Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45017 

• 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. 

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 

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. 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 2009 until it has completed the 

steps in this section to register and pay 

any applicable fee (see 21 U.S.C. 

379j(f)(2)). 

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 in this section. After 

creating a user name and password, log 

onto the Annual Facility User Fee 2009 

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 DFUF Order 

Unless paying by credit card, all 

payments must be in U. S. currency and 

drawn on a U.S. bank. 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. 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 numbers 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. 

Wire transfers may also be used to pay 

annual establishment fees. For wire 

transfer information, please contact the 

user fee helpdesk at 301–827–9539 or 

userfees@fda.gov. 

C. Step Three—Complete the 

Information Online to Update Your 

Establishment’s Annual Registration for 

FY 2009, or to Register a New 

Establishment for FY 2009 

Go to CDRH’s Web site at http:// 

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

click the ‘‘Electronic Registration and 

Listing System (FURLS)’’ link on the left 

of the page. This opens up a new page 

with important information about 

FURLS. After reading this information 

click on the link at the bottom of the 

page. That 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 2008. 

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 

you have any problems with this 

process, e-mail reglist@cdrh.fda.gov or 

call 240–276–0111 for assistance. 

(Note: This e-mail address and phone 

number are for assistance with 

establishment registration only, and not 

for any other aspects of medical device 

user fees.) 

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. Fees are only required for 

those establishments defined in section 

I of this document. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17739 Filed 7–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0427] 

Prescription Drug User Fee Rates for 

Fiscal Year 2009 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

rates for prescription drug user fees for 

fiscal year (FY) 2009. The Federal Food, 

Drug, and Cosmetic Act (the act), as 

amended by the Prescription Drug User 

Fee Amendments of 2007 (PDUFA IV) 

(Title 1 of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA)), authorizes FDA to 

collect user fees for certain applications 

for approval of drug and biological 

products, on establishments where the 

products are made, and on such 

products. Base revenue amounts to be 

generated from PDUFA fees were 

established by PDUFA IV, with 

provisions for certain adjustments. Fee 

revenue amounts for applications, 

establishments, and products are to be 

established each year by FDA so that 

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45018 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

one-third of the PDUFA fee revenues 

FDA collects each year will be generated 

from each of these categories. This 

notice establishes fee rates for FY 2009 

for application fees for an application 

requiring clinical data ($1,247,200), for 

an application not requiring clinical 

data or a supplement requiring clinical 

data ($623,600), for establishment fees 

($425,600), and for product fees 

($71,520). These fees are effective on 

October 1, 2008, and will remain in 

effect through September 30, 2009. For 

applications and supplements that are 

submitted on or after October 1, 2008, 

the new fee schedule must be used. 

Invoices for establishment and product 

fees for FY 2009 will be issued in 

August 2008, using the new fee 

schedule. 

FOR FURTHER INFORMATION CONTACT: 

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 

Sections 735 and 736 of the act (21 

U.S.C. 379g and 379h), establish three 

different kinds of user fees. Fees are 

assessed on the following: (1) Certain 

types of applications and supplements 

for approval of drug and biological 

products, (2) certain establishments 

where such products are made, and (3) 

certain products (section 736(a) of the 

act). When certain conditions are met, 

FDA may waive or reduce fees (section 

736(d) of the act). 

For FY 2008 through FY 2012, the 

base revenue amounts for the total 

revenues from all PDUFA fees are 

established by PDUFA IV. The base 

revenue amount for FY 2008 is to be 

adjusted for workload, and that adjusted 

amount becomes the base amount for 

the remaining 4 fiscal years. That 

adjusted base revenue amount is 

increased for drug safety enhancements 

by $10,000,000 in each of the 

subsequent 4 fiscal years, and the 

increased total is further adjusted each 

year for inflation and workload. Fees for 

applications, establishments, and 

products are to be established each year 

by FDA so that revenues from each 

category will provide one-third of the 

total revenue to be collected each year. 

