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View ICR - OIRA Conclusion

OMB Control No: 0910-0025	ICR Reference No: 202505-0910-012
Status: Active	Previous ICR Reference No: 202406-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Products Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/21/2026
	Date Received in OIRA: 02/27/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	05/31/2026
Responses	4,686,353	0	2,550,391
Time Burden (Hours)	786,423	0	404,602
Cost Burden (Dollars)	0	0	0

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Recordkeeping for Electronic Products
Reporting for Electronic Products	FDA 2579, 3646, FDA 3640, FDA 3645, FDA 3659, FDA 3644, FDA 3630, FDA 3626, FDA 3627, FDA 3639, FDA 3632, FDA 3660, FDA 3629, FDA 3663, FDA 3661, FDA 3801, FDA 3662, FDA 3628, FDA 3634, FDA 3638, FDA 3641, FDA 3643, FDA 3636, FDA 3631, FDA 3647, FDA 3649, FDA 2767, FDA 2877, FDA 3633, FDA 3635, FDA 3637, FDA 3642	, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,
Third party disclosure for Electronic Products

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,686,353	2,550,391	2,135,962
Annual Time Burden (Hours)	786,423	404,602	381,821
Annual Cost Burden (Dollars)	0	0	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: Our estimated burden for the information collection reflects an overall increase of 381,821 hours and a corresponding increase of 2,135,962 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Annual Cost to Federal Government: $4,381,146

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. No

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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