
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document affected by Public Law 107-109 Section 5(a)]
[CITE: 21USC379h]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                              Part C--Fees
 
                    subpart 2--fees relating to drugs
 
Sec. 379h. Authority to assess and use drug fees


(a) Types of fees

    Beginning in fiscal year 1998, the Secretary shall assess and 
collect fees in accordance with this section as follows:

            (1) Human drug application and supplement fee

        (A) In general

            Each person that submits, on or after September 1, 1992, a 
        human drug application or a supplement shall be subject to a fee 
        as follows:
                (i) A fee established in subsection (b) of this section 
            for a human drug application for which clinical data (other 
            than bioavailability or bioequivalence studies) with respect 
            to safety or effectiveness are required for approval.
                (ii) A fee established in subsection (b) of this section 
            for a human drug application for which clinical data with 
            respect to safety or effectiveness are not required or a 
            supplement for which clinical data (other than 
            bioavailability or bioequivalence studies) with respect to 
            safety or effectiveness are required.

        (B) Payment

            The fee required by subparagraph (A) shall be due upon 
        submission of the application or supplement.

        (C) Exception for previously filed application or supplement

            If a human drug application or supplement was submitted by a 
        person that paid the fee for such application or supplement, was 
        accepted for filing, and was not approved or was withdrawn 
        (without a waiver), the submission of a human drug application 
        or a supplement for the same product by the same person (or the 
        person's licensee, assignee, or successor) shall not be subject 
        to a fee under subparagraph (A).

        (D) Refund of fee if application refused for filing

            The Secretary shall refund 75 percent of the fee paid under 
        subparagraph (B) for any application or supplement which is 
        refused for filing.

        (E) Exception for designated orphan drug or indication

            A human drug application for a prescription drug product 
        that has been designated as a drug for a rare disease or 
        condition pursuant to section 360bb of this title shall not be 
        subject to a fee under subparagraph (A), unless the human drug 
        application includes an indication for other than a rare disease 
        or condition. A supplement proposing to include a new indication 
        for a rare disease or condition in a human drug application 
        shall not be subject to a fee under subparagraph (A), if the 
        drug has been designated pursuant to section 360bb of this title 
        as a drug for a rare disease or condition with regard to the 
        indication proposed in such supplement.

        (F) Exception for supplements for pediatric indications

            A supplement to a human drug application proposing to 
        include a new indication for use in pediatric populations shall 
        not be assessed a fee under subparagraph (A).

        (G) Refund of fee if application withdrawn

            If an application or supplement is withdrawn after the 
        application or supplement was filed, the Secretary may refund 
        the fee or a portion of the fee if no substantial work was 
        performed on the application or supplement after the application 
        or supplement was filed. The Secretary shall have the sole 
        discretion to refund a fee or a portion of the fee under this 
        subparagraph. A determination by the Secretary concerning a 
        refund under this paragraph shall not be reviewable.

               (2) Prescription drug establishment fee

        (A) In general

            Except as provided in subparagraph (B), each person that--
                (i) is named as the applicant in a human drug 
            application; and
                (ii) after September 1, 1992, had pending before the 
            Secretary a human drug application or supplement,

        shall be assessed an annual fee established in subsection (b) of 
        this section for each prescription drug establishment listed in 
        its approved human drug application as an establishment that 
        manufactures the prescription drug product named in the 
        application. The annual establishment fee shall be assessed in 
        each fiscal year in which the prescription drug product named in 
        the application is assessed a fee under paragraph (3) unless the 
        prescription drug establishment listed in the application does 
        not engage in the manufacture of the prescription drug product 
        during the fiscal year. The establishment fee shall be payable 
        on or before January 31 of each year. Each such establishment 
        shall be assessed only one fee per establishment, 
        notwithstanding the number of prescription drug products 
        manufactured at the establishment. In the event an establishment 
        is listed in a human drug application by more than one 
        applicant, the establishment fee for the fiscal year shall be 
        divided equally and assessed among the applicants whose 
        prescription drug products are manufactured by the establishment 
        during the fiscal year and assessed product fees under paragraph 
        (3).

        (B) Exception

            If, during the fiscal year, an applicant initiates or causes 
        to be initiated the manufacture of a prescription drug product 
        at an establishment listed in its human drug application--
                (i) that did not manufacture the product in the previous 
            fiscal year; and
                (ii) for which the full establishment fee has been 
            assessed in the fiscal year at a time before manufacture of 
            the prescription drug product was begun;

        the applicant will not be assessed a share of the establishment 
        fee for the fiscal year in which the manufacture of the product 
        began.