This notice uses the fee base revenue 

amount for FY 2008 published on 

October 12, 2007 (72 FR 58103), adjusts 

it for the 2009 drug safety increase (see 

section 736(b)(4) of the act), for 

inflation, and for workload, and then 

establishes the application, 

establishment, and product fees for FY 

2009. These fees are effective on 

October 1, 2008, and will remain in 

effect through September 30, 2009. 

II. Fee Revenue Amount for FY 2009 

The total fee revenue amount for FY 

2009 is $510,665,000, based on the fee 

revenue amount specified in the statute, 

including additional fee funding for 

drug safety and adjustments for inflation 

and changes in workload. The statutory 

amount and a one-time base adjustment 

are described in section II.A and II.B of 

this document. The adjustment for 

inflation is described in section II.C, and 

the adjustment for changes in workload 

in section II.D. 

A. FY 2009 Statutory Fee Revenue 

Amounts Before Adjustments 

PDUFA IV specifies that the fee 

revenue amount before adjustments for 

FY 2009 for all fees is $427,783,000 

($392,783,000 specified in section 

736(b)(1) of the act, plus an additional 

$35,000,000 for drug safety in FY 2009 

specified in section 736(b)(4) of the act). 

B. Base Adjustment to Statutory Fee 

Revenue Amount 

The statute also specifies that 

$354,893,000 of the base amount is to be 

further adjusted for workload increases 

through FY 2007 (see section 

736(b)(1)(B) of the act). The adjustment 

on this amount is to be made in 

accordance with the workload 

adjustment provisions that were in 

effect for FY 2007, except that the 

adjustment for investigational new drug 

(IND) workload is based on the number 

of INDs with a submission in the 

previous 12 months, rather than on the 

number of new commercial INDs 

submitted in the same 12-month period. 

For each fiscal year beginning in FY 

2004, the Prescription Drug User Fee 

Amendments of 2002 (PDUFA III) 

provided that fee revenue amounts, after 

they had been adjusted for inflation, 

should be further adjusted to reflect 

changes in workload for the process for 

the review of human drug applications 

(see section 736(c)(2) of the act). The 

conference report accompanying 

PDUFA III, House of Representatives 

Report number 107–481, provides 

guidance on how the workload 

adjustment provision of PDUFA III is to 

be implemented. Following that 

guidance, FDA calculated the average 

number of each of the four types of 

submissions specified in the workload 

adjustment provision (human drug 

applications, commercial INDs, efficacy 

supplements, and manufacturing 

supplements) received over the 5-year 

period that ended on June 30, 2002 

(base years), and the average number of 

each of these types of applications over 

the most recent 5-year period that ended 

June 30, 2007. PDUFA IV directs that 

this same method be used in making the 

workload adjustment apply to the 2008 

statutory revenue amount, except that 

for this calculation the number of 

commercial INDs with a submission in 

the previous 12 months is used for each 

12-month period rather than the number 

of new commercial INDs submitted (see 

section 736(b) of the act, as amended by 

PDUFA IV). 

The results of these calculations are 

presented in Columns 1 and 2 of Table 

1 of this document. Column 3 reflects 

the percent change in workload over the 

two 5-year periods. Column 4 shows the 

weighting factor for each type of 

application, estimating how much of the 

total FDA drug review workload was 

accounted for by each type of 

application in the table during the most 

recent 5 years. Column 5 of Table 1 of 

this document is the weighted percent 

change in each category of workload. 

This was derived by multiplying the 

weighting factor in each line in Column 

4 by the percent change from the base 

years in Column 3. At the bottom right 

of the table the sum of the values in 

Column 5 is added, reflecting a total 

increase in workload of 11.73 percent 

when compared to the base years. 

