Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 58099 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Medical Device User Fee Rates for 

Fiscal Year 2008 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2008. The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA), 

the Medical Device User Fee 

Stabilization Act of 2005 (MDUFSA), 

and the Medical Device User Fee 

Amendments of 2007 (Title II of the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA)), 

authorizes FDA to collect user fees for 

certain medical device submissions, and 

annual fees both for certain periodic 

reports and for certain establishments 

subject to registration. The FY 2008 fee 

rates are provided in this notice. These 

fees apply from October 1, 2007, 

through September 30, 2008. To avoid 

delay in the review of your application, 

you should pay the fee before or at the 

time you submit your application to 

FDA. The fee you must pay is the fee 

that is in effect on the later of the date 

that your application is received by FDA 

or the date your fee payment is received. 

If you want to pay a reduced small 

business fee, you must qualify as a small 

business before you make your 

submission to FDA; if you do not 

qualify as a small business before you 

make your submission to FDA, you will 

have to pay the higher standard fee. 

This notice provides information on 

how the fees for FY 2008 were 

determined, the payment procedures 

you should follow, and how you may 

qualify for reduced small business fees. 

FOR FURTHER INFORMATION CONTACT: 

For further information on MDUFMA: 

Visit FDA’s Web site, http:// 

www.fda.gov/cdrh/mdufma. 

For questions relating to this notice: 

Yanming Chae, Office of Financial 

Management (HFA–120), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

827–5042. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the act (21 U.S.C. 379j) 

establishes fees for certain medical 

device applications, submissions, 

supplements, and notices (for 

simplicity, this notice refers to these 

collectively as ‘‘submissions’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorily 

defined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the act, the fee rate for each 

type of submission is set at a specified 

percentage of the standard fee for a 

premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics licensing application (BLA)). 

The act specifies the standard fee for a 

premarket application for each year 

from FY 2008 through FY 2012; the 

standard fee for a premarket application 

received by FDA during FY 2008 is 

$185,000. From this starting point, this 

notice establishes FY 2008 fee rates for 

other types of submissions, and for 

periodic reporting, by applying criteria 

specified in the act. 

The act specifies the annual fee for 

establishment registration for each year 

from FY 2008 through FY 2012; the 

registration fee for FY 2008 is $1,706. 

There is no reduction in the registration 

fee for small businesses. An 

establishment must pay the annual 

registration fee if it is any of the 

following types of establishments: 

• Manufacturer. An establishment 

that makes by any means any article that 

is a device, including an establishment 

that sterilizes or otherwise makes such 

article for or on behalf of a specification 

developer or any other person. 

• Single-use device reprocessor. An 

establishment that performs 

manufacturing operations on a singleuse device that has previously been 

used on a patient. 

• Specification developer. An 

establishment that develops 

specifications for a device that is 

distributed under the establishment’s 

name but which performs no 

manufacturing, including an 

establishment that, in addition to 

developing specifications, also arranges 

for the manufacturing of devices labeled 

with another establishment’s name by a 

contract manufacturer. 

The fees for FY 2008 go into effect on 

October 1, 2007, and will remain in 

effect through September 30, 2008. 

II. Fees for FY 2008 

Under the act, all submission fees and 

the periodic reporting fee are set as a 

percent of the standard (full) fee for a 

premarket application (see 21 U.S.C. 

379j(a)(2)(A)), and the act sets the 

standard fee for a premarket application 

at $185,000 for FY 2008 (see 21 U.S.C. 

379j(b); this is referred to as the ‘‘base 

fee’’). The fees set by reference to the 

base (see 21 U.S.C. 379j(a)(2)(A)) fee 

are—

• For a panel-track supplement, 75 

percent of the base fee; 

• For a 180-day supplement, 15 

percent of the base fee; 

• For a real-time supplement, 7 

percent of the base fee; 

• For a 30-day notice, 1.6 percent of 

the base fee; 

• For a 510(k) premarket notification, 

1.84 percent of the base fee; 

• For a 513(g) request for 

classification information, 1.35 percent 

of the base fee; and 

• For an annual fee for periodic 

reporting concerning a class III device, 

3.5 percent of the base fee. 

