Page:United States Statutes at Large Volume 122.djvu/3547

 12 2 STA T .35 2 4PUBLIC LA W 11 0– 31 6— AU G .14 , 200 8andtheirsug gesti o ns f or c hanges to this p artase x pressed under paragraph (2).‘ ‘( 4 ) PUBLICREV IE WOF RECO M ME NDAT ION S . —A fter negotia - tions w ith the regu l ated industr y, the S ecretary shall— ‘‘(A) present the reco m mendations de v eloped under paragraph ( 1 ) to the congressional committees specified in such paragraph ‘‘( B )pu b lish such recommendations in the F ederal R eg- ister; ‘‘( C ) provide for a period of 30 days for the public to provide written comments on such recommendations; ‘‘( D ) hold a meeting at which the public may present its views on such recommendations; and ‘‘( E ) after consideration of such public views and com- ments, revise such recommendations as necessary. ‘‘( 5 ) T RANSMITTAL OF RECOMMENDATIONS.— N ot later than J anuary 15, 2013, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. ‘‘( 6 ) M INUTES OF NE G OTIATION MEETINGS.— ‘‘(A) PUBLIC AVAILABILIT Y .—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall ma k e publicly available, on the I nternet W eb site of the Food and Drug Administra- tion, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry. ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summari z e any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotia- tions and their resolution. ’ ’. SEC.204 .S UN SE TDA TES. (a) AUT H ORI Z ATION.—The amendments made by section 202 shall cease to be effective O ctober 1, 2013. (b) RE P ORTING RE Q UIREMENTS.—The amendment made by sec- tion 203 shall cease to be effective January 31, 2014. TI T LE III — TE CHN IC A LC OR RECTION S TO FD AAA SEC. 3 0 1 .C O NS I DE R ATION O F CERTAIN P ETITIONS. Subparagraph (A) of section 505( q )(1) (21 U .S.C. 355(q)(1)) is amended by adding at the end the following

‘‘Consideration of the petition shall be separate and apart from review and approval of any application.’’. SEC. 302. RE G ISTR Y AND RESU L TS DATA B AN K . Paragraph (3) of section 402( j ) of the Public H ealth Service Act (42 U.S.C. 2 8 2(j)) is amended— (1) in the matter preceding clause (i) in subparagraph (C), by striking ‘‘the following elements’’ and all that follows through ‘‘520(m) of such Act:’’ and inserting ‘‘for each applicable 21USC379j– 22 note. 21 USC 379j–21 note. W e bsi te. D e adl ine. F ede r al R e g ister ,pu bli c ation.

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