Prescription Drug User Fee Rates for Fiscal Year 2012, 45831-45838 [2011-19332]
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Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
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deliver the check to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for
courier delivery only; do not send mail
to this address.)
Please make sure that both of the
following are written on your check: (1)
The FDA lockbox number (Lockbox
979108) and (2) the PIN that is printed
on your order. A copy of your printed
order should also be mailed along with
your check. FDA’s tax identification
number is 53–0196965.
3. If paying with a wire transfer:
Wire transfers may also be used to pay
annual establishment fees. To send a
wire transfer, please read and comply
with the following information:
• Include your order’s unique PIN,
from the upper right-hand corner of
your completed Medical Device User
Fee order, in your wire transfer. Without
the PIN your payment may not be
applied to your facility and your
registration will be delayed.
• The originating financial institution
usually charges a wire transfer fee
between $15 and $35. Please ask your
financial institution about the fee and
include it with your payment to ensure
that your order is fully paid. Use the
following account information when
sending a wire transfer: New York
Federal Reserve Bank, U.S. 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.
EstablishmentRegistration/Blood
EstablishmentRegistration/default.htm.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
click on the Device Registration and
Listing Module (DRLM) of FURLS
button. New establishments will need to
register and existing establishments will
update their annual registration using
selections on the DRLM menu. Once
you choose to register or update your
annual registration, the system will
prompt you through the entry of
information about your establishment
and your devices. If you have any
problems with this process, e-mail:
reglist@cdrh.fda.gov or call 301–796–
7400 for assistance. (Note: this e-mail
address and this telephone number are
for assistance with establishment
registration only, and not for any other
aspects of medical device user fees.)
Problems with BER should be directed
to bloodregis@fda.hhs.gov or call 301–
827–3546.
C. Step Three—Complete the
Information Online To Update Your
Establishment’s Annual Registration for
FY 2012, or to Register a New
Establishment for FY 2012
Go to CDRH’s Web site at https://www.
fda.gov/MedicalDevices/Device
RegulationandGuidance/HowtoMarket
YourDevice/RegistrationandListing/
default.htm and click the ‘‘Access
Electronic Registration’’ link on the left
of the page. This opens up a new page
with important information about the
FDA Unified Registration and Listing
System (FURLS). After reading this
information, click on the link (Access
Electronic Registration) at the bottom of
the page. This link takes you to an FDA
Industry Systems page with tutorials
that demonstrate how to create a new
FURLS user account if your
establishment did not create an account
in FY 2010 or FY 2011. Biologics
manufacturers should register in the
BER system at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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D. Step Four—Enter Your DFUF Order
PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to licensed biologic devices. CBER will
send invoices for payment of the
establishment registration fee to
companies who only manufacture
licensed biologics devices. Fees are only
required for those establishments
defined in section I of this document.
[FR Doc. 2011–19335 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0559]
Prescription Drug User Fee Rates for
Fiscal Year 2012
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2012. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Prescription Drug
User Fee Amendments of 2007 (Title 1
of the Food and Drug Administration
SUMMARY:
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45831
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
document establishes fee rates for FY
2012 for application fees for an
application requiring clinical data
($1,841,500), for an application not
requiring clinical data or a supplement
requiring clinical data ($920,750), for
establishment fees ($520,100), and for
product fees ($98,970). These fees are
effective on October 1, 2011, and will
remain in effect through September 30,
2012. For applications and supplements
that are submitted on or after October 1,
2011, the new fee schedule must be
used. Invoices for establishment and
product fees for FY 2012 will be issued
in August 2011, using the new fee
schedule.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Picard Dr., PI50,
Rm. 210J, Rockville, MD 20850, 301–
796–7103.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C 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 FD&C Act). When certain
conditions are met, FDA may waive or
reduce fees (section 736(d) of the FD&C
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 FYs. That adjusted base
revenue amount is increased for drug
safety enhancements by $10,000,000 in
each of the subsequent 4 FYs, and the
increased total is further adjusted each
year for inflation and workload. Fees for
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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 document uses the fee base
revenue amount for FY 2008 published
in the Federal Register of October 12,
2007 (72 FR 58103) (the October 2007
notice); adjusts it for the FY 2009, FY
2010, FY 2011, and FY 2012 drug safety
increases (see section 736(b)(4) of the
FD&C Act), for inflation, and for
workload, for excess collections through
FY 2011, and for a final year
adjustment; and then establishes the
application, establishment, and product
fees for FY 2012. These fees are effective
on October 1, 2011, and will remain in
effect through September 30, 2012.
II. Fee Revenue Amount for FY 2012
The total fee revenue amount for FY
2012 is $702,172,000, based on the fee
revenue amount specified in the statute,
including additional fee funding for
drug safety and adjustments for
inflation, changes in workload, offset for
excess collections and the final year
adjustment. 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. The adjustment for
estimated excess collections through FY
2012 is described in section III of this
document, and the final year adjustment
is described in section IV of this
document.
A. FY 2012 Statutory Fee Revenue
Amounts Before Adjustments
PDUFA IV specifies that the fee
revenue amount before adjustments for
FY 2012 for all fees is $457,783,000
($392,783,000 specified in section
736(b)(1) of the FD&C Act plus an
additional $65,000,000 for drug safety in
FY 2012 specified in section 736(b)(4)).
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 FD&C Act). The
workload adjustment on this amount is
to be made in accordance with the
workload adjustment provisions that
were in effect for FY 2007, except that
the adjustment for investigational new
drug (IND) workload is based on the
number of INDs with a submission in
the previous 12 months rather than on
the number of new commercial INDs
submitted in the same 12-month period.
This adjustment was explained in detail
in the October 2007 notice. Increasing
the statutorily specified amount of
$354,893,000 by the specified workload
adjuster (11.73 percent) results in an
increase of $41,629,000, rounded to the
nearest thousand. Adding this amount
to the $457,783,000 statutorily specified
amount from section II.A of this
document, results in a total adjusted
PDUFA IV base revenue amount of
$499,412,000, before further adjustment
for inflation and changes in workload
after FY 2007.
C. Inflation Adjustment to FY 2012 Fee
Revenue Amount
PDUFA IV provides that fee revenue
amounts for each FY 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 FY
for which fees are being set; (2) the total
percentage pay change for the previous
FY for Federal employees stationed in
the Washington, DC metropolitan area;
or (3) the average annual change in cost,
per FDA full time equivalent (FTE), of
all personnel compensation and benefits
paid for the first 5 of the previous 6 FYs.
PDUFA IV provides for this annual
adjustment to be cumulative and
compounded annually after FY 2008
(see section 736(c)(1) of the FD&C Act).
The first factor is the CPI increase for
the 12-month period ending in June
2011. The CPI for June 2011 was
225.722 and the CPI for June 2010 was
217.965. (These CPI figures are available
on the Bureau of Labor Statistics (BLS)
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 2011
is 3.559 percent higher than the CPI for
the previous 12-month period.
The second factor is the increase in
pay for the previous FY (FY 2011 in this
case) for Federal employees stationed in
the Washington, DC metropolitan area.
This figure is published by the Office of
Personnel Management (OPM), and
found on their Web site at https://
www.opm.gov/oca/11tables/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 2011 it was 0.00
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 FYs (FY 2006 through
FY 2010). 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 1 of
this document summarizes that actual
cost and FTE use data for the specified
FYs, and provides the percent change
from the previous FY and the average
percent change over the most 5 recent
FYs, which is 3.72 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
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FY2006
Total PC&B ......................
Total FTE .........................
PC&B per FTE .................
Percent Change from Previous Year ....................
FY2007
17:45 Jul 29, 2011
FY2009
Annual average
increase for
latest 5 years
FY2010
$1,114,704,000
9,698
$114,942
$1,144,369,000
9,569
$119,591
$1,215,627,000
9,811
$123,905
$1,464,445,000
11,413
$128,314
$1,634,108,000
12,256
$130,457
............................
............................
............................
