Prescription Drug User Fee Rates for Fiscal Year 2015, 44807-44811 [2014-18113]
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
adjustment factor, the establishment fee
for non-small businesses is to be further
adjusted for a small business adjustment
factor. Section 744K(c)(3)(B) provides
that the small business adjustment
factor is the adjustment to the
establishment fee for non-small
businesses that is necessary to achieve
total fees equaling the total fees that
FDA would have collected if no entity
qualified for the small business
exception in section 744K(c)(4) of the
FD&C Act.
Therefore, to calculate the small
business adjustment to the
establishment fee for non-small
businesses for FY 2015, FDA must
estimate: (1) The number of outsourcing
facilities that will pay the reduced fee
for small businesses for FY 2015; and (2)
the total fee revenue it would have
collected if no entity had qualified for
the small business exception (i.e., if
each outsourcing facility that registers
for FY 2015 were to pay the inflationadjusted fee amount of $15,308). With
respect to (1), FDA estimates that 5
entities will qualify for small business
exceptions for FY 2015. Accordingly,
FDA estimates that 5 entities will pay
the reduced fee for small businesses for
FY 2015. With respect to (2), to estimate
the total number of outsourcing
facilities that will register for FY 2015,
FDA used data submitted to date by
outsourcing facilities through the
voluntary registration process, which
began in December 2013. Accordingly,
FDA estimates that 50 outsourcing
facilities, including 5 small businesses,
will register with the Agency in FY
2015.
If the projected 50 outsourcing
facilities paid the full inflation-adjusted
fee of $15,308, this would result in total
revenue of $765,400 in FY 2015
($15,308 times 50). However, because 5
of the outsourcing facilities expected to
register for FY 2015 are estimated to
qualify for the small business exception
and will pay one-third of the full fee
($5,103 × 5), totaling $25,515 instead of
paying the full fee ($15,308 × 5), which
totals $76,540, this would leave a
shortfall of $51,025 ($76,540 ¥
$25,515). Dividing $51,025 by 45 (the
number of estimated non-small
businesses) yields $1,134 (rounded to
the nearest dollar). Therefore, the FY
2015 small business adjustment to the
establishment fee for non-small
businesses is $1,134.
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1. If paying with a paper check:
Checks must be in U.S. currency from
a U.S. bank and made payable to the
TABLE 4—OUTSOURCING FACILITY
Food and Drug Administration.
FEES
Payments can be mailed to: Food and
Drug Administration, P.O. Box 956733,
Qualified Small Business Establishment Fee .....................................
$5,103 St. Louis, MO 63195–6733. If a check is
Non-Small Business Establishment
sent by a courier that requests a street
Fee ..............................................
16,442 address, the courier can deliver the
Reinspection Fee ............................
15,308 check to: U.S. Bank, Attn: Government
Lockbox 956733, 1005 Convention
III. Fee Payment Options and
Plaza, St. Louis, MO 63101. (Note: This
Procedures
U.S. Bank address is for courier delivery
only; do not send mail to this address.)
A. Establishment Fee
2. If paying with a wire transfer: Use
Once an entity submits registration
the following account information when
information and FDA has reviewed the
sending a wire transfer: New York
information and determined that it is
Federal Reserve Bank, U.S. Dept of
complete, the entity will incur the
Treasury, TREAS NYC, 33 Liberty St.,
annual establishment fee. FDA will send New York, NY 10045, Acct. No.
an invoice to the entity via email, to the 75060099, Routing No. 021030004,
email address indicated in the
SWIFT: FRNYUS33, Beneficiary: FDA,
registration file, or via regular mail if
8455 Colesville Road, Silver Spring, MD
email is not an option. The invoice will
20993. The originating financial
contain information regarding the
institution may charge a wire transfer
obligation incurred, the amount owed,
fee. An outsourcing facility should ask
and payment procedures. A facility will its financial institution about the fee
not be deemed registered as an
and add it to the payment to ensure that
outsourcing facility until it has paid the the order is fully paid. The tax
annual establishment fee under section
identification number of FDA is 53–
744K of the FD&C Act. Accordingly, it
0196965.
is important that facilities seeking to
Dated: July 25, 2014.
operate as registered outsourcing
Leslie Kux,
facilities pay all fees immediately upon
Assistant Commissioner for Policy.
receiving an invoice. If an entity does
not pay the full invoiced amount within [FR Doc. 2014–18111 Filed 7–31–14; 8:45 am]
BILLING CODE 4160–01–P
fifteen calendar days after FDA issues
the invoice, FDA will consider the
submission of registration information
DEPARTMENT OF HEALTH AND
to have been withdrawn and adjust the
HUMAN SERVICES
invoice to reflect that no fee is due.
