[Federal Register: November 3, 2006 (Volume 71, Number 213)]
[Notices]
[Page 64713-64714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no06-75]
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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 userfees@fda.gov.
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