For all submissions other than a 

510(k) premarket notification, a 30-day 

notice, and a 513(g) request for 

classification information, the small 

business fee is 25 percent of the 

standard (full) fee (see 21 U.S.C. 

379j(d)(2)(C)). For a 510(k) premarket 

notification submission, a 30-day notice, 

and a 513(g) request for classification 

information, the small business fee is 50 

percent of the standard (full) fee (see 21 

U.S.C. 379j(e)(2)(C) and (d)(2)(C), 

respectively). There is no small business 

rate for annual establishment 

registration fee; all establishments pay 

the same fee. Table 1 of this document 

sets out the FY 2008 rates for all 

medical device fees. 

TABLE 1.—MEDICAL DEVICE FEES FOR FY 2008 

Standard Fee, as a Percent of 

the Standard Fee for a 

Premarket Application 

FY 2008 

Standard Fee 

FY 2008 Small 

Business Fee 

Application Fee Type 


jlentini on PROD1PC65 with NOTICES
58100 Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 

TABLE 1.—MEDICAL DEVICE FEES FOR FY 2008—Continued 

Standard Fee, as a Percent of 

the Standard Fee for a 

Premarket Application 

FY 2008 

Standard Fee 

FY 2008 Small 

Business Fee 

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)) Set in statute $185,000 $46,250 

Premarket report (submitted under section 515(c)(2) of the act) 100% $185,000 $46,250 

Efficacy supplement (to an approved BLA under section 351 of the 

PHS act) 100% $185,000 $46,250 

Panel-track supplement 75% $138,750 $34,688 

180-day supplement 15% $27,750 $6,938 

Real-time supplement 7% $12,950 $3,237 

510(k) premarket notification submission 1 .84% $3,404 $1,702 

30-day notice 1 .6% $2,960 $1,480 

513(g) request for classification information 1 .35% $2,498 $1,249 

Annual Fee Type 

Annual fee for periodic reporting on a class III device 3 .5% $6,475 $1,619 

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)) Set in statute $1,706 $1,706 

III. How to Qualify as a Small Business 

for Purposes of Medical Device Fees 

If your business has gross receipts or 

sales of no more than $100 million for 

the most-recent tax year, you may 

qualify for reduced small business fees. 

If your business has gross sales or 

receipts of no more than $30 million, 

you may also qualify for a waiver of the 

fee for your first premarket application 

(PMA, PDP, or BLA) or premarket 

report. You must include the gross 

receipts or sales of all of your affiliates 

along with your own gross receipts or 

sales when determining whether you 

meet the $100 million or $30 million 

threshold. If you want to pay the small 

business fee rate for a submission, or 

you want to receive a waiver of the fee 

for your first premarket application or 

premarket report, you should submit the 

materials showing you qualify as a small 

business 60 days before you send your 

submission to FDA. If you make a 

submission before FDA finds that you 

qualify as a small business, you must 

pay the standard fee for that submission. 

If your business qualified as a small 

business for FY 2007, your status as a 

small business will expire at the close 

of business on September 30, 2007. You 

must re-qualify for FY 2008 in order to 

pay fees at the small business rate 

during FY 2008. 

If you are a domestic (U.S.) business, 

and wish to qualify as a small business 

for FY 2008, you must submit the 

following to FDA: 

(1) A completed FY 2008 MDUFMA 

Small Business Qualification 

Certification (Form FDA 3602). This 

form is provided in FDA’s guidance 

document ‘‘FY 2008 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

Web site at http://www.fda.gov/cdrh/ 

mdufma. This form is not available 

separate from the guidance document. 

(2) A certified copy of your Federal 

(U.S.) Income Tax Return for the most 

recent tax year (2006 or later). 

(3) For each of your affiliates, either—

(A) If the affiliate is a domestic (U.S.) 

business, a certified copy of the 

affiliate’s Federal (U.S.) Income Tax 

Return for the most recent tax year, 

or 

(B) If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National 

Taxing Authority Certification 

completed by, and bearing the 

official seal of, the National Taxing 

Authority of the country in which 

the affiliate is headquartered. This 

certification must show the amount 

of gross receipts or sales for the 

most recent tax year, in both U.S. 

dollars and the local currency of the 

country, the exchange rate used in 

converting the local currency to 

U.S. dollars, and the dates of the 

gross receipts or sales collected. 

