,,ib ,union ,calendar ,no4 #bgg #aagth ,,congress #b;d ,session ,h4 ,r4 #eehe ,report ,no4 #aag-cfe ,,in ,,the ,,house ,,of ,,representatives ,october #ae1 #bjba,ms4 ,eshoo introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,june #ac1 #bjbb;,additional sponsors3 ,ms4 ,lofgren1 ,ms4 ,roybal-,allard1 ,mr4 ,thompson of ,california1 ,mr4 ,huffman1 ,mr4 ,costa1 ,mr4 ,suozzi1 ,ms4 ,johnson of ,texas1 ,mr4 ,michael ,f4 ,doyle of ,pennsylvania1 ,ms4 ,wasserman ,schultz1 ,mr4 ,mc,govern1 ,mr4 ,cartwright1 ,mrs4 ,fletcher1 ,mr4 ,crdenas1 ,ms4 ,craig1 ,mrs4 ,trahan1 ,mr4 ,pascrell1 ,mr4 ,courtney1 ,mr4 ,perlmutter1 ,ms4 ,ross1 ,mr4 ,mc,nerney1 ,mrs4 ,napolitano1 ,mr4 ,peters1 ,ms4 ,barragn1 ,mr4 ,levin of ,california1 ,mr4 ,tonko1 ,ms4 ,schrier1 ,ms4 ,blunt ,rochester1 ,mr4 ,khanna1 ,ms4 ,chu1 ,mr4 ,de,saulnier1 ,mr4 ,schiff1 ,ms4 ,speier1 ,mr4 ,aguilar1 ,mr4 ,trone1 ,ms4 ,mc,collum1 ,mr4 ,schrader1 ,ms4 ,jacobs of ,california1 ,mr4 ,quigley1 ,mr4 ,moulton1 ,mr4 ,welch1 ,mr4 ,rush1 ,ms4 ,schakowsky1 ,ms4 ,kuster1 ,ms4 ,kelly of ,illinois1 ,mrs4 ,dingell1 ,ms4 ,matsui1 ,ms4 ,castor of ,florida1 ,mr4 ,o',halleran1 ,ms4 ,de,gette1 ,mr4 ,upton1 ,ms4 ,sewell1 ,mr4 ,sarbanes1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,morelle1 ,mr4 ,grijalva1 ,mr4 ,nadler1 ,mr4 ,mc,eachin1 ,mr4 ,soto1 ,mr4 ,carbajal1 ,mr4 ,bishop of ,georgia1 ,mr4 ,fitzpatrick1 ,mr4 ,lawson of ,florida1 ,mr4 ,burgess1 ,mr4 ,cohen1 ,ms4 ,williams of ,georgia1 and ,ms4 ,brown of ,ohio ,june #ac1 #bjbb,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed,strike out all after the enacting clause and insert the part printed in italic,for text of introduced bill1 see copy of bill as introduced on ,october #ae1 #bjba ,a ,,bill ,to establish the ,advanced ,research ,projects ,agency-,health1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,advanced ,research ,projects ,agency-,health ,act or the ,,arpa-,h ,act4 #b4 ,advanced research projects agency-health ,title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 ,j ,advanced ,research ,projects ,agency-,health #dii;,a4 ,advanced ,research ,projects ,agency-,health 7a7 ,establishment ,there is established1 as an independent operating division within the ,department of ,health and ,human ,services1 the ,advanced ,research ,projects ,agency-,health 7in this part referred to as ,,arpa-,h74 ,not later than #ahj days after the date of enactment of this part1 the ,secretary shall transfer all functions1 personnel1 missions1 activities1 authorities1 and funds of the ,advanced ,research ,projects ,agency for ,health within the ,national ,institutes of ,health1 as in existence on the date of enactment of this part1 to ,,arpa-,h established by the preceding sentence4 7b7 ,goals and methods 7#a7 ,goals ,the goals of ,,arpa-,h shall be to-- 7,a7 foster the development of new1 breakthrough capabilities1 technologies1 systems1 and platforms to accelerate innovations in health and medicine that are not being met by ,federal programs or private entities2 7,b7 revolutionize detection1 diagnosis1 mitigation1 prevention1 treatment1 and curing of serious diseases and medical conditions through the development of transformative health technologies2 7,c7 promote high-risk1 high-reward innovation for the development and translation of transformative health technologies2 and 7,d7 contribute to ensuring the ,united ,states maintains-- 7i7 global leadership in science and innovation2 7ii7 the highest quality of life and health for its citizens2 and 7iii7 an aggressive agenda for innovations to address global health threats that place ,united ,states citizens at risk4 7#b7 ,methods ,,arpa-,h shall achieve the goals specified in paragraph 7#a7 by-- 7,a7 discovering1 identifying1 and promoting revolutionary advances in health sciences2 7,b7 translating scientific discoveries into transformative health technologies2 7,c7 providing resources and support to create platform capabilities that draw on multiple disciplines2 7,d7 using researchers in a wide range of disciplines1 including the life sciences1 the physical sciences1 engineering1 and the computational sciences2 7,e7 delivering advanced proofs of concept that demonstrate potentially clinically meaningful advances2 7,f7 developing new capabilities1 advanced computational tools1 predictive models1 or analytical techniques to identify potential targets and technological strategies for early disease detection and intervention2 7,g7 accelerating transformational technological advances in areas with limited technical certainty2 and 7,h7 prioritizing investments based on such considerations as-- 7i7 scientific opportunity and uniqueness of fit to the strategies and operating practices of ,,arpa-,h2 7ii7 the effect on disease burden1 including unmet patient need1 quality and