Prescription Drug User Fee Rates for Fiscal Year 2009, 45017-45022 [E8-17738]
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Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices
• The date U.S. Bank receives the
payment. U.S. Bank is required to notify
FDA within 1 working day, using the
PIN described previously in this
document.
D. Step Four—Submit Your Application
to FDA With a Copy of the Completed
Medical Device User Fee Cover Sheet
Please submit your application and a
copy of the completed Medical Device
User Fee Cover Sheet to one of the
following addresses:
• Medical device applications should
be submitted to: Food and Drug
Administration, Center for Devices and
Radiological Health, Document Mail
Center (HFZ–401), 9200 Corporate
Blvd., Rockville, MD 20850.
• Biologic applications should be sent
to: Food and Drug Administration,
Center for Biologics Evaluation and
Research, Document Control Center
(HFM–99), suite 200N, 1401 Rockville
Pike, Rockville, MD 20852–1448.
V. Procedures for Paying Annual
Establishment Fees
If you are required to pay an annual
establishment registration fee, you must
pay for each establishment prior to
registration. Payment must be submitted
by first creating a Device Facility Use
Fee (DFUF) order through the User Fee
Web site at https://fdasfinapp8.fda.gov/
OA_HTML/fdaCAcdLogin.jsp. You will
be issued a PIN once you place your
order. After payment has been
processed, you will be issued a payment
confirmation number (PCN). You will
not be able to register your
establishment if you do not have a PIN
and a PCN. An establishment required
to pay an annual establishment
registration fee is not legally registered
in FY 2009 until it has completed the
steps in this section to register and pay
any applicable fee (see 21 U.S.C.
379j(f)(2)).
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A. Step One—Submit a Device Facility
User Fee Order With a PIN From FDA
Before Registering or Submitting
Payment
To submit a DFUF order, you must
create or have previously created a user
account and password for the User Fee
Web site listed in this section. After
creating a user name and password, log
onto the Annual Facility User Fee 2009
store. Complete the DFUF order by
entering the number of establishments
you are registering. Once you are
satisfied that the data on the order is
accurate, electronically transmit that
data to FDA according to instructions on
the screen. Print a copy of the final
DFUF order and note the unique PIN
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located in the upper right-hand corner
of the printed order.
B. Step Two—Pay for Your DFUF Order
Unless paying by credit card, all
payments must be in U. S. currency and
drawn on a U.S. bank. The DFUF order
will include payment information,
including details on how you can pay
online using a credit card or electronic
checks. Follow the instructions
provided to make an electronic
payment. If you prefer not to pay online,
you may pay by a check, in U.S. dollars
and drawn on a U.S. bank, mailed to:
Food and Drug Administration, P.O.
Box 70961, Charlotte, NC 28272–0961.
(Note: This address is different from the
address for payments of application and
annual report fees and is to be used only
for payment of annual establishment
registration fees.)
If a check is sent by a courier that
requests a street address, the courier can
deliver the check to: Wachovia Bank,
Attn: Food and Drug Administration—
Lockbox 70961, rm. NC0810, 1525 West
WT Harris Blvd., Charlotte, NC 28262.
(Note: This Wachovia Bank address is
for courier delivery only; do not send
mail to this address.)
Please make sure that both of the
following numbers are written on your
check: (1) The FDA post office box
number (P.O. Box 70961), 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.
Wire transfers may also be used to pay
annual establishment fees. For wire
transfer information, please contact the
user fee helpdesk at 301–827–9539 or
userfees@fda.gov.
C. Step Three—Complete the
Information Online to Update Your
Establishment’s Annual Registration for
FY 2009, or to Register a New
Establishment for FY 2009
Go to CDRH’s Web site at https://
www.fda.gov/cdrh/reglistpage.html and
click the ‘‘Electronic Registration and
Listing System (FURLS)’’ link on the left
of the page. This opens up a new page
with important information about
FURLS. After reading this information
click on the link at the bottom of the
page. That 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 2008.
Enter your existing account ID and
password to log into FURLS. From the
FURLS/FDA Industry Systems menu,
there will be a button that you will click
to go to the Device Registration and
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45017
Listing Module (DRLM) of FURLS. New
establishments will need to register and
existing establishments will update
their annual registration using choices
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 240–276–0111 for assistance.
(Note: This e-mail address and phone
number are for assistance with
establishment registration only, and not
for any other aspects of medical device
user fees.)
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. Fees are only required for
those establishments defined in section
I of this document.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17739 Filed 7–31–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0427]
Prescription Drug User Fee Rates for
Fiscal Year 2009
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
rates for prescription drug user fees for
fiscal year (FY) 2009. The Federal Food,
Drug, and Cosmetic Act (the act), as
amended by the Prescription Drug User
Fee Amendments of 2007 (PDUFA IV)
(Title 1 of the Food and Drug
Administration Amendments Act of
2007 (FDAAA)), authorizes FDA to
collect user fees for certain applications
for approval of drug and biological
products, on establishments where the
products are made, and on such
products. Base revenue amounts to be
generated from PDUFA fees were
established by PDUFA IV, with
provisions for certain adjustments. Fee
revenue amounts for applications,
establishments, and products are to be
established each year by FDA so that
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one-third of the PDUFA fee revenues
FDA collects each year will be generated
from each of these categories. This
notice establishes fee rates for FY 2009
for application fees for an application
requiring clinical data ($1,247,200), for
an application not requiring clinical
data or a supplement requiring clinical
data ($623,600), for establishment fees
($425,600), and for product fees
($71,520). These fees are effective on
October 1, 2008, and will remain in
effect through September 30, 2009. For
applications and supplements that are
submitted on or after October 1, 2008,
the new fee schedule must be used.
Invoices for establishment and product
fees for FY 2009 will be issued in
August 2008, using the new fee
schedule.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3917.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the act (21
U.S.C. 379g and 379h), establish three
different kinds of user fees. Fees are
assessed on the following: (1) Certain
types of applications and supplements
for approval of drug and biological
products, (2) certain establishments
where such products are made, and (3)
certain products (section 736(a) of the
act). When certain conditions are met,
FDA may waive or reduce fees (section
736(d) of the act).
For FY 2008 through FY 2012, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA IV. The base
revenue amount for FY 2008 is to be
adjusted for workload, and that adjusted
amount becomes the base amount for
the remaining 4 fiscal years. That
adjusted base revenue amount is
increased for drug safety enhancements
by $10,000,000 in each of the
subsequent 4 fiscal years, and the
increased total is further adjusted each
year for inflation and workload. Fees for
applications, establishments, and
products are to be established each year
by FDA so that revenues from each
category will provide one-third of the
total revenue to be collected each year.
