Prescription Drug User Fee Rates for Fiscal Year 2013, 45639-45643 [2012-18711]
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[FR Doc. 2012–18724 Filed 7–31–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0007]
Prescription Drug User Fee Rates for
Fiscal Year 2013
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) 2013. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Prescription Drug
User Fee Amendments of 2012 (Title 1
of the Food and Drug Administration
Safety and Innovation Act (FDASIA),
Public Law 112–144, which was signed
by the President on July 9, 2012)
(PDUFA V)), 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 V, 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
2013 for application fees for an
application requiring clinical data
($1,958,800), for an application not
requiring clinical data or a supplement
requiring clinical data ($979,400), for
establishment fees ($526,500), and for
product fees ($98,380). These fees are
effective on October 1, 2012, and will
remain in effect through September 30,
2013. For applications and supplements
that are submitted on or after October 1,
2012, the new fee schedule must be
used. Invoices for establishment and
product fees for FY 2013 will be issued
SUMMARY:
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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
in August 2012 using the new fee
schedule.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Piccard 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 2013 through FY 2017, the
base revenue amounts for the total
revenues from all PDUFA fees are
established by PDUFA V. The base
revenue amount for FY 2013 is to be
adjusted for inflation and workload, and
that adjusted FY 2013 amount becomes
the base amount for the remaining 4 FYs
of PDUFA V. That FY 2013 base revenue
amount is further adjusted each year
after FY 2013 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.
II. Fee Revenue Amount for FY 2013
The statutory fee revenue amount for
FY 2013 is $693,099,000, prior to
adjustment for inflation and workload
(see section 736(b)(1) of the FD&C Act).
Of this amount, $652,709,000 will be
further adjusted for inflation and
workload, and $40,390,000, for new
initiatives, will not be adjusted in FY
2013.
A. FY 2013 Statutory Fee Revenue
Adjustments for Inflation
PDUFA V specifies that $652,709,000
of the amount for FY 2013 is to be
further adjusted for inflation increases
for FY 2013 using 2 separate
adjustments—one for payroll costs and
one for non-pay costs (see section
736(b)(3)(A) of the FD&C Act).
The component of the inflation
adjustment for payroll costs shall be one
plus the average annual percent change
in the cost of all personnel
compensation and benefits (PC&B) paid
per full-time equivalent position (FTE)
at FDA for the first 3 of the 4 preceding
fiscal years multiplied by the proportion
of PC&B costs to total FDA costs of the
review of human drug applications for
the first 3 of the preceding 4 FYs (see
section 736(c)(1)(B) of the FD&C Act).
The data on total PC&B 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 data for the
specified fiscal years, and provides the
percent change from the previous fiscal
year and the average percent change
over the first 3 of the 4 FYs preceding
FY 2013. The 3 year average is 2.17
percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2009
Total PC&B ..............................................................................
Total FTE .................................................................................
PC&B per FTE .........................................................................
Percent Change from Previous Year ......................................
The statute says that this 2.17 percent
should be multiplied by the proportion
of PC&B for the review of human drug
$1,464,445,000
11,413
$128,314
3.56%
2010
2011
$1,634,108,000
12,526
$130,457
1.67%
applications. Table 2 of this document
shows the amount of PC&B and the total
amount obligated for the process for the
$1,761,655,000
13,331
$132,143
1.29%
3-Year average
..............................
..............................
..............................
2.17%
review of human drug applications for
the same 3 FYs.
TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS FOR THE REVIEW OF HUMAN DRUG
APPLICATIONS
Fiscal year
2009
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Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B percent ..........................................................................
The payroll adjustment is 2.17
percent multiplied by 60 percent (or
1.30 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs for FY 2013 is the average
annual percent change that occurred in
the Consumer Price Index (CPI) for
urban consumers (WashingtonBaltimore, DC–MD–VA–WV; not
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$514,874,163
855,426,294
60%
2010
$573,603,582
931,845,581
62%
seasonally adjusted; all items; annual
index) for the first 3 of the preceding 4
years of available data multiplied by the
proportion of all costs of the process for
the review of human drug applications
other than PC&B (see section
736(c)(1)(C) of the FD&C Act). Table 3
of this document provides the summary
data for the percent change in the
PO 00000
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2011
$596,627,595
1,025,621,707
58%
3-Year average
..............................
..............................
