
[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8543-8544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02613]


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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 March 
8, 2013.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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 (MDUFMA) (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 number of 
cover sheet submissions received by FDA in fiscal years 2009 through 
2011. FDA received cover sheets for the following medical device 
submissions (average annual): 38 premarket approval applications 
(premarket approval application (PMA), product development protocol 
(PDP), postmarketng requirement (PMR), biologics license application 
(BLA)), 3,561 premarket notifications, 12 panel track supplements, 180 
real-time supplements, 127 180-day supplements, 749 30-day notices, 84 
513(g) requests, and 463 annual fees for periodic reporting. The number 
of received annual responses included the 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 June 6, 2012 (77 FR 33469), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one PRA related comment.
    The comment states that the cover sheet ``can be obtained prior to 
payment of the fee and should not be available until payment of the fee 
has been confirmed.'' It is unclear whether the comment addresses the 
topics on which the 60-day notice invited comment. As stated earlier in 
this document, the 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

[[Page 8544]]

account for and track user fees. MDUFMA requires the submission of the 
user fees concurrently with applications (21 U.S.C. 379j(a)(2)(C)). If 
the required fees are not submitted, the review of the application will 
not begin. The User Fee Cover Sheet provides the information necessary 
to either initiate or defer the application review.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
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                                                      No. of                          Average
          Form FDA No.                No. of       Responses per   Total Annual     Burden per      Total Hours
                                    Respondents     Respondent       Responses       Response
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3601............................           5,214               1           5,214            0.30           1,564
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    Dated: February 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02613 Filed 2-5-13; 8:45 am]
BILLING CODE 4160-01-P


