Federal RegisterVol. 63, No. 245Tuesday, December 22, 1998

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Federal RegisterVol. 63, No. 245Tuesday, December 22, 1998 Powered By Docstoc
					                                  Federal Register / Vol. 63, No. 245 / Tuesday, December 22, 1998 / Notices                                                      70777

DEPARTMENT OF HEALTH AND                                              as the agreement between the grantee                     under the Plan Preprint approval for
HUMAN SERVICES                                                        (Indian Tribe or tribal organization) and                both State and Indian Tribes (OMB
                                                                      the Federal government as to how the                     Approval Number 0970–0114). Since
Administration for Children and                                       Block Grant programs will be operated.                   the tribal plan preprint must be revised
Families                                                              The plans provide assurances that the                    to reflect the CCDF amended regulations
                                                                      CCDF funds will be administered in                       (published 7/24/98 at 63 FR 39936–
Proposed Information Collection                                       conformance with legislative
Activity; Comment Request                                                                                                      39998), it is being disaggregated from
                                                                      requirements, Federal regulations at 45                  the State plan preprint approval.
  Proposed Project:                                                   CFR parts 98 and 99 and other                            Therefore, a new collection and OMB
  Title: Child Care and Development                                   applicable instructions or guidelines
                                                                                                                               control number is requested.
Fund Tribal Plan Preprint.                                            issued by the Administration for
  OMB No.: New.                                                       Children and Families (ACF). The Tribal                    Respondents: State, Local or Tribal
  Description: The Child Care and                                     Plan Preprint (ACF Form 118A) is                         Government.
Development Fund Plan Preprint serves                                 currently approved through 5/31/00

                                                                               ANNUAL BURDEN ESTIMATES
                                                                                                                                Number of       Average          Total
                                                                                                                 Number of
                                              Instrument                                                                      responses per   burden hours      burden
                                                                                                                respondents     respondent    per response       hours

CCDF Plan Preprint ..........................................................................................           253              .5             35          4,427
CCDF Plan Amendments .................................................................................                  253              .5              3            380