disparity gaps1 and the potential to preempt progression of serious disease2 and 7iii7 the effect on the fiscal liability of the ,federal ,government with respect to health care and the ability to reduce the cost of care through innovation4 7c7 ,director 7#a7 ,in general ,the ,president shall appoint with the advice and consent of the ,senate1 a director of ,,arpa-,h 7in this part referred to as the ,director74 7#b7 ,qualifications ,the ,director shall be an individual who1 by reason of professional background and experience1 is especially qualified to manage-- 7,a7 research and advanced development programs2 and 7,b7 large-scale1 high-risk initiatives with respect to health research and technology development across multiple sectors1 including generating transformative health technologies and improving health outcomes for patients4 7#c7 ,relationship to secretary ,the ,director shall report directly to the ,secretary4 7#d7 ,duties ,the duties of the ,director shall include the following3 7,a7 ,approve and terminate the projects and programs of ,,arpa-,h4 7,b7 ,set research and development priorities with respect to the goals specified in subsection 7b7 and manage the budget of ,,arpa-,h4 7,c7 ,develop funding criteria and assess the success of programs through the establishment of technical milestones4 7,d7 ,advance the goals under subsection 7b71 through consideration of the advice of the ,,arpa-,h ,interagency ,research ,council established under subsection 7q74 7,e7 ,solicit data1 as needed1 from the ,national ,institutes of ,health and other relevant entities4 7,f7 ,coordinate with the ,director of the ,national ,institutes of ,health to ensure that the programs of ,,arpa-,h build on1 and are informed by1 scientific research supported by the ,national ,institutes of ,health4 7,g7 ,coordinate with the heads of ,federal agencies and1 to the extent practicable1 ensure that the activities of ,,arpa-,h supplement 7and do not supplant7 the efforts of other ,federal agencies4 7,h7 ,ensure ,,arpa-,h does not provide funding for a project unless the program manager determines that the project meets the goals described in subsection 7b77#a74 7#e7 ,term ,the ,director-- 7,a7 shall be appointed for a #e-year term2 and 7,b7 may be reappointed for #a consecutive #e-year term4 7#f7 ,autonomy of agency regarding recommendations and testimony ,no officer or agency of the ,united ,states shall have any authority to require the ,director or any other officer of ,,arpa-,h to submit legislative recommendations1 or testimony or comments on legislation1 to any officer or agency of the ,united ,states for approval1 comments1 or review prior to the submission of such recommendations1 testimony1 or comments to the ,congress1 if such recommendations1 testimony1 or comments to the ,congress include a statement indicating that the views expressed therein are those of the ,director or such officer1 and do not necessarily reflect the views of the ,president or another agency4 7#g7 ,delegation of authority ,the ,director may delegate to any duly authorized employee1 representative1 or agent any power vested in the ,director by law1 except that the ,director may not delegate the power to appoint the ,deputy ,director under paragraph 7#h74 7#h7 ,deputy ,director ,the ,director shall appoint a deputy director to serve as the first assistant to the office4 7d7 ,application of ,paperwork ,reduction ,act ,the ,director may waive the requirements of subchapter ,i of chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act7 with respect to the methods described in subsection 7b77#b74 7e7 ,protection of information ,the following types of information collected by ,,arpa-,h from recipients of financial assistance awards shall be considered commercial and financial information obtained from a person and privileged or confidential and not subject to disclosure under section #eeb7;b77#d7 of title #e1 ,united ,states ,code3 7#a7 ,plans for commercialization of technologies developed under the award1 including business plans1 technology-to market plans1 market studies1 and cost and performance models4 7#b7 ,investments provided to an awardee from third parties 7such as venture capital firms1 hedge funds1 and private equity firms71 including amounts and the percentage of ownership of the awardee provided in return for the investments4 7#c7 ,additional financial support that the awardee-- 7,a7 plans to invest or has invested in the technology developed under the award2 or 7,b7 is seeking from third parties4 7#d7 ,revenue from the licensing or sale of new products or services resulting from research conducted under the award4 7f7 ,sharing information with the ,centers for ,medicare ,medicaid ,services ,the ,director shall timely share relevant information with