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<dc:title>118 HR 10536 IH: Innovation for VA Technology and Entrepreneurship Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2024-12-19</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">I</distribution-code>
<congress display="yes">118th CONGRESS</congress><session display="yes">2d Session</session>
<legis-num display="yes">H. R. 10536</legis-num>
<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
<action display="yes">
<action-date date="20241219">December 19, 2024</action-date>
<action-desc><sponsor name-id="M001220">Mr. McGarvey</sponsor> (for himself and <cosponsor name-id="L000593">Mr. Levin</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HVR00">Committee on Veterans' Affairs</committee-name></action-desc>
</action>
<legis-type>A BILL</legis-type>
<official-title display="yes">To amend title 38, United States Code, to establish a mission of the Veterans Health Administration to innovate, and for other purposes.</official-title>
</form>
<legis-body id="H49168D3BF77E4000B362F7C1BE72AF06" style="OLC">
<section id="H65B1274A0E7A406DAAFEA635970D0851" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Innovation for VA Technology and Entrepreneurship Act</short-title></quote> or the <quote><short-title>INNOVATE Act</short-title></quote>.</text></section> <section id="HE019D59686DA4667A10A54C7BF2FCCB7"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following:</text>
<paragraph id="HF5F83D38642741B9B10AE64588B8A2A1"><enum>(1)</enum><text display-inline="yes-display-inline">The Department of Veterans Affairs offers critical health care services through the Veterans Health Administration (in this section referred to as the <quote>VHA</quote>), serving as the largest integrated health care system, largest medical training organization, and one of the largest employers of health care professionals in the United States. </text></paragraph> <paragraph id="H6392A4681FEA44DE98B0C1E36D071F7C"><enum>(2)</enum><text>Despite its size, assets, and reach, the VHA struggles to engage with private sector entities, particularly early-stage businesses, due to bureaucratic hurdles.</text></paragraph>
<paragraph id="H6BAF4FD26C7E4FFEA324894AB6CDE34A"><enum>(3)</enum><text>If provided new authorities through legislation, the VHA is positioned to create a paradigm shift in health care, revitalizing the way it develops and innovates to improve clinical care and access to health care for veterans, and modeling transformational health care to the private sector, ultimately benefitting all Americans.</text></paragraph> <paragraph id="HE66348F6178F489384E9DEED50EDF74A"><enum>(4)</enum><text>Establishing a fifth mission of the VHA to innovate will ingrain an innovative mindset across all VHA operations, enhance the existing missions and spearhead a new American way in health care, improving health outcomes for veterans, the health of the Nation, and national security.</text></paragraph>
<paragraph id="HC904775775F74B118440455C15CFD08F"><enum>(5)</enum><text>The Office of Innovation of the VHA will authorize, fund, and streamline processes, enhancing the VHA network of innovation programs and fostering collaboration and partnerships with industry, government, and academia.</text></paragraph></section> <section id="H815408F78B9F4A4DB51AE242021C5782" section-type="subsequent-section"><enum>3.</enum><header>Innovation in the Veterans Health Administration</header> <subsection id="H5198857E0A074F99AC9EAE3F5141D4F6"><enum>(a)</enum><header>Mission</header><text display-inline="yes-display-inline">Section 305(b) of title 38, United States Code, is amended—</text>
<paragraph id="H62E896EF85234DA8AF434AA2D97704B8"><enum>(1)</enum><text>by inserting <quote><header-in-text level="paragraph" style="USC"><enum-in-header>(1)</enum-in-header></header-in-text></quote> before <quote>The Under Secretary</quote>; and</text></paragraph> <paragraph id="H5F80C9AD8EA84D97AFF6C485715A1AEA"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text>
<quoted-block style="USC" id="HD00061913C1A40B1A2B29A9A721AB4BF" display-inline="no-display-inline">
