Pub.L. 108-283 To require a report on the conflict in Uganda, and for other purposes. <> ...

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Public Law 108-282
108th Congress

                                 An Act


 
  To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
   animal drugs, and for other purposes. <<NOTE: Aug. 2, 2004 -  [S. 
                                 741]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

TITLE I--MINOR <<NOTE: Minor Use and Minor Species Animal Health Act of 
2004.>> USE AND MINOR SPECIES HEALTH

SECTION 101. <<NOTE: 21 USC 301 note.>> SHORT TITLE.

    This title may be cited as the ``Minor Use and Minor Species Animal 
Health Act of 2004''.
SEC. 102. MINOR <<NOTE: 21 USC 360ccc note.>> USE AND MINOR 
                        SPECIES ANIMAL HEALTH.

    (a) Findings.--Congress makes the following findings:
            (1) There is a severe shortage of approved new animal drugs 
        for use in minor species.
            (2) There is a severe shortage of approved new animal drugs 
        for treating animal diseases and conditions that occur 
        infrequently or in limited geographic areas.
            (3) Because of the small market shares, low-profit margins 
        involved, and capital investment required, it is generally not 
        economically feasible for new animal drug applicants to pursue 
        approvals for these species, diseases, and conditions.
            (4) Because the populations for which such new animal drugs 
        are intended may be small and conditions of animal management 
        may vary widely, it is often difficult to design and conduct 
        studies to establish drug safety and effectiveness under 
        traditional new animal drug approval processes.
            (5) It is in the public interest and in the interest of 
        animal welfare to provide for special procedures to allow the 
        lawful use and marketing of certain new animal drugs for minor 
        species and minor uses that take into account these special 
        circumstances and that ensure that such drugs do not endanger 
        animal or public health.
            (6) Exclusive marketing rights for clinical testing expenses 
        have helped encourage the development of ``orphan'' drugs for 
        human use, and comparable incentives should encourage the 
        development of new animal drugs for minor species and minor 
        uses.

    (b) Amendments to the Federal Food, Drug, and Cosmetic Act.--

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            (1) Definitions.--Section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
        following:

    ``(nn) The term `major species' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary may add 
species to this definition by regulation.
    ``(oo) The term `minor species' means animals other than humans that 
are not major species.
    ``(pp) The term `minor use' means the intended use of a drug in a 
major species for an indication that occurs infrequently and in only a 
small number of animals or in limited geographical areas and in only a 
small number of animals annually.''.
            (2) Three-year exclusivity for minor use and minor species 
        approvals.--Section 512(c)(2)(F) (ii), (iii), and (v) of the 
        Federal Food, Drug, and Cosmetic Act <<NOTE: 21 USC 360b.>> is 
        amended by striking ``(other than bioequivalence or residue 
        studies)'' and inserting ``(other than bioequivalence studies or 
        residue depletion studies, except residue depletion studies for 
        minor uses or minor species)'' every place it appears.
            (3) Scope of review for minor use and minor species 
        applications.--Section 512(d) of the Federal Food, Drug, and 
        Cosmetic Act is amended by adding at the end the following new 
        paragraph:
            ``(5) In reviewing an application that proposes a change to 
        add an intended use for a minor use or a minor species to an 
        approved new animal drug application, the Secretary shall 
        reevaluate only the relevant information in the approved 
        application to determine whether the application for the minor 
        use or minor species can be approved. A decision to approve the 
        application for the minor use or minor species is not, 
        implicitly or explicitly, a reaffirmation of the approval of the 
        original application.''.
            (4) Minor use and minor species new animal drugs.--Chapter V 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 
        seq.) is amended by adding at the end the following:

    ``Subchapter F--New Animal Drugs for Minor Use and Minor Species

``SEC. 571. <<NOTE: 21 USC 360ccc.>> CONDITIONAL APPROVAL OF NEW ANIMAL 
            DRUGS FOR MINOR USE AND MINOR SPECIES.

