Document ID: FDA-2008-N-0427-0001
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Rates for Fiscal Year 2009
Posted Date: 2008-08-01T04:00Z

[Federal Register: August 1, 2008 (Volume 73, Number 149)]
[Notices]               
[Page 45017-45022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au08-76]                         

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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

[[Page 45018]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Column 1  5-Year
                 Application Type                     Average Base     Column 2  Latest   Column 3  Percent   Column 4  Weighting   Column 5  Weighted %
                                                         Years         5-Year  Average          Change               Factor                Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New drug applications (NDAs)/biologics license                 119.6              123.8                3.5%                35.2%                 1.24%
 applications (BLAs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active INDs                                                   4751.8             5528.2               16.3%                44.2%                 7.22%
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45019]]

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)
----------------------------------------------------------------------------------------------------------------
                                                                                                  Annual Average
   Fiscal Year         2003            2004            2005            2006            2007        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              4.09%           8.59%           5.75%           5.70%           4.05%           5.64%
 Previous Year
----------------------------------------------------------------------------------------------------------------

    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

[[Page 45020]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Column 1  5-Year   Column 2  Latest
                 Application Type                     Average Base     5-Year  Average    Column 3  Percent   Column 4  Weighting   Column 5  Weighted %
                                                    Years 2002-2007       2003- 2008            Change               Factor                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 Activity\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Column 3 %
                                            Column 1  5-    Column 2a       Column 2b      Column 2c  is       Change         Column 4       Column 5
             Application Type               Year Average  Latest 5-Year   Adjustment for     Column 2a      (Column 1 to     Weighting      Weighted %
                                             Base Years   Average 2003-     Changes in      Adjusted by     Column 2c or       Factor         Change
                                             2002-2007         2008      Review Activity     Column 2b           2a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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%
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 45021]]

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 
fee-paying 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 fee-paying 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 one-half 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
----------------------------------------------------------------------------------------------------------------
                                                           Column 2  Fee     Column 3  Total
                                       Column 1  Total    Exempt or Waived      Fee Paying       Column 4  12-
        Application or Action          Received Through       Through            Through        Month Fee-Paying
                                      6[sol]30[sol]2008  6[sol]30[sol]2008  6[sol]30[sol]2008      Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data              102.3               40.3               62.0               82.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical                11.1                4.1                7.0                9.3
 data
----------------------------------------------------------------------------------------------------------------
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.

[[Page 45022]]

                         Table 6--Fee-Paying Full Application Equivalent--5-Year Average
----------------------------------------------------------------------------------------------------------------
                                                                                                        5-Year
            Fiscal Year                 2004         2005         2006         2007         2008       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