<paragraph id="H81FC7674A9D14089BE04E1675311CFEA" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The missions of the Veterans Health Administration are the following:</text> <subparagraph id="H226803E0FE2943E6B551E6E33C921CAC"><enum>(A)</enum><text>Providing health care to eligible veterans.</text></subparagraph>
<subparagraph id="H8ADD6374DB59461FA19F273050B3DEFD"><enum>(B)</enum><text>Supporting research to benefit veterans and the Nation.</text></subparagraph> <subparagraph id="H5E15700659CD4B16B2916CA3BFB98964"><enum>(C)</enum><text>Providing education to health care providers in training.</text></subparagraph>
<subparagraph id="H86A25DCCE29C4DE68AD065BE4EC0785A"><enum>(D)</enum><text>Supporting emergency response.</text></subparagraph> <subparagraph id="H35565F33D44A4C78A884CBAFB0BB61FA"><enum>(E)</enum><text display-inline="yes-display-inline">Fostering innovation to advance health care technology and services for veterans and the Nation.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HD8DE1B0307284EEDACD6322DAA1858F8"><enum>(b)</enum><header>Office of Innovation</header>
<paragraph id="H6A640B894F1A4D4D948319499B7C963A"><enum>(1)</enum><header>Establishment</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/38/73">Chapter 73</external-xref> of title 38, United States Code, is amended by adding at the end the following new subchapter: </text> <quoted-block style="USC" id="H4DFD89664C9F4A15B45FC7D4C805A101" display-inline="no-display-inline"> <subchapter id="H5C90BA3E5628421B9C6094A5092328C3"><enum>VI</enum><header>Innovation</header> <section id="H6F0F1402403C4EA8976F924477908DA5"><enum>7391.</enum><header>Office of Innovation</header> <subsection id="HAA0E843BB62E4DC08602E66CB452AD55"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">There is in the Veterans Health Administration an Office of Innovation (in this section referred to as the <quote>Office</quote>). The Office shall be a Federal laboratory, as such term is defined in section 4 of the Stevenson-Wydler Technology Innovation Act of 1980 (<external-xref legal-doc="public-law" parsable-cite="pl/96/480">Public Law 96–480</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/15/3703">15 U.S.C. 3703</external-xref>).</text></subsection>
<subsection id="H987316DC50634975B770C1FE5ADF3E5B"><enum>(b)</enum><header>Function</header><text display-inline="yes-display-inline">The function of the Office is to foster innovation to advance health care and services for veterans and the Nation by—</text> <paragraph id="H70D288AFB74C4BD69C740C60DD34A2C8"><enum>(1)</enum><text display-inline="yes-display-inline">researching, developing, and implementing innovative technologies and services to deliver the best health care practicable to veterans;</text></paragraph>
<paragraph id="H6840495B732B4B35BBF98E69D771EE3F"><enum>(2)</enum><text display-inline="yes-display-inline">assisting, funding, and partnering with non-Department entities that can rapidly accelerate the research, development, commercialization, and implementation of technologies and services described in paragraph (1); and</text></paragraph> <paragraph id="H43CEC3E2743F4C5F8759A9C806A2601F"><enum>(3)</enum><text display-inline="yes-display-inline">adopting a comprehensive approach that works across traditional silos to effectively and efficiently—</text>
<subparagraph id="H3E94A83BFD184B98A6A6883AED8F0325"><enum>(A)</enum><text>use financial and human resources; and</text></subparagraph> <subparagraph id="H7EFA5CDCF1C343239D8606F466E6B1E7"><enum>(B)</enum><text>expedite the development, commercialization, and deployment, of such technologies and solutions.</text></subparagraph></paragraph></subsection>
<subsection id="H5E68E03E401943D3B0F46CC24628C72C"><enum>(c)</enum><header>Chief Innovation Officer</header><text display-inline="yes-display-inline">The head of the Office is the Chief Innovation Officer. The Chief Innovation Officer shall report directly to the Under Secretary for Health.</text></subsection> <subsection id="HC3C738754D1A46CD9D65657D2F079018"><enum>(d)</enum><header>Organization and personnel</header><text display-inline="yes-display-inline">The Office shall be organized in such manner, and its personnel shall perform such duties and have such titles, as the Secretary may prescribe pursuant to this subchapter.</text></subsection></section>
