38444 Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 

implicated in a number of CNS 

disorders, including psychostimulant 

abuse, psychosis and Parkinson’s 

disease. Compounds that bind with high 

affinity and selectivity to D3 receptors 

can not only provide important tools 

with which to study the structure and 

function of this receptor subtype, but 

may also have therapeutic potential in 

the treatment of numerous psychiatric 

and neurologic disorders. 

The 4-phenylpiperazine derivatives 

are an important class of dopamine D3 

selective ligands. However, due to their 

highly lipophilic nature, these 

compounds suffer from solubility 

problems in aqueous media and reduced 

bioavailability. To address this problem, 

a process was designed to introduce 

functionality into the carbon chain 

linker of these compounds. Compared to 

currently available dopamine D3 

receptor ligands, the resulting 

compounds show improved 

pharmacological properties and D3 

selectivities but due to their more 

hydrophilic nature, these derivatives are 

predicted to have improved water 

solubility and bioavailability. 

Applications: 

• Therapeutics for a variety of 

psychiatric and neurologic disorders 

• Research tools to study D3 receptor 

structure and function 

Advantages: 

• Improved pharmacological 

properties and selectivity over existing 

dopamine D3 receptor ligands 

• Hydrophilic nature likely to lead to 

improved water solubility and 

bioavailability 

Development Status: Pre-clinical 

discovery. 

Further R&D Needed: 

• Evaluate selected compounds in 

animal models of drug abuse, psychosis, 

obesity and Parkinson’s disease. 

• Design and synthesize novel, 

functionalized analogs using both 

classical and computational drug design 

to improve D3 receptor affinity and 

selectivity. 

• Evaluate compounds for binding in 

D3 and D2 receptor expressing cell lines 

and in in vitro functional assays. 

• Correlate in vitro binding affinities 

with in vivo function in rats and 

monkeys and evaluate compounds in 

knockout mice models. 

• Pursue PET and SPECT imaging 

agents by radiolabel of D3 ligands and 

evaluation in rats and non-human 

primates. 

Inventors: Amy H. Newman (NIDA), 

Peter Grundt (NIDA), Jianjing Cao 

(NIDA), et al. 

Patent Status: PCT Application No. 

Pct/US2007/71412 filed 15 Jun 2007, 

which published as WO 2008/153573 

on 18 Dec 2008 (HHS Reference No. E– 

128–2006/0–PCT–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Charlene Sydnor, 

PhD; 301–435–4689; 

sydnorc@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Drug Abuse’s 

Medications Discovery Research Branch 

is seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 4- 

phenylpiperazine derivatives as 

dopamine D3 selective ligands. Please 

contact Vio Conley, MS at 301–435– 

2031 or conleyv@mail.nih.gov for 

additional information. 

High-Yield Methods of Producing 

Biliverdin 

Description of the Technology: This 

invention describes methods of making 

high yields of biliverdin, the 

pharmaceutical compositions of 

biliverdin made using that process, and 

methods of using the compositions 

therapeutically. 

In reaction to a wide range of cellular 

stresses, hemoglobin is naturally 

metabolized to biliverdin, which is then 

quickly metabolized to bilirubin, a bile 

pigment, through a highly conserved set 

of enzymes. Both bilirubin and 

biliverdin are normally processed for 

rapid excretion, and excessive serum 

levels of bilirubin have known toxic 

effects (most notably jaundice). 

Surprisingly, research in the past 

decade has shown that decreasing 

serum levels correlate inversely with the 

prognosis of various disorders, such as 

ischemia/reperfusion injuries, 

atherosclerosis, organ transplantation, 

and several autoimmune diseases. 

Indeed, in animal-model studies, 

inducing a mild case of jaundice 

actually improved outcome. 

Unfortunately, bilirubin is relatively 

insoluble, and so is not a practical 

pharmaceutical itself. 