  Estimated Total Annual Burden                                       DEPARTMENT OF HEALTH AND                                 I. Background
Hours: 4,807.                                                         HUMAN SERVICES                                              The PDUFA (Pub. L. 102–571), as
  In compliance with the requirements                                                                                          amended by the FDAMA (Pub. L. 105–
of Section 3506(c)(2)(A) the Paperwork                                Food and Drug Administration                             115), establishes three different kinds of
Reduction Act of 1995, the                                                                                                     user fees. Fees are assessed on: (1)
Administration for Children and                                       Establishment of Prescription Drug                       Certain types of applications and
Families is soliciting public comment                                 User Fee Rates for Fiscal Year 1999                      supplements for approval of drug and
on the specific aspects of the                                                                                                 biological products, (2) certain
information collection described above.                               AGENCY:       Food and Drug Administration,
                                                                                                                               establishments where such products are
Copies of the proposed collection of                                  HHS.
                                                                                                                               made, and (3) certain products (21
information can be obtained and                                       ACTION:      Notice.                                     U.S.C. 379h(a)). When certain
comments may be forwarded by writing                                                                                           conditions are met, FDA may waive or
to the Administration for Children and                                SUMMARY:   The Food and Drug                             reduce fees (21 U.S.C. 379h(d)).
Families, Office of Information Services,                             Administration (FDA) is announcing the                      For 1998 through 2002, under the
370 L’Enfant Promenade, S.W.,                                         rates for prescription drug user fees for                amendments enacted in the FDAMA,
Washington, D.C. 20447, Attn: ACF                                     fiscal year (FY) 1999. The Prescription                  the application fee rates are set in the
Reports Clearance Officer. All requests                               Drug User Fee Act of 1992 (the PDUFA),                   statute, but are to be adjusted annually
should be identified by the title of the                              as amended by the Food and Drug                          for cumulative inflation since 1997.
information collection.                                               Administration Modernization Act of                      Total application fee revenues are
  The Department specifically requests                                1997 (the FDAMA), authorizes FDA to                      structured to increase or decrease each
comments on: (a) whether the proposed                                 collect user fees for certain applications               year as the number of fee-paying
collection of information is necessary                                for approval of drug and biological                      applications submitted to FDA increases
for the proper performance of the                                                                                              or decreases (workload adjustment).
                                                                      products, on establishments where the
functions of the agency, including                                                                                                For 1998 through 2002, FDA is
                                                                      products are made, and on such                           required to set fee rates for
whether the information shall have                                    products. Fees for applications for FY
practical utility; (b) the accuracy of the                                                                                     establishment and product categories
                                                                      1999 were set by the FDAMA, subject to                   each year, so that the total fee revenue
agency’s estimate of the burden of the                                adjustment for inflation. Total
proposed collection of information; (c)                                                                                        from each of these two categories are
                                                                      application fee revenues fluctuate with                  projected to be equal to the total
the quality,utility, and clarity of the                               the number of fee-paying applications
information to be collected; and (d)                                                                                           revenue FDA expects to collect from
                                                                      FDA receives. Fees for establishments                    application fees that year. This
ways to minimize the burden of the
                                                                      and products are calculated so that total                procedure continues the arrangement
collection of information on
                                                                      revenues from each category will                         under which one-third of the total user
respondents, including through the use
                                                                      approximate FDA’s estimate of the                        fee revenue is projected to come from
of automated collection techniques or
                                                                      revenues to be derived from                              each of the three types of fees--
other forms of information technology.
Consideration will be given to                                        applications.                                            application fees, establishment fees, and
comments and suggestions submitted                                    FOR FURTHER INFORMATION CONTACT:                         product fees.
within 60 days of this publication.                                   Michael E. Roosevelt, Office of                             This notice establishes fee rates for FY
                                                                      Financial Management (HFA–120),                          1999 for application, establishment, and
  Dated: December 15, 1998.                                                                                                    product fees. These fees are retroactive
Bob Sargis,                                                           Food and Drug Administration, 5600
                                                                                                                               to October 1, 1998, and will remain in
Acting Reports Clearance Officer.                                     Fishers Lane, Rockville, MD 20857,
                                                                                                                               effect through September 30, 1999. For
[FR Doc. 98–33792 Filed 12–21–98; 8:45 am]
                                                                                                                               fees already paid on applications and
BILLING CODE 4184–01–M                                                SUPPLEMENTARY INFORMATION:                               supplements submitted on or after
70778                Federal Register / Vol. 63, No. 245 / Tuesday, December 22, 1998 / Notices

