H. R. 2508
One Hundred Fourth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Wednesday,
the third day of January, one thousand nine hundred and ninety-six
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.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
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 inves-
tigations (other than bioequivalence or residue studies)
and,’’ and inserting ‘‘substantial evidence of the effective-
ness of the drug involved, any studies of animal safety,
or,’’; and
(B) by striking ‘‘essential to’’ and inserting ‘‘required
for’’.
H. R. 2508—2
(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 investiga-
tions’’ 
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, rec-
ommends, 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 combina-
tion, 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 informa-
tion 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) refus-
ing to approve an application for a combination animal drug
intended for use other than in animal feed or drinking water