The applicant should also submit a 

statement signed by the head of the 

applicant’s firm or by its chief 

financial officer that the applicant 

has submitted certifications for all 

of its affiliates, identifying the 

name(s) of each affiliate(s), or that 

the applicant has no affiliates. The 

National Taxing Authority is the 

foreign equivalent of the U.S. 

Internal Revenue Service. 

If you are a foreign business, and wish 

to qualify as a small business for FY 

2008, you must submit the following: 

(1) A completed FY 2008 MDUFMA 

Foreign Small Business Qualification 

Certification (Form FDA 3602A). This 

form is provided in FDA’s guidance 

document ‘‘FY 2008 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

Web site at http://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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 58101 

both U.S. dollars and the local currency 

of the country, the exchange rate used 

in converting the local currency to U.S. 

dollars, and the dates of the gross 

receipts or sales collected. 

(3) For each of your affiliates, either—

(A) If the affiliate is a domestic (U.S.) 

business, a certified copy of the 

affiliate’s Federal (U.S.) Income Tax 

Return for the most recent tax year 

(2006 or later), or 

(B) If the affiliate is a foreign business 

and cannot submit a Federal (U.S.) 

Income Tax Return, a National 

Taxing Authority Certification 

completed by, and bearing the 

official seal of, the National Taxing 

Authority of the country in which 

the firm is headquartered. This 

certification must show the amount 

of gross receipts or sales for the 

most recent tax year, in both U.S. 

dollars and the local currency of the 

country, the exchange rate used in 

converting the local currency to 

U.S. dollars, and the dates of the 

gross receipts or sales collected. 

The applicant should also submit a 

statement signed by the head of the 

applicant’s firm or by its chief 

financial officer that the applicant 

has submitted certifications for all 

of its affiliates, identifying the 

name(s) of each affiliate(s), or that 

the applicant has no affiliates. The 

National Taxing Authority is the 

foreign equivalent of the U.S. 

Internal Revenue Service. 

IV. Procedures for Paying Application 

and Annual Report Fees 

If your application or submission is 

subject to a fee and is received by FDA 

from October 1, 2007, through 

September 30, 2008, you must pay the 

fee in effect for FY 2008. The later of the 

date that the application or annual 

report is received in the reviewing 

center’s document room or the date that 

the check is received by US Bank 

determines whether the fee rates for FY 

2007 or FY 2008 apply. FDA must 

receive the correct fee at the time that 

an application or annual report is 

submitted, or the application or annual 

report will not be accepted for filing or 

review. 

FDA requests that you follow the 

steps in this section before submitting a 

medical device application or annual 

report subject to a fee. Please pay close 

attention to these procedures to ensure 

that FDA links the fee with the correct 

application. (Note: In no case should the 

check for the fee be submitted to FDA 

with the application.) 

A. Step One—Secure a Payment 

Identification Number and Medical 

Device User Fee Cover Sheet From FDA 

Before Submitting Either the 

Application or the Payment. Note: FY 

2008 fee rates will be available on the 

Cover Sheet Web site beginning on the 

date of publication of this notice 

Log onto the MDUFMA Web site at 

http://www.fda.gov/oc/mdufma and, 

under the forms heading, click on the 

link ‘‘User Fee Cover Sheet.’’ Complete 

the Medical Device User Fee Cover 

Sheet. Be sure you choose the correct 

application submission date range. After 

completing data entry, print a copy of 

the Medical Device User Fee Cover 

Sheet and note the unique Payment 

Identification Number located in the 

upper right-hand corner of the printed 

cover sheet. 

B. Step Two—Electronically Transmit a 

Copy of the Printed Cover Sheet with the 

Payment Identification Number to 

FDA’s Office of Financial Management 

Once you are satisfied that the data on 

the cover sheet is accurate, 

electronically transmit that data to FDA 

according to instructions on the screen. 

Because electronic transmission is 

possible, applicants are required to set 

up a user account and use passwords to 

assure data security in the creation and 

electronic submission of cover sheets. 

