276 
mitigation strategy, for drugs in the phar-
macological class; 
‘‘(ii) seek public comment about such 
action; and 
‘‘(iii) after seeking such comment, 
issue an order addressing such regulatory 
action. 
‘‘(8) 
INTERNATIONAL
COORDINATION.—The 
Secretary may coordinate the timetable for submis-
sion of assessments under subsection (d), or a study 
or clinical trial under section 505(o)(3), with efforts 
to identify and assess the serious risks of such drug 
by the marketing authorities of other countries 
whose drug approval and risk management processes 
the Secretary deems comparable to the drug ap-
proval and risk management processes of the United 
States. If the Secretary takes action to coordinate 
such timetable, the Secretary shall give notice to the 
public of the action not later than 5 days after the 
action. 
‘‘(9) EFFECT.—Use of the processes described 
in paragraphs (7) and (8) shall not delay action on 
an application or a supplement to an application for 
a drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
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277 
‘‘(1) IN GENERAL.—A drug that is the subject 
of an abbreviated new drug application under section 
505(j) is subject to only the following elements of 
the risk evaluation and mitigation strategy required 
under subsection (a) for the applicable listed drug: 
‘‘(A) A Medication Guide or patient pack-
age insert, if required under subsection (e) for 
the applicable listed drug. 
‘‘(B) Restrictions on distribution or use, if 
required under subsection (f) for the listed 
drug. A drug that is the subject of an abbre-
viated new drug application and the listed drug 
shall use a single, shared system under sub-
section (f)(4). The Secretary may waive the re-
quirement under the preceding sentence for a 
drug that is the subject of an abbreviated new 
drug application if the Secretary determines 
that— 
‘‘(i) it is not practical for the drug to 
use such single, shared system; or 
‘‘(ii) the burden of using the single, 
shared system outweighs the benefit of 
using the single system. 
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278 
‘‘(2) ACTION BY SECRETARY.—For an applica-
ble listed drug for which a drug is approved under 
section 505(j), the Secretary— 
‘‘(A) shall undertake any communication 
plan to health care providers required under 
subsection (e)(3) for the applicable listed drug; 
and 
‘‘(B) shall inform the responsible person 
for the drug that is so approved if the risk eval-
uation and mitigation strategy for the applica-
ble listed drug is modified. 
‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(1) IN
GENERAL.—There is established a 
Drug Safety Oversight Board. 
‘‘(2) COMPOSITION; 
MEETINGS.—The Drug 
Safety Oversight Board shall— 
‘‘(A) be composed of scientists and health 
care practitioners appointed by the Secretary, 
each of whom is an employee of the Federal 
Government; 
‘‘(B) include representatives from offices 
throughout the Food and Drug Administration; 
‘‘(C) include at least 1 representative from 
each of the National Institutes of Health and 
the Department of Health and Human Services 
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