Document ID: FDA-2012-N-0536-0006
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: 2016-04-11T04:00Z

[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Page 21356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08154]

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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) 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 May 11, 
2016.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 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 the 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 October 21, 2015 (80 FR 63793), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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.........................................           5,214                1            5,214   0.30 (18 minutes)....................           1,564
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08154 Filed 4-8-16; 8:45 am]
 BILLING CODE 4164-01-P