View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0340	ICR Reference No: 202112-0910-002
Status: Historical Active	Previous ICR Reference No: 202011-0910-003
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: 12/20/2021
	Date Received in OIRA: 12/17/2021
Terms of Clearance: Approved with the understanding that, upon approval of this request, FDA will discontinue OMB control number 0910-0641.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	12/31/2022	12/31/2022
Responses	8,760	0	7,860
Time Burden (Hours)	98,495	0	94,895
Cost Burden (Dollars)	1,950,000	0	1,950,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	8,760	7,860	900
Annual Time Burden (Hours)	98,495	94,895	3,600
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: For efficiency of agency operations, we are requesting to consolidate two related information collections, OMB Control Nos. 0910-0641 and 0910-0340. Accordingly, we have adjusted the estimated burden in control number 0910-0340 by 900 responses and 3,600 hours annually to reflect this change. Upon approval of this request, we intend to discontinue the collection of information currently approved under OMB control number 0910-0641.

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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