Outsourcing facilities that registered
Food and Drug Administration
in FY 2014 and wish to maintain their
[Docket No. FDA–2014–N–0007]
status as an outsourcing facility in FY
2015 must register during the annual
Prescription Drug User Fee Rates for
registration period that lasts from
Fiscal Year 2015
October 1, 2014 to December 31, 2014.
Failure to register and complete
AGENCY: Food and Drug Administration,
payment by December 31, 2014, will
HHS.
result in a loss of status as an
ACTION: Notice.
outsourcing facility on January 1, 2015.
Entities should submit their registration SUMMARY: The Food and Drug
Administration (FDA) is announcing the
information no later than December 10,
2014 to allow enough time for review of rates for prescription drug user fees for
fiscal year (FY) 2015. The Federal Food,
the registration information, invoicing,
Drug, and Cosmetic Act (the FD&C Act),
and payment of fees before the end of
as amended by the Prescription Drug
the registration period.
User Fee Amendments of 2012 (PDUFA
B. Reinspection Fee
V), authorizes FDA to collect user fees
for certain applications for the review of
FDA will issue invoices for each
human drug and biological products, on
reinspection via email, to the email
address indicated in the registration file, establishments where the products are
made, and on such products. This
or via regular mail if email is not an
notice establishes the fee rates for FY
option.
2015.
C. Fee Payment Procedures
FOR FURTHER INFORMATION CONTACT:
Entities may remit payments via
Robert J. Marcarelli, Office of Financial
check or wire transfer.
Management, Food and Drug
C. Summary of FY 2015 Fee Rates
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
Administration, 8455 Colesville Rd.,
COLE–14202F, Silver Spring, MD
20993–0002, 301–796–7223.
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 the review of human
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, which
became the base amount for the
remaining 4 FYs of PDUFA V, is
$718,669,000, as published in the
Federal Register of August 1, 2012 (77
FR 45639). The 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.
This document provides fee rates for
FY 2015 for an application requiring
clinical data ($2,335,200), for an
application not requiring clinical data or
a supplement requiring clinical data
($1,167,600), for an establishment
($569,200), and for a product
($110,370). These fees are effective on
October 1, 2014, and will remain in
effect through September 30, 2015. For
applications and supplements that are
submitted on or after October 1, 2014,
the new fee schedule must be used.
Invoices for establishment and product
fees for FY 2015 will be issued in
August 2014 using the new fee
schedule.
II. Fee Revenue Amount for FY 2015
The base revenue amount for FY 2015
is $718,669,000 prior to adjustments for
inflation and workload (see section
736(c)(1) and (c)(2) of the FD&C Act).
A. FY 2015 Statutory Fee Revenue
Adjustments for Inflation
PDUFA V specifies that the
$718,669,000 is to be further adjusted
for inflation increases for FY 2015 using
two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (see
section 736(c)(1) of the FD&C Act).
The component of the inflation
adjustment for payroll costs shall be 1
plus the average annual percent change
in the cost of all PC&B paid per full-time
equivalent (FTE) position at FDA for the
first 3 of the preceding 4 FYs,
multiplied by the proportion of PC&B
costs to total FDA costs of process for
the review of human drug applications
for the first 3 of the preceding 4 FYs (see
section 736(c)(1)(A) and (c)(1)(B) of the
FD&C Act). The 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 summarizes that actual cost
and FTE data for the specified FYs, and
provides the percent changes from the
previous FYs and the average percent
changes over the first 3 of the 4 FYs
preceding FY 2015. The 3-year average
is 1.8829 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
Fiscal year
2011
Total PC&B ......................................................................................
Total FTE .........................................................................................
PC&B per FTE .................................................................................
Percent Change from Previous Year ..............................................