the ,administrator of the ,centers for ,medicare ,medicaid ,services that may help to expedite determinations of coverage of transformative health technologies developed by ,,arpa-,h4 7g7 ,expediting breakthroughs through cooperation with the ,food and ,drug ,administration 7#a7 ,in general ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,director1 may take actions to facilitate translation of transformative health technology into tangible solutions for patients and to expedite development of drugs1 devices1 and biological products1 including through-- 7,a7 helping to ensure that drug1 device1 or biological product development programs1 in as efficient a manner as possible1 gather the nonclinical and clinical data necessary to advancing the development of such products and to obtaining their approval1 licensure1 or clearance1 as applicable1 by the ,food and ,drug ,administration under sections #eje1 #eaj7k71 and #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act and section #cea of this ,act2 7,b7 expediting review of investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 review of investigational device exemptions under section #ebj7;g7 of such ,act1 and review of applications for approval1 licensure1 and clearance of drugs1 devices1 or biological products under sections #eje1 #eaj7k71 and #eae of such ,act1 and section #cea of this ,act2 and 7,c7 meeting at appropriate intervals with the ,director and any member of the ,,arpa-,h ,interagency ,research ,council to discuss the development status of drugs1 devices1 or biological products and projects that are the highest priorities to ,,arpa-,h1 unless the ,director and the ,commissioner of ,food and ,drugs determine that any such meetings are not necessary4 7#b7 ,relation to otherwise authorized activities of the ,,fda ,the authority specified in paragraph 7#a7 shall not be construed as limiting the authority of the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 with respect to the review and approval1 clearance1 authorization for emergency use1 or licensure of drugs1 devices1 or biological products under the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act4 7#c7 ,reimbursement ,the ,director1 using funds made available to ,,arpa-,h1 may reimburse the ,food and ,drug ,administration for expenditures made by the ,food and ,drug ,administration for activities carried out under this section that have been identified by the ,commissioner of ,food and ,drugs and the ,director as being carried out by the ,food and ,drug ,administration4 7h7 ,awards 7#a7 ,in general ,in carrying out this section1 the ,director may make awards including-- 7,a7 grants and cooperative agreements1 which shall-- 7i7 be subject to the uniform administrative requirements1 cost principles1 and audit requirements for ,federal awards contained in part #bjj of title #b1 ,code of ,federal ,regulations 7or successor regulations72 and 7ii7 include the total line-item and itemized indirect facilities and administrative costs that shall be made publicly available and published in a machine-readable format2 7,b7 contracts subject to the ,federal ,acquisition ,regulation2 7,c7 multi-year contracts under section #cijc of title #da1 ,united ,states ,code2 7,d7 prizes2 and 7,e7 other transactions4 7#b7 ,exemptions for certain requirements ,research funded by ,,arpa-,h shall not be subject to the requirements of section #djf7;a77#c77;,a77ii7 or section #dib4 7i7 ,facilities authority 7#a7 ,in general ,the ,director may acquire 7by purchase1 lease1 condemnation1 or otherwise71 construct1 improve1 repair1 operate1 and maintain such real and personal property as may be necessary to carry out this section4 7#b7 ,lease of nonexcess property ,the ,director may enter into a lease under this section with any person or entity 7including another department or agency of the ,federal ,government or an entity of a ,state or local government7 with regard to any nonexcess real property and related personal property under the jurisdiction of the ,director4 7#c7 ,utilization of lease funds 7,a7 ,in general ,the ,director may utilize1 without further appropriation1 amounts of cash consideration received for a lease entered into under this subsection to cover the full costs to ,,arpa-,h in connection with the lease4 ,funds received as such cash consideration shall remain available until expended4 7,b7 ,capital revitalization and improvements ,of any amounts of cash consideration received under this subsection that are not utilized in accordance with subparagraph 7,a71 without further appropriation-- 7i7 #ce percent shall-- 7,i7 be deposited in a capital asset account to be established by the ,director2 7,,ii7 be available for maintenance1 capital revitalization1 and improvements of the real property