<section id="HEFCAF6C299864ED6B6D80C982F63B15A"><enum>7392.</enum><header>Hiring authorities</header>
<subsection id="H5EEF7F2ABB894B0386B0A253DD5AB157" display-inline="no-display-inline"><enum>(a)</enum><header>Exemption from civil service laws for certain employees</header>
<paragraph commented="no" display-inline="yes-display-inline" id="HEED21C92B1D0478F8E0538CF13B4EAAE"><enum>(1)</enum><text display-inline="yes-display-inline">To carry out the function of the Office of Innovation, the Secretary may—</text> <subparagraph id="H1ADE42E0E6C14A5E8671BD4C3EFE9A94" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">appoint not more than 250 professional, clinical, and other employees (which may include permanent, temporary, or term-limited appointments) of the Department, without regard to—</text>
<clause id="HDBA15A9C78B54417ADBF396D25210232"><enum>(i)</enum><text>any provision of title 5 governing appointments and removals under the civil service laws; or</text></clause> <clause id="H8A3CEF93AAAC4928979BD971E96E2D28"><enum>(ii)</enum><text>any provision of chapter 7 of this title; and</text></clause></subparagraph>
<subparagraph id="H4FF286F29C2B4ECAAA5F7699CC94003F" indent="up1"><enum>(B)</enum><text>fix the base pay compensation of an employee appointed under this subsection—</text> <clause id="H5EE0090975514131AEFD39146224BF9F"><enum>(i)</enum><text display-inline="yes-display-inline">without regard to any other provision of law, including the General Schedule under section 5332 of title 5; and</text></clause>
<clause id="H85E14772D2E9410D8C58F78B3C51FA3D"><enum>(ii)</enum><text>at a rate determined by the Secretary that does not exceed the amount of annual compensation (excluding expenses) established by section 102 of title 3.</text></clause></subparagraph></paragraph> <paragraph id="H4EA172F93A46456A85CFB694A6785FB9" indent="up1"><enum>(2)</enum><text>In carrying out paragraph (1), the Secretary shall—</text>
<subparagraph id="HFD60DC16D84C4F26B0F8A43B0D74B0AB"><enum>(A)</enum><text>make lawful efforts to recruit a diverse workforce, including individuals under represented in clinical and other relevant technical and non-technical areas of expertise, including racial and ethnic minorities; and</text></subparagraph> <subparagraph id="HBC19DD9D6BBF4991AA7559D4E0D87E50"><enum>(B)</enum><text>recruit employees with a variety of professional experiences and backgrounds, or demonstrated expertise in a wide range of relevant disciplines and management skills.</text></subparagraph></paragraph>
<paragraph id="H1939461794C74BB6B9006ABE9D128610" display-inline="no-display-inline" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">If the Secretary determines that maximum number of positions under paragraph (1) is insufficient, the Secretary shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a written notification of such determination.</text></paragraph> <paragraph id="H2861B3874FB94C5C95E74C0B2F0FF06F" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">The Secretary may enter into an agreement with a private entity to identify and recruit highly qualified candidates for a position described in paragraph (1).</text></paragraph></subsection>
<subsection id="H99B1049F728848119769D985C288DD3D"><enum>(b)</enum><header>Other employees</header><text>The Secretary may use any other authority under this title to hire administrative, financial, clerical, and other employees necessary to support employees appointed under subsection (a).</text></subsection> <subsection id="H5AE0FC265110444C8793CEED9CEEB5F3"><enum>(c)</enum><header>Waiver of Intergovernmental Personnel Act Mobility Program limits</header><text display-inline="yes-display-inline">The Secretary may waive the limit on the period and number of assignments required under section 3372(a) of title 5 with respect to an individual who carries out the function established by section 7391(b) of this title under the mobility program under subchapter VI of chapter 33 of such title (commonly referred to as the <quote>Intergovernmental Personnel Act Mobility Program</quote>).</text></subsection>
