115 S2852 IS: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
U.S. Senate
2018-05-15
text/xml
EN
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.
1.Short title; table of contents
(a)This Act may be cited as the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
.
(b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents. Sec. 2. References in Act. TITLE I—Strengthening the national health security strategy Sec. 101. National Health Security Strategy. TITLE II—Improving preparedness and response Sec. 201. Improving benchmarks and standards for preparedness and response. Sec. 202. Amendments to preparedness and response programs. Sec. 203. Regional health care emergency preparedness and response systems. Sec. 204. Public health and health care system situational awareness and biosurveillance capabilities. Sec. 205. Strengthening and supporting the public health emergency rapid response fund. Sec. 206. Improving preparedness for and response to all-hazards by public health emergency volunteers. TITLE III—Reaching all communities Sec. 301. Strengthening and assessing the emergency response workforce. Sec. 302. Health system infrastructure to improve preparedness and response. Sec. 303. Considerations for at-risk individuals. Sec. 304. Improving emergency preparedness and response considerations for children. Sec. 305. Reauthorizing the National Advisory Committee on Children and Disasters. Sec. 306. Guidance for participation in exercises and drills. TITLE IV—Prioritizing a threat-based approach Sec. 401. Assistant Secretary for Preparedness and Response. Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. Sec. 403. Strategic National Stockpile. Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other significant threats. Sec. 405. Reporting on the Federal Select Agent Program. TITLE V—Increasing communication in medical countermeasure advanced research and development Sec. 501. Medical countermeasure budget plan. Sec. 502. Material threat and medical countermeasure notifications. Sec. 503. Availability of regulatory management plans. Sec. 504. The Biomedical Advanced Research and Development Authority and the BioShield Special Reserve Fund. TITLE VI—Advancing technologies for medical countermeasures Sec. 601. Administration of countermeasures. Sec. 602. Medical countermeasure master files. Sec. 603. Animal rule report. TITLE VII—Miscellaneous provisions Sec. 701. Reauthorizations and extensions. Sec. 702. Technical amendments. 2.Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Public Health Service Act (42 U.S.C. 201 et seq.).
<enum>I</enum><header>Strengthening the national health security strategy </header>
<section id="id357024A53B204A59968275385E7435D4"><enum>101.</enum><header>National Health Security Strategy</header>
<text display-inline="no-display-inline">Section 2802 (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1</external-xref>) is amended—</text> <paragraph id="id47037EDEF2D2452F98BA5B9F5FF59652"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph commented="no" id="id16918cf08aa2410984161345dfdbaf08"><enum>(A)</enum><text>in paragraph (1)—</text> <clause commented="no" id="idABCBADFA7A08404F90E1EAD9CDF86849"><enum>(i)</enum><text>by striking <quote>2014</quote> and inserting <quote>2018</quote>; and</text>
</clause><clause id="idC6DD83436BFD4B99A9E93A57063F05FE"><enum>(ii)</enum><text>by striking the second sentence and inserting the following: <quote>Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in section 504(a)(19) of the Homeland Security Act of 2002), the National Incident Management System (as defined in section 501(7) of such Act), and the National Response Plan developed pursuant to section 504 of such Act, or any successor plan.</quote>;</text>
</clause></subparagraph><subparagraph id="id8432529203614c4ab23e6d8e3255efb5"><enum>(B)</enum><text>in paragraph (2), by inserting before the period at the end of the second sentence the following: <quote>, and an analysis of any changes to the evidence-based benchmarks and objective standards under sections 319C–1 and 319C–2</quote>; and</text>
</subparagraph><subparagraph id="id522b7dddabaa4588a87231baf795aa6e"><enum>(C)</enum><text>in paragraph (3)—</text> <clause id="id73f552dda24e458f8d9e58de686e8adb"><enum>(i)</enum><text>by striking <quote>2009</quote> and inserting <quote>2022</quote>;</text>
</clause><clause id="id9d2c1f872384459c9c6a3d8c5187f9af"><enum>(ii)</enum><text>by inserting <quote>(including gaps in the environmental health workforce), describing the status of such workforce</quote> after <quote>gaps in such workforce</quote>;</text> </clause><clause id="id39b1beca445a4ce8aba31d51256f5b22"><enum>(iii)</enum><text>by striking <quote>and identifying strategies</quote> and inserting <quote>identifying strategies</quote>; and</text>
</clause><clause id="id258593ca4d774efe862aa73b34d8a1aa"><enum>(iv)</enum><text>by inserting before the period at the end <quote>, and identifying current capabilities to meet the requirements of section 2803</quote>; and</text> </clause></subparagraph></paragraph><paragraph id="idF5FDB4196F844EFA92DFFE8E9F41024D"><enum>(2)</enum><text>in subsection (b)—</text>
<subparagraph id="idd562c7d179c8452e8f2114df4a5360d0"><enum>(A)</enum><text>in paragraph (2)—</text> <clause id="id6F328C2029634648885A76CFBE52278E"><enum>(i)</enum><text>in subparagraph (A), by striking <quote>and investigation</quote> and inserting <quote>investigation, and related information technology activities</quote>;</text>
</clause><clause id="id2269418C07D742868FA6FC4B9428A260"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>and decontamination</quote> and inserting <quote>decontamination, relevant health care services and supplies, and transportation and disposal of medical waste</quote>; and</text>
</clause><clause id="id823445E8B1E14D60911F5FC0608FFCC2"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id9C4BE4F223914B76AFACCC1C786F5503" style="OLC"> <subparagraph id="id63EDA2B4FE6A45A281A3FE533C4C936A"><enum>(E)</enum><text>Response to environmental hazards.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="idfb8b924bfcd446cca7f4e2f32d27aa77"><enum>(B)</enum><text>in paragraph (3)(F), by inserting <quote>or exposures to agents that could cause a public health emergency</quote> before the period;</text> </subparagraph><subparagraph id="id85fab46426654d8786ff3ef11850ad52"><enum>(C)</enum><text>in paragraph (5), by inserting <quote>and other applicable compacts</quote> after <quote>Compact</quote>; and</text>
</subparagraph><subparagraph id="idD4A7585ED2D84F61A4E2B37CE4055A43"><enum>(D)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idB1B500667A60435B936BA6828682FEE6" style="OLC"> <paragraph id="idE1D5B3CFB57D46D48C5D6BCB498C0BB0"><enum>(9)</enum><header>Zoonotic disease, food, and agriculture</header><text>In consultation with the Secretary of Agriculture, improving coordination among Federal, State, local, tribal, and territorial entities to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.</text>
</paragraph><paragraph id="id98179702fb40427f94958f6f67a350d8"><enum>(10)</enum><header>Global health security</header><text>Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></section><enum>II</enum><header>Improving preparedness and response</header>
<section id="idF74E041F548045EBBF288564B8584720"><enum>201.</enum><header>Improving benchmarks and standards for preparedness and response</header>
<subsection id="id7aa0a19f44a24044a6647a8f4b74aa49"><enum>(a)</enum><header>Evaluating measurable evidence-Based benchmarks and objective standards</header><text>Section 319C–1 (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3a">42 U.S.C. 247d–3a</external-xref>) is amended by inserting after subsection (j) the following:</text>
<quoted-block display-inline="no-display-inline" id="id0a31812b01c440fd8bf17d903d555025" style="OLC">
<subsection id="id7F51FA6A625349E28D41F51972F98BA5"><enum>(k)</enum><header>Evaluation</header>
<paragraph id="ideeea71ca971144f8aaa0300b976b2111"><enum>(1)</enum><header>In general</header><text>Not later than 2 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title> and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under section 2802, at such time as such strategy is submitted.</text>
</paragraph><paragraph id="id51b1cb1a49404b9eaceaf8e9347510c9"><enum>(2)</enum><header>Content</header><text>The evaluation under this paragraph shall include—</text> <subparagraph id="id9e19f2ca60d84627b9528ebf4281e1bf"><enum>(A)</enum><text>a review of evidence-based benchmarks and objective standards, and associated metrics and targets;</text>
</subparagraph><subparagraph id="id0d7ee58365a24f74900752e4c516f0b1"><enum>(B)</enum><text>a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802;</text>
</subparagraph><subparagraph id="id6E38E732CF584FCEAEAFF2CC4116E9A8"><enum>(C)</enum><text>a description of amounts received by eligible entities, as described in subsection (b) and section 319C–2(b), and amounts received by sub-recipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and</text>
</subparagraph><subparagraph id="id063af0a006364ed99322de9626078227"><enum>(D)</enum><text>recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 2802.</text></subparagraph></paragraph></subsection><after-quoted-block>. </after-quoted-block></quoted-block>
</subsection><subsection id="idBDA8A90048AB4922AAED0AA8CA2F9656"><enum>(b)</enum><header>Evaluating the partnership for State and regional hospital preparedness</header><text>Section 319C–2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking <quote>section 319C–1(g), (i), and (j)</quote> and inserting <quote>section 319C–1(g), (i), (j), and (k)</quote>.</text>
</subsection></section><section id="id73B081EAB2DE4EFF9F2E3DA1FB56196D"><enum>202.</enum><header>Amendments to preparedness and response programs</header>
<subsection id="idDC0E9E3AC5BD481897A9E581863C7D29"><enum>(a)</enum><header>Cooperative agreement applications for improving State and local public health security</header><text>Section 319C–1 (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3a">42 U.S.C. 247d–3a</external-xref>) is amended—</text> <paragraph id="id61036ab03df14a8384c9321721128336"><enum>(1)</enum><text>in subsection (a), by inserting <quote>, acting through the Director of the Centers for Disease Control and Prevention,</quote> after <quote>the Secretary</quote>; and</text>
</paragraph><paragraph id="id03C79CF2199A43689263F37EEF98C021"><enum>(2)</enum><text>in subsection (b)(2)(A)—</text> <subparagraph id="id147E4BB2291E45B8826F02C187E251A5"><enum>(A)</enum><text>in clause (vi), by inserting <quote>, including public health agencies with specific expertise that may be relevant to public health security, such as environmental health agencies,</quote> after <quote>stakeholders</quote>;</text>
</subparagraph><subparagraph id="idc350e55df3c040be8bccbab97c605f02"><enum>(B)</enum><text>by redesignating clauses (vii) through (ix) as clauses (viii) through (x); and</text> </subparagraph><subparagraph id="idaca0964aa2114e449cb75c996b3603ca"><enum>(C)</enum><text>by inserting after clause (vi) the following:</text>
<quoted-block display-inline="no-display-inline" id="id66726ea0af714b3bb84c76faa355ca25" style="OLC">
<clause id="id66be86751bef46829362158a2d698bd6"><enum>(vii)</enum><text>a description of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs following a public health emergency;</text></clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection id="id8B3E5278DE1745F2A34BE8215A549A75"><enum>(b)</enum><header>Partnership for State and regional hospital preparedness To improve surge capacity</header><text>Section 319C–2 (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3b">42 U.S.C. 247d–3b</external-xref>) is amended—</text> <paragraph id="idC408BAF7424342299559D23ED5D6EA67"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph id="id606411BD279C438C90384AA5AC8273C6"><enum>(A)</enum><text>by inserting <quote>, acting through the Assistant Secretary for Preparedness and Response,</quote> after <quote>The Secretary</quote>; and</text> </subparagraph><subparagraph id="idE6C489BF80A140E79252169437175571"><enum>(B)</enum><text>by striking <quote>preparedness for public health emergencies</quote> and inserting <quote>preparedness for, and response to, public health emergencies in accordance with subsection (c)</quote>; and</text>
</subparagraph></paragraph><paragraph id="idDE0255434ABF4D94976C618869931AC5"><enum>(2)</enum><text>in subsection (b)(1)(A)—</text> <subparagraph commented="no" id="id98375D9488D544099844496A2D4A2119"><enum>(A)</enum><text>in clause (iii), by redesignating subclauses (I) through (III) as items (aa) through (cc), respectively, and adjusting the margins accordingly;</text>
</subparagraph><subparagraph commented="no" id="id43FC58EC7BA24FBAB0E0DAE08BBB9CEF"><enum>(B)</enum><text>by redesignating clauses (i) through (iii) as subclauses (I) through (III) respectively, and adjusting the margins accordingly;</text>
</subparagraph><subparagraph commented="no" id="idB4C81033D3A64AF5B77B0CF37FE32294"><enum>(C)</enum><text>by striking <quote>partnership consisting of—</quote> and inserting “partnership—</text> <quoted-block display-inline="no-display-inline" id="id0C60CE60D1C54C06888F3F9A7ED2363A" style="OLC"> <clause id="idF0C2235730B04AA6A138D9BFAAB5DC0C"><enum>(i)</enum><text>consisting of—</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="id06F0D7179CE4462586C2D1C4F562CB0F"><enum>(D)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idD77ED94B287F4E2B9DB5ABC11C83F343" style="OLC"> <clause id="idC370E0B72235496BB70F2DB4A29B90AC"><enum>(ii)</enum><text>that may include one or more emergency medical service organizations or emergency management organizations; and</text></clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection id="id3CAB20F89F99496980FD82968BFB47E5"><enum>(c)</enum><header>Public health security grants authorization of appropriations</header><text>Section 319C–1(h)(1)(A) (42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking <quote>$641,900,000 for fiscal year 2014</quote> and all that follows through the period at the end and inserting <quote>$685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and (5)).</quote>.</text>
</subsection><subsection id="idc263d78dcfb749148ab6b19429198914"><enum>(d)</enum><header>Partnership for State and regional hospital preparedness authorization of appropriations</header><text>Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is amended—</text> <paragraph id="idED718365C64C4545BCA4C6E9A73908DD"><enum>(1)</enum><text>by amending paragraph (1) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id7EB38111B4CF4BDB90F13AC5AC99E9A9" style="OLC">
<paragraph id="id33427B6AD2134CB68F9249A8DB77116E"><enum>(1)</enum><header>In general</header>
<subparagraph id="id73C3165599104A23AEF5A226D7749A6A"><enum>(A)</enum><header>Authorization of appropriations</header><text>For purposes of carrying out this section and section 319C–3, in accordance with subparagraph (B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019 through 2023.</text>
</subparagraph><subparagraph id="id2509FBCD57AE4CB9A53C8F38A8A3D003"><enum>(B)</enum><header>Reservations of amounts for regional systems</header>