assets and related personal property under the jurisdiction of the ,director2 and 7,,iii7 remain available until expended2 and 7ii7 the remaining #fe percent shall be available to the respective center or facility of ,,arpa-,h engaged in the lease of nonexcess real property1 and shall remain available until expended for maintenance1 capital revitalization1 and improvements of the real property assets and related personal property at the respective center or facility subject to the concurrence of the ,director4 7,c7 ,no utilization for daily operating costs ,amounts utilized under subparagraph 7,b7 may not be utilized for daily operating costs4 7#d7 ,locations 7,a7 ,in general ,,arpa-,h1 including its headquarters1 shall not be located on any part of the existing ,national ,institutes of ,health campuses4 7,b7 ,considerations ,in determining the location of facilities1 the ,director shall make a fair and open consideration of-- 7i7 the characteristics of the intended location2 and 7ii7 the extent to which such location will facilitate advancement of the goals and methods specified in subsection 7b74 7j7 ,personnel 7#a7 ,in general ,the ,director may-- 7,a7 make and rescind appointments of scientific1 engineering1 medical1 and professional personnel1 which may include temporary or time-limited appointments as determined by the ,director to fulfill the mission of ,,arpa-,h1 without regard to any provision in title #e1 ,united ,states ,code1 governing appointments and removals under the civil service laws1 and fix the base pay compensation of such personnel at a rate to be determined by the ,director1 up to the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code2 and 7,b7 contract with private recruiting firms for the hiring of qualified staff referenced in subparagraph 7,a74 7#b7 ,additional staff ,the ,director may use1 to the same extent and in the same manner as the ,secretary1 all authorities in existence on the date of the enactment of this section that are provided to the ,secretary to hire administrative1 financial1 contracts1 legislative affairs1 information technology1 ethics1 and communications staff1 and such other staff as may be identified by the ,director as necessary to carry out this section4 7#c7 ,additional considerations ,in appointing personnel under this subsection1 the ,director-- 7,a7 may contract with private entities2 7,b7 shall make efforts to recruit and retain a diverse workforce1 including individuals underrepresented in science and medicine and racial and ethnic minorities 7as long as such efforts comply with applicable ,federal civil rights law72 and 7,c7 shall recruit program managers with expertise in a wide range of relevant disciplines1 including life sciences1 the physical sciences1 engineering1 and the computational sciences4 7#d7 ,additional hiring authority ,to the extent needed to carry out the authorities vested by paragraph 7#a71 the ,director may utilize hiring authorities under sections #ccga through #ccgf of title #e1 ,united ,states ,code1 to staff ,,arpa-,h with employees from other ,federal agencies1 ,state and local governments1 ,indian ,tribes and ,tribal organizations1 institutions of higher education1 and other organizations1 as described in such sections4 7#e7 ,existing authorities ,the authorities granted by this section are-- 7,a7 in addition to existing authorities granted to the ,secretary2 and 7,b7 are not intended to supersede or modify any existing authorities4 7#f7 ,authority to accept ,federal detailees ,the ,director may accept officers or employees of the ,united ,states or members of the uniformed service on a detail from an element of the ,federal ,government on a reimbursable or a nonreimbursable basis1 as jointly agreed to by the heads of the receiving and detailing elements1 for a period not to exceed #c years4 7k7 ,program managers 7#a7 ,in general ,the ,director shall appoint program managers for #c-year terms 7and may reappoint such program managers for #a consecutive #c-year term7 for the programs carried out by ,,arpa-,h4 7#b7 ,duties ,a program manager shall-- 7,a7 establish1 in consultation with the ,director or ,deputy ,director1 research and development goals for programs1 including timelines and milestones1 and make such goals available to the public2 7,b7 collaborate with experts from the ,national ,institutes of ,health and other ,federal agencies and experts in relevant scientific fields to identify research and development gaps and opportunities2 7,c7 convene workshops and meetings1 as needed1 with entities such as patients1 patient advocacy groups1 practitioners1 professional societies1 and other stakeholders to solicit input on programs and goals2 7,d7 manage applications and proposals1 through the appropriate officials for