[Federal Register Volume 72, Number 197 (Friday, October 12, 2007)]
[Notices]
[Pages 58099-58102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5051]



[[Page 58099]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Medical Device User Fee Rates for Fiscal Year 2008

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing the fee 
rates and payment procedures for medical device user fees for fiscal 
year (FY) 2008. The Federal Food, Drug, and Cosmetic Act (the act), as 
amended by the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA), the Medical Device User Fee Stabilization Act of 2005 
(MDUFSA), and the Medical Device User Fee Amendments of 2007 (Title II 
of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), 
authorizes FDA to collect user fees for certain medical device 
submissions, and annual fees both for certain periodic reports and for 
certain establishments subject to registration. The FY 2008 fee rates 
are provided in this notice. These fees apply from October 1, 2007, 
through September 30, 2008. To avoid delay in the review of your 
application, you should pay the fee before or at the time you submit 
your application to FDA. The fee you must pay is the fee that is in 
effect on the later of the date that your application is received by 
FDA or the date your fee payment is received. If you want to pay a 
reduced small business fee, you must qualify as a small business before 
you make your submission to FDA; if you do not qualify as a small 
business before you make your submission to FDA, you will have to pay 
the higher standard fee. This notice provides information on how the 
fees for FY 2008 were determined, the payment procedures you should 
follow, and how you may qualify for reduced small business fees.

FOR FURTHER INFORMATION CONTACT:
    For further information on MDUFMA: Visit FDA's Web site, http://www.fda.gov/cdrh/mdufma.
    For questions relating to this notice: Yanming Chae, Office of 
Financial Management (HFA-120), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5042.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the act (21 U.S.C. 379j) establishes fees for 
certain medical device applications, submissions, supplements, and 
notices (for simplicity, this notice refers to these collectively as 
``submissions''); for periodic reporting on class III devices; and for 
the registration of certain establishments. Under statutorily defined 
conditions, a qualified applicant may receive a fee waiver or may pay a 
lower small business fee (see 21 U.S.C. 379j(d) and (e)).
    Under the act, the fee rate for each type of submission is set at a 
specified percentage of the standard fee for a premarket application (a 
premarket application is a premarket approval application (PMA), a 
product development protocol (PDP), or a biologics licensing 
application (BLA)). The act specifies the standard fee for a premarket 
application for each year from FY 2008 through FY 2012; the standard 
fee for a premarket application received by FDA during FY 2008 is 
$185,000. From this starting point, this notice establishes FY 2008 fee 
rates for other types of submissions, and for periodic reporting, by 
applying criteria specified in the act.
    The act specifies the annual fee for establishment registration for 
each year from FY 2008 through FY 2012; the registration fee for FY 
2008 is $1,706. There is no reduction in the registration fee for small 
businesses. An establishment must pay the annual registration fee if it 
is any of the following types of establishments:
     Manufacturer. An establishment that makes by any means any 
article that is a device, including an establishment that sterilizes or 
otherwise makes such article for or on behalf of a specification 
developer or any other person.
     Single-use device reprocessor. An establishment that 
performs manufacturing operations on a single-use device that has 
previously been used on a patient.
     Specification developer. An establishment that develops 
specifications for a device that is distributed under the 
establishment's name but which performs no manufacturing, including an 
establishment that, in addition to developing specifications, also 
arranges for the manufacturing of devices labeled with another 
establishment's name by a contract manufacturer.
    The fees for FY 2008 go into effect on October 1, 2007, and will 
remain in effect through September 30, 2008.