C. Step Three—Mail Payment and a 

Copy of the Completed Medical Device 

User Fee Cover Sheet to the St. Louis 

Address Specified in This Section 

• Make the payment in U.S. currency 

by check, bank draft, or U.S. Postal 

money order payable to the Food and 

Drug Administration. (FDA’s tax 

identification number is 53–0196965, 

should your accounting department 

need this information.) 

• Please write your application’s 

unique Payment Identification Number, 

from the upper right-hand corner of 

your completed Medical Device User 

Fee Cover Sheet, on your check, bank 

draft, or U.S. Postal money order. 

• Mail the payment and a copy of the 

completed Medical Device User Fee 

Cover Sheet to: Food and Drug 

Administration, P.O. Box 956733, St. 

Louis, MO 63195–6733. (Please note 

that this address is for payments of 

application and annual report fees only 

and is not to be used for payment of 

annual establishment registration fees.) 

If you prefer to send a check by a 

courier (such as FEDEX, DHL, UPS, 

etc.), the courier may deliver the check 

to: US Bank, Attn: Government Lockbox 

956733, 1005 Convention Plaza, St. 

Louis, MO 63101. (Note: This address is 

for courier delivery only. Contact the US 

Bank at 314–418–4821 if you have any 

questions concerning courier delivery.) 

It is helpful if the fee arrives at the 

bank at least 1 day before the 

application arrives at FDA. FDA records 

the official application receipt date as 

the later of the following: 

• The date the application was 

received by FDA. 

• The date US Bank receives the 

payment. US Bank is required to notify 

FDA within 1 working day, using the 

Payment Identification Number 

described previously. 

D. Step Four—Submit Your Application 

to FDA with a Copy of the Completed 

Medical Device User Fee Cover Sheet 

Please submit your application and a 

copy of the completed Medical Device 

User Fee Cover Sheet to one of the 

following addresses: 

• Medical device applications should 

be submitted to: Food and Drug 

Administration, Center for Devices and 

Radiological Health, Document Mail 

Center (HFZ–401), 9200 Corporate 

Blvd., Rockville, MD 20850. 

• Biologic applications should be sent 

to: Food and Drug Administration, 

Center for Biologics Evaluation and 

Research, Document Control Center 

(HFM–99), suite 200N, 1401 Rockville 

Pike, Rockville, MD 20852–1448. 

V. Procedures for Paying Annual 

Establishment Fees 

Procedures for paying annual 

establishment fees are different from the 

previously mentioned procedures for 

paying application, submission, and 

annual report fees. An establishment is 

not legally registered in FY 2008 until 

it has both completed the following 

steps to register and paid any fee that 

may be applicable (see 21 U.S.C. 

379j(f)(2)). 

A. Step One—Complete the Information 

Online to Update Your Establishment’s 

Registration for FY 2008, or to Register 

a New Establishment for FY 2008 

Log onto CDRH’s Web site at http:// 

www.fda.gov/cdrh/reglistpage.html and 

follow the link from that page to the 

FDA Unified Registration and Listing 

System (FURLS). If you already have a 

registered medical device establishment, 

FDA has sent you a letter that contains 

your account ID and password for 

logging into FURLS. If you are an owner 

or operator registering for the first time, 

you will need to create a FURLS 

account. There are tutorials available 

from the FURLS/FDA Industry Systems 

homepage that demonstrate how to 

create FURLS user accounts. 


jlentini on PROD1PC65 with NOTICES
58102 Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices 

Once you obtain your account ID and 

password, you will enter them and log 

into FURLS. From the FURLS/FDA 

Industry Systems menu, there will be a 

button that you will click to go to the 

Device Registration and Listing Module 

(DRLM) of FURLS. New establishments 

will register their establishment and 

existing establishments will re-register 

their establishments using choices on 

the DRLM menu. Once you make your 

selection—either Register a Facility or 

Annual Re-registration—the system will 

prompt you through the entry of 

information about your establishment 

and your devices. 

If you have any problems with this 

process you may call 240–276–0111 for 

assistance. (Note: This phone number is 

for assistance with establishment 

registration and establishment fee 

payment only, and not for any other 

aspects of medical device user fees.) 

