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View ICR - OIRA Conclusion

OMB Control No: 0910-0073	ICR Reference No: 202401-0910-008
Status: Active	Previous ICR Reference No: 202212-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Quality System Regulation Amendments: FINAL RULE
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: 08/27/2024
	Date Received in OIRA: 03/20/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2027	36 Months From Approved	01/31/2026
Responses	87,252	0	382,512
Time Burden (Hours)	10,304,731	0	10,239,552
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	87,252	382,512	-295,260
Annual Time Burden (Hours)	10,304,731	10,239,552	65,179
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: Upon implementation of the final rule, we expect the information collection to reflect a decrease of 295,260 responses and an increase of 65,179 hours annually.

Annual Cost to Federal Government: $3,400,000

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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