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S. 316 (is) To amend the Child Care and Development Block Grant Act of 1990 to improve the availability of child care and development services during periods outside normal school hours, and for other purposes. [Introduced in Senate] ...


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106th CONGRESS
  2d Session
                                S. 3169

  To amend the Federal Food, Drug, and Cosmetic Act and the Internal 
 Revenue Code of 1986 with respect to drugs for minor animal species, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

            October 5 (legislative day, September 22), 2000

 Mr. Sessions (for himself, Mr. Bingaman, Mr. Allard, Mr. Johnson, Mr. 
Crapo, and Mrs. Lincoln) introduced the following bill; which was read 
             twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act and the Internal 
 Revenue Code of 1986 with respect to drugs for minor animal species, 
                        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 Animal Species Health and 
Welfare Act of 2000''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) There is a severe shortage of approved animal drugs for 
        use in minor species.
            (2) There is a severe shortage of approved 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 animal drug manufacturers to pursue 
        approvals for these species, diseases, and conditions.
            (4) Because the populations for which such drugs are 
        intended are small and conditions of animal management may vary 
        widely, it is often difficult or impossible to design and 
        conduct studies to establish drug safety and effectiveness 
        under traditional animal drug approval processes.
            (5) It is in the public interest and in the interest of 
        animal welfare to provide for special procedures to sanction 
        the lawful use and marketing of animal drugs for minor species 
        and minor uses that take into account these special 
        circumstances and that ensure that such drugs do not endanger 
        the 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 will help 
        encourage the development and sanctioning for lawful marketing 
        of animal drugs for minor species and minor uses.

SEC. 3. AMENDMENTS AFFECTING THE FOOD AND DRUG ADMINISTRATION.

    (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 `minor species' means animals other than cattle, 
horses, swine, chickens, turkeys, dogs, and cats, except that the 
Secretary may amend this definition by regulation.
    ``(ll) The term `minor use' means the use of a drug--
            ``(1) in a minor species, or
            ``(2) in an animal species other than a minor species for a 
        disease or condition that occurs infrequently or in limited 
        geographic areas, except that the Secretary may amend this 
        definition by regulation.
    ``(mm) The term `species with no human food safety concern' means 
an animal species, or life stage of an animal species, that is not 
customarily used for food for humans and does not endanger the public 
health.''.
    (b) Minor Use 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 new subchapter:

              ``SUBCHAPTER F--ANIMAL DRUGS FOR MINOR USES

                 ``designation of drugs for minor uses

    ``Sec. 571. (a) Prior to the submission of an application for 
approval of a new animal drug under section 512(b), a manufacturer or 
sponsor of such drug may request that the Secretary designate such drug 
as a drug for a minor use. The Secretary shall designate such drug as a 
drug for minor use if the Secretary finds that such drug is or will be 
investigated for a minor use and the application for such drug is 
approved under section 512. A request for a designation of a drug under 
this subsection shall contain the consent of the applicant to notice 
being given by the Secretary under subsection (c) respecting the 
designation of the drug.
    ``(b) The designation of a drug as a drug for a minor use under 
subsection (a) shall be subject to the condition that--
            ``(1) if an application was approved for the drug under 
        section 512(c), the manufacturer of the drug will notify the 
        Secretary of any discontinuance of the production of the drug 
        at least 1 year before discontinuance; and
            ``(2) if an application has not been approved for the drug 
        under section 512(c) and if preclinical investigations or 
        investigations under section 512(j) are being conducted with 
        the drug, the manufacturer or sponsor of the drug will notify 
        the Secretary of any decision to discontinue active pursuit of 
        approval of an application under section 512(b).
    ``(c) Notice respecting the designation of a drug under subsection 
(a) shall be made available to the public.

