PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 937
dkrause on GSDDPC44 with PUBLAW
‘‘(i) give notice of the deferral to the holder of the approved covered application not later than 5 days after the deferral; ‘‘(ii) publish the deferral in the Federal Register; and ‘‘(iii) give notice to the public of any public meetings to be convened under subparagraph (A), including a description of the deferral. ‘‘(C) PUBLIC MEETINGS.—Such public meetings may include— ‘‘(i) 1 or more meetings of the responsible person for such drugs; ‘‘(ii) 1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as provided for under paragraph (6); or ‘‘(iii) 1 or more workshops of scientific experts and other stakeholders. ‘‘(D) ACTION.—After considering the discussions from any meetings under subparagraph (A), the Secretary may— ‘‘(i) announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological 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, in consultation with the offices described in subsection (c)(2), may coordinate the timetable for submission 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 approval and risk management processes of the United States. If the Secretary takes action to coordinate such timetable, the Secretary shall give notice to the responsible person. ‘‘(9) EFFECT.—Use of the processes described in paragraphs (7) and (8) shall not be the sole source of delay of action on an application or a supplement to an application for a drug. ‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— ‘‘(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 package insert, if required under subsection (e) for the applicable listed drug. ‘‘(B) Elements to assure safe use, if required under subsection (f) for the listed drug. A drug that is the subject of an abbreviated new drug application and the listed drug shall use a single, shared system under subsection (f). The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application, and permit the applicant to
VerDate Aug 31 2005
13:52 Jan 23, 2009
Federal Register, publication. Public information.