This notice uses the fee base revenue
amount for FY 2008 published on
October 12, 2007 (72 FR 58103), adjusts
it for the 2009 drug safety increase (see
section 736(b)(4) of the act), for
inflation, and for workload, and then
establishes the application,
establishment, and product fees for FY
2009. These fees are effective on
October 1, 2008, and will remain in
effect through September 30, 2009.
II. Fee Revenue Amount for FY 2009
The total fee revenue amount for FY
2009 is $510,665,000, based on the fee
revenue amount specified in the statute,
including additional fee funding for
drug safety and adjustments for inflation
and changes in workload. The statutory
amount and a one-time base adjustment
are described in section II.A and II.B of
this document. The adjustment for
inflation is described in section II.C, and
the adjustment for changes in workload
in section II.D.
A. FY 2009 Statutory Fee Revenue
Amounts Before Adjustments
PDUFA IV specifies that the fee
revenue amount before adjustments for
FY 2009 for all fees is $427,783,000
($392,783,000 specified in section
736(b)(1) of the act, plus an additional
$35,000,000 for drug safety in FY 2009
specified in section 736(b)(4) of the act).
B. Base Adjustment to Statutory Fee
Revenue Amount
The statute also specifies that
$354,893,000 of the base amount is to be
further adjusted for workload increases
through FY 2007 (see section
736(b)(1)(B) of the act). The adjustment
on this amount is to be made in
accordance with the workload
adjustment provisions that were in
effect for FY 2007, except that the
adjustment for investigational new drug
(IND) workload is based on the number
of INDs with a submission in the
previous 12 months, rather than on the
number of new commercial INDs
submitted in the same 12-month period.
For each fiscal year beginning in FY
2004, the Prescription Drug User Fee
Amendments of 2002 (PDUFA III)
provided that fee revenue amounts, after
they had been adjusted for inflation,
should be further adjusted to reflect
changes in workload for the process for
the review of human drug applications
(see section 736(c)(2) of the act). The
conference report accompanying
PDUFA III, House of Representatives
Report number 107–481, provides
guidance on how the workload
adjustment provision of PDUFA III is to
be implemented. Following that
guidance, FDA calculated the average
number of each of the four types of
submissions specified in the workload
adjustment provision (human drug
applications, commercial INDs, efficacy
supplements, and manufacturing
supplements) received over the 5-year
period that ended on June 30, 2002
(base years), and the average number of
each of these types of applications over
the most recent 5-year period that ended
June 30, 2007. PDUFA IV directs that
this same method be used in making the
workload adjustment apply to the 2008
statutory revenue amount, except that
for this calculation the number of
commercial INDs with a submission in
the previous 12 months is used for each
12-month period rather than the number
of new commercial INDs submitted (see
section 736(b) of the act, as amended by
PDUFA IV).
The results of these calculations are
presented in Columns 1 and 2 of Table
1 of this document. Column 3 reflects
the percent change in workload over the
two 5-year periods. Column 4 shows the
weighting factor for each type of
application, estimating how much of the
total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 5 years. Column 5 of Table 1 of
this document is the weighted percent
change in each category of workload.
This was derived by multiplying the
weighting factor in each line in Column
4 by the percent change from the base
years in Column 3. At the bottom right
of the table the sum of the values in
Column 5 is added, reflecting a total
increase in workload of 11.73 percent
when compared to the base years.
TABLE 1—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO FY 2009 STATUTORY BASE
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Application Type
Column 1
5-Year Average
Base Years
New drug applications
(NDAs)/biologics license
applications (BLAs)
Column 3
Percent Change
Column 4
Weighting Factor
Column 5
Weighted % Change
119.6
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123.8
3.5%
35.2%
1.24%
4751.8
Active INDs
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Column 2
Latest 5-Year
Average
5528.2
16.3%
44.2%
7.22%
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TABLE 1—SUMMARY WORKLOAD ADJUSTER CALCULATION TO BE APPLIED TO FY 2009 STATUTORY BASE—Continued
Application Type
Column 1
5-Year Average
Base Years
Efficacy supplements
Column 2
Latest 5-Year
Average
Column 3
Percent Change
Column 4
Weighting Factor
Column 5
Weighted % Change
159.2
2.6%
7.4%
0.20%
2100.6
Manufacturing supplements
163.4
2589.2
23.3%
13.2%
3.07%
FY 2008 workload adjuster to be applied to the statutory base
Increasing the PDUFA IV statutorily
specified amount of $354,893,000 by the
specified workload adjuster (11.73
percent) results in an increase of
$41,629,000, rounded to the nearest
thousand dollars. Adding this amount to
the $427,783,000 statutorily specified
amount from section II.A of this
document, results in a total adjusted
PDUFA IV base revenue amount of
$469,412,000, before further adjustment
for inflation and changes in workload
after FY 2007.
C. Inflation Adjustment to FY 2009 Fee
Revenue Amount
PDUFA IV provides that fee revenue
amounts for each fiscal year after 2008
shall be adjusted for inflation. The
adjustment must reflect the greater of:
(1) The total percentage change that
occurred in the Consumer Price Index
(CPI) (all items; U.S. city average)
during the 12-month period ending June
30 preceding the fiscal year for which
fees are being set; (2) the total
percentage pay change for the previous
11.73%
fiscal year for Federal employees
stationed in the Washington, DC
metropolitan area; or (3) the average
annual change in cost, per full time
equivalent (FTE) FDA position, of all
personnel compensation and benefits
paid for the first 5 of the previous 6
fiscal years. PDUFA IV provides for this
annual adjustment to be cumulative and
compounded annually after FY 2008
(see section 736(c)(1) of the act).
The first factor is the CPI increase for
the 12-month period ending in June
2008. The CPI for June 2008 was
218.815, and the CPI for June 2007 was
208.352. (These CPI figures are available
on the Bureau of Labor statistics Web
site, 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.) The CPI for June 2008 is 5.05
percent higher than the CPI for the
previous 12-month period.
The second factor is the increase in
pay for the previous fiscal year (FY 2008
in this case) for Federal employees
stationed in the Washington, DC
metropolitan area. This figure is
published by the Office of Personnel
Management, and found on their Web
site, https://www.opm.gov/oca/08tables/
html/dcb.asp, above the salary table. For
FY 2008 it was 4.49 percent.