The statute specifies that this 1.8829
percent should be multiplied by the
proportion of PC&B costs to total FDA
2012
$1,761,655,000
13,331
$132,147
1.2954%
2013
$1,824,703,000
13,382
$136,355
3.1843%
costs of the process for the review of
human drug applications. Table 2 shows
the PC&B and the total obligations for
$1,927,703,000
13,974
$137,949
1.1690%
3-Year average
............................
............................
............................
1.8829%
the process for the review of human
drug applications for 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
2011
tkelley on DSK3SPTVN1PROD with NOTICES
Total PC&B ......................................................................................
Total Costs .......................................................................................
PC&B Percent ..................................................................................
The payroll adjustment is 1.8829
percent from table 1 multiplied by
58.1286 percent (or 1.0945 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs is the average annual
percent change that occurred in the
Consumer Price Index (CPI) for urban
consumers (Washington-Baltimore, DCMD-VA-WV; not seasonally adjusted; all
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2012
$596,627,595
$1,025,621,707
58.1723%
$ 592,642,252
$1,032,419,218
57.4033%
items; annual index) for the first 3 years
of the preceding 4 years of available
data multiplied by the proportion of all
costs other than PC&B costs to total
costs of the process for the review of
human drug applications for the first 3
years of the preceding 4 fiscal years (see
section 736(c)(1)(C) of the FD&C Act).
Table 3 provides the summary data for
the percent changes in the specified CPI
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2013
$568,206,210
$966,169,007
58.8102%
3-Year average
............................
............................
58.1286%
for the Washington-Baltimore 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–
CUURA311SA0’’ and then clicking on
the ‘‘Retrieve Data’’ button.
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TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-BALTIMORE AREA
Year
2011
Annual CPI .......................................................................................
Annual Percent Change ..................................................................
To calculate the inflation adjustment
for non-payroll costs, we multiply the
2.3568 percent by the proportion of all
costs other than PC&B to total costs of
the process for the review of human
drug applications obligated. Since
58.1286 percent was obligated for PC&B
as shown in table 2, 41.8714 percent is
the portion of costs other than PC&B
(100 percent minus 58.1286 percent
equals 41.8714 percent). The nonpayroll adjustment is 2.3568 percent
times 41.8714 percent, or 0.9868
percent.
Next, we add the payroll adjustment
(1.0945 percent) to the non-payroll
adjustment (0.9868 percent), for a total
inflation adjustment of 2.0813 percent
(rounded) for FY 2015.
PDUFA V provides for this inflation
adjustment to be compounded after FY
2013 (see section 736(c)(1) of the FD&C
Act). This factor for FY 2015 (2.0813
percent) is compounded by adding 1
and then multiplying by 1 plus the
inflation adjustment factor for FY 2014
(2.20 percent), as published in the
2012
146.975
3.3449%
2013
150.212
2.2024%
Federal Register of August 2, 2013 (78
FR 46980 at 46982), which equals to
1.043271 (rounded) (1.020813 times
1.0220) for FY 2015. We then multiply
the base revenue amount for FY 2015
($718,669,000) by 1.043271, yielding an
inflation-adjusted amount of
$749,766,526.
B. FY 2015 Statutory Fee Revenue
Adjustments for Workload
The statute specifies that after the
$718,669,000 has been adjusted for
inflation, the inflation-adjusted amount
shall be further adjusted for workload
(see section 736(c)(2) of the FD&C Act).
To calculate the FY 2015 workload
adjustment, 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 3-year period that ended on
3-Year average
152.500
1.5232%
............................
2.3568%
June 30, 2012 (base years), and the
average number of each of these types
of applications over the most recent 3
year period that ended June 30, 2014.
The calculations are summarized in
table 4. The 3-year averages for each
application category are provided in
column 1 (‘‘3-Year Average Base Years
2010–2012’’) and column 2 (‘‘3-Year
Average 2012–2014’’). 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 3 years. Column 5 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. The
sum of the values in column 5 is added,
reflecting an increase in workload of
7.49 percent (rounded) for FY 2015
when compared to the base years.
TABLE 4—WORKLOAD ADJUSTER CALCULATION FOR FY 2015
3-Year
average base
years 2010–
2012
Percent
change
(column 1 to
column 2)
Weighting
factor
(percent)
Weighted
percent
change
Column 1
Application type
3-Year
average 2012–
2014
Column 2
Column 3
Column 4
Column 5
New Drug Applications/Biologics License Applications .......