<clause id="id21D8287939AD4D32B67A41FDF229E9C4"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 319C–3.</text>
</clause><clause id="id1F3740AD349D46E991BB67352F8D2ABF"><enum>(ii)</enum><header>Reservations contingent on continued appropriations</header><text>If the amount appropriated under subparagraph (A) for fiscal year 2019 or a subsequent fiscal year is less than or equal the amount so appropriated for the previous fiscal year, the amount that may be reserved under clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.</text></clause></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id662C8493236A43F3AE6C63E990A3021C"><enum>(2)</enum><text>in paragraph (2), by striking <quote>paragraph (1) for a fiscal year</quote> and inserting <quote>paragraph (1)(A) for a fiscal year and not reserved for the purpose described in paragraph (1)(B)(i)</quote>; and</text>
</paragraph><paragraph id="id729F49EE388641C1BBA326595045349F"><enum>(3)</enum><text>in paragraph (3)(A), by striking <quote>paragraph (1) and not reserved under paragraph (2)</quote> and inserting <quote>paragraph (1)(A) and not reserved under paragraph (1)(B)(i) or (2)</quote>.</text> </paragraph></subsection></section><section id="idA43163034FD34FF6BA3A757841DBD049"><enum>203.</enum><header>Regional health care emergency preparedness and response systems</header> <subsection id="idAEC5B2BB508942BF8DDA2A21DC52734E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Part B of title III (<external-xref legal-doc="usc" parsable-cite="usc/42/243">42 U.S.C. 243</external-xref> et seq.) is amended by inserting after section 319C–2 the following:</text>
<quoted-block display-inline="no-display-inline" id="idF62F5FFAD3F143C1B6C93D201F16C6B0" style="OLC">
<section id="id232A190822274B6C9A2F7090CF13D203"><enum>319C–3.</enum><header>Guidelines for regional health care emergency preparedness and response systems</header>
<subsection id="idaec4244d14fe442dae6a7192b6aa4c3c"><enum>(a)</enum><header>Purpose</header><text>It is the purpose of this section to identify and provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, and in advance of, a public health emergency, including threats posed by one or more chemical, biological, radiological, and nuclear agents, including emerging infectious diseases.</text>
</subsection><subsection id="idCF3A4FA46A324E7AB932E7C340D94675"><enum>(b)</enum><header>Guidelines</header><text>The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, heads of such other Federal agencies as the Secretary determines to be appropriate, and State, local, tribal, and territorial public health officials, shall, not later than 2 years after the date of enactment of this section—</text>
<paragraph id="id203a8eb422814d6ba5ff5b82da7bf839"><enum>(1)</enum><text>identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—</text>
<subparagraph id="ida1ec26dfbb3b4e558dd1cae97d0ba05f"><enum>(A)</enum><text>a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including—</text>
<clause id="id9626EC263A08447EBD3D2F899124BD96"><enum>(i)</enum><text>the manner in which the system will coordinate with and integrate the partnerships established under section 319C–2(b); and</text>
</clause><clause id="id48A56561F757482C9458E1B5157581D2"><enum>(ii)</enum><text>informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;</text>
</clause></subparagraph><subparagraph id="id6c93c210c78c40b7bb60b33fbaed77e1"><enum>(B)</enum><text>physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;</text>
</subparagraph><subparagraph id="idedc52a638b6443a6be099d5ab83b40c4"><enum>(C)</enum><text>protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;</text>
</subparagraph><subparagraph id="idac558d7279504a8493c0206710f1247b"><enum>(D)</enum><text>in a manner that allows for disease containment (within the meaning of section 2802(b)(2)(B)), coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as applicable and appropriate, between systems in different States or regions; and</text>
</subparagraph><subparagraph id="id02bf90a0c5dd400baaaa569e3e6144cb"><enum>(E)</enum><text>the needs of children and other at-risk individuals;</text> </subparagraph></paragraph><paragraph id="id3bc7cc8dc61a43258475dfaed6d74ed1"><enum>(2)</enum><text>make such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security; and</text>
</paragraph><paragraph id="id63954c596fe44f58983778c47af82211"><enum>(3)</enum><text>update such guidelines as appropriate, including based on input received pursuant to subsections (c), (e), and (f), to address new and emerging public health threats.</text>
</paragraph></subsection><subsection id="id6ed9ac2c3e5a4220a6da2531e4b2d2ed"><enum>(c)</enum><header>Considerations</header><text>In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—</text>
<paragraph id="idd655a1fa07b74262b3930faec8bf174e"><enum>(1)</enum><text>include input from hospitals and health care facilities, including health care coalitions under section 319C–2, State, local, tribal, and territorial public health departments, and health care or subject matter experts, including experts with relevant expertise in chemical, biological, radiological, or nuclear threats, and emerging infectious disease as the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);</text>
</paragraph><paragraph id="id5C11795360244DA29EC318CFD3C44038"><enum>(2)</enum><text>consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, and other experts that the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);</text>
</paragraph><paragraph id="idcc7175774dc6463084484e22183fb673"><enum>(3)</enum><text>consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and</text>
</paragraph><paragraph id="id6018255128ba46d8b1886c8fb9318879"><enum>(4)</enum><text>consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.</text>
</paragraph></subsection><subsection id="idccd5f65aa6fd4088b09327ef41841fc9"><enum>(d)</enum><header>Technical assistance</header><text>The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary of Labor for Occupational Safety and Health, may provide technical assistance and consultation towards meeting the guidelines described in subsection (b).</text>
</subsection><subsection id="idae140e43063645bf83e3327cabf96954"><enum>(e)</enum><header>Demonstration project for regional health care preparedness and response systems</header>
<paragraph id="id439e54353ab1428a8da2e37d107f6543"><enum>(1)</enum><header>In general</header><text>The Assistant Secretary for Preparedness and Response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection (b) to improve medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve specialty care expertise for all-hazards response, and coordinate medical preparedness and response across State, local, tribal, territorial, and regional jurisdictions.</text>
</paragraph><paragraph id="id126B06D6FF814BF48E233CBFBDE72BFB"><enum>(2)</enum><header>Sunset</header><text>The authority under this subsection shall expire on September 30, 2023.</text> </paragraph></subsection><subsection id="id30DC0BE2F99D4D70939618C6209B342F"><enum>(f)</enum><header>GAO report to Congress</header> <paragraph id="id10a69bd96a3642e4b3c533ca2c2c3510"><enum>(1)</enum><header>Report</header><text>Not later than 3 years after the date of enactment of this section, the Comptroller General of the United States (referred to in this subsection as the <quote>Comptroller General</quote>) shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives, a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under subsection (b), including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines.</text>
</paragraph><paragraph id="id1b0967a460f54b1cbe68149b5f118325"><enum>(2)</enum><header>Content</header><text>The Comptroller General shall include in the report under paragraph (1)—</text> <subparagraph id="idCF745E8E0A024624B5C4E3238606147D"><enum>(A)</enum><text>data on the preparedness and response capabilities that have been informed by the guidelines under subsection (b) to improve regional emergency health care preparedness and response capability, including hospital and health care facility capacity and medical surge capabilities to prepare for, and respond to, public health emergencies; and</text>
</subparagraph><subparagraph id="idEA7675FC1AEA45768D25CD671EE87CF9"><enum>(B)</enum><text>recommendations to reduce gaps in incentives for regional health partners, including hospitals and health care facilities to improve capacity and medical surge capabilities to prepare for, and respond to, public health emergencies, consistent with subsection (a), which may include consideration of facilities participating in programs under section 319C–2, programs under the Centers for Medicare & Medicaid Services (including innovative health care delivery and payment models), and input from private sector financial institutions.</text>
</subparagraph></paragraph><paragraph id="id36acbc4d767246ad854cad9d816feccc"><enum>(3)</enum><header>Consultation</header><text>In carrying out paragraphs (1) and (2), the Comptroller General shall consult with the heads of appropriate Federal agencies, including—</text>
<subparagraph id="idefc4608300bf4535b5a14f7e8db99241"><enum>(A)</enum><text>the Assistant Secretary for Preparedness and Response;</text> </subparagraph><subparagraph id="id3bb8fda7d4624353a071f5e3407d3bc0"><enum>(B)</enum><text>the Director of the Centers for Disease Control and Prevention;</text>
</subparagraph><subparagraph id="id2e474b13431649e7b131928fb9f679f9"><enum>(C)</enum><text>the Administrator of the Centers for Medicare & Medicaid Services;</text> </subparagraph><subparagraph id="ida3d7a824f80049da88ff8dd54c60a8d1"><enum>(D)</enum><text>the Assistant Secretary for Mental Health and Substance Use;</text>
</subparagraph><subparagraph id="idAA3094B2947E4EF89A2BB4B70E029ACC"><enum>(E)</enum><text>the Assistant Secretary of Labor for Occupational Safety and Health;</text> </subparagraph><subparagraph id="id0a7ff98dbe81404585a007408da915ab"><enum>(F)</enum><text>the Secretary of Veterans Affairs; and</text>
</subparagraph><subparagraph id="id357d25a1f83c4e64bf95218e43a0fe6d"><enum>(G)</enum><text>the heads of such other Federal agencies as the Secretary determines appropriate.</text> </subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="idc3b19808c1c249b8bd5be4ddb12f70d5"><enum>(b)</enum><header>Annual reports</header><text>Section 319C–2(i)(1) (42 U.S.C. 247d–3b(i)(1)) is amended by inserting after the first sentence the following <quote>The reports submitted under this paragraph shall also include progress towards the implementation of section 319C–3.</quote>.</text>
</subsection><subsection id="idEA2117DED1274FDD9A343DFDDA2B8789"><enum>(c)</enum><header>National health security strategy incorporation of regionalized emergency preparedness and response</header><text>Section 2802(b)(3) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1(b)(3)</external-xref>) is amended—</text> <paragraph id="idFF3028C8B1A649F39329D2F3C6418C21"><enum>(1)</enum><text>in the matter preceding subparagraph (A), by striking <quote>including mental health</quote> and inserting “including pharmacies, mental health facilities,”; and</text>
</paragraph><paragraph id="id3F07488569A34A9880E2FB634E2D7794"><enum>(2)</enum><text>by amending subparagraph (G) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id3203A3E93FE24446A4CE105C31E7A159" style="OLC"> <subparagraph id="id287A1333456F499B981892A40B8D79D6"><enum>(G)</enum><text>Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems, which may include the implementation of guidelines for regional health care emergency preparedness and response systems under section 319C–3.</text></subparagraph><after-quoted-block>. </after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="id00e837ae14b44a91973b5bc449842027"><enum>(d)</enum><header>Improving State and local public health security</header>
<paragraph id="id8cc59077a8b747358e863f173ddf8972"><enum>(1)</enum><header>State and local security</header><text>Section 319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by striking <quote>, and local emergency plans.</quote> and inserting <quote>, local emergency plans, and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section 319C–3.</quote>.</text>
</paragraph><paragraph id="ided78980c34bb41d5bd25174e44162255"><enum>(2)</enum><header>Partnerships</header><text>Section 319C–2(d)(1)(A) (42 U.S.C. 247d–3b(d)(1)(A)) is amended—</text> <subparagraph id="ida073a74654844af0b835dd73ab69852d"><enum>(A)</enum><text>in clause (i), by striking <quote>; and</quote> and inserting <quote>;</quote>;</text>
</subparagraph><subparagraph id="idED744F43260A4AFD9D3463C580238A1D"><enum>(B)</enum><text>by redesignating clause (ii) as clause (iii); and</text> </subparagraph><subparagraph commented="no" id="id2b88642aaac942af8f609d64f6032a45"><enum>(C)</enum><text>inserting after clause (i), the following:</text>
<quoted-block display-inline="no-display-inline" id="ide0855c63373d40059c3f2f252fcb3993" style="OLC">
<clause commented="no" id="id40f712dd18294fe392982b0aa61ab634"><enum>(ii)</enum><text>among one or more facilities in a regional health care emergency system under section 319C–3; and</text></clause><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection></section><section id="idFF5AED3DB9B64C3D8E425CCED697CF45"><enum>204.</enum><header>Public health and health care system situational awareness and biosurveillance capabilities</header> <subsection id="idF40E840F28F54FCFB2ED36964FFD35C4"><enum>(a)</enum><header>Facilities, capacities, and biosurveillance capabilities</header> <text display-inline="yes-display-inline">Section 319D (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended—</text>
<paragraph id="idCE4437379D1747198F30297A175A823E"><enum>(1)</enum><text>in the section heading, by striking <quote><header-in-text level="section" style="OLC">Revitalizing</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">Facilities and capacities of</header-in-text></quote>;</text> </paragraph><paragraph id="idD04BC0C2FABD4D03B32DF7A034DECDF5"><enum>(2)</enum><text>in subsection (a)—</text>
<subparagraph id="id07EB0C75230845C48F7F495684765B9B"><enum>(A)</enum><text>in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">Facilities; capacities</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">In general</header-in-text></quote>;</text> </subparagraph><subparagraph id="id00A8CB657D1943AFA6649FA843811389"><enum>(B)</enum><text>in paragraph (1), by striking <quote>and improved</quote> and inserting <quote>, improved, and appropriately maintained</quote>;</text>
</subparagraph><subparagraph id="id803a4c03788f4c5f8ced959e6d3257d0"><enum>(C)</enum><text>in paragraph (3), in the matter preceding subparagraph (A), by striking <quote>expand, enhance, and improve</quote> and inserting <quote>expand, improve, enhance, and appropriately maintain</quote>; and</text> </subparagraph><subparagraph id="idA8E0C1D989F34F408473FB1D53882412"><enum>(D)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id61791A9FD7D34585AC48B3CEB37CEB3F" style="OLC">