<subsection id="H22D2B11321F84181887B9816769C8DA2"><enum>(d)</enum><header>Authority To accept Federal detailees</header><text display-inline="yes-display-inline">Upon request of the Secretary, the head of any Federal department or agency may detail, on a reimbursable or nonreimbursable basis (as determined by the Secretary and such head), any personnel of that department or agency to the Department to assist in carrying out the function of the Office of Innovation. Such a detail may not exceed three years.</text></subsection> <subsection id="HD3E45E02F2F3443E83480F755F0C4DEF"><enum>(e)</enum><header>Recordkeeping</header><text>The Secretary shall keep records regarding the exercise of authorities under this section. Such records shall include the following:</text>
<paragraph id="HCCBF8CFE447A44FFA81FA7E5482A91AF"><enum>(1)</enum><text>the number of appointments made;</text></paragraph> <paragraph id="HBBB3189C9BAC4CE5AF1D3AF7158AB931"><enum>(2)</enum><text>the types of positions filled, including titles, occupational series, and grade;</text></paragraph>
<paragraph id="H523A74D7D13448B0896CF4122DABE2DB"><enum>(3)</enum><text>the number of positions filled for which notices were publicly issued;</text></paragraph> <paragraph id="HCB4081A6B0A847C7B287AF7F9D5B98D6"><enum>(4)</enum><text>the number of qualified applicants who applied for such positions;</text></paragraph>
<paragraph id="H23BE28C0F8C44DE1AF1D344D4494A943"><enum>(5)</enum><text>the qualification criteria for such positions; and,</text></paragraph> <paragraph id="HB975CF7D976C4D6C9938B63944A315C1"><enum>(6)</enum><text>the demographic information of individuals hired for such positions.</text></paragraph></subsection>
<subsection id="HD92960BD709E4EEF959D5DAEBB16E7E6"><enum>(f)</enum><header>Report</header><text display-inline="yes-display-inline">Not less than once annually, the Secretary shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives a report on appointments under this section. Such report shall include the number of such appointments and an explanation of how such employees carry out the function established by section 7391(b) of this title.</text></subsection></section> <section id="H995496B5D08A45A9A6F83D226BBD15C4" commented="no"><enum>7393.</enum><header>Acceleration fund</header> <subsection id="H21AE5402B8DE4AAAA65D5C9D8F54825C" display-inline="no-display-inline" commented="no"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">There is established an account, to be known as the <quote>Veterans Health Care Innovation Acceleration Fund</quote> (in this section referred to as the <quote>Fund</quote>), which shall be available to carry out the function of the Office of Innovation, in addition to such amounts that are otherwise available for such purpose. To manage the fund, the Secretary may—</text>
<paragraph id="H5C99C8DEE9D94CF3903E613158641944" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text>accept monies from authorized sources for the Fund;</text></paragraph> <paragraph id="H9F28EC381C844416926C6108158FDCF9"><enum>(2)</enum><text>accept and distribute monies within the Department as the Secretary determines necessary;</text></paragraph>
<paragraph id="H6D715231D8E947A184200723957BEE88"><enum>(3)</enum><text>establish a health care franchise function; and</text></paragraph> <paragraph id="H2531D2DF62B049D58A1EDCB836582111"><enum>(4)</enum><text display-inline="yes-display-inline">pay for expenses (including information technology or acquisition, advisory, or legal services, whether provided by an employee of the Department or pursuant to an agreement with a non-Department entity) that the Secretary determines necessary to carry out the function of the Office of Innovation, without regard to restrictions on funding type.</text></paragraph></subsection>
<subsection id="H59CF2FFA6CCA4F21AA6362B62EA4F31E" commented="no"><enum>(b)</enum><header>Authorization of appropriations</header>