Active Commercial INDs ......................................................
Efficacy Supplements ..........................................................
Manufacturing Supplements ................................................
124.3
6830.0
136.3
2548.3
141.3
7141.3
156.7
2433.7
13.6766
4.5578
14.9670
¥4.4971
37.3
41.4
7.5
13.8
5.10
1.89
1.12
¥0.62
FY 2015 Workload Adjuster .................................................
........................
........................
........................
........................
7.49
Table 5 shows the calculation of the
revenue amount for FY 2015. The
$718,669,000 subject to adjustment on
the first line is multiplied by the
inflation adjustment factor of 1.043271,
resulting in the inflation-adjusted
amount on the third line, $749,766,526.
That amount is then multiplied by one
plus the workload adjustment of 7.49
percent, resulting in the inflation and
workload adjusted amount of
$805,924,000 on the fifth line, rounded
to the nearest thousand dollars.
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 5—PDUFA REVENUE AMOUNT FOR FY 2015, SUMMARY CALCULATION
FY 2013 Revenue Amount and Base Subsequent FYs as published in the Federal Register of August 1, 2012 (77
FR 45639) (Rounded to nearest thousand dollars).
Inflation Adjustment Factor for FY 2015 (1 plus 4.3271 percent) .....................................................................................
Inflation Adjusted Amount ..................................................................................................................................................
Workload Adjustment Factor for FY 2015 (1 plus 7.49 percent) .......................................................................................
Inflation and Workload Adjusted Amount (Rounded to nearest thousand dollars) ...........................................................
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$718,669,000
Line 1.
1.043271
$749,766,526
1.0749
$805,924,000
Line
Line
Line
Line
2.
3.
4.
5.
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
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
($805,924,000), or a total of
$268,641,333, is the amount of fee
revenue that will be derived from each
of these fee categories: Application Fees,
Establishment Fees, and Product Fees.
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 $268,641,333 in FY
2015.
B. Estimate of the Number of Fee-Paying
Applications and Setting the
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 FY
by averaging the number of fee-paying
FAEs received in the 3 most recently
completed FYs.
In estimating the number of feepaying 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 onefourth 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 shows, the average number
of fee-paying FAEs received annually in
the most recent 3-year period is 115.042
FAEs. FDA will set fees for FY 2015
based on this estimate as the number of
full application equivalents that will
pay fees.
TABLE 6—FEE-PAYING FAE 3-YEAR AVERAGE
FY
2011
2012
2013
3-Year average
Fee-Paying FAEs .............................................................................
108.250
122.375
114.500
115.042
The FY 2015 application fee is
estimated by dividing the average
number of full applications that paid
fees over the latest 3 years, 115.042, into
the fee revenue amount to be derived
from application fees in FY 2015,
$268,641,333. The result, rounded to the
nearest hundred dollars, is a fee of
$2,335,200 per full application requiring
clinical data, and $1,167,600 per
application not requiring clinical data or
per supplement requiring clinical data.
tkelley on DSK3SPTVN1PROD with NOTICES
IV. Fee Calculations for Establishment
and Product Fees
A. Establishment Fees
At the beginning of FY 2014, the
establishment fee was based on an
estimate that 455 establishments would
be subject to and would pay fees. By the
end of FY 2014, FDA estimates that 509
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 20
establishment fee waivers or reductions
will be made for FY 2014. In addition,
FDA estimates that another 17 full
establishment fees will be exempted this
year based on the orphan drug
exemption in section 736(k) of the FD&C
Act. Subtracting 37 establishments (20
waivers, plus the estimated 17
establishments under the orphan
exemption) from 509 leaves a net of 472
fee-paying establishments. FDA will use
472 to estimate the FY 2015
establishments paying fees. The fee per
establishment is determined by dividing
the adjusted total fee revenue to be
derived from establishments
($268,641,333) by the estimated 472
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establishments, for an establishment fee
rate for FY 2015 of $569,200 (rounded
to the nearest hundred dollars).
TABLE 7—FEE SCHEDULE FOR FY
2015
Fee category
B. Product Fees
At the beginning of FY 2014, the
product fee was based on an estimate
that 2,425 products would be subject to
and would pay product fees. By the end
of FY 2014, FDA estimates that 2,545
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 69 waivers and reductions
granted. In addition, FDA estimates that
another 42 product fees will be
exempted this year based on the orphan
drug exemption in section 736(k) of the
FD&C Act. FDA estimates that 2,434
products will qualify for product fees in
FY 2014, after allowing for an estimated
111 waivers and reductions, including
the orphan drug products, and will use
this number for its FY 2015 estimate.