                  (3) Prescription drug product fee

        (A) In general

            Except as provided in subparagraph (B), each person--
                (i) who is named as the applicant in a human drug 
            application for a prescription drug product which has been 
            submitted for listing under section 360 of this title, and
                (ii) who, after September 1, 1992, had pending before 
            the Secretary a human drug application or supplement,

        shall pay for each such prescription drug product the annual fee 
        established in subsection (b) of this section. Such fee shall be 
        payable for the fiscal year in which the product is first 
        submitted for listing under section 360 of this title, or is 
        submitted for relisting under section 360 of this title if the 
        product has been withdrawn from listing and relisted. After such 
        fee is paid for that fiscal year, such fee shall be payable on 
        or before January 31 of each year. Such fee shall be paid only 
        once for each product for a fiscal year in which the fee is 
        payable.

        (B) Exception

            The listing of a prescription drug product under section 360 
        of this title shall not require the person who listed such 
        product to pay the fee prescribed by subparagraph (A) if such 
        product is the same product as a product approved under an 
        application filed under section 355(b)(2) or 355(j) of this 
        title, under an abbreviated application filed under section 357 
        of this title (as in effect on the day before November 21, 
        1997), or under an abbreviated new drug application pursuant to 
        regulations in effect prior to the implementation of the Drug 
        Price Competition and Patent Term Restoration Act of 1984.

(b) Fee amounts

    Except as provided in subsections (c), (d), (f), and (g) of this 
section, the fees required under subsection (a) of this section shall be 
determined and assessed as follows:

                 (1) Application and supplement fees

        (A) Full fees

            The application fee under subsection (a)(1)(A)(i) of this 
        section shall be $250,704 in fiscal year 1998, $256,338 in each 
        of fiscal years 1999 and 2000, $267,606 in fiscal year 2001, and 
        $258,451 in fiscal year 2002.

        (B) Other fees

            The fee under subsection (a)(1)(A)(ii) of this section shall 
        be $125,352 in fiscal year 1998, $128,169 in each of fiscal 
        years 1999 and 2000, $133,803 in fiscal year 2001, and $129,226 
        in fiscal year 2002.

            (2) Total fee revenues for establishment fees

        The total fee revenues to be collected in establishment fees 
    under subsection (a)(2) of this section shall be $35,600,000 in 
    fiscal year 1998, $36,400,000 in each of fiscal years 1999 and 2000, 
    $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal year 
    2002.

               (3) Total fee revenues for product fees

        The total fee revenues to be collected in product fees under 
    subsection (a)(3) of this section in a fiscal year shall be equal to 
    the total fee revenues collected in establishment fees under 
    subsection (a)(2) of this section in that fiscal year.

(c) Adjustments

                      (1) Inflation adjustment

        The fees and total fee revenues established in subsection (b) of 
    this section shall be adjusted by the Secretary by notice, published 
    in the Federal Register, for a fiscal year to reflect the greater 
    of--
            (A) the total percentage change that occurred during the 
        preceding fiscal year in the Consumer Price Index for all urban 
        consumers (all items; U.S. city average), or
            (B) the total percentage change for such fiscal year in 
        basic pay under the General Schedule in accordance with section 
        5332 of title 5, as adjusted by any locality-based comparability 
        payment pursuant to section 5304 of such title for Federal 
        employees stationed in the District of Columbia.

    The adjustment made each fiscal year by this subsection will be 
    added on a compounded basis to the sum of all adjustments made each 
    fiscal year after fiscal year 1997 under this subsection.

                      (2) Annual fee adjustment

        Subject to the amount appropriated for a fiscal year under 
    subsection (g) of this section, the Secretary shall, within 60 days 
    after the end of each fiscal year beginning after September 30, 
    1997, adjust the establishment and product fees described in 
    subsection (b) of this section for the fiscal year in which the 
    adjustment occurs so that the revenues collected from each of the 
    categories of fees described in paragraphs (2) and (3) of subsection 
    (b) of this section shall be set to be equal to the revenues 
    collected from the category of application and supplement fees 
    described in paragraph (1) of subsection (b) of this section.

                              (3) Limit

        The total amount of fees charged, as adjusted under this 
    subsection, for a fiscal year may not exceed the total costs for 
    such fiscal year for the resources allocated for the process for the 
    review of human drug applications.

