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Federal Register: Medical Device User Fee Rates for Fiscal Year 2011

Tue, 08/03/2010 - 5:31am
U.S. Food & Drug Administration

[Federal Register: August 3, 2010 (Volume 75, Number 148)]

[Notices]

[Page 45641-45646]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr03au10-79]

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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.

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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, http://

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

http://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

http://www.fda.gov/cdrh/mdufma. This form is not available separate

from the guidance document.

2. A National Taxing Authority Certification, completed by, and

bearing the official seal of, the National Taxing Authority of the

country in which the firm is headquartered. This Certification must

show the amount of gross receipts or sales for the most recent tax

year, in 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: http://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 http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/HowtoMarketYourDevice/

RegistrationandListing/default.htm and click the ``Access Electronic

Registration'' link on the left of the page. This opens up a new page

with important information about the FDA Unified Registration and

Listing System (FURLS). After reading this information, click on the

link (Access Electronic Registration) at the bottom of the page. This

link takes you to an FDA Industry Systems page with tutorials that

demonstrate how to create a new FURLS user account if your

establishment did not create an account in FY 2009 or FY 2010.

Biologics manufacturers should register in the BER system at http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/

BloodEstablishmentRegistration/default.htm.

Enter your existing account ID and password to log into FURLS. From

the FURLS/FDA Industry Systems menu, 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

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