The FY 2015 product fee rate is
determined by dividing the adjusted
total fee revenue to be derived from
product fees ($268,641,333) by the
estimated 2,434 products for a FY 2015
product fee of $110,370 (rounded to the
nearest ten dollars).
V. Fee Schedule for FY 2015
The fee rates for FY 2015 are set out
in table 7:
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Fee rates for
FY 2015
Applications:
Requiring clinical data .......
Not requiring clinical data
Supplements requiring
clinical data ....................
Establishments .....................
Products ................................
$2,335,200
1,167,600
1,167,600
569,200
110,370
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 on or after
October 1, 2014. 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.)
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Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
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. Please ask your financial institution
about the fee and add it to your payment
to ensure that your fee is fully paid. The
account information for wire transfers 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, 8455 Colesville Rd.,
14th Floor, Silver Spring, MD 20993–
0002.
Application fees can also be paid
online with an electronic check (ACH).
FDA has partnered with the U.S.
Department of the Treasury to use
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 FDA
is 53–0196965.
B. Establishment and Product Fees
FDA will issue invoices for
establishment and product fees for FY
2015 under the new fee schedule in
August 2014. Payment will be due on
October 1, 2014. FDA will issue
invoices in November 2015 for any
products and establishments subject to
fees for FY 2015 that qualify for fee
assessments after the August 2014
billing.
Dated: July 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–18113 Filed 7–31–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
Notice of Correction
The National Institutes of Health NIH
published in the Federal Register on
July 18, 2014 a notice titled ‘‘Proposed
Collection; 60-Day Comment Request; A
Generic Submission for Formative
Research, Pre-Testing, Stakeholder
Measures and Advocate Forms at NCI’’
[79 FR 42023]. The notice contained an
incorrect email address for Kelley
Landy, Acting Director of the Office of
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Advocacy Relations. The correct email
address is kelley.landy@nih.gov.
Dated: July 28, 2014.
Cynthia Chaves,
NIH Federal Register Liaison.
[FR Doc. 2014–18087 Filed 7–31–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Recruitment and
Screening for the Insight Into
Determination of Exceptional Aging
and Longevity (IDEAL) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 2, 2014,
Vol. 79, page 18569 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute on Aging (NIA),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Luigi Ferrucci, M.D., Ph.D., NIA
Clinical Research Branch, Harbor
Hospital, 5th Floor, 3001 S. Hanover,
Baltimore, MD 21225 or call non-tollfree number (410) 350–3936 or Email
your request, including your address to:
Ferruccilu@grc.nia.nih.gov. Formal
SUMMARY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
44811
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Recruitment and
Screening for the Insight into
Determination of Exceptional Aging and
Longevity (IDEAL) Study (OMB#: 0925–
0631). National Institute on Aging
(NIA), National Institutes of Health
(NIH).
Need and Use of Information Collection
Longevity combined with good health
and functionality at the end of life
represents a common goal. Although
research has examined correlates of long
life and functional decline, we still
know relatively little about why certain
individuals live in excellent health into
their eighties while others succumb to
failing health at much younger ages.
Understanding the mechanisms
important to ideal aging may provide
new opportunity for health promotion
and disability prevention is this rapidly
growing segment of the population.
The purpose of IDEAL (Insight into
the Determinants of Exceptional Aging
and Longevity) is to recruit into the
Baltimore Longitudinal Study on Aging
(BLSA) exceptionally long lived and
healthy individuals and to learn what
makes them so resilient and resistant to
disease and disability, and to identify
potential interventions that may
contribute to the IDEAL condition. By
enrolling the IDEAL cohort in the BLSA
their biologic, physiologic, behavioral
and functional characteristics will be
evaluated using the same methods used
with the current cohort who will serve
as a type of control group. The first aim
is to identify factors and characteristics
that distinguish IDEAL from non-IDEAL
individuals. We intend to compare the
two groups to identify factors that
discriminate IDEAL aging from nonIDEAL aging individuals. The second
aim is to identify physiological,
environmental and behavioral
characteristics that are risk factors for
losing the IDEAL condition over several
years or longer. We postulate that the
mechanisms of extreme longevity
probably differ from those associated
with delay or escape from disease and
disability. As is customary in the BLSA,
we plan to follow this cohort for life
with yearly visits. This is a request for
OMB to approve a reinstatement with
change of Recruitment and Screening
for the Insight into Determination of
Exceptional Aging and Longevity
(IDEAL) Study for 3 years.
OMB approval is requested for 3
years. There is no annualized cost to
respondents. The total estimated
annualized burden hours are 333.
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44807-44811]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18113]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0007]
Prescription Drug User Fee Rates for Fiscal Year 2015
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for prescription drug user fees for fiscal year (FY) 2015. The Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA
to collect user fees for certain applications for the review of human
drug and biological products, on establishments where the products are
made, and on such products. This notice establishes the fee rates for
FY 2015.
FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of
Financial Management, Food and Drug
[[Page 44808]]
Administration, 8455 Colesville Rd., COLE-14202F, Silver Spring, MD
20993-0002, 301-796-7223.
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 the review of human 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, which became the base amount for the
remaining 4 FYs of PDUFA V, is $718,669,000, as published in the
Federal Register of August 1, 2012 (77 FR 45639). The 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.
This document provides fee rates for FY 2015 for an application
requiring clinical data ($2,335,200), for an application not requiring
clinical data or a supplement requiring clinical data ($1,167,600), for
an establishment ($569,200), and for a product ($110,370). These fees
are effective on October 1, 2014, and will remain in effect through
September 30, 2015. For applications and supplements that are submitted
on or after October 1, 2014, the new fee schedule must be used.
Invoices for establishment and product fees for FY 2015 will be issued
in August 2014 using the new fee schedule.
II. Fee Revenue Amount for FY 2015
The base revenue amount for FY 2015 is $718,669,000 prior to
adjustments for inflation and workload (see section 736(c)(1) and
(c)(2) of the FD&C Act).
A. FY 2015 Statutory Fee Revenue Adjustments for Inflation
PDUFA V specifies that the $718,669,000 is to be further adjusted
for inflation increases for FY 2015 using two separate adjustments--one
for personnel compensation and benefits (PC&B) and one for non-PC&B
costs (see section 736(c)(1) of the FD&C Act).
The component of the inflation adjustment for payroll costs shall
be 1 plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) position at FDA for the first 3 of
the preceding 4 FYs, multiplied by the proportion of PC&B costs to
total FDA costs of process for the review of human drug applications
for the first 3 of the preceding 4 FYs (see section 736(c)(1)(A) and
(c)(1)(B) of the FD&C Act). The 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 summarizes that actual cost and FTE data for the specified
FYs, and provides the percent changes from the previous FYs and the
average percent changes over the first 3 of the 4 FYs preceding FY
2015. The 3-year average is 1.8829 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
Fiscal year 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $1,761,655,000 $1,824,703,000 $1,927,703,000 ................
Total FTE............................... 13,331 13,382 13,974 ................
PC&B per FTE............................ $132,147 $136,355 $137,949 ................
Percent Change from Previous Year....... 1.2954% 3.1843% 1.1690% 1.8829%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 1.8829 percent should be multiplied
by the proportion of PC&B costs to total FDA costs of the process for
the review of human drug applications. Table 2 shows the PC&B and the
total obligations for the process for the review of human drug
applications for 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 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.............................. $596,627,595 $ 592,642,252 $568,206,210 ................
Total Costs............................. $1,025,621,707 $1,032,419,218 $966,169,007 ................
PC&B Percent............................ 58.1723% 57.4033% 58.8102% 58.1286%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 1.8829 percent from table 1 multiplied by
58.1286 percent (or 1.0945 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs 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 years of the preceding 4 years of
available data multiplied by the proportion of all costs other than
PC&B costs to total costs of the process for the review of human drug
applications for the first 3 years of the preceding 4 fiscal years (see
section 736(c)(1)(C) of the FD&C Act). Table 3 provides the summary
data for the percent changes in the specified CPI for the Washington-
Baltimore 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-CUURA311SA0'' and then clicking on the
``Retrieve Data'' button.
[[Page 44809]]
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Baltimore Area
----------------------------------------------------------------------------------------------------------------
Year 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.............................. 146.975 150.212 152.500 ................