5.70
4.05
3.61
3.56
1.67
3.72
The inflation increase for FY 2012 is
3.72 percent. This is the greater of the
CPI change during the 12-month period
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ending June 30 preceding the FY for
which fees are being set (3.559 percent),
the increase in pay for the previous FY
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(FY 2011 in this case) for Federal
employees stationed in the Washington,
DC metropolitan area (0.00 percent), and
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the average annual change in cost, per
FDA FTE, of all personnel
compensation and benefits paid for the
first 5 of the previous 6 FYs (3.72
percent). Because the average change in
pay per FTE (3.72 percent) is the highest
of the three factors, it becomes the
inflation adjustment for total fee
revenue for FY 2012.
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 FY
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 FDA FTE, of all
personnel compensation and benefits
paid for the first 5 of the previous 6 FYs
(5.64 percent).
The inflation adjustment for FY 2010
was 5.54 percent. This is the greater of
the CPI increase during the 12-month
period ending June 30 preceding the FY
for which fees were being set (June 30,
2009) (negative 1.43 percent), the
increase in pay for FY 2009 for Federal
employees stationed in Washington, DC
(4.78 percent), or the average annual
change in cost, per FDA FTE, of all
personnel compensation and benefits
paid for the first 5 of the previous 6 FYs
(5.54 percent).
The inflation adjustment for FY 2011
was 4.53 percent. This is the greater of
the CPI increase during the 12-month
period ending June 30 preceding the FY
for which fees were being set (June 30,
2010) (1.053 percent), the increase in
pay for FY 2010 for Federal employees
stationed in Washington, DC (2.42
percent), or the average annual change
in cost, per FDA FTE, of all personnel
compensation and benefits paid for the
first 5 of the previous 6 FYs (4.53
percent).
PDUFA IV provides for this inflation
adjustment to be cumulative and
compounded annually after FY 2008
(see section 736(c)(1) of the FD&C Act).
This factor for FY 2012 (3.72 percent) is
compounded by adding one to it and
then multiplying it by one plus the
inflation adjustment factor for FY 2011
(4.53 percent) and by one plus the
inflation adjustment factor for FY 2010
(5.54 percent) and by one plus the
inflation adjustment factor for FY 2009
(5.64 percent). The result of this
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multiplication of the inflation factors for
the 4 years since FY 2008 (1.0372 times
1.0453 times 1.0554 times 1.0564
percent) becomes the inflation
adjustment for FY 2012. This inflation
adjustment for FY 2012 is 20.88 percent.
Increasing the FY 2012 fee revenue
base of $499,412,000, by 20.88 percent
yields an inflation-adjusted fee revenue
amount for FY 2012 of $603,689,000,
rounded to the nearest thousand dollars,
before the application of the FY 2012
workload adjustment.
D. Workload Adjustment to the FY 2012
Inflation Adjusted Fee Revenue Amount
PDUFA IV does not allow FDA to
adjust the total revenue amount for
workload beginning in FY 2010, unless
an independent accounting firm study is
complete (see section 736(c)(2)(C) of the
FD&C 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
prescribed in PDUFA IV.
For each fiscal year beginning in FY
2009, PDUFA IV provides that fee
revenue amounts, after they have been
adjusted for inflation, shall be further
adjusted to reflect changes in workload
for the process for the review of human
drug applications (see section 736(c)(2)
of the FD&C Act). PDUFA IV continues
the Prescription Drug User Fee
Amendments of 2002 (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, 2011.
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45833
The calculations are summarized in
table 2 of this document. The 5-year
averages for each application category
are provided in Column 1 (‘‘5–Year
Average Base Years 2002–2007’’) and
Column 2a (‘‘5-Year Average 2007–
2011’’).
PDUFA IV specifies that FDA make
additional adjustments for changes in
review activities to human drug
applications and active commercial
INDs. These adjustments, specified
under PDUFA IV, are summarized in
columns 2b and 2c in table 2 of this
document. The number in the new drug
applications/biologics license
applications (NDAs/BLAs) line of
column 2b of table 2 of this document
is the percent by which the average
workload for meetings, annual reports,
and labeling supplements for NDAs and
BLAs has changed from the 5-year
period 2002 through 2007, to the 5-year
period 2007 through 2011. Likewise, the
number in the ‘‘Active commercial
INDs’’ line of column 2b of table 2 of
this document is the percent by which
the workload for meetings and special
protocol assessments for active
commercial INDs has changed from the
5-year period 2002 through 2007, to the
5-year period 2007 through 2011. 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 2 of this document
reflects the percent change in workload
from column 1 to column 2c. Column 4
of table 2 of this document shows the
weighting factor for each type of
application, estimating how much of the
total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 5 years. Column 5 of table 2 of
this document is the weighted percent
change in each category of workload.
This was derived by multiplying the
weighting factor in each line in column
4 by the percent change from the base
years in column 3. At the bottom right
of table 2 of this document is the sum
of the values in column 5 that are
added, reflecting an increase in
workload of 8.12 percent for FY 2012
when compared to the base years.
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TABLE 2—WORKLOAD ADJUSTER CALCULATION FOR FY 2012
Column 1
5-year
average base
years
2002–2007
Application type
NDAs/BLAs ......................................
Active commercial INDs ...................
Efficacy supplements .......................
Manufacturing supplements .............
FY 2012 Workload Adjuster .....
Column 2b
Adjustment
for changes
in review
activity
Column 2c
(Column 2a
increased by
column 2b)
Column 3
Percent
change
(column 1 to
column 2c)
130.8
6520.6
157.4
2606.8
¥0.01%
¥2.41
NA
NA
130.8
6363.2
157.4
2606.8
5.6%
15.1
¥3.7
0.7
35.3%
42.4
9.9
12.4
1.99%
6.40
¥0.36
0.08
......................
....................
......................
....................
....................
8.12
Column 2a
5-year
average
2007–2011
123.8
5,528.2
163.4
2589.2
........................
The FY 2012 workload adjuster
reflected in the calculations in table 3 of
this document is 8.12 percent. Therefore
the inflation-adjusted revenue amount
of $603,689,000 from section II.C of this
document will be increased by the FY
2012 workload adjuster of 8.12 percent,
resulting in a total adjusted revenue
amount in FY 2012 of $652,709,000,
rounded to the nearest thousand dollars.
E. Rent and Rent-Related Adjustment to
the FY 2011 Adjusted Fee Revenue
Amount
PDUFA specifies that for FY 2010 and
each subsequent FY, the revenue
amount will be decreased if the actual
cost paid for rent and rent-related
Column 5
Weighted
percent
change
Column 4
Weighting
factor
expenses for preceding FYs are less than
estimates made for such FYs in FY 2006
(see section 736(c)(3) of the FD&C Act).
Table 3 of this document shows the
estimates of rent and rent-related costs
for FY 2008 through FY 2010 made in
2006 and the actual costs for these 3
FYs, the only FYs for which complete
data are available at this time.
TABLE 3—COMPARISON OF ACTUAL AND ESTIMATED RENT AND RENT-RELATED EXPENSES FOR THE CENTER FOR DRUG
EVALUATION AND RESEARCH (CDER) AND THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
Estimates made in 2006
Actual amounts paid
FY 2008
FY 2009
FY 2010
Total
FY 2008
FY 2009
FY 2010
Total
CDER ............................................
CBER ............................................
$46,732,000
22,295,000
$40,415,000
23,067,000
$41,589,000
25,652,000
$128,736,000
71,014,000
$51,619,000
26,715,000
$64,687,250
26,966,750
$58,049,000
27,815,000
$174,355,250
81,496,750
Total .......................................
69,027,000
63,482,000
67,241,000
199,750,000
78,334,000
91,654,000
85,864,000
255,852,000
Because FY 2008 through FY 2010
costs for rent and rent-related items in
total ($255,852,000) exceeded the
estimates of these costs made in FY
2006 ($199,750,000), no decrease in the
FY 2012 estimated PDUFA revenues is
required under this provision of
PDUFA.
III. Offset for Excess Collections
Through FY 2011
Under the provisions of PDUFA III,
which applies to user fees collected for
FY 2002 through FY 2007, if the amount
of fees collected for a FY exceeds the
amount of fees specified in
appropriation acts for that FY, the
excess amount shall be credited to
FDA’s appropriation account and shall
be subtracted from the amount of fees
that would otherwise be authorized to
be collected in a subsequent FY (See 21
U.S.C. 379h(g)(4) as amended by
PDUFA III). In setting PDUFA fees for
FY 2007 in August of 2006, some offsets
were made under these provisions, but
some offsets still need to be made based
on final collection data for that period.