60%
specified CPI for the BaltimoreWashington area. The data is published
by the Bureau of Labor Statistics and
can be found on their Web site at https://
data.bls.gov/cgi-bin/surveymost?cu by
checking the box marked ‘‘WashingtonBaltimore All Items, November 1996 =
100 ¥ CUURA311SAO’’ and then
clicking on the retrieve data button.
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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN BALTIMORE-WASHINGTON AREA CPI
Year
2009
Annual CPI ...............................................................................
Annual Percent Change ..........................................................
To complete the inflation adjustment
for non-pay costs, we multiply the 1.76
percent by the proportion of costs of the
process for the review of human drug
applications obligated for costs other
than PC&B. Since 60 percent was
obligated for PC&B as shown in table 2
of this document, 40 percent is the
portion of costs other than PC&B (100
percent minus 60 percent equals 40
percent). The non-payroll adjustment is
2.5 percent times 40 percent, or 0.71
percent.
To complete the inflation adjustment,
we add the payroll component (1.30
percent) to the non-pay component
(0.71 percent), for a total inflation
adjustment of 2.01 percent (rounded),
and then add one, making 1.0201. We
then multiply the amount specified in
the statute ($652,709,000) by 1.0201
percent, yielding an inflation adjusted
amount of $665,828,451.
B. FY 2013 Statutory Fee Revenue
Adjustments for Workload
PDUFA V specifies that after the
$652,709,000 has been adjusted for
inflation, the inflation adjusted amount
($665,828,451) shall be further adjusted
for workload (see section 736(b)(3)(B) of
the FD&C Act). For FY 2013 the
workload adjustment will be the
percentage by which the workload
adjustment for FY 2013 exceeds the
workload adjuster for FY 2012, if both
such adjustments were calculated using
the 5 year base period consisting of FYs
2003 through 2007. As published in the
2010
140.718
0.23%
2011
142.915
1.72%
Federal Register of August 1, 2011 (76
FR 45831), the FY 2012 workload
calculated as directed was 8.12 percent.
To calculate the FY 2013 adjustment
factor, 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
(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, 2012.
The calculations are summarized in
table 4 of this document. The 5-year
averages for each application category
are provided in column 1 (‘‘5-Year
Average Base Years 2003–2007’’) and
column 2a (‘‘5-Year Average 2008–
2012’’).
PDUFA specifies that FDA make
additional adjustments for changes in
review activities to human drug
applications and active commercial
INDs. These adjustments, started under
PDUFA IV, are summarized in columns
2b and 2c in table 4 of this document.
The number in the new drug
applications/biologics license
applications (NDAs/BLAs) line of
column 2b of table 4 of this document
is the percent by which the average
workload for meetings, annual reports,
3-Year average
146.975
3.34%
..............................
1.76%
and labeling supplements for NDAs and
BLAs has changed from the 5-year
period 2003 through 2007, to the 5-year
period 2008 through 2012. 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 2003 through 2007, to the
5-year period 2008 through 2012. 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 4 of this document
reflects the percent change in workload
from column 1 to column 2c. Column 4
of table 4 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 4 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 4 of this document is the sum
of the values in column 5 that are
added, reflecting an increase in
workload of 9.99 percent for FY 2013
when compared to the base years.
TABLE 4—WORKLOAD ADJUSTER CALCULATIONS FOR FY 2013
Column 1
Column 2a
Column 2b
Column 2c
Column 3
Column 4
Column 5
5-Year
Average
base years
2003–2007
5-Year
Average
2008–2012
Adjustment
for changes
in review
activity
Column 2a
increased
by column
2b
Percent
change (column 1 to
column 2c)
Weighting
factor
Weighted
percent
change
NDAs/BLAs ..............................................
Active commercial INDs ...........................
Efficacy supplements ...............................
Manufacturing Supplements ....................
123.8
5,528.2
163.4
2589.2
134.4
6724.2
153.8
2575.4
0.08%
¥3.13%
NA
NA
134.5
6513.7
153.8
2575.4
8.6%
17.8%
¥5.9%
¥0.5%
39.6%
40.3%
9.5%
10.6%
3.42%
7.18%
¥0.56%
¥0.06%
FY 2013 Workload Adjuster .....................
....................
....................
....................
....................
....................
....................