The third factor is the average change
in FDA cost for compensation and
benefits per FTE over the previous 5 of
the most recent 6 fiscal years (FY 2002
through FY 2007). The data on total
compensation paid and number of FTEs
paid, from which the average cost per
FTE can be derived, are published in
FDA’s Justification of Estimates for
Appropriations Committees. Table 2 of
this document summarizes that actual
cost and FTE use data for the specified
fiscal years, and provides the percent
change from the previous fiscal year and
the average percent change over the
most 5 recent fiscal years, which is 5.64
percent.
TABLE 2—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE ($000)
Fiscal Year
2003
2004
2005
2006
Annual Average Increase
for Latest 5
Years
2007
Total PC&B
$971,255
$1,042,749
$1,077,604
$1,114,704
$1,144,369
Total FTEs
10257
10141
9910
9698
9569
$94.692
$102.825
$108.739
$114,942
$119.591
4.09%
8.59%
5.75%
5.70%
4.05%
PC&B per FTE
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% Change from Previous Year
Because the average change in pay per
FTE (5.64 percent) is the highest of the
three factors, it becomes the inflation
adjustment for total fee revenue for FY
2009. Increasing the FY 2009 fee
revenue base of $469,412,000 by 5.64
percent yields an inflation-adjusted fee
revenue amount for FY 2009 of
$495,887,000, rounded to the nearest
thousand dollars, before addition of the
FY 2009 workload adjustment.
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D. Workload Adjustment to the FY 2009
Inflation Adjusted Fee Revenue Amount
For each fiscal year beginning in FY
2009, PDUFA IV provides that fee
revenue amounts, after they have been
adjusted for inflation, shall be further
adjusted to reflect changes in workload
for the process for the review of human
drug applications (see section 736(c)(2)
of the act). PDUFA IV continues the
PDUFA III workload adjustment with
modifications, and provides for a new
additional adjustment for changes in
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5.64%
review activity. PDUFA IV also specifies
that for FY 2009 the additional
adjustment for changes in review
activity may not result in a total
workload adjustment that is more than
2 percentage points higher than it would
have been in the absence of the
adjustment for changes in review
workload (see section 736(c)(2)(B) of the
act).
Therefore, FDA will first calculate the
FY 2009 workload adjustment without
the PDUFA IV adjustment for changes in
review activity. Then FDA will apply
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the adjustment for changes in review
activity, to determine if the total
workload adjustment is no more than 2
percentage points higher than it would
have been in the absence of the
adjustment for changes in review
activity.
In calculating the FY 2009 workload
adjustment without the PDUFA IV
adjustment for changes in review
activity, FDA will follow the guidance
provided in the conference report
accompanying the Prescription Drug
User Fee Amendments of 2002, House
of Representatives Report number 107–
481, using active commercial INDs
rather than newly submitted
commercial INDs as the surrogate for
IND workload, as specified by PDUFA
IV.
FDA calculated the average number of
each of the four types of applications
specified in the workload adjustment
provision: (1) Human drug applications,
(2) active commercial investigational
new drug applications (applications that
have at least one submission during the
previous 12 months), (3) efficacy
supplements, and (4) manufacturing
supplements received over the 5-year
period that ended on June 30, 2007
(base years), and the average number of
each of these types of applications over
the most recent 5-year period that ended
June 30, 2008.
The calculations are summarized in
Table 3 of this document. The 5-year
averages for each application category
are provided in Column 1 (5-Year
Average Base Years 2002–2007) and
Column 2 (Latest 5-Year Average 2003–
2008). Column 3 reflects the percent
change in workload from Column 1 to
Column 2. Column 4 shows the
weighting factor for each type of
application, estimating how much of the
total FDA drug review workload was
accounted for by each type of
application in the table during the most
recent 5 years. Column 5 of Table 1 is
the weighted percent change in each
category of workload. This was derived
by multiplying the weighting factor in
each line in Column 4 by the percent
change from the base years in Column
3. At the bottom right of Table 3 of this
document is the sum of the values in
Column 5 that are added, reflecting an
increase in workload of 2.98 percent for
FY 2009 when compared to the base
years, but before taking into account the
impact of change in review activity.
TABLE 3—PRELIMINARY WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITHOUT ADJUSTMENT FOR CHANGES IN
REVIEW ACTIVITY
Column 1
5-Year Average
Base Years 2002–
2007
Application Type
NDAs/BLAs
Column 2
Latest 5-Year
Average 2003–
2008
Column 3
Percent Change
Column 4
Weighting Factor
Column 5
Weighted % Change
123.8
1.24%
5897.6
2.5%
45.2%
1.11%
173.0
5.9%
8.3%
0.49%
2589.2
Manufacturing supplements
33.3%
163.4
Efficacy supplements
3.7%
5755.8
Active commercial INDs
128.4
2616.2
1.0%
13.2%
0.14%
FY 2009 workload adjuster without adjustment changes for review activity
PDUFA IV specifies that FDA make
additional adjustments for changes in
review activities to the first two
categories (human drug applications
and active commercial INDs). These
adjustments, specified under PDUFA IV,
are summarized in the new Columns 2b
and 2c in Table 4 of this document. The
number in the NDAs/BLAs line of
Column 2b of Table 4 of this document
2.98%
is the percent by which the average
workload for meetings, annual reports,
and labeling supplements for NDAs and
BLAs has changed from the 5-year
period 2002 through 2007 to the 5-year
period 2003 through 2008. Likewise, the
number in the active commercial INDs
line of Column 2b of Table 4 of this
document is the percent by which the
workload for meetings and special
protocol assessments for active
commercial INDs has changed from the
5-year period 2002 through 2007 to the
5-year period 2003 through 2008. There
is no entry in the last two lines of
column 2b because the adjustment for
changes in review workload does not
apply to the workload for efficacy
supplements and manufacturing
supplements.
TABLE 4—FINAL WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITH ADJUSTMENT FOR CHANGES IN REVIEW
ACTIVITY1
Column 1
5-Year Average Base
Years 2002–
2007
Column 2b
Adjustment for
Changes in Review Activity
123.8
128.4
-0.55%
127.7
3.1%
33.3%
1.05
Active commercial INDs
5755.8
5897.6
+0.39%
5920.6
2.9%
45.2%
1.31
Efficacy supplements
163.4
173.0
NA
173.3
5.9%
8.3%
0.49%
Manufacturing
supplements
2589.2
2516.2
NA
2616.2
1.0%
13.2%
0.14%
Application Type
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NDAs/BLAs
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Column 2c
is Column 2a Adjusted by Column
2b
Column 3 %
Change
(Column 1 to
Column 2c or
2a)
Column 2a
Latest 5-Year
Average
2003–2008
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Column 4
Weighting
Factor
Column 5
Weighted %
Change
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TABLE 4—FINAL WORKLOAD ADJUSTER CALCULATION FOR FY 2009 WITH ADJUSTMENT FOR CHANGES IN REVIEW
ACTIVITY1—Continued
Application Type
Column 1
5-Year Average Base
Years 2002–
2007
Column 2a
Latest 5-Year
Average
2003–2008
Column 2b
Adjustment for
Changes in Review Activity
Column 2c
is Column 2a Adjusted by Column
2b
Column 3 %
Change
(Column 1 to
Column 2c or
2a)
Column 4
Weighting
Factor
FY 2009 workload adjuster with adjustment changes for review activity
1 Numbers
Column 5
Weighted %
Change
2.98%
may not add due to rounding.