Table 4 shows the amount of fees
specified in FDA’s annual appropriation
for each year from FY 2003 through FY
2007; the amounts FDA has collected for
each year; the amount of offset
previously taken; and the cumulative
difference. FDA will take this difference
as an offset against FY 2012 fee
collections.
TABLE 4—OFFSETS REMAINING TO BE TAKEN FOR PDUFA III, FY 2003–2007
Fees
appropriated
Fees collected
Excess collections offset
under section
736(g)(4) of
the FD&C Act
when 2007
fees were set
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
$222,900,000
249,825,000
284,394,000
305,332,000
352,200,000
$218,302,684
258,333,700
287,178,231
313,514,278
370,934,966
........................
$7,230,906
........................
........................
........................
........................
$1,277,794
2,784,231
8,209,278
18,734,966
Cumulative difference to be offset against FY 2012 collections ..............
........................
........................
........................
30,974,959
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Fiscal year
2003
2004
2005
2006
2007
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Remaining
excess
collections
to be offset
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In addition, under the provisions of
PDUFA, as amended by PDUFA IV, if
the sum of the cumulative amount of the
fees collected for FY 2008 through 2010,
and the amount of fees estimated to be
collected under this section III of the
document for FY 2011, exceeds the
cumulative amount appropriated for
fees for FYs 2008 through 2011, the
excess will be credited to FDA’s
appropriation account and subtracted
from the amount of fees that FDA would
45835
August 4, 2010 (75 FR 46956). In FY
2011, application fee revenues to date
are less than anticipated when fees were
set in August 2010. The bottom line of
table 5 of this document shows the
estimated cumulative difference
between fee amounts specified in
appropriation acts for FY 2008 through
FY 2011 and PDUFA fee amounts
collected.
otherwise be authorized to collect for
FY 2012 under the FD&C Act (21 U.S.C.
379h(g)(4) as amended by PDUFA IV).
Table 5 of this document shows the
amounts specified in appropriation acts
for each year from FY 2008 through FY
2011, and the amounts FDA has
collected for FYs 2008, 2009, and 2010
as of March 31, 2011, and the amount
that FDA estimated it would collect in
FY 2011 when it published the notice of
FY 2011 fees in the Federal Register on
TABLE 5—OFFSETS TO BE TAKEN FOR THE PDUFA IV PERIOD, FY 2008–2011 FOR FY 2008–2010, FEES COLLECTED
THROUGH 3/31/2011; FOR FY 2011, ESTIMATE AS OF 3/31/2011
Fees appropriated
Fees collected
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
estimate ..............................................................................................................................
$459,412,000
510,665,000
578,162,000
667,057,000
$479,582,086
521,496,042
567,877,548
619,070,000
$20,170,086
10,831,042
(10,284,452)
(47,987,000)
Cumulative difference ...........................................................................................................
........................
........................
(27,270,324)
Fiscal year
2008
2009
2010
2011
The cumulative fees collected for FYs
2008 through 2011 are estimated to be
more than $27 million less than the
cumulative fee amounts specified in
appropriation acts during this same
period. Under section 736(g)(4) of the
FD&C Act, an offset is only made if the
cumulative fees collected exceed
cumulative fee appropriations for this
period. Accordingly, there will be no
offset of fees attributable to the PDUFA
IV period of FYs 2008 through 2012.
The only offset will be for the
$30,974,959 for the PDUFA III period.
Reducing the inflation and workload
adjusted estimate of total revenue of
$652,709,000 by the PDUFA III offset of
$30,975,000 (rounded to the nearest
thousand dollars) results in a revenue
estimate of $621,734,000, before the
final year adjustment.
srobinson on DSK4SPTVN1PROD with NOTICES
IV. Final Year Adjustment
Under the provisions of PDUFA, as
amended, the Secretary of Health and
Human Services may, in addition to the
inflation and workload adjustments,
further increase the fees and fee
revenues if such an adjustment is
necessary to provide for not more than
3 months of operating reserves of
carryover user fees for the process for
the review of human drug applications
for the first 3 months of FY 2013. The
rationale for the amount of this increase
shall be contained in the annual notice
establishing fee revenues and fees for
FY 2012 (see 21 U.S.C. 379h(c)(4)).
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Difference
about 17 fewer paid full application fees
were received by FDA than expected,
causing a revenue shortfall, FDA is
assuming that about 5.5 fewer full
applications will be received in both FY
2011 and FY 2012, resulting in
$150,611,598 shortfalls of over $8,382,000 and
30,975,000 $8,694,000 each year, respectively, that
will have to be covered from the
carryover balances. Thus the amount of
29,771,000 carry-over balance FDA expects to be
2,500,000 available for obligation at the end of FY
2012 is $32,393,598, as shown in the
37,896,000
last line of table 6 of this document.
TABLE 6—ESTIMATED CARRYOVER
BALANCE AT THE END OF FY 2012,
AFTER DEDUCTION OF ESTIMATED
FY 2011–2012 OPERATING COSTS
Total carryover balance end
of FY 2010 ........................
Used for offset in 2012 .........
Used for additional 53 FTE
(FDAAA drug safety), FY
2011–2012 ........................
Reserve for refunds ..............
Used for CBER move to
White Oak .........................
Used to cover 2011 estimated revenue shortfalls ..
Used to cover 2012 estimated revenue shortfalls ..
Estimated 2012 end of FY
carryover balance .............
8,382,000
8,694,000
32,393,598
As of September 30, 2010, FDA had
cash carryover balances of
$150,611,598. However, of this amount,
a total of $30,975,000 will be used to
cover the cost of the reduction in fee
revenue that will result from the offset
in fees for excess collections during
PDUFA III. A total of $29,771,000 will
be used in FY 2011 and FY 2012 to
cover the cost of additional FTEs
allocated in FY 2009 to address
increased PDUFA workload associated
with new drug safety provisions under
FDAAA. A total of $2,500,000 is not
available to FDA to obligate because it
represents the minimum amount FDA
will need to keep in reserve for refunds
that will need to be made. A total of
$37,896,000 is expected to be used for
the CBER move to the White Oak
campus in FY 2012–2014. Based on
FDA’s experience in FY 2010 when
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Fmt 4703
Sfmt 4703
TABLE 7—ESTIMATED FEE REVENUE
NEEDED TO SUSTAIN FY 2012 OPERATIONS FOR THE FIRST 3 MONTHS
OF FY 2013
Estimated total spending
from fees in FY 2012 ........
Estimated FY 2013 inflation
costs at 3.72% ..................
Estimated FY 2013 funds to
sustain FY 2012 operations .................................
Estimated fees needed for 3
months in FY 2013 ...........
Estimated end-of-FY 2012
carryover balance .............
Additional revenue needed
for 3 months in FY 2013 ...
$652,709,000
24,280,775
676,989,755
169,247,444
32,393,598
136,854,000
In FY 2012, FDA expects to spend a
total of $652,709,000, as noted at the
end of section III of this document. To
sustain current operations in FY 2012,
with an anticipated inflation rate of 3.72
percent, FDA expects to obligate a total
of $676,989,775 in FY 2013—or a total
of about $169,247,444 during the first 3
months of FY 2013. The available
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carryover balance at the beginning of FY
2013 is estimated at $32,393,598. Thus
FDA would need an additional
$136,854,000 ($169,247,444 minus
$32,393,598, rounded to the nearest
thousand dollars) as the final year
adjustment to assure sufficient operating
reserves for the first 3 months of FY
2013.
FDA recognizes that adding
$136,854,000 to the fee revenue costs in
FY 2012 poses a substantial burden on
the regulated industry at a time when it
is undergoing significant financial
strain. In light of this, and in light of the
fact that the legislative language
authorizing the final year adjustment
allows FDA discretion in whether to
make this adjustment for a full 3 months
of operating reserves or for a shorter
period, FDA has decided to balance its
own risks with the amount of burden
the final year adjustment will place on
the industry. In making this decision,
FDA has decided to assume more risk,
making the final year adjustment to
allow for only 2 months of operating
reserves instead of for 3 months of
operating reserves. Accordingly FDA
will make the final year adjustment for
a lesser amount, as derived in table 8 of
this document.