making grants1 cooperative agreements1 contracts1 prizes1 and other transaction awards for advanced research that may show particular promise1 especially in areas in which the private sector and the ,federal ,government have not undertaken sufficient research2 7,e7 issue funding opportunity announcements1 using uniform administrative processes1 as appropriate2 7,f7 select1 on the basis of merit1 each of the projects to be supported under a program carried out by ,,arpa-,h1 and taking into consideration-- 7i7 the scientific and technical merit of the proposed project2 7ii7 the capabilities of the applicants to successfully carry out the proposed project2 7iii7 the unmet needs or ability to improve health outcomes within patient populations2 7iv7 future commercial applications of the project or the feasibility of partnering with one or more commercial entities2 7v7 the potential for interdisciplinarity of the approach of the project2 and 7vi7 such other criteria as established by the ,director2 7,g7 conduct project reviews within #ah months of funding awards to identify milestones and monitor progress of such milestones with respect to each project and prior to disbursement of new funds2 7,h7 provide recommendations to the ,director with respect to advancing the goals specified in subsection 7b72 7,i7 cultivate opportunities for the commercial application or community use of successful projects1 including through the establishment of partnerships between or among awardees2 7,j7 identify innovative cost-sharing arrangements for ,,arpa-,h projects2 7,k7 provide recommendations to expand1 restructure1 or terminate research partnerships or projects2 and 7,l7 ensure that-- 7i7 animal studies meet the ,federal animal research requirements pursuant of the ,public ,health ,service ,policy on ,humane ,care and ,use of ,laboratory ,animals2 and 7ii7 applications apply statistical modeling approaches and appropriately justify animal sample sizes to meet project goals4 7l7 ,reports and evaluation 7#a7 ,annual report 7,a7 ,in general ,beginning not later than #a year after the date of enactment of this section1 and each fiscal year thereafter1 the ,director shall submit a report on the actions undertaken1 and results generated1 by ,,arpa-,h1 including-- 7i7 a description of projects supported by ,,arpa-,h in the previous fiscal year and whether such projects are meeting the goals developed by the ,director pursuant to subsection 7c77#d77;,c72 7ii7 a description of projects terminated in the previous fiscal year1 and the reason for such termination2 7iii7 a description of programs starting in the next fiscal year1 as available2 7iv7 activities conducted in coordination with other ,federal agencies2 7v7 an analysis of the extent of coordination conducted pursuant to subsections 7c77#d77;,f7 and 7f71 including successes and barriers with respect to achieving the goals under subsection 7b72 7vi7 a description of the demographic 7including racial and gender7 diversity if available of direct recipients and performers in funded projects and of the ,,arpa-,h workforce2 and 7vii7 a disclosure by the reward recipients of whether the principal investigators named on the award participate in foreign talent programs1 including the provision of copies of all grants1 contracts1 or other agreements related to such programs1 and other supporting documentation related to such programs1 as a condition of receipt of ,federal extramural biomedical research funding awarded4 7,b7 ,submission to ,congress ,the report under subparagraph 7,a7 shall be submitted to-- 7i7 the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives2 and 7ii7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate4 7#b7 ,evaluation 7,a7 ,in general ,not later than #e years after the date of the enactment of this section1 the ,secretary shall enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine under which the ,national ,academies agree to study and evaluate whether ,,arpa-,h is meeting the goals specified in subsection 7b74 7,b7 ,submission of results ,the agreement entered into under subparagraph 7,a7 shall require the ,national ,academies of ,sciences1 ,engineering1 and ,medicine to submit the results of the evaluation conducted under such agreement to the ,secretary1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7m7 ,strategic plan ,not later than #a year after the date of the enactment of this section1 and every #c years thereafter1 the ,director shall provide to the relevant committees of ,congress a strategic plan describing how ,,arpa-,h will carry out investments each fiscal year in the following #c-year period4 7n7 ,independent review ,not later than #a year after the date of the enactment of this section1 and every #c years thereafter1 the ,comptroller ,general of the ,united ,states shall conduct an independent review of the research portfolio of the ,department of ,health and ,human ,services1 including ,,arpa-,h1 the ,national ,institutes of ,health1 the ,food and ,drug ,administration1 and the ,biomedical ,advanced ,research and ,development ,authority-- 7#a7 to assess the degree of unnecessary duplication of existing ,federal programs and projects2 and 7#b7 to make recommendations regarding any potential reorganization1 consolidation1 or termination of such programs and projects4 7o7 ,prioritization ,the ,director shall-- 7#a7 prioritize awarding grants1 cooperative agreements1 contracts1 prizes1 and other transaction awards to domestic recipients conducting the research on transformative health technology in the ,united ,states2 7#b7 as appropriate and practicable1 ensure that nondomestic recipients of any grants1 cooperative agreements1 contracts1 prizes1 and other transactions under this section are conducting research in collaboration with a domestic recipient2 7#c7 not award any grants1 cooperative agreements1 contracts1 prizes1 and other transactions to nondomestic recipients subject to malign foreign influence or organized under the laws of a malign foreign country2 and 7#d7 in accordance with the requirements of chapter #cc of title #da1 ,united ,states ,code1 and the ,federal ,acquisition ,regulation1 only award grants1 cooperative agreements1 contracts1 prizes1 and other transactions to individual persons that do not have more than #c ongoing concurrent grants1 cooperative agreements1 contracts1 prizes1 and other transactions under this section4 7p7 ,additional consultation ,in carrying out this section1 the ,director may consult with-- 7#a7 the ,president's ,council of ,advisors on ,science and ,technology2 7#b7 peers in the scientific community1 including academia and industry2 7#c7 an existing advisory committee providing advice to the ,secretary or the head of any operating or staff division of the ,department2 7#d7 a new interagency research council organized to support the programs of ,,arpa-,h and to provide advice and assistance on-- 7,a7 specific program tasks2 or 7,b7 the overall direction of ,,arpa-,h2 and 7#e7 any other entity the ,director may deem appropriate4 7q7 ,,arpa-,h ,interagency ,research ,council 7#a7 ,in general ,the ,director shall establish an interagency advisory committee to be known as the ,,arpa-,h ,interagency ,research ,council 7referred to in this subsection as the ,research ,council74 7#b7 ,membership ,the ,research ,council may include any or all of the following members1 or designees3 7,a7 ,the ,director of the ,national ,institutes of ,health4 7,b7 ,the ,director of ,national ,center for ,advancing ,translational ,sciences4 7,c7 ,the ,director of ,office of ,science and ,technology ,policy4 7,d7 ,the ,commissioner of ,food and ,drugs4 7,e7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7,f7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,g7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7,h7 ,the ,director of the ,agency for ,healthcare ,research and ,quality4 7,i7 ,the ,director of the ,office of ,minority ,health4 7,j7 ,the ,administrator of the ,health ,resources and ,services ,administration4 7,k7 ,the ,director of the ,defense ,advanced ,research ,projects ,agency4 7,l7 ,the ,director of the ,national ,science ,foundation4 7,m7 ,the ,director of the ,office of ,science of the ,department of ,energy4 7,n7 ,the ,director of the ,advanced ,research ,projects ,agency-,energy4 7,o7 ,the ,assistant ,secretary for ,preparedness and ,response4 7,p7 ,representatives of any ,federal agency with subject matter expertise that the ,director determines is necessary for the successful completion of a project carried out pursuant to this section4 7,q7 ,any other entity the ,director may deem appropriate4 7#c7 ,duties ,the ,research ,council shall advise the ,director1 including by-- 7,a7 making recommendations on-- 7i7 research priorities that will provide the greatest return on investment with respect to improving human health2 7ii7 avoiding duplication of efforts in the ,federal ,government2 and 7iii7 improving coordination with other ,federal agencies2 and 7,b7 identifying and developing strategies to address regulatory1 reimbursement1 and market barriers to commercialization or adoption of transformative health technologies1 including technologies intended to preempt serious disease4 7#d7 ,advisory nature ,the function of the ,research ,council shall be advisory in nature4 ,nothing in this subsection shall be construed as granting the ,research ,council authority over any activities or functions of ,,arpa-,h4 7#e7 ,meetings ,not later than #a year after the date of the enactment of this section1 and every