Prescription Drug User Fee Rates for Fiscal Year 2010, 38451-38456 [E9-18457]
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Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0339]
Prescription Drug User Fee Rates for
Fiscal Year 2010
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice.
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SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2010. The Federal Food,
Drug, and Cosmetic Act (the act), as
amended by the Prescription Drug User
Fee Amendments of 2007 (Title 1 of the
Food and Drug Administration
Amendments Act of 2007 (FDAAA))
(PDUFA IV), authorizes FDA to collect
user fees for certain applications for
approval of drug and biological
products, on establishments where the
products are made, and on such
products. Base revenue amounts to be
generated from PDUFA fees were
established by PDUFA IV, with
provisions for certain adjustments. Fee
revenue amounts for applications,
establishments, and products are to be
established each year by FDA so that
one-third of the PDUFA fee revenues
FDA collects each year will be generated
from each of these categories. This
notice establishes fee rates for FY 2010
for application fees for an application
requiring clinical data ($1,405,500), for
an application not requiring clinical
data or a supplement requiring clinical
data ($702,750), for establishment fees
($457,200), and for product fees
($77,720). These fees are effective on
October 1, 2009, and will remain in
effect through September 30, 2010. For
applications and supplements that are
submitted on or after October 1, 2009,
the new fee schedule must be used.
Invoices for establishment and product
fees for FY 2010 will be issued in
August 2009, using the new fee
schedule.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3917.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the act (21
U.S.C. 379g and 379h, respectively),
establish three different kinds of user
fees. Fees are assessed on the following:
(1) Certain types of applications and
supplements for approval of drug and
biological products, (2) certain
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establishments where such products are
made, and (3) certain products (section
736(a) of the act). When certain
conditions are met, FDA may waive or
reduce fees (section 736(d) of the act).
For FY 2008 through FY 2012, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA IV. The base
revenue amount for FY 2008 is to be
adjusted for workload, and that adjusted
amount becomes the base amount for
the remaining 4 fiscal years. That
adjusted base revenue amount is
increased for drug safety enhancements
by $10,000,000 in each of the
subsequent 4 fiscal years, and the
increased total is further adjusted each
year for inflation and workload. Fees for
applications, establishments, and
products are to be established each year
by FDA so that revenues from each
category will provide one-third of the
total revenue to be collected each year.
This notice uses the fee base revenue
amount for FY 2008 published in the
Federal Register of October 12, 2007 (72
FR 58103), adjusts it for the 2010 drug
safety increase (see section 736(b)(4) of
the act) for inflation, and for workload,
and then establishes the application,
establishment, and product fees for FY
2010. These fees are effective on
October 1, 2009, and will remain in
effect through September 30, 2010.
II. Fee Revenue Amount for FY 2010
The total fee revenue amount for FY
2010 is $569,207,000, based on the fee
revenue amount specified in the statute,
including additional fee funding for
drug safety and adjustments for inflation
and changes in workload. The statutory
amount and a one-time base adjustment
are described in sections II.A and II.B of
this document. The adjustment for
inflation is described in section II.C of
this document, and the adjustment for
changes in workload in section II.D of
this document.
A. FY 2010 Statutory Fee Revenue
Amounts Before Adjustments
PDUFA IV specifies that the fee
revenue amount before adjustments for
FY 2010 for all fees is $437,783,000
($392,783,000 specified in section
736(b)(1) of the act plus an additional
$45,000,000 for drug safety in FY 2010
specified in section 736(b)(4) of the act).
B. Base Adjustment to Statutory Fee
Revenue Amount
The statute also specifies that
$354,893,000 of the base amount is to be
further adjusted for workload increases
through FY 2007 (see section
736(b)(1)(B) of the act). The adjustment
on this amount is to be made in
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38451
accordance with the workload
adjustment provisions that were in
effect for FY 2007, except that the
adjustment for investigational new drug
(IND) workload is based on the number
of INDs with a submission in the
previous 12 months rather than on the
number of new commercial INDs
submitted in the same 12-month period.
For each FY beginning in FY 2004,
the Prescription Drug User Fee
Amendments of 2002 (PDUFA III)
provided that fee revenue amounts, after
they had been adjusted for inflation,
should be further adjusted to reflect
changes in workload for the process for
the review of human drug applications
(see section 736(c)(2) of the act). The
conference report accompanying
PDUFA III, House of Representatives
Report number 107–481, provides
guidance on how the workload
adjustment provision of PDUFA III is to
be implemented. Following that
guidance, FDA calculated the average
number of each of the four types of
submissions specified in the workload
adjustment provision (human drug
applications, commercial INDs, efficacy
supplements, and manufacturing
supplements) received over the 5-year
period that ended on June 30, 2002
(base years), and the average number of
each of these types of applications over
the most recent 5-year period that ended
June 30, 2007. PDUFA IV directs that
this same method be used in making the
workload adjustment apply to the 2008
statutory revenue amount, except that
for this calculation the number of
commercial INDs with a submission in
the previous 12 months is used for each
12-month period rather than the number
of new commercial INDs submitted (see
section 736(b) of the act, as amended by
PDUFA IV).
The results of these calculations are
presented in the first two columns of
table 1 of this document. Column 3
reflects the percent change in workload
over the two 5-year periods. Column 4
shows the weighting factor for each type
of application, estimating how much of
the total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 5 years. Column 5 of table 1 of
this document is the weighted percent
change in each category of workload.
This was derived by multiplying the
weighting factor in each line in column
4 by the percent change from the base
years in column 3. At the bottom right
of the table the sum of the values in
column 5 is added, reflecting a total
increase in workload of 11.73 percent
when compared to the base years.
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TABLE 1.—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO PDUFA IV STATUTORY BASE
Column 1
5-Year Average
Base Years (Ending 6/30/2002)
Application Type
NDAs/biologics license applications
(BLAs)
Column 2
5-Year Average
(Ending
6/30/2007)
Column 3
Percent Change
Column 5
Weighted Percent
Change
Column 4
Weighting Factor
119.6
3.5%
35.2%
1.24%
4,751.8
5,528.2
16.3%
44.2%
7.22%
159.2
163.4
2.6%
7.4%
0.20%
2,100.6
Active INDs
123.8
2,589.2
23.3%
13.2%
3.07%
Efficacy supplements
Manufacturing supplements
Workload adjuster to be applied to the statutory base
Increasing the PDUFA IV statutorily
specified amount of $354,893,000 by the
specified workload adjuster (11.73
percent) results in an increase of
$41,629,000, rounded to the nearest
thousand. Adding this amount to the
$437,783,000 statutorily specified
amount from section II.A of this
document, results in a total adjusted
PDUFA IV base revenue amount of
$479,412,000, before further adjustment
for inflation and changes in workload
after FY 2007.