<paragraph commented="no" display-inline="yes-display-inline" id="H355F8860A07C47B0873DF761E8C486FF"><enum>(1)</enum><text display-inline="yes-display-inline">There are authorized to be appropriated to the Fund such sums as may be necessary to carry out the function of the Office of Innovation. Such sums shall remain available until expended or five years after receipt.</text></paragraph> <paragraph id="HC1795701A45E4BB98E97D8801D80F4D7" indent="up1"><enum>(2)</enum><text>The budget request for the Fund shall be separate from the rest of the budget of the Department.</text></paragraph>
<paragraph id="H57405990E1234D699CCEF0C51A3A1D92" commented="no" indent="up1"><enum>(3)</enum><text>Appropriations for the Fund shall be separate and distinct from the rest of the budget for the Department and not affect annual operational dollar allocations.</text></paragraph></subsection> <subsection id="HFEBBDF55F89749F4B06E5057351E7DF6" commented="no"><enum>(c)</enum><header>Non-Profit corporations</header><text display-inline="yes-display-inline">To support the administration of the Fund with regard to acceptance of certain types of external funding, the Secretary shall authorize existing nonprofit corporations, established under section 7361 of this title, to carry out the function of the Office of Innovation.</text></subsection>
<subsection id="H629E55DFAF9741FF8891CC20DBB2F237" commented="no"><enum>(d)</enum><header>Report to Congress</header><text>The Secretary shall submit to Congress a detailed account, program, and project allocations of the amount recommended for allocation in a fiscal year from amounts in the Fund—</text> <paragraph id="H87CA40A92CFC46E184E8CB27530C4FBC" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">for Fiscal Years 2026 and 2027, not later than 60 days after the date of enactment of the Innovation for VA Technology and Entrepreneurship Act; and</text></paragraph>
<paragraph id="H7F06D036AE6048519E01B5590DABC383" commented="no"><enum>(2)</enum><text>for each fiscal year thereafter through 2035, as part of the annual budget submission of the President under section 1105(a) of title 31.</text></paragraph></subsection></section> <section id="H74F68DBF4ED9472F8B904EB96756DB03"><enum>7394.</enum><header>Agreements with non-Department entities for access to key assets of the Department</header> <subsection id="H9B78B6EB2BD74455BDC22967984D3B28"><enum>(a)</enum><header>Authority</header><text>The Secretary may enter into an agreement under which the Secretary provides a non-Department entity access to a key asset of the Department so such entity may develop a technology or service that—</text>
<paragraph id="H04D0640261F44F78BDC82AD0E932232D"><enum>(1)</enum><text display-inline="yes-display-inline">supports the strategic plan of the Department regarding health care; and</text></paragraph> <paragraph id="H5CD6A297AFF141499DCA6C4217F90743"><enum>(2)</enum><text display-inline="yes-display-inline">addresses a veteran-specific core competency.</text></paragraph></subsection>
<subsection id="HF4DA14FC0389405AABA3CF48F3E920E8"><enum>(b)</enum><header>Fees</header>
<paragraph commented="no" display-inline="yes-display-inline" id="H30486726C4A34DB098FB0C95358FF548"><enum>(1)</enum><text>Subject to paragraphs (2) and (3), the Secretary shall negotiate fees under this section on a case-by-case basis, taking into consideration factors including the costs and benefits to the United States of such agreement.</text></paragraph> <paragraph id="HEFE5F781A4534E6CAE6AE589303B2AF6" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The Secretary shall discount a fee under this section if the entity is a small business concern owned and controlled by a veteran.</text></paragraph>
<paragraph id="H53166CDF85F345CC8CAC325A5613524F" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The Secretary shall not charge a fee under this section if the entity is a small business concern owned and controlled by a veteran with a service-connected disability.</text></paragraph></subsection> <subsection id="H9C5AF202AF724B52A9F0ECE7D0D107A7"><enum>(c)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HD0EDA96DD8534C958B1C178C9962654E"><enum>(1)</enum><text>The term <quote>key asset</quote> includes the following:</text> <subparagraph id="H6A76B525DA60410F8344399A6361F669"><enum>(A)</enum><text>Subject matter expertise &amp; perspective.</text></subparagraph>