TABLE 1—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO FY 2009 STATUTORY BASE

Application Type 

Column 1 

5-Year Average 

Base Years 

Column 2 

Latest 5-Year 

Average 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted % Change 

New drug applications 

(NDAs)/biologics license 

applications (BLAs) 119 .6 123 .8 3 .5% 35 .2% 1 .24% 

Active INDs 4751 .8 5528 .2 16 .3% 44 .2% 7 .22% 

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Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45019 

TABLE 1—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO FY 2009 STATUTORY BASE—Continued 

Application Type 

Column 1 

5-Year Average 

Base Years 

Column 2 

Latest 5-Year 

Average 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted % Change 

Efficacy supplements 159 .2 163 .4 2 .6% 7 .4% 0 .20% 

Manufacturing supplements 2100 .6 2589 .2 23 .3% 13 .2% 3 .07% 

FY 2008 workload adjuster to be applied to the statutory base 11 .73% 

Increasing the PDUFA IV statutorily 

specified amount of $354,893,000 by the 

specified workload adjuster (11.73 

percent) results in an increase of 

$41,629,000, rounded to the nearest 

thousand dollars. Adding this amount to 

the $427,783,000 statutorily specified 

amount from section II.A of this 

document, results in a total adjusted 

PDUFA IV base revenue amount of 

$469,412,000, before further adjustment 

for inflation and changes in workload 

after FY 2007. 

C. Inflation Adjustment to FY 2009 Fee 

Revenue Amount 

PDUFA IV provides that fee revenue 

amounts for each fiscal year after 2008 

shall be adjusted for inflation. The 

adjustment must reflect the greater of: 

(1) The total percentage change that 

occurred in the Consumer Price Index 

(CPI) (all items; U.S. city average) 

during the 12-month period ending June 

30 preceding the fiscal year for which 

fees are being set; (2) the total 

percentage pay change for the previous 

fiscal year for Federal employees 

stationed in the Washington, DC 

metropolitan area; or (3) the average 

annual change in cost, per full time 

equivalent (FTE) FDA position, of all 

personnel compensation and benefits 

paid for the first 5 of the previous 6 

fiscal years. PDUFA IV provides for this 

annual adjustment to be cumulative and 

compounded annually after FY 2008 

(see section 736(c)(1) of the act). 

The first factor is the CPI increase for 

the 12-month period ending in June 

2008. The CPI for June 2008 was 

218.815, and the CPI for June 2007 was 

208.352. (These CPI figures are available 

on the Bureau of Labor statistics Web 

site, http://data.bls.gov/cgi-bin/ 

surveymost?bls by checking the first box 

under ‘‘Price Indexes’’ and then clicking 

‘‘Retrieve Data’’ at the bottom of the 

page.) The CPI for June 2008 is 5.05 

percent higher than the CPI for the 

previous 12-month period. 

The second factor is the increase in 

pay for the previous fiscal year (FY 2008 

in this case) for Federal employees 

stationed in the Washington, DC 

metropolitan area. This figure is 

published by the Office of Personnel 

Management, and found on their Web 

site, http://www.opm.gov/oca/08tables/ 

html/dcb.asp, above the salary table. For 

FY 2008 it was 4.49 percent. 

The third factor is the average change 

in FDA cost for compensation and 

benefits per FTE over the previous 5 of 

the most recent 6 fiscal years (FY 2002 

through FY 2007). The data on total 

compensation paid and number of FTEs 

paid, from which the average cost per 

FTE can be derived, are published in 

FDA’s Justification of Estimates for 

Appropriations Committees. Table 2 of 

this document summarizes that actual 

cost and FTE use data for the specified 

fiscal years, and provides the percent 

change from the previous fiscal year and 

the average percent change over the 

most 5 recent fiscal years, which is 5.64 

percent. 

TABLE 2—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE ($000) 

Fiscal Year 2003 2004 2005 2006 2007 

Annual Average Increase 

for Latest 5 

Years 

Total PC&B $971,255 $1,042,749 $1,077,604 $1,114,704 $1,144,369 

Total FTEs 10257 10141 9910 9698 9569 

PC&B per FTE $94.692 $102.825 $108.739 $114,942 $119.591 

% Change from Previous Year 4.09% 8.59% 5.75% 5.70% 4.05% 5.64% 

Because the average change in pay per 

FTE (5.64 percent) is the highest of the 

three factors, it becomes the inflation 

adjustment for total fee revenue for FY 

2009. Increasing the FY 2009 fee 

revenue base of $469,412,000 by 5.64 

percent yields an inflation-adjusted fee 

revenue amount for FY 2009 of 

$495,887,000, rounded to the nearest 

thousand dollars, before addition of the 

FY 2009 workload adjustment. 

