primary reason the new animal drug approval proc-
ess has become so burdensome;
(5) there are not sufficient approved animal
drugs available to treat every specific disease or con-
dition found in each species of animal;
(6) it would benefit the public health and safety
to have many additional animal drugs reviewed and
approved by the Food and Drug Administration;
(7) economic and regulatory incentives are nec-
essary to encourage manufacturers of animal drugs
to convert unlabeled uses of the drugs to approved,
labeled uses; and
(8) it is important that the Center for Veteri-
nary Medicine of the Food and Drug Administration
promptly implement the recently developed mission,
vision, and guiding principles of the Center so that
the Food and Drug Administration is a global leader
as a public health organization that enables the mar-
keting of safe and effective products.
SEC. 3. EVIDENCE OF EFFECTIVENESS.
(a) ORIGINAL APPLICATIONS.—Section 512(d) (21
U.S.C. 360b(d)) is amended by striking paragraph (3) and
by adding at the end the following:
‘‘(4)(A) As used in this subsection and subsections
(c)(2)(F)(iii) and (e)(1)(C), the term ‘substantial evi-
dence’ means evidence from 1 or more scientifically sound
studies, including as appropriate in vitro studies, studies
in laboratory animals (including a target species),
bioequivalence studies, and any studies voluntarily under-
taken by or for the applicant, that taken together provide
reasonable assurance that the drug will have the claimed
or intended effect of the drug.
‘‘(B) For purposes of subparagraph (A), a study shall
be considered to be scientifically sound if the study is de-
signed and conducted in a manner that is consistent with
generally recognized scientific procedures and principles.’’.
(b) 
SUPPLEMENTAL
APPLICATIONS.—Section
512(c)(2)(F)(iii) (21 U.S.C. 360b(c)(2)(F)(iii)) is amend-
ed—
(1) by striking ‘‘reports of new clinical or field
investigations (other than bioequivalence or residue
studies) and’’ and inserting ‘‘substantial evidence (as
defined in subsection (d)(4)) of the effectiveness of
the drug involved, any studies of animal safety, or’’;
and
(2) by striking ‘‘essential to’’ and inserting ‘‘,
required for’’.
(c) MINOR SPECIES AND USES.—Section 512(d)(1)
(21 U.S.C. 360b(d)(1)) is amended by adding at the end
the following new sentence: ‘‘Subparagraph (E) shall not
apply to a claim for use of the drug described in subpara-
graph (E) in a minor species, or for a minor use of the
drug, as the terms ‘minor species’ and ‘minor use’ are de-
fined in regulations issued by the Secretary, if there is
an application filed under subsection (b) for the drug, and
the application is approved, prior to the submission of the
claim.’’.
(d) COMBINATION
DRUGS.—Section 512(d) (21
U.S.C. 360b(d)) is amended by inserting before paragraph
(4) (as added by subsection (a)) the following new para-
graph:
‘‘(3) In a case in which a new animal drug contains
more than 1 active ingredient, or the labeling of the drug
prescribes, recommends, or suggests use of the drug in
combination with another animal drug, and the active in-
gredients or drugs in the combination have been sepa-
rately approved for particular uses and species prior to
the approval of the application for the same uses and spe-
cies in combination (or, in the absence of such approvals,
after evaluating the safety and efficacy of the combination
itself), the Secretary may only consider with respect to the
combination whether any of the active ingredients or any
of the drugs in the combination, respectively, at the long-
est withdrawal time of any of the active ingredients or
drugs in the combination, respectively, is above its safe
concentration, i.e. exceeds its established tolerance (as
measured by its marker residue), or interferes with the
methods of analysis for another of the active ingredients
or drugs in the combination, respectively.’’.
(e) 
WITHDRAWAL
OF
APPROVAL.—Section
512(e)(1)(C) (21 U.S.C. 360b(e)(1)(C)) is amended by in-
serting after ‘‘substantial evidence’’ the following: ‘‘(as de-
fined in subsection (d)(4))’’.
(f) IMPLEMENTATION.—
(1) IN
GENERAL.—Not later than 6 months
after the date of enactment of this Act, the Sec-
retary shall issue proposed regulations implementing
the amendments made by this section. Not later
than 18 months after the date of enactment of this
Act, the Secretary shall issue final regulations imple-
menting the amendments.
(2) CONTENTS.—In issuing regulations imple-
menting the amendments made by this section, and
in taking an action to review an application for ap-
proval 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 ex-
emption for a new animal drug under subsection (j)
of such section, that is pending or has been submit-
ted prior to the effective date of the regulations, the
Secretary shall—
(A) further define the term ‘‘substantial
evidence’’, as defined in subsection (d)(4) of
such section, in a manner that encourages the
submission of applications for production drugs
that conserve food resources, of applications for
veterinary prescription drugs whose use is de-
signed to rely on the experience and training of
practitioners in establishing effective doses for
such drugs, and of supplemental applications,
including applications seeking approval for uses
of animal drugs in minor species, for minor
uses of such drugs, and for permitted unlabeled
uses of such drugs;
(B) take into account the proposals con-
tained in the citizen petition (FDA Docket No.