The 2009 workload adjuster with
adjustment for changes in review
activity at the bottom of Table 4 of this
document is 2.98 percent exactly the
same as the workload adjuster without
those changes at the bottom of Table 3
of this document. Therefore the
inflation-adjusted revenue amount of
$495,887,000 from section II.B of this
document will be multiplied by the
2009 workload adjuster of 2.98 percent,
resulting in a total adjusted revenue
amount in FY 2009 of $510,665,000,
rounded to the nearest thousand dollars.
PDUFA specifies that one-third of the
total fee revenue is to be derived from
application fees, one-third from
establishment fees, and one-third from
product fees (see section 736(b)(2) of the
act). Accordingly, one-third of the total
revenue amount, or $ 170,222,000,
rounded to the nearest thousand dollars,
is the total amount of fee revenue that
will be derived from each of these fee
categories.
III. Application Fee Calculations
A. Application Fee Revenues and
Application Fees
Application fees will be set to
generate one-third of the total fee
revenue amount, or $170,222,000,
rounded to the nearest thousand dollars,
in FY 2009, as calculated in section II.D
of this document.
B. Estimate of Number of Fee-Paying
Applications and Establishment of
Application Fees
For FY 2008 through FY 2012, FDA
will estimate the total number of feepaying full application equivalents
(FAEs) it expects to receive the next
fiscal year by averaging the number of
fee-paying FAEs received in the 5 most
recent fiscal years. This use of the
rolling average of the 5 most recent
fiscal years is the same method that has
applied for the last 6 years.
In estimating the number of feepaying FAEs that FDA will receive in
FY 2009, the 5-year rolling average for
the most recent 5 years will be based on
actual counts of fee-paying FAEs
received for FY 2004 through FY 2008.
For FY 2008, FDA is estimating the
number of fee-paying FAEs for the full
year based on the actual count for the
first 9 months and estimating the
number for the final 3 months, as we
have done for the past 6 years.
Table 5 of this document shows, in
Column 1, the total number of each type
of FAE received in the first 9 months of
FY 2008, whether fees were paid or not.
Column 2 shows the number of FAEs for
which fees were waived or exempted
during this period, and Column 3 shows
the number of fee-paying FAEs received
through June 30, 2008. Column 4
estimates the 12-month total fee-paying
FAEs for FY 2008 based on the
applications received through June 30,
2008. All of the counts are in FAEs. A
full application requiring clinical data
counts as one FAE. An application not
requiring clinical data counts as 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.
TABLE 5—FY 2008 FULL APPLICATION EQUIVALENTS RECEIVED THROUGH JUNE 30, 2008, AND PROJECTED THROUGH
SEPTEMBER 30, 2008
Column 1
Total Received
Through
6/30/2008
Application or Action
Applications requiring clinical data
Column 2
Fee Exempt or
Waived Through
6/30/2008
Column 3
Total Fee Paying
Through
6/30/2008
Column 4
12-Month FeePaying Projection
102.3
40.3
62.0
82.7
Applications not requiring clinical data
11.1
4.1
7.0
9.3
Supplements requiring clinical data
45.0
6.0
39.0
52.0
0.5
0.7
108.5
144.7
Withdrawn or refused to file
0.5
mstockstill on PROD1PC66 with NOTICES
Total
158.9
In the first 9 months of FY 2008, FDA
received 158.9 FAEs, of which 108.5
were fee-paying. Based on data from the
last 9 fiscal years, on average, 25 percent
of the applications submitted each year
come in the final 3 months. Dividing
VerDate Aug<31>2005
0
19:39 Jul 31, 2008
Jkt 214001
50.4
108.5 by 3 and multiplying by 4
extrapolates the amount to the full 12
months of the fiscal year and projects
the number of fee-paying FAEs in FY
2008 at 144.7.
As Table 6 of this document shows,
the average number of fee-paying FAEs
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
received annually in the most recent 5year period, and including our estimate
for FY 2008, is 136.5 FAEs. FDA will set
fees for FY 2009 based on this estimate
as the number of FAEs that will pay
fees.
E:\FR\FM\01AUN1.SGM
01AUN1
45022
Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices
TABLE 6—FEE-PAYING FULL APPLICATION EQUIVALENT—5-YEAR AVERAGE
Fiscal Year
2004
Fee-Paying FAEs
145.1
The FY 2009 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 5 years, 136.5, into
the fee revenue amount to be derived
from application fees in FY 2009,
$170,222,000. The result, rounded to the
nearest $100, is a fee of $1,247,200 per
full application requiring clinical data,
and $623,600 per application not
requiring clinical data or per
supplement requiring clinical data.
IV. Fee Calculations for Establishment
and Product Fees
A. Establishment Fees
At the beginning of FY 2008, the
establishment fee was based on an
estimate that 390 establishments would
be subject to, and would pay, fees. By
the end of FY 2008, FDA estimates that
435 establishments will have been
billed for establishment fees, before all
decisions on requests for waivers or
reductions are made. As in previous
years, FDA again estimates that a total
of 25 establishment fee waivers or
reductions will be made for FY 2008. In
addition, FDA estimates that another 10
full establishment fees will be exempted
this year based on the orphan drug
exemption in the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (see section 736(k) of the
act). Subtracting 35 establishments (25
plus the estimated 10 establishments
under the orphan exemption) from 435
leaves a net of 400 fee-paying
establishments. FDA will use 400 for its
FY 2009 estimate of establishments
paying fees, after taking waivers and
reductions into account. The fee per
establishment is determined by dividing
the adjusted total fee revenue to be
derived from establishments
($170,222,000) by the estimated 400
establishments, for an establishment fee
rate for FY 2009 of $425,600 (rounded
to the nearest $100).
mstockstill on PROD1PC66 with NOTICES
B. Product Fees
At the beginning of FY 2008, the
product fee was based on an estimate
that 2,355 products would be subject to,
and would pay, product fees. By the end
of FY 2008, FDA estimates that 2,450
products will have been billed for
product fees, before all decisions on
requests for waivers or reductions are
made. FDA assumes that there will be
VerDate Aug<31>2005
19:39 Jul 31, 2008
2005
Jkt 214001
2006
121.5
136.7
about 40 waivers and reductions
granted, the same amount estimated last
year. In addition, FDA estimates that
another 30 product fees will be
exempted this year based on the orphan
drug exemption in FDAAA (see section
736(k) of the act). FDA estimates that
2,380 products will qualify for product
fees in FY 2008, after allowing for
waivers and reductions, including the
orphan drug products eligible under the
FDAAA exemption, and will use this
number for its FY 2009 estimate.