TABLE 8—ESTIMATED FEE REVENUE NEEDED TO SUSTAIN FY 2012 OPERATIONS FOR THE FIRST 2 MONTHS OF FY 2013
srobinson on DSK4SPTVN1PROD with NOTICES
Estimated total spending from fees in FY 2012 ............................................................................................................................
Estimated FY 2013 inflation costs at 3.72% .................................................................................................................................
Estimated 2013 funds to sustain 2012 operations ........................................................................................................................
Estimated fees needed for 2 months in FY 2013 .........................................................................................................................
Estimated 2012 end of FY carryover balance ...............................................................................................................................
Additional revenue needed for 2 months in 2013 .........................................................................................................................
Rounding this amount to the nearest
thousand dollars results in a final year
adjustment of $80,438,000. Adding this
amount to the total of $621,743,000, the
total after the offset adjustment at the
end of section III of this document,
results in a total revenue target of
$702,172,000, rounded to the nearest
thousand dollars, for FY 2012.
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
FD&C Act). Accordingly, one-third of
the total revenue amount (rounded to
the nearest thousand dollars), or a total
of $234,057,000 is the total amount of
fee revenue that will be derived from
each of these fee categories: Application
Fees, Establishment Fees, and Product
Fees.
While the fee revenue amount
anticipated in FY 2012 is $702,172,000,
as the previous paragraph shows, FDA
assumes that the fee appropriation for
FY 2012 will be 5 percent higher, or
$737,281,000, rounded to the nearest
thousand dollars. The PDUFA IV 5-Year
Financial Plan, (which can be found at
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm153456.htm) states in Assumption
14 (Fee Revenue and Annual
Appropriation Amount) that the PDUFA
workload adjuster is a lagging
adjustment dampened by averages over
five years, and will not help FDA keep
up with workload if there are sudden
increases in the number of applications
to be reviewed in the current fiscal year.
Appropriated amounts for PDUFA fee
revenue each year are estimated at 5
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percent higher than estimated fee
revenues for each year, to provide FDA
with the ability to cope with surges in
application review workload should
that occur. If FDA collects less than the
fee estimate at the beginning of the year
and less than the fee appropriation, then
collections rather than appropriations
set the upper limit on how much FDA
may actually keep and spend. If,
however, FDA collects more than fee
estimates at the beginning of the year,
due to a workload surge, a slightly
higher fee appropriation will permit
FDA to keep and spend the higher
collections in order to respond to a real
surge in review workload that caused
the increased collections—an
unexpected increase in the number of
applications that FDA must review in
accordance with PDUFA goals. For this
reason, in most FY since 1993, actual
appropriations have slightly exceeded
PDUFA fee revenue estimates made
each year.
V. 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 $234,057,000, in FY
2012, as calculated previously in this
document.
B. Estimate of the Number of Fee-Paying
Applications and the 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 FY
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Fmt 4703
Sfmt 4703
$652,709,000
24,280,775
676,989,775
112,831,629
32,393,598
80,438,031
by averaging the number of fee-paying
FAEs received in the 5 most recent
fiscal years. Using a rolling average of
the 5 most recent fiscal years is the same
method that has been applied for the
last 8 years.
In estimating the number of feepaying FAEs that FDA will receive in
FY 2012, the 5-year rolling average for
the most recent 5 years will be based on
actual counts of fee-paying FAEs
received for FY 2007 through FY 2011.
For FY 2011, FDA is estimating the
number of fee-paying FAEs for the full
year based on the actual count for the
first 9 months and estimating the
number for the final 3 months, as we
have done for the past 8 years.
Table 9 of this document shows, in
column 1, the total number of each type
of FAE received in the first 9 months of
FY 2011, 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, 2011. Column 4
estimates the 12-month total fee-paying
FAEs for FY 2011 based on the
applications received through June 30,
2011. 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 9—FY 2011 FULL APPLICATION EQUIVALENTS RECEIVED THROUGH JUNE 30, 2011, AND PROJECTED THROUGH
SEPTEMBER 30, 2011
Column 2
Fees exempted or
waived
through
6/30/2011
Column 1
Total
received
through
6/30/2011
Column 3
Total fee
paying
through
6/30/2011
Column 4
12-Month
fee paying
projection
Applications requiring clinical data ..................................................................................
Applications not requiring clinical data ............................................................................
Supplements requiring clinical data .................................................................................
Withdrawn or refused to file ............................................................................................
55
9.5
44.5
1.625
18
5.5
9
1.25
37
4
35.5
.375
Total ..........................................................................................................................
110.625
33.75
76.875
In the first 9 months of FY 2011, FDA
received 110.625 FAEs, of which 76.875
were fee-paying. Based on data from the
last 10 FYs, on average, 25 percent of
the applications submitted each year
come in the final 3 months. Dividing
76.875 by 3 and multiplying by 4
extrapolates the amount to the full 12
months of the FY and projects the
number of fee-paying FAEs in FY 2011
at 102.5.
As table 10 of this document shows,
the average number of fee-paying FAEs
49.33
5.33
47.88
.5
102.5
received annually in the most recent 5year period, and including our estimate
for FY 2011, is 127.1 FAEs. FDA will set
fees for FY 2011 based on this estimate
as the number of full application
equivalents that will pay fees.
TABLE 10—FEE-PAYING FAE 5-YEAR AVERAGE
Fiscal year
2007
2008
2009
2010
2011
estimate
5-Year
average
Fee-Paying FAEs .............................................................
134.4
140.0
140.3
118.4
102.5
127.1
FDA will use 450 for its FY 2012
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 ($234,057,000) by the
estimated 450 establishments, for an
establishment fee rate for FY 2012 of
$520,100 (rounded to the nearest $100).
VI. Fee Calculations for Establishment
and Product Fees
srobinson on DSK4SPTVN1PROD with NOTICES
The FY 2012 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 5 years, 127.1, into
the fee revenue amount to be derived
from application fees in FY 2012,
$234,057,000. The result, rounded to the
nearest $100, is a fee of $1,841,500 per
full application requiring clinical data,
and $920,750 per application not
requiring clinical data or per
supplement requiring clinical data.
At the beginning of FY 2011, the
product fee was based on an estimate
that 2,385 products would be subject to
and would pay product fees. By the end
of FY 2011, 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 55 waivers and reductions
granted. 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 FD&C Act). FDA estimates
that 2,365 products will qualify for
product fees in FY 2011, after allowing
for waivers and reductions, including
the orphan drug products eligible under
the FDAAA exemption, and will use
this number for its FY 2012 estimate.
The FY 2012 product fee rate is
determined by dividing the adjusted
total fee revenue to be derived from
A. Establishment Fees
At the beginning of FY 2011, the
establishment fee was based on an
estimate that 415 establishments would
be subject to, and would pay, fees. By
the end of FY 2011, FDA estimates that
475 establishments will have been
billed for establishment fees, before all
decisions on requests for waivers or
reductions are made. FDA estimates that
a total of 10 establishment fee waivers
or reductions will be made for FY 2011.
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 FD&C Act). Subtracting 25
establishments (10 waivers, plus the
estimated 15 establishments under the
orphan exemption) from 450 leaves a
net of 415 fee-paying establishments.
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B. Product Fees
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
product fees ($234,057,000) by the
estimated 2,365 products for a FY 2012
product fee of $98,970 (rounded to the
nearest $10).
VII. Fee Schedule for FY 2012
The fee rates for FY 2012 are set out
in table 11 of this document.
TABLE 11—FEE SCHEDULE FOR FY
2012
Fee category
Fee rates for
FY 2012
Applications ..........................
Requiring clinical data ...
Not requiring clinical
data ............................
Supplements requiring
clinical data ................
Establishments .....................
Products ................................
........................
$1,841,500
920,750
920,750
520,100
98,970
IX. 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, 2011. 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
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Federal Register / Vol. 76, No. 147 / Monday, August 1, 2011 / Notices
identification (ID) number on your
check, bank draft, or postal money
order. Your payment can be mailed to:
Food and Drug Administration, P.O.
