,,ii #aaith ,,congress #ast ,session ,s4 #bfif ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #c1 #bjbe,mr4 ,padilla 7for himself and ,mr4 ,young7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a ,foundation for ,enabling ,biotechnology ,innovation4 #a4 ,short title ,this ,act may be cited as the ,foundation for ,enabling ,biotechnology ,innovation ,act4 #b4 ,foundation for ,enabling ,biotechnology ,innovation 7a7 ,establishment ,the ,director of the ,national ,science ,foundation shall establish a nonprofit foundation to be known as the ,foundation for ,enabling ,biotechnology ,innovation4 7b7 ,mission ,the mission of the ,foundation for ,enabling ,biotechnology ,innovation 7referred to in this ,act as the ,foundation7 shall be to accelerate commercialization of biotechnology products in the ,united ,states by supporting and enhancing the capacity of ,federal agencies and fostering collaboration across sectors4 7c7 ,activities ,in carrying out its mission under subsection 7b71 the ,foundation may carry out the following3 7#a7 ,promote public-private partnerships that leverage expertise and resources across sectors to foster innovation and address challenges in commercialization of biotechnology products4 7#b7 ,convene relevant stakeholders to develop expert recommendations on biotechnology commercialization1 including horizon scanning for emerging technologies and regulation of novel products that may be commercialized in the future4 7#c7 ,advance collaboration and dialogue between ,federal agencies that contribute to commercialization of biotechnology and relevant stakeholders1 including industry1 institutions of higher education1 and nonprofit and philanthropic organizations4 7#d7 ,support and conduct public engagement1 education1 and outreach activities about innovation1 regulation1 commercialization1 and use of biotechnology products1 including to evaluate efficacy of communication methods4 7#e7 ,facilitate market access for ,united ,states biotechnology products1 including through international engagement1 commercial and regulatory diplomacy1 and development of shared norms and standards4 7#f7 ,support studies1 projects1 and research on topics such as market acceptance and regulatory process improvement1 including through direct funding1 grants1 competitions1 and other methods4 7#g7 ,develop and implement education and fellowship programs1 which may include-- 7,a7 short courses on biotechnology product commercialization2 7,b7 shadowing experiences with relevant ,federal agencies2 7,c7 capstone projects1 in which participants develop ideas to advance biotechnology commercialization2 and 7,d7 support for participants such as stipends1 travel1 health insurance1 professional development1 and other appropriate expenditures as determined appropriate by the ,foundation4 7#h7 ,provide direct support to ,federal agencies for discrete or ongoing projects4 7#i7 ,conduct other activities as determined necessary by the ,foundation to carry out its mission4 7d7 ,limitation ,the ,foundation shall not be an agency or instrumentality of the ,federal ,government and the ,foundation shall not conduct any regulation of biotechnology products or any other products4 7e7 ,support ,the ,foundation may receive1 administer1 solicit1 accept1 and use funds1 gifts1 devises1 or bequests1 either absolutely or in trust of real or personal property or any income therefrom or other interest therein to support activities under subsection 7c71 except that this subsection shall not apply if any of such is from a foreign country of concern or a foreign entity of concern4 7f7 ,tax exempt status ,the ,board of the ,foundation for ,enabling ,biotechnology ,innovation shall take all necessary and appropriate steps to ensure the ,foundation is an organization described in section #eja7;c7 of the ,internal ,revenue ,code of #aihf1 and exempt from taxation under section #eja7;a7 of such ,code4 7g7 ,board of directors 7#a7 ,establishment ,the ,foundation for ,enabling ,biotechnology ,innovation shall be governed by a ,board of ,directors 7referred to in this section as the ,board74 7#b7 ,composition ,the ,board shall be composed of the following3 7,a7 ,not fewer than #e voting members described in paragraph 7#d74 7,b7 ,ex officio nonvoting members described in paragraph 7#e74 7#c7 ,initial members ,the ,director of the ,national ,science ,foundation shall-- 7,a7 seek to enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine to develop a list of individuals to serve as members of the ,board who are well-qualified and meet the requirements in paragraph 7#d72 and 7,b7 appoint the initial members of the ,board from such list not