C. Inflation Adjustment to FY 2010 Fee
Revenue Amount
PDUFA IV provides that fee revenue
amounts for each fiscal year after FY
2008 shall be adjusted for inflation. The
adjustment must reflect the greater of
the following amounts: (1) The total
percentage change that occurred in the
Consumer Price Index (CPI) (all items;
U.S. city average) during the 12-month
period ending June 30 preceding the
fiscal year for which fees are being set;
(2) the total percentage pay change for
the previous fiscal year for Federal
employees stationed in the Washington,
11.73%
DC metropolitan area; or (3) the average
annual change in cost, per full time
equivalent (FTE) FDA position, of all
personnel compensation and benefits
paid for the first 5 of the previous 6
fiscal years. PDUFA IV provides for this
annual adjustment to be cumulative and
compounded annually after FY 2008
(see section 736(c)(1) of the act).
The first factor is the CPI increase for
the 12-month period ending in June
2009. The CPI for June 2009 was
215.693, and the CPI for June 2008 was
218.815. (These CPI figures are available
on the Bureau of Labor Statistics Web
site at https://data.bls.gov/cgi-bin/
surveymost?bls by checking the first box
under ‘‘Price Indexes’’ and then clicking
‘‘Retrieve Data’’ at the bottom of the
page.) (FDA has verified the Web site
address, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.) The CPI for June 2009
is 1.43 percent lower than the CPI for
the previous 12-month period.
The second factor is the increase in
pay for the previous fiscal year (FY 2009
in this case) for Federal employees
stationed in the Washington, DC
metropolitan area. This figure is
published by the Office of Personnel
Management, and found on their Web
site at https://www.opm.gov/flsa/oca/
09tables/html/dcb.asp above the salary
table. (FDA has verified the Web site
address, but FDA is not responsible for
any subsequent changes to the Web site
after this document publishes in the
Federal Register.) For FY 2009 it was
4.78 percent.
The third factor is the average change
in FDA cost for compensation and
benefits per FTE over the previous 5 of
the most recent 6 fiscal years (FY 2003
through 2008). The data on total
compensation paid and numbers of FTE
paid, from which the average cost per
FTE can be derived, are published in
FDA’s Justification of Estimates for
Appropriations Committees. Table 2 of
this document summarizes that actual
cost and FTE use data for the specified
fiscal years, and provides the percent
change from the previous fiscal year and
the average percent change over the
most 5 recent fiscal years, which is 5.54
percent.
TABLE 2.—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal Year
2004
Total PC&B
2007
2008
$1,077,604
$1,114,704
$1,144,369
9,910
9,698
9,569
9,811
$102,825
$108,739
$114,942
$119,591
$123,905
8.59%
5.75%
5.70%
4.05%
3.61%
% Change from previous year
The inflation increase for FY 2010 is
5.54 percent. This is the greater of the
CPI change during the 12-month period
ending June 30 preceding the fiscal year
for which fees are being set (-1.43
percent), the increase in pay for the
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Annual Average Increase
for Latest 5
Years
$1,215,627
10,141
PC&B per FTE
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2006
$1,042,749
Total FTE
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2005
previous fiscal year (FY 2009 in this
case) for Federal employees stationed in
the Washington, DC metropolitan area
(4.78 percent), and the average annual
change in cost, per FTE FDA position,
of all personnel compensation and
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5.54%
benefits paid for the first 5 of the
previous 6 fiscal years (5.54 percent).
Because the average change in pay per
FTE (5.54 percent) is the highest of the
three factors, it becomes the inflation
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adjustment for total fee revenue for FY
2010.
The inflation adjustment for FY 2009
was 5.64 percent. This is the greater of
the CPI increase during the 12-month
period ending June 30 preceding the
fiscal year for which fees were being set
(June 30, 2008, which was 5.05 percent),
the increase in pay for FY 2008 for
Federal employees stationed in
Washington, DC (4.49 percent), or the
average annual change in cost, per FTE
FDA position, of all personnel
compensation and benefits paid for the
first 5 of the previous 6 fiscal years (5.64
percent).
PDUFA IV provides for this inflation
adjustment to be cumulative and
compounded annually after FY 2008
(see section 736(c)(1) of the act). This
factor for FY 2010 (5.54 percent) is
compounded by adding one to it and
then multiplying it by one plus the
inflation adjustment factor for FY 2009
(5.64 percent). The result of this
multiplication of the inflation factors for
the 2 years since FY 2008 (1.0554 times
1.0564 percent) becomes the inflation
adjustment for FY 2010. This inflation
adjustment for FY 2010 is 11.15 percent.
Increasing the FY 2010 fee revenue
base of $479,412,000, by 11.15 percent
yields an inflation-adjusted fee revenue
amount for FY 2010 of $532,866,000,
rounded to the nearest thousand dollars,
before the application of the FY 2010
workload adjustment.
D. Workload Adjustment to the FY 2010
Inflation Adjusted Fee Revenue Amount
PDUFA IV does not allow FDA to
adjust the total revenue amount for
workload beginning in FY 2010 unless
the independent accounting firm study
is complete (see section 736(c)(2)(C) of
the act). That study, conducted by
Deloitte Touche, LLP, was completed on
March 31, 2009, and is available online
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm164339.htm. The study found that
the adjustment methodology used by
FDA reasonably captures changes in
workload for reviewing human drug
applications under PDUFA IV.
Accordingly, FDA continues to use the
workload adjustment methodology that
it utilized in FY 2009, and FDA intends
to continue using this methodology
through the end of PDUFA IV.
For each fiscal year beginning in FY
2009, PDUFA IV provides that fee
revenue amounts, after they have been
adjusted for inflation, shall be further
adjusted to reflect changes in workload
for the process for the review of human
drug applications (see section 736(c)(2)
of the act). PDUFA IV continues the
PDUFA III workload adjustment with
modifications, and provides for a new
additional adjustment for changes in
review activity.
FDA calculated the average number of
each of the four types of applications
specified in the workload adjustment
provision: (1) Human drug applications,
(2) active commercial INDs
(applications that have at least one
submission during the previous 12
months), (3) efficacy supplements, and
(4) manufacturing supplements received
over the 5-year period that ended on
June 30, 2007 (base years), and the
average number of each of these types
of applications over the most recent 5year period that ended June 30, 2009.
The calculations are summarized in of
table 3 of this document. The 5-year
averages for each application category
are provided in Column 1 (‘‘5-Year
Average Base Years 2002–2007’’) and
Column 2a (‘‘5 Year Average 2004–
2009’’).