Box 979107, St. Louis, MO 63197–9000.
If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to: U.S.
Bank, Attention: Government Lockbox
979107, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only.)
Please make sure that the FDA post
office box number (P.O. Box 979107) 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 may charge 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, U.S. Dept of
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA,
1350 Piccard Dr., Rockville, MD, 20850.
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
srobinson on DSK4SPTVN1PROD with NOTICES
FDA will issue invoices for
establishment and product fees for FY
2012 under the new fee schedule in
August 2011. Payment will be due on
October 1, 2011. FDA will issue
invoices in November 2012 for any
products and establishments subject to
fees for FY 2012 that qualify for fee
assessments after the August 2011
billing.
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–19332 Filed 7–29–11; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Combination Cancer Therapy Using an
IL13-Targeted Toxin and a Vaccine
Description of Technology: Typical
cancer treatments such as
chemotherapy, radiation therapy and
surgical resection are non-specific
processes that kill healthy cells as well
as diseased cells, ultimately resulting in
discomfort and undesirable side-effects
for patients. In an effort to reduce the
burden on cancer patients, a
tremendous effort has been placed on
developing ways to increase the
specificity of cancer treatments. One
way to increase specificity is to identify
proteins which are present on the
surface of cancer cells but absent on
normal healthy cells, and use that
protein as a target for delivering a
therapeutic agent. Because the
therapeutic agent only reaches the
diseased cell, patients are less likely to
experience non-specific side-effects,
reducing their pain burden during
treatment.
IL13-receptor-alpha-2 (IL13–Ra2) is a
cell surface protein that is selectively
expressed on certain diseased cells,
including cancer cells. IL13–Ra2 binds
to the cytokine IL13, suggesting that a
therapeutic agent fused to IL13 can
target and kill only those cancer cells
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Frm 00082
Fmt 4703
Sfmt 4703
which express IL13–Ra2. Our inventors
previously constructed fusion proteins
comprising (1) IL13 and (2) an active
fragment of the bacterial toxin
Pseudomonas exotoxin A (PE). These
IL13–PE fusion proteins demonstrated
the ability to selectively kill cancer cells
that overexpressed IL13–Ra2, as well as
other types of diseased cells (asthma,
pulmonary fibrosis) which
overexpressed IL13–Ra2. This suggested
that IL13–PE fusion proteins were
excellent candidates for new therapeutic
agents.
The inventors recently sought
methods to increase the effectiveness of
these IL13–PE fusion proteins in the
treatment of disease. This technology is
directed to a combination therapy
comprising (a) a DNA vaccine against
IL13–Ra2 and (b) an IL13–PE fusion
protein. By combining these therapeutic
approaches it is possible to kill certain
cell types that express IL13–Ra2 at high
levels (such as cancer cells), making this
combinatorial approach an attractive
potential therapeutic.
Applications:
• Treatment of diseases associated
with the increased expression of IL13–
Ra2
• Relevant diseases include
pulmonary fibrosis, asthma and cancers
such as pancreatic cancer, glioblastoma
multiforme and other head and neck
cancers
Advantages:
• The DNA vaccine only affects cells
where IL13–Ra2 expression is
increased, limiting their effects to
diseased cells
• IL13–PE fusion proteins also only
kill cells that overexpress IL13–Ra2,
allowing specific targeting of treatment
• Targeted treatment decreases nonspecific killing of healthy, essential
cells, resulting in fewer side-effects and
healthier patients
Development Status: Preclinical stage
of development.
Inventors: Puri et al. (FDA).
Patent Status: US provisional
application 61/451,331 (HHS reference
E–104–2011/0–US–01).
For more information, see:
• US Patents 5,614,191, 5,919,456
and 6,518,061 (HHS technology
reference E–266–1994/0)
• US Patent Publication US
20040136959 A1 (HHS technology
reference E–032–2000/0)
• US Patent 7,541,040 (HHS
technology reference E–296–2001/0)
Licensing Status: Available for
licensing.
Licensing Contact: David A.
Lambertson, PhD; 301–435–4632;
lambertsond@mail.nih.gov.
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]]>Agencies
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45831-45838]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19332]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0559]
Prescription Drug User Fee Rates for Fiscal Year 2012
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) 2012. The Federal
Food, Drug, and Cosmetic Act (the FD&C 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 document establishes fee
rates for FY 2012 for application fees for an application requiring
clinical data ($1,841,500), for an application not requiring clinical
data or a supplement requiring clinical data ($920,750), for
establishment fees ($520,100), and for product fees ($98,970). These
fees are effective on October 1, 2011, and will remain in effect
through September 30, 2012. For applications and supplements that are
submitted on or after October 1, 2011, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2012 will be
issued in August 2011, using the new fee schedule.
FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Picard Dr.,
PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the FD&C 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 FD&C Act). When certain conditions are met, FDA
may waive or reduce fees (section 736(d) of the FD&C 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 FYs. That
adjusted base revenue amount is increased for drug safety enhancements
by $10,000,000 in each of the subsequent 4 FYs, and the increased total
is further adjusted each year for inflation and workload. Fees for
[[Page 45832]]
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 document uses the fee base revenue amount for FY 2008
published in the Federal Register of October 12, 2007 (72 FR 58103)
(the October 2007 notice); adjusts it for the FY 2009, FY 2010, FY
2011, and FY 2012 drug safety increases (see section 736(b)(4) of the
FD&C Act), for inflation, and for workload, for excess collections
through FY 2011, and for a final year adjustment; and then establishes
the application, establishment, and product fees for FY 2012. These
fees are effective on October 1, 2011, and will remain in effect
through September 30, 2012.
II. Fee Revenue Amount for FY 2012
The total fee revenue amount for FY 2012 is $702,172,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation, changes in
workload, offset for excess collections and the final year adjustment.
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. The adjustment
for estimated excess collections through FY 2012 is described in
section III of this document, and the final year adjustment is
described in section IV of this document.
A. FY 2012 Statutory Fee Revenue Amounts Before Adjustments
PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2012 for all fees is $457,783,000 ($392,783,000 specified in
section 736(b)(1) of the FD&C Act plus an additional $65,000,000 for
drug safety in FY 2012 specified in section 736(b)(4)).
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 FD&C Act). The workload adjustment on this
amount is to be made in accordance with the workload adjustment
provisions that were in effect for FY 2007, except that the adjustment
for investigational new drug (IND) workload is based on the number of
INDs with a submission in the previous 12 months rather than on the
number of new commercial INDs submitted in the same 12-month period.
This adjustment was explained in detail in the October 2007 notice.
Increasing the statutorily specified amount of $354,893,000 by the
specified workload adjuster (11.73 percent) results in an increase of
$41,629,000, rounded to the nearest thousand. Adding this amount to the
$457,783,000 statutorily specified amount from section II.A of this
document, results in a total adjusted PDUFA IV base revenue amount of
$499,412,000, before further adjustment for inflation and changes in
workload after FY 2007.
C. Inflation Adjustment to FY 2012 Fee Revenue Amount
PDUFA IV provides that fee revenue amounts for each FY 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 FY for
which fees are being set; (2) the total percentage pay change for the
previous FY for Federal employees stationed in the Washington, DC
metropolitan area; or (3) the average annual change in cost, per FDA
full time equivalent (FTE), of all personnel compensation and benefits
paid for the first 5 of the previous 6 FYs. PDUFA IV provides for this
annual adjustment to be cumulative and compounded annually after FY
2008 (see section 736(c)(1) of the FD&C Act).
The first factor is the CPI increase for the 12-month period ending
in June 2011. The CPI for June 2011 was 225.722 and the CPI for June
2010 was 217.965. (These CPI figures are available on the Bureau of
Labor Statistics (BLS) 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 2011 is 3.559 percent higher than
the CPI for the previous 12-month period.
The second factor is the increase in pay for the previous FY (FY
2011 in this case) for Federal employees stationed in the Washington,
DC metropolitan area. This figure is published by the Office of
Personnel Management (OPM), and found on their Web site at https://www.opm.gov/oca/11tables/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 2011 it was 0.00 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 FYs (FY
2006 through FY 2010). 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 1 of this document summarizes that actual cost and
FTE use data for the specified FYs, and provides the percent change
from the previous FY and the average percent change over the most 5
recent FYs, which is 3.72 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual average
FY2006 FY2007 FY2008 FY2009 FY2010 increase for
latest 5 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B.................................. $1,114,704,000 $1,144,369,000 $1,215,627,000 $1,464,445,000 $1,634,108,000 ................