    ``(a)(1) Except as provided in paragraph (3) of this section, any 
person may file with the Secretary an application for conditional 
approval of a new animal drug intended for a minor use or a minor 
species. Such an application may not be a supplement to an application 
approved under section 512. Such application must comply in all respects 
with the provisions of section 512 of this Act except sections 
512(a)(4), 512(b)(2), 512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 
512(e), 512(h), and 512(n) unless otherwise stated in this section, and 
any additional provisions of this section. New animal drugs are subject 
to application of the same safety standards that would be applied to 
such drugs under section 512(d) (including, for antimicrobial new animal 
drugs, with respect to antimicrobial resistance).
    ``(2) The applicant shall submit to the Secretary as part of an 
application for the conditional approval of a new animal drug--

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            ``(A) all information necessary to meet the requirements of 
        section 512(b)(1) except section 512(b)(1)(A);
            ``(B) <<NOTE: Reports.>> full reports of investigations 
        which have been made to show whether or not such drug is safe 
        under section 512(d) (including, for an antimicrobial new animal 
        drug, with respect to antimicrobial resistance) and there is a 
        reasonable expectation of effectiveness for use;
            ``(C) data for establishing a conditional dose;
            ``(D) projections of expected need and the justification for 
        that expectation based on the best information available;
            ``(E) information regarding the quantity of drug expected to 
        be distributed on an annual basis to meet the expected need; and
            ``(F) a commitment that the applicant will conduct 
        additional investigations to meet the requirements for the full 
        demonstration of effectiveness under section 512(d)(1)(E) within 
        5 years.

    ``(3) A person may not file an application under paragraph (1) if--
            ``(A) the application seeks conditional approval of a new 
        animal drug that is contained in, or is a product of, a 
        transgenic animal.
            ``(B) the person has previously filed an application for 
        conditional approval under paragraph (1) for the same drug in 
        the same dosage form for the same intended use whether or not 
        subsequently conditionally approved by the Secretary under 
        subsection (b), or
            ``(C) the person obtained the application, or data or other 
        information contained therein, directly or indirectly from the 
        person who filed for conditional approval under paragraph (1) 
        for the same drug in the same dosage form for the same intended 
        use whether or not subsequently conditionally approved by the 
        Secretary under subsection (b).

    ``(b) <<NOTE: Deadline.>> Within 180 days after the filing of an 
application pursuant to subsection (a), or such additional period as may 
be agreed upon by the Secretary and the applicant, the Secretary shall 
either--
            ``(1) <<NOTE: Federal Register, publication.>> issue an 
        order, effective for one year, conditionally approving the 
        application if the Secretary finds that none of the grounds for 
        denying conditional approval, specified in subsection (c) of 
        this section applies and publish a Federal Register notice of 
        the conditional approval, or
            ``(2) give the applicant notice of an opportunity for an 
        informal hearing on the question whether such application can be 
        conditionally approved.

    ``(c) If the Secretary finds, after giving the applicant notice and 
an opportunity for an informal hearing, that--
            ``(1) any of the provisions of section 512(d)(1) (A) through 
        (D) or (F) through (I) are applicable;
            ``(2) the information submitted to the Secretary as part of 
        the application and any other information before the Secretary 
        with respect to such drug, is insufficient to show that there is 
        a reasonable expectation that the drug will have the effect it 
        purports or is represented to have under the conditions of use 
        prescribed, recommended, or suggested in the proposed labeling 
        thereof; or
            ``(3) another person has received approval under section 512 
        for the same drug in the same dosage form for the same

[[Page 118 STAT. 894]]

        intended use, and that person is able to assure the availability 
        of sufficient quantities of the drug to meet the needs for which 
        the drug is intended;

the Secretary shall issue an order refusing to conditionally approve the 
application. <<NOTE: Federal Register, publication.>> If, after such 
notice and opportunity for an informal hearing, the Secretary finds that 
paragraphs (1) through (3) do not apply, the Secretary shall issue an 
order conditionally approving the application effective for one year and 
publish a Federal Register notice of the conditional approval. Any order 
issued under this subsection refusing to conditionally approve an 
application shall state the findings upon which it is based.

