View Information Collection Request (ICR) Package

OMB Control No: 0910-0511	ICR Reference No: 202401-0910-006
Status: Active	Previous ICR Reference No: 202303-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)
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: 03/27/2025
	Date Received in OIRA: 09/30/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2028	36 Months From Approved	03/31/2025
Responses	30,397	0	30,387
Time Burden (Hours)	7,596	0	7,446
Cost Burden (Dollars)	0	0	0

Abstract: This information collection implements FDA's Medical Device User Fee Program authorized under the Federal Food, Drug, and Cosmetic Act. Respondents to the information collection are sponsors of medical devices subject to the statutory and regulatory provisions governing these products.

Authorizing Statute(s): US Code: 21 USC 374
   PL: Pub.L. 107 - 250 201 Name of Law: Medical Device User Fee and Modernization Act
   PL: Pub.L. 110 - 85 201 Name of Law: Food and Drug Administration Amendments Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 14890	02/29/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 76851	09/19/2024
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	30,397	30,387	10
Annual Time Burden (Hours)	7,596	7,446	150
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: This information collection reflects adjustments. In our March 2023 change request submission, we erroneously excluded the information collection entitled, “Notification of the intent to use an Accredited Person”. We have included the information collection activity in this renewal. The information collection, therefore, reflects a cumulative increase in burden by 10 annual responses and 150 burden hours. Also in the change request, we moved the 513(g) guidance to this ICR. We subsequently, on August 23, 2024, issued technical/Level 2 updates to the guidance to reflect that 513(g) requests can be submitted using CDRH’s eSTAR voluntary guided submission preparation tool (noted above in section 3 of this supporting statement, and as noted in the approved March 2023 change request). We have provided the current guidance document, “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” with this request for approval.

Annual Cost to Federal Government: $8,369,328

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

View ICR - OIRA Conclusion