Sec. 303. REAUTHORIZATION; REPORTING REQUIREMENTS
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## SEC. 303 REAUTHORIZATION; REPORTING REQUIREMENTS Part 7 of subchapter C of chapter VII, as added by section 302 of this Act, is amended by inserting after section 744B the following: > > ## “SEC. 744C REAUTHORIZATION; REPORTING REQUIREMENTS > > **[**[21 U.S.C. 379j-43](/us/usc/t21/s379j-43)**]** > > > ### “(a) Performance Report > > Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. > > > ### “(b) Fiscal Report > > Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year. > > > ### “(c) Public Availability > > The Secretary shall make the reports required under subsections
(a)and
(b)available to the public on the Internet Web site of the Food and Drug Administration. > > > ### “(d) Reauthorization > > > #### “(1) Consultation > > In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2017, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with— > > > ##### “(A) > > the Committee on Energy and Commerce of the House of Representatives; > > > ##### “(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 generic drug industry. > > > #### “(2) Prior public input > > Prior to beginning negotiations with the generic drug 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 generic drug 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 generic drug 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, 2017, 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 Internet 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 generic drug industry. > > > ##### “(B) Content > > The minutes described under subparagraph
(A)shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.” > . **[**Sections 304 was repealed effective on October 1, 2017 by section 305(c)(1) of Public Law 115–52.**]**
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