9.99%
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Application type
Since the calculated workload
adjustment for 2013 (9.99 percent) is
greater than the 8.12 percent that was
calculated last year for FY 2012 the
difference between the two, 1.87 percent
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(9.99 percent minus 8.12 percent), and
that is the amount of the workload
adjustment for FY 2013 (see section
736(b)(3)(B) of the FD&C Act).
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Table 5 of this document shows the
calculation of the revenue amount for
FY 2013. The $652,709,000 subject to
adjustment on the first line is multiplied
by the combined inflation adjustment
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factor of 1.0201, resulting in the
inflation adjusted amount on the third
line. That amount is then multiplied by
one plus the workload adjustment of
1.87 percent, resulting in the inflation
and workload adjusted amount of
$678,279,443 on the fifth line. Finally
the portion of the FY 2013 fees not
subject to adjustment ($40,390,000) is
added, resulting in the total FY 2013 fee
revenue amount of $718,669,000 on the
last line of table 5 of this document.
TABLE 5—PDUFA REVENUE AMOUNT
FOR FY 2013 AND BASE FOR SUBSEQUENT YEARS
Portion of FY 2013 Revenues Subject to Adjustments ..............................
Amount of Inflation Adjustment Factor for FY 2013
Inflation Adjusted Amount
(1 plus 2.01 percent) .......
Workload Adjustment Factor for FY 2013 (1 plus
1.87 percent) ...................
Inflation and Workload Adjusted Amount .................
Portion of 2013 Revenues
Not Subject to Adjustment ................................
FY 2013 Revenue Amount
and Base for Subsequent
Years (Rounded to nearest thousand dollars) ......
$652,709,000
1.0201
$665,828,451
1.0187
$678,279,443
$40,390,000
$718,669,000
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
($718,669,000), or a total of
$239,556,333, is the 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 2013 is $718,669,000,
as the previous paragraph shows, FDA
assumes that the fee appropriation for
FY 2013 will be 5 percent higher, or
$754,602,000, rounded to the nearest
thousand dollars. The latest PDUFA 5Year 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
5 years, and will not help FDA keep up
with workload if there are sudden
increases in the number of applications
to be reviewed in the current fiscal year.
Appropriated amounts for PDUFA fee
revenue each year are estimated at 5
percent higher than estimated fee
revenues for each year, to provide FDA
with the ability to cope with surges in
application review workload should
that occur. If FDA collects less than the
fee estimate at the beginning of the year
and less than the fee appropriation, then
collections rather than appropriations
set the upper limit on how much FDA
may actually keep and spend. If,
however, FDA collects more than fee
estimates at the beginning of the year,
due to a workload surge, a slightly
higher fee appropriation will permit
FDA to keep and spend the higher
collections in order to respond to a 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 fiscal years since 1993,
actual appropriations have slightly
exceeded PDUFA fee revenue estimates
made each year.
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 $239,556,333 in FY
2013, as calculated previously in this
document.
B. Estimate of the Number of Fee-Paying
Applications and the Establishment of
Application Fees
For FY 2013 through FY 2017, 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 3 most
recently completed fiscal years. This
will avoid having FDA try to estimate
the number it expects to receive in the
current fiscal year.
In estimating the number of feepaying FAEs, 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.
As Table 6 of this document shows,
the average number of fee-paying FAEs
received annually in the most recent 3year period is 122.3 FAEs. FDA will set
fees for FY 2013 based on this estimate
as the number of full application
equivalents that will pay fees.
TABLE 6—FEE-PAYING FAE 3-YEAR AVERAGE
Fiscal year
2009
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Fee-Paying FAEs .....................................................................
The FY 2013 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 3 years, 122.3, into
the fee revenue amount to be derived
from application fees in FY 2013,
$239,556,333. The result, rounded to the
nearest $100, is a fee of $1,958,800 per
full application requiring clinical data,
and $979,400 per application not
requiring clinical data or per
supplement requiring clinical data.
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2010
140.3
118.4
IV. Fee Calculations for Establishment
and Product Fees
A. Establishment Fees
At the beginning of FY 2012, the
establishment fee was based on an
estimate that 450 establishments would
be subject to, and would pay, fees. By
the end of FY 2012, FDA estimates that
480 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
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2011
3-Year average
108.25
122.3
or reductions will be made for FY 2012.
In addition, FDA estimates that another
15 full establishment fees will be
exempted this year based on the orphan
drug exemption in the Food and Drug
Administration Amendments Act
(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 480 leaves a
net of 455 fee-paying establishments.