Biliverdin has lower direct toxicity 

and substantially greater solubility than 

bilirubin, and also appears to have some 

direct therapeutic effects similar to 

bilirubin. Accordingly, biliverdin has 

been widely studied lately. Generating 

high yields of pure biliverdin is 

difficult, however, because any system 

with the enzymes to break down 

hemoglobin also has enzymes 

converting biliverdin to bilirubin. The 

inventors have created a system of 

generating microorganisms (yeast) 

lacking the enzymes that break 

biliverdin down to bilirubin. 

Applications: Production of biliverdin 

for immunomodulatory and 

cytoprotective therapy (or adjuvant) in 

any condition involving an overactive 

immune response. 

Advantages: 

• High yield of biliverdin with low 

contamination of bilirubin. 

• Produces only active isomers of 

biliverdin. 

• Unlike prior methods, new method 

uses starting material that is 

inexpensive and plentiful. 

Development Status: Successful 

generation of Candida albicans with 

biliverdin-generating system. 

Inventors: Michael L. Pendrak and 

David D. Roberts (NCI). 

Patent Status: HHS Reference No. E– 

040–2004/0—Issued U.S. Patent 

7,504,243; Pending U.S. Application 12/ 

364,054 (divisional, filed 02 Feb 2009). 

Relevant Publication: ML Pendrak et 

al. Heme oxygenase in Candida albicans 

is regulated by hemoglobin and is 

necessary for metabolism of exogenous 

heme and hemoglobin to alphabiliverdin. J Biol Chem. 20 Jan 

2004;279(5):3426–3433. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Bruce Goldstein, 

JD, MS; (301) 435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The Laboratory of Pathology in the 

Center for Cancer Research of the 

National Cancer Institute is seeking 

parties interested in collaborative 

research directed toward clinical 

applications of biliverdin. For more 

information about the research, please 

contact either Dr. Michael Pendrak 

(NCI/CCR Laboratory of Pathology) at 

(301) 496–6264, or Dr. April Franks 

(NCI Technology Transfer Center) at 

(301) 496–0477. 

Dated: July 28, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–18496 Filed 7–31–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0338] 

Medical Device User Fee Rates for 

Fiscal Year 2010 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 


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fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2010. 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 2010 fee 

rates are provided in this document. 

These fees apply from October 1, 2009, 

through September 30, 2010. 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 2010 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/MedicalDevice

UserFeeand/Modernization

ActMDUFMA/default.htm. 

For questions relating to this notice: 

David Miller, Office of Financial 

Management (HFA–100), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301– 

827–3917. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the act (21 USC 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 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 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 2010 is 

$217,787. From this starting point, this 

document establishes FY 2010 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 2010 is $2,008. 

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 2010 go into effect on 

October 1, 2009, and will remain in 

effect through September 30, 2010. 

II. Fees for FY 2010 

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 $217,787 

for FY 2010 (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) 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 $2,008 on 

FY 2010, 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 2010 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).) FDA estimates that the 

number of establishments submitting 

fees in FY 2009 will be 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 2010 rates for all medical device 

fees. 


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TABLE 1.—MEDICAL DEVICE FEES FOR FY 2010 

Application Fee Type 

Standard Fee, as a Percent of 

the Standard Fee for a 

Premarket Application 

FY 2010 Standard Fee FY 2010 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 $217,787 $54,447 

Premarket report (submitted under section 515(c)(2) 

of the act) 100% $217,787 $54,447 

Efficacy supplement (to an approved BLA under section 351 of the PHS Act) 100% $217,787 $54,447 

Panel-track supplement 75% $163,340 $40,835 

180-day supplement 15% $32,668 $8,167 

Real-time supplement 7% $15,245 $3,811 

510(k) premarket notification submission 1.84% $4,007 $2,004 

30-day notice 1.6% $3,485 $1,742 

513(g) (21 U.S.C. 360c(g)) request for classification 

information 1.35% $2,940 $1,470 

Annual Fee Type 

Annual fee for periodic reporting on a class III device 3.5% $7,623 $1,906 

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 $2,008 $2,008 

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 2009, your status as a 

small business will expire at the close 

of business on September 30, 2009. You 

must re-qualify for FY 2010 in order to 

pay small business fees during FY 2010. 