Total FTE................................... 9,698 9,569 9,811 11,413 12,256 ................
PC&B per FTE................................ $114,942 $119,591 $123,905 $128,314 $130,457 ................
Percent Change from Previous Year........... 5.70 4.05 3.61 3.56 1.67 3.72
--------------------------------------------------------------------------------------------------------------------------------------------------------
The inflation increase for FY 2012 is 3.72 percent. This is the
greater of the CPI change during the 12-month period ending June 30
preceding the FY for which fees are being set (3.559 percent), the
increase in pay for the previous FY (FY 2011 in this case) for Federal
employees stationed in the Washington, DC metropolitan area (0.00
percent), and
[[Page 45833]]
the average annual change in cost, per FDA FTE, of all personnel
compensation and benefits paid for the first 5 of the previous 6 FYs
(3.72 percent). Because the average change in pay per FTE (3.72
percent) is the highest of the three factors, it becomes the inflation
adjustment for total fee revenue for FY 2012.
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 FY 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 FDA FTE, of all personnel compensation and
benefits paid for the first 5 of the previous 6 FYs (5.64 percent).
The inflation adjustment for FY 2010 was 5.54 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the FY for which fees were being set (June 30, 2009)
(negative 1.43 percent), the increase in pay for FY 2009 for Federal
employees stationed in Washington, DC (4.78 percent), or the average
annual change in cost, per FDA FTE, of all personnel compensation and
benefits paid for the first 5 of the previous 6 FYs (5.54 percent).
The inflation adjustment for FY 2011 was 4.53 percent. This is the
greater of the CPI increase during the 12-month period ending June 30
preceding the FY for which fees were being set (June 30, 2010) (1.053
percent), the increase in pay for FY 2010 for Federal employees
stationed in Washington, DC (2.42 percent), or the average annual
change in cost, per FDA FTE, of all personnel compensation and benefits
paid for the first 5 of the previous 6 FYs (4.53 percent).
PDUFA IV provides for this inflation adjustment to be cumulative
and compounded annually after FY 2008 (see section 736(c)(1) of the
FD&C Act). This factor for FY 2012 (3.72 percent) is compounded by
adding one to it and then multiplying it by one plus the inflation
adjustment factor for FY 2011 (4.53 percent) and by one plus the
inflation adjustment factor for FY 2010 (5.54 percent) and by one plus
the inflation adjustment factor for FY 2009 (5.64 percent). The result
of this multiplication of the inflation factors for the 4 years since
FY 2008 (1.0372 times 1.0453 times 1.0554 times 1.0564 percent) becomes
the inflation adjustment for FY 2012. This inflation adjustment for FY
2012 is 20.88 percent.
Increasing the FY 2012 fee revenue base of $499,412,000, by 20.88
percent yields an inflation-adjusted fee revenue amount for FY 2012 of
$603,689,000, rounded to the nearest thousand dollars, before the
application of the FY 2012 workload adjustment.
D. Workload Adjustment to the FY 2012 Inflation Adjusted Fee Revenue
Amount
PDUFA IV does not allow FDA to adjust the total revenue amount for
workload beginning in FY 2010, unless an independent accounting firm
study is complete (see section 736(c)(2)(C) of the FD&C 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
prescribed in PDUFA IV.
For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
FD&C Act). PDUFA IV continues the Prescription Drug User Fee Amendments
of 2002 (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, 2011.
The calculations are summarized in table 2 of this document. The 5-
year averages for each application category are provided in Column 1
(``5-Year Average Base Years 2002-2007'') and Column 2a (``5-Year
Average 2007-2011'').
PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to human drug applications and active commercial
INDs. These adjustments, specified under PDUFA IV, are summarized in
columns 2b and 2c in table 2 of this document. The number in the new
drug applications/biologics license applications (NDAs/BLAs) line of
column 2b of table 2 of this document is the percent by which the
average workload for meetings, annual reports, and labeling supplements
for NDAs and BLAs has changed from the 5-year period 2002 through 2007,
to the 5-year period 2007 through 2011. Likewise, the number in the
``Active commercial INDs'' line of column 2b of table 2 of this
document is the percent by which the workload for meetings and special
protocol assessments for active commercial INDs has changed from the 5-
year period 2002 through 2007, to the 5-year period 2007 through 2011.
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 2 of this document reflects the percent change in
workload from column 1 to column 2c. Column 4 of table 2 of this
document shows the weighting factor for each type of application,
estimating how much of the total FDA drug review workload was accounted
for by each type of application in the table during the most recent 5
years. Column 5 of table 2 of this document is the weighted percent
change in each category of workload. This was derived by multiplying
the weighting factor in each line in column 4 by the percent change
from the base years in column 3. At the bottom right of table 2 of this
document is the sum of the values in column 5 that are added,
reflecting an increase in workload of 8.12 percent for FY 2012 when
compared to the base years.
[[Page 45834]]
Table 2--Workload Adjuster Calculation for FY 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 3
Column 1 5- Column 2a 5- Column 2b Column 2c Percent Column 5
year average year Adjustment (Column 2a change Column 4 Weighted
Application type base years average for changes increased by (column 1 Weighting percent
2002-2007 2007-2011 in review column 2b) to column factor change
activity 2c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs................................................ 123.8 130.8 -0.01% 130.8 5.6% 35.3% 1.99%
Active commercial INDs................................... 5,528.2 6520.6 -2.41 6363.2 15.1 42.4 6.40
Efficacy supplements..................................... 163.4 157.4 NA 157.4 -3.7 9.9 -0.36
Manufacturing supplements................................ 2589.2 2606.8 NA 2606.8 0.7 12.4 0.08
----------------------------------------------------------------------------------------------
FY 2012 Workload Adjuster............................ ............. ............ ........... ............ ........... ........... 8.12
--------------------------------------------------------------------------------------------------------------------------------------------------------
The FY 2012 workload adjuster reflected in the calculations in
table 3 of this document is 8.12 percent. Therefore the inflation-
adjusted revenue amount of $603,689,000 from section II.C of this
document will be increased by the FY 2012 workload adjuster of 8.12
percent, resulting in a total adjusted revenue amount in FY 2012 of
$652,709,000, rounded to the nearest thousand dollars.
E. Rent and Rent-Related Adjustment to the FY 2011 Adjusted Fee Revenue
Amount
PDUFA specifies that for FY 2010 and each subsequent FY, the
revenue amount will be decreased if the actual cost paid for rent and
rent-related expenses for preceding FYs are less than estimates made
for such FYs in FY 2006 (see section 736(c)(3) of the FD&C Act). Table
3 of this document shows the estimates of rent and rent-related costs
for FY 2008 through FY 2010 made in 2006 and the actual costs for these
3 FYs, the only FYs for which complete data are available at this time.
Table 3--Comparison of Actual and Estimated Rent and Rent-Related Expenses for the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimates made in 2006 Actual amounts paid
-------------------------------------------------------------------------------------------------------------------
FY 2008 FY 2009 FY 2010 Total FY 2008 FY 2009 FY 2010 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER................................ $46,732,000 $40,415,000 $41,589,000 $128,736,000 $51,619,000 $64,687,250 $58,049,000 $174,355,250
CBER................................ 22,295,000 23,067,000 25,652,000 71,014,000 26,715,000 26,966,750 27,815,000 81,496,750
-------------------------------------------------------------------------------------------------------------------
Total........................... 69,027,000 63,482,000 67,241,000 199,750,000 78,334,000 91,654,000 85,864,000 255,852,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Because FY 2008 through FY 2010 costs for rent and rent-related
items in total ($255,852,000) exceeded the estimates of these costs
made in FY 2006 ($199,750,000), no decrease in the FY 2012 estimated
PDUFA revenues is required under this provision of PDUFA.
