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View ICR - OIRA Conclusion

OMB Control No: 0910-0340	ICR Reference No: 201911-0910-009
Status: Historical Active	Previous ICR Reference No: 201612-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Format and Content Requirements for Over-the-Counter Drug Product Labeling
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/31/2019
	Date Received in OIRA: 12/05/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved	01/31/2020
Responses	7,859	0	961
Time Burden (Hours)	94,320	0	11,523
Cost Burden (Dollars)	1,950,000	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	7,859	961	6,898
Annual Time Burden (Hours)	94,320	11,523	82,797
Annual Cost Burden (Dollars)	1,950,000	0	1,950,000

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: The information collection reflects adjustments. We have adjusted our estimate to reflect an increase of 82,797 hours and a corresponding increase of 6,898 disclosures. The increase corresponds with agency data on the number of labeling reviews associated with new OTC drug product submissions. We discuss this more fully in our supporting statement at question 15.

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? Uncollected

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

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