
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC379g]

 
                        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. 379g. Definitions

    For purposes of this part:
        (1) The term ``human drug application'' means an application 
    for--
            (A) approval of a new drug submitted under section 355(b)(1) 
        of this title,
            (B) approval of a new drug submitted under section 355(b)(2) 
        of this title after September 30, 1992, which requests approval 
        of--
                (i) a molecular entity which is an active ingredient 
            (including any salt or ester of an active ingredient), or
                (ii) an indication for a use,

        that had not been approved under an application submitted under 
        section 355(b) of this title, or
            (C) licensure of a biological product under section 262 of 
        title 42.

    Such term does not include a supplement to such an application, does 
    not include an application with respect to whole blood or a blood 
    component for transfusion, does not include an application with 
    respect to a bovine blood product for topical application licensed 
    before September 1, 1992, an allergenic extract product, or an in 
    vitro diagnostic biologic product licensed under section 262 of 
    title 42, does not include an application with respect to a large 
    volume parenteral drug product approved before September 1, 1992, 
    does not include an application for a licensure of a biological 
    product for further manufacturing use only, and does not include an 
    application or supplement submitted by a State or Federal Government 
    entity for a drug that is not distributed commercially. Such term 
    does include an application for licensure, as described in 
    subparagraph (D), of a large volume biological product intended for 
    single dose injection for intravenous use or infusion.
        (2) The term ``supplement'' means a request to the Secretary to 
    approve a change in a human drug application which has been 
    approved.
        (3) The term ``prescription drug product'' means a specific 
    strength or potency of a drug in final dosage form--
            (A) for which a human drug application has been approved, 
        and
            (B) which may be dispensed only under prescription pursuant 
        to section 353(b) of this title.

    Such term does not include whole blood or a blood component for 
    transfusion, does not include a bovine blood product for topical 
    application licensed before September 1, 1992, an allergenic extract 
    product, or an in vitro diagnostic biologic product licensed under 
    section 262 of title 42, does not include a large volume parenteral 
    drug product approved before September 1, 1992, does not include a 
    biological product that is licensed for further manufacturing use 
    only, and does not include a drug that is not distributed 
    commercially and is the subject of an application or supplement 
    submitted by a State or Federal Government entity. Such term does 
    include a large volume biological product intended for single dose 
    injection for intravenous use or infusion.
        (4) The term ``final dosage form'' means, with respect to a 
    prescription drug product, a finished dosage form which is approved 
    for administration to a patient without substantial further 
    manufacturing.
        (5) The term ``prescription drug establishment'' means a foreign 
    or domestic place of business which is at one general physical 
    location consisting of one or more buildings all of which are within 
    five miles of each other and at which one or more prescription drug 
    products are manufactured in final dosage form. For purposes of this 
    paragraph, the term ``manufactured'' does not include packaging.
        (6) The term ``process for the review of human drug 
    applications'' means the following activities of the Secretary with 
    respect to the review of human drug applications and supplements:
            (A) The activities necessary for the review of human drug 
        applications and supplements.
            (B) The issuance of action letters which approve human drug 
        applications or which set forth in detail the specific 
        deficiencies in such applications and, where appropriate, the 
        actions necessary to place such applications in condition for 
        approval.
            (C) The inspection of prescription drug establishments and 
        other facilities undertaken as part of the Secretary's review of 
        pending human drug applications and supplements.
            (D) Activities necessary for the review of applications for 
        licensure of establishments subject to section 262 of title 42 
        and for the release of lots of biologics under such section.
            (E) Monitoring of research conducted in connection with the 
        review of human drug applications.

        (7) The term ``costs of resources allocated for the process for 
    the review of human drug applications'' means the expenses incurred 
    in connection with the process for the review of human drug 
    applications for--
            (A) officers and employees of the Food and Drug 
        Administration, contractors of the Food and Drug Administration, 
        advisory committees, and costs related to such officers, 
        employees, and committees and to contracts with such 
        contractors,
            (B) management of information, and the acquisition, 
        maintenance, and repair of computer resources,
            (C) leasing, maintenance, renovation, and repair of 
        facilities and acquisition, maintenance, and repair of fixtures, 
        furniture, scientific equipment, and other necessary materials 
        and supplies, and
            (D) collecting fees under section 379h of this title and 
        accounting for resources allocated for the review of human drug 
        applications and supplements.