II. Fees for FY 2008

    Under the act, all submission fees and the periodic reporting fee 
are set as a percent of the standard (full) fee for a premarket 
application (see 21 U.S.C. 379j(a)(2)(A)), and the act sets the 
standard fee for a premarket application at $185,000 for FY 2008 (see 
21 U.S.C. 379j(b); this is referred to as the ``base fee''). The fees 
set by reference to the base (see 21 U.S.C. 379j(a)(2)(A)) fee are--
     For a panel-track supplement, 75 percent of the base fee;
     For a 180-day supplement, 15 percent of the base fee;
     For a real-time supplement, 7 percent of the base fee;
     For a 30-day notice, 1.6 percent of the base fee;
     For a 510(k) premarket notification, 1.84 percent of the 
base fee;
     For a 513(g) request for classification information, 1.35 
percent of the base fee; and
     For an annual fee for periodic reporting concerning a 
class III device, 3.5 percent of the base fee.
    For all submissions other than a 510(k) premarket notification, a 
30-day notice, and a 513(g) request for classification information, the 
small business fee is 25 percent of the standard (full) fee (see 21 
U.S.C. 379j(d)(2)(C)). For a 510(k) premarket notification submission, 
a 30-day notice, and a 513(g) request for classification information, 
the small business fee is 50 percent of the standard (full) fee (see 21 
U.S.C. 379j(e)(2)(C) and (d)(2)(C), respectively). There is no small 
business rate for annual establishment registration fee; all 
establishments pay the same fee. Table 1 of this document sets out the 
FY 2008 rates for all medical device fees.

                                    Table 1.--Medical Device Fees for FY 2008
----------------------------------------------------------------------------------------------------------------
                                               Standard Fee, as a Percent
                                                of the Standard Fee for a   FY 2008  Standard    FY 2008 Small
                                                  Premarket Application            Fee            Business Fee
----------------------------------------------------------------------------------------------------------------
Application Fee Type
----------------------------------------------------------------------------------------------------------------

[[Page 58100]]

 
Premarket application (a PMA submitted under           Set in statute                $185,000            $46,250
 section 515(c)(1) of the act (21 U.S.C.
 360e(c)(1)), a PDP submitted under section
 515(f) of the act, or a BLA submitted under
 section 351 of the Public Health Service
 (PHS) Act (42 U.S.C. 262))
----------------------------------------------------------------------------------------------------------------
Premarket report (submitted under section                        100%                $185,000            $46,250
 515(c)(2) of the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an approved BLA                          100%                $185,000            $46,250
 under section 351 of the PHS act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement                                            75%                $138,750            $34,688
----------------------------------------------------------------------------------------------------------------
180-day supplement                                                15%                 $27,750             $6,938
----------------------------------------------------------------------------------------------------------------
Real-time supplement                                               7%                 $12,950             $3,237
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification submission                            1.84%              $3,404             $1,702
----------------------------------------------------------------------------------------------------------------
30-day notice                                                       1.6%               $2,960             $1,480
----------------------------------------------------------------------------------------------------------------
513(g) request for classification                                   1.35%              $2,498             $1,249
 information
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class                        3.5%               $6,475             $1,619
 III device
----------------------------------------------------------------------------------------------------------------
Annual establishment registration fee (to be           Set in statute                  $1,706             $1,706
 paid by each establishment that is a
 manufacturer, a single-use device
 reprocessor, or a specification developer,
 as defined by 21 U.S.C. 379i(13))
----------------------------------------------------------------------------------------------------------------

