116 S2333 IS: Pandemic and All-Hazards Preparedness and Response Act
U.S. Senate
2023-07-18
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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 Response Act
.(b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—State and local readiness and responseSec. 101. Temporary reassignment of State and local personnel during a public health emergency.Sec. 102. Public Health Emergency Preparedness program.Sec. 103. Improving and enhancing participation of EMS organizations in the hospital preparedness program.Sec. 104. Improving medical readiness and response capabilities.Sec. 105. Pilot program to support State medical stockpiles.Sec. 106. Enhancing domestic wastewater surveillance for pathogen detection.Sec. 107. Reauthorization of Mosquito Abatement for Safety and Health program.TITLE II—Federal planning and coordinationSec. 201. All-Hazards Emergency Preparedness and Response.Sec. 202. National Health Security Strategy.Sec. 203. Improving development and distribution of diagnostic tests.Sec. 204. Pilot program for public health data availability.Sec. 205. Combating antimicrobial resistance.Sec. 206. Strategic National Stockpile and material threats.Sec. 207. Medical countermeasures for viral threats with pandemic potential.Sec. 208. Public Health Emergency Medical Countermeasures Enterprise.Sec. 209. Strengthening public health communication.Sec. 210. Fellowship and training programs.Sec. 211. Assessment of COVID–19 mitigation policies.TITLE III—Addressing the needs of all individualsSec. 301. Transition of certain countermeasures between compensation programs.Sec. 302. Accelerating injury compensation program administration and ensuring program integrity.Sec. 303. Compensation for injuries relating to the public health emergency caused by SARS–CoV–2.Sec. 304. Review of regulations.Sec. 305. Supporting individuals with disabilities, older adults, and other at-risk individuals during emergency responses.Sec. 306. National advisory committees.Sec. 307. Research and coordination of activities concerning the long-term health effects of SARS–CoV–2 infection.Sec. 308. National Academies study on prizes.TITLE IV—Strengthening biosecuritySec. 401. Treatment of genetic variants and synthetic products of select agents and toxins.Sec. 402. Establishment of no-fault reporting system.Sec. 403. Evaluation of the Federal Select Agent Program and related policies.Sec. 404. Supporting research and laboratory surge capacity.Sec. 405. Gene synthesis.Sec. 406. Limitation related to countries of concern conducting certain research.Sec. 407. Assessment of artificial intelligence threats to health security.TITLE V—Preventing drug shortagesSec. 501. Improving notification procedures in case of increased demand for critical drugs.Sec. 502. Reporting on supply chains.Sec. 503. Reporting on use of new authorities and requirements with respect to drug shortages.TITLE VI—Additional reauthorizations and technical amendmentsSec. 601. Medical countermeasure priority review voucher.Sec. 602. Epidemic Intelligence Service loan repayment program.Sec. 603. Vaccine tracking and distribution.Sec. 604. Regional health care emergency preparedness and response systems.Sec. 605. Emergency system for advance registration of volunteer health professional.Sec. 606. Limited antitrust exemption.Sec. 607. Trauma care.Sec. 608. Military and civilian partnership for trauma readiness.Sec. 609. National Disaster Medical System.Sec. 610. Volunteer Medical Reserve Corps.Sec. 611. Epidemiology-laboratory capacity grants.Sec. 612. Veterans Affairs.Sec. 613. Technical amendments.<enum>I</enum><header>State and local readiness and response</header><section id="id774391f903a742c79e2baeadaaa3fd44"><enum>101.</enum><header>Temporary reassignment of State and local personnel during a public health emergency</header><text display-inline="no-display-inline">Section 319(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d">42 U.S.C. 247d(e)</external-xref>) is amended—</text><paragraph id="idfcb3d93e829d4078830e5ee74449c350"><enum>(1)</enum><text>in paragraph (1), by striking <quote>such Governor or tribal organization's designee</quote> and inserting <quote>the designee of the Governor or Tribal organization, or the State or Tribal health official</quote>;</text></paragraph><paragraph id="idd5e87743aa65414682cad3a54d4737fe"><enum>(2)</enum><text>in paragraph (2)(B)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ideda839c7968843f1aae35adbefc1d706"><enum>(A)</enum><text>in the matter preceding clause (i), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization, or the State or Tribal health official</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idea08d4004d3343318eed25e3f5c981f9"><enum>(B)</enum><text>in clause (v), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization or State or Tribal health official</quote>;</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd4c5f953986246c9a4f928f4bad54851"><enum>(3)</enum><text>in paragraph (6)—</text><subparagraph id="id3979dae2517e4c0fbdfa00daa106a47d"><enum>(A)</enum><text>in the matter preceding subparagraph (A)—</text><clause