III. Offset for Excess Collections Through FY 2011
Under the provisions of PDUFA III, which applies to user fees
collected for FY 2002 through FY 2007, if the amount of fees collected
for a FY exceeds the amount of fees specified in appropriation acts for
that FY, the excess amount shall be credited to FDA's appropriation
account and shall be subtracted from the amount of fees that would
otherwise be authorized to be collected in a subsequent FY (See 21
U.S.C. 379h(g)(4) as amended by PDUFA III). In setting PDUFA fees for
FY 2007 in August of 2006, some offsets were made under these
provisions, but some offsets still need to be made based on final
collection data for that period. Table 4 shows the amount of fees
specified in FDA's annual appropriation for each year from FY 2003
through FY 2007; the amounts FDA has collected for each year; the
amount of offset previously taken; and the cumulative difference. FDA
will take this difference as an offset against FY 2012 fee collections.
Table 4--Offsets Remaining To Be Taken for PDUFA III, FY 2003-2007
----------------------------------------------------------------------------------------------------------------
Excess
collections
offset under Remaining
Fees section excess
Fiscal year appropriated Fees collected 736(g)(4) of collections
the FD&C Act to be offset
when 2007 fees
were set
----------------------------------------------------------------------------------------------------------------
2003............................................ $222,900,000 $218,302,684 .............. ..............
2004............................................ 249,825,000 258,333,700 $7,230,906 $1,277,794
2005............................................ 284,394,000 287,178,231 .............. 2,784,231
2006............................................ 305,332,000 313,514,278 .............. 8,209,278
2007............................................ 352,200,000 370,934,966 .............. 18,734,966
---------------------------------------------------------------
Cumulative difference to be offset against .............. .............. .............. 30,974,959
FY 2012 collections........................
----------------------------------------------------------------------------------------------------------------
[[Page 45835]]
In addition, under the provisions of PDUFA, as amended by PDUFA IV,
if the sum of the cumulative amount of the fees collected for FY 2008
through 2010, and the amount of fees estimated to be collected under
this section III of the document for FY 2011, exceeds the cumulative
amount appropriated for fees for FYs 2008 through 2011, the excess will
be credited to FDA's appropriation account and subtracted from the
amount of fees that FDA would otherwise be authorized to collect for FY
2012 under the FD&C Act (21 U.S.C. 379h(g)(4) as amended by PDUFA IV).
Table 5 of this document shows the amounts specified in
appropriation acts for each year from FY 2008 through FY 2011, and the
amounts FDA has collected for FYs 2008, 2009, and 2010 as of March 31,
2011, and the amount that FDA estimated it would collect in FY 2011
when it published the notice of FY 2011 fees in the Federal Register on
August 4, 2010 (75 FR 46956). In FY 2011, application fee revenues to
date are less than anticipated when fees were set in August 2010. The
bottom line of table 5 of this document shows the estimated cumulative
difference between fee amounts specified in appropriation acts for FY
2008 through FY 2011 and PDUFA fee amounts collected.
Table 5--Offsets To Be Taken for the PDUFA IV Period, FY 2008-2011 for FY 2008-2010, Fees Collected Through 3/31/
2011; for FY 2011, Estimate as of 3/31/2011
----------------------------------------------------------------------------------------------------------------
Fees
Fiscal year appropriated Fees collected Difference
----------------------------------------------------------------------------------------------------------------
2008............................................................ $459,412,000 $479,582,086 $20,170,086
2009............................................................ 510,665,000 521,496,042 10,831,042
2010............................................................ 578,162,000 567,877,548 (10,284,452)
2011 estimate................................................... 667,057,000 619,070,000 (47,987,000)
-----------------------------------------------
Cumulative difference....................................... .............. .............. (27,270,324)
----------------------------------------------------------------------------------------------------------------
The cumulative fees collected for FYs 2008 through 2011 are
estimated to be more than $27 million less than the cumulative fee
amounts specified in appropriation acts during this same period. Under
section 736(g)(4) of the FD&C Act, an offset is only made if the
cumulative fees collected exceed cumulative fee appropriations for this
period. Accordingly, there will be no offset of fees attributable to
the PDUFA IV period of FYs 2008 through 2012. The only offset will be
for the $30,974,959 for the PDUFA III period. Reducing the inflation
and workload adjusted estimate of total revenue of $652,709,000 by the
PDUFA III offset of $30,975,000 (rounded to the nearest thousand
dollars) results in a revenue estimate of $621,734,000, before the
final year adjustment.
IV. Final Year Adjustment
Under the provisions of PDUFA, as amended, the Secretary of Health
and Human Services may, in addition to the inflation and workload
adjustments, further increase the fees and fee revenues if such an
adjustment is necessary to provide for not more than 3 months of
operating reserves of carryover user fees for the process for the
review of human drug applications for the first 3 months of FY 2013.
The rationale for the amount of this increase shall be contained in the
annual notice establishing fee revenues and fees for FY 2012 (see 21
U.S.C. 379h(c)(4)).
Table 6--Estimated Carryover Balance at the End of FY 2012, After
Deduction of Estimated FY 2011-2012 Operating Costs
------------------------------------------------------------------------
------------------------------------------------------------------------
Total carryover balance end of FY 2010.................. $150,611,598
Used for offset in 2012................................. 30,975,000
Used for additional 53 FTE (FDAAA drug safety), FY 2011- 29,771,000
2012...................................................
Reserve for refunds..................................... 2,500,000
Used for CBER move to White Oak......................... 37,896,000
Used to cover 2011 estimated revenue shortfalls......... 8,382,000
Used to cover 2012 estimated revenue shortfalls......... 8,694,000
Estimated 2012 end of FY carryover balance.............. 32,393,598
------------------------------------------------------------------------
As of September 30, 2010, FDA had cash carryover balances of
$150,611,598. However, of this amount, a total of $30,975,000 will be
used to cover the cost of the reduction in fee revenue that will result
from the offset in fees for excess collections during PDUFA III. A
total of $29,771,000 will be used in FY 2011 and FY 2012 to cover the
cost of additional FTEs allocated in FY 2009 to address increased PDUFA
workload associated with new drug safety provisions under FDAAA. A
total of $2,500,000 is not available to FDA to obligate because it
represents the minimum amount FDA will need to keep in reserve for
refunds that will need to be made. A total of $37,896,000 is expected
to be used for the CBER move to the White Oak campus in FY 2012-2014.
Based on FDA's experience in FY 2010 when about 17 fewer paid full
application fees were received by FDA than expected, causing a revenue
shortfall, FDA is assuming that about 5.5 fewer full applications will
be received in both FY 2011 and FY 2012, resulting in shortfalls of
over $8,382,000 and $8,694,000 each year, respectively, that will have
to be covered from the carryover balances. Thus the amount of carry-
over balance FDA expects to be available for obligation at the end of
FY 2012 is $32,393,598, as shown in the last line of table 6 of this
document.
Table 7--Estimated Fee Revenue Needed To Sustain FY 2012 Operations for
the First 3 Months of FY 2013
------------------------------------------------------------------------
------------------------------------------------------------------------
Estimated total spending from fees in FY 2012........... $652,709,000
Estimated FY 2013 inflation costs at 3.72%.............. 24,280,775
Estimated FY 2013 funds to sustain FY 2012 operations... 676,989,755
Estimated fees needed for 3 months in FY 2013........... 169,247,444
Estimated end-of-FY 2012 carryover balance.............. 32,393,598
Additional revenue needed for 3 months in FY 2013....... 136,854,000
------------------------------------------------------------------------
In FY 2012, FDA expects to spend a total of $652,709,000, as noted
at the end of section III of this document. To sustain current
operations in FY 2012, with an anticipated inflation rate of 3.72
percent, FDA expects to obligate a total of $676,989,775 in FY 2013--or
a total of about $169,247,444 during the first 3 months of FY 2013. The
available
[[Page 45836]]
carryover balance at the beginning of FY 2013 is estimated at
$32,393,598. Thus FDA would need an additional $136,854,000
($169,247,444 minus $32,393,598, rounded to the nearest thousand
dollars) as the final year adjustment to assure sufficient operating
reserves for the first 3 months of FY 2013.