PDUFA IV specifies that FDA make
additional adjustments for changes in
review activities to the first two
categories (human drug applications
and active commercial INDs). These
adjustments, specified under PDUFA IV,
are summarized in columns 2b and 2c
in table 3 of this document. The number
in the NDAs/BLAs line of column 2b of
table 3 of this document is the percent
by which the average workload for
meetings, annual reports, and labeling
supplements for NDAs and BLAs has
changed from the 5-year period 2002
through 2007 to the 5-year period 2004
through 2009. Likewise, the number in
the ‘‘Active commercial INDs’’ line of
column 2b of table 3 of this document
is the percent by which the workload for
meetings and special protocol
assessments for active commercial INDs
has changed from the 5-year period
2002 through 2007 to the 5-year period
2004 through 2009. There is no entry in
the last two lines of column 2b because
the adjustment for changes in review
workload does not apply to the
workload for efficacy supplements and
manufacturing supplements.
Column 3 of table 3 of this document
reflects the percent change in workload
from column 1 to column 2c. Column 4
shows the weighting factor for each type
of application, estimating how much of
the total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 5 years. Column 5 of table 3 of
this document is the weighted percent
change in each category of workload.
This was derived by multiplying the
weighting factor in each line in column
4 by the percent change from the base
years in column 3. At the bottom right
of table 3 of this document is the sum
of the values in column 5 that are
added, reflecting an increase in
workload of 6.82 percent for FY 2010
when compared to the base years.
TABLE 3.—WORKLOAD ADJUSTER CALCULATION FOR FY 2010
Application Type
Column 1
5-Year Average Base
Years 2002–
2007
NDAs/BLAs
Efficacy supplements
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Column 2b
Adjustment for
Changes in
Review Activity
Column 2c is
Column 2a Increased by
Column 2b
Column 3
Percent
Change (Column 1 to Column 2c)
Column 4
Weighting
Factor
Column 5
Weighted Percent Change
123.8
Active commercial
INDs1
Manufacturing supplements
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Column 2a
5-Year Average 2004–
2009
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133.0
-0.73%
132.0
6.6%
34.8%
2.31%
5,528.2
6,078.0
-0.71%
6,035.0
9.2%
44.5%
4.08%
163.4
169.4
NA
169.4
3.7%
8.7%
0.32%
2,589.2
2,613.6
NA
2,613.6
0.9%
12.0%
0.11%
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TABLE 3.—WORKLOAD ADJUSTER CALCULATION FOR FY 2010—Continued
Application Type
Column 1
5-Year Average Base
Years 2002–
2007
Column 2a
5-Year Average 2004–
2009
Column 2b
Adjustment for
Changes in
Review Activity
Column 3
Percent
Change (Column 1 to Column 2c)
Column 2c is
Column 2a Increased by
Column 2b
Column 4
Weighting
Factor
Column 5
Weighted Percent Change
FY 2010 workload adjuster
6.82%
1 Table
3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years
of 2002–2007 as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has
been corrected in the revised number of 5528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY
2009 would have been 3.76 percent rather than the 2.98 percent published in the Federal Register last year.
The 2010 workload adjuster reflected
in the calculations in table 3 of this
document is 6.82 percent. Therefore the
inflation-adjusted revenue amount of
$532,866,000 from section II.C of this
document will be increased by the 2010
workload adjuster of 6.82 percent,
resulting in a total adjusted revenue
amount in FY 2010 of $569,207,000,
rounded to the nearest thousand dollars.
E. Rent and Rent-Related Adjustment to
the FY 2010 Adjusted Fee Revenue
Amount
PDUFA specifies that for FY 2010 and
each subsequent fiscal year, the revenue
amount will be decreased if the actual
cost paid for rent and rent-related
expenses for preceding fiscal years are
less than estimates made for such fiscal
years in FY 2006 (see section 736(c)(3)
of the act). The only fiscal year which
has been completed, and for which FDA
has complete data at this time, is FY
2008. Table 4 of this document shows
the estimates of rent and rent-related
costs for FY 2008 made in 2006 and the
actual costs at the end of the fiscal year.
TABLE 4.—COMPARISON OF ACTUAL AND ESTIMATED RENT AND RENT-RELATED EXPENSES FOR FY 2008
Estimates Made in 2006
Actual FY 2008 Year-End Costs
Center for Drug Evaluation and Research rent & rent-related expenses
$46,732,000
$51,619,000
Center for Biologics Evaluation and Research rent & rent-related
expenses
$22,295,000
$26,715,000
TOTAL
$69,027,000
$78,334,000
Because FY 2008 costs for rent and
rent-related items exceeded the
estimates of these costs made in 2006,
no decrease in the FY 2010 estimated
PDUFA revenues is required under this
provision of PDUFA.
PDUFA specifies that one-third of the
total fee revenue is to be derived from
application fees, one-third from
establishment fees, and one-third from
product fees (see section 736(b)(2) of the
act). Accordingly, one-third of the total
revenue amount ($569,207,000), i.e.,
$189,736,000 (rounded to the nearest
thousand dollars), is the total amount of
fee revenue that will be derived from
each of these fee categories.
III. Application Fee Calculations
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A. Application Fee Revenues and
Application Fees
Application fees will be set to
generate one-third of the total fee
revenue amount, or $189,736,000,
rounded to the nearest thousand dollars,
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in FY 2010, as calculated previously in
this document.
B. Estimate of Number of Fee-Paying
Applications and Establishment of
Application Fees
For FY 2008 through FY 2012, FDA
will estimate the total number of feepaying 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 feepaying FAEs that FDA will receive in
FY 2010, the 5-year rolling average for
the most recent 5 years will be based on
actual counts of fee-paying FAEs
received for FY 2005 through FY 2009.
For FY 2009, FDA is estimating the
number of fee-paying FAEs for the full
year based on the actual count for the
first 9 months and estimating the
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number for the final 3 months, as we
have done for the past 7 years.
Table 5 of this document shows, in
column 1, the total number of each type
of FAE received in the first 9 months of
FY 2009, whether fees were paid or not.
Column 2 shows the number of FAEs for
which fees were waived or exempted
during this period, and column 3 shows
the number of fee-paying FAEs received
through June 30, 2009. Column 4
estimates the 12-month total fee-paying
FAEs for FY 2009 based on the
applications received through June 30,
2009. All of the counts are in FAEs. A
full application requiring clinical data
counts as one FAE. An application not
requiring clinical data counts as onehalf 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.
