[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45359-45363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18647]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0785]
Medical Device User Fee Rates for Fiscal Year 2013
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Medical Device User Fee Amendments of 2012
(Title 2 of the Food and Drug Administration Safety and Innovation Act,
Public Law 112-144, which was signed by the President on July 9, 2012)
(MDUFA III), authorizes FDA to collect user fees for certain medical
device submissions, and annual fees both for certain periodic reports
and for establishments subject to registration. The FY 2013 fee rates
are provided in this document. These fees apply from October 1, 2012,
through September 30, 2013. 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 recognized by the U.S. Treasury. 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 document provides
information on how the fees for FY 2013 were determined, the payment
procedures you should follow, and how you may qualify for reduced small
business fees.
FOR FURTHER INFORMATION CONTACT: For information on Medical Device User
Fees: Visit FDA's Web site, http://www.fda.gov/mdufa.
For questions relating to this notice: David Miller, Office of
Financial Management (HFA-100), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-7103.
SUPPLEMENTARY INFORMATION:
I. Background
Section 738 of the FD&C Act (21 U.S.C 379j) establishes fees for
certain medical device applications, submissions, supplements, and
notices (for simplicity, this document refers to these collectively as
``submissions'' or ``applications''); 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).) Additionally, the Secretary may, at the Secretary's sole
discretion, grant a fee waiver or reduction if the Secretary finds that
such waiver or reduction is in the interest of public health. (See 21
U.S.C. 379j(f).)
Under the FD&C 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
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2013 through FY 2017; the
base fee for a premarket application received by FDA during FY 2013 is
$248,000. From this starting point, this document establishes FY 2013
fee rates for other types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
The FD&C Act specifies the base fee for establishment registration
for each year from FY 2013 through FY 2017; the registration fee for FY
2013 is $2,575. There is no reduction in the registration fee for small
businesses. Each establishment that is registered (or is required to
register) with the Secretary under section 510 of the FD&C Act (21
U.S.C. 360) because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a device is
required to pay the annual fee for establishment registration.
II. Fees for FY 2013
Under the FD&C 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).) For FY 2013, the standard
fee is the base fee; for FY 2014 through FY 2017, the base fee will be
adjusted as specified in the FD&C Act so for these fiscal years, the
standard fee will be the adjusted base fee. (See 21 U.S.C. 379j(b) and
(c).) The standard fee for a premarket application, including a BLA,
and for a premarket report and a BLA efficacy supplement, is $248,000
for FY 2013. (See 21 U.S.C. 379j(b).) The fees set by reference to the
standard fee for a premarket application are:
For a panel-track supplement, 75 percent of the standard
fee;
For a 180-day supplement, 15 percent of the standard fee;
For a real-time supplement, 7 percent of the standard fee;
For a 30-day notice, 1.6 percent of the standard fee;
For a 510(k) premarket notification, 2 percent of the
standard fee;
For a 513(g) request for classification information, 1.35
percent of the standard fee; and
For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard 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 for the
submission. (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 for the submission. (See 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C).)
The statute sets the annual fee for establishment registration at
$2,575 in FY 2013. There is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
Table 1 of this document set out the FY2013 rates for all medical
device fees.
[[Page 45360]]
Table 1--Medical Device Fees for FY 2013
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Standard fee, as a percent of
Application fee type the standard fee for a premarket FY 2013 FY 2013 small
application standard fee business fee
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Premarket application (a PMA submitted under Base Fee Adjusted as Specified $248,000 $62,000
section 515(c)(1) of the FD&C Act (21 U.S.C. in the Statute.
360e(c)(1)), a PDP submitted under section
515(f) of the FD&C Act (21 U.S.C. 360e(f)),
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%............................ 248,000 62,000
515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA under 100%............................ 248,000 62,000
section 351 of the PHS Act).
Panel-track supplement........................ 75%............................. 186,000 46,500
180-day supplement............................ 15%............................. 37,200 9,300
Real-time supplement.......................... 7%.............................. 17,360 4,340
510(k) premarket notification submission...... 2%.............................. 4,960 2,480
30-day notice................................. 1.6%............................ 3,968 1,984
513(g) (21 U.S.C. 360c(g)) request for 1.35%........................... 3,348 1,674
classification information.
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Annual Fee Type
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Annual fee for periodic reporting on a class 3.5%............................ 8,680 2,170
III device.
