[Federal Register Volume 73, Number 149 (Friday, August 1, 2008)]
[Notices]
[Pages 45017-45022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17738]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0427]
Prescription Drug User Fee Rates for Fiscal Year 2009
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2009. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (PDUFA IV) (Title 1 of the Food and
Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to
collect user fees for certain applications for approval of drug and
biological products, on establishments where the products are made, and
on such products. Base revenue amounts to be generated from PDUFA fees
were established by PDUFA IV, with provisions for certain adjustments.
Fee revenue amounts for applications, establishments, and products are
to be established each year by FDA so that
[[Page 45018]]
one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This notice establishes fee
rates for FY 2009 for application fees for an application requiring
clinical data ($1,247,200), for an application not requiring clinical
data or a supplement requiring clinical data ($623,600), for
establishment fees ($425,600), and for product fees ($71,520). These
fees are effective on October 1, 2008, and will remain in effect
through September 30, 2009. For applications and supplements that are
submitted on or after October 1, 2008, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2009 will be
issued in August 2008, using the new fee schedule.
FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3917.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the act (21 U.S.C. 379g and 379h),
establish three different kinds of user fees. Fees are assessed on the
following: (1) Certain types of applications and supplements for
approval of drug and biological products, (2) certain establishments
where such products are made, and (3) certain products (section 736(a)
of the act). When certain conditions are met, FDA may waive or reduce
fees (section 736(d) of the act).
For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 fiscal
years. That adjusted base revenue amount is increased for drug safety
enhancements by $10,000,000 in each of the subsequent 4 fiscal years,
and the increased total is further adjusted each year for inflation and
workload. Fees for applications, establishments, and products are to be
established each year by FDA so that revenues from each category will
provide one-third of the total revenue to be collected each year.
This notice uses the fee base revenue amount for FY 2008 published
on October 12, 2007 (72 FR 58103), adjusts it for the 2009 drug safety
increase (see section 736(b)(4) of the act), for inflation, and for
workload, and then establishes the application, establishment, and
product fees for FY 2009. These fees are effective on October 1, 2008,
and will remain in effect through September 30, 2009.
II. Fee Revenue Amount for FY 2009
The total fee revenue amount for FY 2009 is $510,665,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation and changes
in workload. The statutory amount and a one-time base adjustment are
described in section II.A and II.B of this document. The adjustment for
inflation is described in section II.C, and the adjustment for changes
in workload in section II.D.
A. FY 2009 Statutory Fee Revenue Amounts Before Adjustments
PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2009 for all fees is $427,783,000 ($392,783,000 specified in
section 736(b)(1) of the act, plus an additional $35,000,000 for drug
safety in FY 2009 specified in section 736(b)(4) of the act).
B. Base Adjustment to Statutory Fee Revenue Amount
The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the act). The adjustment on this amount is to
be made in accordance with the workload adjustment provisions that were
in effect for FY 2007, except that the adjustment for investigational
new drug (IND) workload is based on the number of INDs with a
submission in the previous 12 months, rather than on the number of new
commercial INDs submitted in the same 12-month period.
For each fiscal year beginning in FY 2004, the Prescription Drug
User Fee Amendments of 2002 (PDUFA III) provided that fee revenue
amounts, after they had been adjusted for inflation, should be further
adjusted to reflect changes in workload for the process for the review
of human drug applications (see section 736(c)(2) of the act). The
conference report accompanying PDUFA III, House of Representatives
Report number 107-481, provides guidance on how the workload adjustment
provision of PDUFA III is to be implemented. Following that guidance,
FDA calculated the average number of each of the four types of
submissions specified in the workload adjustment provision (human drug
applications, commercial INDs, efficacy supplements, and manufacturing
supplements) received over the 5-year period that ended on June 30,
2002 (base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2007. PDUFA IV directs that this same method be used in making the
workload adjustment apply to the 2008 statutory revenue amount, except
that for this calculation the number of commercial INDs with a
submission in the previous 12 months is used for each 12-month period
rather than the number of new commercial INDs submitted (see section
736(b) of the act, as amended by PDUFA IV).