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TABLE 5.—FY 2009 FULL APPLICATION EQUIVALENTS RECEIVED THROUGH JUNE 30, 2009, AND PROJECTED THROUGH
SEPTEMBER 30, 2009
Column 1
Total Received
Through
6/30/2009
Application or Action
Column 2
Fee Exempt or
Waived Through
6/30/2009
Column 3
Total Fee Paying
Through
6/30/2009
Column 4
12-Month FeePaying Projection
Applications requiring clinical data
88.75
32.75
56
74.7
Applications not requiring clinical data
15.5
4.5
11
14.7
Supplements requiring clinical data
47.5
8.5
39
52
Withdrawn or refused to file
0.625
Total
0
153.375
In the first 9 months of FY 2009, FDA
received 153.375 FAEs, of which 106.25
were fee-paying. Based on data from the
last 10 fiscal years, on average, 25
percent of the applications submitted
each year come in the final 3 months.
0.625
45.75
Dividing 106.25 by 3 and multiplying by
4 extrapolates the amount to the full 12
months of the fiscal year and projects
the number of fee-paying FAEs in FY
2008 at 142.2.
As table 6 of this document shows,
the average number of fee-paying FAEs
0.8
106.25
142.2
received annually in the most recent 5year period, and including our estimate
for FY 2009, is 135.0 FAEs. FDA will set
fees for FY 2010 based on this estimate
as the number of full application
equivalents that will pay fees.
TABLE 6.—FEE-PAYING FAE 5-YEAR AVERAGE
Fiscal Year
2005
Fee-Paying FAEs
2006
121.5
2007
136.7
2008
134.4
140.0
FDA will use 415 for its FY 2010
estimate of establishments paying fees,
after taking waivers and reductions into
account. The fee per establishment is
determined by dividing the adjusted
total fee revenue to be derived from
establishments ($189,736,000) by the
estimated 415 establishments, for an
establishment fee rate for FY 2010 of
$457,200 (rounded to the nearest $100).
IV. Fee Calculations for Establishment
and Product Fees
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The FY 2010 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 5 years, 135.0, into
the fee revenue amount to be derived
from application fees in FY 2010,
$189,736,000. The result, rounded to the
nearest $100, is a fee of $1,405,500 per
full application requiring clinical data,
and $702,750 per application not
requiring clinical data or per
supplement requiring clinical data.
At the beginning of FY 2009, the
product fee was based on an estimate
that 2,380 products would be subject to
and would pay product fees. By the end
of FY 2009, FDA estimates that 2,450
products will have been billed for
product fees, before all decisions on
requests for waivers, reductions, or
exemptions are made. FDA assumes that
there will be about 50 waivers and
reductions granted. In addition, FDA
estimates that another 20 product fees
will be exempted this year based on the
orphan drug exemption in FDAAA (see
section 736(k) of the act). FDA estimates
that 2,380 products will qualify for
product fees in FY 2009, after allowing
for waivers and reductions, including
the orphan drug products eligible under
the FDAAA exemption, and will use
this number for its FY 2010 estimate.
Accordingly, the FY 2010 product fee
rate is determined by dividing the
adjusted total fee revenue to be derived
A. Establishment Fees
At the beginning of FY 2009, the
establishment fee was based on an
estimate that 400 establishments would
be subject to, and would pay, fees. By
the end of FY 2009, FDA estimates that
450 establishments will have been
billed for establishment fees, before all
decisions on requests for waivers or
reductions are made. FDA again
estimates that a total of 20 establishment
fee waivers or reductions will be made
for FY 2009. In addition, FDA estimates
that another 15 full establishment fees
will be exempted this year based on the
orphan drug exemption in FDAAA (see
section 736(k) of the act). Subtracting 35
establishments (20 waivers plus the
estimated 15 establishments under the
orphan exemption) from 450 leaves a
net of 415 fee-paying establishments.
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
2009
5-Year Average
142.2
from product fees ($189,736,000) by the
estimated 2,380 products for a FY 2010
product fee of $79,720 (rounded to the
nearest $10).
V. Fee Schedule for FY 2010
The fee rates for FY 2010 are set out
in table 7 of this document:
TABLE 7.
B. Product Fees
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
135.0
Fee Category
APPLICATIONS
Requiring clinical data .......
Not requiring clinical data
Supplements requiring clinical data .........................
ESTABLISHMENTS ..............
PRODUCTS ..........................
Fee Rates for
FY 2010
$1,405,500
$702,750
$702,750
$457,200
$79,720
VIII. Fee Payment Options and
Procedures
A. Application Fees
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received after September
30, 2009. Payment must be made in U.S.
currency by check, bank draft, or U.S.
postal money order payable to the order
of the Food and Drug Administration.
Please include the user fee
identification (ID) number on your
E:\FR\FM\03AUN1.SGM
03AUN1
38456
Federal Register / Vol. 74, No. 147 / Monday, August 3, 2009 / Notices
check, bank draft, or postal money
order. Your payment can be mailed to:
Food and Drug Administration, P.O.
Box 70963, Charlotte, NC 28272–0963.
If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to:
Wachovia Bank, Attn: Food and Drug
Administration Lockbox 70963, 1525
West WT Harris Blvd., rm. NC0810,
Charlotte, NC 28262. (Note: This
Wachovia Bank address is for courier
delivery only.)
Please make sure that the FDA post
office box number (P.O. Box 70963) is
written on the check, bank draft, or
postal money order.
Wire transfer payment may also be
used. Please reference your unique user
fee ID number when completing your
transfer. The originating financial
institution usually charges a wire
transfer fee between $15.00 and $35.00.
Please ask your financial institution
about the fee and include it with your
payment to ensure that your fee is fully
paid. The account information is as
follows: New York Federal Reserve
Bank, US Dept of Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane,
Rockville, MD 20857.
Application fees can also be paid
online with an electronic check (ACH).
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a Web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of the
Food and Drug Administration is 53–
0196965.
sroberts on DSKD5P82C1PROD with NOTICES
B. Establishment and Product Fees
FDA will issue invoices for
establishment and product fees for FY
2010 under the new fee schedule in
August 2009. Payment will be due on
October 1, 2009. FDA will issue
invoices in November 2010 for any
products and establishments subject to
fees for FY 2010 that qualify for fees
after the August 2009 billing.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–18457 Filed 7–31–09; 8:45 am]
BILLING CODE 4160–01–S
VerDate Nov<24>2008
16:05 Jul 31, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; Report of Altered
Systems of Records
AGENCY: Department of Health and
Human Services (HHS), Health
Resources and Services Administration
(HRSA).
ACTION: Notice of Altered Systems of
Records (SOR).
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
the Health Resources and Services
Administration (HRSA) is proposing to
alter four existing systems of records
(SORs) for the reasons indicated below:
09–15–0002: Records of Patient’s
Personal Valuables and Monies, HHS/
HRSA/BPHC
HRSA is updating the system
location, categories of individuals
covered by the system, storage,
retrievability, safeguards, retention and
disposal, system manager, and
notification procedure. HRSA is also
adding a new routine use, number 3
(breach notification language).