        (8) The term ``adjustment factor'' applicable to a fiscal year 
    is the lower of--
            (A) the Consumer Price Index for all urban consumers (all 
        items; United States city average) for April of the preceding 
        fiscal year divided by such Index for April 1997, or
            (B) the total of discretionary budget authority provided for 
        programs in the domestic category for the immediately preceding 
        fiscal year (as reported in the Office of Management and Budget 
        sequestration preview report, if available, required under 
        section 254(c) of the Balanced Budget and Emergency Deficit 
        Control Act of 1985 [2 U.S.C. 904(c)]) divided by such budget 
        authority for fiscal year 1997 (as reported in the Office of 
        Management and Budget final sequestration report submitted after 
        the end of the 105th Congress, 1st Session).

    The terms ``budget authority'' and ``category'' in subparagraph (B) 
    are as defined in the Balanced Budget and Emergency Deficit Control 
    Act of 1985 [2 U.S.C. 900 et seq.], as in effect as of September 1, 
    1992.
        (9) The term ``affiliate'' means a business entity that has a 
    relationship with a second business entity if, directly or 
    indirectly--
            (A) one business entity controls, or has the power to 
        control, the other business entity; or
            (B) a third party controls, or has power to control, both of 
        the business entities.

(June 25, 1938, ch. 675, Sec. 735, as added Pub. L. 102-571, title I, 
Sec. 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105-115, title 
I, Secs. 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326.)

                          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

    The Balanced Budget and Emergency Deficit Control Act of 1985, 
referred to in par. (8), is title II of Pub. L. 99-177, Dec. 12, 1985, 
99 Stat. 1038, as amended, which enacted chapter 20 (Sec. 900 et seq.) 
and sections 654 to 656 of Title 2, The Congress, amended sections 602, 
622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 
1109 of Title 31, Money and Finance, and section 911 of Title 42, The 
Public Health and Welfare, repealed section 661 of Title 2, enacted 
provisions set out as notes under section 900 of Title 2 and section 911 
of Title 42, and amended provisions set out as a note under section 621 
of Title 2. For complete classification of this Act to the Code, see 
Short Title note set out under section 900 of Title 2 and Tables.


