267 
‘‘(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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268 
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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269 
later than 5 business days of scheduling 
the dispute for review, shall publish by 
posting on the Internet or otherwise a no-
tice that the dispute will be reviewed by 
the Drug Safety Oversight Board. 
‘‘(B) SCHEDULING REVIEW.—If a respon-
sible person requests review under subpara-
graph (A), the Secretary— 
‘‘(i) shall schedule the dispute for re-
view at 1 of the next 2 regular meetings of 
the Drug Safety Oversight Board, which-
ever meeting date is more practicable; or 
‘‘(ii) may convene a special meeting of 
the Drug Safety Oversight Board to review 
the matter more promptly, including to 
meet an action deadline on an application 
(including a supplemental application). 
‘‘(C) AGREEMENT AFTER DISCUSSION OR 
ADMINISTRATIVE APPEALS.— 
‘‘(i) FURTHER DISCUSSION OR ADMIN-
ISTRATIVE APPEALS.—A request for review 
under subparagraph (A) shall not preclude 
further discussions to reach agreement on 
the risk evaluation and mitigation strategy, 
and such a request shall not preclude the 
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use of administrative appeals within the 
Food and Drug Administration to reach 
agreement on the strategy, including ap-
peals as described in letters of the Sec-
retary (relating to the use of fees collected 
under section 736 to expedite the drug de-
velopment process and the process for the 
review of human drug applications) for 
procedural or scientific matters involving 
the review of human drug applications and 
supplemental applications that cannot be 
resolved at the divisional level. 
‘‘(ii) AGREEMENT
TERMINATES
DIS-
PUTE RESOLUTION.—At any time before a 
decision and order is issued under sub-
paragraph (G) , the Secretary and the re-
sponsible person may reach an agreement 
on the risk evaluation and mitigation strat-
egy through further discussion or adminis-
trative appeals, terminating the dispute 
resolution process, and the Secretary shall 
issue an action letter or order, as appro-
priate, that describes the strategy. 
‘‘(D) MEETING
OF
THE
BOARD.—At a 
meeting of the Drug Safety Oversight Board 
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271 
described in subparagraph (B), the Board 
shall— 
‘‘(i) hear from both parties; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The 
Secretary shall ensure that the proceedings of 
any such meeting are recorded, transcribed, and 
made public within 30 days of the meeting. The 
Secretary shall redact the transcript to protect 
any trade secrets or other confidential informa-
tion described in section 552(b)(4) of title 5, 
United States Code. 
‘‘(F) 
RECOMMENDATION
OF
THE 
BOARD.—Not later than 5 days after any such 
meeting, the Drug Safety Oversight Board shall 
provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 
days after the Board provides such written rec-
ommendation to the Secretary, the Secretary 
shall make the recommendation available to the 
public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION
LETTER.—With respect 
to a proposal or assessment referred to in 
paragraph (1), the Secretary shall issue an 
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272 
action letter that resolves the dispute not 
later than the later of— 
‘‘(I) the action deadline referred 
to in paragraph (3)(A); or 
‘‘(II) 7 days after receiving the 
recommendation of the Drug Safety 
Oversight Board. 
‘‘(ii) ORDER.—With respect to an as-
sessment of an approved risk evaluation 
and mitigation strategy under subsection 
(g)(1) or under any of subparagraphs (B) 
through (D) of subsection (g)(2), the Sec-
retary shall issue an order, which shall be 
made public, that resolves the dispute not 
later than 7 days after receiving the rec-
ommendation of the Drug Safety Oversight 
Board. 
‘‘(H) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided for under subparagraph 
(G). 
‘‘(I) EFFECT
ON
ACTION
DEADLINE.— 
With respect to a proposal or assessment re-
ferred to in paragraph (1), the Secretary shall 
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