The results of these calculations are presented in Columns 1 and 2
of Table 1 of this document. Column 3 reflects the percent change in
workload over the two 5-year periods. Column 4 shows the weighting
factor for each type of application, estimating how much of the total
FDA drug review workload was accounted for by each type of application
in the table during the most recent 5 years. Column 5 of Table 1 of
this document is the weighted percent change in each category of
workload. This was derived by multiplying the weighting factor in each
line in Column 4 by the percent change from the base years in Column 3.
At the bottom right of the table the sum of the values in Column 5 is
added, reflecting a total increase in workload of 11.73 percent when
compared to the base years.
Table 1--Summary Workload Adjuster Calculation to be Applied to FY 2009 Statutory Base
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Column 1 5-Year
Application Type Average Base Column 2 Latest Column 3 Percent Column 4 Weighting Column 5 Weighted %
Years 5-Year Average Change Factor Change
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New drug applications (NDAs)/biologics license 119.6 123.8 3.5% 35.2% 1.24%
applications (BLAs)
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Active INDs 4751.8 5528.2 16.3% 44.2% 7.22%
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[[Page 45019]]
Efficacy supplements 159.2 163.4 2.6% 7.4% 0.20%
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Manufacturing supplements 2100.6 2589.2 23.3% 13.2% 3.07%
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FY 2008 workload adjuster to be applied to the statutory base 11.73%
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Increasing the PDUFA IV statutorily specified amount of $354,893,000 by
the specified workload adjuster (11.73 percent) results in an increase
of $41,629,000, rounded to the nearest thousand dollars. Adding this
amount to the $427,783,000 statutorily specified amount from section
II.A of this document, results in a total adjusted PDUFA IV base
revenue amount of $469,412,000, before further adjustment for inflation
and changes in workload after FY 2007.
C. Inflation Adjustment to FY 2009 Fee Revenue Amount
PDUFA IV provides that fee revenue amounts for each fiscal year
after 2008 shall be adjusted for inflation. The adjustment must reflect
the greater of: (1) The total percentage change that occurred in the
Consumer Price Index (CPI) (all items; U.S. city average) during the
12-month period ending June 30 preceding the fiscal year for which fees
are being set; (2) the total percentage pay change for the previous
fiscal year for Federal employees stationed in the Washington, DC
metropolitan area; or (3) the average annual change in cost, per full
time equivalent (FTE) FDA position, of all personnel compensation and
benefits paid for the first 5 of the previous 6 fiscal years. PDUFA IV
provides for this annual adjustment to be cumulative and compounded
annually after FY 2008 (see section 736(c)(1) of the act).
The first factor is the CPI increase for the 12-month period ending
in June 2008. The CPI for June 2008 was 218.815, and the CPI for June
2007 was 208.352. (These CPI figures are available on the Bureau of
Labor statistics Web site, http://data.bls.gov/cgi-bin/surveymost?bls
by checking the first box under ``Price Indexes'' and then clicking
``Retrieve Data'' at the bottom of the page.) The CPI for June 2008 is
5.05 percent higher than the CPI for the previous 12-month period.
The second factor is the increase in pay for the previous fiscal
year (FY 2008 in this case) for Federal employees stationed in the
Washington, DC metropolitan area. This figure is published by the
Office of Personnel Management, and found on their Web site, http://www.opm.gov/oca/08tables/html/dcb.asp, above the salary table. For FY
2008 it was 4.49 percent.
The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 fiscal
years (FY 2002 through FY 2007). The data on total compensation paid
and number of FTEs paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees. Table 2 of this document summarizes that
actual cost and FTE use data for the specified fiscal years, and
provides the percent change from the previous fiscal year and the
average percent change over the most 5 recent fiscal years, which is
5.64 percent.
Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change ($000)
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Annual Average
Fiscal Year 2003 2004 2005 2006 2007 Increase for
Latest 5 Years
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Total PC&B $971,255 $1,042,749 $1,077,604 $1,114,704 $1,144,369 ..............
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Total FTEs 10257 10141 9910 9698 9569 ..............
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PC&B per FTE $94.692 $102.825 $108.739 $114,942 $119.591 ..............
