View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0645	ICR Reference No: 201810-0910-001
Status: Historical Active	Previous ICR Reference No: 201602-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
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: 10/22/2018
	Date Received in OIRA: 10/19/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	05/31/2019	05/31/2019
Responses	1,867,657	0	1,867,657
Time Burden (Hours)	1,120,849	0	1,120,849
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,867,657	1,867,657
Annual Time Burden (Hours)	1,120,849	1,120,849
Annual Cost Burden (Dollars)	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: Burden changes reflect fluctuations in adverse event reporting and new electronic reporting features. These changes are discussed more fully in the agency's supporting statement.

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. 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

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.