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

and wish to qualify as a small business 

for FY 2010, you must submit the 

following to FDA: 

(1) A completed FY 2010 MDUFMA 

Small Business Qualification 

Certification (Form FDA 3602). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2010 Medical Device 

User Fee Small Business Qualification 

and Certification,’’ available on FDA’s 

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

MedicalDevices/Device

RegulationandGuidance/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 2009, except— 

• If you submit your FY 2010 

MDUFMA Small Business Qualification 

before April 15, 2010, and you have not 

yet filed your return for 2009, you may 

use tax year 2008. 

• If you submit your FY 2010 

MDUFMA Small Business Qualification 

on or after April 15, 2010, and have not 

yet filed your 2009 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 


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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 

2010, you must submit the following: 

(1) A completed FY 2010 MDUFMA 

Foreign Small Business Qualification 

Certification (Form FDA 3602A). This 

form is provided in FDA’s guidance 

document, ‘‘FY 2010 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 

(2008 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, 2009, 

through September 30, 2010, you must 

pay the fee in effect for FY 2010. 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 2009 or FY 2010 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 2009 and FY 2010 fee rates will 

be available on the Cover Sheet Web 

Site beginning on the date of 

publication of this document, and only 

the FY 2010 rates will appear after 

September 30, 2009) 

Log on to the MDUFMA Web site at: 

http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Overview/MedicalDeviceUser

FeeandModernizationActMDUFMA/ 

default.htm and, under the MDUFMA 

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. (Two choices 

will be offered until October 1, 2009. 

One choice is for applications that will 

be received on or before September 30, 

2009, which will be subject to FY 2009 

fee rates. A second choice is for 

applications that will be received on or 

after October 1, 2009, which will be 

subject to FY 2010 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 the 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 $4,000.00. 

(3) If paying with a wire transfer: 

• Please include your application’s 

unique PIN, from the upper right-hand 

corner of your completed Medical 


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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 

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, 5600 Fishers Lane, 

Rockville, MD 20857. 

D. Step Four—Submit Your Application 

to FDA With a Copy of the Completed 

Medical Device User Fee Cover Sheet 

For all applications sent after August 

1, 2009, 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 Use 

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 2010 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 Device Facility 

User Fee 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 2010 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: 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 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, US.. 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 2010, or to Register a New 

Establishment for FY 2010 

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. 

Biologics license manufacturers should 

register in the BER system at http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/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 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices 38449 

their annual registration using choices 

on the DRLM menu. Once you choose 

to register or update your annual 

registration the system will prompt you 

through the entry of information about 

your establishment and your devices. If 

you have any problems with this 

process, 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 28, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18456 Filed 7–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Meeting; Moving Into the 

Future—New Dimensions and 

Strategies for Women’s Health 

Research for the National Institutes of 

Health 

Notice is hereby given that the Office 

of Research on Women’s Health 

(ORWH), Office of the Director, National 

Institutes of Health, Department of 

Health and Human Services, in 

collaboration with the Warren Alpert 

Medical School of Brown University 

and the Women & Infants Hospital of 

Rhode Island, will convene a public 

hearing and scientific workshop on 

September 21–23, 2009, at the Women 

& Infants Hospital of Rhode Island 

Conference Center, Providence, Rhode 

Island. 

Purpose of the Meeting 

With rapid advances in science and 

wider global understanding of women’s 

health and sex/gender contributions to 

well-being and disease, the purpose of 

the meeting is to ensure that NIH 

continues to support cutting-edge 

women’s health research that is based 

upon the most advanced techniques and 

methodologies. The meeting format is 

designed to promote an interactive 

discussion involving leading scientists, 

advocacy groups, public policy experts, 

health care providers, and the general 

public. The Providence meeting is the 

third in a series that will be convened 

throughout the Nation to help the 

ORWH and NIH move into the next 

decade of women’s health research. 