October 1, 1998, FDA will bill              A. Inflation Adjustment to Application       B. Estimate of Total Application Fee
applicants for the difference between       Fees                                         Revenue
fees paid and fees due under the new fee                                                    Total application fee revenues for
schedule. For applications and                 Application fees are assessed at
                                            different rates for qualifying               1999 will be determined by the number
supplements submitted after December                                                     of fee-paying applications FDA receives
31, 1998, the new fee schedule must be      applications depending on whether the
                                            applications require clinical data on        in FY 1999 (from October 1, 1998,
used. Invoices for establishment and                                                     through September 30, 1999) multiplied
product fees for FY 1999 will be issued     safety or effectiveness (other than
                                            bioavailability or bioequivalence            by the fee rates calculated in the
in December 1999, using the new fee                                                      preceding paragraph. Before fees can be
schedules.                                  studies) (21 U.S.C. 379h(a)(1)(A) and
                                                                                         set for establishment and product fee
                                            (b)). Applications that require clinical
II. Inflation and Workload Adjustment                                                    categories, each of which are projected
                                            data are subject to the full application
Process                                                                                  to be equal to total revenues FDA
                                            fee. Applications that do not require
                                                                                         collects from application fees, FDA
                                            clinical data and supplements that
   The PDUFA, as amended by the                                                          must first estimate its total 1999
                                            require clinical data are assessed one-
FDAMA, provides that fee rates for each                                                  application fee revenues. To do this
                                            half the fee of applications that require
FY shall be adjusted by notice in the                                                    FDA has traditionally calculated the
                                            clinical data. If FDA refuses to file an
Federal Register. The adjustment must                                                    number of full application fees FDA
                                            application or supplement, 75 percent
reflect the greater of: (1) The total                                                    received in the preceding fiscal year,
                                            of the application fee is refunded to the
percentage change that occurred during                                                   made an allowance for waivers and
                                            applicant (21 U.S.C. 379h(a)(1)(D)).
the preceding FY in the Consumer Price                                                   exemptions, and used that figure as a
Index (CPI), or (2) the total percentage       The application fees described            basis for estimating the next year’s
pay change for that FY for Federal          previously are set out in the FDAMA for      application volume.
                                            1999 ($256,338 for applications                 For FY 1998, FDA received and filed
employees stationed in the Washington,
                                            requiring clinical data, and $128,169 for    101 human drug applications that
DC metropolitan area. The FDAMA
                                            applications not requiring clinical data     require clinical data for approval, 23
provides for this annual adjustment to
                                            or supplements requiring clinical data)      that did not require clinical data for
be cumulative and compounded
                                            (21 U.S.C. 379h(b)(1)), but must be          approval, and 93 supplements to human
annually after 1997 (see 21 U.S.C.
                                            adjusted for cumulative inflation since      drug applications that require clinical
                                            1997. That adjustment each year is to be     data for approval. Because applications
   The FDAMA also structures the total      the greater of: (1) The total percentage     that do not require clinical data and
application fee revenue to increase or      change that occurred during the              supplements that require clinical data
decrease each year as the number of fee-    preceding FY in the CPI (all items; U.S.     are assessed only one-half the full fee,
paying applications submitted to FDA        city average); or (2) the total percentage   the equivalent number of these
increases or decreases. This provision      pay change for that FY for Federal           applications subject to the full fee is
allows revenues to rise or fall as this     employees, as adjusted for any locality-     determined by summing these
portion of FDA’s workload rises or falls.   based payment applicable to employees        categories and dividing by 2. This
To implement this provision each year,      stationed in the District of Columbia.       amount is then added to the number of
FDA will estimate the number of fee-        The FDAMA provides for this annual           applications that require clinical data to
paying applications it anticipates          adjustment to be cumulative and              arrive at the equivalent number of
receiving. The number of applications       compounded annually after 1997 (see 21       applications that may be subject to full
estimated will then be multiplied by the    U.S.C. 379h(c)).                             application fees.
inflation-adjusted statutory application       The adjustment for FY 1998 was 2.45          In addition, as of September 30, 1998,
fee. This calculation will produce the      percent (62 FR 64849, December 9,            FDA assessed fees for three applications
FDA estimate of total application fee       1997). This was the greater of the CPI       that required clinical data, one
revenues to be received.                    increase for FY 1997 (2.15 percent) and      application that did not require clinical
                                            the increase in applicable Federal           data, and one supplement, all of which
   The PDUFA also provides that FDA
                                            salaries (2.45 percent).                     were refused filing or withdrawn before
shall adjust the rates for establishment
                                                                                         filing. After refunds, the full application
and product fees so that the total             The adjustment for FY 1999 is 3.68        paid one-fourth the full application fee
revenues from each of these categories      percent. This is the greater of the CPI      and is counted as one-fourth of an
is projected to equal the revenues FDA      increase for FY 1998 (1.49 percent) and      application, and the application that did
expects to collect from application fees    the increase in applicable Federal           not require clinical data and the
that year. The FDAMA provides that the      salaries (3.68 percent).                     supplement each paid one-eighth of the
new fee rates based on these                   Compounding these amounts (1.0245         full application fee and are each
calculations be adjusted within 60 days     times 1.0368) yields a total compounded      counted as one-eighth of an application.
after the end of each FY (21 U.S.C.         inflation of 6.22 percent for FY 1999.          Using this methodology, the
379h(c)(2)).                                The adjusted application fee rates are       approximate equivalent number of
III. Inflation Adjustment and Estimate      computed by applying the inflation           applications that required clinical data
of Total Application Fee Revenue            percentage for FY 1999 (106.22 percent)      and were subject to fees in FY 1998 was
                                            to the FY 1999 statutory application fee     160, before any exemptions, waivers or
  The FDAMA provides that the               rates stated previously. For FY 1999 the     reductions. Under the FDAMA, FDA
application fee rates set out in the        adjusted application fee rates are           may waive fees for certain small
statute be adjusted each year for           $272,282 for applications requiring          businesses submitting their first
cumulative inflation since 1997. It also    clinical data, and $136,141 for              application and certain orphan products
provides for total application fee          applications not requiring clinical data     are exempted from application fees. In
revenues to increase or decrease based      or supplements requiring clinical data.      addition, the FDAMA excludes from
on increases or decreases in the number     These amounts must be submitted with         fees bulk biological products that are
of fee-paying applications submitted.       all applications during FY 1999.             further manufactured, and provides
                          Federal Register / Vol. 63, No. 245 / Tuesday, December 22, 1998 / Notices                                70779