FDA will use 455 for its FY 2013
estimate of establishments paying fees,
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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 ($239,556,333) by the
estimated 455 establishments, for an
establishment fee rate for FY 2013 of
$526,500 (rounded to the nearest $100).
B. Product Fees
At the beginning of FY 2012, the
product fee was based on an estimate
that 2,365 products would be subject to
and would pay product fees. By the end
of FY 2012, FDA estimates that 2,525
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 50 waivers and reductions
granted. In addition, FDA estimates that
another 40 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 2,435 products will qualify for
product fees in FY 2012, after allowing
for waivers and reductions, including
the orphan drug products eligible under
the FDAAA exemption, and will use
this number for its FY 2013 estimate.
The FY 2013 product fee rate is
determined by dividing the adjusted
total fee revenue to be derived from
product fees ($239,556,333) by the
estimated 2,435 products for a FY 2013
product fee of $98,380 (rounded to the
nearest $10).
V. Fee Schedule for FY 2013
The fee rates for FY 2013 are set out
in Table 7 of this document:
TABLE 7—FEE SCHEDULE FOR FY
2013
Fee category
Fee rates for
FY 2013
Applications:
Requiring clinical data ...
Not requiring clinical
data ............................
Supplements requiring
clinical data ................
Establishments .....................
Products ................................
$1,958,800
979,400
B. Establishment and Product Fees
979,400
526,500
98,380
FDA will issue invoices for
establishment and product fees for FY
2013 under the new fee schedule in
August 2012. Payment will be due on
October 1, 2012. FDA will issue
invoices in November 2013 for any
products and establishments subject to
fees for FY 2013 that qualify for fee
assessments after the August 2012
billing.
tkelley on DSK3SPTVN1PROD with NOTICES
VI. Fee Payment Options and
Procedures
A. Application Fees
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received after September
30, 2012. Payment must be made in U.S.
currency by check, bank draft, or U.S.
postal money order payable to the order
VerDate Mar<15>2010
19:53 Jul 31, 2012
of the Food and Drug Administration.
Please include the user fee
identification (ID) number on your
check, bank draft, or postal money
order. Your payment can be mailed to:
Food and Drug Administration, P.O.
Box 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.
Contact the U.S. Bank at 314–418–4013
if you have any questions concerning
courier delivery.)
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.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD.
Application fees can also be paid
online with an electronic check (ACH).
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a Web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of the
Food and Drug Administration is 53–
0196965.
Jkt 226001
45643
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and AIDS Related Research.
Date: August 16–17, 2012.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Vascular Hematology I.
Date: August 29, 2012.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802, Bethesda, MD 20892, (301) 435–
1210, chaudhaa@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: July 26, 2012.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–18711 Filed 7–31–12; 8:45 am]
[FR Doc. 2012–18689 Filed 7–31–12; 8:45 am]
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]]>Agencies
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45639-45643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18711]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0007]
Prescription Drug User Fee Rates for Fiscal Year 2013
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) 2013. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2012 (Title 1 of the Food and
Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-
144, which was signed by the President on July 9, 2012) (PDUFA V)),
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 V, 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 2013 for application fees for an application requiring
clinical data ($1,958,800), for an application not requiring clinical
data or a supplement requiring clinical data ($979,400), for
establishment fees ($526,500), and for product fees ($98,380). These
fees are effective on October 1, 2012, and will remain in effect
through September 30, 2013. For applications and supplements that are
submitted on or after October 1, 2012, the new fee schedule must be
used. Invoices for establishment and product fees for FY 2013 will be
issued
[[Page 45640]]
in August 2012 using the new fee schedule.
FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial
Management (HFA-100), Food and Drug Administration, 1350 Piccard 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 2013 through FY 2017, the base revenue amounts for the total
revenues from all PDUFA fees are established by PDUFA V. The base
revenue amount for FY 2013 is to be adjusted for inflation and
workload, and that adjusted FY 2013 amount becomes the base amount for
the remaining 4 FYs of PDUFA V. That FY 2013 base revenue amount is
further adjusted each year after FY 2013 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.
