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: 0910-0844	ICR Reference No: 201904-0910-011
Status: Historical Inactive	Previous ICR Reference No: 201707-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device De Novo Classification Process
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 04/29/2019
	Date Received in OIRA: 04/17/2019
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

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

Annual Cost to Federal Government: $5,406,100

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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