[Federal Register Volume 60, Number 231 (Friday, December 1, 1995)]
[Notices]
[Pages 61702-61704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29420]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES-
Food and Drug Administration-
Establishment Prescription Drug User Fee Revenues and Rates
Fiscal Year 1996
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is establishing user fee revenues and rates for Fiscal Year (FY) 1996.
The Prescription Drug User Fee Act of 1992 (the PDUFA) 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 marketed products. Fees for applications, establishments, and
products for FY 1993 were established by the PDUFA. Fees for future
years are to be determined by FDA using criteria delineated in the
statute.
FOR FURTHER INFORMATION CONTACT: Michael E. Roosevelt, Office of
Financial Management (HFA-120), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4872.
SUPPLEMENTARY INFORMATION:
I. Background
The PDUFA (Pub. L. 102-571) establishes three different kinds of
user fees. Fees are assessed on: (1) Certain types of applications and
supplements for approval of drug and biologic products, (2) certain
establishments where such products are made, and (3) certain marketed
products (21 U.S.C. 379h(a))). When certain conditions are met, FDA may
waive or reduce fees (21 U.S.C. 379h(d)). Under the PDUFA, one-third of
the total user fee revenue for each FY must come from each of the three
types of fees.
For FY 1993, the total revenues to be derived from fees and the fee
rates for each of the categories were established in the PDUFA (21
U.S.C. 379h(b)(1)). For FY 1994 through 1997, however, the PDUFA
establishes only target total fee revenues and fees. For these years,
FDA is authorized to increase the total fee revenues and to establish
new fee rates for each of the three categories so that the revised
total fee revenues are realized (21 U.S.C. 379h(c)).
This notice establishes total fee rates for FY 1996. These fees are
retroactive to October 1, 1995, and will remain in effect through
September 30, 1996. For fees already paid on applications and
[[Page 61703]]
supplements submitted on or after October 1, 1995, FDA will refund
applicants for the difference between fees paid and fees due under the
new fee schedules. For applications and supplements submitted after
December 31, 1995, the new fee schedule should be used. Invoices for
establishment and product fees for FY 1996 will be issued in December
1995, using the new fee schedules.
I. Revenue Increase and Fee Adjustment Process
The PDUFA provides that total fee revenues for each FY, as set out
in the original fee schedule (see 21 U.S.C. 379h(b)(1)), shall be
increased by notice in the Federal Register. The increase must reflect
the greater of : (1) The total percentage increase that occurred during
the FY in the Consumer Price Index (the CPI) (all items; U.S. city
average), or (2) the total percentage pay increase for that FY for
Federal employees, as adjusted for any locality-based payment
applicable to employees stationed in the District of Columbia (see 21
U.S.C. 379h(c)(1)). The PDUFA also provides that within 60 days after
the end of each FY, FDA shall adjust the user fee rates in each of the
three categories of fees (application, establishment, and product) to
achieve the revised total fee revenues. The new individual user fees
must be adjusted in a manner that maintains the proportions established
in the original fee schedules, so that approximately one-third of the
revenues will come each from applications, establishments, and product
fees (21 U.S.C. 379h(c)(2)).
III. Total Fee Revenue Adjustment
For FY 1995, the total percentage increase in the CPI was 2.54
percent, whereas the increase in applicable Federal salaries for FY
1996 is 2.54 percent. Thus, for computing the total fee revenues for FY
1996, the percentage is 2.54. The new adjusted total fee revenue is
computed by applying the increase as a percentage (102.54 percent) to
the FY 1996 target fee revenue amount from the PDUFA schedule ($78
million). The FY 1996 total adjusted fee revenue amount then totals
$79,981,200.
IV. Fee Calculations for Application, Establishment, and Product
Fees
The PDUFA provides that in making adjustments to the user fee
rates, the one-third proportionality must be maintained among
application, product, and establishment fees. Thus, the amount of
revenues to be obtained from each category are $26,660,400 ($79,981,200
divided by 3).
A. Application Fees
Application fees are assessed on each ``human drug application,''
as defined in the PDUFA (see 21 U.S.C. 379g(1)). Application fees are
levied for: (1) Review of certain new drug applications submitted after
September 1, 1992, under section 505(b)(1) of the act (21 U.S.C.
355(b)(1)); (2) for review of an application for certain molecular
entities or indications for use submitted after September 30, 1992,
under section 505(b)(2) of the act; (3) review of applications for
initial certifications or approvals of antibiotic drugs submitted after
September 1, 1992, under section 507 of the act (21 U.S.C. 357); and
(4) for review of applications for licensure of certain biological
products under the Public Health Service Act (42 U.S.C. 262).
Fees are assessed at different rates for qualifying applications
depending on whether the applications require clinical data on safety
and effectiveness (other than bioavailability or bioequivalence
studies) (21 U.S.C. 379h(a)(1)(A) and 379h(b)). Applications that
require clinical data are subject to the full application fee.
Applications that do not require clinical data and supplements that
require clinical data are assessed one-half the fee of applications
with clinical data.
In most cases, a first payment of 50 percent of an application or
supplement fee is due at the time the application or supplement is
submitted (21 U.S.C. 379h(a)(1)(B)(i)). The final payment is due 30
days from the date FDA issues an invoice after issuance of an action
letter for the application (see 21 U.S.C. 379g(6)(B)), or at the time
an application is withdrawn, unless FDA waives this portion of the fee
(21 U.S.C. 379h(a)(1)(A)(ii)). If FDA refuses to file an application or
supplement, one-half of the first payment is refunded to the applicant
(21 U.S.C. 379h(a)(1)(D)).