FDA recognizes that adding $136,854,000 to the fee revenue costs in
FY 2012 poses a substantial burden on the regulated industry at a time
when it is undergoing significant financial strain. In light of this,
and in light of the fact that the legislative language authorizing the
final year adjustment allows FDA discretion in whether to make this
adjustment for a full 3 months of operating reserves or for a shorter
period, FDA has decided to balance its own risks with the amount of
burden the final year adjustment will place on the industry. In making
this decision, FDA has decided to assume more risk, making the final
year adjustment to allow for only 2 months of operating reserves
instead of for 3 months of operating reserves. Accordingly FDA will
make the final year adjustment for a lesser amount, as derived in table
8 of this document.
Table 8--Estimated Fee Revenue Needed To Sustain FY 2012 Operations for
the First 2 Months of FY 2013
------------------------------------------------------------------------
------------------------------------------------------------------------
Estimated total spending from fees in FY 2012........ $652,709,000
Estimated FY 2013 inflation costs at 3.72%........... 24,280,775
Estimated 2013 funds to sustain 2012 operations...... 676,989,775
Estimated fees needed for 2 months in FY 2013........ 112,831,629
Estimated 2012 end of FY carryover balance........... 32,393,598
Additional revenue needed for 2 months in 2013....... 80,438,031
------------------------------------------------------------------------
Rounding this amount to the nearest thousand dollars results in a
final year adjustment of $80,438,000. Adding this amount to the total
of $621,743,000, the total after the offset adjustment at the end of
section III of this document, results in a total revenue target of
$702,172,000, rounded to the nearest thousand dollars, for FY 2012.
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 FD&C Act).
Accordingly, one-third of the total revenue amount (rounded to the
nearest thousand dollars), or a total of $234,057,000 is the total
amount of fee revenue that will be derived from each of these fee
categories: Application Fees, Establishment Fees, and Product Fees.
While the fee revenue amount anticipated in FY 2012 is
$702,172,000, as the previous paragraph shows, FDA assumes that the fee
appropriation for FY 2012 will be 5 percent higher, or $737,281,000,
rounded to the nearest thousand dollars. The PDUFA IV 5-Year Financial
Plan, (which can be found at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm153456.htm) states in Assumption 14 (Fee
Revenue and Annual Appropriation Amount) that the PDUFA workload
adjuster is a lagging adjustment dampened by averages over five years,
and will not help FDA keep up with workload if there are sudden
increases in the number of applications to be reviewed in the current
fiscal year. Appropriated amounts for PDUFA fee revenue each year are
estimated at 5 percent higher than estimated fee revenues for each
year, to provide FDA with the ability to cope with surges in
application review workload should that occur. If FDA collects less
than the fee estimate at the beginning of the year and less than the
fee appropriation, then collections rather than appropriations set the
upper limit on how much FDA may actually keep and spend. If, however,
FDA collects more than fee estimates at the beginning of the year, due
to a workload surge, a slightly higher fee appropriation will permit
FDA to keep and spend the higher collections in order to respond to a
real surge in review workload that caused the increased collections--an
unexpected increase in the number of applications that FDA must review
in accordance with PDUFA goals. For this reason, in most FY since 1993,
actual appropriations have slightly exceeded PDUFA fee revenue
estimates made each year.
V. 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 $234,057,000, in FY 2012, as calculated previously
in this document.
B. Estimate of the Number of Fee-Paying Applications and the
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 FY by averaging the number of fee-paying FAEs received in the
5 most recent fiscal years. Using a rolling average of the 5 most
recent fiscal years is the same method that has been applied for the
last 8 years.
In estimating the number of fee-paying FAEs that FDA will receive
in FY 2012, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2007
through FY 2011. For FY 2011, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 8 years.
Table 9 of this document shows, in column 1, the total number of
each type of FAE received in the first 9 months of FY 2011, 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, 2011. Column 4
estimates the 12-month total fee-paying FAEs for FY 2011 based on the
applications received through June 30, 2011. 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 45837]]
Table 9--FY 2011 Full Application Equivalents Received Through June 30, 2011, and Projected Through September
30, 2011
----------------------------------------------------------------------------------------------------------------
Column 2
Column 1 Fees Column 3 Column 4
Total exempted or Total fee 12-Month
received waived paying fee paying
through 6/ through 6/ through 6/ projection
30/2011 30/2011 30/2011
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data........................ 55 18 37 49.33
Applications not requiring clinical data.................... 9.5 5.5 4 5.33
Supplements requiring clinical data......................... 44.5 9 35.5 47.88
Withdrawn or refused to file................................ 1.625 1.25 .375 .5
---------------------------------------------------
Total................................................... 110.625 33.75 76.875 102.5
----------------------------------------------------------------------------------------------------------------
In the first 9 months of FY 2011, FDA received 110.625 FAEs, of
which 76.875 were fee-paying. Based on data from the last 10 FYs, on
average, 25 percent of the applications submitted each year come in the
final 3 months. Dividing 76.875 by 3 and multiplying by 4 extrapolates
the amount to the full 12 months of the FY and projects the number of
fee-paying FAEs in FY 2011 at 102.5.
As table 10 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 2011, is 127.1 FAEs. FDA will set fees
for FY 2011 based on this estimate as the number of full application
equivalents that will pay fees.
Table 10--Fee-Paying FAE 5-Year Average
----------------------------------------------------------------------------------------------------------------
2011 5-Year
Fiscal year 2007 2008 2009 2010 estimate average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs............. 134.4 140.0 140.3 118.4 102.5 127.1
----------------------------------------------------------------------------------------------------------------
The FY 2012 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
127.1, into the fee revenue amount to be derived from application fees
in FY 2012, $234,057,000. The result, rounded to the nearest $100, is a
fee of $1,841,500 per full application requiring clinical data, and
$920,750 per application not requiring clinical data or per supplement
requiring clinical data.
VI. Fee Calculations for Establishment and Product Fees
A. Establishment Fees
At the beginning of FY 2011, the establishment fee was based on an
estimate that 415 establishments would be subject to, and would pay,
fees. By the end of FY 2011, FDA estimates that 475 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. FDA estimates that a total
of 10 establishment fee waivers or reductions will be made for FY 2011.
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 FD&C Act). Subtracting 25 establishments (10
waivers, plus the estimated 15 establishments under the orphan
exemption) from 450 leaves a net of 415 fee-paying establishments. FDA
will use 450 for its FY 2012 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 ($234,057,000) by the estimated 450
establishments, for an establishment fee rate for FY 2012 of $520,100
(rounded to the nearest $100).
B. Product Fees
At the beginning of FY 2011, the product fee was based on an
estimate that 2,385 products would be subject to and would pay product
fees. By the end of FY 2011, 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 55 waivers and reductions granted. 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 FD&C Act).
FDA estimates that 2,365 products will qualify for product fees in FY
2011, after allowing for waivers and reductions, including the orphan
drug products eligible under the FDAAA exemption, and will use this
number for its FY 2012 estimate. The FY 2012 product fee rate is
determined by dividing the adjusted total fee revenue to be derived
from product fees ($234,057,000) by the estimated 2,365 products for a
FY 2012 product fee of $98,970 (rounded to the nearest $10).
VII. Fee Schedule for FY 2012
The fee rates for FY 2012 are set out in table 11 of this document.
Table 11--Fee Schedule for FY 2012
------------------------------------------------------------------------
Fee rates for
Fee category FY 2012
------------------------------------------------------------------------
Applications............................................ ..............
Requiring clinical data............................. $1,841,500
Not requiring clinical data......................... 920,750
Supplements requiring clinical data................. 920,750
Establishments.......................................... 520,100
Products................................................ 98,970
------------------------------------------------------------------------
IX. 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, 2011. 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
[[Page 45838]]
identification (ID) number on your check, bank draft, or postal money
order. Your payment can be mailed to: Food and Drug Administration,
P.O. Box 979107, St. Louis, MO 63197-9000.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: U.S. Bank, Attention:
Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for courier delivery only.)
Please make sure that the FDA post office box number (P.O. Box
979107) 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 may charge 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, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD, 20850.
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
2012 under the new fee schedule in August 2011. Payment will be due on
October 1, 2011. FDA will issue invoices in November 2012 for any
products and establishments subject to fees for FY 2012 that qualify
for fee assessments after the August 2011 billing.
Dated: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19332 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P
