[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64713-64714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0247]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Medical Device User Fee Cover Sheet

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 
December 4, 2006.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 (the act), as amended by 
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250), 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, determine the amount of the fee required, 
and account for and track user fees. The form provides a cross-
reference of the fees submitted for an application with the actual 
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.
    According to the FDA database system, there are an estimated 4,600 
manufacturers of products subject to MDUFMA. However, not all 
manufacturers will have any cover sheet submissions in a given year and 
some may have multiple cover sheet submissions. The total number of 
annual responses is based on the number of coversheet submissions 
received by FDA in fiscal year (FY) 2005. CDRH received 4,436 annual 
responses that included the following: 43 premarket approval 
applications, 4,071 premarket notifications, 22 modular premarket 
applications, 1 product development protocol, 1 premarket report, 15 
panel track supplements, 174 real-time supplements, and 109 180-day 
supplements. CBER received 106 annual responses that included the 
following: 2 premarket approval applications, 16 biologics license 
applications, 84 premarket notifications, 1 modular premarket 
application, 2 180-day supplements, and 1 real-time supplement. The 
number of received

[[Page 64714]]

annual responses in FY 2005 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.
    In the Federal Register of June 29, 2006 (71 FR 37082), FDA 
published a 60-day notice soliciting comments on the proposed 
collection of information. In response to that notice, one comment was 
received regarding the MDUFMA cover sheet. FDA responded as follows 
``The current layout of the online form is to ensure information and 
questions presented on the Web site are easy to read for all users. 
When this system was constructed, the Food and Drug Administration was 
limited to the format and the layout of questions and answers. FDA took 
an already approved form and created an interactive system that 
determines the payments of requested applications based on the answers 
to the questions. The questions are sequential. After completing the 
first question, the system decides and chooses the next question for 
the customers. This Federal Register notice renews the current 
construction. Careful consideration during the next review will be 
given and FDA will certainly consider the commenter's suggestion of 
saving screen refresh time.''
    As noted previously, FDA will be glad to take under consideration 
the commenter's template and the ability to download the form, when the 
next update or review is initiated. You can, however, retrieve an 
existing cover sheet by logging into the system, and clicking on the 
name of the cover sheet. The retrieved form is a photo shot html 
format. Thus, no changes can be made directly onto the form. To print 
the cover sheet, please select ``Print Cover Sheet'' on the bottom of 
the form. Currently, the printed cover sheet contains all information 
on one page. Again, FDA will be glad to consider this request during 
the next review. The current cover sheet is designed to contain all 
information on one page. By creating more room on the left margin, the 
form may extend to two pages.
    Having instructions 1 through 6 on the cover sheet seems redundant. 
However, at the time, when creating the interactive system, FDA took 
into consideration that once a cover sheet is completed and ready to 
mail, all information would be displayed on the same page. Instructions 
1 through 6 are very important information for all customers to follow 
in order to expedite the application review process. The instructions 
printed on the cover sheet provide easy access for all customers to 
learn about them, especially for new users. FDA will continue to use 
the current form. For other questions regarding submitted cover sheets, 
please contact the User Fee Hotline at 301-827-9539, or e-mail the User 
Fee Financial Support Team at [email protected].
    The most likely respondents would be medical device manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                     Form FDA No.                          Respondents         per Response          Responses           Response         Total Hours
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3601                                                                4,600                     1              4,600               0.30              1,380
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Total                                                                                                                                              1,380
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18557 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S