Annual establishment registration fee (to be Base Fee Adjusted as Specified 2,575 2,575
paid by the establishment engaged in the in the Statute.
manufacture, preparation, propagation,
compounding, or processing of a device, 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 (full) fee for that submission.
If your business qualified as a small business for FY 2012, your
status as a small business will expire at the close of business on
September 30, 2012. You must re-qualify for FY 2013 in order to pay
small business fees during FY 2013.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2013, you must submit the following to FDA:
1. A completed FY 2013 MDUFA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2013 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
http://www.fda.gov/mdufa. 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. The most recent tax year will be 2012,
except:
If you submit your FY 2013 MDUFA Small Business
Qualification before April 15, 2013, and you have not yet filed your
return for 2012, you may use tax year 2011.
If you submit your FY 2013 MDUFA Small Business
Qualification on or after April 15, 2013, and have not yet filed your
2012 return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
3. For each of your affiliates, either:
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
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. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. 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 must 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 of each affiliate, or that
the applicant has no affiliates.
If you are a foreign business, and wish to qualify as a small
business for FY 2013, you must submit the following:
1. A completed FY 2013 MDUFA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2013 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
http://www.fda.gov/mdufa. 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 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:
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 (2011 or later), or
If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing
[[Page 45361]]
Authority Certification completed by, and bearing the official seal of,
the National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. 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
for the gross receipts or sales collected. The applicant must 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 of each affiliate, or
that the applicant has no affiliates.
IV. Procedures for Paying Application Fees
If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2012, through September 30,
2013, you must pay the fee in effect for FY 2013. The later of the date
that the application is received in the reviewing center's document
room or the date the U.S. Treasury recognizes the payment determines
whether the fee rates for FY 2012 or FY 2013 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
FDA requests that you follow the steps below before submitting a
medical device application subject to a fee 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 (PIN) and Medical
Device User Fee Cover Sheet From FDA Before Submitting Either the
Application or the Payment
Log on to the MDUFA Web site at: http://www.fda.gov/mdufa, click on
``MDUFA FORMS'' at the left side of the page, and then under the MDUFA
Forms heading, click on the link ``Create MDUFA User Fee Cover Sheet.''
Complete the Medical Device User Fee cover sheet. Be sure you choose
the correct application submission date range. (Two choices will be
offered until October 1, 2012. One choice is for applications that will
be received on or before September 30, 2012, which will be subject to
FY 2012 fee rates. A second choice is for applications that will be
received on or after October 1, 2012, which will be subject to FY 2013
fee rates.) After completing data entry, print a copy of the Medical
Device User Fee cover sheet and note the unique PIN 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 PIN 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--Submit Payment for the Completed Medical Device User Fee
Cover Sheet as Described in This Section, Depending on the Method You
Will Use to Make Payment
1. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank
and made 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 PIN, from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet, on your check.
Mail the paper check and a copy of the completed 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 Federal Express
(FedEx), DHL, United Parcel Service (UPS), etc.), the courier may
deliver the check to: U.S. Bank, Attn: Government Lockbox 956733, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This address is for
courier delivery only. Contact the U.S. Bank at 314-418-4013 if you
have any questions concerning courier delivery.)
FDA records the official application receipt date as the later of
the following: (1) The date the application was received by FDA or (2)
the date the U.S. Treasury recognizes the payment. It is helpful if the
fee payment arrives at the bank at least 1 day before the application
arrives at FDA.
2. If Paying With Credit Card or Electronic Check (Automated
Clearing House (ACH)):
FDA has partnered with the U.S. Department of the Treasury to
utilize www.Pay.gov, a Web-based payment system, for online electronic
payment. You may make a payment via electronic check or credit card
after submitting your cover sheet. To pay online, select the ``Pay
Now'' button. Credit card transactions for cover sheets are limited to
$5,000.00.
3. If paying with a wire transfer:
Please include your application's unique PIN, from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet, in your wire transfer. Without the PIN your payment may not be
applied to your cover sheet and review of your application will be
delayed.
The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
cover sheet is fully paid.
Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Drive,
Rockville, MD 20850.
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:
1. Medical device applications should be submitted to: Food and
Drug Administration, Center for Devices and Radiological Health,
Document Mail Center, Bldg. 66, rm. 0609, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002.
