[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Notices]
[Pages 46952-46957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19116]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0390]


Prescription Drug User Fee Rates for Fiscal Year 2011

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) 2011. 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

[[Page 46953]]

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 2011 for 
application fees for an application requiring clinical data 
($1,542,000), for an application not requiring clinical data or a 
supplement requiring clinical data ($771,000), for establishment fees 
($497,200), and for product fees ($86,520). These fees are effective on 
October 1, 2010, and will remain in effect through September 30, 2011. 
For applications and supplements that are submitted on or after October 
1, 2010, the new fee schedule must be used. Invoices for establishment 
and product fees for FY 2011 will be issued in August 2010, using the 
new fee schedule.

FOR FURTHER INFORMATION CONTACT:  David Miller, Office of Financial 
Management (HFA-100), Food and Drug Administration, 1350 Picard Dr., 
PI50 RM210J, Rockville, MD 20850, 301-796-7103.

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 FY 2010 and FY 2011 drug safety increases (see section 
736(b)(4) of the act), for inflation, and for workload, and then 
establishes the application, establishment, and product fees for FY 
2011. These fees are effective on October 1, 2010, and will remain in 
effect through September 30, 2011.

II. Fee Revenue Amount for FY 2011

    The total fee revenue amount for FY 2011 is $619,070,000, 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 2011 Statutory Fee Revenue Amounts Before Adjustments

    PDUFA IV specifies that the fee revenue amount before adjustments 
for FY 2011 for all fees is $447,783,000 ($392,783,000 specified in 
section 736(b)(1) of the act plus an additional $55,000,000 for drug 
safety in FY 2011 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 workload 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. 
This adjustment was explained in detail in the Federal Register of 
October 12, 2007 (72 FR 58103). Increasing the 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 $447,783,000 statutorily specified 
amount from section II.A of this document, results in a total adjusted 
PDUFA IV base revenue amount of $489,412,000, before further adjustment 
for inflation and changes in workload after FY 2007.

C. Inflation Adjustment to FY 2011 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 2010. The CPI for June 2010 was 217.965 and the CPI for June 
2009 was 215.693. (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 2010 is 1.053 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 2010 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/oca/10tables/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 2010 it was 2.42 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 2004 through 2009). The data on total compensation paid and 
numbers of FTE

[[Page 46954]]

paid, from which the average cost per FTE can be derived, are published 
in FDA's Justification of Estimates for Appropriations Committees. 
Table 1 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 4.53 percent.

                                  Table 1.--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                         Annual Average
                   Fiscal Year                          2005             2006             2007             2008             2009          Increase for
                                                                                                                                         Latest 5 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B                                             $1,077,604       $1,114,704       $1,144,369       $1,215,627       $1,464,445  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total FTE                                                   9,910            9,698            9,569             9811           11,413  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
PC&B per FTE                                             $108,739         $114,942         $119,591         $123,905         $128,314  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
% Change from Previous Year                                 5.75%            5.70%            4.05%            3.61%            3.56%              4.53%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The inflation increase for FY 2011 is 4.53 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 (1.053 percent), 
the increase in pay for the previous fiscal year (FY 2010 in this case) 
for Federal employees stationed in the Washington, DC metropolitan area 
(2.42 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 (4.53 percent). Because the average 
change in pay per FTE (4.53 percent) is the highest of the three 
factors, it becomes the inflation adjustment for total fee revenue for 
FY 2011.
    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).
    The inflation adjustment for FY 2010 was 5.54 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, 2009) 
(negative 1.43 percent), the increase in pay for FY 2009 for Federal 
employees stationed in Washington, DC (4.78 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 (5.54 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 2011 (4.53 percent) is compounded by adding 
one to it and then multiplying it by one plus the inflation adjustment 
factor for FY 2010 (5.54 percent) and by one plus the inflation 
adjustment factor for FY 2009 (5.64 percent). The result of this 
multiplication of the inflation factors for the 3 years since FY 2008 
(1.04.53 times 1.0554 times 1.0564 percent) becomes the inflation 
adjustment for FY 2011. This inflation adjustment for FY 2010 is 16.54 
percent.
    Increasing the FY 2011 fee revenue base of $489,412,000, by 16.54 
percent yields an inflation-adjusted fee revenue amount for FY 2011 of 
$570,371,000, rounded to the nearest thousand dollars, before the 
application of the FY 2011 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 
prescribed in 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, 2010.
    The calculations are summarized in table 2 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 2006-2010'').
    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 2 of this 
document. The number in the NDAs/BLAs line of column 2b of table 2 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 2006 through 2010. Likewise, the number in the ``Active 
commercial INDs'' line of column 2b of table 2 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 2006 through 2010. There 
is no entry in the last two lines of column 2b because

[[Page 46955]]

the adjustment for changes in review workload does not apply to the 
workload for efficacy supplements and manufacturing supplements.
    Column 3 of table 2 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 2 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 2 of this document is the sum of the 
values in column 5 that are added, reflecting an increase in workload 
of 8.54 percent for FY 2011 when compared to the base years.

