
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2866-2867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-790]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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

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 
February 18, 2010.

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 e-mailed 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 (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 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 (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

[[Page 2867]]

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 (PMAs) (PDP, PMR, and BLA),\1\ 3,625 premarket 
notifications, 8 modular premarket applications, 9 panel track 
supplements, 201 real-time supplements, 173 180-day supplements, 633 
30-day notices, 93 513(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 PMAs, 1 BLA efficacy supplement, 50 premarket 
notifications, 3 180-day supplements, 2 real-time supplements, 20 30-
day notices, 3 513(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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                     Activity                         FDA Form No.        No. of       Frequency  per    Total Annual      Hours per       Total Hours
                                                                       Respondents        Response        Responses         Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Device Manufacturers......................            3601            5,192                1            5,192            18/60            1,558
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the Federal Register of October 15, 2009 (74 FR 52965), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-790 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S