(d) Fee waiver or reduction

                           (1) In general

        The Secretary shall grant a waiver from or a reduction of one or 
    more fees assessed under subsection (a) of this section where the 
    Secretary finds that--
            (A) such waiver or reduction is necessary to protect the 
        public health,
            (B) the assessment of the fee would present a significant 
        barrier to innovation because of limited resources available to 
        such person or other circumstances,
            (C) the fees to be paid by such person will exceed the 
        anticipated present and future costs incurred by the Secretary 
        in conducting the process for the review of human drug 
        applications for such person,
            (D) assessment of the fee for an application or a supplement 
        filed under section 355(b)(1) of this title pertaining to a drug 
        containing an active ingredient would be inequitable because an 
        application for a product containing the same active ingredient 
        filed by another person under section 355(b)(2) of this title 
        could not be assessed fees under subsection (a)(1) of this 
        section, or
            (E) the applicant involved is a small business submitting 
        its first human drug application to the Secretary for review.

                      (2) Use of standard costs

        In making the finding in paragraph (1)(C), the Secretary may use 
    standard costs.

               (3) Rules relating to small businesses

        (A) ``Small business'' defined

            In paragraph (1)(E), the term ``small business'' means an 
        entity that has fewer than 500 employees, including employees of 
        affiliates.

        (B) Waiver of application fee

            The Secretary shall waive under paragraph (1)(E) the 
        application fee for the first human drug application that a 
        small business or its affiliate submits to the Secretary for 
        review. After a small business or its affiliate is granted such 
        a waiver, the small business or its affiliate shall pay--
                (i) application fees for all subsequent human drug 
            applications submitted to the Secretary for review in the 
            same manner as an entity that does not qualify as a small 
            business; and
                (ii) all supplement fees for all supplements to human 
            drug applications submitted to the Secretary for review in 
            the same manner as an entity that does not qualify as a 
            small business.

(e) Effect of failure to pay fees

    A human drug application or supplement submitted by a person subject 
to fees under subsection (a) of this section shall be considered 
incomplete and shall not be accepted for filing by the Secretary until 
all fees owed by such person have been paid.

(f) Assessment of fees

                           (1) Limitation

        Fees may not be assessed under subsection (a) of this section 
    for a fiscal year beginning after fiscal year 1997 unless 
    appropriations for salaries and expenses of the Food and Drug 
    Administration for such fiscal year (excluding the amount of fees 
    appropriated for such fiscal year) are equal to or greater than the 
    amount of appropriations for the salaries and expenses of the Food 
    and Drug Administration for the fiscal year 1997 (excluding the 
    amount of fees appropriated for such fiscal year) multiplied by the 
    adjustment factor applicable to the fiscal year involved.

                            (2) Authority

        If the Secretary does not assess fees under subsection (a) of 
    this section during any portion of a fiscal year because of 
    paragraph (1) and if at a later date in such fiscal year the 
    Secretary may assess such fees, the Secretary may assess and collect 
    such fees, without any modification in the rate, for human drug 
    applications and supplements, prescription drug establishments, and 
    prescription drug products at any time in such fiscal year 
    notwithstanding the provisions of subsection (a) of this section 
    relating to the date fees are to be paid.

(g) Crediting and availability of fees

                           (1) In general

        Fees collected for a fiscal year pursuant to subsection (a) of 
    this section shall be credited to the appropriation account for 
    salaries and expenses of the Food and Drug Administration and shall 
    be available in accordance with appropriation Acts until expended 
    without fiscal year limitation. Such sums as may be necessary may be 
    transferred from the Food and Drug Administration salaries and 
    expenses appropriation account without fiscal year limitation to 
    such appropriation account for salaries and expenses with such 
    fiscal year limitation. The sums transferred shall be available 
    solely for the process for the review of human drug applications.

               (2) Collections and appropriation acts

        The fees authorized by this section--
            (A) shall be collected in each fiscal year in an amount 
        equal to the amount specified in appropriation Acts, or 
        otherwise made available for obligation, for such fiscal year, 
        and
            (B) shall only be collected and available to defray 
        increases in the costs of the resources allocated for the 
        process for the review of human drug applications (including 
        increases in such costs for an additional number of full-time 
        equivalent positions in the Department of Health and Human 
        Services to be engaged in such process) over such costs, 
        excluding costs paid from fees collected under this section, for 
        fiscal year 1997 multiplied by the adjustment factor.

