View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0340	ICR Reference No: 202412-0910-011
Status: Active	Previous ICR Reference No: 202212-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/24/2025
	Date Received in OIRA: 12/26/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2028	36 Months From Approved	02/28/2026
Responses	29,130	0	29,118
Time Burden (Hours)	134,268	0	134,124
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	29,130	29,118	12
Annual Time Burden (Hours)	134,268	134,124	144
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: Publication of ACNU final rule increases ICR by 144 hours and 12 disclosures annually.

Annual Cost to Federal Government: $1,001,407

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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