240 
Secretary on the status of the study. Unless the 
applicant demonstrates good cause for failure to 
comply with such timeline, the applicant shall 
be in violation of this subsection. The Secretary 
shall determine what constitutes good cause 
under the preceding sentence. 
‘‘(4) SAFETY LABELING CHANGES REQUESTED 
BY SECRETARY.— 
‘‘(A) NEW
SAFETY
INFORMATION.—The 
Secretary shall promptly notify the responsible 
person if the Secretary becomes aware of new 
safety information that the Secretary believes 
should be included in the labeling of the drug. 
‘‘(B) RESPONSE TO NOTIFICATION.—Fol-
lowing notification pursuant to subparagraph 
(A), the responsible person shall within 30 
days— 
‘‘(i) submit a supplement proposing 
changes to the approved labeling to reflect 
the new safety information, including 
changes to boxed warnings, contraindica-
tions, warnings, precautions, or adverse re-
actions; or 
‘‘(ii) notify the Secretary that the re-
sponsible person does not believe a labeling 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00240
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
241 
change is warranted and submit a state-
ment detailing the reasons why such a 
change is not warranted. 
‘‘(C) REVIEW.—Upon receipt of such sup-
plement, the Secretary shall promptly review 
and act upon such supplement. If the Secretary 
disagrees with the proposed changes in the sup-
plement or with the statement setting forth the 
responsible person’s reasons why no labeling 
change is necessary, the Secretary shall initiate 
discussions with the responsible person to reach 
agreement on whether the labeling for the drug 
should be modified to reflect the new safety in-
formation, and if so, the contents of such label-
ing changes. 
‘‘(D) 
DISCUSSIONS.—Such 
discussions 
shall not extend for more than 30 days after 
the response to the notification under subpara-
graph (B), unless the Secretary determines an 
extension of such discussion period is war-
ranted. 
‘‘(E) ORDER.—Within 15 days of the con-
clusion of the discussions under subparagraph 
(D), the Secretary may issue an order directing 
the responsible person to make such a labeling 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00241
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
242 
change as the Secretary deems appropriate to 
address the new safety information. Within 15 
days of such an order, the responsible person 
shall submit a supplement containing the label-
ing change. 
‘‘(F) DISPUTE
RESOLUTION.—Within 5 
days of receiving an order under subparagraph 
(E), the responsible person may appeal using 
the Food and Drug Administration’s normal 
dispute resolution procedures established by the 
Secretary in regulation and guidance. 
‘‘(G) VIOLATION.—If the change required 
by an order under subparagraph (E) is not 
made by the date so specified, the responsible 
person shall be considered to be in violation of 
this section. 
‘‘(H) SERIOUS PUBLIC HEALTH THREAT.— 
Notwithstanding subparagraphs (A) through 
(F), if the Secretary concludes that failure to 
make such a labeling change is necessary to 
protect against a serious public health threat, 
the Secretary may accelerate the timelines in 
such subparagraphs. 
‘‘(I) RULE OF CONSTRUCTION.—This para-
graph shall not be construed to affect the re-
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00242
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS