Medical Device User Fee Rates for Fiscal Year 2011, 45641-45646 [2010-19038]
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Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Notices
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the 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.
III. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). Information in
an application on the product and
process development and justification
for the final formulation and system
design is approved by OMB under
control numbers 0910–0001 and 0910–
0014.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19041 Filed 8–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2009–D–0181]
Guidance for Industry on Label
Comprehension Studies for
Nonprescription Drug Products;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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availability of a guidance for industry
entitled ‘‘Label Comprehension Studies
for Nonprescription Drug Products.’’ The
guidance provides recommendations on
the design of label comprehension
studies that can be used to assess the
extent to which consumers understand
the information conveyed by proposed
nonprescription drug product labeling.
This guidance finalizes the draft
guidance published on May 1, 2009.
DATES: Submit either electronic or
written comments on agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Murewa Oguntimein, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm.
5475,Silver Spring, MD 20993–0002,
301–796–4869.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘Label
Comprehension Studies for
Nonprescription Drug Products.’’ This
guidance is intended for individuals or
organizations involved in the
development of label comprehension
studies for nonprescription drug
products. This guidance discusses
general concepts that should be
considered in the design and conduct of
a label comprehension study. This
guidance also incorporates advice
obtained from the September 25, 2006,
meeting of the Nonprescription Drug
Advisory Committee that considered
issues related to the analysis and
interpretation of consumer studies
conducted to support marketing of
nonprescription drug products, and
comments submitted to the draft
guidance published in the Federal
Register of May 1, 2009 (74 FR 20322).
This guidance is being issued
consistent with FDA’s good guidance
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45641
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on label
comprehension studies for
nonprescription drug products. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19043 Filed 8–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0363]
Medical Device User Fee Rates for
Fiscal Year 2011
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
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Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Notices
fee rates and payment procedures for
medical device user fees for fiscal year
(FY) 2011. The Federal Food, Drug, and
Cosmetic Act (the act), as amended by
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 2011 fee
rates are provided in this document.
These fees apply from October 1, 2010,
through September 30, 2011. 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 document provides information on
how the fees for FY 2011 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 MDUFMA: Visit
FDA’s Web site, https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUser
FeeandModernization
ActMDUFMA/default.htm.
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:
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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 document refers to these
collectively as ‘‘submissions’’); for
periodic reporting on class III devices;
and for the registration of certain
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establishments. Under statutorilydefined 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 license 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 2011 is
$236,298. From this starting point, this
document establishes FY 2011 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 2011 is $2,179.
There is no reduction in the registration
fee for small businesses. An
establishment must pay the 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 additional
processing and 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 2011 go into effect on
October 1, 2010, and will remain in
effect through September 30, 2011.
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II. Fees for FY 2011
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,
including a BLA, a premarket report,
and an efficacy supplement, at $236,298
for FY 2011 (see 21 U.S.C. 379j(b)); this
is referred to as the ‘‘base fee’’). The fees
set by reference to the base 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) (21 U.S.C. 360c(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).)
The statute sets the annual fee for
establishment registration at $2,179 in
FY 2011, and there is no small business
rate for the annual establishment
registration fee; all establishments pay
the same fee. The statute authorizes
increases in the annual establishment
fee for FY 2011 and subsequent years if
the estimated number of establishments
submitting fees for FY 2009 is fewer
than 12,250. (See 21 U.S.C.
379j(c)(2)(A).) The number of
establishments submitting fees in FY
2009 was in excess of 12,250, so no
establishment fee increase is warranted
under this provision of the statute.
Table 1 of this document sets out the
FY 2011 rates for all medical device
fees.
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45643
TABLE 1.—MEDICAL DEVICE FEES FOR FY 2011
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
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))
FY 2011 Standard
Fee
FY 2011 Small
Business Fee
Set in Statute
$236,298
$59,075
Premarket report (submitted under section 515(c)(2) of the act)
100%
$236,298
$59,075
Efficacy supplement (to an approved BLA under section 351 of the
PHS Act)
100%
$236,298
$59,075
Panel-track supplement
75%
$177,224
$44,306
180-day supplement
15%
$35,445
$8,861
Real-time supplement
7%
$16,541
$4,135
1.84%
$4,348
$2,174
1.6%
$3,781
$1,890
1.35%
$3,190
$1,595
3.5%
$8,270
$2,068
Set in Statute
$2,179
$2,179
510(k) premarket notification submission
30-day notice
513(g) request for classification information
Annual Fee Type
Annual fee for periodic reporting on a class III device
Annual establishment registration fee (to be 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 2010, your status as a
small business will expire at the close
of business on September 30, 2010. You
must re-qualify for FY 2011 in order to
pay small business fees during FY 2011.
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If you are a domestic (U.S.) business,
and wish to qualify as a small business
for FY 2011, you must submit the
following to FDA:
1. A completed FY 2011 MDUFMA
Small Business Qualification
Certification (Form FDA 3602). This
form is provided in FDA’s guidance
document, ‘‘FY 2011 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Web site at https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/Overview/
MedicalDeviceUserFee
andModernizationActMDUFMA/
default.htm. 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 2010, except—
• If you submit your FY 2011
MDUFMA Small Business Qualification
before April 15, 2011, and you have not
yet filed your return for 2010, you may
use tax year 2009.
• If you submit your FY 2011
MDUFMA Small Business Qualification
on or after April 15, 2011, and have not
yet filed your 2010 return because you
obtained an extension, you may submit
your most-recent return filed prior to
the extension.
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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 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 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
2011, you must submit the following:
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1. A completed FY 2011 MDUFMA
Foreign Small Business Qualification
Certification (Form FDA 3602A). This
form is provided in FDA’s guidance
document, ‘‘FY 2011 Medical Device
User Fee Small Business Qualification
and Certification,’’ available on FDA’s
Internet site at https://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
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
(2009 or later), 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 for 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 of each
affiliate, or that the applicant has no
affiliates.
IV. Procedures for Paying Application
and Annual Report Fees
If your application or submission is
subject to a fee and your payment is
received by FDA from October 1, 2010,
through September 30, 2011, you must
pay the fee in effect for FY 2011. 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
U.S. Bank determines whether the fee
rates for FY 2010 or FY 2011 apply.
FDA must receive the correct fee at the
time that an application or annual
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report is submitted, or the application or
annual report will not be accepted for
filing or review.
FDA requests that you follow the
steps below 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 (PIN) and
Medical Device User Fee Cover Sheet
From FDA Before Submitting Either the
Application or the Payment. (Note: Both
the FY 2010 and FY 2011 fee rates will
be available on the Cover Sheet Web
Site beginning on the date of
publication of this document, and only
the FY 2011 rates will appear after
September 30, 2010)
Log on to the MDUFMA Web site at:
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Overview/MedicalDeviceUserFee
andModernizationActMDUFMA/
default.htm and, under the MDUFMA
Forms heading, click on the link ‘‘Create
a 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, 2010.
One choice is for applications that will
be received on or before September 30,
2010, which will be subject to FY 2010
fee rates. A second choice is for
applications that will be received on or
after October 1, 2010, which will be
subject to FY 2011 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:
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• 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 314–418–4821
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: (1) The date
the application was received by FDA or
(2) the date U.S. Bank receives the
payment. U.S. Bank is required to notify
FDA within 1 working day, using the
PIN described previously in this
document.
(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
Pay.gov, a Web-based payment
application, for online electronic
payment. Pay.gov can now be used to
submit online payments for cover sheets
to FDA. You now have the option to
make a payment via electronic check or
credit card after submitting your
coversheet. 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 you
application will be delayed.
• The originating financial institution
usually charges a wire transfer fee
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between $15.00 and $35.00. 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 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.
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—WO66, 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.
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V. Procedures for Paying Annual
Establishment Fees
If you are required to pay an annual
establishment registration fee, you must
pay for each establishment prior to
registration. Payment must be submitted
by first creating a Device Facility User
Fee (DFUF) order through the User Fee
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 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 2011 until it has completed the
steps below to register and pay any
applicable fee. (See 21 U.S.C. 379j(f)(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 and
Research (CBER) will send
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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 2011 store.
Complete the DFUF order by entering
the number of establishments you are
registering. 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 Device
Facility User Fee Order
Unless paying by credit card, all
payments must be in U.S. currency and
drawn on a U.S. bank.
(1) If paying with 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 checks. 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
70961, Charlotte, NC 28272–0961.
(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: Wells Fargo, Attn:
Food and Drug Administration—
Lockbox 70961, rm. NC0810, 1525 West
WT Harris Blvd., Charlotte, NC 28262.
(Note: This Wells Fargo 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 70961) 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
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45645
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 Medical Device 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
usually charges a wire transfer fee
between $15.00 and $35.00. 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,
5600 Fishers Lane, Rockville, MD
20857.
C. Step Three—Complete the
Information Online to Update Your
Establishment’s Annual Registration for
FY 2011, or to Register a New
Establishment for FY 2011
Go to CDRH’s Web site at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
HowtoMarketYourDevice/Registration
andListing/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 2009 or FY 2010. Biologics
manufacturers should register in the
BER system at https://www.fda.gov/
BiologicsBloodVaccines/
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,
there will be a button that you will click
to go to the Device Registration and
Listing Module (DRLM) of FURLS. New
establishments will need to 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
E:\FR\FM\03AUN1.SGM
03AUN1
45646
Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Notices
you have any problems with this
process, e-mail: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
this e-mail 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 BER 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 licensed biologic devices. CBER will
send invoices for payment of the
establishment registration fee to
companies who only manufacture
licensed biologics devices. Fees are only
required for those establishments
defined in section I of this document.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19038 Filed 8–2–10; 8:45 am]
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; SBIR
Phase II Topic 59.
Date: August 20, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: July 28, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–19012 Filed 8–2–10; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
erowe on DSK5CLS3C1PROD with NOTICES
National Institute of Mental Health;
Notice of Closed Meetings
Food and Drug Administration
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; SBIR
Phase II Topic 60.
Date: August 18, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
VerDate Mar<15>2010
14:41 Aug 02, 2010
Jkt 220001
[Docket No. FDA–2010–N–0001]
Design of Clinical Trials of Aerosolized
Antimicrobials for the Treatment of
Cystic Fibrosis; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding scientific
issues in clinical development of
aerosolized antimicrobials for the
management and/or treatment of
patients with cystic fibrosis.
Aerosolized antimicrobials are used to
treat chronic bacterial infection in the
lungs and thus improve the respiratory
symptoms in patients with cystic
fibrosis. This public workshop is
intended to provide information for and
gain perspective from health care
providers, patients and patient advocacy
organizations, academia, and industry
on various aspects of the design of
clinical trials of aerosolized
SUMMARY:
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antimicrobials in patients with cystic
fibrosis. The input from this public
workshop will help in developing topics
for further discussion.
Dates and Times: The public
workshop will be held on September 23,
2010, from 8:30 a.m. to 5:30 p.m. and on
September 24, 2010, from 8 a.m. to 4
p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel,8777
Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on
a first-come, first-served basis.
Contact Persons: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research,Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and fax number) to
CFWORKSHOP@fda.hhs.gov Persons
without access to the Internet can call
301–796–1300 to register. Persons
needing a sign language interpreter or
other special accommodations should
notify Christine Moser or Lori Benner
(see Contact Persons) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding scientific considerations in
the design of clinical trials of
aerosolized antimicrobials to treat
chronic bacterial infection in the lungs
and thus improve the respiratory
symptoms in patients with cystic
fibrosis. The development of clinical
trial endpoints to establish efficacy is a
major challenge in the design of
informative clinical trials of aerosolized
antimicrobials for the management and/
or treatment of patients with cystic
fibrosis. The workshop will include
discussion of clinical trial endpoints to
establish efficacy, such as timing and
definitions of pulmonary exacerbations,
changes in the results of pulmonary
function testing, and changes on patient
reported outcome measures. An
important consideration will be the
evaluation of new aerosolized
antimicrobials in the context of
approved aerosolized antimicrobials on
the basis of these or other efficacy
endpoints. Other issues in the design of
clinical trials of aerosolized
antimicrobials include: The
development of drug resistance and
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45641-45646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19038]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0363]
Medical Device User Fee Rates for Fiscal Year 2011
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 45642]]
fee rates and payment procedures for medical device user fees for
fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the
act), as amended by 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 2011 fee
rates are provided in this document. These fees apply from October 1,
2010, through September 30, 2011. 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 document provides information on how the
fees for FY 2011 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 MDUFMA: Visit FDA's Web site, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm.
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 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''); 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 license 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 2011 is $236,298. From
this starting point, this document establishes FY 2011 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
2011 is $2,179. There is no reduction in the registration fee for small
businesses. An establishment must pay the 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 additional processing and 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 2011 go into effect on October 1, 2010, and will
remain in effect through September 30, 2011.
II. Fees for FY 2011
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, including a BLA, a premarket
report, and an efficacy supplement, at $236,298 for FY 2011 (see 21
U.S.C. 379j(b)); this is referred to as the ``base fee''). The fees set
by reference to the base 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) (21 U.S.C. 360c(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).)
The statute sets the annual fee for establishment registration at
$2,179 in FY 2011, and there is no small business rate for the annual
establishment registration fee; all establishments pay the same fee.
The statute authorizes increases in the annual establishment fee for FY
2011 and subsequent years if the estimated number of establishments
submitting fees for FY 2009 is fewer than 12,250. (See 21 U.S.C.
379j(c)(2)(A).) The number of establishments submitting fees in FY 2009
was in excess of 12,250, so no establishment fee increase is warranted
under this provision of the statute.
Table 1 of this document sets out the FY 2011 rates for all medical
device fees.
[[Page 45643]]
Table 1.--Medical Device Fees for FY 2011
----------------------------------------------------------------------------------------------------------------
Standard Fee, as a
Percent of the Standard FY 2011 Small
Application Fee Type Fee for a Premarket FY 2011 Standard Fee Business Fee
Application
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under Set in Statute $236,298 $59,075
section 515(c)(1) of the act (21 U.S.C.
360e(c)(1)), a PDP submitted under section
515(f) of the act, or a BLA submitted under
section 351 of the Public Health Service
(PHS) Act (42 U.S.C. 262))
----------------------------------------------------------------------------------------------------------------
Premarket report (submitted under section 100% $236,298 $59,075
515(c)(2) of the act)
----------------------------------------------------------------------------------------------------------------
Efficacy supplement (to an approved BLA under 100% $236,298 $59,075
section 351 of the PHS Act)
----------------------------------------------------------------------------------------------------------------
Panel-track supplement 75% $177,224 $44,306
----------------------------------------------------------------------------------------------------------------
180-day supplement 15% $35,445 $8,861
----------------------------------------------------------------------------------------------------------------
Real-time supplement 7% $16,541 $4,135
----------------------------------------------------------------------------------------------------------------
510(k) premarket notification submission 1.84% $4,348 $2,174
----------------------------------------------------------------------------------------------------------------
30-day notice 1.6% $3,781 $1,890
----------------------------------------------------------------------------------------------------------------
513(g) request for classification information 1.35% $3,190 $1,595
----------------------------------------------------------------------------------------------------------------
Annual Fee Type
----------------------------------------------------------------------------------------------------------------
Annual fee for periodic reporting on a class 3.5% $8,270 $2,068
III device
----------------------------------------------------------------------------------------------------------------
Annual establishment registration fee (to be Set in Statute $2,179 $2,179
paid by each establishment that is a
manufacturer, a single-use device
reprocessor, or a specification developer,
as defined by 21 U.S.C. 379i(13))
----------------------------------------------------------------------------------------------------------------
III. How to Qualify as a Small Business for Purposes of Medical Device
Fees
If your business has gross receipts or sales of no more than $100
million for the most-recent tax year, you may qualify for reduced small
business fees. If your business has gross sales or receipts of no more
than $30 million, you may also qualify for a waiver of the fee for your
first premarket application (PMA, PDP, or BLA) or premarket report. You
must include the gross receipts or sales of all of your affiliates
along with your own gross receipts or sales when determining whether
you meet the $100 million or $30 million threshold. If you want to pay
the small business fee rate for a submission, or you want to receive a
waiver of the fee for your first premarket application or premarket
report, you should submit the materials showing you qualify as a small
business 60 days before you send your submission to FDA. If you make a
submission before FDA finds that you qualify as a small business, you
must pay the standard fee for that submission.
If your business qualified as a small business for FY 2010, your
status as a small business will expire at the close of business on
September 30, 2010. You must re-qualify for FY 2011 in order to pay
small business fees during FY 2011.