D. Workload Adjustment to the FY 2009 

Inflation Adjusted Fee Revenue Amount 

For each fiscal year beginning in FY 

2009, PDUFA IV provides that fee 

revenue amounts, after they have been 

adjusted for inflation, shall be further 

adjusted to reflect changes in workload 

for the process for the review of human 

drug applications (see section 736(c)(2) 

of the act). PDUFA IV continues the 

PDUFA III workload adjustment with 

modifications, and provides for a new 

additional adjustment for changes in 

review activity. PDUFA IV also specifies 

that for FY 2009 the additional 

adjustment for changes in review 

activity may not result in a total 

workload adjustment that is more than 

2 percentage points higher than it would 

have been in the absence of the 

adjustment for changes in review 

workload (see section 736(c)(2)(B) of the 

act). 

Therefore, FDA will first calculate the 

FY 2009 workload adjustment without 

the PDUFA IV adjustment for changes in 

review activity. Then FDA will apply 

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45020 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

the adjustment for changes in review 

activity, to determine if the total 

workload adjustment is no more than 2 

percentage points higher than it would 

have been in the absence of the 

adjustment for changes in review 

activity. 

In calculating the FY 2009 workload 

adjustment without the PDUFA IV 

adjustment for changes in review 

activity, FDA will follow the guidance 

provided in the conference report 

accompanying the Prescription Drug 

User Fee Amendments of 2002, House 

of Representatives Report number 107–

481, using active commercial INDs 

rather than newly submitted 

commercial INDs as the surrogate for 

IND workload, as specified by PDUFA 

IV. 

FDA calculated the average number of 

each of the four types of applications 

specified in the workload adjustment 

provision: (1) Human drug applications, 

(2) active commercial investigational 

new drug applications (applications that 

have at least one submission during the 

previous 12 months), (3) efficacy 

supplements, and (4) manufacturing 

supplements received over the 5-year 

period that ended on June 30, 2007 

(base years), and the average number of 

each of these types of applications over 

the most recent 5-year period that ended 

June 30, 2008. 

The calculations are summarized in 

Table 3 of this document. The 5-year 

averages for each application category 

are provided in Column 1 (5-Year 

Average Base Years 2002–2007) and 

Column 2 (Latest 5-Year Average 2003–

2008). Column 3 reflects the percent 

change in workload from Column 1 to 

Column 2. Column 4 shows the 

weighting factor for each type of 

application, estimating how much of the 

total FDA drug review workload was 

accounted for by each type of 

application in the table during the most 

recent 5 years. Column 5 of Table 1 is 

the weighted percent change in each 

category of workload. This was derived 

by multiplying the weighting factor in 

each line in Column 4 by the percent 

change from the base years in Column 

3. At the bottom right of Table 3 of this 

document is the sum of the values in 

Column 5 that are added, reflecting an 

increase in workload of 2.98 percent for 

FY 2009 when compared to the base 

years, but before taking into account the 

impact of change in review activity. 

