Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)

Forms and Documents

Document Name	Status
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601) Form	Modified
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form	Modified
0511_Supporting Statement_2024.docx Supporting Statement A	2024-09-27

IC Document Collections

IC ID	Document Title	Status
6227	Medical Device User Fee Cover Sheet (Form FDA 3601) Form	Modified
268231	Notification of the intent to use an Accredited Person Other-AP Program	New
259088	Requests for Information under 513(g) of the FFDCA Other-Agency Guidance	Modified
258930	Request for Accreditation - Third Party Inspections Other-Statutory Authority	Unchanged
248796	Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form	Modified

ICR Details

OMB Control No: 0910-0511	ICR Reference No: 202401-0910-006
Status: Received in OIRA	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	Date Submitted to OIRA: 09/30/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2024
Responses	30,397	30,387
Time Burden (Hours)	7,596	7,446
Cost Burden (Dollars)	0	0

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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.

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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

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

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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

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Device Facility User Fee Cover Sheet (Form FDA 3601(a))	FDA 3601(a)	Device Facility User Fee
Medical Device User Fee Cover Sheet (Form FDA 3601)	FDA 3601	Medical Device User Fee Cover Sheet
Notification of the intent to use an Accredited Person
Request for Accreditation - Third Party Inspections
Requests for Information under 513(g) of the FFDCA

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	30,397	30,387	0	0	10	0
Annual Time Burden (Hours)	7,596	7,446	0	0	150	0
Annual Cost Burden (Dollars)	0	0	0	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.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/30/2024

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