Annual Percent Change................... 3.3449% 2.2024% 1.5232% 2.3568%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-payroll costs, we
multiply the 2.3568 percent by the proportion of all costs other than
PC&B to total costs of the process for the review of human drug
applications obligated. Since 58.1286 percent was obligated for PC&B as
shown in table 2, 41.8714 percent is the portion of costs other than
PC&B (100 percent minus 58.1286 percent equals 41.8714 percent). The
non-payroll adjustment is 2.3568 percent times 41.8714 percent, or
0.9868 percent.
Next, we add the payroll adjustment (1.0945 percent) to the non-
payroll adjustment (0.9868 percent), for a total inflation adjustment
of 2.0813 percent (rounded) for FY 2015.
PDUFA V provides for this inflation adjustment to be compounded
after FY 2013 (see section 736(c)(1) of the FD&C Act). This factor for
FY 2015 (2.0813 percent) is compounded by adding 1 and then multiplying
by 1 plus the inflation adjustment factor for FY 2014 (2.20 percent),
as published in the Federal Register of August 2, 2013 (78 FR 46980 at
46982), which equals to 1.043271 (rounded) (1.020813 times 1.0220) for
FY 2015. We then multiply the base revenue amount for FY 2015
($718,669,000) by 1.043271, yielding an inflation-adjusted amount of
$749,766,526.
B. FY 2015 Statutory Fee Revenue Adjustments for Workload
The statute specifies that after the $718,669,000 has been adjusted
for inflation, the inflation-adjusted amount shall be further adjusted
for workload (see section 736(c)(2) of the FD&C Act).
To calculate the FY 2015 workload adjustment, 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 3-year period that ended on June 30, 2012 (base
years), and the average number of each of these types of applications
over the most recent 3 year period that ended June 30, 2014.
The calculations are summarized in table 4. The 3-year averages for
each application category are provided in column 1 (``3-Year Average
Base Years 2010-2012'') and column 2 (``3-Year Average 2012-2014'').
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 3 years. Column 5 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. The sum of the values in column 5 is added,
reflecting an increase in workload of 7.49 percent (rounded) for FY
2015 when compared to the base years.
Table 4--Workload Adjuster Calculation for FY 2015
----------------------------------------------------------------------------------------------------------------
3-Year average Percent change Weighting
base years 3-Year average (column 1 to factor Weighted
2010-2012 2012-2014 column 2) (percent) percent change
Application type Column 1 Column 2 Column 3 Column 4 Column 5
----------------------------------------------------------------------------------------------------------------
New Drug Applications/Biologics 124.3 141.3 13.6766 37.3 5.10
License Applications...........
Active Commercial INDs.......... 6830.0 7141.3 4.5578 41.4 1.89
Efficacy Supplements............ 136.3 156.7 14.9670 7.5 1.12
Manufacturing Supplements....... 2548.3 2433.7 -4.4971 13.8 -0.62
-------------------------------------------------------------------------------
FY 2015 Workload Adjuster....... .............. .............. .............. .............. 7.49
----------------------------------------------------------------------------------------------------------------
Table 5 shows the calculation of the revenue amount for FY 2015.
The $718,669,000 subject to adjustment on the first line is multiplied
by the inflation adjustment factor of 1.043271, resulting in the
inflation-adjusted amount on the third line, $749,766,526. That amount
is then multiplied by one plus the workload adjustment of 7.49 percent,
resulting in the inflation and workload adjusted amount of $805,924,000
on the fifth line, rounded to the nearest thousand dollars.
Table 5--PDUFA Revenue Amount for FY 2015, Summary Calculation
------------------------------------------------------------------------
------------------------------------------------------------------------
FY 2013 Revenue Amount and Base $718,669,000 Line 1.
Subsequent FYs as published in the
Federal Register of August 1, 2012
(77 FR 45639) (Rounded to nearest
thousand dollars).
Inflation Adjustment Factor for FY 1.043271 Line 2.
2015 (1 plus 4.3271 percent).
Inflation Adjusted Amount........... $749,766,526 Line 3.
Workload Adjustment Factor for FY 1.0749 Line 4.
2015 (1 plus 7.49 percent).
Inflation and Workload Adjusted $805,924,000 Line 5.
