Document ID: FDA-2012-N-0536-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device User Fee Cover Sheet
Posted Date: 2012-06-06T04:00Z

[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Notices]
[Pages 33469-33470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13666]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on Form FDA 3601, entitled 
``Medical Device User Fee Cover Sheet,'' which must be submitted along 
with certain medical device product applications, supplements, and fee 
payment of those applications.

DATES: Submit either electronic or written comments on the collection 
of information by August 6, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

[[Page 33470]]

tracking system. The information collected is used by FDA's Center for 
Devices and Radiological Health (CDRH) and the Center for Biologics 
Evaluation and Research (CBER) 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 (PMA, 
PDP, PMR, BLA),\1\ 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).
---------------------------------------------------------------------------

    \1\ PMA means premarket approval application, PDP means product 
development protocol, PMR means postmarketing requirements, and BLA 
means biologics license applications.
---------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         FDA Form Number             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
3601............................           5,214               1           5,214             .30           1,564
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13666 Filed 6-5-12; 8:45 am]
BILLING CODE 4160-01-P