II. Fee Revenue Amount for FY 2013
The statutory fee revenue amount for FY 2013 is $693,099,000, prior
to adjustment for inflation and workload (see section 736(b)(1) of the
FD&C Act). Of this amount, $652,709,000 will be further adjusted for
inflation and workload, and $40,390,000, for new initiatives, will not
be adjusted in FY 2013.
A. FY 2013 Statutory Fee Revenue Adjustments for Inflation
PDUFA V specifies that $652,709,000 of the amount for FY 2013 is to
be further adjusted for inflation increases for FY 2013 using 2
separate adjustments--one for payroll costs and one for non-pay costs
(see section 736(b)(3)(A) of the FD&C Act).
The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all
personnel compensation and benefits (PC&B) paid per full-time
equivalent position (FTE) at FDA for the first 3 of the 4 preceding
fiscal years multiplied by the proportion of PC&B costs to total FDA
costs of the review of human drug applications for the first 3 of the
preceding 4 FYs (see section 736(c)(1)(B) of the FD&C Act). The data on
total PC&B 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 data
for the specified fiscal years, and provides the percent change from
the previous fiscal year and the average percent change over the first
3 of the 4 FYs preceding FY 2013. The 3 year average is 2.17 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2009 2010 2011 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $1,464,445,000 $1,634,108,000 $1,761,655,000 .................
Total FTE........................... 11,413 12,526 13,331 .................
PC&B per FTE........................ $128,314 $130,457 $132,143 .................
Percent Change from Previous Year... 3.56% 1.67% 1.29% 2.17%
----------------------------------------------------------------------------------------------------------------
The statute says that this 2.17 percent should be multiplied by the
proportion of PC&B for the review of human drug applications. Table 2
of this document shows the amount of PC&B and the total amount
obligated for the process for the review of human drug applications for
the same 3 FYs.
Table 2--PC&B as a Percent of Fee Revenues Spent on the Process for the Review of Human Drug Applications
----------------------------------------------------------------------------------------------------------------
Fiscal year 2009 2010 2011 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $514,874,163 $573,603,582 $596,627,595 .................
Total Costs......................... 855,426,294 931,845,581 1,025,621,707 .................
PC&B percent........................ 60% 62% 58% 60%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.17 percent multiplied by 60 percent (or
1.30 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs for FY 2013 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual index) for the first 3 of the preceding 4 years of available
data multiplied by the proportion of all costs of the process for the
review of human drug applications other than PC&B (see section
736(c)(1)(C) of the FD&C Act). Table 3 of this document provides the
summary data for the percent change in the specified CPI for the
Baltimore-Washington area. The data is published by the Bureau of Labor
Statistics and can be found on their Web site at https://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ``Washington-Baltimore
All Items, November 1996 = 100 - CUURA311SAO'' and then clicking on the
retrieve data button.
[[Page 45641]]
Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
----------------------------------------------------------------------------------------------------------------
Year 2009 2010 2011 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 140.718 142.915 146.975 .................
Annual Percent Change............... 0.23% 1.72% 3.34% 1.76%
----------------------------------------------------------------------------------------------------------------
To complete the inflation adjustment for non-pay costs, we multiply
the 1.76 percent by the proportion of costs of the process for the
review of human drug applications obligated for costs other than PC&B.
Since 60 percent was obligated for PC&B as shown in table 2 of this
document, 40 percent is the portion of costs other than PC&B (100
percent minus 60 percent equals 40 percent). The non-payroll adjustment
is 2.5 percent times 40 percent, or 0.71 percent.
To complete the inflation adjustment, we add the payroll component
(1.30 percent) to the non-pay component (0.71 percent), for a total
inflation adjustment of 2.01 percent (rounded), and then add one,
making 1.0201. We then multiply the amount specified in the statute
($652,709,000) by 1.0201 percent, yielding an inflation adjusted amount
of $665,828,451.
B. FY 2013 Statutory Fee Revenue Adjustments for Workload
PDUFA V specifies that after the $652,709,000 has been adjusted for
inflation, the inflation adjusted amount ($665,828,451) shall be
further adjusted for workload (see section 736(b)(3)(B) of the FD&C
Act). For FY 2013 the workload adjustment will be the percentage by
which the workload adjustment for FY 2013 exceeds the workload adjuster
for FY 2012, if both such adjustments were calculated using the 5 year
base period consisting of FYs 2003 through 2007. As published in the
Federal Register of August 1, 2011 (76 FR 45831), the FY 2012 workload
calculated as directed was 8.12 percent.