                                                   Table 2.--Workload Adjuster Calculation for FY 2011
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Column 1        Column 2a       Column 2b       Column 2c       Column 3        Column 4        Column 5
                                         ---------------------------------------------------------------------------------------------------------------
                                                                          Adjustment for
            Application Type              5-Year Average  5-Year Average    Changes in     is Column 2a   Percent Change     Weighting       Weighted
                                            Base Years       2006-2010        Review       increased by    (Column 1 to       Factor      Percent Change
                                             2002-2007                       Activity        Column 2b      Column 2c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs                                          123.8           134.8          -0.49%           134.1            8.4%           33.9%           2.83%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs                           5,528.2          6320.0          -1.60%          6218.7           12.5%           43.7%           5.46%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy Supplements                               163.4           164.4              NA           164.4            0.6%            9.6%           0.06%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing Supplements                         2589.2          2628.6              NA          2628.6            1.5%           12.8%           0.19%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2011 Workload Adjuster                                                                                                                          8.54%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The 2011 workload adjuster reflected in the calculations in table 3 
of this document is 8.54 percent. Therefore the inflation-adjusted 
revenue amount of $570,376,000 from section II.C of this document will 
be increased by the 2011 workload adjuster of 8.54 percent, resulting 
in a total adjusted revenue amount in FY 2011 of $619,070,000, rounded 
to the nearest thousand dollars.
    While the fee revenue amount anticipated in FY 2011 is 
$619,070,000, as the previous paragraph shows, FDA assumes that the fee 
appropriation for FY 2011 will be 5 percent higher, or $650,024,000, 
rounded to the nearest thousand dollars. The PDUFA IV 5-Year Financial 
Plan, (which can be found at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm153456.htm) states in Assumption 14 (Fee 
Revenue and Annual Appropriation Amount) that the PDUFA workload 
adjuster is a lagging adjustment dampened by averages over 5 years and 
will not help FDA keep up with workload if there are sudden increases 
in the number of applications to be reviewed in the current fiscal 
year. Appropriated amounts for PDUFA fee revenue each year are 
estimated at 5 percent higher than estimated fee revenues for each 
year, to provide FDA with the ability to cope with surges in 
application review workload should that occur. If FDA collects less 
than the fee estimate at the beginning of the year and less than the 
fee appropriation, then collections rather than appropriations set the 
upper limit on how much FDA may actually keep and spend. If, however, 
FDA collects more than fee estimates at the beginning of the year, due 
to a workload surge, a slightly higher fee appropriation will permit 
FDA to keep and spend the higher collections in order to respond to a 
very real surge in review workload that caused the increased 
collections--an unexpected increase in the number of applications that 
FDA must review in accord with PDUFA goals. For this reason, in most 
fiscal years since 1993, actual appropriations have slightly exceeded 
PDUFA fee revenue estimates made each year.

E. Rent and Rent-Related Adjustment to the FY 2011 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 years which have been completed, and for 
which FDA has data at this time, are FY 2008 and FY 2009. Table 3 of 
this document shows the estimates of rent and rent-related costs for FY 
2008 and FY 2009 made in 2006 and the actual costs for these two fiscal 
years.

  Table 3.--Comparison of Actual and Estimated Rent and Rent-Related Expenses for the Center for Drug Evaluation and Research (CDER) and the Center for
                                                        Biologics Evaluation and Research (CBER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Estimates Made in 2006                        Actual Costs at Fiscal Year End
                                                   -----------------------------------------------------------------------------------------------------
                                                        FY 2008          FY 2009           Total           FY 2008          FY 2009           Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER                                                    $46,732,000      $40,415,000      $87,147,000      $51,619,000      $64,687,250     $116,306,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER                                                    $22,295,000      $23,067,000      $45,362,000      $26,715,000      $26,966,750      $53,681,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                   $69,027,000      $63,482,000     $132,509,000      $78,334,000      $91,654,000     $169,988,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 46956]]

