[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38451-38456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18457]



[[Page 38451]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0339]


Prescription Drug 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 rates 
for prescription drug user fees for fiscal year (FY) 2010. The Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription 
Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug 
Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), 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 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 2010 
for application fees for an application requiring clinical data 
($1,405,500), for an application not requiring clinical data or a 
supplement requiring clinical data ($702,750), for establishment fees 
($457,200), and for product fees ($77,720). These fees are effective on 
October 1, 2009, and will remain in effect through September 30, 2010. 
For applications and supplements that are submitted on or after October 
1, 2009, the new fee schedule must be used. Invoices for establishment 
and product fees for FY 2010 will be issued in August 2009, 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, 
respectively), 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 
in the Federal Register of October 12, 2007 (72 FR 58103), adjusts it 
for the 2010 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 2010. These fees are effective 
on October 1, 2009, and will remain in effect through September 30, 
2010.

II. Fee Revenue Amount for FY 2010

    The total fee revenue amount for FY 2010 is $569,207,000, 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 sections II.A and II.B of this document. The adjustment 
for inflation is described in section II.C of this document, and the 
adjustment for changes in workload in section II.D of this document.

A. FY 2010 Statutory Fee Revenue Amounts Before Adjustments

    PDUFA IV specifies that the fee revenue amount before adjustments 
for FY 2010 for all fees is $437,783,000 ($392,783,000 specified in 
section 736(b)(1) of the act plus an additional $45,000,000 for drug 
safety in FY 2010 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 FY 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 the first two 
columns 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.

[[Page 38452]]



            Table 1.--Summary Workload Adjuster Calculation to be Applied to PDUFA IV Statutory Base
----------------------------------------------------------------------------------------------------------------
                Column 1  5-Year
 Application   Average Base Years   Column 2  5-Year   Column 3  Percent       Column 4       Column 5  Weighted
     Type            (Ending         Average (Ending         Change        Weighting Factor     Percent Change
               6[sol]30[sol]2002)  6[sol]30[sol]2007)
----------------------------------------------------------------------------------------------------------------
NDAs/                       119.6               123.8              3.5%              35.2%                1.24%
 biologics
 license
 applications
 (BLAs)
----------------------------------------------------------------------------------------------------------------
Active INDs               4,751.8             5,528.2             16.3%              44.2%                7.22%
----------------------------------------------------------------------------------------------------------------
Efficacy                    159.2               163.4              2.6%               7.4%                0.20%
 supplements
----------------------------------------------------------------------------------------------------------------
Manufacturing             2,100.6             2,589.2             23.3%              13.2%                3.07%
 supplements
----------------------------------------------------------------------------------------------------------------
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. Adding 
this amount to the $437,783,000 statutorily specified amount from 
section II.A of this document, results in a total adjusted PDUFA IV 
base revenue amount of $479,412,000, before further adjustment for 
inflation and changes in workload after FY 2007.

C. Inflation Adjustment to FY 2010 Fee Revenue Amount

    PDUFA IV provides that fee revenue amounts for each fiscal year 
after FY 2008 shall be adjusted for inflation. The adjustment must 
reflect the greater of the following amounts: (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 2009. The CPI for June 2009 was 215.693, and the CPI for June 
2008 was 218.815. (These CPI figures are available on the Bureau of 
Labor Statistics Web site at 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.) (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.) 
The CPI for June 2009 is 1.43 percent lower than the CPI for the 
previous 12-month period.
    The second factor is the increase in pay for the previous fiscal 
year (FY 2009 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 at http://www.opm.gov/flsa/oca/09tables/html/dcb.asp above the salary table. (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.) For FY 2009 it was 4.78 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 2003 through 2008). The data on total compensation paid and 
numbers of FTE 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 
5.54 percent.