Accordingly, the FY 2009 product fee
rate is determined by dividing the
adjusted total fee revenue to be derived
from product fees ($170,222,000) by the
estimated 2,380 products for a FY 2009
product fee of $71,520 (rounded to the
nearest $10).
V. Fee Schedule for FY 2009
The fee rates for FY 2009 are set out
in Table 7 of this document.
TABLE 7
Fee Rates for
FY 2009
Fee Category
APPLICATIONS
Requiring clinical data
Not requiring clinical data
Supplements requiring
clinical data
ESTABLISHMENTS
$1,247,200
$623,600
134.4
2008
5-Year
Average
144.7
136.5
Wachovia Bank, Attn: Food and Drug
Administration Lockbox 70963, 1525
West WT Harris Blvd., rm. NC0810,
Charlotte, NC 28262. (Note: This
Wachovia Bank address is for courier
delivery only.)
Please make sure that the FDA post
office box number (P.O. Box 70963) is
written on the check. The tax
identification number of the Food and
Drug Administration is 53–0196965.
Wire transfer payment may also be
used. The routing and transit number is
021030004 and the account number is
75060099.
B. Establishment and Product Fees
FDA will issue invoices for
establishment and product fees for FY
2009 under the new fee schedule in
August 2008. Payment will be due on
October 1, 2008. FDA will issue
invoices in November 2009 for any
products and establishments subject to
fees for FY 2009 that qualify for fees
after the August 2008 billing.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17738 Filed 7–31–08; 8:45 am]
BILLING CODE 4160–01–S
$623,600
$425,600
PRODUCTS
2007
$71,520
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
VI. Implementation of Adjusted Fee
Schedule
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
A. Application Fees
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Advisory Council on Alcohol
Abuse and Alcoholism.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received after September
30, 2008. Payment must be made in U.S.
currency by check, bank draft, or U.S.
postal money order payable to the order
of the Food and Drug Administration.
Please include the user fee ID number
on your check. Your payment can be
mailed to: Food and Drug
Administration, P.O. Box 70963,
Charlotte, NC 28272–0963.
If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 73, Number 149 (Friday, August 1, 2008)]
[Notices]
[Pages 45017-45022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0427]
Prescription Drug User Fee Rates for Fiscal Year 2009
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2009. The Federal
Food, Drug, and Cosmetic Act (the act), as amended by the Prescription
Drug User Fee Amendments of 2007 (PDUFA IV) (Title 1 of the Food and
Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to
collect user fees for certain applications for approval of drug and
biological products, on establishments where the products are made, and
on such products. Base revenue amounts to be generated from PDUFA fees
were established by PDUFA IV, with provisions for certain adjustments.
Fee revenue amounts for applications, establishments, and products are
to be established each year by FDA so that
[[Page 45018]]
one-third of the PDUFA fee revenues FDA collects each year will be
generated from each of these categories. This notice establishes fee
rates for FY 2009 for application fees for an application requiring
clinical data ($1,247,200), for an application not requiring clinical
data or a supplement requiring clinical data ($623,600), for
establishment fees ($425,600), and for product fees ($71,520). These
fees are effective on October 1, 2008, and will remain in effect
through September 30, 2009. For applications and supplements that are
submitted on or after October 1, 2008, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2009 will be
issued in August 2008, using the new fee schedule.
FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3917.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 735 and 736 of the act (21 U.S.C. 379g and 379h),
establish three different kinds of user fees. Fees are assessed on the
following: (1) Certain types of applications and supplements for
approval of drug and biological products, (2) certain establishments
where such products are made, and (3) certain products (section 736(a)
of the act). When certain conditions are met, FDA may waive or reduce
fees (section 736(d) of the act).
For FY 2008 through FY 2012, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA IV. The base
revenue amount for FY 2008 is to be adjusted for workload, and that
adjusted amount becomes the base amount for the remaining 4 fiscal
years. That adjusted base revenue amount is increased for drug safety
enhancements by $10,000,000 in each of the subsequent 4 fiscal years,
and the increased total is further adjusted each year for inflation and
workload. Fees for applications, establishments, and products are to be
established each year by FDA so that revenues from each category will
provide one-third of the total revenue to be collected each year.
This notice uses the fee base revenue amount for FY 2008 published
on October 12, 2007 (72 FR 58103), adjusts it for the 2009 drug safety
increase (see section 736(b)(4) of the act), for inflation, and for
workload, and then establishes the application, establishment, and
product fees for FY 2009. These fees are effective on October 1, 2008,
and will remain in effect through September 30, 2009.
II. Fee Revenue Amount for FY 2009
The total fee revenue amount for FY 2009 is $510,665,000, based on
the fee revenue amount specified in the statute, including additional
fee funding for drug safety and adjustments for inflation and changes
in workload. The statutory amount and a one-time base adjustment are
described in section II.A and II.B of this document. The adjustment for
inflation is described in section II.C, and the adjustment for changes
in workload in section II.D.
A. FY 2009 Statutory Fee Revenue Amounts Before Adjustments
PDUFA IV specifies that the fee revenue amount before adjustments
for FY 2009 for all fees is $427,783,000 ($392,783,000 specified in
section 736(b)(1) of the act, plus an additional $35,000,000 for drug
safety in FY 2009 specified in section 736(b)(4) of the act).
B. Base Adjustment to Statutory Fee Revenue Amount
The statute also specifies that $354,893,000 of the base amount is
to be further adjusted for workload increases through FY 2007 (see
section 736(b)(1)(B) of the act). The adjustment on this amount is to
be made in accordance with the workload adjustment provisions that were
in effect for FY 2007, except that the adjustment for investigational
new drug (IND) workload is based on the number of INDs with a
submission in the previous 12 months, rather than on the number of new
commercial INDs submitted in the same 12-month period.