    Because FY 2008 and FY 2009 costs for rent and rent-related items 
in total ($69,988,000) exceeded the estimates of these costs made in 
2006 ($132,509,000), no decrease in the FY 2011 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 ($619,070,000), 
i.e., $206,356,667, 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 $206,356,667, in FY 2011, 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 7 years.
    In estimating the number of fee-paying FAEs that FDA will receive 
in FY 2011, the 5-year rolling average for the most recent 5 years will 
be based on actual counts of fee-paying FAEs received for FY 2006 
through FY 2010. For FY 2010, 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 8 years.
    Table 4 of this document shows, in column 1, the total number of 
each type of FAE received in the first 9 months of FY 2010, 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, 2010. Column 4 
estimates the 12-month total fee-paying FAEs for FY 2010 based on the 
applications received through June 30, 2010. 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 4.--FY 2010 Full Application Equivalents Received Through June 30, 2010, and Projected Through September
                                                    30, 2010
----------------------------------------------------------------------------------------------------------------
                             Column 1               Column 2               Column 3               Column 4
                     -------------------------------------------------------------------------------------------
                                                Fees Exempted or
                          Total Received      Waived Through 6/30/     Total Fee Paying     12-Month Fee Paying
                        Through 6/30/2010             2010            Through 6/30/2010          Projection
----------------------------------------------------------------------------------------------------------------
Applications                             59                     17                     42                     56
 requiring clinical
 data
----------------------------------------------------------------------------------------------------------------
Applications not                         14                    5.5                    8.5                  11.33
 requiring clinical
 data
----------------------------------------------------------------------------------------------------------------
Supplements                            43.5                    6.5                     37                  49.33
 requiring clinical
 data
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused                   1.25                  0.625                  06.25                   0.83
 to file
----------------------------------------------------------------------------------------------------------------
Total                                117.75                 29.625                 88.125                  117.5
----------------------------------------------------------------------------------------------------------------

    In the first 9 months of FY 2009, FDA received 117.75 FAEs, of 
which 88.125 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 88.125 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 2010 at 117.5.
    As table 5 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 2010, is 133.8 FAEs. FDA will set fees for FY 2011 
based on this estimate as the number of full application equivalents 
that will pay fees.

                                     Table 5.--Fee-Paying FAE 5-Year Average
----------------------------------------------------------------------------------------------------------------
                                                                                                      5-Year
   Fiscal Year         2006            2007            2008            2009          2010 est.        Average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs            136.7           134.4           140.0           140.3           117.5           133.8
----------------------------------------------------------------------------------------------------------------

    The FY 2011 application fee is estimated by dividing the average 
number of full applications that paid fees over the latest 5 years, 
133.8, into the fee revenue amount to be derived from application fees 
in FY 2011, $206,356,667. The result, rounded to the nearest $100, is a 
fee of $1,542,000 per full application requiring clinical data, and 
$771,000 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 2010, the establishment fee was based on an 
estimate that 415 establishments would be subject to, and would pay, 
fees. By

[[Page 46957]]

the end of FY 2010, FDA estimates that 445 establishments will have 
been billed for establishment fees, before all decisions on requests 
for waivers or reductions are made. FDA estimates that a total of 15 
establishment fee waivers or reductions will be made for FY 2010. 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 30 establishments (15 waivers 
plus the estimated 15 establishments under the orphan exemption) from 
445 leaves a net of 415 fee-paying establishments. FDA will use 415 for 
its FY 2011 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 ($206,356,667) by the estimated 415 establishments, 
for an establishment fee rate for FY 2011 of $497,200 (rounded to the 
nearest $100).

B. Product Fees

    At the beginning of FY 2010, 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 2010, FDA estimates that 2,460 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 25 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 2,385 products will qualify for product fees in FY 
2010, after allowing for waivers and reductions, including the orphan 
drug products eligible under the FDAAA exemption, and will use this 
number for its FY 2011 estimate. Accordingly, the FY 2011 product fee 
rate is determined by dividing the adjusted total fee revenue to be 
derived from product fees ($206,356,667) by the estimated 2,385 
products for a FY 2011 product fee of $86,520 (rounded to the nearest 
$10).

V. Fee Schedule for FY 2011

    The fee rates for FY 2011 are set out in table 6 of this document:

                    Table 6--Fee Schedule for FY 2011
------------------------------------------------------------------------
                Fee Category                     Fee Rates for FY 2011
------------------------------------------------------------------------
Applications                                  ..........................
------------------------------------------------------------------------
  Requiring clinical data                     $1,542,000
------------------------------------------------------------------------
  Not requiring clinical data                 $771,000
------------------------------------------------------------------------
  Supplements requiring clinical data         $771,000
------------------------------------------------------------------------
Establishments                                $497,200
------------------------------------------------------------------------
Products                                      $86,520
------------------------------------------------------------------------

VI. 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, 2010. 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 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: Wells Fargo, Attn: Food 
and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd., rm. 
D1113-022, Charlotte, NC 28262. (Note: This Wells Fargo 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, 1350 Piccard Dr., Rockville, MD.
    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 
2011 under the new fee schedule in August 2010. Payment will be due on 
October 1, 2010. FDA will issue invoices in November 2011 for any 
products and establishments subject to fees for FY 2011 that qualify 
for fees after the August 2010 billing.

    Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19116 Filed 8-3-10; 8:45 am]
BILLING CODE 4160-01-S