PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 935
dkrause on GSDDPC44 with PUBLAW
described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 for procedural or scientific matters involving the review of human drug applications and supplemental applications that cannot be resolved at the divisional level. At the time a review has been scheduled under subparagraph (B) and notice of such review has been posted, the responsible person shall either withdraw the request under subparagraph (A) or terminate the use of such administrative appeals. ‘‘(ii) AGREEMENT TERMINATES DISPUTE RESOLUTION.—At any time before a decision and order is issued under subparagraph (G) , the Secretary (in consultation with the offices described in subsection (c)(2)) and the responsible person may reach an agreement on the risk evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the strategy. ‘‘(D) MEETING OF THE BOARD.—At a meeting of the Drug Safety Oversight Board described in subparagraph (B), the Board shall— ‘‘(i) hear from both parties via written or oral presentation; 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 90 days of the meeting. The Secretary shall redact the transcript to protect any trade secrets and other information that is exempted from disclosure under section 552 of title 5, United States Code, or section 552a 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 recommendation 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 action letter that resolves the dispute not later than the later of— ‘‘(I) the action deadline for the action letter on the application; or ‘‘(II) 7 days after receiving the recommendation of the Drug Safety Oversight Board. ‘‘(ii) ORDER.—With respect to an assessment 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 Secretary shall issue an order, which shall be made public, that resolves the dispute not later than 7 days after
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00933
Fmt 6580
Sfmt 6581
Public information. Deadline.
Deadlines. Public information.
Deadlines.
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