III. How to Qualify as a Small Business for Purposes of Medical Device 
Fees

    If your business has gross receipts or sales of no more than $100 
million for the most-recent tax year, you may qualify for reduced small 
business fees. If your business has gross sales or receipts of no more 
than $30 million, you may also qualify for a waiver of the fee for your 
first premarket application (PMA, PDP, or BLA) or premarket report. You 
must include the gross receipts or sales of all of your affiliates 
along with your own gross receipts or sales when determining whether 
you meet the $100 million or $30 million threshold. If you want to pay 
the small business fee rate for a submission, or you want to receive a 
waiver of the fee for your first premarket application or premarket 
report, you should submit the materials showing you qualify as a small 
business 60 days before you send your submission to FDA. If you make a 
submission before FDA finds that you qualify as a small business, you 
must pay the standard fee for that submission.
    If your business qualified as a small business for FY 2007, your 
status as a small business will expire at the close of business on 
September 30, 2007. You must re-qualify for FY 2008 in order to pay 
fees at the small business rate during FY 2008.
    If you are a domestic (U.S.) business, and wish to qualify as a 
small business for FY 2008, you must submit the following to FDA:
    (1) A completed FY 2008 MDUFMA Small Business Qualification 
Certification (Form FDA 3602). This form is provided in FDA's guidance 
document ``FY 2008 Medical Device User Fee Small Business Qualification 
and Certification,'' available on FDA's Web site at http://www.fda.gov/cdrh/mdufma. This form is not available separate from the guidance 
document.
    (2) A certified copy of your Federal (U.S.) Income Tax Return for 
the most recent tax year (2006 or later).
    (3) For each of your affiliates, either--
    (A) If the affiliate is a domestic (U.S.) business, a certified 
copy of the affiliate's Federal (U.S.) Income Tax Return for the most 
recent tax year, or
    (B) If the affiliate is a foreign business and cannot submit a 
Federal (U.S.) Income Tax Return, a National Taxing Authority 
Certification completed by, and bearing the official seal of, the 
National Taxing Authority of the country in which the affiliate is 
headquartered. This certification must show the amount of gross 
receipts or sales for the most recent tax year, in both U.S. dollars 
and the local currency of the country, the exchange rate used in 
converting the local currency to U.S. dollars, and the dates of the 
gross receipts or sales collected. The applicant should also submit a 
statement signed by the head of the applicant's firm or by its chief 
financial officer that the applicant has submitted certifications for 
all of its affiliates, identifying the name(s) of each affiliate(s), or 
that the applicant has no affiliates. The National Taxing Authority is 
the foreign equivalent of the U.S. Internal Revenue Service.
    If you are a foreign business, and wish to qualify as a small 
business for FY 2008, you must submit the following:
    (1) A completed FY 2008 MDUFMA Foreign Small Business Qualification 
Certification (Form FDA 3602A). This form is provided in FDA's guidance 
document ``FY 2008 Medical Device User Fee Small Business Qualification 
and Certification,'' available on FDA's Web site at http://www.fda.gov/cdrh/mdufma. This form is not available separate from the guidance 
document.
    (2) A National Taxing Authority Certification, completed by, and 
bearing the official seal of, the National Taxing Authority of the 
country in which the firm is headquartered. This certification must 
show the amount of gross receipts or sales for the most recent tax 
year, in

[[Page 58101]]

both U.S. dollars and the local currency of the country, the exchange 
rate used in converting the local currency to U.S. dollars, and the 
dates of the gross receipts or sales collected.
    (3) For each of your affiliates, either--
    (A) If the affiliate is a domestic (U.S.) business, a certified 
copy of the affiliate's Federal (U.S.) Income Tax Return for the most 
recent tax year (2006 or later), or
    (B) If the affiliate is a foreign business and cannot submit a 
Federal (U.S.) Income Tax Return, a National Taxing Authority 
Certification completed by, and bearing the official seal of, the 
National Taxing Authority of the country in which the firm is 
headquartered. This certification must show the amount of gross 
receipts or sales for the most recent tax year, in both U.S. dollars 
and the local currency of the country, the exchange rate used in 
converting the local currency to U.S. dollars, and the dates of the 
gross receipts or sales collected. The applicant should also submit a 
statement signed by the head of the applicant's firm or by its chief 
financial officer that the applicant has submitted certifications for 
all of its affiliates, identifying the name(s) of each affiliate(s), or 
that the applicant has no affiliates. The National Taxing Authority is 
the foreign equivalent of the U.S. Internal Revenue Service.