exceptions for certain supplements for          applications that require clinical data        substantial departure from FDA
pediatric indications. In FY 1998               will qualify for fees in FY 1999, after        experience over the past 5 years. Over
waivers or exemptions applied to 41.5           allowing for exemptions, waivers, or           that period the estimated number of fee-
equivalents of full applications.               reductions.                                    paying applications increased fairly
Therefore, based solely on 1998 data,              This estimate based on the data from        consistently at a rate of about 7 percent
FDA estimates that approximately 118.5          1998 alone predicts a substantial drop         each year, as set out in Table 1 of this
(160 minus 41.5) equivalent                     in applications, and represents a              document.

                                                                  TABLE 1.
                                 Year                                        Estimated Number of Fee-Paying Full Application Equivalents

                                 1993                                                                   116
                                 1994                                                                   124
                                 1995                                                                   131
                                 1996                                                                   141
                                 1997                                                                   169
                                 1998                                                                  118.5

   Since the volume of fee-paying               damping effect on year-to-year fee and           This will mean that our estimated
applications FDA received in 1998               revenue fluctuations and allows for            number of applications will be higher in
represents such a substantial departure         more stability in both fee levels paid by      1998 than it would have been under our
from the trend experienced over the             industry and in agency resource                previous estimating method. It will also
previous 5 years, and since sharp               planning. Under this approach, the             mean that in future years, if there is a
changes produce disruptive volatility in        analysis takes into account the number         sudden rise in application volume, the
both fees and revenues, FDA                     of fee-paying PDUFA submissions each           regression analysis process will dampen
reexamined the process to be used in            year since PDUFA began in 1993,                the effect of such year-to-year increases
estimating the next year’s application          adjusts those numbers conservatively to        as well. We believe that this is a fair and
volume. FDA considered several                  reflect additional exemptions/waivers          reasonable approach, and that it will
different approaches (continuation of           that would have been granted between
                                                                                               insulate fees and revenues from
current method, using a 2- or 3-year            1993 and 1997 if the current law
                                                                                               significant fluctuations that may occur
rolling average, and linear regression)         governing exemptions and waivers had
and chose the linear regression                 been in effect then, and fits the best line    in any single year.
projection method as the best alternative       to those data points. The extension of           Using this approach, a linear
for this estimate.                              that line to the next year estimates the       regression line based on the adjusted
   Linear regression is well suited to          number of submissions for that year.           number of fee-paying full application
situations like this where there are            Beginning now for FY 1999, FDA will            equivalent submissions since 1993
several years of historical data, the           make this annual estimate based on a           projects the receipt of 150 fee-paying
potential exists for shifts from year-to-       linear regression analysis of data on all      full application equivalent submissions
year, and there is no obvious causative         fee-paying full application equivalent         in 1999, as reflected in Table 2 and the
rationale to reasonably predict the year-       submissions from 1993 through the              graphic of this document.
to-year fluctuations. It also provides a        latest year (1998 in this case).