In setting the specific rate for each type of fee, FDA is required
to estimate the numbers of applications, supplements, establishments,
and products that it expects will qualify for fees in FY 1996. FDA
makes this estimate based on the number of products, establishments, or
applications subject to fees in FY 1995.
For FY 1995, FDA received and assessed fees for 87 filed
applications that require clinical data, 36 applications that did not
require clinical data, and 62 supplements that require clinical data.
Because applications that do not require clinical data and supplements
that require clinical data are assessed only one-half the full fee
(that is, one-half the fee due on an application that requires clinical
data), the equivalent number of these applications subject to the full
fee is determined by summing these categories and dividing by 2. This
amount is then added to the number of applications that require
clinical data to arrive at the equivalent number of applications
subject to full application fees.
In addition, as of September 30, 1995, FDA refused to file, or
there were withdrawn before filing, two applications that required
clinical data, and four applications that did not require clinical
data. After refunds, each of the former applications paid one-fourth
the full application fee and are counted as one-fourth of an
application. Similarly, after refunds, each of the latter applications
paid one-eighth of the full application fee rate and are counted as
one-eighth of an application.
Using this methodology, the approximate equivalent number of
applications that required clinical data and were assessed fees in FY
1995 was 137, before any further decisions were made on requests for
waivers or reductions. Additional waivers or reductions of FY 1995 fees
are expected to account for approximately 6 equivalents of applications
that require clinical data. Therefore, FDA estimates that approximately
131 equivalent applications that require clinical data will qualify for
fees in FY 1996, after allowing for possible waivers or reductions.
Thus, the FY 1996 application fee rate is determined by dividing the
adjusted total fee revenue to be derived from applications
($26,660,400) by the equivalent number of applications projected to
qualify for fees in FY 1996 (131), for a fee of $204,000 per
application that requires clinical data (rounded to the nearest
$1,000). A fee of one-half this amount or $102,000 applies to
applications that do not require clinical data and to supplements that
require clinical data. The following calculations summarize the
determination of FY 1996 application fee rates:
87 applications that require clinical data, +
(362) applications that do not require clinical data, +
(622) supplements that require clinical data, + (24)
applications that require clinical data and which FDA refuses to file
or the sponsor withdraws before filing, + (48) other
applications that FDA refuses to file or the sponsor withdraws before
filing minus 6 waivers or reductions = 131 (the estimated number of
``full fee'' applications for FY 1996 based on FY 1995 experience).
$26,660,400 (FY 1996 estimated revenue to be derived from
applications)
[[Page 61704]]
131 (the estimated number of applications for FY 1996) =
$204,000 per application (rounded to the nearest $1,000).
For applications that do not require clinical data and
supplements that require clinical data, the rate will be one-half the
full application fee or $102,000.
B. Establishment Fees
The FY 1995 establishment fee was based on an estimate of 200
establishments subject to fees. In FY 1995, 203 establishments
qualified for fees before any decisions on requests for waivers or
reductions were made. FDA estimates that approximately 197
establishments will qualify for fees in FY 1996 after allowing for
possible waivers or reductions. Thus, the number 197 was used in
setting the new establishment fee rate. The fee per establishment is
determined by dividing the adjusted total fee revenue to be derived
from establishments ($26,660,400), by the estimated 197 establishments,
for an establishment fee rate for FY 1996 of $135,300 (rounded to the
nearest $100).
C. Product Fees
The FY 1995 product fee was based on an estimate that 2,116
products would be subject to product fees in FY 1995. For FY 1995,
2,135 products qualified for fees before any decisions on requests for
waivers or reductions were made. However, FDA estimates that only 2,115
products will qualify for product fees in FY 1996, after allowing for
estimated waivers or reductions. Accordingly, the FY 1996 product fee
rate was determined by dividing the adjusted total fee revenue to be
derived from product fees ($26,660,400) by the estimated 2,115 products
for a product fee rate of $12,600 (rounded to the nearest $100).
V. Adjusted Fee Schedules for FY 1996
The fee rates for FY 1996 are set out in the following table:
------------------------------------------------------------------------
Fee rates for FY
Fee category 1996
------------------------------------------------------------------------
Applications..........................................
Requiring clinical data $204,000
Not requiring clinical data 102,000
Supplements requiring clinical data 102,000
Establishments........................................ 135,300
Products.............................................. 12,600
------------------------------------------------------------------------
VI. Implementation of Adjusted Fee Schedule
A. Application Fees
Any application or supplement subject to fees under the PDUFA that
is submitted after December 31, 1995, must be accompanied by the
appropriate application fee established in the new fee schedule. FDA
will refund applicants who submitted application fees between October
1, 1995, and December 31, 1995, based on the adjusted rate schedule.
B. Establishment and Product Fees
By December 31, 1995, FDA will issue invoices for establishments
and product fees for FY 1996 under the new fee schedules. Payment will
be due by January 31, 1996. FDA will issue invoices in October 1996 for
any products and establishments subject to fees for FY 1996 that
qualify for fees after the December 1995 billing.
Dated: November 28, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-29420 Filed 11-29-95; 11:13 am]
BILLING CODE 4160-01-F