fiscal year thereafter1 the ,director shall convene meetings of the ,research ,council1 including conferences or workshops1 as needed4 ,the ,research ,council may function through established or ad hoc committees1 task forces1 or interagency groups to-- 7,a7 share information on health innovations funded by ,,arpa-,h2 and 7,b7 receive input on areas of particular promise for ,,arpa-,h projects4 7r7 ,technology transfer office ,the ,director may establish within ,,arpa-,h an ,office of ,technology ,transfer to facilitate1 where appropriate1 the transfer of federally-owned or federally-originated technology to recipients of an award under this section 7other than ,federal ,government entities74 7s7 ,follow-on production award authority 7#a7 ,in general ,an other transaction entered into by the ,director under subsection 7h77#a7 for a project may provide for the award of a follow-on production contract or transaction to the participants in the transaction by ,,arpa-,h or another ,federal agency4 ,for purposes of this paragraph1 such an other transaction includes all individual subprojects awarded under the transaction to a consortium of ,united ,states industry and academic institutions4 7#b7 ,relation to competitive procedures ,a follow-on production contract or transaction under paragraph 7#a7 may be awarded to the participants in the transaction without the use of competitive procedures 7as defined in section #aeb of title #da1 ,united ,states ,code71 notwithstanding the requirements of division ,c of subtitle ,i of such title #da1 if-- 7,a7 competitive procedures were used for the selection of parties for participation in the other transaction2 and 7,b7 the participants in the other transaction successfully completed the project provided for in the transaction4 7#c7 ,precondition ,a follow-on production contract or transaction may be awarded pursuant to this subsection when the ,director determines that an individual project or subproject as part of a consortium is successfully completed by the participants4 7#d7 ,clarification ,award of a follow-on production contract or transaction pursuant to this subsection shall not be made contingent upon the successful completion of all activities within a consortium as a condition for an award for follow-on production of a successfully completed project or subproject within that consortium4 7#e7 ,other authorities ,contracts and transactions entered into by ,,arpa-,h pursuant to this subsection may be awarded pursuant to division ,c of subtitle ,i of title #da1 ,united ,states ,code1 or under such procedures1 terms1 and conditions as the ,director or head of such agency may establish by regulation4 7t7 ,rule of construction ,the authorities under this section1 with respect to the ,director1 are additional authorities that do not supersede or modify any existing authorities4 7u7 ,definitions ,in this part3 7#a7 ,advanced proofs of concept ,the term advanced proofs of concept means data1 a prototype1 or other experimental evidence that-- 7,a7 may precede the development of transformative health technologies2 and 7,b7 demonstrates the feasibility of a new concept4 7#b7 ,biological product ,the term biological product has the meaning given such term in section #cea7;i74 7#c7 ,department ,the term ,department means the ,department of ,health and ,human ,services4 7#d7 ,drug2 device ,the terms drug and device have the meanings given such terms in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#e7 ,federal acquisition regulation ,the term ,federal ,acquisition ,regulation means the ,federal ,acquisition ,regulation issued pursuant to section #acjc7;a77#a7 of title #da1 ,united ,states ,code4 7#f7 ,federal agency ,the term ,federal agency has the meaning given such term in section #ccga of title #e1 ,united ,states ,code4 7#g7 ,prize ,the term prize means a prize as such term is used in section #bd of the ,stevenson-,wydler ,technology ,innovation ,act of #aihj4 7#h7 ,transformative health technology ,the term transformative health technology means a drug1 biological product1 intervention1 platform1 tool1 or device-- 7,a7 that should be prioritized to detect1 diagnose1 mitigate1 prevent1 cure1 or treat a serious disease or medical condition for which there are unmet needs2 and 7,b7 for which-- 7i7 significant scientific uncertainty and regulatory risk exist2 or 7ii7 incentives in the commercial market are unlikely to result in the adequate or timely development of such drug1 biological product1 intervention1 platform1 tool1 or device4 7v7 ,authorization of appropriations ,there is authorized to be appropriated #ejj1jjj1jjj for each of fiscal years #bjbc through #bjbg1 to remain available until expended4 4 ,june #ac1 #bjbb,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed