[Federal Register: October 12, 2007 (Volume 72, Number 197)]
[Notices]
[Page 58099-58102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12oc07-62]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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Standard Fee, as a Percent
of the Standard Fee for a FY 2008 Standard FY 2008 Small
Premarket Application Fee Business Fee
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Application Fee Type
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[[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))
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Premarket report (submitted under section 100% $185,000 $46,250
515(c)(2) of the act)
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Efficacy supplement (to an approved BLA 100% $185,000 $46,250
under section 351 of the PHS act)
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Panel-track supplement 75% $138,750 $34,688
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180-day supplement 15% $27,750 $6,938
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Real-time supplement 7% $12,950 $3,237
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510(k) premarket notification submission 1.84% $3,404 $1,702
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30-day notice 1.6% $2,960 $1,480
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513(g) request for classification 1.35% $2,498 $1,249
information
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Annual Fee Type
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Annual fee for periodic reporting on a class 3.5% $6,475 $1,619
III device
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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))
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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