                                                                  TABLE 2.
     Year                 1993           1994              1995               1996             1997             1998              1999

Adjusted Fee-
  Paying Full
  Equivalents            101.0          108.9            112.5               136.3            161.5            118.5
  Line                   103.9          111.6            119.3               127.0            134.6            142.3             150.0

70780                    Federal Register / Vol. 63, No. 245 / Tuesday, December 22, 1998 / Notices

                                     Federal Register / Vol. 63, No. 245 / Tuesday, December 22, 1998 / Notices                                                                                         70781

   The total FY 1999 application fee                                        billed for establishment fees, before all                                    product fees. By the end of FY 1998,
revenue is estimated by multiplying the                                     decisions on requests for waivers or                                         2,279 products qualified and were billed
adjusted application fee rate ($272,282)                                    reductions were made. We estimate that                                       for product fees before all decisions on
by the equivalent number of                                                 a total of 25 establishment fee waivers                                      requests for waivers or reductions were
applications projected to qualify for fees                                  will be granted in 1998, for a net of 318                                    made. Assuming that there will be about
in FY 1999 (150), for a total estimated                                     fee-paying establishments. In FY 1999                                        55 waivers granted, FDA estimates that
application fee revenue in 1999 of                                          fees will be based on an estimate of 318                                     2,224 products will qualify for product
$40,842,300. This is the amount of                                          establishments paying fees after taking                                      fees in FY 1999, after allowing for
revenue that FDA is also expected to                                        waivers into account. The fee per                                            waivers and exemptions. Accordingly,
derive both from establishment fees and                                     establishment is determined by dividing                                      the FY 1999 product fee rate is
from product fees.                                                          the adjusted total fee revenue to be                                         determined by dividing the adjusted
                                                                            derived from establishments                                                  total fee revenue to be derived from
IV. Fee Calculations for Establishment                                      ($40,842,300), by the estimated 318
and Product Fees                                                                                                                                         product fees ($40,842,300) by the
                                                                            establishments, for an establishment fee                                     estimated 2,224 products for a product
A. Establishment Fees                                                       rate for FY 1999 of $128,435 (rounded
                                                                                                                                                         fee rate of $18,364 (rounded to the
                                                                            to the nearest dollar).
  At the beginning of FY 1998 the                                                                                                                        nearest dollar).
establishment fee was based on an                                           B. Product Fees
                                                                                                                                                         V. Adjusted Fee Schedules for FY 1999
estimate of 275 establishments subject                                        At the beginning of FY 1998 the
to fees. By the end of FY 1998, 343                                         product fee was based on an estimate                                           The fee rates for FY 1999 are set out
establishments qualified for and were                                       that 2,100 products would be subject to                                      in Table 3 of this document.

                                                                                                        TABLE 3.
                                                                                Fee Category                                                                                             Fee Rates For FY 1999

    Requiring clinical data ................................................................................................................................................                 $272,282
    Not requiring clinical data ...........................................................................................................................................                  $136,141
    Supplements requiring clinical data ............................................................................................................................                         $136,141
Establishments ...................................................................................................................................................................           $128,435
Products .............................................................................................................................................................................        $18,364