For each fiscal year beginning in FY 2004, the Prescription Drug
User Fee Amendments of 2002 (PDUFA III) provided that fee revenue
amounts, after they had been adjusted for inflation, should be further
adjusted to reflect changes in workload for the process for the review
of human drug applications (see section 736(c)(2) of the act). The
conference report accompanying PDUFA III, House of Representatives
Report number 107-481, provides guidance on how the workload adjustment
provision of PDUFA III is to be implemented. Following that guidance,
FDA calculated the average number of each of the four types of
submissions specified in the workload adjustment provision (human drug
applications, commercial INDs, efficacy supplements, and manufacturing
supplements) received over the 5-year period that ended on June 30,
2002 (base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2007. PDUFA IV directs that this same method be used in making the
workload adjustment apply to the 2008 statutory revenue amount, except
that for this calculation the number of commercial INDs with a
submission in the previous 12 months is used for each 12-month period
rather than the number of new commercial INDs submitted (see section
736(b) of the act, as amended by PDUFA IV).
The results of these calculations are presented in Columns 1 and 2
of Table 1 of this document. Column 3 reflects the percent change in
workload over the two 5-year periods. Column 4 shows the weighting
factor for each type of application, estimating how much of the total
FDA drug review workload was accounted for by each type of application
in the table during the most recent 5 years. Column 5 of Table 1 of
this document is the weighted percent change in each category of
workload. This was derived by multiplying the weighting factor in each
line in Column 4 by the percent change from the base years in Column 3.
At the bottom right of the table the sum of the values in Column 5 is
added, reflecting a total increase in workload of 11.73 percent when
compared to the base years.
Table 1--Summary Workload Adjuster Calculation to be Applied to FY 2009 Statutory Base
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 5-Year
Application Type Average Base Column 2 Latest Column 3 Percent Column 4 Weighting Column 5 Weighted %
Years 5-Year Average Change Factor Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
New drug applications (NDAs)/biologics license 119.6 123.8 3.5% 35.2% 1.24%
applications (BLAs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active INDs 4751.8 5528.2 16.3% 44.2% 7.22%
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45019]]
Efficacy supplements 159.2 163.4 2.6% 7.4% 0.20%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements 2100.6 2589.2 23.3% 13.2% 3.07%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2008 workload adjuster to be applied to the statutory base 11.73%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increasing the PDUFA IV statutorily specified amount of $354,893,000 by
the specified workload adjuster (11.73 percent) results in an increase
of $41,629,000, rounded to the nearest thousand dollars. Adding this
amount to the $427,783,000 statutorily specified amount from section
II.A of this document, results in a total adjusted PDUFA IV base
revenue amount of $469,412,000, before further adjustment for inflation
and changes in workload after FY 2007.
C. Inflation Adjustment to FY 2009 Fee Revenue Amount
PDUFA IV provides that fee revenue amounts for each fiscal year
after 2008 shall be adjusted for inflation. The adjustment must reflect
the greater of: (1) The total percentage change that occurred in the
Consumer Price Index (CPI) (all items; U.S. city average) during the
12-month period ending June 30 preceding the fiscal year for which fees
are being set; (2) the total percentage pay change for the previous
fiscal year for Federal employees stationed in the Washington, DC
metropolitan area; or (3) the average annual change in cost, per full
time equivalent (FTE) FDA position, of all personnel compensation and
benefits paid for the first 5 of the previous 6 fiscal years. PDUFA IV
provides for this annual adjustment to be cumulative and compounded
annually after FY 2008 (see section 736(c)(1) of the act).
The first factor is the CPI increase for the 12-month period ending
in June 2008. The CPI for June 2008 was 218.815, and the CPI for June
2007 was 208.352. (These CPI figures are available on the Bureau of
Labor statistics Web site, 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.) The CPI for June 2008 is
5.05 percent higher than the CPI for the previous 12-month period.
The second factor is the increase in pay for the previous fiscal
year (FY 2008 in this case) for Federal employees stationed in the
Washington, DC metropolitan area. This figure is published by the
Office of Personnel Management, and found on their Web site, https://
www.opm.gov/oca/08tables/html/dcb.asp, above the salary table. For FY
2008 it was 4.49 percent.
The third factor is the average change in FDA cost for compensation
and benefits per FTE over the previous 5 of the most recent 6 fiscal
years (FY 2002 through FY 2007). The data on total compensation paid
and number of FTEs paid, from which the average cost per FTE can be
derived, are published in FDA's Justification of Estimates for
Appropriations Committees. Table 2 of this document summarizes that
actual cost and FTE use data for the specified fiscal years, and
provides the percent change from the previous fiscal year and the
average percent change over the most 5 recent fiscal years, which is
5.64 percent.
Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change ($000)
----------------------------------------------------------------------------------------------------------------
Annual Average
Fiscal Year 2003 2004 2005 2006 2007 Increase for
Latest 5 Years
----------------------------------------------------------------------------------------------------------------
Total PC&B $971,255 $1,042,749 $1,077,604 $1,114,704 $1,144,369 ..............
----------------------------------------------------------------------------------------------------------------
Total FTEs 10257 10141 9910 9698 9569 ..............
----------------------------------------------------------------------------------------------------------------
PC&B per FTE $94.692 $102.825 $108.739 $114,942 $119.591 ..............
----------------------------------------------------------------------------------------------------------------
% Change from 4.09% 8.59% 5.75% 5.70% 4.05% 5.64%
Previous Year
----------------------------------------------------------------------------------------------------------------
Because the average change in pay per FTE (5.64 percent) is the
highest of the three factors, it becomes the inflation adjustment for
total fee revenue for FY 2009. Increasing the FY 2009 fee revenue base
of $469,412,000 by 5.64 percent yields an inflation-adjusted fee
revenue amount for FY 2009 of $495,887,000, rounded to the nearest
thousand dollars, before addition of the FY 2009 workload adjustment.
D. Workload Adjustment to the FY 2009 Inflation Adjusted Fee Revenue
Amount
For each fiscal year beginning in FY 2009, PDUFA IV provides that
fee revenue amounts, after they have been adjusted for inflation, shall
be further adjusted to reflect changes in workload for the process for
the review of human drug applications (see section 736(c)(2) of the
act). PDUFA IV continues the PDUFA III workload adjustment with
modifications, and provides for a new additional adjustment for changes
in review activity. PDUFA IV also specifies that for FY 2009 the
additional adjustment for changes in review activity may not result in
a total workload adjustment that is more than 2 percentage points
higher than it would have been in the absence of the adjustment for
changes in review workload (see section 736(c)(2)(B) of the act).
