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: 202111-0910-009
Status: Historical Active	Previous ICR Reference No: 201905-0910-006
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: 01/10/2022
	Date Received in OIRA: 12/02/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2025	36 Months From Approved	08/31/2022
Responses	73	0	185
Time Burden (Hours)	12,377	0	10,730
Cost Burden (Dollars)	5	0	7,283

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute
Annual Number of Responses	73	185	-112
Annual Time Burden (Hours)	12,377	10,730	1,647
Annual Cost Burden (Dollars)	5	7,283	-7,278

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: The information collection includes program changes and adjustments. Consistent with estimates found in our analysis of impacts for RIN 0910-AH53, we have increased our estimate of the total number of respondents since last OMB review and approval. Also, the burden we previously attributed to guidance instruction regarding De Novo classification requests and withdrawals, we now attribute to requirements found in agency regulations. However, in our estimated burden per response for a De Novo request, we continue to account for burden that may be associated with completion of the Acceptance Checklist. Finally, we have corrected an inadvertent error found in our proposed rulemaking. Cumulatively, these changes and adjustments result in an overall annual increase of burden by 1,647 hours and decrease of responses by 112.

Annual Cost to Federal Government: $5,626,100

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? No

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.