<paragraph id="id52877D43A00649A6A480D0E7BDE048B9"><enum>(4)</enum><header>Study of resources for facilities and capacities</header><text>Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id23AE1265EF0640CA8B1782DCA91E0ACA"><enum>(3)</enum><text>in subsection (b)—</text> <subparagraph id="id4B02509FA2BA4E1986A017D40C9432AF"><enum>(A)</enum><text>in the subsection heading, by striking <quote><header-in-text level="subsection" style="OLC">national</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">Establishment of systems of public health </header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" id="idD96591C8F776438CAA81C684CD541132"><enum>(B)</enum><text>in paragraph (1)(B), by inserting <quote>immunization information systems,</quote> after <quote>centers,</quote>;</text> </subparagraph><subparagraph commented="no" id="idDA51BB072FB9425A974B87FEEB56385B"><enum>(C)</enum><text>in paragraph (2)—</text>
<clause id="ide7cec58ffab14ab18ed19e8acda78eab"><enum>(i)</enum><text>by inserting <quote>develop a plan to, and</quote> after <quote>The Secretary shall</quote>; and</text> </clause><clause id="idd512ee5be17e427da374cc3d9e68ad8c"><enum>(ii)</enum><text>by inserting <quote>and in a form readily usable for analytical approaches</quote> after <quote>in a secure manner</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" id="id3259CDD8FBB64A97B05CEB394308C2D4"><enum>(D)</enum><text>by amending paragraph (3) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="id09F640A309624C4D98D65C9971E0A963" style="OLC"> <paragraph id="id9ab1d1d0e7e34be2bd18c33d58759f4e"><enum>(3)</enum><header>Standards</header> <subparagraph id="id129FC57A445E45E0ACF5B76AFFFD7847"><enum>(A)</enum><header>In general</header><text>Not later than 1 year after the date of the enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary, in cooperation with health care providers, State, local, tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as necessary. Such standards shall be made available on the internet website of the Department of Health and Human Services, in a manner that does not compromise national security.</text>
</subparagraph><subparagraph id="idc7ca9445a70642dc98a426e3e1831eac"><enum>(B)</enum><header>Deference to standards development organizations</header><text>In adopting and implementing standards under this subsection and subsection (c), the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="id9540FD7737E142B6BD7F07BF9B99BC32"><enum>(4)</enum><text>in subsection (c)—</text> <subparagraph commented="no" id="id5D7D503316A54C4195006C1E6058DB9B"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause commented="no" id="id2D2FB3A34D8447C5A8A53FBA24624E27"><enum>(i)</enum><text>by striking <quote>Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, the Secretary</quote> and inserting <quote>The Secretary</quote>;</text>
</clause><clause commented="no" id="id9CF8C35E9E40408582AE65203D4462AF"><enum>(ii)</enum><text>by inserting <quote>, and improve as applicable and appropriate,</quote> after <quote>shall establish</quote>;</text> </clause><clause commented="no" id="id3BFCA4BFBBE44AAD997849D59A44EE51"><enum>(iii)</enum><text>by striking <quote>of rapid</quote> and inserting <quote>of, rapid</quote>; and</text>
</clause><clause id="id4e7523766b454ac2b155c64afd976241"><enum>(iv)</enum><text>by striking <quote>such connectivity</quote> and inserting <quote>such interoperability</quote>;</text> </clause></subparagraph><subparagraph commented="no" id="idBABB0869FA4849B4B1BF5126E158BBA2"><enum>(B)</enum><text>by amending paragraph (2) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idF0A3D68CA1A54044BB9FF9E61E146684" style="OLC">
<paragraph id="id9174BFF342CA4CA8A2F3DFE8563EF4AA"><enum>(2)</enum><header>Coordination and consultation</header><text>In establishing and improving the network under paragraph (1) the Secretary shall—</text> <subparagraph id="id9C1EAAE94DE344D299D06185238EF401"><enum>(A)</enum><text>facilitate coordination among agencies within the Department of Health and Human Services that provide or have the potential to provide information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and</text>
</subparagraph><subparagraph id="idE1DDE798C55048DCAC0733FC4185983D"><enum>(B)</enum><text>consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, and the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id08523FAC3C284893B6C97F34523B2A6E"><enum>(C)</enum><text>in paragraph (3)—</text> <clause id="id16E26A688DD544E595ABF5069AE68C4F"><enum>(i)</enum><text>by redesignating subparagraphs (A) through (E) as clauses (i) through (v), respectively, and adjusting the margins accordingly;</text>
</clause><clause id="id4DD756385E9544798807CA98CEB7D057"><enum>(ii)</enum><text>in clause (iv), as so redesignated—</text> <subclause id="id5630B62125C44A5BB33856EE495958FC"><enum>(I)</enum><text>by inserting <quote>immunization information programs,</quote> after <quote>poison control,</quote>; and</text>
</subclause><subclause id="id6CDFEDD9C2DF4466A27E73D011C55863"><enum>(II)</enum><text>by striking <quote>and clinical laboratories</quote> and inserting <quote>, clinical laboratories, and public environmental health agencies</quote>;</text> </subclause></clause><clause id="idD72B5E1FA02D444A8412507EC9B1A457"><enum>(iii)</enum><text>by striking <quote>The network</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idF4C48DA41C1145689131CAAAFECEC3A8" style="OLC">
<subparagraph id="id170F5D4C1923488D97A6B3722B432BA6"><enum>(A)</enum><header>In general</header><text>The network</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause><clause id="id071B87657499424EA5AFB478E5D6D939"><enum>(iv)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id468AE3B5511B4C738C455A8BD775752C" style="OLC">
<subparagraph id="idEFAD05ADED52443C87A0D487139EE129"><enum>(B)</enum><header>Review</header><text>Not later than 2 years after the date of the enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title> and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under subparagraph (A). The Secretary shall provide such review to the congressional committees of jurisdiction.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" id="id73C16187BC104D61B4ED78456346F761"><enum>(D)</enum><text>in paragraph (5)—</text> <clause commented="no" id="idB3E431052B6647F28231D330A0272C6A"><enum>(i)</enum><text>by redesignating subparagraphs (A) through (D) as clauses (i) through (iv), respectively, and adjusting the margins accordingly;</text>
</clause><clause commented="no" id="idA9EAB89966DF4A60B005FDEA2042B1A0"><enum>(ii)</enum><text>by striking <quote>In establishing</quote> and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="idB073163516F64914A8350F28B48AEB9F" style="OLC"> <subparagraph id="idE5A7A30790DA4B079ED7000795C235B8"><enum>(A)</enum><header>In general</header><text>In establishing</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block>
</clause><clause commented="no" id="idFBBC7D4D514A4954B3FB030B11A388CD"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id44257C6C9E7344DEA0F3DA4CFB9B0545" style="OLC"> <subparagraph id="idB7234C7EFEEB4964B8BC1C1B79CB3D5E"><enum>(B)</enum><header>Public meeting</header> <clause id="id0C1A319B54B9495AA13B34012503D1DA"><enum>(i)</enum><header>In general</header><text>Not later than 180 days after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).</text>
</clause><clause id="id12517A07DE704750A86D0DF2E1EB63FC"><enum>(ii)</enum><header>Experts</header><text>The public meeting shall include representatives of relevant Federal agencies (including representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), State, local, tribal, and territorial public health officials, stakeholders with expertise in biosurveillance and situational awareness, and stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction and forecasting), and other representatives as the Secretary determines appropriate.</text>
</clause><clause id="id05B8719004554F5C9BB0803C0CFDE76B"><enum>(iii)</enum><header>Topics</header><text>Such public meeting shall include a discussion of—</text> <subclause id="id9648C8CFB1E342909F1EDF144F7DF707"><enum>(I)</enum><text>data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;</text>
</subclause><subclause id="idF62FD366D9F345B18BD2FF4308D50D9D"><enum>(II)</enum><text>standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;</text>
</subclause><subclause commented="no" id="id2EC0CBDF7B7C4BC888001F8443FCA4E4"><enum>(III)</enum><text>strategies to encourage the access, exchange, and use of information;</text> </subclause><subclause commented="no" id="id21961D531D1143B9902D4C7EC67E465E"><enum>(IV)</enum><text>considerations for State, local, tribal, and territorial capabilities and infrastructure related to data exchange and interoperability;</text>
</subclause><subclause id="id2c01709b3a604cb490090a474d3b864d"><enum>(V)</enum><text>privacy and security protections provided at the Federal, State, local, tribal, and territorial levels, and by nongovernmental stakeholders; and</text>
</subclause><subclause id="id0A1B97D2D02C43A3BD1F2BCE09636407"><enum>(VI)</enum><text>opportunities for the incorporation of innovative technologies to improve the network.</text></subclause></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause><clause commented="no" id="id39F3367C15E34D9286F2C6DBDD9741C0"><enum>(iv)</enum><text>in subparagraph (A), as so designated by clause (ii)—</text>
<subclause commented="no" id="id4CEF1A3AB7BC49FBB80D538E9DB2EEF6"><enum>(I)</enum><text>in clause (i), as so redesignated—</text> <item commented="no" id="idB21BECE5A5AA467B8FE5155C671E9C47"><enum>(aa)</enum><text>by striking <quote>as determined</quote> and inserting <quote>as adopted</quote>; and</text>
</item><item commented="no" id="idE96B5BA843C04187A701EE61421A503E"><enum>(bb)</enum><text>by inserting <quote>and the National Institute of Standards and Technology</quote> after <quote>Office of the National Coordinator for Health Information Technology</quote>;</text> </item></subclause><subclause commented="no" id="idFD8F9AAACCCD498FBC1ED094A5E367F3"><enum>(II)</enum><text>in clause (iii), as so redesignated, by striking <quote>; and</quote> and inserting a semicolon;</text>
</subclause><subclause commented="no" id="id3900B2A14A824B12A3AB7FFA35653F28"><enum>(III)</enum><text>in clause (iv), as so redesignated, by striking the period and inserting <quote>; and</quote>; and</text> </subclause><subclause commented="no" id="id9333FC2D7E8C42D98F08FD420EA8BFB4"><enum>(IV)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7A9FAD60633D43368E0DD121D1B5F1EF" style="OLC">
<clause id="id2793511DAB124C2D85B4BD67E64F73C0"><enum>(v)</enum><text>pilot test standards and implementation specifications, consistent with the process described in section 3002(b)(3)(C), which State, local, tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause></clause></subparagraph><subparagraph id="id5ACC3D997D604A3095ED83AA774BAEF6"><enum>(E)</enum><text>by redesignating paragraph (6) as paragraph (7);</text> </subparagraph><subparagraph id="id58004C435F364C1388FA3FFED3ADEC2C"><enum>(F)</enum><text>by inserting after paragraph (5) the following:</text>
<quoted-block display-inline="no-display-inline" id="idCE2C20BFB29340FFA93A89C46BF94877" style="OLC">
<paragraph id="idB5CE26A3033F46CA83A01CE17E0953DA"><enum>(6)</enum><header>Strategy and implementation plan</header>
<subparagraph id="idBF01A67233134E0198356B44C19E7C47"><enum>(A)</enum><header>In general</header><text>Not later than 18 months after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary shall submit to the appropriate committees of Congress a coordinated strategy and an accompanying implementation plan that—</text>
<clause id="id763284BDC60F47628826810BF42B1F79"><enum>(i)</enum><text>is informed by the public meeting under paragraph (5)(B);</text> </clause><clause id="id5EF1A37BC9E04454BDA4BF12BD648375"><enum>(ii)</enum><text>includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);</text>
</clause><clause id="idBFE359D62A124672BABF63FB12F01C33"><enum>(iii)</enum><text>identifies and demonstrates the measurable steps the Secretary will carry out to—</text> <subclause id="id72B48168EA964A57BDD5A016F9844A77"><enum>(I)</enum><text>develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);</text>
</subclause><subclause id="id093C59C12CDC446E93100D015BECD06E"><enum>(II)</enum><text>modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;</text>
</subclause><subclause id="idBC5A8EE5577E4B28B16A8C1462D2DCC3"><enum>(III)</enum><text>improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies; and</text>
</subclause><subclause id="idA8EF92AC88D543EAAC3C20173D9F2FCE"><enum>(IV)</enum><text>test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;</text>
</subclause></clause><clause id="id5E88D253D6F04335B08A3CAF3F922F2F"><enum>(iv)</enum><text>includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii); and</text>
</clause><clause id="idD81FE1E9CA7F48BAACF753C6F09D3F83"><enum>(v)</enum><text>establishes dates by which each measurable step under clause (iii) will be implemented.</text> </clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> <quoted-block display-inline="no-display-inline" id="id57b04758184f4e87aa72d5f9f84696f4" style="OLC"> <subparagraph id="id83F73E6DBE244451931A62919F10AB5E"><enum>(B)</enum><header>Annual budget plan</header><text>Not later than 2 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title> and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section. Such budget plan shall include—</text>
<clause id="id253a9d164177423686b7784f646d13c9"><enum>(i)</enum><text>a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);</text>
</clause><clause id="id57a613ddc49d43a5af37de8ec639762b"><enum>(ii)</enum><text>estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);</text>
</clause><clause id="idc6ce6bd9829947e9acf9ca212b215255"><enum>(iii)</enum><text>the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and</text>
</clause><clause id="idc91c9ed7e64a42feb90da6151a3fe061"><enum>(iv)</enum><text>a strategy to minimize and address such gaps and improve inefficiencies.</text> </clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="id47787f2da3b649a38d703c6ac2290a07"><enum>(G)</enum><text>in paragraph (7), as so redesignated—</text>
<clause id="id15D3F61BD57840AD80E5C5E3748FF180"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>(taking into account zoonotic disease, including gaps in scientific understanding of the interactions between human, animal, and environmental health)</quote> after <quote>human health</quote>;</text>
</clause><clause id="idA67B3788A1F74467A0189CD603854895"><enum>(ii)</enum><text>in subparagraph (B)—</text> <subclause id="id317726D676AA44779146410AD01B6457"><enum>(I)</enum><text>by inserting <quote>and gaps in surveillance programs</quote> after <quote>surveillance programs</quote>; and</text>
</subclause><subclause id="id7685ED7604124BB1AE6A13FA1F944A76"><enum>(II)</enum><text>by striking <quote>; and</quote> and inserting a semicolon;</text> </subclause></clause><clause id="id9963D989219E4B5F84CD4721921F1F03"><enum>(iii)</enum><text>in subparagraph (C)—</text>
<subclause id="id8338C448B31548BE9383FF2DAE81A37E"><enum>(I)</enum><text>by inserting <quote>, animal health organizations related to zoonotic disease,</quote> after <quote>health care entities</quote>; and</text> </subclause><subclause id="idD9FAF79F925F42C7A61A52118CBB571F"><enum>(II)</enum><text>by striking the period and inserting <quote>; and</quote>; and</text>