commented="no" display-inline="no-display-inline" id="idb26171ba09af48bd8a26b8b6b43e1f7e"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>Reauthorization Act of 2013</quote> and inserting <quote>and Response Act</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="idb7c701f606784c5d97b91bff2e44cb45"><enum>(ii)</enum><text>by striking <quote>appropriate committees of the Congress</quote> and inserting <quote>Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf8873f4657744d1f90746dcd2d8ffcdf"><enum>(B)</enum><text>in subparagraph (A), by inserting <quote>, including requests from State or Tribal health officials</quote> before the semicolon; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1faaf72cc6f740578ce9488bc763fe19"><enum>(4)</enum><text>in paragraph (7)(A), by striking <quote>tribal organization</quote> and inserting <quote>Tribal organization</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9a46ad54db3845819241c9c3f285ba58"><enum>(5)</enum><text>in paragraph (8), by striking <quote>2023</quote> and inserting <quote>2028</quote>.</text></paragraph></section><section id="id7d9cce020f2b40818337e3eb0a26010f"><enum>102.</enum><header>Public Health Emergency Preparedness program</header><text display-inline="no-display-inline">Section 319C–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3a">42 U.S.C. 247d–3a</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id87c7af26e70a4616b1c0792f0f4e84cb"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id5afb214e31a4479089408b3b4ff1ea86"><enum>(A)</enum><text>in subparagraph (A)(ii), by striking <quote>influenza</quote> and inserting <quote>response planning</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idde6c125cef7e4976b0476d183cb0eab8"><enum>(B)</enum><text>in subparagraph (H), by inserting <quote>, such as community-based organizations, including faith-based organizations, and other public and private entities</quote> after <quote>stakeholders</quote>; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id38a340dadfd3488cbb9d875a1cda267f"><enum>(2)</enum><text>in subsection (g)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7e4b531df20f46f38e39e95405613055"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), in the matter preceding subparagraph (A), by inserting <quote>and the ability of each entity receiving an award under subsection (a) to respond to all-hazards threats</quote> before the period at the end of the first sentence; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id66d64fbd2b8142f0a2a9f8ba620a1156"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="id782411a040dc40e185b0fe09848e9f6e"><enum>(i)</enum><text>in the paragraph heading, by striking <quote><header-in-text style="OLC" level="paragraph">influenza</header-in-text></quote> and inserting <quote><header-in-text style="OLC" level="paragraph">response</header-in-text></quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="idb5e1243adad443c5a9c6e22414a49de1"><enum>(ii)</enum><text>in subparagraph (A)—</text><subclause commented="no" display-inline="no-display-inline" id="id4391dc879578475492e723f8c33cf758"><enum>(I)</enum><text>by striking <quote>to pandemic influenza</quote> and inserting <quote>to a pathogen causing a pandemic, including pandemic influenza</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="id7302ddf312c0443d951c085e3749969d"><enum>(II)</enum><text>by striking <quote>such pandemic influenza</quote> and inserting <quote>such pandemic response</quote>;</text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd801330695c34782980656c3972448a2"><enum>(C)</enum><text>in paragraph (5)—</text><clause commented="no" display-inline="no-display-inline" id="id481176c0fd6f4c1ebd4e07c2fbac9da5"><enum>(i)</enum><text>in the paragraph heading, by striking <quote><header-in-text style="OLC" level="paragraph">influenza</header-in-text></quote> and inserting <quote><header-in-text style="OLC" level="paragraph">pandemic response</header-in-text></quote>; </text></clause><clause commented="no" display-inline="no-display-inline" id="id065c8f99f22d4cd5b1931c48b5b4567c"><enum>(ii)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A), by striking <quote>2019</quote> and inserting <quote>2025</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="iddd8c98e494734cba8d30c2cd9f54fe81"><enum>(iii)</enum><text>in clause (i), by striking <quote>2018</quote> and inserting <quote>2024</quote>; and</text></clause><clause id="id0a44d13294de4b85a677894e12ee3114"><enum>(iv)</enum><text>in subparagraph (B), by striking <quote>pandemic influenza</quote> and inserting <quote>a pathogen causing a pandemic</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id261a58af9c6449b0af94f15c4e6928de"><enum>(D)</enum><text>in paragraph (6)—</text><clause commented="no" display-inline="no-display-inline" id="id1a5c0a0d610741cd8c4b66bf566d79cb"><enum>(i)</enum><text>in subparagraph (A), in the matter preceding clause (i), by striking <quote>The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section of section 319C–2</quote> and inserting <quote>The Secretary shall withhold from an entity pursuant to paragraph (5) for noncompliance with the requirements of this section or section 319C–2 as follows</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id9ec0b08651444601bce23ac6321066ac"><enum>(ii)</enum><text>in