Therefore, FDA will first calculate the FY 2009 workload adjustment
without the PDUFA IV adjustment for changes in review activity. Then
FDA will apply
[[Page 45020]]
the adjustment for changes in review activity, to determine if the
total workload adjustment is no more than 2 percentage points higher
than it would have been in the absence of the adjustment for changes in
review activity.
In calculating the FY 2009 workload adjustment without the PDUFA IV
adjustment for changes in review activity, FDA will follow the guidance
provided in the conference report accompanying the Prescription Drug
User Fee Amendments of 2002, House of Representatives Report number
107-481, using active commercial INDs rather than newly submitted
commercial INDs as the surrogate for IND workload, as specified by
PDUFA IV.
FDA calculated the average number of each of the four types of
applications specified in the workload adjustment provision: (1) Human
drug applications, (2) active commercial investigational new drug
applications (applications that have at least one submission during the
previous 12 months), (3) efficacy supplements, and (4) manufacturing
supplements received over the 5-year period that ended on June 30, 2007
(base years), and the average number of each of these types of
applications over the most recent 5-year period that ended June 30,
2008.
The calculations are summarized in Table 3 of this document. The 5-
year averages for each application category are provided in Column 1
(5-Year Average Base Years 2002-2007) and Column 2 (Latest 5-Year
Average 2003-2008). Column 3 reflects the percent change in workload
from Column 1 to Column 2. Column 4 shows the weighting factor for each
type of application, estimating how much of the total FDA drug review
workload was accounted for by each type of application in the table
during the most recent 5 years. Column 5 of Table 1 is the weighted
percent change in each category of workload. This was derived by
multiplying the weighting factor in each line in Column 4 by the
percent change from the base years in Column 3. At the bottom right of
Table 3 of this document is the sum of the values in Column 5 that are
added, reflecting an increase in workload of 2.98 percent for FY 2009
when compared to the base years, but before taking into account the
impact of change in review activity.
Table 3--Preliminary Workload Adjuster Calculation for FY 2009 Without Adjustment for Changes in Review Activity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 5-Year Column 2 Latest
Application Type Average Base 5-Year Average Column 3 Percent Column 4 Weighting Column 5 Weighted %
Years 2002-2007 2003- 2008 Change Factor Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs 123.8 128.4 3.7% 33.3% 1.24%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs 5755.8 5897.6 2.5% 45.2% 1.11%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements 163.4 173.0 5.9% 8.3% 0.49%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements 2589.2 2616.2 1.0% 13.2% 0.14%
--------------------------------------------------------------------------------------------------------------------------------------------------------
FY 2009 workload adjuster without adjustment changes for review activity 2.98%
--------------------------------------------------------------------------------------------------------------------------------------------------------
PDUFA IV specifies that FDA make additional adjustments for changes
in review activities to the first two categories (human drug
applications and active commercial INDs). These adjustments, specified
under PDUFA IV, are summarized in the new Columns 2b and 2c in Table 4
of this document. The number in the NDAs/BLAs line of Column 2b of
Table 4 of this document is the percent by which the average workload
for meetings, annual reports, and labeling supplements for NDAs and
BLAs has changed from the 5-year period 2002 through 2007 to the 5-year
period 2003 through 2008. Likewise, the number in the active commercial
INDs line of Column 2b of Table 4 of this document is the percent by
which the workload for meetings and special protocol assessments for
active commercial INDs has changed from the 5-year period 2002 through
2007 to the 5-year period 2003 through 2008. There is no entry in the
last two lines of column 2b because the adjustment for changes in
review workload does not apply to the workload for efficacy supplements
and manufacturing supplements.
Table 4--Final Workload Adjuster Calculation for FY 2009 With Adjustment for Changes in Review Activity\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 3 %
Column 1 5- Column 2a Column 2b Column 2c is Change Column 4 Column 5
Application Type Year Average Latest 5-Year Adjustment for Column 2a (Column 1 to Weighting Weighted %
Base Years Average 2003- Changes in Adjusted by Column 2c or Factor Change
2002-2007 2008 Review Activity Column 2b 2a)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs 123.8 128.4 -0.55% 127.7 3.1% 33.3% 1.05
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active commercial INDs 5755.8 5897.6 +0.39% 5920.6 2.9% 45.2% 1.31
--------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy supplements 163.4 173.0 NA 173.3 5.9% 8.3% 0.49%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Manufacturing supplements 2589.2 2516.2 NA 2616.2 1.0% 13.2% 0.14%
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 45021]]
FY 2009 workload adjuster with adjustment changes for review activity 2.98%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers may not add due to rounding.
The 2009 workload adjuster with adjustment for changes in review
activity at the bottom of Table 4 of this document is 2.98 percent
exactly the same as the workload adjuster without those changes at the
bottom of Table 3 of this document. Therefore the inflation-adjusted
revenue amount of $495,887,000 from section II.B of this document will
be multiplied by the 2009 workload adjuster of 2.98 percent, resulting
in a total adjusted revenue amount in FY 2009 of $510,665,000, rounded
to the nearest thousand dollars.
PDUFA specifies that one-third of the total fee revenue is to be
derived from application fees, one-third from establishment fees, and
one-third from product fees (see section 736(b)(2) of the act).
Accordingly, one-third of the total revenue amount, or $ 170,222,000,
rounded to the nearest thousand dollars, is the total amount of fee
revenue that will be derived from each of these fee categories.
III. Application Fee Calculations
A. Application Fee Revenues and Application Fees
Application fees will be set to generate one-third of the total fee
revenue amount, or $170,222,000, rounded to the nearest thousand
dollars, in FY 2009, as calculated in section II.D of this document.
B. Estimate of Number of Fee-Paying Applications and Establishment of
Application Fees
For FY 2008 through FY 2012, FDA will estimate the total number of
fee-paying full application equivalents (FAEs) it expects to receive
the next fiscal year by averaging the number of fee-paying FAEs
received in the 5 most recent fiscal years. This use of the rolling
average of the 5 most recent fiscal years is the same method that has
applied for the last 6 years.
In estimating the number of fee-paying FAEs that FDA will receive
in FY 2009, the 5-year rolling average for the most recent 5 years will
be based on actual counts of fee-paying FAEs received for FY 2004
through FY 2008. For FY 2008, FDA is estimating the number of fee-
paying FAEs for the full year based on the actual count for the first 9
months and estimating the number for the final 3 months, as we have
done for the past 6 years.