IV. Procedures for Paying Application and Annual Report Fees

    If your application or submission is subject to a fee and is 
received by FDA from October 1, 2007, through September 30, 2008, you 
must pay the fee in effect for FY 2008. The later of the date that the 
application or annual report is received in the reviewing center's 
document room or the date that the check is received by US Bank 
determines whether the fee rates for FY 2007 or FY 2008 apply. FDA must 
receive the correct fee at the time that an application or annual 
report is submitted, or the application or annual report will not be 
accepted for filing or review.
    FDA requests that you follow the steps in this section before 
submitting a medical device application or annual report subject to a 
fee. Please pay close attention to these procedures to ensure that FDA 
links the fee with the correct application. (Note: In no case should 
the check for the fee be submitted to FDA with the application.)

A. Step One--Secure a Payment Identification Number and Medical Device 
User Fee Cover Sheet From FDA Before Submitting Either the Application 
or the Payment. Note: FY 2008 fee rates will be available on the Cover 
Sheet Web site beginning on the date of publication of this notice

    Log onto the MDUFMA Web site at http://www.fda.gov/oc/mdufma and, 
under the forms heading, click on the link ``User Fee Cover Sheet.'' 
Complete the Medical Device User Fee Cover Sheet. Be sure you choose 
the correct application submission date range. After completing data 
entry, print a copy of the Medical Device User Fee Cover Sheet and note 
the unique Payment Identification Number located in the upper right-
hand corner of the printed cover sheet.

B. Step Two--Electronically Transmit a Copy of the Printed Cover Sheet 
with the Payment Identification Number to FDA's Office of Financial 
Management

    Once you are satisfied that the data on the cover sheet is 
accurate, electronically transmit that data to FDA according to 
instructions on the screen. Because electronic transmission is 
possible, applicants are required to set up a user account and use 
passwords to assure data security in the creation and electronic 
submission of cover sheets.

C. Step Three--Mail Payment and a Copy of the Completed Medical Device 
User Fee Cover Sheet to the St. Louis Address Specified in This Section

     Make the payment in U.S. currency by check, bank draft, or 
U.S. Postal money order payable to the Food and Drug Administration. 
(FDA's tax identification number is 53-0196965, should your accounting 
department need this information.)
     Please write your application's unique Payment 
Identification Number, from the upper right-hand corner of your 
completed Medical Device User Fee Cover Sheet, on your check, bank 
draft, or U.S. Postal money order.
     Mail the payment and a copy of the completed Medical 
Device User Fee Cover Sheet to: Food and Drug Administration, P.O. Box 
956733, St. Louis, MO 63195-6733. (Please note that this address is for 
payments of application and annual report fees only and is not to be 
used for payment of annual establishment registration fees.)
    If you prefer to send a check by a courier (such as FEDEX, DHL, 
UPS, etc.), the courier may deliver the check to: US Bank, Attn: 
Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. 
(Note: This address is for courier delivery only. Contact the US Bank 
at 314-418-4821 if you have any questions concerning courier delivery.)
    It is helpful if the fee arrives at the bank at least 1 day before 
the application arrives at FDA. FDA records the official application 
receipt date as the later of the following:
     The date the application was received by FDA.
     The date US Bank receives the payment. US Bank is required 
to notify FDA within 1 working day, using the Payment Identification 
Number described previously.

D. Step Four--Submit Your Application to FDA with a Copy of the 
Completed Medical Device User Fee Cover Sheet

    Please submit your application and a copy of the completed Medical 
Device User Fee Cover Sheet to one of the following addresses:
     Medical device applications should be submitted to: Food 
and Drug Administration, Center for Devices and Radiological Health, 
Document Mail Center (HFZ-401), 9200 Corporate Blvd., Rockville, MD 
20850.
     Biologic applications should be sent to: Food and Drug 
Administration, Center for Biologics Evaluation and Research, Document 
Control Center (HFM-99), suite 200N, 1401 Rockville Pike, Rockville, MD 
20852-1448.

V. Procedures for Paying Annual Establishment Fees

    Procedures for paying annual establishment fees are different from 
the previously mentioned procedures for paying application, submission, 
and annual report fees. An establishment is not legally registered in 
FY 2008 until it has both completed the following steps to register and 
paid any fee that may be applicable (see 21 U.S.C. 379j(f)(2)).

