Board

(1) Establishment (A) In general The Foundation shall have a Board of Directors (referred to in this part as the “Board”), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members. (B) Ex officio members The ex officio members of the Board shall be the following individuals or their designees: (i) The Commissioner. (ii) The Director of the National Institutes of Health. (iii) The Director of the Centers for Disease Control and Prevention. (iv) The Director of the Agency for Healthcare Research and Quality. (C) Appointed members (i) In general The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members— (I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries; (II) 3 shall be representatives of academic research organizations; (III) 2 shall be representatives of patient or consumer advocacy organizations; (IV) 1 shall be a representative of health care providers; and (V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation. (ii) Additional members The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries. (iii) Requirements (I) Expertise The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics. (II) Federal employees No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B). For purposes of this section, the term “employee of the Federal Government” does not include a special Government employee, as that term is defined in section 202(a) of title 18 . (D) Initial meeting (i) In general Not later than 30 days after September 27, 2007 , the Secretary shall convene a meeting of the ex officio members of the Board to— (I) incorporate the Foundation; and (II) appoint the members of the Board in accordance with subparagraph (C). (ii) Service of ex officio members Upon the appointment of the members of the Board under clause (i)(II)— (I) the terms of service of the Director of the Centers for Disease Control and Prevention and of the Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall terminate; and (II) the Commissioner and the Director of the National Institutes of Health shall continue to serve as ex officio members of the Board, but shall be nonvoting members. (iii) Chair The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.

Source

21 USC § 379dd(d)(1)


Scoping language

in this part
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