<subparagraph id="HC63B2217D4204AF294312C101F6664B9"><enum>(B)</enum><text>Properly protected data sets.</text></subparagraph> <subparagraph id="H8A508D5A6D1748D0AD862F897F574A03"><enum>(C)</enum><text>Research evaluations, studies, and trials.</text></subparagraph>
<subparagraph id="HEE84469ACD1C4098BDE7007AB291925A"><enum>(D)</enum><text display-inline="yes-display-inline">Customer feedback and insights.</text></subparagraph> <subparagraph id="H4C7BABAB9D084569890296008CF10FDE"><enum>(E)</enum><text>Simulation and production test environments.</text></subparagraph>
<subparagraph id="H5D68A19F600D4B238AED67BAD3F0684C"><enum>(F)</enum><text>Health care professionals, students, and trainees.</text></subparagraph> <subparagraph id="HAED02729AE37401F9154E53D8FDF31BC"><enum>(G)</enum><text>Advanced manufacturing and three-dimensional printing.</text></subparagraph>
<subparagraph id="HF26671C7BCBC47F1BC28870904944FC9"><enum>(H)</enum><text>Engagement from other Federal entities.</text></subparagraph> <subparagraph id="H97FBDC3F2FA54A51B919DBE8C694123F"><enum>(I)</enum><text>A network of academic affiliates.</text></subparagraph></paragraph>
<paragraph id="H06D2576C85F448C088ABAA4783CB98E0"><enum>(2)</enum><text display-inline="yes-display-inline">The term <quote>veteran-specific core competency</quote> means a health condition that the Secretary determines disproportionately affects veterans. Such term includes the following:</text> <subparagraph id="HAC63894C775542B198EAA7DFCBBC8392"><enum>(A)</enum><text>Prostheses.</text></subparagraph>
<subparagraph id="H17EEF5BD7E824F6199E80CF38C7C1904"><enum>(B)</enum><text>Spinal cord injury.</text></subparagraph> <subparagraph id="HAC309821BF544AA69B57A5CE6BFD8615"><enum>(C)</enum><text>Toxic exposure.</text></subparagraph>
<subparagraph id="HF4514F256B854778A956B01E9155BF7C"><enum>(D)</enum><text>Traumatic brain injury.</text></subparagraph> <subparagraph id="HFEE987123A514577814EFD5AB1401670"><enum>(E)</enum><text>Mental health (including suicide prevention and post-traumatic stress disorder);</text></subparagraph>
<subparagraph id="HE32A45690F9B4D7A894B70D9A966B941"><enum>(F)</enum><text>Diabetes.</text></subparagraph> <subparagraph id="HB8DAC8826D334FDB943936ED66ED8FCD"><enum>(G)</enum><text>Heart disease.</text></subparagraph>
<subparagraph id="HBA9A6D8E4A5F44FF805FFBF1EB1FF8F3"><enum>(H)</enum><text>Obesity.</text></subparagraph> <subparagraph id="H1B32461EE6BC4EAFB7EB69D4676BE33E"><enum>(I)</enum><text>Cancer.</text></subparagraph></paragraph></subsection></section>
<section id="H2E805FAC55354AE49865FD31FEDD662E"><enum>7395.</enum><header>Advance market commitments</header>
<subsection id="HCE8BEB3E49AC4B55BDF2D62AD7F5596F"><enum>(a)</enum><header>Authority</header><text display-inline="yes-display-inline">The Secretary may enter into an advance market commitment, under which the Secretary shall guarantee to purchase, for a predetermined price, a technology or service provided by an entity that addresses an unmet need in the provision of health care to veterans.</text></subsection> <subsection id="H56B4FEE009C544CB82E7421900A7D9D6"><enum>(b)</enum><header>Requirements</header><text>An advanced market commitment under this section shall include the following:</text>
<paragraph id="H0E0517BF96574F97A7D75B808ED03843"><enum>(1)</enum><text>Clearly defined and transparent rules.</text></paragraph> <paragraph id="H1FD68EC731C141ECA71E464AE797BBBD"><enum>(2)</enum><text>Clear definition of the technology or service to ensure safety, effectiveness, and feasible delivery.</text></paragraph>
<paragraph id="H5CF40616ED1B4634B1C09E09FFBA43FF"><enum>(3)</enum><text>Dispute settlement mechanisms.</text></paragraph> <paragraph id="H752FB8D3A81146FDAEE7BEEBDC4C9F32"><enum>(4)</enum><text>The ability to modify the terms of the agreement on the basis of new information regarding the number of veterans to be served with such technology or service.</text></paragraph></subsection>