    ``(d) A conditional approval under this section is effective for a 
1-year period and is thereafter renewable by the Secretary annually for 
up to 4 additional 1-year terms. A conditional approval shall be in 
effect for no more than 5 years from the date of approval under 
subsection (b)(1) or (c) of this section unless extended as provided for 
in subsection (h) of this section. <<NOTE: Applicability.>> The 
following shall also apply:
            ``(1) <<NOTE: Deadline.>> No later than 90 days from the end 
        of the 1-year period for which the original or renewed 
        conditional approval is effective, the applicant may submit a 
        request to renew a conditional approval for an additional 1-year 
        term.
            ``(2) A conditional approval shall be deemed renewed at the 
        end of the 1-year period, or at the end of a 90-day extension 
        that the Secretary may, at the Secretary's discretion, grant by 
        letter in order to complete review of the renewal request, 
        unless the Secretary determines before the expiration of the 1-
        year period or the 90-day extension that--
                    ``(A) the applicant failed to submit a timely 
                renewal request;
                    ``(B) the request fails to contain sufficient 
                information to show that--
                          ``(i) the applicant is making sufficient 
                      progress toward meeting approval requirements 
                      under section 512(d)(1)(E), and is likely to be 
                      able to fulfill those requirements and obtain an 
                      approval under section 512 before the expiration 
                      of the 5-year maximum term of the conditional 
                      approval;
                          ``(ii) the quantity of the drug that has been 
                      distributed is consistent with the conditionally 
                      approved intended use and conditions of use, 
                      unless there is adequate explanation that ensures 
                      that the drug is only used for its intended 
                      purpose; or
                          ``(iii) the same drug in the same dosage form 
                      for the same intended use has not received 
                      approval under section 512, or if such a drug has 
                      been approved, that the holder of the approved 
                      application is unable to assure the availability 
                      of sufficient quantities of the drug to meet the 
                      needs for which the drug is intended; or
                    ``(C) any of the provisions of section 512(e)(1) (A) 
                through (B) or (D) through (F) are applicable.
            ``(3) If the Secretary determines before the end of the 1-
        year period or the 90-day extension, if granted, that a 
        conditional approval should not be renewed, the Secretary shall 
        issue an order refusing to renew the conditional approval, and 
        such conditional approval shall be deemed withdrawn and no

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        longer in effect. The Secretary shall thereafter provide an 
        opportunity for an informal hearing to the applicant on the 
        issue whether the conditional approval shall be reinstated.

    ``(e)(1) The Secretary shall issue an order withdrawing conditional 
approval of an application filed pursuant to subsection (a) if the 
Secretary finds that another person has received approval under section 
512 for the same drug in the same dosage form for the same intended use 
and that person is able to assure the availability of sufficient 
quantities of the drug to meet the needs for which the drug is intended.
    ``(2) The Secretary shall, after due notice and opportunity for an 
informal hearing to the applicant, issue an order withdrawing 
conditional approval of an application filed pursuant to subsection (a) 
if the Secretary finds that--
            ``(A) any of the provisions of section 512(e)(1) (A) through 
        (B) or (D) through (F) are applicable; or
            ``(B) on the basis of new information before the Secretary 
        with respect to such drug, evaluated together with the evidence 
        available to the Secretary when the application was 
        conditionally approved, that there is not a reasonable 
        expectation that such drug will have the effect it purports or 
        is represented to have under the conditions of use prescribed, 
        recommended, or suggested in the labeling thereof.

    ``(3) The Secretary may also, after due notice and opportunity for 
an informal hearing to the applicant, issue an order withdrawing 
conditional approval of an application filed pursuant to subsection (a) 
if the Secretary finds that any of the provisions of section 512(e)(2) 
are applicable.
    ``(f)(1) The label and labeling of a new animal drug with a 
conditional approval under this section shall--
            ``(A) bear the statement, `conditionally approved by FDA 
        pending a full demonstration of effectiveness under application 
        number'; and
            ``(B) contain such other information as prescribed by the 
        Secretary.

    ``(2) An intended use that is the subject of a conditional approval 
under this section shall not be included in the same product label with 
any intended use approved under section 512.
    ``(g) A conditionally approved new animal drug application may not 
be amended or supplemented to add indications for use.
    ``(h) <<NOTE: Deadline.>> 180 days prior to the termination date 
established under subsection (d) of this section, an applicant shall 
have submitted all the information necessary to support a complete new 
animal drug application in accordance with section 512(b)(1) or the 
conditional approval issued under this section is no longer in effect. 
Following review of this information, the Secretary shall either--
            ``(1) issue an order approving the application under section 
        512(c) if the Secretary finds that none of the grounds for 
        denying approval specified in section 512(d)(1) applies, or
            ``(2) give the applicant an opportunity for a hearing before 
        the Secretary under section 512(d) on the question whether such 
        application can be approved.

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