09–15–0003: Contract Physicians and
Consultants, HHS/HRSA/BPHC
HRSA is updating the system
location, categories of individuals
covered by the system, categories of
records in the system, authority for
maintenance of the system, retention
and disposal, and system manager.
HRSA is also adding a new routine use,
number 6 (breach notification language).
09–15–0007: Patient’s Medical Record
System Public Health Service
Hospitals, HHS/HRSA/BPHC
HRSA is updating the system location
(Appendix 2—Federal Records Centers),
categories of individuals covered by the
system, categories of records in the
system, authority for maintenance of the
system, purpose of the system, physical
safeguards, retention and disposal,
system manager, and notification
procedure. HRSA is deleting four
routine uses, numbers 6 (Bureau of
Prisons (BP) to report results of
examination and treatment of patients
examined and/or treated for and on
behalf of the BP), 7 (Federal, state or
private health benefit plans for billing
purposes), 14 (Disclosure may be made
to a private firm for the purpose of
collating, analyzing, aggregating or
otherwise refining records in this
system. The contractor is required to
maintain Privacy Act safeguards with
respect to such records), and 19 (To
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
organizations or individuals with
agreements to provide photocopying or
medical record data abstracting services.
(a) PBS may inform the sexual and/or
needle-sharing partner(s) of a subject
individual who is infected with the
human immunodeficiency virus (HIV)
of their exposure to HIV, under the
following circumstances:
1. The information has been obtained
in the course of clinical activities at PHS
facilities carried out by PHS personnel
or contractors;
2. The PHS employee or contractor
has made reasonable efforts to counsel
and encourage the subject individual to
provide the information to the
individual’s sexual or needle-sharing
partner(s);
3. The PBS employee or contractor
determines that the subject individual is
unlikely to provide the information to
the sexual or needle-sharing partner(s)
or that the provision of such
information cannot reasonably be
verified; and
4. The notification of the partner(s) is
made, whenever possible, by the subject
individual’s physician or by a
professional counselor and shall follow
standard counseling practices. (b) PHS
may disclose information to State or
local public health departments, to
assist in the notification of the subject
individual’s sexual and/or needlesharing partner(s), or in the verification
that the subject individual has, notified
such sexual or needle-sharing partner(s).
HRSA is also adding one new routine
use, number 16 (breach notification
language).
09–15–0028: Public Health Service
Clinical Affiliation Trainee Records,
HHS/HRSA/BPHC
HRSA is updating the system
location, authority for maintenance of
the system, retrievability, safeguards,
retention and disposal, and system
manager. HRSA is also deleting one
routine use, number 2 (to
representatives of medical/allied health
training program accreditation of PHS
Training Programs), and adding a new
routine use, number 6 (breach
notification language).
DATES: HRSA filed an altered system
report with the Chair of the House
Committee on Government Reform and
Oversight, the Chair of the Senate
Committee on Homeland Security and
Governmental Affairs, and the
Administrator, Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB) on July
23, 2009. To ensure all parties have
adequate time in which to comment, the
altered systems, including the routine
uses, will become effective 30 days from
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 74, Number 147 (Monday, August 3, 2009)]
[Notices]
[Pages 38451-38456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18457]
[[Page 38451]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0339]
Prescription Drug User Fee Rates for Fiscal Year 2010
AGENCY: Food and Drug Administration, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2010. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug
Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes
FDA to collect user fees for certain applications for approval of drug
and biological products, on establishments where the products are made,
and on such products. Base revenue amounts to be generated from PDUFA
fees were established by PDUFA IV, with provisions for certain
adjustments. Fee revenue amounts for applications, establishments, and
products are to be established each year by FDA so that one-third of
the PDUFA fee revenues FDA collects each year will be generated from
each of these categories. This notice establishes fee rates for FY 2010
for application fees for an application requiring clinical data
($1,405,500), for an application not requiring clinical data or a
supplement requiring clinical data ($702,750), for establishment fees
($457,200), and for product fees ($77,720). These fees are effective on
October 1, 2009, and will remain in effect through September 30, 2010.
For applications and supplements that are submitted on or after October
1, 2009, the new fee schedule must be used. Invoices for establishment
and product fees for FY 2010 will be issued in August 2009, using the
new fee schedule.
FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3917.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the act (21 U.S.C. 379g and 379h,
respectively), establish three different kinds of user fees. Fees are
assessed on the following: (1) Certain types of applications and
supplements for approval of drug and biological products, (2) certain
establishments where such products are made, and (3) certain products
(section 736(a) of the act). When certain conditions are met, FDA may
waive or reduce fees (section 736(d) of the act).
For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 fiscal
years. That adjusted base revenue amount is increased for drug safety
enhancements by $10,000,000 in each of the subsequent 4 fiscal years,
and the increased total is further adjusted each year for inflation and
workload. Fees for applications, establishments, and products are to be
established each year by FDA so that revenues from each category will
provide one-third of the total revenue to be collected each year.
This notice uses the fee base revenue amount for FY 2008 published
in the Federal Register of October 12, 2007 (72 FR 58103), adjusts it
for the 2010 drug safety increase (see section 736(b)(4) of the act)
for inflation, and for workload, and then establishes the application,
establishment, and product fees for FY 2010. These fees are effective
on October 1, 2009, and will remain in effect through September 30,
2010.
II. Fee Revenue Amount for FY 2010
The total fee revenue amount for FY 2010 is $569,207,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation and changes
in workload. The statutory amount and a one-time base adjustment are
described in sections II.A and II.B of this document. The adjustment
for inflation is described in section II.C of this document, and the
adjustment for changes in workload in section II.D of this document.
A. FY 2010 Statutory Fee Revenue Amounts Before Adjustments
PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2010 for all fees is $437,783,000 ($392,783,000 specified in
section 736(b)(1) of the act plus an additional $45,000,000 for drug
safety in FY 2010 specified in section 736(b)(4) of the act).
B. Base Adjustment to Statutory Fee Revenue Amount
The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the act). The adjustment on this amount is to
be made in accordance with the workload adjustment provisions that were
in effect for FY 2007, except that the adjustment for investigational
new drug (IND) workload is based on the number of INDs with a
submission in the previous 12 months rather than on the number of new
commercial INDs submitted in the same 12-month period.