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% Change from 4.09% 8.59% 5.75% 5.70% 4.05% 5.64%
Previous Year
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Because the average change in pay per FTE (5.64 percent) is the
highest of the three factors, it becomes the inflation adjustment for
total fee revenue for FY 2009. Increasing the FY 2009 fee revenue base
of $469,412,000 by 5.64 percent yields an inflation-adjusted fee
revenue amount for FY 2009 of $495,887,000, rounded to the nearest
thousand dollars, before addition of the FY 2009 workload adjustment.
D. Workload Adjustment to the FY 2009 Inflation Adjusted Fee Revenue
Amount
For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
act). PDUFA IV continues the PDUFA III workload adjustment with
modifications, and provides for a new additional adjustment for changes
in review activity. PDUFA IV also specifies that for FY 2009 the
additional adjustment for changes in review activity may not result in
a total workload adjustment that is more than 2 percentage points
higher than it would have been in the absence of the adjustment for
changes in review workload (see section 736(c)(2)(B) of the act).
Therefore, FDA will first calculate the FY 2009 workload adjustment
without the PDUFA IV adjustment for changes in review activity. Then
FDA will apply
[[Page 45020]]
the adjustment for changes in review activity, to determine if the
total workload adjustment is no more than 2 percentage points higher
than it would have been in the absence of the adjustment for changes in
review activity.
In calculating the FY 2009 workload adjustment without the PDUFA IV
adjustment for changes in review activity, FDA will follow the guidance
provided in the conference report accompanying the Prescription Drug
User Fee Amendments of 2002, House of Representatives Report number
107-481, using active commercial INDs rather than newly submitted
commercial INDs as the surrogate for IND workload, as specified by
PDUFA IV.
FDA calculated the average number of each of the four types of
applications specified in the workload adjustment provision: (1) Human
drug applications, (2) active commercial investigational new drug
applications (applications that have at least one submission during the
previous 12 months), (3) efficacy supplements, and (4) manufacturing
supplements received over the 5-year period that ended on June 30, 2007
(base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2008.
The calculations are summarized in Table 3 of this document. The 5-
year averages for each application category are provided in Column 1
(5-Year Average Base Years 2002-2007) and Column 2 (Latest 5-Year
Average 2003-2008). Column 3 reflects the percent change in workload
from Column 1 to Column 2. Column 4 shows the weighting factor for each
type of application, estimating how much of the total FDA drug review
workload was accounted for by each type of application in the table
during the most recent 5 years. Column 5 of Table 1 is the weighted
percent change in each category of workload. This was derived by
multiplying the weighting factor in each line in Column 4 by the
percent change from the base years in Column 3. At the bottom right of
Table 3 of this document is the sum of the values in Column 5 that are
added, reflecting an increase in workload of 2.98 percent for FY 2009
when compared to the base years, but before taking into account the
impact of change in review activity.
Table 3--Preliminary Workload Adjuster Calculation for FY 2009 Without Adjustment for Changes in Review Activity
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Column 1 5-Year Column 2 Latest
Application Type Average Base 5-Year Average Column 3 Percent Column 4 Weighting Column 5 Weighted %
Years 2002-2007 2003- 2008 Change Factor Change
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NDAs/BLAs 123.8 128.4 3.7% 33.3% 1.24%
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Active commercial INDs 5755.8 5897.6 2.5% 45.2% 1.11%
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Efficacy supplements 163.4 173.0 5.9% 8.3% 0.49%
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Manufacturing supplements 2589.2 2616.2 1.0% 13.2% 0.14%
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FY 2009 workload adjuster without adjustment changes for review activity 2.98%
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PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to the first two categories (human drug
applications and active commercial INDs). These adjustments, specified
under PDUFA IV, are summarized in the new Columns 2b and 2c in Table 4
of this document. The number in the NDAs/BLAs line of Column 2b of
Table 4 of this document is the percent by which the average workload
for meetings, annual reports, and labeling supplements for NDAs and
BLAs has changed from the 5-year period 2002 through 2007 to the 5-year
period 2003 through 2008. Likewise, the number in the active commercial
INDs line of Column 2b of Table 4 of this document is the percent by
which the workload for meetings and special protocol assessments for
active commercial INDs has changed from the 5-year period 2002 through
2007 to the 5-year period 2003 through 2008. There is no entry in the
last two lines of column 2b because the adjustment for changes in
review workload does not apply to the workload for efficacy supplements
and manufacturing supplements.
