PUBLIC LAW 100-670—NOV. 16, 1988 102 STAT. 3979

food safety studies (other than bioequivalence or residue studies)
essential to the approval of the application and conducted or spon-
sored by the applicant, the Secretary may not make the approval of
an application submitted under subsection (b)(2) for the conditions of
approval of such drug in the subsection (b)(l) application effective
before the expiration of 3 years from the date of the approval of the
application under subsection (b)(l) for such drug.

"(iii) If a supplement to an application approved under subsection
(b)(l) is approved after the date of enactment of this paragraph and
the supplement contains reports of new clinical or field investiga-
tions (other than bioequivalence or residue studies) and, in the case
of food producing animals, human food safety studies (other than
bioequivalence or residue studies) essential to the approval of the
supplement and conducted or sponsored by the person submitting
the supplement, the Secretary may not make the approval of an
application submitted under subsection (b)(2) for a change approved
in the supplement effective before the expiration of 3 years from the
date of the approval of the supplement.

"(iy) An applicant under subsection (b)d) who comes within the
provisions of clause (i) of this subparagraph as a result of an
application which seeks approval for a use solely in non-food produc-
ing animals, may elect, within 10 days of receiving such approval, to
waive clause (i) of this subparagraph, in which event the limitation
on approval of applications submitted under subsection (b)(2) set
forth in clause (ii) of this subparagraph shall be applicable to the
subsection (b)(D application.

"(v) If an application (including any supplement to a new animal
drug application) submitted under subsection (bXD for a new animal
drug for a food-producing animal use, which includes an active
ingredient (including any ester or salt of the active ingredient)
which has been the subject of a waiver under subparagraph (B)(iv) is
approved after the date of enactment of this paragraph, and if the
application contains reports of clinical or field investigations or
human food safety studies (other than bioequivalence or residue
studies) essential to the new approval of the application and con-
ducted or sponsored by the applicant, the Secretary may not make
the approval of an application (including any supplement to such
application) submitted under subsection (bX2) for the new conditions
of approval of such drug in the subsection (bXD application effective
before the expiration of five years from the date of approval of the
application under subsection (b)(D for such drug. The provisions of
this paragraph shall apply only to the first approval for a food-
producing animal use for the same applicant after the waiver under
subparagraph (BXiv).

"(G) If an approved application submitted under subsection (bX2)
for a new animal drug refers to a drug the approval of which was
withdrawn or suspended for grounds described in paragraph (1) or
(2) of subsection (e) or was withdrawn or suspended under this
subparagraph or which, as determined by the Secretary, has been
withdrawn from sale for safety or effectiveness reasons, the ap-
proval of the drug under this paragraph shall be withdrawn or
suspended—

"(i) for the same period as the withdrawal or suspension
under subsection (e) or this subparagraph, or

"(ii) if the approved new animal drug has been withdrawn
from sale, for the period of withdrawal from sale or, if earlier,