91P–0434/CP) jointly submitted by the Amer-
ican Veterinary Medical Association and the
Animal Health Institute, dated October 21,
1991;
(C)(i) provide for the opportunity for a
conference prior to the submission of an appli-
cation for approval of a new animal drug under
such section, and prior to the submission of a
request for an investigational exemption under
subsection (j) of such section, to make a deci-
sion establishing a submission or an investiga-
tional requirement (which decision shall bind
the Secretary and the applicant or requester
unless the Secretary by order determines that a
documented scientific requirement essential to
the determination of safety or effectiveness of
the animal drug involved has appeared after the
conference); and
(ii) not later than 10 days after each such
conference, by written order, provide a scientific
justification specific to the animal drug and in-
tended uses under consideration for requiring
studies of types other than the types of studies
specified in subsection (d)(4) of such section, as
being essential to provide substantial evidence
of effectiveness for the intended uses of the
drug;
SEC. 4. TIMEFRAME FOR APPROVAL.
The first sentence of section 512(c)(1) (21 U.S.C.
360b(c)(1)) is amended by striking ‘‘one hundred and
eighty’’ and inserting ‘‘90’’.
SEC. 5. DISPUTE RESOLUTION.
Section 
512(c)(1) 
(21 
U.S.C. 
360b(c)(1)) 
is
amended—
(1) in the first sentence—
(A) by redesignating subparagraphs (A)
and (B) as clauses (i) and (ii), respectively; and
(B) by inserting ‘‘(A)’’ after ‘‘(1)’’;
(2) in the second sentence, by striking ‘‘If’’ and
inserting the following:
‘‘(C) If’’; and
(3) by inserting after subparagraph (A) (as des-
ignated by paragraph (1)(B)) the following new sub-
paragraph:
‘‘(B)(i) At any time prior to the issuance of the notice
under subparagraph (A)(ii), the applicant may, in writing,
notify the Secretary that an impasse exists in the review
of the application with respect to a specifically identified
issue that is preventing the issuance of an order under
subparagraph (A)(i).
‘‘(ii) On receipt of the notification from the applicant,
the Secretary shall refer the disputed issue—
‘‘(I) to an existing (as of the date of the notifi-
cation) advisory committee having expertise related
to the issue;
‘‘(II) to an advisory committee convened in ac-
cordance with the procedure in section 721(b)(5)(D);
or
‘‘(III) to a special Government employee, as de-
fined in section 202(a) of title 18, United States
Code, who is acceptable to the Secretary and the ap-
plicant.
‘‘(iii) The applicant and representatives of the Sec-
retary may consult with the committee or employee on the
matter referred. The committee or employee shall submit
to the Secretary and the applicant a report containing rec-
ommendations (including a statement of reasons for the
recommendations) regarding the matter not later than 60
days after the date of the referral, or not later than 90
days after the date of the referral if the committee or em-
ployee considers the additional 30 days to be necessary.
Not later than 30 days after the date of receiving the re-
port, the Secretary shall, in writing, confirm or modify the
recommendations received, providing reasons and ref-
erence to data before the committee or employee for any
modification.’’.
SEC. 6. LIMITATION ON RESIDUES.
Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is
amended to read as follows:
‘‘(F) on 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 re-
sult in a residue of such drug in excess of a toler-
ance found by the Secretary to be safe for such
drug;’’.
SEC. 7. EXPORT OF NEW ANIMAL DRUGS.
(a) EXPORT
IN
ACCORDANCE
WITH
FOREIGN
LAW.—Section 801(e)(1) (21 U.S.C. 381(e)(1)) is amend-
ed by striking the last sentence.
(b) EXPORTS
OF CERTAIN UNAPPROVED PROD-
UCTS.—Section 802 (21 U.S.C. 382) is amended—
(1) in subsection (a)(1)(A), by striking ‘‘or sec-
tion 512’’;
(2) in subsection (b)(1)—
(A) in subparagraph (A)—
(i) by striking the comma at the end
of clause (ii) and inserting ‘‘, or’’;
(ii) by striking ‘‘or’’ at the end of
clause (iii); and
(iii) by striking clause (iv); and
(B) in subparagraph (C)—
(i) by striking ‘‘or 512,’’ and inserting
a comma; and
(ii) by striking ‘‘or 512(d) or’’ and in-
serting ‘‘of this Act or section’’;
(3) in subsection (c)(1)(C), by striking ‘‘505 or
512,’’ and inserting ‘‘505,’’; and
(4) in subsection (d)—
(A) in paragraph (3), by striking ‘‘505 or
512,’’ and inserting ‘‘505,’’; and
(B) in paragraph (4)—
(i) by striking ‘‘or 512(j)’’; and
(ii) by striking ‘‘505 or 512,’’ and in-
serting ‘‘505,’’.
SEC. 8. REPORT TO CONGRESS.
The Secretary shall study any efficiencies in the new
animal drug approval process that are caused by the
amendments made by this Act. Not later than 24 months
after the date of enactment of this Act, the Secretary shall
submit to the appropriate committees of Congress a report
containing the results of the study.
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