[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Notices]
[Pages 46952-46957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19116]
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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.
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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
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Annual Average
Fiscal Year 2005 2006 2007 2008 2009 Increase for
Latest 5 Years
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Total PC&B $1,077,604 $1,114,704 $1,144,369 $1,215,627 $1,464,445 .................
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Total FTE 9,910 9,698 9,569 9811 11,413 .................
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PC&B per FTE $108,739 $114,942 $119,591 $123,905 $128,314 .................
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% Change from Previous Year 5.75% 5.70% 4.05% 3.61% 3.56% 4.53%
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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
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Column 1 Column 2a Column 2b Column 2c Column 3 Column 4 Column 5
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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)
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NDAs/BLAs 123.8 134.8 -0.49% 134.1 8.4% 33.9% 2.83%
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Active commercial INDs 5,528.2 6320.0 -1.60% 6218.7 12.5% 43.7% 5.46%
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Efficacy Supplements 163.4 164.4 NA 164.4 0.6% 9.6% 0.06%
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Manufacturing Supplements 2589.2 2628.6 NA 2628.6 1.5% 12.8% 0.19%
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FY 2011 Workload Adjuster 8.54%
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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)
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Estimates Made in 2006 Actual Costs at Fiscal Year End
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FY 2008 FY 2009 Total FY 2008 FY 2009 Total
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CDER $46,732,000 $40,415,000 $87,147,000 $51,619,000 $64,687,250 $116,306,250
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CBER $22,295,000 $23,067,000 $45,362,000 $26,715,000 $26,966,750 $53,681,750
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Total $69,027,000 $63,482,000 $132,509,000 $78,334,000 $91,654,000 $169,988,000
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[[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
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Column 1 Column 2 Column 3 Column 4
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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
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Applications 59 17 42 56
requiring clinical
data
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Applications not 14 5.5 8.5 11.33
requiring clinical
data
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Supplements 43.5 6.5 37 49.33
requiring clinical
data
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Withdrawn or refused 1.25 0.625 06.25 0.83
to file
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Total 117.75 29.625 88.125 117.5
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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
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5-Year
Fiscal Year 2006 2007 2008 2009 2010 est. Average
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Fee-Paying FAEs 136.7 134.4 140.0 140.3 117.5 133.8
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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
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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