TABLE 3—PRELIMINARY WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITHOUT ADJUSTMENT FOR CHANGES IN

REVIEW ACTIVITY

Application Type 

Column 1 

5-Year Average 

Base Years 2002–

2007 

Column 2 

Latest 5-Year 

Average 2003–

2008 

Column 3 

Percent Change 

Column 4 

Weighting Factor 

Column 5 

Weighted % Change 

NDAs/BLAs 123 .8 128 .4 3 .7% 33 .3% 1 .24% 

Active commercial INDs 5755 .8 5897 .6 2 .5% 45 .2% 1 .11% 

Efficacy supplements 163 .4 173 .0 5 .9% 8 .3% 0 .49% 

Manufacturing supplements 2589 .2 2616 .2 1 .0% 13 .2% 0 .14% 

FY 2009 workload adjuster without adjustment changes for review activity 2 .98% 

PDUFA IV specifies that FDA make 

additional adjustments for changes in 

review activities to the first two 

categories (human drug applications 

and active commercial INDs). These 

adjustments, specified under PDUFA IV, 

are summarized in the new Columns 2b 

and 2c in Table 4 of this document. The 

number in the NDAs/BLAs line of 

Column 2b of Table 4 of this document 

is the percent by which the average 

workload for meetings, annual reports, 

and labeling supplements for NDAs and 

BLAs has changed from the 5-year 

period 2002 through 2007 to the 5-year 

period 2003 through 2008. Likewise, the 

number in the active commercial INDs 

line of Column 2b of Table 4 of this 

document is the percent by which the 

workload for meetings and special 

protocol assessments for active 

commercial INDs has changed from the 

5-year period 2002 through 2007 to the 

5-year period 2003 through 2008. There 

is no entry in the last two lines of 

column 2b because the adjustment for 

changes in review workload does not 

apply to the workload for efficacy 

supplements and manufacturing 

supplements. 

TABLE 4—FINAL WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITH ADJUSTMENT FOR CHANGES IN REVIEW

ACTIVITY1

Application Type 

Column 1 

5-Year Average Base 

Years 2002–

2007 

Column 2a 

Latest 5-Year 

Average 

2003–2008 

Column 2b 

Adjustment for 

Changes in Review Activity 

Column 2c 

is Column 2a Adjusted by Column 

2b 

Column 3 % 

Change 

(Column 1 to 

Column 2c or 

2a) 

Column 4 

Weighting 

Factor 

Column 5 

Weighted % 

Change 

NDAs/BLAs 123 .8 128 .4 -0 .55% 127 .7 3 .1% 33 .3% 1 .05 

Active commercial INDs 5755 .8 5897 .6 +0 .39% 5920 .6 2 .9% 45 .2% 1 .31 

Efficacy supplements 163 .4 173 .0 NA 173 .3 5 .9% 8 .3% 0 .49% 

Manufacturing 

supplements 2589 .2 2516 .2 NA 2616 .2 1 .0% 13 .2% 0 .14% 

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TABLE 4—FINAL WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITH ADJUSTMENT FOR CHANGES IN REVIEW

ACTIVITY1—Continued 

Application Type 

Column 1 

5-Year Average Base 

Years 2002–

2007 

Column 2a 

Latest 5-Year 

Average 

2003–2008 

Column 2b 

Adjustment for 

Changes in Review Activity 

Column 2c 

is Column 2a Adjusted by Column 

2b 

Column 3 % 

Change 

(Column 1 to 

Column 2c or 

2a) 

Column 4 

Weighting 

Factor 

Column 5 

Weighted % 

Change 

FY 2009 workload adjuster with adjustment changes for review activity 2 .98% 

1 Numbers may not add due to rounding. 

The 2009 workload adjuster with 

adjustment for changes in review 

activity at the bottom of Table 4 of this 

document is 2.98 percent exactly the 

same as the workload adjuster without 

those changes at the bottom of Table 3 

of this document. Therefore the 

inflation-adjusted revenue amount of 

$495,887,000 from section II.B of this 

document will be multiplied by the 

2009 workload adjuster of 2.98 percent, 

resulting in a total adjusted revenue 

amount in FY 2009 of $510,665,000, 

rounded to the nearest thousand dollars. 

PDUFA specifies that one-third of the 

total fee revenue is to be derived from 

application fees, one-third from 

establishment fees, and one-third from 

product fees (see section 736(b)(2) of the 

act). Accordingly, one-third of the total 

revenue amount, or $ 170,222,000, 

rounded to the nearest thousand dollars, 

is the total amount of fee revenue that 

will be derived from each of these fee 

categories. 

III. Application Fee Calculations 

A. Application Fee Revenues and 

Application Fees 

Application fees will be set to 

generate one-third of the total fee 

revenue amount, or $170,222,000, 

rounded to the nearest thousand dollars, 

in FY 2009, as calculated in section II.D 

of this document. 