</subclause></clause><clause id="idE9697391BEF44E16B2567312A781E21D"><enum>(iv)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="idFD345CA5E759453EA9ED82247F6FDFB2" style="OLC"> <subparagraph id="idB416A149602B4B91A8BEC657D4BF2D8F"><enum>(D)</enum><text>provide recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section 2802.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="id5DA367B498E94F6D882E69C8929ADB3D"><enum>(H)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="ida415582344834de68d3668698e3cd861" style="OLC"> <paragraph id="id726dc38791754a26becaa3e7ebedece0"><enum>(8)</enum><header>Situational awareness and biosurveillance as a national security priority</header><text>The Secretary, on a periodic basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id6B5DCEDFCD664C428D3CF02162143143"><enum>(5)</enum><text>in subsection (d)—</text> <subparagraph id="id8cc42a47fcd94b1a92eeb8c066e15dda"><enum>(A)</enum><text>in paragraph (1)—</text>
<clause id="id8B8678E18112457DA765DAD744CC0365"><enum>(i)</enum><text>by inserting <quote>environmental health agencies,</quote> after <quote>public health agencies,</quote>; and</text> </clause><clause id="id313D3F4CD0D14E58B04873A42B17CADA"><enum>(ii)</enum><text>by inserting <quote>immunization programs,</quote> after <quote>poison control centers,</quote>; and</text>
</clause></subparagraph><subparagraph id="id8C53F3B818AE422D8431366195D078C4"><enum>(B)</enum><text>in paragraph (2)—</text> <clause id="idAA1245A33D3C44FBA75F5A80DBA3FC44"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>and</quote> at the end;</text>
</clause><clause id="id39CAD51F6B3B43E4839708E355CEB3D4"><enum>(ii)</enum><text>in subparagraph (C), by striking the period and inserting <quote>; and</quote>; and</text> </clause><clause id="id699218BA140E442BA007B9CD0CC754A6"><enum>(iii)</enum><text>by adding after subparagraph (C) the following:</text>
<quoted-block display-inline="no-display-inline" id="idF6E1C79F52FB47268F40F17BA3F9B7BC" style="OLC">
<subparagraph id="id044F14BC5EFF48D1B3CF1BFABF33210A"><enum>(D)</enum><text>an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="id42AD509875874868870B3EDD3EA8E91C"><enum>(C)</enum><text>by striking paragraph (5) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id88FE42B2B87C47DC8BBAAAD55D5C1EF5" style="OLC"> <paragraph id="id6A2AB15C03B242B1804FC9527D177812"><enum>(5)</enum><header>Technical assistance</header><text>The Secretary may provide technical assistance to States, localities, tribes, and territories or a consortium of States, localities, tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="idFCC93F8933AE4960B5B037ADE7054F16"><enum>(6)</enum><text>by redesignating subsections (f) and (g) as subsections (h) and (i), respectively; and</text> </paragraph><paragraph id="idD5B494794D174B1389927BC8AF8EBA02"><enum>(7)</enum><text>by inserting after subsection (e) the following:</text>
<quoted-block display-inline="no-display-inline" id="id769431F01DCA4B7B83C346A9A8DB6885" style="OLC">
<subsection id="id68FB16C12B3C4FBAB76E1E186BF1930D"><enum>(f)</enum><header>Timeline</header><text>The Secretary shall accomplish the purposes under subsections (b) and (c) no later than September 30, 2023, and shall provide a justification to Congress for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).</text>
</subsection><subsection id="idDD7D87ABFB8646E9A747EEF537D8F934"><enum>(g)</enum><header>Independent evaluation</header><text>Not later than 3 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report concerning the activities conducted under subsections (b) and (c), and provide recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="id9eeba11afc9844cdaff0ba58f8f9f26a"><enum>(b)</enum><header>Authorization of appropriations</header><text>Subsection (h) of section 319D (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>), as redesignated by subsection (a)(6), is amended by striking <quote>$138,300,000 for each of fiscal years 2014 through 2018</quote> and inserting <quote>$161,800,000 for each of fiscal years 2019 through 2023</quote>.</text>
</subsection></section><section id="idBFFAEB7DCC954AA3BB9D683762A9470E"><enum>205.</enum><header>Strengthening and supporting the public health emergency rapid response fund</header>
<text display-inline="no-display-inline">Section 319 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d</external-xref>) is amended—</text> <paragraph id="id5C82DC1075BD4BC6A776000F05C31103"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph id="id9DF1AE2C4F4D40C9B043348E419ED41C"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text> <clause id="idC87EEA44C12144039D7AC5835ED5BE49"><enum>(i)</enum><text display-inline="yes-display-inline">in the first sentence, by inserting <quote>or if the Secretary determines there is the significant potential for a public health emergency, to allow the Secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency</quote> before the period; and</text>
</clause><clause id="id8B910C6B957741F68B96BFB0CFEAD9AA"><enum>(ii)</enum><text>by inserting <quote>The Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities.</quote> after the first sentence;</text>
</clause></subparagraph><subparagraph id="id0B12A3DFD03442E9AB4668158AAD3742"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating paragraph (2) as paragraph (3);</text> </subparagraph><subparagraph id="idE00AD71F22934EDD8D2EF96998D030C8"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the following:</text>
<quoted-block display-inline="no-display-inline" id="id6C00CA20C8824698BAE2D1A89929C4B6" style="OLC">
<paragraph id="id4DF6B6AFD0424E91B5D5344F495E0BD3"><enum>(2)</enum><header>Uses</header><text>The Secretary may use amounts in the Fund established under paragraph (1), to—</text> <subparagraph id="idc7f92f4686354b5b94332c439cefb0a5"><enum>(A)</enum><text>facilitate coordination between and among Federal, State, local, tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency (including communication of such entities with relevant international entities, as applicable);</text>
</subparagraph><subparagraph id="idCAE5B764373A40C7865C32200A7F6136"><enum>(B)</enum><text>make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 319C–1 or 319C–2;</text>
</subparagraph><subparagraph id="idbf631c6a257f4fb684cae66b1015e800"><enum>(C)</enum><text>facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 319F–2), qualified countermeasures (as defined in section 319F–1), or qualified pandemic or epidemic products (as defined in section 319F–3), that are applicable to the public health emergency or potential public health emergency under paragraph (1);</text>
</subparagraph><subparagraph id="id1a75838524bb4fdca6e945d0e6b6ca76"><enum>(D)</enum><text>strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information on such public health emergency or potential public health emergency, including the systems under section 319D;</text>
</subparagraph><subparagraph id="id381c487610284c0fb2b804870b2082a3"><enum>(E)</enum><text>support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel expenses under section 2812, and the Medical Reserve Corps under section 2813; and</text>
</subparagraph><subparagraph id="id68f9e17ee9834f109c1c80c964c9f0f6"><enum>(F)</enum><text>other activities, as the Secretary determines applicable and appropriate.</text></subparagraph></paragraph><after-quoted-block>; and </after-quoted-block></quoted-block> </subparagraph><subparagraph id="id8B757FD80CD94CECAA4073A702C5D409"><enum>(D)</enum><text>by inserting after paragraph (3), as so redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="id668EE854EBD9487BAAEFAF28722DCF6B" style="OLC">
<paragraph id="idFE926424026E4FDA8A5B822B9411705B"><enum>(4)</enum><header>Review</header><text>Not later than 2 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section, and provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives on policies to improve such Fund for the uses described in paragraph (2).</text>
</paragraph><paragraph id="id8C118A59AA8A4EDD93B330FBFD913411"><enum>(5)</enum><header>GAO report</header><text>Not later than 4 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Comptroller General of the United States shall conduct a review of the Fund under this section, including the uses and the resources available in the Fund.</text></paragraph><after-quoted-block>; and </after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="idCE0B412054234020848D418068A9AA31"><enum>(2)</enum><text>in subsection (c)—</text> <subparagraph id="idE36BD5D10E9D49BD96F115C33756C721"><enum>(A)</enum><text>by inserting <quote>rapidly respond to public health emergencies or potential public health emergencies and</quote> after <quote>used to</quote>; and</text>
</subparagraph><subparagraph id="id389846CA8AC94B0DB732DC72B31D900E"><enum>(B)</enum><text>by striking <quote>section.</quote> and inserting <quote>Act or funds otherwise provided for emergency response.</quote>.</text> </subparagraph></paragraph></section><section id="idba0be3ab26ff4a26971ed0967943c649"><enum>206.</enum><header>Improving preparedness for and response to all-hazards by public health emergency volunteers</header><text display-inline="no-display-inline">Section 319I (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7b">42 U.S.C. 247d–7b</external-xref>) is amended:</text>
<paragraph commented="no" id="idd2d2da1fb4d64d928b46429e96d88eed"><enum>(1)</enum><text>in subsection (a), by adding at the end the following: <quote>Such health care professionals may include members of the National Disaster Medical System, members of the Medical Reserve Corps, and individual health care professionals.</quote>;</text>
</paragraph><paragraph id="idca30bc73cd8e4ec88469f3d491457ea6"><enum>(2)</enum><text>in subsection (i) by adding at the end <quote>In order to inform the development of such mechanisms by States, the Secretary shall make available information and material provided by States that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical services during a public health emergency. Such information shall be made publicly available in a manner that does not jeopardize national security.</quote>; and</text>
</paragraph><paragraph id="id97167f15041a432fb2360093cc5e05a3"><enum>(3)</enum><text>in subsection (k) by striking <quote>$2014 through 2018</quote> and inserting <quote>2019 through 2023</quote>.</text> </paragraph></section><enum>III</enum><header>Reaching all communities</header> <section id="id69DB464CF69E4B6A81D380AEE4E43923"><enum>301.</enum><header>Strengthening and assessing the emergency response workforce</header> <subsection id="id903b81b9363e4709821515765403404b"><enum>(a)</enum><header>National Disaster Medical System</header><text>Clause (ii) of section 2812(a)(3)(A) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11(a)(3)(A)</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idd1440934384642d582c710a57bf7ac3b" style="OLC">
<clause id="id4c58d2c352734778afcc0cf1d410e568"><enum>(ii)</enum><text>be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified, or there is a significant potential for a public health emergency.</text>
</clause><after-quoted-block>. </after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="id7d7e6fa5d5894a59aa72a079dbe2298d"><enum>(b)</enum><header>Volunteer Medical Reserve Corps</header><text>Section 2813(a) (<external-xref legal-doc="usc" parsable-cite="usc/42/42">42 U.S.C. 42</external-xref> U.S.C. 300hh–15(a)) is amended by striking the second sentence and inserting <quote>The Secretary may appoint a Director to head the Corps and oversee the activities of the Corps chapters that exist at the State, local, and tribal levels.</quote></text>
</subsection><subsection id="idE8EF5281925E434B9F6644157BAC822E"><enum>(c)</enum><header>Review of the national disaster medical system</header><text>Section 2812(b)(2) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11(b)(2)</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id7312cf95343a4d1db2f8e4172592c28e" style="OLC">
<paragraph id="id55a4b75bfb2c41a7986339f2e71d2c2b"><enum>(2)</enum><header>Joint review and medical surge capacity strategic plan</header>
<subparagraph id="idF3A605D95C38404CB3965478861AC926"><enum>(A)</enum><header>Review</header><text>Not later than 180 days after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the National Disaster Medical System. Such review shall include—</text>
<clause id="idC036B0741C8146C5B348699AAD606DA5"><enum>(i)</enum><text>an evaluation of medical surge capacity, as described in section 2803(a);</text>
</clause><clause id="idDA788BF1B1C444689D199DFD1CF382ED"><enum>(ii)</enum><text>an assessment of the available workforce of the intermittent disaster response personnel described in subsection (c);</text>
</clause><clause id="id1FF602C3F45B41BAA55F196C47158046"><enum>(iii)</enum><text>the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency;</text>
</clause><clause id="id3DFD8ADCC5F44E15AB9AC90F52682655"><enum>(iv)</enum><text>the effectiveness of efforts to recruit, retain, and train such workforce; and</text>
</clause><clause id="idDB8B9166B6F84C99BB21EBD360DE4978"><enum>(v)</enum><text>gaps that may exist in such workforce and recommendations for addressing such gaps.</text>
</clause></subparagraph><subparagraph id="id8ABF226BDFA6416CB0108FE8EB660BBE"><enum>(B)</enum><header>Updates</header><text>As part of the National Health Security Strategy under section 2802, the Secretary shall update the findings from the review under subparagraph (A) and provide recommendations to modify the policies of the National Disaster Medical System as necessary.</text></subparagraph></paragraph><after-quoted-block>. </after-quoted-block></quoted-block>
</subsection><subsection id="id779b69b21b97409ea7e8f7fe92825395"><enum>(d)</enum><header>Notification of NDMS Shortage</header><text>Section 2812(c) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11(c)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE316C5F7059A4169B998FEF499A57DAD" style="OLC">
<paragraph id="id7A0BF2690BC142E78FEB961A959D71BB"><enum>(3)</enum><header>Service benefit</header><text>Individuals appointed to serve under this subsection shall be considered public safety officers under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The Secretary shall provide notification to eligible individuals of any effect such designation may have on other benefits for which such individuals are eligible, including benefits from private entities.</text>
</paragraph><paragraph id="idA66F29FED1ED4024A7EA2B72BFED5B68"><enum>(4)</enum><header>Notification</header><text>Not later than 30 days after the date on which the Secretary determines the number of intermittent disaster response personnel of such System is insufficient to address a public health emergency or potential public health emergency, the Secretary shall submit to the congressional committees of jurisdiction a notification detailing the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency, and any identified measures to address such shortage.</text>
</paragraph><paragraph id="id96870F0425B54803BB4993922B335BEA"><enum>(5)</enum><header>Certain appointments</header>
<subparagraph id="idE8238AFFCAD6401F80976AEBA1CE6D13"><enum>(A)</enum><header>In general</header><text>If the Secretary determines that the number of intermittent disaster response personnel within the National Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect.</text>