B. Step Two—Determine Whether an 

Annual Registration Fee is Required and 

Get Your Invoice if a Fee is Due 

After you enter your establishment 

registration information into the system, 

you will be informed whether or not the 

payment of an annual registration fee is 

required to complete your registration 

(these fees are only required for device 

manufacturers, single-use re-processors, 

and specification developers as stated in 

section I of this document). If your 

establishment is subject to a fee, you 

will be given a summary sheet that: (1) 

Tells you what your payment options 

are and (2) leads you to a link for your 

specific invoice, which will be available 

on-line as a portable document format 

(PDF) file that you should print copies 

of; one to submit with your payment (if 

not submitted electronically) and the 

other to keep for your records. 

C. Step Three—Pay Your Invoice, if 

Required 

Make the payment, if required, in U.S. 

currency. The summary page will 

include payment information that may 

permit you the option of paying 

electronically. If that option is provided, 

you may follow the instructions 

provided to make payment 

electronically. If that option is not 

provided, or you choose not to make 

your payment electronically, you may 

pay by check. 

Your check, made in U.S. dollars and 

drawn on a U.S. bank, can be mailed to: 

Food and Drug Administration, P.O. 

Box 70961, Charlotte, NC 28272–0961. 

(Please note that this is different than 

the address for payments of application 

and annual report fees and is to be used 

only for payment of annual 

establishment registration fees.) 

If checks are to be sent by a courier 

that requests a street address, the 

courier can deliver the checks to: 

Wachovia Bank, Attn: Food and Drug 

Administration—Lockbox 70961, rm. 

NC0810, 1525 West WT Harris Blvd., 

Charlotte, NC 28262. (Note: This 

Wachovia Bank address is for courier 

delivery only; do not send mail to this 

address.) 

Please make sure that the FDA post 

office box number (P.O. Box 70961) is 

written on the check, along with the 

invoice number printed on your invoice. 

A copy of your printed invoice should 

also be mailed in the same envelope 

with your check. FDA’s tax 

identification number is 53–0196965. 

Wire transfers may also be used to pay 

annual establishment fees. The routing 

and transit number is 021030004 and 

the account number is 75060099. The 

invoice number should also be included 

with any wire transfer information, to 

assure that the invoice is properly 

credited. 

FDA is in the process of 

implementing alternate Web-based 

payment methods, and the option of 

electronic payment may not be 

immediately available for FY 2008 

payments. For more information on 

these payment options and when they 

will be available, please visit FDA’s 

Web site at http://www.fda.gov, select 

the appropriate user fee type, and click 

on ‘‘User Fee Cover Sheet.’’

Dated: October 4, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. 07–5051 Filed 10–9–07; 12:06 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

In Vitro Analysis of Cell/Scaffold 

Medical Products; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Center for Biologics Evaluation 

and Research and Center for Devices 

and Radiological Health, and the 

National Institute of Standards and 

Technology are announcing a public 

workshop entitled: In Vitro Analysis of 

Cell/Scaffold Medical Products. The 

purpose of the public workshop is to 

discuss issues that should be considered 

when evaluating cell/scaffold medical 

products and to determine which test 

methods are currently available and 

which new analytical procedures 

should be further researched for the 

evaluation of cell/scaffold medical 

products. 

Date and Time: The public workshop 

will be held on December 6 and 7, 2007, 

from 8:30 a.m. to 4 p.m. 

Location: The public workshop will 

be held at the National Transportation 

and Safety Board, 490 L’Enfant Plaza 

East, SW., Washington, DC 20594. 

Contact Person: Bernadette Kawaley, 

Center for Biologics Evaluation and 

Research (HFM–43), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–2000, FAX: 301–827–3079, email: CBERTraining@fda.hhs.gov 

(Subject line: Tissue Engineering 

Workshop). 

Registration: Mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person by November 15, 2007. 

There is no registration fee for the 

public workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please contact 

Bernadette Kawaley (see Contact 

Person) at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: The 

public workshop will feature 

presentations by experts from the 

medical field and the government. The 

first day of the workshop will include 

discussions on in vitro assays of product 

performance. The second day of the 

workshop will include discussions on 

tools for quantifying the response of 

cells and tissues. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet athttp://www.fda.gov/cber/ 

minutes/workshop-min.htm. 

Dated: October 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–20191 Filed 10–11–07; 8:45 am] 

BILLING CODE 4160–01–S 


jlentini on PROD1PC65 with NOTICES