Table 4--Final Workload Adjuster Calculation for FY 2009 With Adjustment for Changes in Review Activity\1\
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Column 3 %
Column 1 5- Column 2a Column 2b Column 2c is Change Column 4 Column 5
Application Type Year Average Latest 5-Year Adjustment for Column 2a (Column 1 to Weighting Weighted %
Base Years Average 2003- Changes in Adjusted by Column 2c or Factor Change
2002-2007 2008 Review Activity Column 2b 2a)
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NDAs/BLAs 123.8 128.4 -0.55% 127.7 3.1% 33.3% 1.05
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Active commercial INDs 5755.8 5897.6 +0.39% 5920.6 2.9% 45.2% 1.31
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Efficacy supplements 163.4 173.0 NA 173.3 5.9% 8.3% 0.49%
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Manufacturing supplements 2589.2 2516.2 NA 2616.2 1.0% 13.2% 0.14%
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[[Page 45021]]
FY 2009 workload adjuster with adjustment changes for review activity 2.98%
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\1\ Numbers may not add due to rounding.
The 2009 workload adjuster with adjustment for changes in review
activity at the bottom of Table 4 of this document is 2.98 percent
exactly the same as the workload adjuster without those changes at the
bottom of Table 3 of this document. Therefore the inflation-adjusted
revenue amount of $495,887,000 from section II.B of this document will
be multiplied by the 2009 workload adjuster of 2.98 percent, resulting
in a total adjusted revenue amount in FY 2009 of $510,665,000, rounded
to the nearest thousand dollars.
PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the act).
Accordingly, one-third of the total revenue amount, or $ 170,222,000,
rounded to the nearest thousand dollars, is the total amount of fee
revenue that will be derived from each of these fee categories.
III. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate one-third of the total fee
revenue amount, or $170,222,000, rounded to the nearest thousand
dollars, in FY 2009, as calculated in section II.D of this document.
B. Estimate of Number of Fee-Paying Applications and Establishment of
Application Fees
For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next fiscal year by averaging the number of fee-paying FAEs
received in the 5 most recent fiscal years. This use of the rolling
average of the 5 most recent fiscal years is the same method that has
applied for the last 6 years.
In estimating the number of fee-paying FAEs that FDA will receive
in FY 2009, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2004
through FY 2008. For FY 2008, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 6 years.
Table 5 of this document shows, in Column 1, the total number of
each type of FAE received in the first 9 months of FY 2008, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and Column 3 shows the
number of fee-paying FAEs received through June 30, 2008. Column 4
estimates the 12-month total fee-paying FAEs for FY 2008 based on the
applications received through June 30, 2008. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half an FAE, as
does a supplement requiring clinical data. An application that is
withdrawn, or refused for filing, counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant initially paid one-half of the full application
fee amount.
Table 5--FY 2008 Full Application Equivalents Received Through June 30, 2008, and Projected Through September
30, 2008
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Column 2 Fee Column 3 Total
Column 1 Total Exempt or Waived Fee Paying Column 4 12-
Application or Action Received Through Through Through Month Fee-Paying
6[sol]30[sol]2008 6[sol]30[sol]2008 6[sol]30[sol]2008 Projection
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Applications requiring clinical data 102.3 40.3 62.0 82.7
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Applications not requiring clinical 11.1 4.1 7.0 9.3
data
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Supplements requiring clinical data 45.0 6.0 39.0 52.0
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Withdrawn or refused to file 0.5 0 0.5 0.7
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Total 158.9 50.4 108.5 144.7
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In the first 9 months of FY 2008, FDA received 158.9 FAEs, of which
108.5 were fee-paying. Based on data from the last 9 fiscal years, on
average, 25 percent of the applications submitted each year come in the
final 3 months. Dividing 108.5 by 3 and multiplying by 4 extrapolates
the amount to the full 12 months of the fiscal year and projects the
number of fee-paying FAEs in FY 2008 at 144.7.