</subparagraph><subparagraph id="id51F28C649BF64F89B8BC0AAA5EA84EB8"><enum>(B)</enum><header>Sunset</header><text>The authority under this paragraph shall expire on September 30, 2021.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="idc75f4afc1e4b4fd2928ab8829d6a034c"><enum>(e)</enum><header>Public safety officer benefits</header><text>Section 1204(9) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10284">34 U.S.C. 10284(9)</external-xref>) is amended—</text>
<paragraph id="idd7af405e94ae45d588935c3252283991"><enum>(1)</enum><text>in subparagraph (C)(ii), by striking <quote>or</quote> at the end;</text> </paragraph><paragraph id="ida88efc42ab3d4194a8bd2caee37b6b04"><enum>(2)</enum><text>in subparagraph (D), by striking the period and inserting <quote>; or</quote>; and</text>
</paragraph><paragraph id="id005efa0e379c4d89805fced72b6e4027"><enum>(3)</enum><text>by inserting after subparagraph (D) the following:</text> <quoted-block display-inline="no-display-inline" id="id199FB20402324A8B90549F56D663C7DB" style="OLC"> <subparagraph id="idecad69940a8143689af7abec6b737ca4"><enum>(E)</enum><text>an individual appointed to the National Disaster Medical System under section 2812 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11</external-xref>) who is performing official duties of the Department of Health and Human Services, if those official duties are related to responding to a public health emergency or potential public health emergency, or other activities for which the Secretary of Health and Human Services has activated such National Disaster Medical System.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ida7f050bbf74440a5bd56dc7c29b4e51c"><enum>(f)</enum><header>National disaster medical system authorization of appropriations</header><text>Section 2812(g) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-11">42 U.S.C. 300hh–11(g)</external-xref>) is amended by striking <quote>$52,700,000 for each of fiscal years 2014 through 2018</quote> and inserting <quote>$57,400,000 for each of fiscal years 2019 through 2023</quote>.</text> </subsection><subsection id="id2283b41168b24279b213c01e549c90e5"><enum>(g)</enum><header>Medical Reserve Corps Authorization of Appropriations</header><text>Section 2813(i) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-15">42 U.S.C. 300hh–15(i)</external-xref>) is amended by striking <quote>2014 through 2018</quote> and inserting <quote>2019 through 2023</quote>.</text>
</subsection></section><section id="id13B02EF121AA46199AFC5161E57C69C5"><enum>302.</enum><header>Health system infrastructure to improve preparedness and response</header>
<subsection id="id26128e063650490fb333379fed70cdad"><enum>(a)</enum><header>Coordination of preparedness</header><text>Section 2811(b)(5) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10(b)(5)</external-xref>) is amended by adding at the end the following: <quote>Such logistical support shall include working with other relevant Federal, State, local, tribal, and territorial public health officials and private sector partners to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including an emergency under section 319, an emergency or major disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.</quote>.</text>
</subsection><subsection commented="no" id="id0757f33ba5ea48abad354bd9774677e8"><enum>(b)</enum><header>Manufacturing Capacity</header><text>Section 2811(d)(2)(C) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10(d)(2)(C)</external-xref>) is amended by inserting <quote>, and ancillary medical supplies to assist with the utilization of such products,</quote> after <quote>products</quote>.</text>
</subsection></section><section id="idc9dbf475453749a580508addbd769e37"><enum>303.</enum><header>Considerations for at-risk individuals</header>
<subsection id="id1f87478972ef49e787707e43c34e49bc"><enum>(a)</enum><header>At-Risk individuals in the National Health Security Strategy</header><text>Section 2802(b)(4)(B) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1(b)(4)(B)</external-xref>) is amended—</text> <paragraph id="id3b7733c0cb83435db158c3fe4896c372"><enum>(1)</enum><text>by striking <quote>this section and sections 319C–1, 319F, and 319L,</quote> and inserting <quote>this Act </quote>; and</text>
</paragraph><paragraph id="idf3ddafaf5c7e491c812d740bbc3a30bb"><enum>(2)</enum><text>by striking <quote>special</quote> and inserting <quote>access or functional</quote>.</text> </paragraph></subsection><subsection id="id3f25e20538734b63838aba2916b1e4e4"><enum>(b)</enum><header>Countermeasure considerations</header><text>Section 319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended—</text>
<paragraph id="id4807462C74ED47E6B1B10FF5AFD4EB22"><enum>(1)</enum><text>by striking <quote>elderly</quote> and inserting <quote>senior citizens</quote>; and</text> </paragraph><paragraph id="id16BAB3BD6BE54BA6834A907528B9ABC5"><enum>(2)</enum><text>by inserting <quote>with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products</quote> before the period.</text>
</paragraph></subsection></section><section id="id766B7685164749BDAF2259FC5160F04E"><enum>304.</enum><header>Improving emergency preparedness and response considerations for children</header><text display-inline="no-display-inline">Part B of title III (<external-xref legal-doc="usc" parsable-cite="usc/42/243">42 U.S.C. 243</external-xref> et seq.) is amended by inserting after section 319D the following:</text>
<quoted-block display-inline="no-display-inline" id="id19cfd7098da24fbc934ff11cecc1f8ad" style="OLC">
<section id="id377cef5ceb3943a798c7061bbb53798a"><enum>319D–1.</enum><header>Children’s preparedness unit</header>
<subsection id="idF3B29FE114CC44AB8FB58EBF5C995C7D"><enum>(a)</enum><header>Enhancing emergency preparedness for children</header>
<text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the <quote>Director</quote>), shall maintain an internal team of experts, to be known as the Children's Preparedness Unit (referred to in this subsection as the <quote>Unit</quote>), to work collaboratively to provide guidance on the considerations for, and the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the Director regarding emergency preparedness and response efforts pertaining to children at the Centers for Disease Control and Prevention.</text>
</subsection><subsection id="id4372045154314497ab63a8ba0963734a"><enum>(b)</enum><header>Expertise</header><text>The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-behavior pediatrician, and may also include behavioral scientists, child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the Secretary determines appropriate.</text>
</subsection><subsection id="id178c0bbc5fb840b58d297cdcd8f13647"><enum>(c)</enum><header>Duties</header><text>The team described in subsection (a) may—</text> <paragraph id="idf0115a84ec1c4df28af05c104e5e2c5a"><enum>(1)</enum><text>assist State, local, tribal, and territorial emergency planning and response activities related to children, which may include developing, identifying, and sharing best practices;</text>
</paragraph><paragraph id="id7f0798eca33144ceb79ca68374a44ddb"><enum>(2)</enum><text>provide technical assistance, training, and consultation to Federal, State, local, tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections 319C–1 and 319C–2;</text>
</paragraph><paragraph id="id9faf63f4e99c496cad2ed106d21e8e69"><enum>(3)</enum><text>improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency, including public awareness of such methods;</text>
</paragraph><paragraph id="id0ab760d19e664d36a7ebaa4a4071a788"><enum>(4)</enum><text>coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections 319C–2 and 319C–3, to address gaps and inefficiencies in emergency preparedness and response efforts for children;</text>
</paragraph><paragraph id="id08845f6b7e64498ba12eddd3eaa9b55b"><enum>(5)</enum><text>provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for, and responding to, public health emergencies; and</text>
</paragraph><paragraph id="id1e463615c1b244f78c645a492f078b81"><enum>(6)</enum><text>carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.</text></paragraph></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block>
</section><section id="id983bb0cf74084c42af532d728144994f"><enum>305.</enum><header>Reauthorizing the National Advisory Committee on Children and Disasters</header><text display-inline="no-display-inline">Section 2811A (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10a">42 U.S.C. 300hh–10a</external-xref>) is amended—</text> <paragraph id="idd84ce736699842949732c212e1ed402f"><enum>(1)</enum><text>in subsection (b)(2), by inserting <quote>, mental and behavioral,</quote> after <quote>medical</quote>;</text>
</paragraph><paragraph id="idA4EEE13BBEB945AC8715D27C7BDC15C7"><enum>(2)</enum><text>in subsection (d)—</text> <subparagraph id="idFD462BF2FC1B4DB8BD088B3118E3CA1E"><enum>(A)</enum><text>in paragraph (1), by striking <quote>15</quote> and inserting <quote>25</quote>; and</text>
</subparagraph><subparagraph id="id297f878d5e394154869a78de78e13365"><enum>(B)</enum><text>by striking paragraph (2) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="id457369824b824f89ac76640d32ace810" style="OLC"> <paragraph id="idf1120d3eddba4f73a5ad4700aca453d2"><enum>(2)</enum><header>Required non-Federal members</header><text>The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals to perform the duties described in subsections (b) and (c), including—</text>
<subparagraph id="id2c5e7d171eb744fca4b904f139470907"><enum>(A)</enum><text>at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;</text>
</subparagraph><subparagraph id="idf017094651c143cb876c796e8db108a8"><enum>(B)</enum><text>at least 2 representatives from State, local, tribal, or territorial agencies with expertise in pediatric disaster planning, preparedness, response, or recovery;</text>
</subparagraph><subparagraph id="id878f1f8666424195903b4ee96cc3b31d"><enum>(C)</enum><text>at least 4 members representing health care professionals, which may include members with expertise in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric patients affected by chemical, biological, radiological, or nuclear agents and emerging infectious diseases; pediatric mental or behavioral health related to children affected by a public health emergency; or pediatric primary care; and</text>
</subparagraph><subparagraph id="id4a5dc1d2877240d182c468744b19aca4"><enum>(D)</enum><text>other members as the Secretary determines appropriate, of whom—</text> <clause id="idd5b490424bcb458caff03df3c7ae7e36"><enum>(i)</enum><text>at least one such member shall represent a children’s hospital;</text>
</clause><clause id="id74b9ebc804dd465aa431475c16678bf7"><enum>(ii)</enum><text>at least one such member shall be an individual with expertise in schools or child care settings;</text> </clause><clause id="id9c805de53ea040abaa8c2140d49ce12d"><enum>(iii)</enum><text>at least one such member shall be an individual with expertise in children and youth with special health care needs; and</text>
</clause><clause id="id433ee35cb0a046638fcd50fc6b68f176"><enum>(iv)</enum><text>at least one such member shall be an individual with expertise in the needs of parents or family caregivers, including the parents or caregivers of children with disabilities.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
<quoted-block display-inline="no-display-inline" id="id9b52ac61a18e4b438382a7e4845dc344" style="OLC">
<paragraph id="idd1bb6c3fb84b498ab5ea928de1d1952b"><enum>(3)</enum><header>Federal members</header><text>The Advisory Committee under paragraph (1) shall include the following Federal members or their designees:</text>
<subparagraph id="id0b7b705737ff4bc28532323e98025ced"><enum>(A)</enum><text>The Assistant Secretary for Preparedness and Response.</text> </subparagraph><subparagraph id="id335ea51839564adfa3ccf4228fe5c728"><enum>(B)</enum><text>The Director of the Biomedical Advanced Research and Development Authority.</text>
</subparagraph><subparagraph id="idf35586b2877942998bd84dc47fac9793"><enum>(C)</enum><text>The Director of the Centers for Disease Control and Prevention.</text> </subparagraph><subparagraph id="id1b303f064995493c82c4c470e9acc917"><enum>(D)</enum><text>The Commissioner of Food and Drugs.</text>
</subparagraph><subparagraph id="ida14fea202060412eb59d2a2c3290cabf"><enum>(E)</enum><text>The Director of the National Institutes of Health.</text> </subparagraph><subparagraph id="idc1226b550bf74e368fcb13a04368c585"><enum>(F)</enum><text>The Assistant Secretary of the Administration for Children and Families.</text>
</subparagraph><subparagraph id="id861b2ba829c74c66a7022566f4077c72"><enum>(G)</enum><text>The Administrator of the Health Resources and Services Administration.</text> </subparagraph><subparagraph id="id42dad8b474e84b4197a05828ba50fa80"><enum>(H)</enum><text>The Administrator of the Federal Emergency Management Agency.</text>
</subparagraph><subparagraph id="idd0af5a04cdf140f5a471478c59b5566e"><enum>(I)</enum><text>The Administrator of the Administration for Community Living.</text> </subparagraph><subparagraph id="ida96b9ae4a0c64883bad81742436038cf"><enum>(J)</enum><text>The Secretary of Education.</text>
</subparagraph><subparagraph id="id5C2BCD667B6B43AF9404613E196A9928"><enum>(K)</enum><text>Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services Administration and the Department of Homeland Security) as the Secretary determines appropriate to fulfill the duties of the Advisory Committee under subsections (b) and (c).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
<quoted-block display-inline="no-display-inline" id="id7f1e48830ebd4e2094c13fb70748a5a2" style="OLC">
<paragraph id="id52c2261489014afbb5700f9471f34af2"><enum>(4)</enum><header>Term of appointment</header><text>Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.</text>
</paragraph><paragraph id="id2d9f30544f4842cf8274d56fa6ca266f"><enum>(5)</enum><header>Consecutive appointments; maximum terms</header><text>A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than 2 of which may be served consecutively.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id93E214B895564CE0B12C2A4C0DDBD17B"><enum>(3)</enum><text>in subsection (e), by adding at the end <quote>At least one meeting per year shall be an in-person meeting.</quote>; and</text> </paragraph><paragraph id="idE36DDF35AC664C4E8801086D039054EC"><enum>(4)</enum><text>in subsection (f) by striking <quote>2018</quote> and inserting <quote>2023</quote>.</text>
</paragraph></section><section commented="no" id="id1FA34A8A5E9D488F9DFAA09CA2A74BF9"><enum>306.</enum><header>Guidance for participation in exercises and drills</header><text display-inline="no-display-inline">Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final guidance regarding the participation of State, local, tribal, and territorial public health department or agency personnel funded in whole or in part through programs authorized under this Act in drills and operational exercises in order to identify, inform, and address the gaps in and policies related to all-hazards medical and public health preparedness and response, which may include drills and operational exercises that incorporate medical surge capacity planning, medical countermeasure distribution and administration, and preparing for and responding to identified threats for that region. The Secretary shall consult with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies as necessary and appropriate in the development of such guidance. The Secretary shall make the guidance available on the internet website of the Department of Health and Human Services.</text>