                 (3) Authorization of appropriations

        There are authorized to be appropriated for fees under this 
    section--
            (A) $106,800,000 for fiscal year 1998;
            (B) $109,200,000 for fiscal year 1999;
            (C) $109,200,000 for fiscal year 2000;
            (D) $114,000,000 for fiscal year 2001; and
            (E) $110,100,000 for fiscal year 2002,

    as adjusted to reflect adjustments in the total fee revenues made 
    under this section and changes in the total amounts collected by 
    application, supplement, establishment, and product fees.

                             (4) Offset

        Any amount of fees collected for a fiscal year under this 
    section that exceeds the amount of fees specified in appropriation 
    Acts for such fiscal year shall be credited to the appropriation 
    account of the Food and Drug Administration as provided in paragraph 
    (1), and shall be subtracted from the amount of fees that would 
    otherwise be authorized to be collected under this section pursuant 
    to appropriation Acts for a subsequent fiscal year.

(h) Collection of unpaid fees

    In any case where the Secretary does not receive payment of a fee 
assessed under subsection (a) of this section within 30 days after it is 
due, such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, and refunds

    To qualify for consideration for a waiver or reduction under 
subsection (d) of this section, or for a refund of any fee collected in 
accordance with subsection (a) of this section, a person shall submit to 
the Secretary a written request for such waiver, reduction, or refund 
not later than 180 days after such fee is due.

(j) Construction

    This section may not be construed to require that the number of 
full-time equivalent positions in the Department of Health and Human 
Services, for officers, employers, and advisory committees not engaged 
in the process of the review of human drug applications, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.

(June 25, 1938, ch. 675, Sec. 736, as added Pub. L. 102-571, title I, 
Sec. 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105-115, title 
I, Sec. 103(a)-(g), Nov. 21, 1997, 111 Stat. 2299-2304.)

                          Amendment of Section

        For termination of amendment by section 107 of Pub. L. 105-115, 
    see Effective and Termination Dates of 1997 Amendment note below.

                         Termination of Section

        For termination of section by section 105 of Pub. L. 102-571, 
    see Termination Date note below.

                       References in Text

    Section 357 of this title, referred to in subsec. (a)(3)(B), was 
repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21, 1997, 111 
Stat. 2325.
    The Drug Price Competition and Patent Term Restoration Act of 1984, 
referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept. 24, 1984, 98 
Stat. 1585. For complete classification of this Act to the Code, see 
Short Title of 1984 Amendment note set out under section 301 of this 
title and Tables.


