PUBLIC LAW 100-670—NOV. 16, 1988 102 STAT. 3977

drug has been withdrawn from sale for safety or effectiveness
reasons;

"(x) the application does not meet any other requirement of
subsection (n); or

"(xi) the application contains an untrue statement of material
fact.

"(B) If the Secretary finds that a new animal drug for which an
application is submitted under subsection (b)(2) is bioequivalent to
the approved new animal drug referred to in such application and
that residues of the new animal drug are consistent with the
tolerances established for such approved new animal drug but at a
withdrawal period which is different than the withdrawal period
approved for such approved new animal drug, the Secretary may
establish, on the basis of information submitted, such different
withdrawal period as the withdrawal period for the new animal
drug for purposes of the approval of such application for such drug.
"(C) Within 180 days of the initial receipt of an application under
subsection (b)(2) or within such additional period as may be agreed
upon by the Secretary and the applicant, the Secretary shall ap-
prove or disapprove the application.

"(D) The approval of an application filed under subsection (b)(2)
shall be made effective on the last applicable date determined under
the following:

"(i) If the applicant only made a certification described in
clause (i) or (ii) of subsection (n)(l)(G) or in both such clauses, the
approval may be made effective immediately.

'(ii) If the applicant made a certification described in clause
(iii) of subsection (n)(l)(G), the approval may be made effective
on the date certified under clause (iii).

"(iii) If the applicant made a certification described in clause Courts, U.S.
(iv) of subsection (n)(D(G), the approval shall be made effective
immediately unless an action is brought for infringement of a
patent which is the subject of the certification before the expira-
tion of 45 days from the date the notice provided under subsec-
tion (n)(2)(B)(i) is received. If such an action is brought before
the expiration of such days, the approval shall be made effective
upon the expiration of the 30 month period beginning on the
date of the receipt of the notice provided under subsection
(n)(2)(B) or such shorter or longer period as the court may order
because either party to the action failed to reasonably cooperate
in expediting the action, except that if before the expiration of
such period—

"(I) the court decides that such patent is invalid or not
infringed, the approval shall be made effective on the date
of the court decision,

"(II) the court decides that such patent has been in-
fringed, the approval shall be made effective on such date
as the court orders under section 271(e)(4XA) of title 35,
United States Code, or

"(III) the court grants a preliminary injunction prohibit-
ing the applicant from engaging in the commercial manu-
facture or sale of the drug until the court decides the issues
of patent validity and infringement and if the court decides
that such patent is invalid or not infringed, the approval
shall be made effective on the date of such court decision.
In such an action, each of the parties shall reasonably cooperate
in expediting the action. Until the expiration of 45 days from