Amount (Rounded to nearest thousand
dollars).
------------------------------------------------------------------------
[[Page 44810]]
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 ($805,924,000), or a
total of $268,641,333, is the amount of fee revenue that will be
derived from each of these fee categories: Application Fees,
Establishment Fees, and Product Fees.
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 $268,641,333 in FY 2015.
B. Estimate of the Number of Fee-Paying Applications and Setting the
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 FY by averaging the number of fee-paying FAEs received in the
3 most recently completed FYs.
In estimating the number of fee-paying 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.
As table 6 shows, the average number of fee-paying FAEs received
annually in the most recent 3-year period is 115.042 FAEs. FDA will set
fees for FY 2015 based on this estimate as the number of full
application equivalents that will pay fees.
Table 6--Fee-Paying FAE 3-Year Average
----------------------------------------------------------------------------------------------------------------
FY 2011 2012 2013 3-Year average
----------------------------------------------------------------------------------------------------------------
Fee-Paying FAEs..................... 108.250 122.375 114.500 115.042
----------------------------------------------------------------------------------------------------------------
The FY 2015 application fee is estimated by dividing the average
number of full applications that paid fees over the latest 3 years,
115.042, into the fee revenue amount to be derived from application
fees in FY 2015, $268,641,333. The result, rounded to the nearest
hundred dollars, is a fee of $2,335,200 per full application requiring
clinical data, and $1,167,600 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 2014, the establishment fee was based on an
estimate that 455 establishments would be subject to and would pay
fees. By the end of FY 2014, FDA estimates that 509 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 20 establishment fee waivers or reductions will be made for FY 2014.
In addition, FDA estimates that another 17 full establishment fees will
be exempted this year based on the orphan drug exemption in section
736(k) of the FD&C Act. Subtracting 37 establishments (20 waivers, plus
the estimated 17 establishments under the orphan exemption) from 509
leaves a net of 472 fee-paying establishments. FDA will use 472 to
estimate the FY 2015 establishments paying fees. The fee per
establishment is determined by dividing the adjusted total fee revenue
to be derived from establishments ($268,641,333) by the estimated 472
establishments, for an establishment fee rate for FY 2015 of $569,200
(rounded to the nearest hundred dollars).
B. Product Fees
At the beginning of FY 2014, the product fee was based on an
estimate that 2,425 products would be subject to and would pay product
fees. By the end of FY 2014, FDA estimates that 2,545 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 69 waivers and reductions granted. In addition, FDA estimates
that another 42 product fees will be exempted this year based on the
orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates
that 2,434 products will qualify for product fees in FY 2014, after
allowing for an estimated 111 waivers and reductions, including the
orphan drug products, and will use this number for its FY 2015
estimate. The FY 2015 product fee rate is determined by dividing the
adjusted total fee revenue to be derived from product fees
($268,641,333) by the estimated 2,434 products for a FY 2015 product
fee of $110,370 (rounded to the nearest ten dollars).
V. Fee Schedule for FY 2015
The fee rates for FY 2015 are set out in table 7:
Table 7--Fee Schedule for FY 2015
------------------------------------------------------------------------
Fee rates for
Fee category FY 2015
------------------------------------------------------------------------
Applications:
Requiring clinical data............................... $2,335,200
Not requiring clinical data........................... 1,167,600
Supplements requiring clinical data................... 1,167,600
Establishments.......................................... 569,200
Products................................................ 110,370
------------------------------------------------------------------------
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 on or after October 1, 2014. 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.)
[[Page 44811]]
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.
Please ask your financial institution about the fee and add it to your
payment to ensure that your fee is fully paid. The account information
for wire transfers 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, 8455 Colesville Rd., 14th Floor, Silver Spring, MD
20993-0002.
Application fees can also be paid online with an electronic check
(ACH). FDA has partnered with the U.S. Department of the Treasury to
use 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 FDA is 53-0196965.
B. Establishment and Product Fees
FDA will issue invoices for establishment and product fees for FY
2015 under the new fee schedule in August 2014. Payment will be due on
October 1, 2014. FDA will issue invoices in November 2015 for any
products and establishments subject to fees for FY 2015 that qualify
for fee assessments after the August 2014 billing.
Dated: July 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18113 Filed 7-31-14; 8:45 am]
BILLING CODE 4164-01-P