As Table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 5-year period, and including
our estimate for FY 2008, is 136.5 FAEs. FDA will set fees for FY 2009
based on this estimate as the number of FAEs that will pay fees.
[[Page 45022]]
Table 6--Fee-Paying Full Application Equivalent--5-Year Average
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5-Year
Fiscal Year 2004 2005 2006 2007 2008 Average
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Fee-Paying FAEs 145.1 121.5 136.7 134.4 144.7 136.5
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The FY 2009 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
136.5, into the fee revenue amount to be derived from application fees
in FY 2009, $170,222,000. The result, rounded to the nearest $100, is a
fee of $1,247,200 per full application requiring clinical data, and
$623,600 per application not requiring clinical data or per supplement
requiring clinical data.
IV. Fee Calculations for Establishment and Product Fees
A. Establishment Fees
At the beginning of FY 2008, the establishment fee was based on an
estimate that 390 establishments would be subject to, and would pay,
fees. By the end of FY 2008, FDA estimates that 435 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. As in previous years, FDA
again estimates that a total of 25 establishment fee waivers or
reductions will be made for FY 2008. In addition, FDA estimates that
another 10 full establishment fees will be exempted this year based on
the orphan drug exemption in the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (see section 736(k) of the act).
Subtracting 35 establishments (25 plus the estimated 10 establishments
under the orphan exemption) from 435 leaves a net of 400 fee-paying
establishments. FDA will use 400 for its FY 2009 estimate of
establishments paying fees, after taking waivers and reductions into
account. The fee per establishment is determined by dividing the
adjusted total fee revenue to be derived from establishments
($170,222,000) by the estimated 400 establishments, for an
establishment fee rate for FY 2009 of $425,600 (rounded to the nearest
$100).
B. Product Fees
At the beginning of FY 2008, the product fee was based on an
estimate that 2,355 products would be subject to, and would pay,
product fees. By the end of FY 2008, FDA estimates that 2,450 products
will have been billed for product fees, before all decisions on
requests for waivers or reductions are made. FDA assumes that there
will be about 40 waivers and reductions granted, the same amount
estimated last year. In addition, FDA estimates that another 30 product
fees will be exempted this year based on the orphan drug exemption in
FDAAA (see section 736(k) of the act). FDA estimates that 2,380
products will qualify for product fees in FY 2008, after allowing for
waivers and reductions, including the orphan drug products eligible
under the FDAAA exemption, and will use this number for its FY 2009
estimate. Accordingly, the FY 2009 product fee rate is determined by
dividing the adjusted total fee revenue to be derived from product fees
($170,222,000) by the estimated 2,380 products for a FY 2009 product
fee of $71,520 (rounded to the nearest $10).
V. Fee Schedule for FY 2009
The fee rates for FY 2009 are set out in Table 7 of this document.
Table 7
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Fee Category Fee Rates for FY 2009
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APPLICATIONS
Requiring clinical data $1,247,200
Not requiring clinical data $623,600
------------------------------------------------------------------------
Supplements requiring clinical data $623,600
------------------------------------------------------------------------
ESTABLISHMENTS $425,600
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PRODUCTS $71,520
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VI. Implementation of Adjusted Fee Schedule
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2008. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee ID number on your check. Your payment can be
mailed to: Food and Drug Administration, P.O. Box 70963, Charlotte, NC
28272-0963.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: Wachovia Bank, Attn:
Food and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd.,
rm. NC0810, Charlotte, NC 28262. (Note: This Wachovia Bank address is
for courier delivery only.)
Please make sure that the FDA post office box number (P.O. Box
70963) is written on the check. The tax identification number of the
Food and Drug Administration is 53-0196965.
Wire transfer payment may also be used. The routing and transit
number is 021030004 and the account number is 75060099.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2009 under the new fee schedule in August 2008. Payment will be due on
October 1, 2008. FDA will issue invoices in November 2009 for any
products and establishments subject to fees for FY 2009 that qualify
for fees after the August 2008 billing.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17738 Filed 7-31-08; 8:45 am]
BILLING CODE 4160-01-S