                               Amendments

    1997--Subsec. (a). Pub. L. 105-115, Secs. 103(a)(1), 107, 
temporarily substituted ``Beginning in fiscal year 1998'' for 
``Beginning in fiscal year 1993'' in introductory provisions. See 
Effective and Termination Dates of 1997 Amendment note below.
    Subsec. (a)(1)(B). Pub. L. 105-115, Secs. 103(a)(2)(A), 107, 
temporarily amended heading and text of subpar. (B) generally. Prior to 
amendment, text read as follows:
    ``(i) First payment.--50 percent of the fee required by subparagraph 
(A) shall be due upon submission of the application or supplement.
    ``(ii) Final payment.--The remaining 50 percent of the fee required 
by subparagraph (A) shall be due upon--
        ``(I) the expiration of 30 days from the date the Secretary 
    sends to the applicant a letter designated by the Secretary as an 
    action letter described in section 379g(6)(B) of this title, or
        ``(II) the withdrawal of the application or supplement after it 
    is filed unless the Secretary waives the fee or a portion of the fee 
    because no substantial work was performed on such application or 
    supplement after it was filed.
The designation under subclause (I) or the waiver under subclause (II) 
shall be solely in the discretion of the Secretary and shall not be 
reviewable.'' See Effective and Termination Dates of 1997 Amendment note 
below.
    Subsec. (a)(1)(D). Pub. L. 105-115, Secs. 103(a)(2)(B), 107, 
temporarily substituted ``refused'' for ``not accepted'' in heading and 
``75 percent'' for ``50 percent'', ``subparagraph (B)'' for 
``subparagraph (B)(i)'', and ``refused'' for ``not accepted'' in text. 
See Effective and Termination Dates of 1997 Amendment note below.
    Subsec. (a)(1)(E) to (G). Pub. L. 105-115, Secs. 103(a)(2)(C), 107, 
temporarily added subpars. (E) to (G). See Effective and Termination 
Dates of 1997 Amendment note below.
    Subsec. (a)(2). Pub. L. 105-115, Secs. 103(a)(3), 107, temporarily 
reenacted heading without change and amended text generally. Prior to 
amendment, text read as follows: ``Each person that--
        ``(A) owns a prescription drug establishment, at which is 
    manufactured at least 1 prescription drug product which is not the, 
    or not the same as a, product approved under an application filed 
    under section 355(b)(2) or 355(j) of this title, and
        ``(B) after September 1, 1992, had pending before the Secretary 
    a human drug application or supplement,
shall be subject to the annual fee established in subsection (b) of this 
section for each such establishment, payable on or before January 31 of 
each year.'' See Effective and Termination Dates of 1997 Amendment note 
below.
    Subsec. (a)(3)(A). Pub. L. 105-115, Secs. 103(a)(4)(A), 107, 
temporarily substituted, in cl. (i), ``has been submitted for listing'' 
for ``is listed'' and, in closing provisions, ``Such fee shall be 
payable for the fiscal year in which the product is first submitted for 
listing under section 360 of this title, or is submitted for relisting 
under section 360 of this title if the product has been withdrawn from 
listing and relisted. After such fee is paid for that fiscal year, such 
fee shall be payable on or before January 31 of each year. Such fee 
shall be paid only once for each product for a fiscal year in which the 
fee is payable.'' for ``Such fee shall be payable at the time of the 
first such listing of such product in each calendar year. Such fee shall 
be paid only once each year for each listed prescription drug product 
irrespective of the number of times such product is listed under section 
360 of this title.'' See Effective and Termination Dates of 1997 
Amendment note below.
    Subsec. (a)(3)(B). Pub. L. 105-115, Secs. 103(a)(4)(B), 107, 
temporarily substituted ``355(j) of this title, under an abbreviated 
application filed under section 357 of this title (as in effect on the 
day before November 21, 1997), or under an abbreviated new drug 
application pursuant to regulations in effect prior to the 
implementation of the Drug Price Competition and Patent Term Restoration 
Act of 1984.'' for ``355(j) of this title.''. See Effective and 
Termination Dates of 1997 Amendment note below.
    Subsec. (b). Pub. L. 105-115, Secs. 103(b), 107, temporarily amended 
subsec. (b) generally. Prior to amendment, subsec. (b) related to fee 
amounts, including a schedule of fees in par. (1) and fee exceptions for 
certain small businesses in par. (2). See Effective and Termination 
Dates of 1997 Amendment note below.
    Subsec. (c). Pub. L. 105-115, Secs. 103(c)(1), 107, temporarily 
substituted ``Adjustments'' for ``Increases and adjustments'' in 
heading. See Effective and Termination Dates of 1997 Amendment note 
below.
    Subsec. (c)(1). Pub. L. 105-115, Secs. 103(c)(2), 107, temporarily 
substituted ``Inflation adjustment'' for ``Revenue increase'' in 
heading, ``The fees and total fee revenues established in subsection (b) 
of this section shall be adjusted by the Secretary'' for ``The total fee 
revenues established by the schedule in subsection (b)(1) of this 
section shall be increased by the Secretary'' in introductory 
provisions, and ``change'' for ``increase'' after ``total percentage'' 
in subpars. (A) and (B), and inserted at end ``The adjustment made each 
fiscal year by this subsection will be added on a compounded basis to 
the sum of all adjustments made each fiscal year after fiscal year 1997 
under this subsection.'' See Effective and Termination Dates of 1997 
Amendment note below.
    Subsec. (c)(2). Pub. L. 105-115, Secs. 103(c)(3), 107, temporarily 
substituted ``September 30, 1997, adjust the establishment and product 
fees described in subsection (b) of this section for the fiscal year in 
which the adjustment occurs so that the revenues collected from each of 
the categories of fees described in paragraphs (2) and (3) of subsection 
(b) of this section shall be set to be equal to the revenues collected 
from the category of application and supplement fees described in 
paragraph (1) of subsection (b) of this section.'' for ``October 1, 
1992, adjust the fees established by the schedule in subsection (b)(1) 
of this section for the following fiscal year to achieve the total fee 
revenues, as may be increased under paragraph (1). Such fees shall be 
adjusted under this paragraph to maintain the proportions established in 
such schedule.'' See Effective and Termination Dates of 1997 Amendment 
note below.
    Subsec. (c)(3). Pub. L. 105-115, Secs. 103(c)(4), 107, temporarily 
substituted ``this subsection'' for ``paragraph (2)''. See Effective and 
Termination Dates of 1997 Amendment note below.
    Subsec. (d). Pub. L. 105-115, Secs. 103(d), 107, temporarily struck 
out introductory provisions which read ``The Secretary shall grant a 
waiver from or a reduction of 1 or more fees under subsection (a) of 
this section where the Secretary finds that--'' and closing provisions 
which read ``In making the finding in paragraph (3), the Secretary may 
use standard costs.'', inserted designation, heading, and introductory 
provisions of par. (1), redesignated former pars. (1) to (4) as subpars. 
(A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and 
(3). See Effective and Termination Dates of 1997 Amendment note below.
    Subsec. (f)(1). Pub. L. 105-115, Secs. 103(e), 107, temporarily 
substituted ``fiscal year 1997'' for ``fiscal year 1993'' and ``fiscal 
year 1997 (excluding the amount of fees appropriated for such fiscal 
year)'' for ``fiscal year 1992''. See Effective and Termination Dates of 
1997 Amendment note below.
    Subsec. (g)(1). Pub. L. 105-115, Secs. 103(f)(1), 107, temporarily 
inserted at end ``Such sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and expenses appropriation 
account without fiscal year limitation to such appropriation account for 
salaries and expenses with such fiscal year limitation. The sums 
transferred shall be available solely for the process for the review of 
human drug applications.'' See Effective and Termination Dates of 1997 
Amendment note below.
    Subsec. (g)(2)(A). Pub. L. 105-115, Secs. 103(f)(2)(A), 107, 
temporarily substituted ``Acts, or otherwise made available for 
obligation,'' for ``Acts''. See Effective and Termination Dates of 1997 
Amendment note below.
    Subsec. (g)(2)(B). Pub. L. 105-115, Secs. 103(f)(2)(B), 107, 
temporarily substituted ``over such costs, excluding costs paid from 
fees collected under this section, for fiscal year 1997'' for ``over 
such costs for fiscal year 1992''. See Effective and Termination Dates 
of 1997 Amendment note below.
    Subsec. (g)(3), (4). Pub. L. 105-115, Secs. 103(f)(3), 107, 
temporarily added pars. (3) and (4) and struck out heading and text of 
former par. (3). Text read as follows: ``There are authorized to be 
appropriated for fees under this section--
        ``(A) $36,000,000 for fiscal year 1993,
        ``(B) $54,000,000 for fiscal year 1994,
        ``(C) $75,000,000 for fiscal year 1995,
        ``(D) $78,000,000 for fiscal year 1996, and
        ``(E) $84,000,000 for fiscal year 1997,
as adjusted to reflect increases in the total fee revenues made under 
subsection (c)(1) of this section.'' See Effective and Termination Dates 
of 1997 Amendment note below.
    Subsecs. (i), (j). Pub. L. 105-115, Secs. 103(g), 107, temporarily 
added subsec. (i) and redesignated former subsec. (i) as (j). See 
Effective and Termination Dates of 1997 Amendment note below.