<subsection id="H45712FD6AEFF4ADFAF9CA1F4E2994904"><enum>(c)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 120 days after executing an advance market agreement, the Secretary shall submit to the House and Senate Committees on Veterans Affairs an annual report on the status and efficacy of such agreement.</text></subsection></section> <section id="H9448E9B9DC084BBBAA538053494BC9C6"><enum>7396.</enum><header>Other transactional authorities</header> <subsection id="HF97A110D2A2C41EDB1136EDF99236860"><enum>(a)</enum><header>Authority</header><text display-inline="yes-display-inline">The Secretary may enter into an agreement, other than a contract, cooperative agreement, or grant agreement, with a non-Department entity that principally operates in the United States, to conduct activities associated with basic or applied research, prototyping, or production deployment, if—</text>
<paragraph id="H021BDD7D4BB64218A3D0F369B28395EB"><enum>(1)</enum><text display-inline="yes-display-inline">the Senior Procurement Executive of the Department has determined that a contract, cooperative agreement, or grant agreement is not feasible or appropriate; and</text></paragraph> <paragraph id="H507A75AFE49449F78DCCD8DECC4DDC02"><enum>(2)</enum><text display-inline="yes-display-inline">the cost to the United States to carry out such agreement does not exceed—</text>
<subparagraph id="H08E3BB35F584453FBB7285E73F86B849"><enum>(A)</enum><text>$10,000,000 (including all options); or</text></subparagraph> <subparagraph id="H6BD043FE21E7453B85A63C3ED6638928"><enum>(B)</enum><text>a greater amount that the Senior Procurement Executive determines appropriate.</text></subparagraph></paragraph></subsection>
<subsection id="H5789EB0B153C45D49601FCA2EDAD041C"><enum>(b)</enum><header>Limitation</header><text display-inline="yes-display-inline">The only kinds of research on human embryonic stem cells that may be conducted pursuant to an agreement under this section are the following:</text> <paragraph id="HE73F76BB7EF44E3CA85DEDA804434FCB"><enum>(1)</enum><text>Research involving the derivation and use of human embryonic germ cells from fetal tissue that complies with—</text>
<subparagraph id="H2486EDA0D39E402D8C4F75294EBC71CB"><enum>(A)</enum><text display-inline="yes-display-inline">sections 498, 498A, and 498B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/289g">42 U.S.C. 289g</external-xref>, 289g–1, 289–2);</text></subparagraph> <subparagraph id="H3C297B1CF5BB4E3EA860BFE30046842C"><enum>(B)</enum><text>title 45, Code of Federal Regulations, part 46, subpart B;</text></subparagraph>
<subparagraph id="H9A18860CC8374D318BF07BECE40C55A3"><enum>(C)</enum><text>applicable regulations of the Food and Drug Administration; and</text></subparagraph> <subparagraph id="H750D7DF648A34AC696266E5AE2C18699"><enum>(D)</enum><text>any other applicable Federal, State, or local law.</text></subparagraph></paragraph>
<paragraph id="H226409E1959E43C8A201EF66B462BD10"><enum>(2)</enum><text>Research on existing human embryonic stem cell lines in accordance with criteria established by the Director of the National Institutes of Health.</text></paragraph></subsection> <subsection id="H3C8938EDA7B64660817186A083AB1CAC"><enum>(c)</enum><header>Reimbursement</header><text>Any amounts received by the Secretary under this section shall be used to reimburse the accounts from which funds were used to incur the expenses of carrying out this section. </text></subsection>
<subsection id="HD1FFBBF0E309417E85C7D6EA7FF96B82"><enum>(d)</enum><header>Reporting; transparency</header><text display-inline="yes-display-inline">The Secretary shall—</text> <paragraph id="HD367FE70876149E3B29409CB6D196E94"><enum>(1)</enum><text display-inline="yes-display-inline">submit to the appropriate congressional committees—</text>
<subparagraph id="H63BB600BE23543BF96BEFDD78FC67B14"><enum>(A)</enum><text>a copy of each determination under subsection (a)(1);</text></subparagraph> <subparagraph id="H368E5A62E5914B9C9928F23F3C434BBE"><enum>(B)</enum><text display-inline="yes-display-inline">not less than twice each year, a report on agreements made under this section; and</text></subparagraph>
<subparagraph id="HE0CB020607B941DBB7A4E410B651056F"><enum>(C)</enum><text display-inline="yes-display-inline">upon request, any information regarding an agreement made under this section; and</text></subparagraph></paragraph> <paragraph id="HF8FF364FAE58473D93FC9C5C56CC5EBF"><enum>(2)</enum><text display-inline="yes-display-inline">ensure that the terms of an agreement under this section permit the Comptroller General of the United States to examine the records relating to such agreement of—</text>