later than #ahj days after the date of enactment of this ,act4 7#d7 ,voting members 7,a7 ,representation ,the voting members of the ,board shall be drawn from a broad cross-section of stakeholders across sectors1 regions1 and communities1 including from institutions of higher education1 industry1 and nonprofit and philanthropic organizations4 7,b7 ,experience ,the voting members of the ,board shall have the experience and qualifications to provide advice and information to advance the mission of the ,foundation for ,enabling ,biotechnology ,innovation4 7,c7 ,federal employees ,no employee of the ,federal ,government may be appointed as a voting member of the ,board4 7#e7 ,nonvoting members 7,a7 ,ex officio members ,the ex officio members of the ,board shall be designated by-- 7i7 the ,director of the ,national ,science ,foundation2 7ii7 the ,secretary of ,defense2 7iii7 the ,secretary of ,agriculture2 7iv7 the ,secretary of ,health and ,human ,services2 7v7 the ,administrator of the ,environmental ,protection ,agency2 and 7vi7 the heads of other agencies1 as agreed upon by the ,board4 7,b7 ,no voting power ,the ex officio members described in subparagraph 7,a7 shall not have voting power on the ,board4 7#f7 ,chair and vice chair 7,a7 ,in general ,the ,board shall designate1 from among its voting members-- 7i7 an individual to serve as the ,chair of the ,board2 and 7ii7 an individual to serve as the ,vice ,chair of the ,board4 7,b7 ,terms ,the term of service of the ,chair and ,vice ,chair of the ,board shall end on the earlier of-- 7i7 the date that is #c years after the date on which the ,chair or ,vice ,chair of the ,board is designated for the respective position2 or 7ii7 the last day of the term of service of the member1 as determined under paragraph 7#g71 who is designated to be ,chair or ,vice ,chair of the ,board4 7,c7 ,representation ,the ,chair and ,vice ,chair of the ,board may not be representatives of the same area of subject matter expertise or entity4 7#g7 ,terms and vacancies 7,a7 ,term limits ,the term of office of each voting member of the ,board shall be not more than #e years1 except that a member of the ,board may continue to serve after the expiration of their term1 if no new member is appointed to replace the departing ,board member4 7,b7 ,initial members ,of the initial members of the ,board appointed under paragraph 7#c71 half of such members shall serve for #d years and half of such members shall serve for #e years1 as determined by the ,chair of the ,board4 7,c7 ,vacancies ,any vacancy in the voting membership of the ,board-- 7i7 shall be filled in accordance with the bylaws of the ,foundation by individuals who are well qualified and meet the requirements in paragraph 7#d72 7ii7 shall not affect the power of the remaining members to carry out the duties of the ,board2 and 7iii7 shall be filled by an individual selected by the ,board4 7,d7 ,renewal ,board members may be renewed for additional terms1 as long as the individual continues to meet the requirements in paragraph 7#d74 7#h7 ,quorum ,a majority of the voting members of the ,board shall constitute a quorum for the purposes of conducting the business of the ,board4 7#i7 ,duties ,the ,board shall carry out the following3 7,a7 ,establish bylaws for the ,foundation in accordance with paragraph 7#aj74 7,b7 ,provide overall direction for the activities of the ,foundation and establish priority activities4 7,c7 ,coordinate with the ,director of the ,national ,science ,foundation regarding the activities of the ,foundation for ,enabling ,biotechnology ,innovation to ensure consistency with the programs and policies of the ,national ,science ,foundation and other ,federal agencies4 7,d7 ,evaluate the performance of the ,chief ,executive ,officer of the ,foundation4 7,e7 ,actively solicit and accept funds1 gifts1 grants1 devises1 or bequests of real or personal property to the ,foundation1 including from private entities4 7,f7 ,carry out any other necessary activities of the ,foundation4 7#aj7 ,bylaws ,the ,board shall establish bylaws for the ,foundation1 ensuring that-- 7,a7 the bylaws of the ,foundation shall include-- 7i7 policies for the selection of the ,board members1 officers1 employees1 agents1 and contractors of the ,foundation2 7ii7 policies1 including ethical and disclosure standards1 including-- 7,i7 the acceptance1 solicitation1 and disposition of donations and grants to the ,foundation1 including appropriate limits on the ability of donors to designate1 by stipulation or restriction1 the use or recipient of donated funds2 and 7,,ii7 the disposition of assets of the ,foundation2 7iii7 policies that subject all