            Effective and Termination Dates of 1997 Amendment

    Amendment by Pub. L. 105-115 effective Oct. 1, 1997, and ceases to 
be effective Oct. 1, 2002, see sections 106 and 107 of Pub. L. 105-115, 
set out as notes under section 379g of this title.


                            Termination Date

    Section not in effect after Oct. 1, 1997, see section 105 of Pub. L. 
102-571, set out as a note under section 379g of this title.


                  Special Rule for Waivers and Refunds

    Section 103(h) of Pub. L. 105-115 provided that: ``Any requests for 
waivers or refunds for fees assessed under section 736 of the Federal 
Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of 
enactment of this Act [Nov. 21, 1997] shall be submitted in writing to 
the Secretary of Health and Human Services within 1 year after the date 
of enactment of this Act. Any requests for waivers or refunds pertaining 
to a fee for a human drug application or supplement accepted for filing 
prior to October 1, 1997 or to a product or establishment fee required 
by such Act for a fiscal year prior to fiscal year 1998, shall be 
evaluated according to the terms of the Prescription Drug User Fee Act 
of 1992 [see section 101(a) of Pub. L. 102-571, set out as a Short Title 
of 1992 Amendment note under section 301 of this title] (as in effect on 
September 30, 1997) and part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] (as in 
effect on September 30, 1997). The term ``person'' in such Acts shall 
continue to include an affiliate thereof.''

                  Section Referred to in Other Sections

    This section is referred to in sections 356, 379g of this title; 
title 42 section 282.