For each FY beginning in FY 2004, the Prescription Drug User Fee
Amendments of 2002 (PDUFA III) provided that fee revenue amounts, after
they had been adjusted for inflation, should be further adjusted to
reflect changes in workload for the process for the review of human
drug applications (see section 736(c)(2) of the act). The conference
report accompanying PDUFA III, House of Representatives Report number
107-481, provides guidance on how the workload adjustment provision of
PDUFA III is to be implemented. Following that guidance, FDA calculated
the average number of each of the four types of submissions specified
in the workload adjustment provision (human drug applications,
commercial INDs, efficacy supplements, and manufacturing supplements)
received over the 5-year period that ended on June 30, 2002 (base
years), and the average number of each of these types of applications
over the most recent 5-year period that ended June 30, 2007. PDUFA IV
directs that this same method be used in making the workload adjustment
apply to the 2008 statutory revenue amount, except that for this
calculation the number of commercial INDs with a submission in the
previous 12 months is used for each 12-month period rather than the
number of new commercial INDs submitted (see section 736(b) of the act,
as amended by PDUFA IV).
The results of these calculations are presented in the first two
columns of table 1 of this document. Column 3 reflects the percent
change in workload over the two 5-year periods. Column 4 shows the
weighting factor for each type of application, estimating how much of
the total FDA drug review workload was accounted for by each type of
application in the table during the most recent 5 years. Column 5 of
table 1 of this document is the weighted percent change in each
category of workload. This was derived by multiplying the weighting
factor in each line in column 4 by the percent change from the base
years in column 3. At the bottom right of the table the sum of the
values in column 5 is added, reflecting a total increase in workload of
11.73 percent when compared to the base years.
[[Page 38452]]
Table 1.--Summary Workload Adjuster Calculation to be Applied to PDUFA IV Statutory Base
----------------------------------------------------------------------------------------------------------------
Column 1 5-Year
Application Average Base Years Column 2 5-Year Column 3 Percent Column 4 Column 5 Weighted
Type (Ending Average (Ending Change Weighting Factor Percent Change
6[sol]30[sol]2002) 6[sol]30[sol]2007)
----------------------------------------------------------------------------------------------------------------
NDAs/ 119.6 123.8 3.5% 35.2% 1.24%
biologics
license
applications
(BLAs)
----------------------------------------------------------------------------------------------------------------
Active INDs 4,751.8 5,528.2 16.3% 44.2% 7.22%
----------------------------------------------------------------------------------------------------------------
Efficacy 159.2 163.4 2.6% 7.4% 0.20%
supplements
----------------------------------------------------------------------------------------------------------------
Manufacturing 2,100.6 2,589.2 23.3% 13.2% 3.07%
supplements
----------------------------------------------------------------------------------------------------------------
Workload adjuster to be applied to the statutory base 11.73%
----------------------------------------------------------------------------------------------------------------
Increasing the PDUFA IV statutorily specified amount of
$354,893,000 by the specified workload adjuster (11.73 percent) results
in an increase of $41,629,000, rounded to the nearest thousand. Adding
this amount to the $437,783,000 statutorily specified amount from
section II.A of this document, results in a total adjusted PDUFA IV
base revenue amount of $479,412,000, before further adjustment for
inflation and changes in workload after FY 2007.
C. Inflation Adjustment to FY 2010 Fee Revenue Amount
PDUFA IV provides that fee revenue amounts for each fiscal year
after FY 2008 shall be adjusted for inflation. The adjustment must
reflect the greater of the following amounts: (1) The total percentage
change that occurred in the Consumer Price Index (CPI) (all items; U.S.
city average) during the 12-month period ending June 30 preceding the
fiscal year for which fees are being set; (2) the total percentage pay
change for the previous fiscal year for Federal employees stationed in
the Washington, DC metropolitan area; or (3) the average annual change
in cost, per full time equivalent (FTE) FDA position, of all personnel
compensation and benefits paid for the first 5 of the previous 6 fiscal
years. PDUFA IV provides for this annual adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
act).
The first factor is the CPI increase for the 12-month period ending
in June 2009. The CPI for June 2009 was 215.693, and the CPI for June
2008 was 218.815. (These CPI figures are available on the Bureau of
Labor Statistics Web site at https://data.bls.gov/cgi-bin/surveymost?bls
by checking the first box under ``Price Indexes'' and then clicking
``Retrieve Data'' at the bottom of the page.) (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
The CPI for June 2009 is 1.43 percent lower than the CPI for the
previous 12-month period.
The second factor is the increase in pay for the previous fiscal
year (FY 2009 in this case) for Federal employees stationed in the
Washington, DC metropolitan area. This figure is published by the
Office of Personnel Management, and found on their Web site at https://www.opm.gov/flsa/oca/09tables/html/dcb.asp above the salary table. (FDA
has verified the Web site address, but FDA is not responsible for any
subsequent changes to the Web site after this document publishes in the
Federal Register.) For FY 2009 it was 4.78 percent.
The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 fiscal
years (FY 2003 through 2008). The data on total compensation paid and
numbers of FTE paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees. Table 2 of this document summarizes that
actual cost and FTE use data for the specified fiscal years, and
provides the percent change from the previous fiscal year and the
average percent change over the most 5 recent fiscal years, which is
5.54 percent.
Table 2.--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Annual Average
Fiscal Year 2004 2005 2006 2007 2008 Increase for
Latest 5 Years
----------------------------------------------------------------------------------------------------------------
Total PC&B $1,042,749 $1,077,604 $1,114,704 $1,144,369 $1,215,627 ..............
----------------------------------------------------------------------------------------------------------------
Total FTE 10,141 9,910 9,698 9,569 9,811 ..............
----------------------------------------------------------------------------------------------------------------
PC&B per FTE $102,825 $108,739 $114,942 $119,591 $123,905 ..............
----------------------------------------------------------------------------------------------------------------
% Change from 8.59% 5.75% 5.70% 4.05% 3.61% 5.54%
previous year
----------------------------------------------------------------------------------------------------------------
The inflation increase for FY 2010 is 5.54 percent. This is the
greater of the CPI change during the 12-month period ending June 30
preceding the fiscal year for which fees are being set (-1.43 percent),
the increase in pay for the previous fiscal year (FY 2009 in this case)
for Federal employees stationed in the Washington, DC metropolitan area
(4.78 percent), and the average annual change in cost, per FTE FDA
position, of all personnel compensation and benefits paid for the first
5 of the previous 6 fiscal years (5.54 percent). Because the average
change in pay per FTE (5.54 percent) is the highest of the three
factors, it becomes the inflation
[[Page 38453]]
adjustment for total fee revenue for FY 2010.
The inflation adjustment for FY 2009 was 5.64 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the fiscal year for which fees were being set (June 30, 2008,
which was 5.05 percent), the increase in pay for FY 2008 for Federal
employees stationed in Washington, DC (4.49 percent), or the average
annual change in cost, per FTE FDA position, of all personnel
compensation and benefits paid for the first 5 of the previous 6 fiscal
years (5.64 percent).