employees1 fellows1 trainees1 and other agents of the ,foundation 7including appointed voting members and ex officio members of the ,board7 to conflict-of-interest standards2 and 7iv7 the specific duties of the ,chief ,executive ,officer of the ,foundation2 and 7,b7 the bylaws of the ,foundation and activities carried out under such bylaws do not-- 7i7 reflect unfavorably upon the ability of the ,foundation to carry out its responsibilities or official duties in a fair and objective manner2 or 7ii7 compromise1 or appear to compromise1 the integrity of any ,federal ,governmental agency or program1 or any officer or employee employed by1 or involved in a ,federal ,governmental agency or program4 7#aa7 ,compensation 7,a7 ,in general ,members of the ,board may not receive compensation for serving on the ,board4 7,b7 ,certain expenses ,in accordance with the bylaws of the ,foundation1 members of the ,board may be reimbursed for travel expenses1 including per diem in lieu of subsistence and other necessary expenses incurred in carrying out the duties of the ,board4 7#ab7 ,personal liability ,the members of the ,board shall not be personally liable for carrying out the duties of the ,board1 except for malfeasance4 7h7 ,administration 7#a7 ,chief executive officer 7,a7 ,in general ,the ,foundation shall have a ,chief ,executive ,officer who shall be appointed by the ,board1 and who shall serve at the pleasure of the ,board1 and for whom the ,board shall establish the rate of compensation4 7,b7 ,duties ,subject to the bylaws established under subsection 7g77#aj71 the ,chief ,executive ,officer shall be responsible for-- 7i7 carrying out the activities of the ,foundation under subsection 7c72 7ii7 hiring1 promoting1 compensating1 and discharging officers and employees of the ,foundation and defining the duties of such officers and employees2 7iii7 accepting and administering donations to the ,foundation and administering the assets of the ,foundation2 7iv7 entering into contracts and executing legal instruments as appropriate in carrying out the activities of the ,foundation2 and 7v7 performing other functions as necessary to operate the ,foundation4 7#b7 ,strategic plan ,not later than #a year after the appointment of the ,chief ,executive ,officer1 the ,foundation shall submit to the ,director of the ,national ,science ,foundation1 the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate1 and the ,committee on ,science1 ,space1 and ,technology of the ,house of ,representatives a strategic plan that contains the following3 7,a7 ,a plan for the ,foundation to become financially self-sustaining not later than #e years after the submission of the strategic plan1 aside from regular appropriations4 7,b7 ,short- and long-term objectives of the ,foundation1 as identified by the ,board4 7,c7 ,the efforts the ,foundation will take to be transparent in the processes of the ,foundation4 7,d7 ,the financial goals and benchmarks of the ,foundation for the #aj years following the submission of the strategic plan4 7,e7 ,the efforts the ,foundation will make to ensure maximum complementarity and minimum redundancy with ,federal activities related to biotechnology commercialization4 7#c7 ,report 7,a7 ,in general ,not later than #ah months after the appointment of the ,chief ,executive ,officer1 and not later than ,february #a of each year thereafter1 the ,foundation shall publish a report describing the activities of the ,foundation during the immediately preceding fiscal year that includes the accomplishments1 operations1 activities1 and financial condition of the ,foundation4 7,b7 ,financial condition ,each such report shall include a comprehensive statement of all support provided to the ,foundation1 including funds1 gifts1 grants1 devises1 or bequests of real or personal property1 and describing the amount of support from each person or entity1 the persons or entities from which such support is received1 and any restrictions on the purposes for which such support may be used4 7,c7 ,publication ,the ,foundation shall make copies of each report submitted under this paragraph available-- 7i7 to the ,director of the ,national ,science ,foundation1 the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate1 and the ,committee on ,science1 ,space1 and ,technology of the ,house of ,representatives2 and 7ii7 for public inspection1 and shall upon request1 provide a copy of the report to any individual for a charge not to exceed the cost of providing such copy4 7#d7 ,audits and disclosure ,the ,foundation shall-- 7,a7 provide for annual audits of the financial condition of the ,foundation1 including a full list of the ,foundation's