B. Estimate of Number of Fee-Paying 

Applications and Establishment of 

Application Fees 

For FY 2008 through FY 2012, FDA 

will estimate the total number of feepaying full application equivalents 

(FAEs) it expects to receive the next 

fiscal year by averaging the number of 

fee-paying FAEs received in the 5 most 

recent fiscal years. This use of the 

rolling average of the 5 most recent 

fiscal years is the same method that has 

applied for the last 6 years. 

In estimating the number of feepaying FAEs that FDA will receive in 

FY 2009, the 5-year rolling average for 

the most recent 5 years will be based on 

actual counts of fee-paying FAEs 

received for FY 2004 through FY 2008. 

For FY 2008, FDA is estimating the 

number of fee-paying FAEs for the full 

year based on the actual count for the 

first 9 months and estimating the 

number for the final 3 months, as we 

have done for the past 6 years. 

Table 5 of this document shows, in 

Column 1, the total number of each type 

of FAE received in the first 9 months of 

FY 2008, whether fees were paid or not. 

Column 2 shows the number of FAEs for 

which fees were waived or exempted 

during this period, and Column 3 shows 

the number of fee-paying FAEs received 

through June 30, 2008. Column 4 

estimates the 12-month total fee-paying 

FAEs for FY 2008 based on the 

applications received through June 30, 

2008. All of the counts are in FAEs. A 

full application requiring clinical data 

counts as one FAE. An application not 

requiring clinical data counts as onehalf an FAE, as does a supplement 

requiring clinical data. An application 

that is withdrawn, or refused for filing, 

counts as one-fourth of an FAE if the 

applicant initially paid a full 

application fee, or one-eighth of an FAE 

if the applicant initially paid one-half of 

the full application fee amount. 

TABLE 5—FY 2008 FULL APPLICATION EQUIVALENTS RECEIVED THROUGH JUNE 30, 2008, AND PROJECTED THROUGH

SEPTEMBER 30, 2008 

Application or Action 

Column 1 

Total Received 

Through 

6/30/2008 

Column 2 

Fee Exempt or 

Waived Through 

6/30/2008 

Column 3 

Total Fee Paying 

Through 

6/30/2008 

Column 4 

12-Month FeePaying Projection 

Applications requiring clinical data 102 .3 40 .3 62 .0 82 .7 

Applications not requiring clinical data 11 .1 4 .1 7 .0 9 .3 

Supplements requiring clinical data 45 .0 6 .0 39 .0 52 .0 

Withdrawn or refused to file 0 .5 0 0 .5 0 .7 

Total 158 .9 50 .4 108 .5 144 .7 

In the first 9 months of FY 2008, FDA 

received 158.9 FAEs, of which 108.5 

were fee-paying. Based on data from the 

last 9 fiscal years, on average, 25 percent 

of the applications submitted each year 

come in the final 3 months. Dividing 

108.5 by 3 and multiplying by 4 

extrapolates the amount to the full 12 

months of the fiscal year and projects 

the number of fee-paying FAEs in FY 

2008 at 144.7. 

As Table 6 of this document shows, 

the average number of fee-paying FAEs 

received annually in the most recent 5- 

year period, and including our estimate 

for FY 2008, is 136.5 FAEs. FDA will set 

fees for FY 2009 based on this estimate 

as the number of FAEs that will pay 

fees. 

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45022 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

TABLE 6—FEE-PAYING FULL APPLICATION EQUIVALENT—5-YEAR AVERAGE

Fiscal Year 2004 2005 2006 2007 2008 5-Year 

Average 

Fee-Paying FAEs 145.1 121.5 136.7 134.4 144.7 136.5 

The FY 2009 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest 5 years, 136.5, into 

the fee revenue amount to be derived 

from application fees in FY 2009, 

$170,222,000. The result, rounded to the 

nearest $100, is a fee of $1,247,200 per 

full application requiring clinical data, 

and $623,600 per application not 

requiring clinical data or per 

supplement requiring clinical data. 

