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	New
0511_Supporting Statement_2021.docx Supporting Statement A	2021-08-16

IC Document Collections

IC ID	Document Title	Status
6227	Medical Device User Fee Cover Sheet (Form FDA 3601) Form	Modified
248796	Device Facility User Fee Cover Sheet (Form FDA 3601(a)) Form	New

ICR Details

OMB Control No: 0910-0511	ICR Reference No: 202107-0910-002
Status: Received in OIRA	Previous ICR Reference No: 201907-0910-009
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: 09/07/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2022
Responses	30,268	6,379
Time Burden (Hours)	5,950	1,914
Cost Burden (Dollars)	0	0

---

Abstract: The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the "Medical Device User Fee Cover Sheet", is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. Form FDA 3601(a), the “Device Facility User Fee Cover Sheet,” is designed to collect payments for the annual establishment registration fee for medical device establishments

---

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

---

Number of Information Collection (IC) in this ICR: 2

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

---

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	30,268	6,379	0	0	23,889	0
Annual Time Burden (Hours)	5,950	1,914	0	0	4,036	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 changes and adjustments. By revising the collection to include Form FDA 3601(a), Device Facility User Fee Cover Sheet, and adjustment to the number of respondents for Form FDA 3601, there is an increase of 4,036 hours and a corresponding increase of 23,889 responses.

---

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

---

Common Form ICR:  No

---

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: 09/07/2021

---