written agreement referred to in paragraph (1). Not
later than 60 days after the submission of the report
of the studies, the Secretary shall determine if such
studies were or were not conducted in accordance
with the original written request and the written
agreement and reported in accordance with the re-
quirements of the Secretary for filing and so notify
the sponsor or holder.
‘‘(3) OTHER METHODS TO MEET THE STUDIES
REQUIREMENT.—If the sponsor or holder and the
Secretary have not agreed in writing on the proto-
cols for the studies, the studies requirement of sub-
section (a) or (c) is satisfied when such studies have
been completed and the reports accepted by the Sec-
retary. Not later than 90 days after the submission
of the reports of the studies, the Secretary shall ac-
cept or reject such reports and so notify the sponsor
or holder. The Secretary’s only responsibility in ac-
cepting or rejecting the reports shall be to deter-
mine, within the 90 days, whether the studies fairly
respond to the written request, whether such studies
have been conducted in accordance with commonly
accepted scientific principles and protocols, and
whether such studies have been reported in accord-
ance with the requirements of the Secretary for fil-
ing.
‘‘(e) DELAY OF EFFECTIVE DATE FOR CERTAIN AP-
PLICATIONS; PERIOD OF MARKET EXCLUSIVITY.—If the
Secretary determines that the acceptance or approval of
an application under section 505(b)(2) or 505(j) for a
drug may occur after submission of reports of pediatric
studies under this section, which were submitted prior to
the expiration of the patent (including any patent exten-
sion) or market exclusivity protection, but before the Sec-
retary has determined whether the requirements of sub-
section (d) have been satisfied, the Secretary shall delay
the acceptance or approval under section 505(b)(2) or
505(j), respectively, until the determination under sub-
section (d) is made, but such delay shall not exceed 90
days. In the event that requirements of this section are
satisfied, the applicable period of market exclusivity re-
ferred to in subsection (a) or (c) shall be deemed to have
been running during the period of delay.
‘‘(f) NOTICE OF DETERMINATIONS ON STUDIES RE-
QUIREMENT.—The Secretary shall publish a notice of any
determination that the requirements of subsection (d)
have been met and that submissions and approvals under
section 505(b)(2) or (j) for a drug will be subject to the
provisions of this section.
‘‘(g) DEFINITIONS.—As used in this section, the term
‘pediatric studies’ or ‘studies’ means at least one clinical
investigation (that, at the Secretary’s discretion, may in-
clude pharmacokinetic studies) in pediatric age-groups in
which a drug is anticipated to be used.
‘‘(h) LIMITATION.—The holder of an approved appli-
cation for a new drug that has already received six months
of market exclusivity under subsection (a) or subsection
(c) may, if otherwise eligible, obtain six months of market
exclusivity under subsection (c)(1)(B) for a supplemental
application, except that the holder is not eligible for exclu-
sivity under subsection (c)(2).’’
‘‘(i) SUNSET.—No period of market exclusivity shall
be granted under this section based on studies commenced
after January 1, 2004. The Secretary shall conduct a
study and report to Congress not later than January 1,
2003 based on the experience under the program. The
study and report shall examine all relevant issues, includ-
ing—
‘‘(1) the effectiveness of the program in improv-
ing information about important pediatric uses for
approved drugs;
‘‘(2) the adequacy of the incentive provided
under this section;
‘‘(3) the economic impact of the program; and
‘‘(4) any suggestions for modification that the
Secretary deems appropriate.’’.
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