View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0844	ICR Reference No: 201905-0910-006
Status: Historical Active	Previous ICR Reference No: 201707-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: De Novo Classification Process (Evaluation of Automatic Class III Designation)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/06/2019
	Date Received in OIRA: 07/11/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	09/30/2020
Responses	185	0	57
Time Burden (Hours)	10,730	0	7,330
Cost Burden (Dollars)	7,283	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	185	57	128
Annual Time Burden (Hours)	10,730	7,330	3,400
Annual Cost Burden (Dollars)	7,283	0	7,283

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 3,400 hours. We attribute this adjustment to the addition of the Acceptance Checklist and the Recommended Content Checklist and to an increase in the number of submissions we received during the approval period.

Annual Cost to Federal Government: $5,205,720

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? Uncollected

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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