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H.R. 207 (ih) ...


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108th CONGRESS
  1st Session
                                H. R. 2079

 To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
                 animal drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 13, 2003

   Mr. Pickering (for himself, Mr. John, Mr. Berry, Mr. Thompson of 
  Mississippi, Mr. Towns, Mr. Alexander, Mr. Ross, Mr. Greenwood, Ms. 
 Bordallo, Mr. Otter, Mr. Upton, Mr. Lipinski, Mr. Boswell, Mr. Goode, 
    Mr. Bonner, Mr. Aderholt, Mr. Bachus, Mr. Davis of Alabama, Mr. 
    Bonilla, Mr. Everett, Mr. Putnam, Mr. Edwards, and Mr. Simpson) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with regard to new 
                 animal drugs, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Minor Use and Minor Species Animal 
Health Act of 2003''.

SEC. 2. 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 and tax credits 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.

SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) 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:
    ``(kk) The term `major species' means cattle, horses, swine, 
chickens, turkeys, dogs, and cats, except that the Secretary may revise 
this definition by regulation.
    ``(ll) The term `minor species' means animals other than humans 
that are not major species.
    ``(mm) The term `minor use' means the intended use of a drug in a 
major species for an indication that occurs infrequently or in limited 
geographical areas.''.
    (b) 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 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.
    (c) 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.''.
    (d) 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. 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.
    ``(2) The applicant shall submit to the Secretary as part of an 
application for the conditional approval of a new animal drug--
            ``(A) all information necessary to meet the requirements of 
        section 512(b)(1) except section 512(b)(1)(A);
            ``(B) full reports of investigations which have been made 
        to show whether or not such drug is safe 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 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
            ``(B) 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) 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) 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, 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 
        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.
    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. 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. The following shall also apply:
            ``(1) 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 
        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) 180 days prior to the termination date established under 
subsection (d)(1) 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.
Upon issuance of an order approving the application, product labeling 
and administrative records of approval shall be modified accordingly. 
If the Secretary has not issued an order under section 512(c) approving 
such application prior to the termination date established under 
subsection (d)(1) of this section, the conditional approval issued 
under this section is no longer in effect unless the Secretary grants 
an extension of an additional 180-day period so that the Secretary can 
complete review of the application. The decision to grant an extension 
is committed to the discretion of the Secretary and not subject to 
judicial review.
    ``(i) The decision of the Secretary under subsection (c), (d), or 

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