                 ``protection for drugs for minor uses

    ``Sec. 572. (a) Except as provided in subsection (b):
            ``(1) If the Secretary approves an application filed 
        pursuant to section 512 for a drug designated under section 571 
        for a minor use, no active ingredient (including any salt or 
        ester of the active ingredient) of which has been approved in 
        any other application under section 512, the Secretary may not 
        approve or conditionally approve another application submitted 
        under section 512 or section 573 for such drug for such minor 
        use for a person who is not the holder of such approved 
        application until the expiration of 10 years from the date of 
        the approval of the application.
            ``(2) If the Secretary approves an application filed 
        pursuant to section 512 for a drug designated under section 571 
        for a minor use, which includes an active ingredient (including 
an ester or salt of the active ingredient) that has been approved in 
any other application under section 512, the Secretary may not approve 
or conditionally approve another application submitted under section 
512 or section 573 for such drug for such minor use for a person who is 
not the holder of such approved application until the expiration of 7 
years from the date of approval of the application.
    ``(b) If an application filed pursuant to section 512 is approved 
for a drug designated under section 571, the Secretary may, during the 
10-year or 7-year period beginning on the date of the application 
approval, approve or conditionally approve another application under 
section 512 or section 573 for such drug for such minor use for a 
person who is not the holder of such approved application if--
            ``(1) the Secretary finds, after providing the holder 
        notice and opportunity for the submission of views, that in 
        such period the holder of the approved application cannot 
        assure the availability of sufficient quantities of the drug to 
        meet the needs for which the drug was designated; or
            ``(2) such holder provides the Secretary in writing the 
        consent of such holder for the approval or conditional approval 
        of other applications before the expiration of such 10-year or 
        7-year period.