</section><enum>IV</enum><header>Prioritizing a threat-based approach </header>
<section id="id263281107e0349a68b990132d5239bdb"><enum>401.</enum><header>Assistant Secretary for Preparedness and Response</header><text display-inline="no-display-inline">Section 2811(b) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10(b)</external-xref>) is amended—</text> <paragraph id="id3c7fd72ce1984c90bd2c7ac3d797177b"><enum>(1)</enum><text>in the matter preceding paragraph (1) by inserting <quote>utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to</quote> after <quote>shall</quote>; and</text>
</paragraph><paragraph id="ide17a5cc5febc4e67a79d12e0202c8bdf"><enum>(2)</enum><text>in paragraph (4) by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id277B46DA3ED84484B56D1ACE8A4CA64C" style="OLC"> <subparagraph id="id5C7BCBBB19444CF8B5D2ABC54E5F3B60"><enum>(I)</enum><header>Threat awareness</header><text>Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="id41b695e0586f4b28a098edf0822e965a"><enum>402.</enum><header>Public Health Emergency Medical Countermeasures Enterprise</header>
<subsection id="idF5D272F32CFC41578A55840EEC988282"><enum>(a)</enum><header>In general</header><text>Title XXVIII is amended by inserting after section 2811 (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10</external-xref>) the following:</text>
<quoted-block display-inline="no-display-inline" id="idE554D1841CBD467296DF8BF46E7C587B" style="OLC">
<section id="id69DFD2EF378C41A4BCD2A450E2A9F5EC"><enum>2811–1.</enum><header>Public health emergency medical countermeasures enterprise</header>
<subsection id="iddd1c218e7bfb4501b574d4e4059513f4"><enum>(a)</enum><header>In general</header><text>The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the <quote>PHEMCE</quote>). The Assistant Secretary for Preparedness and Response shall serve as chair of the PHEMCE.</text>
</subsection><subsection id="id888352dcf1b04b8b8323145c74473dee"><enum>(b)</enum><header>Members</header><text>The PHEMCE shall include each of the following members, or the designee of such members:</text> <paragraph id="id8dd3eec105c74f8e98161f9d3fc08b6b"><enum>(1)</enum><text>The Assistant Secretary for Preparedness and Response.</text>
</paragraph><paragraph id="id119d139fb2e245979c62e4c80d58d259"><enum>(2)</enum><text>The Director of the Centers for Disease Control and Prevention.</text> </paragraph><paragraph id="id2826d319e5a94d388abde058866aaebe"><enum>(3)</enum><text>The Director of the National Institutes of Health.</text>
</paragraph><paragraph id="id8b65db476bdb42ae912b251b5952b992"><enum>(4)</enum><text>The Commissioner of Food and Drugs.</text> </paragraph><paragraph id="id341c00b514d94536ae948c82b686ca5b"><enum>(5)</enum><text>The Secretary of Defense.</text>
</paragraph><paragraph id="id305184cf79504aba87e5c2fb75bfbd46"><enum>(6)</enum><text>The Secretary of Homeland Security.</text> </paragraph><paragraph id="id6e6d48371570439ca0785413795e2e65"><enum>(7)</enum><text>The Secretary of Agriculture.</text>
</paragraph><paragraph id="id3331a461143c4ad1af2a7e84601e23be"><enum>(8)</enum><text>The Secretary of Veterans Affairs.</text> </paragraph><paragraph id="idf1e30ff86cae400ebf9a82ce85e29891"><enum>(9)</enum><text>Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, and the Director of the Strategic National Stockpile, as the Secretary determines appropriate.</text>
</paragraph></subsection><subsection id="idc0497b30e75346368d2ee26c2fe4b2ff"><enum>(c)</enum><header>Functions</header>
<paragraph id="id2DB1234C86F94B31AD9053CBE4AE40E6"><enum>(1)</enum><header>In general</header><text>The functions of the PHEMCE shall include the following:</text> <subparagraph id="id72c7d7743ead42e9bbee15a40d65fa9c"><enum>(A)</enum><text>Establish a process pursuant to section 2811(d)(2)(B) to make recommendations to the Secretary regarding the prioritization of research, development, and procurement of countermeasures, as defined in section 319F–2(c), based on the health security needs of the United States. Such recommendations shall be informed by the National Health Security Strategy pursuant to section 2802, the Strategic National Stockpile review required under section 319F–2(a)(2), the countermeasures budget plan pursuant to section 2811(b)(7), and an assessment of current national security threats, including chemical, biological, radiological and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.</text>
</subparagraph><subparagraph id="idf1e384d1b2684bdb8a3c7f9fc1254dd7"><enum>(B)</enum><text>Identify national health security needs, including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs (including any regulatory challenges), and provide for alignment of countermeasure procurement with recommendations under subparagraph (A).</text>
</subparagraph><subparagraph id="ida6916dd9483247c5970c44e664acce4a"><enum>(C)</enum><text>Develop strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 319F–2(a).</text>
</subparagraph><subparagraph id="id0992b5ad1dde4834828a88a562feeac3"><enum>(D)</enum><text>Provide consultation for the development of the strategy and implementation plan under section 2811(d).</text>
</subparagraph></paragraph><paragraph id="id74E802E1824A47CD8218428F29D749E0"><enum>(2)</enum><header>Input</header><text>In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and consider input from State, local, tribal, and territorial public health departments, as appropriate.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idd754b984304c4cf4b063d0549e90cc70"><enum>(b)</enum><header>Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan</header><text>Section 2811(d)(1) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10(d)(1)</external-xref>) is amended—</text> <paragraph id="id46B8AEFF5D3B46C79F91418AA763316F"><enum>(1)</enum><text>by striking <quote>Not later than 180 days after the date of enactment of this subsection, and every year thereafter</quote> and inserting <quote>Not later than March 15, 2020, and biennially thereafter</quote>; and</text>
</paragraph><paragraph id="id57BDDF574C0543B4803AE8BBB4CC570A"><enum>(2)</enum><text>by striking <quote>Director of Biomedical</quote> and all that follows through <quote>Food and Drugs</quote> and inserting <quote>Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1</quote>.</text> </paragraph></subsection></section><section id="id2cb2a1c3877e4597a2f0492b1c21c5ea"><enum>403.</enum><header>Strategic National Stockpile</header> <subsection id="id7A1F3304766A42F7BEA44BE94AAA8838"><enum>(a)</enum><text>Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is amended—</text>
<paragraph id="id66280c8b54994ea3b09330a805b4db2a"><enum>(1)</enum><text>by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and</text> </paragraph><paragraph id="ide09a5830d9d5469ca1449b3e88d1936c"><enum>(2)</enum><text>in paragraph (1)—</text>
<subparagraph id="id58847411f35941d1819a6ca4e691a399"><enum>(A)</enum><text>by inserting <quote>and optimize</quote> after <quote>provide for</quote>;</text> </subparagraph><subparagraph id="id9879ffa3009d434e80ed0e862c7b0afd"><enum>(B)</enum><text>by inserting <quote>and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2)</quote> before the period of the first sentence; and</text>
</subparagraph><subparagraph id="id07bc6b294be743878f64237974cc2c00"><enum>(C)</enum><text>by striking the second sentence;</text> </subparagraph></paragraph><paragraph id="idFABFE8C2AA804CDB8E763C3CAD2CCEE9"><enum>(3)</enum><text>by inserting after paragraph (1) the following:</text>
<quoted-block display-inline="no-display-inline" id="idbc6040c9c1c74876a7476117f7178683" style="OLC">
<paragraph id="id0c1faa1eb56448cf82f8a33a3873be80"><enum>(2)</enum><header>Threat-based review</header>
<subparagraph id="id7b428f4d10734b0baf15610f5cf34e5a"><enum>(A)</enum><header>In general</header><text>The Secretary shall conduct a biennial threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811–1(c)(1)(A). Such review shall be submitted biennially, beginning on March 15, 2019, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, in a manner that does not compromise national security.</text>
</subparagraph><subparagraph id="ide72d6df33cde4b11997eaf8d588ca613"><enum>(B)</enum><header>Additions, modifications, and replenishments</header><text>Each biennial threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—</text>
<clause id="id9429099D2E2A4241A5822F6BDD7D436A"><enum>(i)</enum><text>information regarding—</text> <subclause id="id116e62e26305446ebfe69a26f23e0b63"><enum>(I)</enum><text>the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;</text>
</subclause><subclause id="ida41791d549974e8f96df040d0586299a"><enum>(II)</enum><text>planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;</text>
</subclause><subclause id="id7ee0fbf513434d9fa36255b40a09a6bf"><enum>(III)</enum><text>the presence or lack of a commercial market for the countermeasure at the time of procurement;</text> </subclause><subclause id="id97623504282b48609688b212cbd37afd"><enum>(IV)</enum><text>the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;</text>
</subclause><subclause id="id40b42a0b2bbd40d6bc9a9f14695067be"><enum>(V)</enum><text>an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;</text>
</subclause><subclause id="idcb776448b24444139aa1a0bd6172b403"><enum>(VI)</enum><text>whether such countermeasure is replenishing an expired countermeasure, is a different countermeasure with the same indication that is replacing an expired countermeasure, or is a new addition to the stockpile;</text>
</subclause><subclause id="id52661d1ff4184acd8ceb9725d6d299bd"><enum>(VII)</enum><text>a description of how such additions or modifications align with the countermeasures budget plan as required under section 2811(b)(7), including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and</text>
</subclause><subclause id="id26d254a0d13e42598563ba337f372dc6"><enum>(VIII)</enum><text>appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and</text>
</subclause></clause><clause id="id20a42f9c65fb449bbce898a22b8945ab"><enum>(ii)</enum><text>an assurance that for each countermeasure produced or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment, which need not be provided in advance of procurement.</text></clause></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="ide7bc7373b9b34684ba9f6be443f607c3"><enum>(4)</enum><text>in paragraph (3), as so redesignated—</text> <subparagraph id="id93696544ede449ad8dc086220f991aaf"><enum>(A)</enum><text>in subparagraph (A), by inserting <quote>and the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1</quote> before the semicolon;</text>
</subparagraph><subparagraph id="id12F2BD97A30A495E8673C241D21E0868"><enum>(B)</enum><text>in subparagraph (C), by inserting <quote>, and the availability, deployment, dispensing, and administration of countermeasures</quote> before the semicolon; and</text> </subparagraph><subparagraph id="id220e25ed78e045b38fc1986c3bc6492a"><enum>(C)</enum><text>by amending subparagraph (E) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id9520cf02407a418a8a398252133d1b1a" style="OLC">
<subparagraph id="id1a450e76d223415686681ac0a3552dff"><enum>(E)</enum><text>devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies, State, local, tribal, and territorial agencies, and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id74ed18dd56ec473bbe3cd3b468285838"><enum>(5)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="id2fcf4b6535914d7c9a1b04c2f97cd808" style="OLC"> <paragraph id="iddcd12744fda34e6aa64d56ae157486b4"><enum>(5)</enum><header>GAO report</header> <subparagraph id="id64d205b72499468eb19bcf7cfa998c1a"><enum>(A)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include—</text>
<clause id="id578f7e6069b34358941a912aacb3d6d8"><enum>(i)</enum><text>an assessment of the comprehensiveness and completeness of each biennial threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;</text>
</clause><clause id="id4016b8d63f87434ba854f2a32d7daba0"><enum>(ii)</enum><text>an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;</text>
</clause><clause id="idddb1baebb66d4a72941d20b8475a7088"><enum>(iii)</enum><text>an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;</text>
</clause><clause id="idc621e0046e5a4a0588897ef74c7e1ebc"><enum>(iv)</enum><text>an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;</text>
</clause><clause id="ideb06d63bf7054180a17bf403b7fb430b"><enum>(v)</enum><text>an analysis of how such procurement decisions made progress towards meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);</text>
</clause><clause id="id7a95453cea094a51877677d29775504e"><enum>(vi)</enum><text>a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the emergency health security needs of the stockpile;</text>
</clause><clause id="id4345ad16942c4911b91c5bbf4a63a09c"><enum>(vii)</enum><text>an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General; and</text>
</clause><clause id="ide4b4378d709e446c938f63a795b68990"><enum>(viii)</enum><text>with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities.</text>
</clause></subparagraph><subparagraph id="idae7ab30826ec4222865dea0533131089"><enum>(B)</enum><header>Submission</header><text>Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the appropriate committees of Congress.</text></subparagraph></paragraph><after-quoted-block>. </after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="id4aba83ceab23485d89dfe07a0ed02bdd"><enum>(b)</enum><header>Authorization of appropriations, strategic national stockpile</header><text>Section 319F–2(f)(1) (42 U.S.C. 247d–6b(f)(1)) is amended by striking <quote>$533,800,000 for each of fiscal years 2014 through 2018</quote> and inserting <quote>$610,000,000 for each of fiscal years 2019 through 2023</quote>.</text>
</subsection></section><section id="id1552F2F5E48F4CBE8B4A1DC888C7AF33"><enum>404.</enum><header>Preparing for pandemic influenza, antimicrobial resistance, and other significant threats</header><text display-inline="no-display-inline">Section 319L(c)(4) (247d–7e(c)(4)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id41546D3011C0459E808A199C8205CF4F" style="OLC">
<subparagraph id="id58af4ffadb674312af0fab2b7ca3abdc"><enum>(F)</enum><header>Strategic initiatives</header><text>The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs, supporting innovative candidate products in preclinical and clinical development, to address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of, countermeasures and products, as applicable, to address areas including—</text>
<clause id="id14b07624edf74251b6cff75cbde0aa29"><enum>(i)</enum><text>chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;</text>
</clause><clause id="id973d1b1c745240769c219d9db35f2745"><enum>(ii)</enum><text>threats that consistently exist or continually circulate and have significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and</text>
