Medical Device User Fee Rates for Fiscal Year 2013, 45359-45363 [2012-18647]
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Federal Register / Vol. 77, No. 147 / Tuesday, July 31, 2012 / Notices
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–18603 Filed 7–30–12; 8:45 am]
BILLING CODE 4160–01–P
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.
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
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SUMMARY:
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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,
https://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,
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45359
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.
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Federal Register / Vol. 77, No. 147 / Tuesday, July 31, 2012 / Notices
TABLE 1—MEDICAL DEVICE FEES FOR FY 2013
Standard fee, as a percent of the
standard fee for a premarket
application
Application fee type
Premarket application (a PMA submitted under section 515(c)(1) of the
FD&C Act (21 U.S.C. 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 515(c)(2) of the FD&C Act) ..
Efficacy supplement (to an approved BLA under section 351 of the PHS
Act).
Panel-track supplement .............................................................................
180-day supplement ..................................................................................
Real-time supplement ................................................................................
510(k) premarket notification submission ..................................................
30-day notice .............................................................................................
513(g) (21 U.S.C. 360c(g)) request for classification information .............
FY 2013
standard fee
FY 2013 small
business fee
Base Fee Adjusted as Specified in
the Statute.
$248,000
$62,000
100% ...............................................
100% ...............................................
248,000
248,000
62,000
62,000
75% .................................................
15% .................................................
7% ...................................................
2% ...................................................
1.6% ................................................
1.35% ..............................................
186,000
37,200
17,360
4,960
3,968
3,348
46,500
9,300
4,340
2,480
1,984
1,674
8,680
2,575
2,170
2,575
Annual Fee Type
Annual fee for periodic reporting on a class III device .............................
Annual establishment registration fee (to be paid by the establishment
engaged in the 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
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3.5% ................................................
Base Fee Adjusted as Specified in
the Statute.
document, ‘‘FY 2013 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://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
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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 https://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
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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.
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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:
https://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,
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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)):
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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
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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
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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 righthand 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)
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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 https://
www.fda.gov/MedicalDevices/Device
RegulationandGuidance/HowtoMarket
YourDevice/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 https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/Establishment
Registration/BloodEstablishment
Registration/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
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45363
Federal Register / Vol. 77, No. 147 / Tuesday, July 31, 2012 / Notices
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: reglist@cdrh.fda.gov 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 bloodregis@fda.hhs.gov 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
Proposed Project: Maternal and Child
Health Bureau Performance Measures
for Discretionary Grants (OMB No.
0915–0298)—[Revision]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Number of
respondents
Form
Responses
per
respondent
The Health Resources and Services
Administration’s (HRSA) Maternal and
Child Health Bureau (MCHB) intends to
continue to collect performance data for
Special Projects of Regional and
National Significance (SPRANS),
Community Integrated Service Systems
(CISS), and other grant programs
administered by MCHB.
HRSA’s MCHB proposes to continue
using reporting requirements for
SPRANS projects, CISS projects, and
other grant programs administered by
MCHB, including national performance
measures, previously approved by OMB,
and in accordance with the
‘‘Government Performance and Results
Act (GPRA) of 1993’’ (Pub. L. 103–62).
This Act requires the establishment of
measurable goals for Federal Programs
that can be reported as part of the
budgetary process, thus linking funding
decisions with performance.
Performance measures for MCHB
discretionary grants were initially
approved in January 2003. Approval
from OMB is being sought to continue
the use of these measures. Some of these
measures are specific to certain types of
programs and will not apply to all
grantees. Through the experience of
utilizing these measures, we are
enhancing them to better reflect
program goals. Specifically, additional
outcome measures that can be utilized
by grantees that predominantly provide
infrastructure services are being
developed for submission to OMB.
The estimated response burden is as
follows:
Total
responses
Burden hours
per response
Total burden
hours
900
1
900
41
36,900
Total ..............................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Grant Report ........................................................................
900
........................
900
........................
36,900
Email comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 24, 2012.
Jennifer Riggle,
Deputy Director, Office of Management.
AGENCY:
[FR Doc. 2012–18637 Filed 7–30–12; 8:45 am]
SUMMARY:
BILLING CODE 4165–15–P
VerDate Mar<15>2010
16:48 Jul 30, 2012
Jkt 226001
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45359-45363]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18647]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, https://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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
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)).
----------------------------------------------------------------------------------------------------------------
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
https://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
https://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: https://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
https://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 https://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
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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:
reglist@cdrh.fda.gov 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
bloodregis@fda.hhs.gov 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
