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View ICR - OIRA Conclusion

OMB Control No: 0910-0734	ICR Reference No: 201903-0910-022
Status: Historical Active	Previous ICR Reference No: 201601-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
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: 07/18/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2019
Responses	387	0	449
Time Burden (Hours)	1,620	0	1,880
Cost Burden (Dollars)	121,500	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	387	449	-62
Annual Time Burden (Hours)	1,620	1,880	-260
Annual Cost Burden (Dollars)	121,500	0	121,500

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: Based on a review of safety labeling notifications that were issued during calendar years 2016 and 2017 we have reduced the number of respondents to reflect fewer submissions. We attribute the adjustment to expected variability and note that it results in 62 fewer annual responses and 260 fewer annual burden hours. We have also uploaded costs that were previously reported, but not reflected at www.reginfo.gov.

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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