If you are a domestic (U.S.) business, and wish to qualify as a
small business for FY 2011, you must submit the following to FDA:
1. A completed FY 2011 MDUFMA Small Business Qualification
Certification (Form FDA 3602). This form is provided in FDA's guidance
document, ``FY 2011 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Web site at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. 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 2010,
except--
If you submit your FY 2011 MDUFMA Small Business
Qualification before April 15, 2011, and you have not yet filed your
return for 2010, you may use tax year 2009.
If you submit your FY 2011 MDUFMA Small Business
Qualification on or after April 15, 2011, and have not yet filed your
2010 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 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 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 2011, you must submit the following:
[[Page 45644]]
1. A completed FY 2011 MDUFMA Foreign Small Business Qualification
Certification (Form FDA 3602A). This form is provided in FDA's guidance
document, ``FY 2011 Medical Device User Fee Small Business
Qualification and Certification,'' available on FDA's Internet site at
https://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 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 (2009 or later), 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
for 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 of each affiliate, or
that the applicant has no affiliates.
IV. Procedures for Paying Application and Annual Report Fees
If your application or submission is subject to a fee and your
payment is received by FDA from October 1, 2010, through September 30,
2011, you must pay the fee in effect for FY 2011. 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 U.S.
Bank determines whether the fee rates for FY 2010 or FY 2011 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 below 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 (PIN) and Medical
Device User Fee Cover Sheet From FDA Before Submitting Either the
Application or the Payment. (Note: Both the FY 2010 and FY 2011 fee
rates will be available on the Cover Sheet Web Site beginning on the
date of publication of this document, and only the FY 2011 rates will
appear after September 30, 2010)
Log on to the MDUFMA Web site at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm and, under
the MDUFMA Forms heading, click on the link ``Create a 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, 2010. One choice is for applications that
will be received on or before September 30, 2010, which will be subject
to FY 2010 fee rates. A second choice is for applications that will be
received on or after October 1, 2010, which will be subject to FY 2011
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 314-418-4821 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: (1) The date the
application was received by FDA or (2) the date U.S. Bank receives the
payment. U.S. Bank is required to notify FDA within 1 working day,
using the PIN described previously in this document.
(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 Pay.gov, a Web-based payment application, for online electronic
payment. Pay.gov can now be used to submit online payments for cover
sheets to FDA. You now have the option to make a payment via electronic
check or credit card after submitting your coversheet. 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 you application will be
delayed.
The originating financial institution usually charges a
wire transfer fee
[[Page 45645]]
between $15.00 and $35.00. 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 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.
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--WO66, 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 Annual Establishment Fees
If you are required to pay an annual establishment registration
fee, you must pay for each establishment prior to registration. Payment
must be submitted by first creating a Device Facility User Fee (DFUF)
order through the User Fee 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 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 2011 until it has completed the
steps below to register and pay any applicable fee. (See 21 U.S.C.
379j(f)(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 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 2011 store. Complete the DFUF order
by entering the number of establishments you are registering. 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 Device Facility User Fee Order
Unless paying by credit card, all payments must be in U.S. currency
and drawn on a U.S. bank.
(1) If paying with 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 checks.
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 70961, Charlotte, NC 28272-0961. (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: Wells Fargo, Attn: Food and Drug
Administration--Lockbox 70961, rm. NC0810, 1525 West WT Harris Blvd.,
Charlotte, NC 28262. (Note: This Wells Fargo 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 70961) 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 Medical Device 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 usually charges a
wire transfer fee between $15.00 and $35.00. 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,
5600 Fishers Lane, Rockville, MD 20857.
C. Step Three--Complete the Information Online to Update Your
Establishment's Annual Registration for FY 2011, or to Register a New
Establishment for FY 2011
Go to CDRH'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 2009 or FY 2010.
Biologics manufacturers 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, there will be a button that you
will click to go to the Device Registration and Listing Module (DRLM)
of FURLS. New establishments will need to 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
[[Page 45646]]
you have any problems with this process, e-mail: reglist@cdrh.fda.gov
or call 301-796-7400 for assistance. (Note: this e-mail 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 BER 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 licensed biologic
devices. CBER will send invoices for payment of the establishment
registration fee to companies who only manufacture licensed biologics
devices. Fees are only required for those establishments defined in
section I of this document.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19038 Filed 8-2-10; 8:45 am]
BILLING CODE 4160-01-S
