264 
ficulties completing the study have been en-
countered; and 
‘‘(C) with respect to any postapproval clin-
ical trial required under section 505(o), the sta-
tus of such clinical trial, including whether en-
rollment has begun, the number of participants 
enrolled, the expected completion date, whether 
any difficulties completing the clinical trial have 
been encountered, and registration information 
with respect to requirements under section 
492C of the Public Health Service Act. 
‘‘(4) MODIFICATION.—A modification (whether 
an enhancement or a reduction) to the approved risk 
evaluation and mitigation strategy for a drug may 
include the addition or modification of any element 
under subsection (d) or the addition, modification, 
or removal of any element under subsection (e) or 
(f), such as— 
‘‘(A) modifying the timetable for assess-
ments of the strategy under subsection (d), in-
cluding to eliminate assessments; or 
‘‘(B) adding, modifying, or removing a re-
striction on distribution or use under subsection 
(f). 
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‘‘(5) NO EFFECT ON LABELING CHANGES THAT 
DO NOT REQUIRE PREAPPROVAL.—In the case of a 
labeling change to which section 314.70 of title 21, 
Code of Federal Regulations (or any successor regu-
lation), applies for which the submission of a supple-
mental application is not required or for which dis-
tribution of the drug involved may commence upon 
the receipt by the Secretary of a supplemental appli-
cation for the change, the submission of an assess-
ment of the approved risk evaluation and mitigation 
strategy for the drug under paragraph (2) is not re-
quired. 
‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW 
OF ASSESSMENTS OF APPROVED STRATEGIES.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary 
shall 
promptly review each proposed risk evaluation and 
mitigation strategy for a drug submitted under sub-
section (a) and each assessment of an approved risk 
evaluation and mitigation strategy for a drug sub-
mitted under subsection (g). 
‘‘(2) MARKETING PLAN.—As part of a review 
conducted under this subsection, the Secretary may 
require the applicant to submit information regard-
ing its marketing plan and practices for the drug, so 
as to allow the Secretary to determine whether any 
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of the proposed or ongoing marketing activities un-
dermine any of the requirements of the risk evalua-
tion and mitigation strategy. 
‘‘(3) DISCUSSION.—The Secretary shall initiate 
discussions with a responsible person for purposes of 
this subsection to determine a strategy— 
‘‘(A) if the proposed strategy is submitted 
as part of an application or supplemental appli-
cation under subsection (a) or subsection 
(g)(2)(A), not less than 60 days before the ac-
tion deadline for the application that has been 
agreed to by the Secretary and that has been 
set forth in goals identified in letters of the 
Secretary (relating to the use of fees collected 
under section 736 to expedite the drug develop-
ment process and the process for the review of 
human drug applications); 
‘‘(B) if the assessment is submitted under 
subparagraph (B) or (C) or subsection (g)(2), 
not later than 20 days after such submission; 
‘‘(C) if the assessment is submitted under 
subsection (g)(1) or subsection (g)(2)(D) , not 
later than 30 days after such submission; or 
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‘‘(D) if the assessment is submitted under 
subsection (g)(2)(D), not later than 10 days 
after such submission. 
‘‘(4) ACTION.— 
‘‘(A) IN GENERAL.—Unless the responsible 
person requests the dispute resolution process 
described under paragraph (5), the Secretary 
shall approve and describe the risk evaluation 
and mitigation strategy for a drug, or any 
modification to the strategy— 
‘‘(i) as part of the action letter on the 
application, when a proposed strategy is 
submitted under subsection (a) or an as-
sessment of the strategy is submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 
50 days after the date discussions of such 
modification begin under paragraph (3), 
when an assessment of the strategy is sub-
mitted under subsection (g)(1) or under 
any of subparagraphs (B) through (D) of 
subsection (g)(2). 
‘‘(B) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
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fails to act as provided under subparagraph 
(A). 
‘‘(C) PUBLIC
AVAILABILITY.—Any action 
letter described in subparagraph (A)(i) or order 
described in subparagraph (A)(ii) shall be made 
publicly available. 
‘‘(5) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 
15 days, and not later than 35 days, after 
discussions under paragraph (3) have 
begun, the responsible person may request 
in writing that a dispute about the strat-
egy be reviewed by the Drug Safety Over-
sight Board under subsection (j), except 
that the determination of the Secretary to 
require a risk evaluation and mitigation 
strategy is not subject to review under this 
paragraph. The preceding sentence does 
not prohibit review under this paragraph of 
the particular elements of such a strategy. 
‘‘(ii) SCHEDULING.—Upon receipt of 
a request under clause (i), the Secretary 
shall schedule the dispute involved for re-
view under subparagraph (B) and, not 
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