Table 5 of this document shows, in Column 1, the total number of
each type of FAE received in the first 9 months of FY 2008, whether
fees were paid or not. Column 2 shows the number of FAEs for which fees
were waived or exempted during this period, and Column 3 shows the
number of fee-paying FAEs received through June 30, 2008. Column 4
estimates the 12-month total fee-paying FAEs for FY 2008 based on the
applications received through June 30, 2008. All of the counts are in
FAEs. A full application requiring clinical data counts as one FAE. An
application not requiring clinical data counts as one-half an FAE, as
does a supplement requiring clinical data. An application that is
withdrawn, or refused for filing, counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant initially paid one-half of the full application
fee amount.
Table 5--FY 2008 Full Application Equivalents Received Through June 30, 2008, and Projected Through September
30, 2008
----------------------------------------------------------------------------------------------------------------
Column 2 Fee Column 3 Total
Column 1 Total Exempt or Waived Fee Paying Column 4 12-
Application or Action Received Through Through Through Month Fee-Paying
6[sol]30[sol]2008 6[sol]30[sol]2008 6[sol]30[sol]2008 Projection
----------------------------------------------------------------------------------------------------------------
Applications requiring clinical data 102.3 40.3 62.0 82.7
----------------------------------------------------------------------------------------------------------------
Applications not requiring clinical 11.1 4.1 7.0 9.3
data
----------------------------------------------------------------------------------------------------------------
Supplements requiring clinical data 45.0 6.0 39.0 52.0
----------------------------------------------------------------------------------------------------------------
Withdrawn or refused to file 0.5 0 0.5 0.7
----------------------------------------------------------------------------------------------------------------
Total 158.9 50.4 108.5 144.7
----------------------------------------------------------------------------------------------------------------
In the first 9 months of FY 2008, FDA received 158.9 FAEs, of which
108.5 were fee-paying. Based on data from the last 9 fiscal years, on
average, 25 percent of the applications submitted each year come in the
final 3 months. Dividing 108.5 by 3 and multiplying by 4 extrapolates
the amount to the full 12 months of the fiscal year and projects the
number of fee-paying FAEs in FY 2008 at 144.7.
As Table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 5-year period, and including
our estimate for FY 2008, is 136.5 FAEs. FDA will set fees for FY 2009
based on this estimate as the number of FAEs that will pay fees.
[[Page 45022]]
Table 6--Fee-Paying Full Application Equivalent--5-Year Average
----------------------------------------------------------------------------------------------------------------
5-Year
Fiscal Year 2004 2005 2006 2007 2008 Average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs 145.1 121.5 136.7 134.4 144.7 136.5
----------------------------------------------------------------------------------------------------------------
The FY 2009 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 5 years,
136.5, into the fee revenue amount to be derived from application fees
in FY 2009, $170,222,000. The result, rounded to the nearest $100, is a
fee of $1,247,200 per full application requiring clinical data, and
$623,600 per application not requiring clinical data or per supplement
requiring clinical data.
IV. Fee Calculations for Establishment and Product Fees
A. Establishment Fees
At the beginning of FY 2008, the establishment fee was based on an
estimate that 390 establishments would be subject to, and would pay,
fees. By the end of FY 2008, FDA estimates that 435 establishments will
have been billed for establishment fees, before all decisions on
requests for waivers or reductions are made. As in previous years, FDA
again estimates that a total of 25 establishment fee waivers or
reductions will be made for FY 2008. In addition, FDA estimates that
another 10 full establishment fees will be exempted this year based on
the orphan drug exemption in the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (see section 736(k) of the act).
Subtracting 35 establishments (25 plus the estimated 10 establishments
under the orphan exemption) from 435 leaves a net of 400 fee-paying
establishments. FDA will use 400 for its FY 2009 estimate of
establishments paying fees, after taking waivers and reductions into
account. The fee per establishment is determined by dividing the
adjusted total fee revenue to be derived from establishments
($170,222,000) by the estimated 400 establishments, for an
establishment fee rate for FY 2009 of $425,600 (rounded to the nearest
$100).
B. Product Fees
At the beginning of FY 2008, the product fee was based on an
estimate that 2,355 products would be subject to, and would pay,
product fees. By the end of FY 2008, FDA estimates that 2,450 products
will have been billed for product fees, before all decisions on
requests for waivers or reductions are made. FDA assumes that there
will be about 40 waivers and reductions granted, the same amount
estimated last year. In addition, FDA estimates that another 30 product
fees will be exempted this year based on the orphan drug exemption in
FDAAA (see section 736(k) of the act). FDA estimates that 2,380
products will qualify for product fees in FY 2008, after allowing for
waivers and reductions, including the orphan drug products eligible
under the FDAAA exemption, and will use this number for its FY 2009
estimate. Accordingly, the FY 2009 product fee rate is determined by
dividing the adjusted total fee revenue to be derived from product fees
($170,222,000) by the estimated 2,380 products for a FY 2009 product
fee of $71,520 (rounded to the nearest $10).
V. Fee Schedule for FY 2009
The fee rates for FY 2009 are set out in Table 7 of this document.
Table 7
------------------------------------------------------------------------
Fee Category Fee Rates for FY 2009
------------------------------------------------------------------------
APPLICATIONS
Requiring clinical data $1,247,200
Not requiring clinical data $623,600
------------------------------------------------------------------------
Supplements requiring clinical data $623,600
------------------------------------------------------------------------
ESTABLISHMENTS $425,600
------------------------------------------------------------------------
PRODUCTS $71,520
------------------------------------------------------------------------
VI. Implementation of Adjusted Fee Schedule
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2008. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee ID number on your check. Your payment can be
mailed to: Food and Drug Administration, P.O. Box 70963, Charlotte, NC
28272-0963.
If checks are to be sent by a courier that requests a street
address, the courier can deliver the checks to: Wachovia Bank, Attn:
Food and Drug Administration Lockbox 70963, 1525 West WT Harris Blvd.,
rm. NC0810, Charlotte, NC 28262. (Note: This Wachovia Bank address is
for courier delivery only.)
Please make sure that the FDA post office box number (P.O. Box
70963) is written on the check. The tax identification number of the
Food and Drug Administration is 53-0196965.
Wire transfer payment may also be used. The routing and transit
number is 021030004 and the account number is 75060099.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2009 under the new fee schedule in August 2008. Payment will be due on
October 1, 2008. FDA will issue invoices in November 2009 for any
products and establishments subject to fees for FY 2009 that qualify
for fees after the August 2008 billing.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17738 Filed 7-31-08; 8:45 am]
BILLING CODE 4160-01-S
