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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3601 Medical Device User Fee Cover Sheet	Form	Unchanged	Available
Form FDA 3601 Medical Device User Fee Cover Sheet (Form FDA 3601)	Form	Unchanged	Available
Form FDA 3601(a) Device Facility User Fee	Form	Unchanged	Available
Form FDA 3601(a) Device Facility User Fee Cover Sheet (Form FDA 3601(a))	Form	Unchanged	Repair queued
0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-12	Available
0511 MDUFA Program to add APs formerly under 0510 83C MARCH 2023.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-03-12	Repair queued
0511_Supporting Statement_2021.docx	Supporting Statement A	Uploaded 2021-08-16	Available
0511_Supporting Statement_2021.docx	Supporting Statement A	Uploaded 2021-08-16	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6227	Medical Device User Fee Cover Sheet (Form FDA 3601)	Form	Unchanged	Medical Device User Fee Cover Sheet
6227	Medical Device User Fee Cover Sheet (Form FDA 3601)	Form	Unchanged
259088	Requests for Information under 513(g) of the FFDCA	Other-Agency Guidance	New
258930	Request for Accreditation - Third Party Inspections	Other-Statutory Authority	New
248796	Device Facility User Fee Cover Sheet (Form FDA 3601(a))	Form	Unchanged	Device Facility User Fee
248796	Device Facility User Fee Cover Sheet (Form FDA 3601(a))	Form	Unchanged

ICR Details

OMB Control No: 0910-0511	ICR Reference No: 202303-0910-002
Status: Historical Active	Previous ICR Reference No: 202107-0910-002
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/23/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/13/2023
Terms of Clearance: Approved with the understanding that FDA will discontinue control numbers: 0910-0886 and 0910-0705.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2024	10/31/2024	10/31/2024
Responses	30,387	0	30,268
Time Burden (Hours)	7,446	0	5,950
Cost Burden (Dollars)	0	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:
	85 FR 35939	06/12/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 49542	09/03/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

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
Request for Accreditation - Third Party Inspections
Requests for Information under 513(g) of the FFDCA

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	30,387	30,268	0	0	119	0
Annual Time Burden (Hours)	7,446	5,950	0	0	1,496	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: For operational efficiency we are requesting to account for similar activities within the information collection elements. Burden is attributable to recommendations found in agency guidance.

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Annual Cost to Federal Government: $5,766,054

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: 03/13/2023

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