2. 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 the Annual Fee for Periodic Reporting
As of FY 2011, you are no longer able to create a cover sheet and
obtain a PIN to pay the MDUFA Annual Fee for Periodic Reporting.
Instead, you will be invoiced at the end of the quarter in which your
PMA Periodic Report is due. Invoices will be sent based on the details
included on your PMA file; you are responsible to ensure your billing
information are kept up-to-date (you can
[[Page 45362]]
update your contact for the PMA by submitting an amendment).
1. If paying with a paper check:
All paper checks must be in U.S. currency from a U.S. bank and made
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 invoice number.
Mail the paper check and a copy of invoice 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: U.S. Bank, Attn:
Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier delivery only. Contact the U.S. Bank
at 314-418-4013 if you have any questions concerning courier delivery.)
2. If paying with a wire transfer:
Please include your invoice number in your wire transfer.
Without the invoice number, your payment may not be applied and you may
be referred to collections.
The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
invoice is fully paid.
Use the following account information when sending a wire transfer:
New York Federal Reserve Bank, U.S. Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD 20850.
VI. Procedures for Paying Annual Establishment Fees
In order to pay the annual establishment fee, firms must access the
Device Facility User Fee (DFUF) Web site at https://fdasfinapp8.fda.gov/OA_HTML/fdaCAcdLogin.jsp. (FDA has verified the
Web site address, but FDA is not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)
You will create a DFUF order and you will be issued a PIN once you
place your order. After payment has been processed, you will be issued
a payment confirmation number (PCN). You will not be able to register
your establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2013 until it has completed the steps below to
register and pay any applicable fee. (See 21 U.S.C. 379j(g)(2).)
Companies that do not manufacture any product other than a licensed
biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.
A. Step One--Submit a DFUF Order With a PIN From FDA Before Registering
or Submitting Payment
To submit a DFUF Order, you must create or have previously created
a user account and password for the User Fee Web site listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2013 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. Once you are satisfied that the data on the order is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.
B. Step Two--Pay for Your DFUF Order
Unless paying by credit card, all payments must be in U. S.
currency and drawn on a U.S. bank.
1. If paying by credit card or electronic check (ACH):
The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
2. If paying with a paper check:
If you prefer not to pay online, you may pay by a check, in U.S.
dollars and drawn on a U.S. bank, mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. (Note: This
address is different from the address for payments of application and
annual report fees and is to be used only for payment of annual
establishment registration fees.)
If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only; do not send mail to this
address.)
Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. A copy of your printed order should
also be mailed along with your check. FDA's tax identification number
is 53-0196965.
3. If paying with a wire transfer:
Wire transfers may also be used to pay annual establishment fees.
To send a wire transfer, please read and comply with the following
information:
Include your order's unique PIN, from the upper right-hand
corner of your completed Device Facility User Fee order, in your wire
transfer. Without the PIN your payment may not be applied to your
facility and your registration will be delayed.
The originating financial institution may charge a wire
transfer fee between $15 and $35. Please ask your financial institution
about the fee and include it with your payment to ensure that your
order is fully paid. Use the following account information when sending
a wire transfer: New York Federal Reserve Bank, U.S. Dept of Treasury,
TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099,
Routing No. 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard
Drive, Rockville, MD 20850.
C. Step Three--Complete the Information Online To Update Your
Establishment's Annual Registration for FY 2013, or To Register a New
Establishment for FY 2013
Go to the Center for Devices and Radiological Health's Web site at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm and click the
``Access Electronic Registration'' link on the left of the page. This
opens up a new page with important information about the FDA Unified
Registration and Listing System (FURLS). After reading this
information, click on the link (Access Electronic Registration) at the
bottom of the page. This link takes you to an FDA Industry Systems page
with tutorials that demonstrate how to create a new FURLS user account
if your establishment did not create an account in FY 2012.
Manufacturers of licensed biologics should register in the BER system
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm.
Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to
[[Page 45363]]
register and existing establishments will update their annual
registration using choices on the DRLM menu. Once you choose to
register or update your annual 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, email:
[email protected] or call 301-796-7400 for assistance. (Note: this
email address and this telephone number are for assistance with
establishment registration only, and not for any other aspects of
medical device user fees.) Problems with BERS should be directed to
[email protected] or call 301-827-3546.
D. Step Four--Enter Your DFUF Order PIN and PCN
After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18647 Filed 7-30-12; 8:45 a.m.]
BILLING CODE 4160-01-P