<subparagraph id="HFB70E1C30B9843D5A6DB1F781714F368"><enum>(A)</enum><text>an entity that enters into such an agreement; or</text></subparagraph> <subparagraph id="H2D2A7663E2334A8C8BF97C10DAA50E89"><enum>(B)</enum><text>an entity that otherwise participates in the performance of such agreement.</text></subparagraph></paragraph></subsection>
<subsection id="H3C09A7BB57A741B699D07D273B863E51"><enum>(e)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Senior Procurement Executive shall issue guidance regarding an agreement under this section.</text></subsection> <subsection id="HC799F19F7138424CAB80B2D4B19CCD18"><enum>(f)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H629D0B10ED3D4547ACC2A905F922186C"><enum>(1)</enum><text>The term <quote>appropriate congressional committees</quote> means the following:</text> <subparagraph id="HA569CE894B6D4583989DE47942B9DF4D"><enum>(A)</enum><text>The Committees on Veterans’ Affairs of the House of Representatives and the Senate.</text></subparagraph>
<subparagraph id="H15C2279F95594FBC9666779444055AEB"><enum>(B)</enum><text>The Subcommittees on Military Construction, Veterans’ Affairs, and Related Agencies of the Committees on Appropriations of the House of Representatives and the Senate.</text></subparagraph></paragraph> <paragraph id="H57FAB6BA2EFB40FB935E272B07AC9A9A"><enum>(2)</enum><text>The term <quote>Senior Procurement Executive</quote> means the official of the Department designated under section 1702(c) of title 41.</text></paragraph></subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H22A052A20F9E482DB10121F324302009" commented="no"><enum>(2)</enum><header>Clerical amendment</header><text>The table of sections at the beginning of such chapter is amended by adding at the end the following: </text> <toc container-level="legis-body-container" quoted-block="yes-quoted-block" lowest-level="section" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded"> <toc-quoted-entry style="USC"> <toc-entry idref="H5C90BA3E5628421B9C6094A5092328C3" level="subchapter">SUBCHAPTER VI—INNOVATION</toc-entry> <toc-entry idref="H6F0F1402403C4EA8976F924477908DA5" level="section">Sec. 7391. Office of Innovation.</toc-entry> <toc-entry idref="HEFCAF6C299864ED6B6D80C982F63B15A" level="section">Sec. 7392. Hiring authorities.</toc-entry> <toc-entry idref="H995496B5D08A45A9A6F83D226BBD15C4" level="section">Sec. 7393. Acceleration fund.</toc-entry> <toc-entry idref="H74F68DBF4ED9472F8B904EB96756DB03" level="section">Sec. 7394. Agreements with non-Department entities for access to key assets of the Department.</toc-entry> <toc-entry idref="H2E805FAC55354AE49865FD31FEDD662E" level="section">Sec. 7395. Advance market commitments.</toc-entry> <toc-entry idref="H9448E9B9DC084BBBAA538053494BC9C6" level="section">Sec. 7396. Other transactional authorities.</toc-entry></toc-quoted-entry></toc></paragraph></subsection> <subsection id="HFE3761B802EA4BA19C04CD1528EF8155"><enum>(c)</enum><header>Conforming amendment</header><text>Section 7361 of title 38, United States Code, is amended—</text>
<paragraph id="H01F97634213B42A887C7F758D590CF1E"><enum>(1)</enum><text>in subsection (a), by striking <quote>either research or education or both research and education</quote> and inserting <quote>research, education, or innovation under subchapter VI of this chapter, or any combination thereof</quote>; and</text></paragraph> <paragraph id="H0A7AB30C20B2406A82FDBE791262F2EA"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by striking <quote>research, education, or both</quote> and inserting <quote>research, education, or innovation under subchapter VI of this chapter, or any combination thereof</quote>.</text></paragraph></subsection>
<subsection id="HC2957856E821420292426F15B8F34258"><enum>(d)</enum><header>Implementation</header><text display-inline="yes-display-inline">Not later than 120 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall carry out the amendments made by this section.</text></subsection></section> </legis-body> </bill> 

