View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0645	ICR Reference No: 202109-0910-006
Status: Historical Active	Previous ICR Reference No: 202005-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: FDA Adverse Event and Products Experience Reports; Electronic Submissions
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: 10/07/2021
	Date Received in OIRA: 09/14/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2022	06/30/2022	06/30/2022
Responses	3,013,420	0	3,013,420
Time Burden (Hours)	1,809,396	0	1,809,396
Cost Burden (Dollars)	141,386,203	0	141,386,203

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	3,013,420	3,013,420
Annual Time Burden (Hours)	1,809,396	1,809,396
Annual Cost Burden (Dollars)	141,386,203	141,386,203

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: Our estimated burden for the information collection reflects an overall increase of 688,547 hours and a corresponding increase of 1,145,763 responses. The majority of these adjustments is attributed to the shift in mandatory reports associated with medical devices (mandatory reports via the ESG), which had previously been counted under OMB Control 0910-0291.

Annual Cost to Federal Government: $35,485,483

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. Yes

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

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