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View ICR - OIRA Conclusion

OMB Control No: 0910-0754	ICR Reference No: 202212-0910-003
Status: Active	Previous ICR Reference No: 201911-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Mailing of Important Information About Drugs
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: 01/23/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/19/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2026	36 Months From Approved	01/31/2023
Responses	8	0	13
Time Burden (Hours)	800	0	1,300
Cost Burden (Dollars)	0	0	159,094

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	8	13	-5
Annual Time Burden (Hours)	800	1,300	-500
Annual Cost Burden (Dollars)	0	159,094	-159,094

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 adjustment. We have edited the title to align with the applicable regulation. We have reduced the number of respondents to 6, which results in a decrease of 5 responses and 500 hours annually. Although we include cost information at 12b of our supporting statement, we omit this data from the summary of burden table in accordance with User Guide instruction.

Annual Cost to Federal Government: $36,000

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? No

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