PDUFA IV provides for this inflation adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
act). This factor for FY 2010 (5.54 percent) is compounded by adding
one to it and then multiplying it by one plus the inflation adjustment
factor for FY 2009 (5.64 percent). The result of this multiplication of
the inflation factors for the 2 years since FY 2008 (1.0554 times
1.0564 percent) becomes the inflation adjustment for FY 2010. This
inflation adjustment for FY 2010 is 11.15 percent.
Increasing the FY 2010 fee revenue base of $479,412,000, by 11.15
percent yields an inflation-adjusted fee revenue amount for FY 2010 of
$532,866,000, rounded to the nearest thousand dollars, before the
application of the FY 2010 workload adjustment.
D. Workload Adjustment to the FY 2010 Inflation Adjusted Fee Revenue
Amount
PDUFA IV does not allow FDA to adjust the total revenue amount for
workload beginning in FY 2010 unless the independent accounting firm
study is complete (see section 736(c)(2)(C) of the act). That study,
conducted by Deloitte Touche, LLP, was completed on March 31, 2009, and
is available online at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm164339.htm. The study found that the
adjustment methodology used by FDA reasonably captures changes in
workload for reviewing human drug applications under PDUFA IV.
Accordingly, FDA continues to use the workload adjustment methodology
that it utilized in FY 2009, and FDA intends to continue using this
methodology through the end of PDUFA IV.
For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
act). PDUFA IV continues the PDUFA III workload adjustment with
modifications, and provides for a new additional adjustment for changes
in review activity.
FDA calculated the average number of each of the four types of
applications specified in the workload adjustment provision: (1) Human
drug applications, (2) active commercial INDs (applications that have
at least one submission during the previous 12 months), (3) efficacy
supplements, and (4) manufacturing supplements received over the 5-year
period that ended on June 30, 2007 (base years), and the average number
of each of these types of applications over the most recent 5-year
period that ended June 30, 2009.
The calculations are summarized in of table 3 of this document. The
5-year averages for each application category are provided in Column 1
(``5-Year Average Base Years 2002-2007'') and Column 2a (``5 Year
Average 2004-2009'').
PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to the first two categories (human drug
applications and active commercial INDs). These adjustments, specified
under PDUFA IV, are summarized in columns 2b and 2c in table 3 of this
document. The number in the NDAs/BLAs line of column 2b of table 3 of
this document is the percent by which the average workload for
meetings, annual reports, and labeling supplements for NDAs and BLAs
has changed from the 5-year period 2002 through 2007 to the 5-year
period 2004 through 2009. Likewise, the number in the ``Active
commercial INDs'' line of column 2b of table 3 of this document is the
percent by which the workload for meetings and special protocol
assessments for active commercial INDs has changed from the 5-year
period 2002 through 2007 to the 5-year period 2004 through 2009. There
is no entry in the last two lines of column 2b because the adjustment
for changes in review workload does not apply to the workload for
efficacy supplements and manufacturing supplements.
Column 3 of table 3 of this document reflects the percent change in
workload from column 1 to column 2c. Column 4 shows the weighting
factor for each type of application, estimating how much of the total
FDA drug review workload was accounted for by each type of application
in the table during the most recent 5 years. Column 5 of table 3 of
this document is the weighted percent change in each category of
workload. This was derived by multiplying the weighting factor in each
line in column 4 by the percent change from the base years in column 3.
At the bottom right of table 3 of this document is the sum of the
values in column 5 that are added, reflecting an increase in workload
of 6.82 percent for FY 2010 when compared to the base years.
Table 3.--Workload Adjuster Calculation for FY 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 2b Column 3
Column 1 5- Column 2a 5- Adjustment Column 2c is Percent Column 4 Column 5
Application Type Year Average Year Average for Changes Column 2a Change Weighting Weighted
Base Years 2004-2009 in Review Increased by (Column 1 to Factor Percent
2002-2007 Activity Column 2b Column 2c) Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs 123.8 133.0 -0.73% 132.0 6.6% 34.8% 2.31%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs\1\ 5,528.2 6,078.0 -0.71% 6,035.0 9.2% 44.5% 4.08%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements 163.4 169.4 NA 169.4 3.7% 8.7% 0.32%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements 2,589.2 2,613.6 NA 2,613.6 0.9% 12.0% 0.11%
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 38454]]
FY 2010 workload adjuster 6.82%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Table 3 published in the Federal Register of August 1, 2008 (73 FR 45017), showed the average number of active INDs for the base years of 2002-2007
as 5,755.8. FDA discovered that a small subset of INDs had been double counted in the number reported last year. That error has been corrected in the
revised number of 5528.2 reflected in the table this year. Had the error not been made, the workload adjustment in FY 2009 would have been 3.76
percent rather than the 2.98 percent published in the Federal Register last year.
The 2010 workload adjuster reflected in the calculations in table 3
of this document is 6.82 percent. Therefore the inflation-adjusted
revenue amount of $532,866,000 from section II.C of this document will
be increased by the 2010 workload adjuster of 6.82 percent, resulting
in a total adjusted revenue amount in FY 2010 of $569,207,000, rounded
to the nearest thousand dollars.
E. Rent and Rent-Related Adjustment to the FY 2010 Adjusted Fee Revenue
Amount
PDUFA specifies that for FY 2010 and each subsequent fiscal year,
the revenue amount will be decreased if the actual cost paid for rent
and rent-related expenses for preceding fiscal years are less than
estimates made for such fiscal years in FY 2006 (see section 736(c)(3)
of the act). The only fiscal year which has been completed, and for
which FDA has complete data at this time, is FY 2008. Table 4 of this
document shows the estimates of rent and rent-related costs for FY 2008
made in 2006 and the actual costs at the end of the fiscal year.
Table 4.--Comparison of Actual and Estimated Rent and Rent-Related Expenses for FY 2008
----------------------------------------------------------------------------------------------------------------
Estimates Made in 2006 Actual FY 2008 Year-End Costs
----------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research $46,732,000 $51,619,000
rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and $22,295,000 $26,715,000
Research rent & rent-related expenses
----------------------------------------------------------------------------------------------------------------
TOTAL $69,027,000 $78,334,000
----------------------------------------------------------------------------------------------------------------
Because FY 2008 costs for rent and rent-related items exceeded the
estimates of these costs made in 2006, no decrease in the FY 2010
estimated PDUFA revenues is required under this provision of PDUFA.
PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the act).
Accordingly, one-third of the total revenue amount ($569,207,000),
i.e., $189,736,000 (rounded to the nearest thousand dollars), is the
total amount of fee revenue that will be derived from each of these fee
categories.
III. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate one-third of the total fee
revenue amount, or $189,736,000, rounded to the nearest thousand
dollars, in FY 2010, as calculated previously in this document.
B. Estimate of Number of Fee-Paying Applications and Establishment of
Application Fees
For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next fiscal year by averaging the number of fee-paying FAEs
received in the 5 most recent fiscal years. This use of the rolling
average of the 5 most recent fiscal years is the same method that has
applied for the last 6 years.
In estimating the number of fee-paying FAEs that FDA will receive
in FY 2010, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2005
through FY 2009. For FY 2009, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 7 years.
Table 5 of this document shows, in column 1, the total number of
each type of FAE received in the first 9 months of FY 2009, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and column 3 shows the
number of fee-paying FAEs received through June 30, 2009. Column 4
estimates the 12-month total fee-paying FAEs for FY 2009 based on the
applications received through June 30, 2009. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half an FAE, as
does a supplement requiring clinical data. An application that is
withdrawn, or refused for filing, counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant initially paid one-half of the full application
fee amount.
[[Page 38455]]
Table 5.--FY 2009 Full Application Equivalents Received Through June 30, 2009, and Projected Through September
30, 2009
----------------------------------------------------------------------------------------------------------------
Column 2 Fee Column 3 Total
Column 1 Total Exempt or Waived Fee Paying Column 4 12-
Application or Action Received Through Through Through Month Fee-Paying
6[sol]30[sol]2009 6[sol]30[sol]2009 6[sol]30[sol]2009 Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data 88.75 32.75 56 74.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical 15.5 4.5 11 14.7
data
----------------------------------------------------------------------------------------------------------------
Supplements requiring clinical data 47.5 8.5 39 52
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused to file 0.625 0 0.625 0.8
----------------------------------------------------------------------------------------------------------------
Total 153.375 45.75 106.25 142.2
----------------------------------------------------------------------------------------------------------------
In the first 9 months of FY 2009, FDA received 153.375 FAEs, of
which 106.25 were fee-paying. Based on data from the last 10 fiscal
years, on average, 25 percent of the applications submitted each year
come in the final 3 months. Dividing 106.25 by 3 and multiplying by 4
extrapolates the amount to the full 12 months of the fiscal year and
projects the number of fee-paying FAEs in FY 2008 at 142.2.
As table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 5-year period, and including
our estimate for FY 2009, is 135.0 FAEs. FDA will set fees for FY 2010
based on this estimate as the number of full application equivalents
that will pay fees.
Table 6.--Fee-Paying FAE 5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal Year 2005 2006 2007 2008 2009 5-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs 121.5 136.7 134.4 140.0 142.2 135.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
The FY 2010 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
135.0, into the fee revenue amount to be derived from application fees
in FY 2010, $189,736,000. The result, rounded to the nearest $100, is a
fee of $1,405,500 per full application requiring clinical data, and
$702,750 per application not requiring clinical data or per supplement
requiring clinical data.
IV. Fee Calculations for Establishment and Product Fees
A. Establishment Fees
At the beginning of FY 2009, the establishment fee was based on an
estimate that 400 establishments would be subject to, and would pay,
fees. By the end of FY 2009, FDA estimates that 450 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. FDA again estimates that a
total of 20 establishment fee waivers or reductions will be made for FY
2009. In addition, FDA estimates that another 15 full establishment
fees will be exempted this year based on the orphan drug exemption in
FDAAA (see section 736(k) of the act). Subtracting 35 establishments
(20 waivers plus the estimated 15 establishments under the orphan
exemption) from 450 leaves a net of 415 fee-paying establishments. FDA
will use 415 for its FY 2010 estimate of establishments paying fees,
after taking waivers and reductions into account. The fee per
establishment is determined by dividing the adjusted total fee revenue
to be derived from establishments ($189,736,000) by the estimated 415
establishments, for an establishment fee rate for FY 2010 of $457,200
(rounded to the nearest $100).
B. Product Fees
At the beginning of FY 2009, the product fee was based on an
estimate that 2,380 products would be subject to and would pay product
fees. By the end of FY 2009, FDA estimates that 2,450 products will
have been billed for product fees, before all decisions on requests for
waivers, reductions, or exemptions are made. FDA assumes that there
will be about 50 waivers and reductions granted. In addition, FDA
estimates that another 20 product fees will be exempted this year based
on the orphan drug exemption in FDAAA (see section 736(k) of the act).
FDA estimates that 2,380 products will qualify for product fees in FY
2009, after allowing for waivers and reductions, including the orphan
drug products eligible under the FDAAA exemption, and will use this
number for its FY 2010 estimate. Accordingly, the FY 2010 product fee
rate is determined by dividing the adjusted total fee revenue to be
derived from product fees ($189,736,000) by the estimated 2,380
products for a FY 2010 product fee of $79,720 (rounded to the nearest
$10).
V. Fee Schedule for FY 2010
The fee rates for FY 2010 are set out in table 7 of this document:
Table 7.
------------------------------------------------------------------------
Fee Rates for
Fee Category FY 2010
------------------------------------------------------------------------
APPLICATIONS............................................................
Requiring clinical data............................... $1,405,500
Not requiring clinical data........................... $702,750
Supplements requiring clinical data................... $702,750
ESTABLISHMENTS.......................................... $457,200
PRODUCTS................................................ $79,720
------------------------------------------------------------------------
VIII. Fee Payment Options and Procedures
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2009. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee identification (ID) number on your
[[Page 38456]]
check, bank draft, or postal money order. Your payment can be mailed
to: Food and Drug Administration, P.O. Box 70963, Charlotte, NC 28272-
0963.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: Wachovia Bank, Attn:
Food and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd.,
rm. NC0810, Charlotte, NC 28262. (Note: This Wachovia Bank address is
for courier delivery only.)
Please make sure that the FDA post office box number (P.O. Box
70963) is written on the check, bank draft, or postal money order.
Wire transfer payment may also be used. Please reference your
unique user fee ID number when completing your transfer. The
originating financial institution usually charges a wire transfer fee
between $15.00 and $35.00. Please ask your financial institution about
the fee and include it with your payment to ensure that your fee is
fully paid. The account information is as follows: New York Federal
Reserve Bank, US Dept of Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 5600 Fishers Lane, Rockville, MD 20857.
Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of the Food and Drug Administration
is 53-0196965.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2010 under the new fee schedule in August 2009. Payment will be due on
October 1, 2009. FDA will issue invoices in November 2010 for any
products and establishments subject to fees for FY 2010 that qualify
for fees after the August 2009 billing.
Dated: July 28, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18457 Filed 7-31-09; 8:45 am]
BILLING CODE 4160-01-S