</clause><clause id="idc9ea84ea1de94239abfb5b1bb1a6668d"><enum>(iii)</enum><text>threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious disease, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id9FFA141FC87B4AA9BF41977D85F3F6CF"><enum>405.</enum><header>Reporting on the Federal Select Agent Program</header><text display-inline="no-display-inline">Section 351A(k) (<external-xref legal-doc="usc" parsable-cite="usc/42/262a">42 U.S.C. 262a</external-xref>) is amended—</text> <paragraph id="id042d79ee55554b699912c305a239c069"><enum>(1)</enum><text>by striking <quote>The Secretary</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id3ff1b02dc23b488d87fd3ef657172935" style="OLC">
<paragraph id="idc23859aff58b486abc412a5b7d848a81"><enum>(1)</enum><header>In general</header><text>The Secretary</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph id="idd05415e323d14126bc304a53228ac7de"><enum>(2)</enum><text>by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id205fb55cca41473bbf95488e5da64059" style="OLC">
<paragraph id="id135eff6ea0b04c99b336e1a3c5bda5da"><enum>(2)</enum><header>Implementation of recommendations of the Federal experts security advisory panel and the fast track
action committee on select agent regulations</header>
<subparagraph id="idb34a088749c94158b6e67ac4df3a7b61"><enum>(A)</enum><header>In general</header><text>Not later than 1 year after the date of the enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>, the Secretary shall provide an update to the appropriate committees of Congress on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.</text>
</subparagraph><subparagraph id="id77a16e2565e843a1a2ebc63c890dabe3"><enum>(B)</enum><header>Continued updates</header><text>The Secretary shall provide status updates at 6-month intervals following the submission of the update under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.</text></subparagraph></paragraph><after-quoted-block>. </after-quoted-block></quoted-block>
</paragraph></section><enum>V</enum><header>Increasing communication in medical countermeasure advanced research and development</header>
<section id="id091EF2CF6A2544CC9B2E3DB188C01377"><enum>501.</enum><header>Medical countermeasure budget plan</header>
<text display-inline="no-display-inline">Section 2811(b)(7) (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10(b)(7)</external-xref>) is amended—</text> <paragraph id="idB1CA30CE5C0F467CA58293997796DF73"><enum>(1)</enum><text>in the matter preceding subparagraph (A), by striking <quote>March 1 of each year</quote> and inserting <quote>March 15, 2020 and every 2 years thereafter</quote>;</text>
</paragraph><paragraph id="idAFBBA898CB83472295C9849B3BC11CAA"><enum>(2)</enum><text>by striking subparagraph (A) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="idF4B457862EF04C6FB69A43C583266DEF" style="OLC"> <subparagraph id="idaa75954f89c6411584d9a995496522ca"><enum>(A)</enum><text>include consideration of the entire medical countermeasures enterprise, including—</text>
<clause id="iddd38e2341f514c20bcf933a235dc95a7"><enum>(i)</enum><text>basic research and advanced research and development;</text> </clause><clause id="id70c5651406a94f5d8f78e1fc99169192"><enum>(ii)</enum><text>approval, clearance, licensure, and authorized uses of products;</text>
</clause><clause id="id1ba40f9226f64a9995ae293ccda74fef"><enum>(iii)</enum><text>procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile; and</text>
</clause><clause id="id974ab7a1c5b148c18cc9bd1591fa20b9"><enum>(iv)</enum><text>the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development;</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="ide3042af490f94d66a9e21fea7bfc485c"><enum>(3)</enum><text>by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively;</text> </paragraph><paragraph id="id11CB3CAD61CB4050906A612417A0D3F5"><enum>(4)</enum><text>by inserting after subparagraph (C), the following:</text>
<quoted-block display-inline="no-display-inline" id="id9E2B961060AA43298B904E97B234EC3D" style="OLC">
<subparagraph id="idac05f643246546a39eb38a483e44f089"><enum>(D)</enum><text>identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</paragraph><paragraph id="idF244B02CACC849048E1E7FE93C52D114"><enum>(5)</enum><text>in subparagraph (E), as so redesignated, by striking <quote>March 15 of each year</quote> and inserting <quote>March 15, 2020, and every 2 years thereafter</quote>.</text> </paragraph></section><section id="id0395AF312F8649EDB891770FA1B4C6F0"><enum>502.</enum><header>Material threat and medical countermeasure notifications</header> <subsection id="id15794d77f1c642febf24adce9771cb8e"><enum>(a)</enum><header>Congressional notification of material threat determination</header><text>Section 319F–2(c)(2)(C) (42 U.S.C. 247d–6b(c)(2)(C)) is amended by striking <quote>The Secretary and the Homeland Security Secretary shall promptly notify the appropriate committees of Congress</quote> and inserting <quote>The Secretary and the Secretary of Homeland Security shall send to Congress, on an annual basis, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Government Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives</quote>.</text>
</subsection><subsection id="id9c315864276e414bbd897e4454faca53"><enum>(b)</enum><header>Contracting communications</header>
<paragraph id="id897DA15F74FE41AB8D7E8204976FF204"><enum>(1)</enum><header>Contract duration</header><text>Section 319F–2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) is amended by adding at the end the following: <quote>The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew such contract.</quote>.</text>
</paragraph><paragraph id="idAA3909AF3B9442D5B7A3C74E95ABE661"><enum>(2)</enum><header>Expedited authorities</header><text>Section 319L(c)(5)(B)(i) (42 U.S.C. 247d–7e(c)(5)(B)(i)) is amended by adding at the end the following: <quote>Upon award, extension, or termination of any such contract, grant, cooperative agreement, and other transaction, the Secretary shall provide a written notification to the receiving entity that includes a justification for such award, extension, or termination.</quote>.</text>
</paragraph></subsection></section><section id="idDCE7708CD93D4E4B851E3BD96195EDD2"><enum>503.</enum><header>Availability of regulatory management plans</header><text display-inline="no-display-inline">Section 565(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4(f)</external-xref>) is amended—</text> <paragraph id="id08bef08da94544fe8673bbd784fbd8bc"><enum>(1)</enum><text>by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively;</text>
</paragraph><paragraph id="id509961b1646c4d36a3047e9a8f50a53e"><enum>(2)</enum><text>by inserting after paragraph (2) the following:</text> <quoted-block display-inline="no-display-inline" id="id3715EDFB6C8A49D9BE429987F6B95EE2" style="OLC"> <paragraph id="id8B1BE550D6824DBF88F0D71CE7BE03B3"><enum>(3)</enum><header>Publication</header><text>The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including—</text>
<subparagraph id="idacf48dc5402746db90709ecf08a010ea"><enum>(A)</enum><text>the process by which an applicant may submit a request for a regulatory management plan;</text> </subparagraph><subparagraph id="id59349eab59c640af869592515e305b0a"><enum>(B)</enum><text>the timeframe by which the Secretary is required to respond to such request;</text>
</subparagraph><subparagraph id="id73d4579ac2774fa19fce35808ba81e80"><enum>(C)</enum><text>the information required for the submission of such request;</text> </subparagraph><subparagraph id="id8420f2b73990429cb38f3184bdd399e6"><enum>(D)</enum><text>a description of the types of development milestones and performance targets that could be discussed and included in such plans; and</text>
</subparagraph><subparagraph id="idc0f3be75e12a4d6b92461243b7370b86"><enum>(E)</enum><text>contact information for beginning the regulatory management plan process.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph id="idfd6df131c6b146dab984f7780789ba88"><enum>(3)</enum><text>in paragraph (6), as so redesignated, in the matter preceding subparagraph (A)—</text>
<subparagraph id="id45639e48e86446ccbacf9f4eb6b582a3"><enum>(A)</enum><text>by striking <quote>paragraph (4)(A)</quote> and inserting <quote>paragraph (5)(A)</quote>; and</text> </subparagraph><subparagraph id="id63226a94f9b149b09bb47b734ec1f865"><enum>(B)</enum><text>by striking <quote>paragraph (4)(B)</quote> and inserting <quote>paragraph (5)(B)</quote>; and</text>
</subparagraph></paragraph><paragraph id="iddbd8cb7d0d144f9582c87747e0fcdf32"><enum>(4)</enum><text>in paragraph (7)(A), as so redesignated, by striking <quote>paragraph (3)(A)</quote> and inserting <quote>paragraph (4)(A)</quote>.</text> </paragraph></section><section id="id2926bd2e801a4753b48b20dbaf0c4fcd"><enum>504.</enum><header>The Biomedical Advanced Research and Development Authority and the BioShield Special Reserve Fund</header> <subsection id="idda570557d4c4483d9c4df5b75af4b496"><enum>(a)</enum><header>Bioshield special reserve fund</header><text>Section 319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended—</text>
<paragraph id="id47088a531c8f4ab780f5edf66e07f93b"><enum>(1)</enum><text>by striking <quote>$2,800,000,000 for the period of fiscal years 2014 through 2018</quote> and inserting <quote>$3,500,000,000 for the period of fiscal years 2019 through 2023, to remain available until expended</quote>; and</text> </paragraph><paragraph id="idd55b1d5426b34f9a8660427836ef663f"><enum>(2)</enum><text>by striking the second sentence.</text>
</paragraph></subsection><subsection id="idd663afbf98244362ac4827c725e9fb1c"><enum>(b)</enum><header>The Biomedical Advanced Research and Development Authority</header><text>Section 319L(d)(2) (42 U.S.C. 247d–7e(d)(2)) is amended by striking <quote>$415,000,000 for each of fiscal years 2014 through 2018</quote> and inserting <quote>$611,700,000 for each of fiscal years 2019 through 2023</quote>.</text>
</subsection></section><enum>VI</enum><header>Advancing technologies for medical countermeasures</header>
<section id="id20BFC6ADEC704409B1E4BC688D940D0E"><enum>601.</enum><header>Administration of countermeasures</header><text display-inline="no-display-inline">Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d–7e(c)(4)(D)(iii)) is amended by striking <quote>and platform technologies</quote> inserting <quote>platform technologies, technologies to administer countermeasures, technologies to improve storage, and transportation of countermeasures</quote>.</text>
</section><section id="id0165A384B1104BDC8BF75601E73B7142"><enum>602.</enum><header>Medical countermeasure master files</header>
<subsection id="id944B77E4EF6B4549A98B9CBC7A7AD0E6"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351</external-xref> et seq.) is amended by inserting after section 565A the following:</text>
<quoted-block display-inline="no-display-inline" id="idD7341E3CAF3447EEB47172FEFE52138A" style="OLC">
<section id="idA44D922BC39147AA83F4F25562EB6F08"><enum>565B.</enum><header>Medical countermeasure master files</header>
<subsection id="id87b940e6f5214debb1e5d5f14eca1a3d"><enum>(a)</enum><header>Purpose</header><text>The purpose of this section is to support and accelerate the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support such products to master files, and through clarifying the authority to cross-reference to data and information previously submitted to the Secretary.</text>
</subsection><subsection id="idc7961b23175047ea8d9555d646f3ce01"><enum>(b)</enum><header>Applicability of reference</header>
<paragraph id="idFAC911D5830F4471B8D38108C18F1A79"><enum>(1)</enum><header>In general</header><text>A person may submit data and information to the Secretary with the intent to reference, or to authorize, in writing, another person to reference, such data or information, in accordance with subsections (d) and (e) of section 314.420 of title 21, Code of Federal Regulations (or any successor regulations), to support a medical countermeasure submission (including a supplement or amendment to any such submission), without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file.</text>
</paragraph><paragraph id="id56A9BE42AD0D42699350C264F67DAF29"><enum>(2)</enum><header>Master file holder</header><text>In this section, the term <term>master file holder</term> means a person who submits data and information to the Secretary with the intent to reference or authorize to reference such data or information to support a medical countermeasure submission, as described in paragraph (1).</text>
</paragraph></subsection><subsection id="id33e1bfeb75714d2d801d42fd33756901"><enum>(c)</enum><header>Medical countermeasure master file content</header>
<paragraph id="id73D97B7F17D84475B9CAEFFB92490A39"><enum>(1)</enum><header>In general</header><text>A master file under this section may include information to support and accelerate—</text> <subparagraph id="idB6E6AFA9EEAD4DE0B8B6757CA037FA7C"><enum>(A)</enum><text>the development of medical countermeasure submissions to support the approval, licensure, classification, clearance, conditional approval, or authorization of one or more security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products; and</text>
</subparagraph><subparagraph id="idD385114FF8624530B4658A4958528ED4"><enum>(B)</enum><text>the manufacture of security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products.</text>
</subparagraph></paragraph><paragraph id="idC8EF5384FA6040CFBACD230DB36C3362"><enum>(2)</enum><header>Required updates</header><text>The Secretary may require, as appropriate, that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission.</text>
</paragraph></subsection><subsection id="id6bb92889a41d45028a584ff71be5a1a7"><enum>(d)</enum><header>Sponsor reference</header>
<paragraph id="id699307BAFD4547F0991DC2E961E2A48E"><enum>(1)</enum><header>In general</header><text>Each incorporation of information or data contained in a master file by reference shall describe the incorporated material in a manner in which the Secretary determines appropriate and that permits the review of such information without necessitating resubmission of such information or data. Master files shall be submitted in an electronic format in accordance with section 745A and as specified in applicable guidance.</text>
</paragraph><paragraph id="id21bf5d974dec43bb9f3c61d1c86b738e"><enum>(2)</enum><header>Reference by a master file holder</header><text>A master file holder that is the sponsor of a medical countermeasure submission shall notify the Secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission.</text>
</paragraph><paragraph id="idc51047239af448da9f51b2e557ab9695"><enum>(3)</enum><header>Reference by an authorized person</header><text>A sponsor of a medical countermeasure submission may, where the Secretary determines appropriate, incorporate by reference all or part of the contents of a medical countermeasure master file, if the master file holder authorizes the incorporation in writing.</text>
