Pub.L. 104-251 To amend the Railroad Unemployment Insurance Act to reduce the waiting period for benefits payable under that Act, and for other purposes. <> ...

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Public Law 104-250
104th Congress

                                 An Act


 
    To amend the Federal Food, Drug, and Cosmetic Act to provide for 
improvements in the process of approving and using animal drugs, and for 
         other purposes. <<NOTE: Oct. 9, 1996 -  [H.R. 2508]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Animal Drug 
Availability Act of 1996. 21 USC 301 note.>> 

SECTION 1. SHORT TITLE; REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Animal Drug 
Availability Act of 1996''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321 et seq.).

SEC. 2. EVIDENCE OF EFFECTIVENESS.

    (a) Original Applications.--Paragraph (3) of section 512(d) (21 
U.S.C. 360b(d)) is amended to read as follows:
    ``(3) As used in this section, the term `substantial evidence' means 
evidence consisting of one or more adequate and well 
controlled investigations, such as--
            ``(A) a study in a target species;
            ``(B) a study in laboratory animals;
            ``(C) any field investigation that may be required under 
        this section and that meets the requirements of subsection 
        (b)(3) if a presubmission conference is requested by the 
        applicant;
            ``(D) a bioequivalence study; or
            ``(E) an in vitro study;

 by experts qualified by scientific training and experience to evaluate 
the effectiveness of the drug involved, on the basis of which it could 
fairly and reasonably be concluded by such experts 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 labeling 
or proposed labeling thereof.''.
    (b) Conforming Amendments.--
            (1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21 
        U.S.C. 360b(c)(2)(F)) are each amended--
                    (A) by striking ``reports of new clinical or field 
                investigations (other than bioequivalence or residue 
                studies) and,'' and inserting ``substantial evidence of 
                the effectiveness of the drug involved, any studies of 
                animal safety, or,''; and
                    (B) by striking ``essential to'' and inserting 
                ``required for''.

[[Page 110 STAT. 3152]]

            (2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is 
        amended--
                    (A) by striking ``subparagraph (B)(iv)'' each place 
                it appears and inserting ``clause (iv)'';
                    (B) by striking ``reports of clinical or field 
                investigations'' and inserting ``substantial evidence of 
                the 
                effectiveness of the drug involved, any studies of 
                animal safety,''; and
                    (C) by striking ``essential to'' and inserting 
                ``required for''.

    (c) Combination Drugs.--Section 512(d) (21 U.S.C. 360b(d)), as 
amended by subsection (a) is amended by adding at the end the following:
    ``(4) In a case in which an animal drug contains more than one 
active ingredient, or the labeling of the drug prescribes, recommends, 
or suggests use of the drug in combination with one or more other animal 
drugs, and the active ingredients or drugs intended for use in the 
combination have previously been separately approved for particular uses 
and conditions of use for which they are intended for use in the 
combination--
            ``(A) the Secretary shall not issue an order under paragraph 
        (1)(A), (1)(B), or (1)(D) refusing to approve the application 
        for such combination on human food safety grounds unless the 
        Secretary finds that the application fails to establish that--
                    ``(i) none of the active ingredients or drugs 
                intended for use in the combination, respectively, at 
                the longest withdrawal time of any of the active 
                ingredients or drugs in the combination, respectively, 
                exceeds its established tolerance; or
                    ``(ii) none of the active ingredients or drugs in 
                the combination interferes with the methods of analysis 
                for another of the active ingredients or drugs in the 
                combination, respectively;
            ``(B) the Secretary shall not issue an order under paragraph 
        (1)(A), (1)(B), or (1)(D) refusing to approve the application 
        for such combination on target animal safety grounds unless the 
        Secretary finds that--
                    ``(i)(I) there is a substantiated scientific issue, 
                specific to one or more of the active ingredients or 
                animal drugs in the combination, that cannot adequately 
                be evaluated based on information contained in the 
                application for the combination (including any 
                investigations, studies, or tests for which the 
                applicant has a right of reference or use from the 
                person by or for whom the investigations, studies, or 
                tests were conducted); or
                    ``(II) there is a scientific issue raised by target 
                animal observations contained in studies submitted to 
                the 
                Secretary as part of the application; and
                    ``(ii) based on the Secretary's evaluation of the 
                information contained in the application with respect to 
                the issues identified in clauses (i) (I) and (II), 
                paragraph (1) (A), (B), or (D) apply;
            ``(C) except in the case of a combination that contains a 
        nontopical antibacterial ingredient or animal drug, the 
        Secretary shall not issue an order under paragraph (1)(E) 
        refusing to approve an application for a combination animal drug 
        intended for use other than in animal feed or drinking water