As science and technology advance 

and fields such as computational 

biology demonstrate the power of 

interdisciplinary research, it remain 

critical for sex and gender factors to be 

integrated into broad experimental 

methodologies and scientific 

approaches across the lifespan. 

Biomedical and behavioral research are 

also necessary to understand how 

cultural, ethnic, and racial differences 

influence the causes, diagnosis, 

progression, treatment, and outcome of 

disease among different populations, 

including women of diverse geographic 

locations and socioeconomic 

backgrounds. Furthermore, health 

differences among diverse populations 

of women remain a critical area in need 

of continued focus and attention. 

The ORWH challenges all meeting 

attendees to assist the NIH in defining 

the women’s health research agenda of 

the future by thinking beyond 

traditional women’s health issues. The 

ORWH and NIH ask meeting 

participants to consider creative 

strategies to identify areas of research 

that are best poised for advancement, 

identify innovative ways in which 

persistent issues of health and disease 

can be addressed, and explore new 

horizons of scientific concepts and 

investigative approaches. Attention also 

needs to be paid to new areas of science 

application, new technologies, and 

continuing basic science investigations. 

Clinical questions that are not currently 

the focus of research priorities need to 

be considered to ensure that women’s 

health research is optimally served and 

that the ORWH can continue to provide 

leadership for the benefit of women’s 

health, nationally and internationally. 

Meeting Format 

The meeting will consist of public 

testimony, scientific panels, and eight 

concurrent scientific working groups. 

Specifically, on September 21, 

individuals representing a full spectrum 

of organizations interested in 

biomedical and behavioral research on 

women’s health issues will have an 

opportunity to provide public testimony 

from 1:30 to 5:30 p.m. On September 22 

and 23, plenary sessions will focus on 

the intersection of health care, public 

policy, and biomedical research; on 

emerging issues and trends in health 

care; and on research paradigms of the 

future. The eight concurrent afternoon 

sessions on September 22 will focus on 

a range of research areas, including 

Prenatal, Infancy, and Childhood Years; 

Adolescent Years; Reproductive and 

Middle Years; Pregnancy; Menopausal 

Transition; Elderly, Frail Elderly, and 

Healthy Aging; Oral Health and 

Systemic Conditions; and Careers in 

Dentistry, Bioengineering, and other 

Non-Medical Disciplines. 

On September 23 the morning session 

will be devoted to reports by the 

working group co-chairs regarding the 

recommendations emerging from 

working group deliberations on the 

previous day. The meeting will adjourn 

at 1:15 p.m. on September 23. 

Public Testimony 

The ORWH invites individuals with 

an interest in research related to 

women’s health to provide written and/ 

or oral testimony on these topics and/ 

or on issues related to the sustained 

advancement of women in various 

biomedical careers. Due to time 

constraints, only one representative 

from an organization or professional 

specialty group may give oral testimony. 

Individuals not representing an 

organized entity but a personal point of 

view are similarly invited to present 

written and/or oral testimony. A letter 

of intent to present oral testimony is 

necessary and should be sent 

electronically to http:// 

www.orwhmeetings.com/ 

movingintothefuture/ or by mail to Ms. 

Jory Barone, Educational Services, Inc., 

4350 East-West Highway, Suite 1100, 

Bethesda, MD 20814, no later than 

September 13, 2009. The date of receipt 

of the communication will establish the 

order of those selected to give oral 

testimony at the September meeting. 

Those wishing to present oral 

testimony are also asked to submit a 

written form of their testimony that is 

limited to a maximum of 10 pages, 

double spaced, 12-point font, and 

should include a brief description of 

their organization. Electronic 

submission to the above Web site is 

preferred; however, for those who do 

not have access to electronic means, 

written testimony, bound by the 

restrictions previously noted and 

postmarked no later than September 13, 

2009, can be mailed to Ms. Jory Barone 

at the above address. All written 

presentations must meet the established 


sroberts on DSKD5P82C1PROD with NOTICES