IV. Fee Calculations for Establishment 

and Product Fees 

A. Establishment Fees 

At the beginning of FY 2008, the 

establishment fee was based on an 

estimate that 390 establishments would 

be subject to, and would pay, fees. By 

the end of FY 2008, FDA estimates that 

435 establishments will have been 

billed for establishment fees, before all 

decisions on requests for waivers or 

reductions are made. As in previous 

years, FDA again estimates that a total 

of 25 establishment fee waivers or 

reductions will be made for FY 2008. In 

addition, FDA estimates that another 10 

full establishment fees will be exempted 

this year based on the orphan drug 

exemption in the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (see section 736(k) of the 

act). Subtracting 35 establishments (25 

plus the estimated 10 establishments 

under the orphan exemption) from 435 

leaves a net of 400 fee-paying 

establishments. FDA will use 400 for its 

FY 2009 estimate of establishments 

paying fees, after taking waivers and 

reductions into account. The fee per 

establishment is determined by dividing 

the adjusted total fee revenue to be 

derived from establishments 

($170,222,000) by the estimated 400 

establishments, for an establishment fee 

rate for FY 2009 of $425,600 (rounded 

to the nearest $100). 

B. Product Fees 

At the beginning of FY 2008, the 

product fee was based on an estimate 

that 2,355 products would be subject to, 

and would pay, product fees. By the end 

of FY 2008, FDA estimates that 2,450 

products will have been billed for 

product fees, before all decisions on 

requests for waivers or reductions are 

made. FDA assumes that there will be 

about 40 waivers and reductions 

granted, the same amount estimated last 

year. In addition, FDA estimates that 

another 30 product fees will be 

exempted this year based on the orphan 

drug exemption in FDAAA (see section 

736(k) of the act). FDA estimates that 

2,380 products will qualify for product 

fees in FY 2008, after allowing for 

waivers and reductions, including the 

orphan drug products eligible under the 

FDAAA exemption, and will use this 

number for its FY 2009 estimate. 

Accordingly, the FY 2009 product fee 

rate is determined by dividing the 

adjusted total fee revenue to be derived 

from product fees ($170,222,000) by the 

estimated 2,380 products for a FY 2009 

product fee of $71,520 (rounded to the 

nearest $10). 

V. Fee Schedule for FY 2009 

The fee rates for FY 2009 are set out 

in Table 7 of this document. 

TABLE 7 

Fee Category Fee Rates for 

FY 2009 

APPLICATIONS 

Requiring clinical data $1,247,200 

Not requiring clinical data $623,600 

Supplements requiring 

clinical data 

$623,600 

ESTABLISHMENTS $425,600 

PRODUCTS $71,520 

VI. Implementation of Adjusted Fee 

Schedule 

A. Application Fees 

The appropriate application fee 

established in the new fee schedule 

must be paid for any application or 

supplement subject to fees under 

PDUFA that is received after September 

30, 2008. Payment must be made in U.S. 

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

postal money order payable to the order 

of the Food and Drug Administration. 

Please include the user fee ID number 

on your check. Your payment can be 

mailed to: Food and Drug 

Administration, P.O. Box 70963, 

Charlotte, NC 28272–0963. 

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 70963, 1525 

West WT Harris Blvd., rm. NC0810, 

Charlotte, NC 28262. (Note: This 

Wachovia Bank address is for courier 

delivery only.) 

Please make sure that the FDA post 

office box number (P.O. Box 70963) is 

written on the check. The tax 

identification number of the Food and 

Drug Administration is 53–0196965. 

Wire transfer payment may also be 

used. The routing and transit number is 

021030004 and the account number is 

75060099. 

B. Establishment and Product Fees 

FDA will issue invoices for 

establishment and product fees for FY 

2009 under the new fee schedule in 

August 2008. Payment will be due on 

October 1, 2008. FDA will issue 

invoices in November 2009 for any 

products and establishments subject to 

fees for FY 2009 that qualify for fees 

after the August 2008 billing. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17738 Filed 7–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Council on Alcohol 

Abuse and Alcoholism. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

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