[[Page 110 STAT. 3153]]

        unless the Secretary finds that the application fails to 
        demonstrate that--
                    ``(i) there is substantial evidence that any active 
                ingredient or animal drug intended only for the same use 
                as another active ingredient or animal drug in the 
                combination makes a contribution to labeled 
                effectiveness;
                    ``(ii) each active ingredient or animal drug 
                intended for at least one use that is different from all 
                other active ingredients or animal drugs used in the 
                combination 
                provides appropriate concurrent use for the intended 
                target population; or
                    ``(iii) where based on scientific information the 
                Secretary has reason to believe the active ingredients 
                or animal drugs may be physically incompatible or have 
                disparate dosing regimens, such active ingredients or 
                animal drugs are physically compatible or do not have 
                disparate dosing regimens; and
            ``(D) the Secretary shall not issue an order under paragraph 
        (1)(E) refusing to approve an application for a combination 
        animal drug intended for use in animal feed or drinking water 
        unless the Secretary finds that the application fails to 
        demonstrate that--
                    ``(i) there is substantial evidence that any active 
                ingredient or animal drug intended only for the same use 
                as another active ingredient or animal drug in the 
                combination makes a contribution to the labeled 
                effectiveness;
                    ``(ii) each of the active ingredients or animal 
                drugs intended for at least one use that is different 
                from all other active ingredients or animal drugs used 
                in the combination provides appropriate concurrent use 
                for the intended target population;
                    ``(iii) where a combination contains more than one 
                nontopical antibacterial ingredient or animal drug, 
                there is substantial evidence that each of the 
                nontopical antibacterial ingredients or animal drugs 
                makes a contribution to the labeled effectiveness; or
                    ``(iv) where based on scientific information the 
                Secretary has reason to believe the active ingredients 
                or animal drugs intended for use in drinking water may 
                be physically incompatible, such active ingredients or 
                animal drugs intended for use in drinking water are 
                physically compatible.''.

    (d) Presubmission Conference.--Section 512(b) (21 U.S.C. 360b(b)) is 
amended by adding at the end the following:
    ``(3) Any person intending to file an application under paragraph 
(1) or a request for an investigational exemption under subsection (j) 
shall be entitled to one or more conferences prior to such submission to 
reach an agreement acceptable to the Secretary establishing a submission 
or an investigational requirement, which may include a requirement for a 
field investigation. A decision establishing a submission or an 
investigational requirement shall bind the Secretary and the applicant 
or requestor unless (A) the Secretary and the applicant or requestor 
mutually agree to modify the requirement, or (B) the Secretary by 
written order determines that a substantiated scientific requirement 
essential to the determination of safety or effectiveness of the animal 
drug involved has appeared after the conference. No later than 25 
calendar days after each