         ``conditional approval for minor use new animal drugs

    ``Sec. 573. (a)(1) Except as provided in paragraph (2), any person 
may file with the Secretary an application for conditional approval of 
a new animal drug for a minor use. Such person shall submit to the 
Secretary as part of an application--
            ``(A) reports of investigations which have been made to 
        show whether or not such drug is safe for use;
            ``(B) information to show that there is a reasonable 
        expectation that the drug is effective for its intended use, 
        such as data from a pilot investigation, data from an 
        investigation in a related species, data from a single 
        investigation, data from an investigation using surrogate 
        endpoints, data based on pharmacokinetic extrapolations, data 
        from a short-term investigation, or data from the investigation 
        of closely-related diseases;
            ``(C) the quantity of drug expected to be manufactured and 
        distributed on an annual basis;
            ``(D) a commitment that the applicant will conduct 
        additional investigations to support approval of an application 
        under section 512 within the time frame set forth in subsection 
        (d)(1)(A);
            ``(E) reasonable data for establishing a conditional dose; 
        and
            ``(F) the information required by section 512(b)(1)(B)-(H).
    ``(2) A person may not file an application under paragraph (1) if 
the person has filed a previous application under paragraph (1) for the 
same drug and conditions for use that was conditionally approved by the 
Secretary under subsection (b).
    ``(b)(1) 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 (A) 
issue an order conditionally approving the application if the Secretary 
then finds that none of the grounds for denying conditional approval 
specified in subsection (c) applies, or (B) give the applicant notice 
of an opportunity for an expedited informal hearing on the question 
whether such application is conditionally approvable.
    ``(2) A drug manufactured in a pilot or other small facility may be 
used to demonstrate the safety and effectiveness of the drug and to 
obtain conditional approval for the drug prior to manufacture of the 
drug in a larger facility, unless the Secretary makes a determination 
that a full scale production facility is necessary to ensure the safety 
or effectiveness of the drug.
    ``(c)(1) If the Secretary finds, after due notice to the applicant 
and giving the applicant an opportunity for an expedited informal 
hearing, that--
            ``(A) the investigations, reports of which are required to 
        be submitted to the Secretary pursuant to subsection (a), do 
        not include adequate tests by all methods reasonably applicable 
        to show whether or not such drug is safe for use under the 
        conditions prescribed, recommended, or suggested in the 
        proposed labeling;
            ``(B) the results of such tests show that such drug is 
        unsafe for use under such conditions or do not show that such 
        drug is safe for use under such conditions;
            ``(C) the methods used in, and the facilities and controls 
        used for, the manufacture, processing, and packing of such drug 
        are inadequate to preserve its identity, strength, quality, and 
        purity;
            ``(D) upon the basis of the information submitted to the 
        Secretary as part of the application, or upon the basis of any 
        other information before the Secretary with respect to such 
        drug, the Secretary has insufficient information to determine 
        whether such drug is safe for use under such conditions;
            ``(E) evaluated on the basis of the information submitted 
        to the Secretary as part of the application and any other 
        information before the Secretary with respect to such drug, 
        there is insufficient information 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;
            ``(F) upon the basis of information submitted to the 
        Secretary as part of the application or any other information 
        before the Secretary with respect to such drug, any use 
        prescribed, recommended, or suggested in labeling proposed for 
        such drug will result in a residue of such drug in excess of a 
        tolerance found by the Secretary to be safe for such drug;
            ``(G) based on a fair evaluation of all material facts, 
        such labeling is false or misleading in any particular;
            ``(H) such drug induces cancer when ingested by humans or 
        animal or, after tests which are appropriate for the evaluation 
        of the safety of such drug, induces cancer in humans or animal, 
unless the Secretary finds that, under the conditions for use specified 
in proposed labeling and reasonably certain to be followed in 
practice--
                    ``(i) such drug will not adversely affect the 
                animals for which it is intended; and
                    ``(ii) no residue of such drug will be found (by 
                methods of examination prescribed or approved by the 
                Secretary by regulations, which regulations shall not 
                be subject to subsections (c)) in any edible portion of 
                such animals after slaughter or in any food yielded by 
                or derived from the living animals; or
            ``(I) another person has received approval under section 
        512 for a drug with the same active ingredient or ingredients 
        and the same conditions of 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 hearing, the 
Secretary finds that subparagraphs (A) through (I) do not apply, the 
Secretary shall issue an order conditionally approving the application.
    ``(2) In determining whether such drug is safe for use under the 
conditions prescribed, recommended, or suggested in the proposed 
labeling thereof, the Secretary shall consider, among other relevant 
factors, (A) the probable consumption of such drug and of any substance 
formed in or on food because of the use of such drug, (B) the 
cumulative effect on man or animal of such drug, taking into account 
any chemically or pharmacologically related substance, (C) safety 
factors which in the opinion of experts, qualified by scientific 
training and experience to evaluate the safety of such drugs, are 
appropriate for the use of animal experimentation data, and (D) whether 
the conditions of use prescribed, recommended, or suggested in the 
proposed labeling are reasonably certain to be followed in practice. 
Any order issued under this subsection refusing to approve an 
application shall state the findings upon which it is based.
    ``(d)(1) A conditional approval granted by the Secretary under this 
section shall be effective for a 1-year period. The Secretary shall, 
upon request, renew a conditional approval for up to 4 additional 1-
year terms, unless the Secretary by order makes a finding that--
            ``(A) the applicant is not making appropriate progress 
        toward meeting approval requirements under section 512, and is 
        unlikely to be able to fulfill such requirements and obtain 
        such approval under such section before the 5 year maximum term 
        of the conditional approval expires;
            ``(B) excessive quantities of the drug have been produced, 
        without adequate explanation; or
            ``(C) another drug with the same active ingredient or 
        ingredients for the same conditions of use has received 
        approval under section 512, and the holder of the approved 
        application is able to assure the availability of sufficient 
        quantities of the drug to meet the needs for which the drug is 
        intended.
    ``(2) If the Secretary does not renew a conditional approval, the 
Secretary shall provide due notice and an opportunity for an expedited 
informal hearing to the applicant.
    ``(e)(1) The Secretary shall, after due notice and opportunity for 

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