</paragraph></subsection><subsection id="id22be070e5a5048148e8c1ea0cb4bf3c7"><enum>(e)</enum><header>Acknowledgement of master file by the Secretary</header><text>The Secretary shall provide the master file holder with a written notification indicating that the Secretary has reviewed and relied upon specified information or data within a master file and the purposes for which such information or data was incorporated by reference if the Secretary has reviewed and relied upon such specified information or data to support the approval, classification, conditional approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. The Secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications, as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder.</text>
</subsection><subsection id="id6f429ba31dc4496d923b39bc525d1385"><enum>(f)</enum><header>Rules of construction</header><text>Nothing in this section shall be construed to—</text> <paragraph id="id792D9842437C44ECA642128E81CB5266"><enum>(1)</enum><text>alter the authority of the Secretary to approve, license, classify, clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to this Act or section 351 of the Public Health Service Act (as authorized prior to the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018</short-title>), including the standards of evidence, and applicable conditions, for approval under the applicable Act; or</text>
</paragraph><paragraph id="idB7CB8E87ADC64C668B0D6900EAF3B6C4"><enum>(2)</enum><text>alter the authority of the Secretary under this Act or the Public Health Service Act to determine the types of information or data previously submitted by a sponsor or any other person that may be incorporated by reference in an application, request, or notification for a drug, biological product, or device submitted under sections 505(i), 505(b), 505(j), 512(b)(1), 512(b)(2), 564, 571, 520(g), 515(c), 513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of section 351 of the Public Health Service Act, including a supplement or amendment to any such submission, and the requirements associated with such reference.</text>
</paragraph></subsection><subsection id="id5d4e91981b7847e08fdb4406c3f00ed1"><enum>(g)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="id0CB96B2515F54DEB8FFC48B6E5E03816"><enum>(1)</enum><text>The term <term>medical countermeasure submission</term> means an investigational new drug application under section 505(i), a new drug application under section 505(b), or an abbreviated new drug application under section 505(j) of this Act, a biological product license application under section 351(a) of the Public Health Service Act or a biosimilar biological product license application under section 351(k) of the Public Health Service Act, a new animal drug application under section 512(b)(1) or abbreviated new animal drug application under section 512(b)(2), an application for conditional approval of a new animal drug under 571, an investigational device application under section 520(g), an application with respect to a device under section 515(c), a request for classification of a device under section 513(f)(2), a notification with respect to a device under section 510(k), or request for an emergency use authorization under section 564 to support—</text>
<subparagraph id="idE3B8A324EF7F4D87A46364883F25A938"><enum>(A)</enum><text>the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product; or</text>
</subparagraph><subparagraph id="id85C92A88D1914406B5C5FC7280ABC1EA"><enum>(B)</enum><text>a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.</text>
</subparagraph></paragraph><paragraph id="idbcea44c9c50b4ba688b01fa298e58640"><enum>(2)</enum><text>The terms <term>qualified countermeasure</term>, <term>security countermeasure</term>, and <term>qualified pandemic or epidemic product</term> have the meanings given such terms in sections 319F–1, 319F–2, and 319F–3, respectively, of the Public Health Service Act.</text></paragraph></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block>
</subsection><subsection id="iddeb9088e6ef442e89189db8f44855491"><enum>(b)</enum><header>Stakeholder Input</header><text>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>), acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the Food and Drug Administration can advance the use of tools and technologies to support and accelerate the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including through the reliance on cross-referenced data and information contained within master files and submissions previously submitted to the Secretary as set forth in section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).</text>
</subsection><subsection id="idf73401d9d0574f9fb7a3e88aae7477d0"><enum>(c)</enum><header>Guidance</header><text>Not later than 2 years after the after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and accelerate the development or manufacture of security countermeasures, qualified countermeasures, qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.</text>
</subsection></section><section id="idF703B78769BA461EAC36825AFF130514"><enum>603.</enum><header>Animal rule report</header>
<subsection id="id97E5FD0C3DB14FABA0561BDDC3EDA510"><enum>(a)</enum><header>Study</header><text>The Comptroller General of the United States shall conduct a study on the application of the requirements under section 565(d) of the of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4(d)</external-xref>) (referred to in this section as the <quote>animal rule</quote>) as a component of medical countermeasure advanced development under the Biomedical Advanced Research and Development Authority and regulatory review by the Food and Drug Administration. In conducting such study, the Comptroller General shall examine the following:</text>
<paragraph id="idF6157F0132624EE0A3365C4ED2528C59"><enum>(1)</enum><text>The extent to which advanced development and review of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, including activities facilitate appropriate and efficient design of studies to support approval, licensure, and authorization under the animal rule, consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4(c)</external-xref>) and entitled <quote>Product Development Under the Animal Rule Guidance for Industry</quote> (issued in October 2015), to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved, licensed, or authorized under the animal rule.</text>
</paragraph><paragraph id="idF2EC930EAAEB41A3A7504C040025F9BB"><enum>(2)</enum><text>The consistency of the application of the animal rule among and between review divisions within the Food and Drug Administration.</text>
</paragraph><paragraph id="idF70EE3D209C442C1B624D824D46619EE"><enum>(3)</enum><text>The flexibilities pursuant to the animal rule to address variations in countermeasure development and review processes, including the extent to which qualified animal models are adopted and used within the Food and Drug Administration in regulatory decisionmaking with respect to medical countermeasures.</text>
</paragraph><paragraph id="id2747B12D897049C8BA087BC2A5926E33"><enum>(4)</enum><text>The extent to which the guidance issued under section 565(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4(c)</external-xref>), entitled, <quote>Product Development Under the Animal Rule Guidance for Industry</quote> (issued in October 2015), has assisted in achieving the purposes described in paragraphs (1), (2), and (3).</text>
</paragraph></subsection><subsection id="id571D089624534A8E81C528D66148D028"><enum>(b)</enum><header>Consultations</header><text>In conducting the study under subsection (a), the Comptroller General of the United States shall consult with—</text>
<paragraph id="id26A17E84FC0142F09E45B84E8D2A1824"><enum>(1)</enum><text>the Federal agencies responsible for advancing, reviewing, and procuring medical countermeasures, including the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, and the Department of Defense;</text>
</paragraph><paragraph id="id20B3D2B3B8B34DD595CE560201A2FA90"><enum>(2)</enum><text>manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, and nuclear threats; and</text>
</paragraph><paragraph id="idB04DAE69CB1A40F78865D2E42FAC87E3"><enum>(3)</enum><text>other biodefense stakeholders, as applicable.</text> </paragraph></subsection><subsection id="idA32CD4B12207485DBD44E568452B9E93"><enum>(c)</enum><header>Report</header><text>Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study conducted under subsection (a) and recommendations to improve the application and consistency of the requirements under subsections (c) and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4</external-xref>) to support and expedite the research and development of medical countermeasures, as applicable.</text>
</subsection><subsection id="idAE7D9D9EF3A3498D89579FDA4DD445C2"><enum>(d)</enum><header>Protection of national security</header><text>The Comptroller General of the United States shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security.</text>
</subsection></section><enum>VII</enum><header>Miscellaneous provisions</header>
<section id="id3ECFCE9FE45F4BF3A3A5052FAEFE0657"><enum>701.</enum><header>Reauthorizations and extensions</header>
<subsection commented="no" id="id2EDD46D3DA494067920EEF3A22521791"><enum>(a)</enum><header>Veterans Affairs</header><text>Section 8117(g) of title 38, United States Code, is amended by striking <quote>2014 through 2018</quote> and inserting <quote>2019 through 2023</quote>.</text> </subsection><subsection commented="no" id="id3A7A837848B7421696DACD8747690FD8"><enum>(b)</enum><header>Vaccine tracking and distribution</header><text>Section 319A(e) (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-1">42 U.S.C. 247d–1(e)</external-xref>) is amended by striking <quote>2014 through 2018</quote> and inserting <quote>2019 through 2023</quote>.</text>
</subsection><subsection commented="no" id="idd4eb2d146fcb46beb8420132c365091c"><enum>(c)</enum><header>Temporary reassignment</header><text>Section 319(e)(8) (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d(e)(8)</external-xref>) is amended by striking <quote>2018</quote> and inserting <quote>2023</quote>.</text> </subsection><subsection id="id25ac7973d61a45549eac2533c1e2bf27"><enum>(d)</enum><header>Strategic Innovation Partner</header><text>Section 319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is amended by striking <quote>2022</quote> and inserting <quote>2023</quote>.</text>
</subsection><subsection id="idc5ae32bf13154c98b6d0bf485fa8869b"><enum>(e)</enum><header>Public disclosure exemption</header><text>Section 319L(e)(1)(C) (42 U.S.C. 247d–7e(e)(1)(C)) is amended by striking <quote>12</quote> and inserting <quote>17</quote>.</text>
</subsection><subsection id="id9B8949CD59DE4DF29D4756C8223C36AC"><enum>(f)</enum><header>Limited antitrust exemption</header>
<paragraph id="id25364980AB8841939F99E460A39C5CDC"><enum>(1)</enum><header>In general</header><text>Section 405 of the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d–6a note) is amended—</text> <subparagraph id="idD75D7C2972D1489585F3C746CACC8175"><enum>(A)</enum><text>by redesignating such section as section 319L–1;</text>
</subparagraph><subparagraph id="id91DA404F9E9C4CE2AA1E480C491CC264"><enum>(B)</enum><text>transferring such section to the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/201">42 U.S.C. 201</external-xref> et seq.), to appear after section 319L of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7e">42 U.S.C. 247d–7e</external-xref>);</text>
</subparagraph><subparagraph id="idD10D2120EDD145F7B81BCA8E3FEB725A"><enum>(C)</enum><text>in subsection (a)(1)—</text> <clause id="id2BA854EF6244451888C62AB2BEF042E9"><enum>(i)</enum><text>by striking <quote>Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>)</quote> and inserting <quote>Secretary</quote>;</text>
</clause><clause id="idC72B883C57104E1D952A3757A90EEAB1"><enum>(ii)</enum><text>by striking <quote>of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>)) (as amended by this Act</quote>;</text>
</clause><clause id="id173586C8C6F94A73B537A86F4F0F9463"><enum>(iii)</enum><text>by striking <quote>of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6a">42 U.S.C. 247d–6a</external-xref>)) (as amended by this Act</quote>; and</text> </clause><clause id="id05CB4067C766404A9B9D4C44866F8450"><enum>(iv)</enum><text>by striking <quote>of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6d">42 U.S.C. 247d–6d</external-xref>)</quote>; and</text>
</clause></subparagraph><subparagraph id="idA1D29049AB394EBF8545C1B4948E0A07"><enum>(D)</enum><text>in subsection (b), by striking <quote>12-year</quote> and inserting <quote>17-year</quote>.</text> </subparagraph></paragraph><paragraph id="id6518994e36e14ab3aa4d67059126f9e9"><enum>(2)</enum><header>Effective date</header><text>The amendment made by paragraph (1)(D) shall take effect as if enacted on December 17, 2012.</text>
</paragraph><paragraph id="id732E36FE7CC34448846A3CCBA0154EB1"><enum>(3)</enum><header>Conforming amendment</header><text>The table of contents in section 1(b) of the Pandemic and All-Hazards Preparedness Act (<external-xref legal-doc="public-law" parsable-cite="pl/109/417">Public Law 109–417</external-xref>) is amended by striking the item related to section 405.</text>
</paragraph></subsection></section><section id="id2FFC9CA79B574ACA80AD7182D7DEE7F5"><enum>702.</enum><header>Technical amendments</header>
<subsection id="idC951CB0F68A947C2A9971E61C69B9A0E"><enum>(a)</enum><header>Public Health Service Act</header><text display-inline="yes-display-inline">Title III (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241</external-xref> et seq.) is amended—</text> <paragraph id="idF4D97D127D45444E8567CA3E0C072B4C"><enum>(1)</enum><text>in paragraphs (1) and (5) of section 319F–1(a) (42 U.S.C. 247d–6a(a)), by striking <quote>section 319F(h)</quote> each place such term appears and inserting <quote>section 319F(e)</quote>; and</text>
</paragraph><paragraph id="id5D2637D466124991B332AF94A5DBC840"><enum>(2)</enum><text>in section 319K(a) (42 U.S.C. 247d–7d(a)), by striking <quote>section 319F(h)(4)</quote> and inserting <quote>section 319F(e)(4)</quote>.</text> </paragraph></subsection><subsection id="id0ebb469801f44b7fa532ef3d67c55ed7"><enum>(b)</enum><header>Public health security grants</header><text>Section 319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended—</text>
<paragraph id="idfa8e023100b04e96bb1971543f797f4b"><enum>(1)</enum><text>in subparagraph (C), by striking <quote>individuals,,</quote> and inserting <quote>individuals,</quote>; and</text> </paragraph><paragraph id="idbefd7c7c5e484ddd84c7bf497a662705"><enum>(2)</enum><text>in subparagraph (F), by striking <quote>make satisfactory annual improvement and describe</quote> and inserting <quote>makes satisfactory annual improvement and describes</quote>.</text>
</paragraph></subsection><subsection id="id1e53d5c5bb644ce9bf3153ed0e793e99"><enum>(c)</enum><header>Federal Food, Drug, and Cosmetic Act</header><text>The Federal Food, Drug, and Cosmetic Act is amended—</text> <paragraph id="id20b88ceba4a64e2786aa8373921a4fe7"><enum>(1)</enum><text>in section 564A(e)(2)(A) (21 U.S.C. 360bbb–3a(e)(2)(A)), by striking <quote>subsection (a)(1)(C)(i)</quote> and inserting <quote>subsection (a)(1)(C)</quote>; and</text>
</paragraph><paragraph id="id2d86d5ad9ed64bf59c39fcdfbe2c4e2a"><enum>(2)</enum><text>in section 564B(2)(C) (21 U.S.C. 360bbb–3b(2)(C)), by inserting <quote>or section 564A</quote>.</text></paragraph></subsection></section>