost Burden (Dollars)	1,950,000	1,950,000	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 estimate an additional 575 burden hours to the information collection resulting from provisions under CARES pertaining to OTC drug user fees. Upon implementation of the program we intend to offer a more definitive estimate of the anticipated number of respondents.

Annual Cost to Federal Government: $0

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? Yes

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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