              Table 2.--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
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                                                                                                  Annual Average
   Fiscal Year         2004            2005            2006            2007            2008        Increase for
                                                                                                  Latest 5 Years
----------------------------------------------------------------------------------------------------------------
Total PC&B            $1,042,749      $1,077,604      $1,114,704      $1,144,369      $1,215,627  ..............
----------------------------------------------------------------------------------------------------------------
Total FTE                 10,141           9,910           9,698           9,569           9,811  ..............
----------------------------------------------------------------------------------------------------------------
PC&B per FTE            $102,825        $108,739        $114,942        $119,591        $123,905  ..............
----------------------------------------------------------------------------------------------------------------
% Change from              8.59%           5.75%           5.70%           4.05%           3.61%           5.54%
 previous year
----------------------------------------------------------------------------------------------------------------

    The inflation increase for FY 2010 is 5.54 percent. This is the 
greater of the CPI change during the 12-month period ending June 30 
preceding the fiscal year for which fees are being set (-1.43 percent), 
the increase in pay for the previous fiscal year (FY 2009 in this case) 
for Federal employees stationed in the Washington, DC metropolitan area 
(4.78 percent), and the average annual change in cost, per FTE FDA 
position, of all personnel compensation and benefits paid for the first 
5 of the previous 6 fiscal years (5.54 percent). Because the average 
change in pay per FTE (5.54 percent) is the highest of the three 
factors, it becomes the inflation

[[Page 38453]]

adjustment for total fee revenue for FY 2010.
    The inflation adjustment for FY 2009 was 5.64 percent. This is the 
greater of the CPI increase during the 12-month period ending June 30 
preceding the fiscal year for which fees were being set (June 30, 2008, 
which was 5.05 percent), the increase in pay for FY 2008 for Federal 
employees stationed in Washington, DC (4.49 percent), or the average 
annual change in cost, per FTE FDA position, of all personnel 
compensation and benefits paid for the first 5 of the previous 6 fiscal 
years (5.64 percent).
    PDUFA IV provides for this inflation adjustment to be cumulative 
and compounded annually after FY 2008 (see section 736(c)(1) of the 
act). This factor for FY 2010 (5.54 percent) is compounded by adding 
one to it and then multiplying it by one plus the inflation adjustment 
factor for FY 2009 (5.64 percent). The result of this multiplication of 
the inflation factors for the 2 years since FY 2008 (1.0554 times 
1.0564 percent) becomes the inflation adjustment for FY 2010. This 
inflation adjustment for FY 2010 is 11.15 percent.
    Increasing the FY 2010 fee revenue base of $479,412,000, by 11.15 
percent yields an inflation-adjusted fee revenue amount for FY 2010 of 
$532,866,000, rounded to the nearest thousand dollars, before the 
application of the FY 2010 workload adjustment.

D. Workload Adjustment to the FY 2010 Inflation Adjusted Fee Revenue 
Amount

    PDUFA IV does not allow FDA to adjust the total revenue amount for 
workload beginning in FY 2010 unless the independent accounting firm 
study is complete (see section 736(c)(2)(C) of the act). That study, 
conducted by Deloitte Touche, LLP, was completed on March 31, 2009, and 
is available online at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm164339.htm. The study found that the 
adjustment methodology used by FDA reasonably captures changes in 
workload for reviewing human drug applications under PDUFA IV. 
Accordingly, FDA continues to use the workload adjustment methodology 
that it utilized in FY 2009, and FDA intends to continue using this 
methodology through the end of PDUFA IV.
    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.
    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 INDs (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, 2009.
    The calculations are summarized in of 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 2a (``5 Year 
Average 2004-2009'').
    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 columns 2b and 2c in table 3 of this 
document. The number in the NDAs/BLAs line of column 2b of table 3 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 2004 through 2009. Likewise, the number in the ``Active 
commercial INDs'' line of column 2b of table 3 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 2004 through 2009. 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.
    Column 3 of table 3 of this document reflects the percent change in 
workload from column 1 to column 2c. 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 3 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 table 3 of this document is the sum of the 
values in column 5 that are added, reflecting an increase in workload 
of 6.82 percent for FY 2010 when compared to the base years.