A. Step One--Complete the Information Online to Update Your 
Establishment's Registration for FY 2008, or to Register a New 
Establishment for FY 2008

    Log onto CDRH's Web site at http://www.fda.gov/cdrh/reglistpage.html and follow the link from that page to the FDA Unified 
Registration and Listing System (FURLS). If you already have a 
registered medical device establishment, FDA has sent you a letter that 
contains your account ID and password for logging into FURLS. If you 
are an owner or operator registering for the first time, you will need 
to create a FURLS account. There are tutorials available from the 
FURLS/FDA Industry Systems homepage that demonstrate how to create 
FURLS user accounts.

[[Page 58102]]

    Once you obtain your account ID and password, you will enter them 
and log into FURLS. From the FURLS/FDA Industry Systems menu, there 
will be a button that you will click to go to the Device Registration 
and Listing Module (DRLM) of FURLS. New establishments will register 
their establishment and existing establishments will re-register their 
establishments using choices on the DRLM menu. Once you make your 
selection--either Register a Facility or Annual Re-registration--the 
system will prompt you through the entry of information about your 
establishment and your devices.
    If you have any problems with this process you may call 240-276-
0111 for assistance. (Note: This phone number is for assistance with 
establishment registration and establishment fee payment only, and not 
for any other aspects of medical device user fees.)

B. Step Two--Determine Whether an Annual Registration Fee is Required 
and Get Your Invoice if a Fee is Due

    After you enter your establishment registration information into 
the system, you will be informed whether or not the payment of an 
annual registration fee is required to complete your registration 
(these fees are only required for device manufacturers, single-use re-
processors, and specification developers as stated in section I of this 
document). If your establishment is subject to a fee, you will be given 
a summary sheet that: (1) Tells you what your payment options are and 
(2) leads you to a link for your specific invoice, which will be 
available on-line as a portable document format (PDF) file that you 
should print copies of; one to submit with your payment (if not 
submitted electronically) and the other to keep for your records.

C. Step Three--Pay Your Invoice, if Required

    Make the payment, if required, in U.S. currency. The summary page 
will include payment information that may permit you the option of 
paying electronically. If that option is provided, you may follow the 
instructions provided to make payment electronically. If that option is 
not provided, or you choose not to make your payment electronically, 
you may pay by check.
    Your check, made in U.S. dollars and drawn on a U.S. bank, can be 
mailed to: Food and Drug Administration, P.O. Box 70961, Charlotte, NC 
28272-0961. (Please note that this is different than the address for 
payments of application and annual report fees and is to be used only 
for payment of annual establishment registration fees.)
    If checks are to be sent by a courier that requests a street 
address, the courier can deliver the checks to: Wachovia Bank, Attn: 
Food and Drug Administration--Lockbox 70961, rm. NC0810, 1525 West WT 
Harris Blvd., Charlotte, NC 28262. (Note: This Wachovia Bank address is 
for courier delivery only; do not send mail to this address.)
    Please make sure that the FDA post office box number (P.O. Box 
70961) is written on the check, along with the invoice number printed 
on your invoice. A copy of your printed invoice should also be mailed 
in the same envelope with your check. FDA's tax identification number 
is 53-0196965.
    Wire transfers may also be used to pay annual establishment fees. 
The routing and transit number is 021030004 and the account number is 
75060099. The invoice number should also be included with any wire 
transfer information, to assure that the invoice is properly credited.
    FDA is in the process of implementing alternate Web-based payment 
methods, and the option of electronic payment may not be immediately 
available for FY 2008 payments. For more information on these payment 
options and when they will be available, please visit FDA's Web site at 
http://www.fda.gov, select the appropriate user fee type, and click on 
``User Fee Cover Sheet.''

    Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07-5051 Filed 10-9-07; 12:06 pm]
BILLING CODE 4160-01-S