To calculate the FY 2013 adjustment factor, 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 (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, 2012.
The calculations are summarized in table 4 of this document. The 5-
year averages for each application category are provided in column 1
(``5-Year Average Base Years 2003-2007'') and column 2a (``5-Year
Average 2008-2012'').
PDUFA specifies that FDA make additional adjustments for changes in
review activities to human drug applications and active commercial
INDs. These adjustments, started under PDUFA IV, are summarized in
columns 2b and 2c in table 4 of this document. The number in the new
drug applications/biologics license applications (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 2003 through 2007,
to the 5-year period 2008 through 2012. 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 2003 through 2007, to the 5-year period 2008 through 2012.
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 4 of this document reflects the percent change in
workload from column 1 to column 2c. Column 4 of table 4 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 4 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 4 of this
document is the sum of the values in column 5 that are added,
reflecting an increase in workload of 9.99 percent for FY 2013 when
compared to the base years.
Table 4--Workload Adjuster Calculations for FY 2013
--------------------------------------------------------------------------------------------------------------------------------------------------------
Column 1 Column 2a Column 2b Column 2c Column 3 Column 4 Column 5
------------------------------------------------------------------------------------------
Percent
Application type 5-Year 5-Year Adjustment Column 2a change Weighted
Average Average for changes increased (column 1 Weighting percent
base years 2008-2012 in review by column to column factor change
2003-2007 activity 2b 2c)
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDAs/BLAs.................................................... 123.8 134.4 0.08% 134.5 8.6% 39.6% 3.42%
Active commercial INDs....................................... 5,528.2 6724.2 -3.13% 6513.7 17.8% 40.3% 7.18%
Efficacy supplements......................................... 163.4 153.8 NA 153.8 -5.9% 9.5% -0.56%
Manufacturing Supplements.................................... 2589.2 2575.4 NA 2575.4 -0.5% 10.6% -0.06%
------------------------------------------------------------------------------------------
FY 2013 Workload Adjuster.................................... ........... ........... ........... ........... ........... ........... 9.99%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Since the calculated workload adjustment for 2013 (9.99 percent) is
greater than the 8.12 percent that was calculated last year for FY 2012
the difference between the two, 1.87 percent (9.99 percent minus 8.12
percent), and that is the amount of the workload adjustment for FY 2013
(see section 736(b)(3)(B) of the FD&C Act).
Table 5 of this document shows the calculation of the revenue
amount for FY 2013. The $652,709,000 subject to adjustment on the first
line is multiplied by the combined inflation adjustment
[[Page 45642]]
factor of 1.0201, resulting in the inflation adjusted amount on the
third line. That amount is then multiplied by one plus the workload
adjustment of 1.87 percent, resulting in the inflation and workload
adjusted amount of $678,279,443 on the fifth line. Finally the portion
of the FY 2013 fees not subject to adjustment ($40,390,000) is added,
resulting in the total FY 2013 fee revenue amount of $718,669,000 on
the last line of table 5 of this document.
Table 5--PDUFA Revenue Amount for FY 2013 and Base for Subsequent Years
------------------------------------------------------------------------
------------------------------------------------------------------------
Portion of FY 2013 Revenues Subject to Adjustments..... $652,709,000
Amount of Inflation Adjustment Factor for FY 2013...... 1.0201
Inflation Adjusted Amount (1 plus 2.01 percent)........ $665,828,451
Workload Adjustment Factor for FY 2013 (1 plus 1.87 1.0187
percent)..............................................
Inflation and Workload Adjusted Amount................. $678,279,443
Portion of 2013 Revenues Not Subject to Adjustment..... $40,390,000
FY 2013 Revenue Amount and Base for Subsequent Years $718,669,000
(Rounded to 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 FD&C Act).
Accordingly, one third of the total revenue amount ($718,669,000), or a
total of $239,556,333, is the 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 2013 is
$718,669,000, as the previous paragraph shows, FDA assumes that the fee
appropriation for FY 2013 will be 5 percent higher, or $754,602,000,
rounded to the nearest thousand dollars. The latest PDUFA 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 5 years, and
will not help FDA keep up with workload if there are sudden increases
in the number of applications to be reviewed in the current fiscal
year. Appropriated amounts for PDUFA fee revenue each year are
estimated at 5 percent higher than estimated fee revenues for each
year, to provide FDA with the ability to cope with surges in
application review workload should that occur. If FDA collects less
than the fee estimate at the beginning of the year and less than the
fee appropriation, then collections rather than appropriations set the
upper limit on how much FDA may actually keep and spend. If, however,
FDA collects more than fee estimates at the beginning of the year, due
to a workload surge, a slightly higher fee appropriation will permit
FDA to keep and spend the higher collections in order to respond to a
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 fiscal years
since 1993, actual appropriations have slightly exceeded PDUFA fee
revenue estimates made each year.