                               Amendments

    1997--Par. (1). Pub. L. 105-115, Secs. 102(1), 107, in closing 
provisions, temporarily struck out ``and'' before ``does not include an 
application'' and substituted ``September 1, 1992, does not include an 
application for a licensure of a biological product for further 
manufacturing use only, and does not include an application or 
supplement submitted by a State or Federal Government entity for a drug 
that is not distributed commercially. Such term does include an 
application for licensure, as described in subparagraph (D), of a large 
volume biological product intended for single dose injection for 
intravenous use or infusion'' for ``September 1, 1992'' before period at 
end. See Effective and Termination Dates of 1997 Amendment note below.
    Par. (1)(B) to (D). Pub. L. 105-115, Sec. 125(b)(2)(M), inserted 
``or'' at end of subpar. (B), redesignated subpar. (D) as (C), and 
struck out former subpar. (C) which read as follows: ``initial 
certification or initial approval of an antibiotic drug under section 
357 of this title, or''.
    Par. (3). Pub. L. 105-115, Secs. 102(2), 107, in closing provisions, 
temporarily struck out ``and'' before ``does not include a large volume 
parenteral drug'' and substituted ``September 1, 1992, does not include 
a biological product that is licensed for further manufacturing use 
only, and does not include a drug that is not distributed commercially 
and is the subject of an application or supplement submitted by a State 
or Federal Government entity. Such term does include a large volume 
biological product intended for single dose injection for intravenous 
use or infusion'' for ``September 1, 1992'' before period at end. See 
Effective and Termination Dates of 1997 Amendment note below.
    Par. (4). Pub. L. 105-115, Secs. 102(3), 107, temporarily 
substituted ``without substantial further manufacturing'' for ``without 
further manufacturing''. See Effective and Termination Dates of 1997 
Amendment note below.
    Par. (5). Pub. L. 105-115, Secs. 102(4), 107, temporarily amended 
first sentence generally. Prior to amendment, first sentence read as 
follows: ``The term `prescription drug establishment' means a foreign or 
domestic place of business which is--
        ``(A) at one general physical location consisting of one or more 
    buildings all of which are within 5 miles of each other, at which 
    one or more prescription drug products are manufactured in final 
    dosage form, and
        ``(B) under the management of a person that is listed as the 
    applicant in a human drug application for a prescription drug 
    product with respect to at least one such product.''
See Effective and Termination Dates of 1997 Amendment note below.
    Par. (7)(A). Pub. L. 105-115, Secs. 102(5), 107, temporarily 
substituted ``contractors of the Food and Drug Administration,'' for 
``employees under contract with the Food and Drug Administration who 
work in facilities owned or leased for the Food and Drug 
Administration,'' and ``and committees and to contracts with such 
contractors,'' for ``and committees,''. See Effective and Termination 
Dates of 1997 Amendment note below.
    Par. (8)(A). Pub. L. 105-115, Secs. 102(6)(A), 107, temporarily 
substituted ``April of the preceding fiscal year'' for ``August of the 
preceding fiscal year'' and ``April 1997'' for ``August 1992''. See 
Effective and Termination Dates of 1997 Amendment note below.
    Par. (8)(B). Pub. L. 105-115, Secs. 102(6)(B), 107, temporarily 
substituted ``section 254(c)'' for ``section 254(d)'', ``fiscal year 
1997'' for ``fiscal year 1992'', and ``105th Congress, 1st Session'' for 
``102d Congress, 2d Session''. See Effective and Termination Dates of 
1997 Amendment note below.
    Par. (9). Pub. L. 105-115, Secs. 102(7), 107, temporarily added par. 
(9). See Effective and Termination Dates of 1997 Amendment note below.


            Effective and Termination Dates of 1997 Amendment

    Section 106 of title I of Pub. L. 105-115 provided that: ``The 
amendments made by this subtitle [subtitle A (Secs. 101-107) of title I 
of Pub. L. 105-115, amending this section and section 379h of this 
title] shall take effect October 1, 1997.''
    Section 107 of Pub. L. 105-115 provided that: ``The amendments made 
by sections 102 and 103 [amending this section and section 379h of this 
title] cease to be effective October 1, 2002, and section 104 [enacting 
provisions set out as a note below] ceases to be effective 120 days 
after such date.''


                            Termination Date

    Section 105 of Pub. L. 102-571 provided that: ``The amendments made 
by section 103 [enacting this subpart] shall not be in effect after 
October 1, 1997 and section 104 [enacting provisions set out as a note 
below] shall not be in effect after 120 days after such date.''


                            Savings Provision

    Section 105 of Pub. L. 105-115 provided that: ``Notwithstanding 
section 105 of the Prescription Drug User Fee Act of 1992 [section 105 
of Pub. L. 102-571, set out above], the Secretary shall retain the 
authority to assess and collect any fee required by part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this 
subpart] for a human drug application or supplement accepted for filing 
prior to October 1, 1997, and to assess and collect any product or 
establishment fee required by such Act for a fiscal year prior to fiscal 
year 1998.''


