Page:United States Statutes at Large Volume 121.djvu/862

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[121 STAT. 841]
[121 STAT. 841]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 841

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‘‘(B) the Committee on Health, Education, Labor, and Pensions of the Senate; ‘‘(C) scientific and academic experts; ‘‘(D) health care professionals; ‘‘(E) representatives of patient and consumer advocacy groups; and ‘‘(F) the regulated industry. ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall— ‘‘(A) publish a notice in the Federal Register requesting public input on the reauthorization; ‘‘(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a); ‘‘(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and ‘‘(D) publish the comments on the Food and Drug Administration’s Internet Web site. ‘‘(3) PERIODIC CONSULTATION.—Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph (2). ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— ‘‘(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph; ‘‘(B) publish such recommendations in the Federal Register; ‘‘(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 comments, revise such recommendations as necessary. ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than January 15, 2012, the Secretary shall transmit to the 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) MINUTES OF NEGOTIATION MEETINGS.— ‘‘(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, 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 subparagraph (A) shall summarize any substantive proposal made

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Federal Register, publication.

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