View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0844	ICR Reference No: 202404-0910-004
Status: Active	Previous ICR Reference No: 202111-0910-009
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 with change	Conclusion Date: 04/07/2025
	Date Received in OIRA: 01/03/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2028	36 Months From Approved	04/30/2025
Responses	84	0	73
Time Burden (Hours)	14,379	0	12,377
Cost Burden (Dollars)	5	0	5

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	84	73	11
Annual Time Burden (Hours)	14,379	12,377	2,002
Annual Cost Burden (Dollars)	5	5	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 provided the guidance document, “Electronic Submission Template for Medical Device De Novo Requests” with this request for approval. Given that all submissions were previously received electronically and the ability to voluntarily submit De Novo requests using eSTAR was included in the previous ICR, inclusion of the guidance in this ICR is not expected to impact the estimated burden. Our estimated burden for the information collection reflects an overall increase of 2,002 hours and a corresponding increase of 11 responses. We attribute this adjustment to an increase in the number of submissions received annually.

Annual Cost to Federal Government: $6,974,440

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

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