donors and any restrictions on the purposes for which gifts to the ,foundation may be used2 and 7,b7 make such audits1 and all other records1 documents1 and other papers of the ,foundation1 available to the ,director of the ,national ,science ,foundation and the ,comptroller ,general of the ,united ,states for examination or audit4 7#e7 ,transfer of funds ,the ,foundation may transfer funds and property to ,federal agencies that contribute to commercialization of biotechnology1 which those agencies may accept and use to further the mission of the ,foundation as described in subsection 7b74 7i7 ,integrity 7#a7 ,in general ,to ensure integrity in the operations of the ,foundation1 the ,board shall develop and enforce procedures relating to standards of conduct1 financial disclosure statements1 conflicts of interest 7including recusal and waiver rules71 audits1 and any other matters determined appropriate by the ,board4 7#b7 ,conflicts of interest ,to mitigate conflicts of interest1 any individual who is an officer1 employee1 or member of the ,board is prohibited from any participation in deliberations by the ,foundation of a matter that would directly or predictably affect any financial interest of any of the following3 7,a7 ,such individual4 7,b7 ,a relative of such individual4 7,c7 ,a business organization or other entity in which such individual has an interest1 including an organization or other entity with which such individual is negotiating employment4 7#c7 ,citizenship ,to mitigate risks from malign foreign influence1 any individual who is an officer1 employee1 or member of the ,board shall be-- 7,a7 a citizen or national 7as defined in section #aja of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aaja7;a777 of the ,united ,states2 7,b7 an alien admitted to the ,united ,states as a refugee under section #bjg of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aaeg72 or 7,c7 an alien lawfully admitted for permanent residence 7as defined in section #aja of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #aaja7;a7774 7j7 ,intellectual property ,the ,board shall adopt written standards to govern the ownership and licensing of any intellectual property rights developed by the ,foundation or derived from the collaborative efforts of the ,foundation4 7k7 ,full faith and credit ,the ,united ,states shall not be liable for any debts1 defaults1 acts1 or omissions of the ,foundation4 ,the full faith and credit of the ,united ,states shall not extend to any obligations of the ,foundation4 7l7 ,support services ,the ,director of the ,national ,science ,foundation may provide facilities1 utilities1 and support services to the ,foundation4 7m7 ,non-,applicability ,chapters #e and #aj of title #e1 ,united ,states ,code1 shall not apply to the ,foundation4 7n7 ,separate fund accounts ,the ,board shall ensure that amounts received pursuant to the authorization of appropriations under subsection 7o7 are held in a separate account from any other funds received by the ,foundation4 7o7 ,authorization of appropriations 7#a7 ,national ,science ,foundation ,there are authorized to be appropriated to the ,director of the ,national ,science ,foundation #d1jjj1jjj for fiscal year #bjbf1 and every subsequent year to carry out this section4 7#b7 ,foundation for enabling biotechnology innovation ,from amounts appropriated to the ,national ,science ,foundation for each fiscal year1 the ,director of the ,national ,science ,foundation shall transfer not less than #d1jjj1jjj per year to the ,foundation4 7p7 ,definitions ,in this section3 7#a7 ,board ,the term ,board means the ,board of ,directors of the ,foundation1 established pursuant to subsection 7g74 7#b7 ,foreign country of concern ,the term foreign country of concern has the meaning given such term in section #ajfch of the ,research and ,development1 ,competition1 and ,innovation ,act 7#db ,u4,s4,c4 #aibcg2 enacted as part of division ,b of ,public ,law #aag-afg74 7#c7 ,foreign entity of concern ,the term foreign entity of concern has the meaning given such term in section #ajfch of the ,research and ,development1 ,competition1 and ,innovation ,act 7#db ,u4,s4,c4 #aibcg2 enacted as part of division ,b of ,public ,law #aag-afg74 7#d7 ,foundation ,the term ,foundation means the ,foundation for ,enabling ,biotechnology ,innovation established pursuant to subsection 7a74 7#e7 ,institution of higher education ,the term institution of higher education has the meaning given such term in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja74 7#f7 ,relative ,the term relative has the meaning given such term in section #acaja of title #e1 ,united ,states ,code4