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such conference, the Secretary shall provide a written order setting 
forth a scientific justification specific to the animal drug and 
intended uses under consideration if the agreement referred to in the 
first sentence requires more than one field investigation as being 
essential to provide substantial evidence of effectiveness for the 
intended uses of the drug. Nothing in this paragraph shall be construed 
as compelling the Secretary to require a field investigation.''.
    (e) Implementation.--
            (1) In general.-- <<NOTE: Regulations. Effective date. 21 
        USC 360b note.>> Not later than 6 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue proposed regulations implementing the 
        amendments made by this Act as described in paragraph (2)(A) of 
        this subsection, and not later than 18 months after the date of 
        enactment of this Act, the Secretary shall issue final 
        regulations implementing such amendments. Not later than 12 
        months after the date of enactment of this Act, the Secretary 
        shall issue proposed regulations implementing the other 
        amendments made by this Act as described in paragraphs (2)(B) 
        and (2)(C) of this subsection, and not later than 24 months 
        after the date of enactment of this Act, the Secretary shall 
        issue final regulations implementing such amendments.
            (2) Contents.--In issuing regulations implementing the 
        amendments made by this Act, and in taking an action to review 
        an application for approval of a new animal drug under section 
        512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360b), or a request for an investigational exemption for a new 
        animal drug under subsection (j) of such section, that is 
        pending or has been submitted prior to the effective date of the 
        regulations, the Secretary shall--
                    (A) further define the term ``adequate and well 
                controlled'', as used in subsection (d)(3) of section 
                512 of such Act, to require that field investigations be 
                designed and conducted in a scientifically sound manner, 
                taking into account practical conditions in the field 
                and differences between field conditions and laboratory 
                conditions;
                    (B) further define the term ``substantial 
                evidence'', as defined in subsection (d)(3) of such 
                section, in a manner that encourages the submission of 
                applications and supplemental applications; and
                    (C) take into account the proposals contained in the 
                citizen petition (FDA Docket No. 91P-0434/CP) jointly 
                submitted by the American Veterinary Medical Association 
                and the Animal Health Institute, dated October 21, 1991.
        Until the regulations required by subparagraph (A) are issued, 
        nothing in the regulations published at 21 C.F.R. 514.111(a)(5) 
        (April 1, 1996) shall be construed to compel the Secretary of 
        Health and Human Services to require a field investigation under 
        section 512(d)(1)(E) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360b(d)(1)(E)) or to apply any of its 
        provisions in a manner inconsistent with the considerations for 
        scientifically sound field investigations set forth in 
        subparagraph (A).

    (f) <<NOTE: 21 USC 360b note.>>  Minor Species and Uses.--The 
Secretary of Health and Human Services shall consider legislative and 
regulatory options for facilitating the approval under section 512 of 
the Federal Food, Drug, and Cosmetic Act of animal drugs intended for 
minor species

[[Page 110 STAT. 3155]]

and for minor uses and, within 18 months after the date of enactment of 
this Act, announce proposals for legislative or regulatory change to the 
approval process under such section for animal drugs intended for use in 
minor species or for minor uses.

SEC. 3. LIMITATION ON RESIDUES.

    Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended to read as 
follows:
            ``(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;''.

SEC. 4. IMPORT TOLERANCES.

    Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the 
following new paragraph at the end:
    ``(6) For purposes of section 402(a)(2)(D), a use or intended use of 
a new animal drug shall not be deemed unsafe under this section if the 
Secretary establishes a tolerance for such drug and any edible portion 
of any animal imported into the United States does not contain residues 
exceeding such tolerance. In establishing such tolerance, the Secretary 
shall rely on data sufficient to 
demonstrate that a proposed tolerance is safe based on similar food 
safety criteria used by the Secretary to establish tolerances for 
applications for new animal drugs filed under subsection (b)(1). The 
Secretary may consider and rely on data submitted by the drug 
manufacturer, including data submitted to appropriate regulatory 
authorities in any country where the new animal drug is lawfully used or 
data available from a relevant international organization, to the extent 
such data are not inconsistent with the criteria used by the Secretary 
to establish a tolerance for applications for new animal drugs filed 
under subsection (b)(1). For purposes of this paragraph, `relevant 
international organization' means the Codex Alimenterius Commission or 
other international organization deemed appropriate by the Secretary. 
The Secretary may, under procedures specified by regulation, revoke a 
tolerance established under this paragraph if information demonstrates 
that the use of the new animal drug under actual use conditions results 
in food being imported into the United States with residues exceeding 
the tolerance or if scientific evidence shows the tolerance to be 
unsafe.''.

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