                                                   Table 3.--Workload Adjuster Calculation for FY 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Column 2b                      Column 3
                                                  Column 1  5-  Column 2a  5-    Adjustment    Column 2c is     Percent        Column 4       Column 5
                Application Type                  Year Average   Year Average   for Changes     Column 2a        Change       Weighting       Weighted
                                                   Base Years     2004-2009      in Review     Increased by   (Column 1 to      Factor        Percent
                                                   2002-2007                      Activity      Column 2b      Column 2c)                      Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs                                                123.8          133.0        -0.73%           132.0          6.6%          34.8%          2.31%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs\1\                              5,528.2        6,078.0        -0.71%         6,035.0          9.2%          44.5%          4.08%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements                                     163.4          169.4        NA               169.4          3.7%           8.7%          0.32%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements                              2,589.2        2,613.6        NA             2,613.6          0.9%          12.0%          0.11%
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 38454]]

 
FY 2010 workload adjuster                                                                                                                         6.82%
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\1\ Table 3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years of 2002-2007
  as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has been corrected in the
  revised number of 5528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY 2009 would have been 3.76
  percent rather than the 2.98 percent published in the Federal Register last year.

    The 2010 workload adjuster reflected in the calculations in table 3 
of this document is 6.82 percent. Therefore the inflation-adjusted 
revenue amount of $532,866,000 from section II.C of this document will 
be increased by the 2010 workload adjuster of 6.82 percent, resulting 
in a total adjusted revenue amount in FY 2010 of $569,207,000, rounded 
to the nearest thousand dollars.

E. Rent and Rent-Related Adjustment to the FY 2010 Adjusted Fee Revenue 
Amount

    PDUFA specifies that for FY 2010 and each subsequent fiscal year, 
the revenue amount will be decreased if the actual cost paid for rent 
and rent-related expenses for preceding fiscal years are less than 
estimates made for such fiscal years in FY 2006 (see section 736(c)(3) 
of the act). The only fiscal year which has been completed, and for 
which FDA has complete data at this time, is FY 2008. Table 4 of this 
document shows the estimates of rent and rent-related costs for FY 2008 
made in 2006 and the actual costs at the end of the fiscal year.

             Table 4.--Comparison of Actual and Estimated Rent and Rent-Related Expenses for FY 2008
----------------------------------------------------------------------------------------------------------------
                                                Estimates Made in 2006           Actual FY 2008 Year-End Costs
----------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research                          $46,732,000                         $51,619,000
 rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and                              $22,295,000                         $26,715,000
 Research rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
TOTAL                                                            $69,027,000                         $78,334,000
----------------------------------------------------------------------------------------------------------------

    Because FY 2008 costs for rent and rent-related items exceeded the 
estimates of these costs made in 2006, no decrease in the FY 2010 
estimated PDUFA revenues is required under this provision of PDUFA.
    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 ($569,207,000), 
i.e., $189,736,000 (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 $189,736,000, rounded to the nearest thousand 
dollars, in FY 2010, as calculated previously in 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 2010, the 5-year rolling average for the most recent 5 years will 
be based on actual counts of fee-paying FAEs received for FY 2005 
through FY 2009. For FY 2009, 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 7 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 2009, 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, 2009. Column 4 
estimates the 12-month total fee-paying FAEs for FY 2009 based on the 
applications received through June 30, 2009. 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.

[[Page 38455]]



 Table 5.--FY 2009 Full Application Equivalents Received Through June 30, 2009, and Projected Through September
                                                    30, 2009
----------------------------------------------------------------------------------------------------------------
                                                           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]2009  6[sol]30[sol]2009  6[sol]30[sol]2009      Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data             88.75               32.75             56                  74.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical              15.5                 4.5              11                  14.7
 data
----------------------------------------------------------------------------------------------------------------
Supplements requiring clinical data              47.5                 8.5              39                  52
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused to file                      0.625               0                 0.625               0.8
----------------------------------------------------------------------------------------------------------------
Total                                           153.375              45.75            106.25              142.2
----------------------------------------------------------------------------------------------------------------

    In the first 9 months of FY 2009, FDA received 153.375 FAEs, of 
which 106.25 were fee-paying. Based on data from the last 10 fiscal 
years, on average, 25 percent of the applications submitted each year 
come in the final 3 months. Dividing 106.25 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 142.2.
    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 2009, is 135.0 FAEs. FDA will set fees for FY 2010 
based on this estimate as the number of full application equivalents 
that will pay fees.