        Congressional Findings Concerning Fees Relating to Drugs

    Section 101 of title I of Pub. L. 105-115 provided that: ``Congress 
finds that--
        ``(1) prompt approval of safe and effective new drugs and other 
    therapies is critical to the improvement of the public health so 
    that patients may enjoy the benefits provided by these therapies to 
    treat and prevent illness and disease;
        ``(2) the public health will be served by making additional 
    funds available for the purpose of augmenting the resources of the 
    Food and Drug Administration that are devoted to the process for 
    review of human drug applications;
        ``(3) the provisions added by 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] have 
    been successful in substantially reducing review times for human 
    drug applications and should be--
            ``(A) reauthorized for an additional 5 years, with certain 
        technical improvements; and
            ``(B) carried out by the Food and Drug Administration with 
        new commitments to implement more ambitious and comprehensive 
        improvements in regulatory processes of the Food and Drug 
        Administration; and
        ``(4) the fees authorized by amendments made in this subtitle 
    [subtitle A (Secs. 101-107) of title I of Pub. L. 105-115, amending 
    this section and section 379h of this title] will be dedicated 
    toward expediting the drug development process and the review of 
    human drug applications as set forth in the goals identified, for 
    purposes of part 2 of subchapter C of chapter VII of the Federal 
    Food, Drug, and Cosmetic Act [this subpart], in the letters from the 
    Secretary of Health and Human Services to the chairman of the 
    Committee on Commerce of the House of Representatives and the 
    chairman of the Committee on Labor and Human Resources of the 
    Senate, as set forth in the Congressional Record.''


                             Annual Reports

    Section 104 of Pub. L. 105-115 provided that:
    ``(a) Performance Report.--Beginning with fiscal year 1998, not 
later than 60 days after the end of each fiscal year during which fees 
are collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report concerning the progress of the 
Food and Drug Administration in achieving the goals identified in the 
letters described in section 101(4) [section 101(4) of Pub. L. 105-115 
set out above] during such fiscal year and the future plans of the Food 
and Drug Administration for meeting the goals.
    ``(b) Fiscal Report.--Beginning with fiscal year 1998, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (a), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report on the implementation of the 
authority for such fees during such fiscal year and the use, by the Food 
and Drug Administration, of the fees collected during such fiscal year 
for which the report is made.''


      Congressional Findings Concerning Prescription Drug User Fees

    Section 102 of title I of Pub. L. 102-571 provided that: ``The 
Congress finds that--
        ``(1) prompt approval of safe and effective new drugs is 
    critical to the improvement of the public health so that patients 
    may enjoy the benefits provided by these therapies to treat and 
    prevent illness and disease;
        ``(2) the public health will be served by making additional 
    funds available for the purpose of augmenting the resources of the 
    Food and Drug Administration that are devoted to the process for 
    review of human drug applications; and
        ``(3) the fees authorized by this title [see Short Title of 1992 
    Amendment note, set out under section 301 of this title] will be 
    dedicated toward expediting the review of human drug applications as 
    set forth in the goals identified in the letters of September 14, 
    1992, and September 21, 1992, from the Commissioner of Food and 
    Drugs to the Chairman of the Energy and Commerce Committee of the 
    House of Representatives and the Chairman of the Labor and Human 
    Resources Committee of the Senate, as set forth at 138 Cong. Rec. 
    H9099-H9100 (daily ed. September 22, 1992).''


                             Annual Reports

    Pub. L. 102-571, title I, Sec. 104, Oct. 29, 1992, 106 Stat. 4498, 
which provided that the Secretary of Health and Human Services submit to 
Committee on Energy and Commerce of the House of Representatives and 
Committee on Labor and Human Resources of the Senate, within 60 days 
after the end of each fiscal year during which fees were collected under 
this subpart, a report stating the Food and Drug Administration's 
progress in achieving the goals identified in section 102(3) of Pub. L. 
102-571, set out as a note above, during such fiscal year and that 
agency's future plans for meeting such goals, and within 120 days after 
the end of each fiscal year during which such fees were collected, a 
report on the implementation of the authority for such fees during such 
fiscal year and on the use the Food and Drug Administration made of the 
fees collected during such fiscal year, ceased to be in effect 120 days 
after Oct. 1, 1997. See Termination Date note above.


                       Animal Drug User Fee Study

    Section 108 of Pub. L. 102-571 directed Secretary, in consultation 
with manufacturers of animal drug products and other interested persons, 
to undertake study to evaluate whether, and under what conditions, to 
impose user fees to supplement appropriated funds in order to improve 
process of reviewing applications (including abbreviated and 
supplemental applications) for new animal drugs under section 360b of 
this title, and further provided for submission of study to Congress no 
later than Jan. 4, 1994.
