Document ID: FDA-2012-N-0536-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
Posted Date: 2019-07-17T04:00Z

[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34189-34190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15161]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0536]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device User 
Fee Cover Sheet, Form FDA 3601

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
16, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0511. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device User Fee Cover Sheet, Form FDA 3601

OMB Control Number 0910-0511--Extension

    The Federal Food, Drug, and Cosmetic Act, as amended by the Medical 
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and 
the Medical Device User Fee Amendments of 2007 (Title II of the Food 
and Drug Administration Amendments Act of 2007), 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

[[Page 34190]]

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. The form provides a cross-reference 
between the fees submitted for an application with the actual submitted 
application by using a unique number tracking system. The information 
collected is used by FDA's Center for Devices and Radiological Health 
and FDA's Center for Biologics Evaluation and Research to initiate the 
administrative screening of new medical device applications and 
supplemental applications.
    The total number of annual responses is based on the average number 
of cover sheet submissions received by FDA in recent years. The number 
of received annual responses includes cover sheets for applications 
that were qualified for small businesses and fee waivers or reductions. 
The estimated hours per response are based on past FDA experience with 
the various cover sheet submissions, and range from 5 to 30 minutes. 
The hours per response are based on the average of these estimates (18 
minutes).
    In the Federal Register of December 28, 2018 (83 FR 67287), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received.
    The comment was generally supportive of the user fee cover sheet 
for medical devices. However, the comment also noted that there are 
costs associated with the preparation of the cover sheet. The comment 
did not suggest specific changes to our cost or hour burden estimates 
provided in this information collection request. We have not changed 
our estimates as a result of the comment.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                              Number of
              FDA Form No.                   Number of      responses per     Total annual           Average burden per response           Total hours
                                            respondents       respondent       responses
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3601....................................            6,379                1            6,379  0.30 (18 minutes).........................            1,914
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase of 350 hours and a corresponding increase of 1,165 
responses/records. We attribute this adjustment to an increase in the 
number of submissions we received over the last few years.

    Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15161 Filed 7-16-19; 8:45 am]
 BILLING CODE 4164-01-P