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

ICR 202107-0910-002

OMB: 0910-0511

Federal Form Document

ICR Details
0910-0511 202107-0910-002
Received in OIRA 201907-0910-009
Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet — Form FDA 3601 and Form 3601(a)
Revision of a currently approved collection   No
Regular 09/07/2021
  Requested Previously Approved
36 Months From Approved 08/31/2022
30,268 6,379
5,950 1,914
0 0

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

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

Not associated with rulemaking

  85 FR 35939 06/12/2020
86 FR 49542 09/03/2021

  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
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.

Amber Sanford 301 796-8867 [email protected]


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:
    (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;
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.

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