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 $239,556,333 in FY 2013, as calculated previously in
this document.
B. Estimate of the Number of Fee-Paying Applications and the
Establishment of Application Fees
For FY 2013 through FY 2017, 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 3 most recently completed fiscal years. This will avoid
having FDA try to estimate the number it expects to receive in the
current fiscal year.
In estimating the number of fee-paying FAEs, 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.
As Table 6 of this document shows, the average number of fee-paying
FAEs received annually in the most recent 3-year period is 122.3 FAEs.
FDA will set fees for FY 2013 based on this estimate as the number of
full application equivalents that will pay fees.
Table 6--Fee-Paying FAE 3-Year Average
----------------------------------------------------------------------------------------------------------------
Fiscal year 2009 2010 2011 3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs..................... 140.3 118.4 108.25 122.3
----------------------------------------------------------------------------------------------------------------
The FY 2013 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
122.3, into the fee revenue amount to be derived from application fees
in FY 2013, $239,556,333. The result, rounded to the nearest $100, is a
fee of $1,958,800 per full application requiring clinical data, and
$979,400 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 2012, the establishment fee was based on an
estimate that 450 establishments would be subject to, and would pay,
fees. By the end of FY 2012, FDA estimates that 480 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 2012.
In addition, FDA estimates that another 15 full establishment fees will
be exempted this year based on the orphan drug exemption in the Food
and Drug Administration Amendments Act (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 480 leaves
a net of 455 fee-paying establishments. FDA will use 455 for its FY
2013 estimate of establishments paying fees,
[[Page 45643]]
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 ($239,556,333) by the estimated 455
establishments, for an establishment fee rate for FY 2013 of $526,500
(rounded to the nearest $100).
B. Product Fees
At the beginning of FY 2012, the product fee was based on an
estimate that 2,365 products would be subject to and would pay product
fees. By the end of FY 2012, FDA estimates that 2,525 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 50 waivers and reductions granted. In addition, FDA estimates
that another 40 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 2,435 products will qualify for product fees in FY
2012, after allowing for waivers and reductions, including the orphan
drug products eligible under the FDAAA exemption, and will use this
number for its FY 2013 estimate. The FY 2013 product fee rate is
determined by dividing the adjusted total fee revenue to be derived
from product fees ($239,556,333) by the estimated 2,435 products for a
FY 2013 product fee of $98,380 (rounded to the nearest $10).
V. Fee Schedule for FY 2013
The fee rates for FY 2013 are set out in Table 7 of this document:
Table 7--Fee Schedule for FY 2013
------------------------------------------------------------------------
Fee rates for
Fee category FY 2013
------------------------------------------------------------------------
Applications:
Requiring clinical data............................. $1,958,800
Not requiring clinical data......................... 979,400
Supplements requiring clinical data................. 979,400
Establishments.......................................... 526,500
Products................................................ 98,380
------------------------------------------------------------------------
VI. Fee Payment Options and Procedures
A. Application Fees
The appropriate application fee established in the new fee schedule
must be paid for any application or supplement subject to fees under
PDUFA that is received after September 30, 2012. Payment must be made
in U.S. currency by check, bank draft, or U.S. postal money order
payable to the order of the Food and Drug Administration. Please
include the user fee identification (ID) number on your check, bank
draft, or postal money order. Your payment can be mailed to: Food and
Drug Administration, P.O. Box 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. Contact the
U.S. Bank at 314-418-4013 if you have any questions concerning courier
delivery.)
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. Department of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD.
Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of the Food and Drug Administration
is 53-0196965.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2013 under the new fee schedule in August 2012. Payment will be due on
October 1, 2012. FDA will issue invoices in November 2013 for any
products and establishments subject to fees for FY 2013 that qualify
for fee assessments after the August 2012 billing.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18711 Filed 7-31-12; 8:45 am]
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