                                                         Table 6.--Fee-Paying FAE 5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Fiscal Year                      2005               2006               2007               2008               2009          5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs                                     121.5              136.7              134.4              140.0              142.2              135.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FY 2010 application fee is estimated by dividing the average 
number of full applications that paid fees over the latest 5 years, 
135.0, into the fee revenue amount to be derived from application fees 
in FY 2010, $189,736,000. The result, rounded to the nearest $100, is a 
fee of $1,405,500 per full application requiring clinical data, and 
$702,750 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 2009, the establishment fee was based on an 
estimate that 400 establishments would be subject to, and would pay, 
fees. By the end of FY 2009, FDA estimates that 450 establishments will 
have been billed for establishment fees, before all decisions on 
requests for waivers or reductions are made. FDA again estimates that a 
total of 20 establishment fee waivers or reductions will be made for FY 
2009. In addition, FDA estimates that another 15 full establishment 
fees will be exempted this year based on the orphan drug exemption in 
FDAAA (see section 736(k) of the act). Subtracting 35 establishments 
(20 waivers plus the estimated 15 establishments under the orphan 
exemption) from 450 leaves a net of 415 fee-paying establishments. FDA 
will use 415 for its FY 2010 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 ($189,736,000) by the estimated 415 
establishments, for an establishment fee rate for FY 2010 of $457,200 
(rounded to the nearest $100).

B. Product Fees

    At the beginning of FY 2009, the product fee was based on an 
estimate that 2,380 products would be subject to and would pay product 
fees. By the end of FY 2009, FDA estimates that 2,450 products will 
have been billed for product fees, before all decisions on requests for 
waivers, reductions, or exemptions are made. FDA assumes that there 
will be about 50 waivers and reductions granted. In addition, FDA 
estimates that another 20 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 
2009, after allowing for waivers and reductions, including the orphan 
drug products eligible under the FDAAA exemption, and will use this 
number for its FY 2010 estimate. Accordingly, the FY 2010 product fee 
rate is determined by dividing the adjusted total fee revenue to be 
derived from product fees ($189,736,000) by the estimated 2,380 
products for a FY 2010 product fee of $79,720 (rounded to the nearest 
$10).

V. Fee Schedule for FY 2010

    The fee rates for FY 2010 are set out in table 7 of this document:

                                Table 7.
------------------------------------------------------------------------
                                                           Fee Rates for
                      Fee Category                            FY 2010
------------------------------------------------------------------------
APPLICATIONS............................................................
  Requiring clinical data...............................      $1,405,500
  Not requiring clinical data...........................        $702,750
  Supplements requiring clinical data...................        $702,750
ESTABLISHMENTS..........................................        $457,200
PRODUCTS................................................         $79,720
------------------------------------------------------------------------

VIII. Fee Payment Options and Procedures

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, 2009. 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 identification (ID) number on your

[[Page 38456]]

check, bank draft, or postal money order. 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, bank draft, or postal money order.
    Wire transfer payment may also be used. Please reference your 
unique user fee ID number when completing your transfer. 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 fee is 
fully paid. The account information is as follows: 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.
    Application fees can also be paid online with an electronic check 
(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. The Pay.gov feature is available on the FDA Web site after the 
user fee ID number is generated.
    The tax identification number of the Food and Drug Administration 
is 53-0196965.

B. Establishment and Product Fees

    FDA will issue invoices for establishment and product fees for FY 
2010 under the new fee schedule in August 2009. Payment will be due on 
October 1, 2009. FDA will issue invoices in November 2010 for any 
products and establishments subject to fees for FY 2010 that qualify 
for fees after the August 2009 billing.

    Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18457 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S