VI. Implementation of Adjusted Fee                                          B. Establishment and Product Fees                                            tribal affiliation, if applicable. These
Schedule                                                                                                                                                 scholarships were awarded under the
                                                                               By December 31, 1998, FDA will issue
                                                                                                                                                         authority of Section 103 and 104 of the
A. Application Fees                                                         invoices for establishments and product
                                                                                                                                                         Indian Health Care Improvement Act, 25
                                                                            fees for FY 1999 under the new fee
  Any application or supplement                                                                                                                          U.S.C. 1613–1613a, as amended by the
                                                                            schedules. Payment will be due by
subject to fees under the PDUFA that is                                                                                                                  Indian Health Care Amendments of
                                                                            January 31, 1999. FDA will issue
submitted after December 31, 1998,                                                                                                                       1988, Pub. L. 100–713.
                                                                            invoices in October 1999 for any                                                The following is a list of Indian
must be accompanied by the
                                                                            products and establishments subject to                                       Health Professions Scholarship
appropriate application fee established
                                                                            fees for FY 1999 that qualify for fees                                       Recipients for Fiscal Year 1998:
in the new fee schedule. Payment must
                                                                            after the December 1998 billing.
be made in United States currency by                                                                                                                     Ables, Millicent Elaine, University of Kansas,
check, bank draft, or U.S. postal money                                       Dated: December 15, 1998.                                                    Choctaw Nation of Oklahoma
order payable to the order of the U.S.                                      William K. Hubbard,                                                          Abold-Arellano, Carol Ann, University of
Food and Drug Administration. Please                                        Associate Commissioner for Policy                                              South Dakota, Oglala Sioux of the Pine
include the user fee ID number on your                                      Coordination.                                                                  Ridge Reservation
check.                                                                      [FR Doc. 98–33831 Filed 12–21–98; 8:45 am]                                   Adair, Roger Willard, Arizona State
                                                                                                                                                           University, Cherokee Nation of Oklahoma
  Your check can be mailed to: Food                                         BILLING CODE 4160–01–F                                                       Adams, Hayley M., University of Alaska/
     and Drug Administration, P.O. Box                                                                                                                     Anchorage, Nenana Native Association, AK
     360909, Pittsburgh, PA 15251–6909.                                                                                                                  Aguilar, Dolores E., Presentation College,
  If checks are to be sent by a courier                                     DEPARTMENT OF HEALTH AND                                                       Cheyenne River Sioux Tribe
     that requests a street address, they                                   HUMAN SERVICES                                                               Akers, Margaret Ann, University of Tulsa,
     can be sent to: Mellon Bank, Three                                                                                                                    Muskogee (Creek) Nation, Oklahoma
     Mellon Bank Center, 27th Floor                                         Indian Health Service                                                        Albert, Corrina D., University of New
                                                                                                                                                           Mexico, Pueblo of Laguna
     (FDA 360909), Pittsburgh, PA                                           List of Recipients of Indian Health                                          Alexander, Andrea Lynn, Oklahoma State
     15259–0001. (Note: This Mellon                                         Scholarship Under the Indian Health                                            University, Seminole Nation of Oklahoma
     Bank Address is for courier                                            Scholarship Program                                                          Alexander, Lisa Kalliah, University of
     delivery only.) Please make sure                                                                                                                      Washington School of Med., Confederated
     that the FDA P.O. Box number (P.O.                                       The regulations governing Indian                                             Tribes of the Grand Ronde
     Box 360909) is on the enclosed                                         Health Care Improvement Act Programs                                         Allery, Crystal Vernelle, Minot State
     check.                                                                 (Pub. L. 94–437) provide a 42 CFR                                              University, Turtle Mountain Band
  FDA will bill applicants who                                              36.334 that the Indian Health Service                                        Allick, Albert P., University of Minnesota
submitted application fees between                                          shall publish annually in the Federal                                          Duluth Med School, Turtle Mountain Band
October 1, 1998, and December 31,                                           Register a list of recipients of Indian                                        of Chippewa
1998, based on the adjusted rate                                            Health Scholarships, including the                                           Allison, Rochelle Jade, University of New
schedule.                                                                   name of each recipient, school and                                             Mexico, Navajo Tribe of AZ, NM, & UT

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