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View ICR - OIRA Conclusion

OMB Control No: 0910-0769	ICR Reference No: 202310-0910-001
Status: Active	Previous ICR Reference No: 202010-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Submission to CDRH Allegations of Regulatory Misconduct Associated with Medical Devices
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 with change	Conclusion Date: 11/14/2023
	Date Received in OIRA: 10/12/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2026	36 Months From Approved	11/30/2023
Responses	2,500	0	1,600
Time Burden (Hours)	625	0	400
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,500	1,600	900
Annual Time Burden (Hours)	625	400	225
Annual Cost Burden (Dollars)	0	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: We have increased our estimate of burden by 900 responses and 225 hours. We attribute the adjustment to improved efficiencies regarding the tracking of submissions.

Annual Cost to Federal Government: $1,190,244

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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