[Federal Register Volume 74, Number 198 (Thursday, October 15, 2009)]
[Notices]
[Pages 52965-52967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24825]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0483]


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.

[[Page 52966]]


DATES: Submit written or electronic comments on the collection of 
information by December 14, 2009.

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: Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 (the act), as amended by 
the Medical Device User Fee and Modernization Act of 2002 (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), 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 
(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 year (FY) 2008. CDRH 
received approximately 5,095 annual responses that included the 
following submissions: 16 premarket approval applications (PMA) (PMA, 
PDP, PMR, BLA),\1\ 3,625 premarket notifications, 8 modular premarket 
applications, 9 panel track supplements, 201 real-time supplements, 173 
one hundred eighty-day supplements, 633 thirty-day notices, ninety-
three 513(g) requests, and 337 annual fees for periodic reporting.
---------------------------------------------------------------------------

    \1\ PDP means product development protocol; PMR means 
postmarketing requirements; and BLA means biologics license 
applications.
---------------------------------------------------------------------------

    CBER received approximately 97 annual responses that included the 
following submissions: 2 premarket approval applications (PMA, PDP, 
PMR, BLA), 1 BLA efficacy supplement, 50 premarket notifications, 3 one 
hundred eighty-day supplements, 2 real-time supplements, 20 thirty-day 
notices, 3hree 513(g) requests, and 16 annual fees for periodic 
reporting.
    The number of received annual responses in FY 2008 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. FDA estimates the burden of this collection 
of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
   Form FDA No.       Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
3601                           5,192                  1              5,192                .30            1,557.6
----------------------------------------------------------------------------------------------------------------
Total Hours                                                                                              1,557.6
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 52967]]

    Dated: October 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24825 Filed 10-14-09; 8:45 am]
BILLING CODE 4160-01-S