subparagraph (B), by inserting <quote>with respect to the requirements of this section or section 319C–2</quote> after <quote>paragraph (5)</quote>; and</text></clause></subparagraph></paragraph><paragraph id="id1123c9a9526a4ff0a4b384efe3beeecf"><enum>(3)</enum><text>in subsection (h)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id4687c09478f34af48ade61f55c4abf77"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking <quote>$685,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$735,000,000 for each of fiscal years 2024 through 2028</quote>;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbe80cd0532094700a8c204dd7461ebb6"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text><clause commented="no" display-inline="no-display-inline" id="ida0985d90d8bd42b2ba6b3bfe14f7a86d"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>For fiscal year 2027, the Secretary</quote> and inserting <quote>The Secretary</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id0441e7b83a54443a82a230fec14f6686"><enum>(ii)</enum><text>in subparagraph (D), by striking <quote>for fiscal year 2026</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7497aeed0f8345d482e858b58845148d"><enum>(C)</enum><text>in paragraph (5)(A), by striking <quote>For fiscal year 2007, the Secretary</quote> and inserting <quote>The Secretary</quote>.</text></subparagraph></paragraph></section><section id="id3f8ca6cb2df847a8a105d4ba7b946a0d"><enum>103.</enum><header>Improving and enhancing participation of EMS organizations in the hospital preparedness program</header><subsection commented="no" display-inline="no-display-inline" id="ide9fdb12b5cb742dfb22052236548215f"><enum>(a)</enum><header>Increasing participation by EMS in the hospital preparedness program</header><text>Section 319C–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3b">42 U.S.C. 247d–3b</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="ide9a8f8ce09c44201a40941d5ee2c2744"><enum>(1)</enum><text>in subsection (b)(1)(A)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7b9c5c292ac24d5c86c4e2bfe5bd3feb"><enum>(A)</enum><text display-inline="yes-display-inline">in clause (iii)(III), by striking <quote>; and</quote> and inserting semicolon; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb511d6c297cc4f4e95896c1ce6527195"><enum>(B)</enum><text display-inline="yes-display-inline">by striking clause (iv) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id9b8f56e3bd05414fba3f01c9f0a80b50"><clause id="ide96e1d066b3d4a1ea6836db87485f53a"><enum>(iv)</enum><text>one or more emergency medical service organizations; and</text></clause><clause id="idf28fc70de39d49a3b75e399924d97b03"><enum>(v)</enum><text>to the extent practicable, one or more emergency management organizations; and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7400d895848a45f2a559cddf62865923"><enum>(2)</enum><text>in subsection (g)(1)—</text><subparagraph id="id598E5356955D4EA596C8ECC5AB6D02FD"><enum>(A)</enum><text>by striking the heading and inserting:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id37D357357784452B8F6EB9BA50E70821"><paragraph id="id3A3269834DAB4BFE8E499E5179954AAC"><enum>(1)</enum><header>Local response capabilities</header><subparagraph id="idD5FF34664E0A47ECA535F1384F2CE7A9"><enum>(A)</enum><header>Program coordination</header></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idafea55c608b444979a3c44d50f83c537"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>extent practicable, ensure</quote> and inserting the following: “extent practicable—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id73D0C135123347FB99B6A362BD545E26"><clause commented="no" display-inline="no-display-inline" id="id32de69fae42e456c907255fd4a9d5e1c"><enum>(i)</enum><text display-inline="yes-display-inline">ensure</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id761f9a39fa7041b891fad38913821c8f"><enum>(C)</enum><text>by striking the period and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0dadddb9fd4f45d1b2eb59ca865fef64"><enum>(D)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id5EA80BF2A4184176A4671D5B5A2180E5"><clause id="id53d9d79ee4b3468b80309d36ef7341df"><enum>(ii)</enum><text>seek to increase participation of eligible entities described in subsection (b)(1)(A) with lower participation rates relative to coalitions of other eligible entities, such as coalitions that include emergency medical services organizations and health care facilities in underserved areas.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="idfd6649a919764cdeb60d33a542e7f59a"><enum>(b)</enum><header>Preferences</header><text>Section 319C–2(d)(1)(A)(iii) of the Public Health Service Act (42 U.S.C. 247d–3b(d)(1)(A)(iii)) is amended by striking <quote>subsection (b)(1)(A)(ii)</quote> and inserting <quote>clauses (ii) and (iv) of subsection (b)(1)(A)</quote>.</text></subsection></section><section id="idec7850056a394a1fb34fc6d2ec3f0373"><enum>104.</enum><header>Improving medical readiness and response capabilities</header><text display-inline="no-display-inline">Section 319C–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3b">42 U.S.C. 247d–3b</external-xref>) is amended—</text><paragraph id="idd44a1ac3f1b24fedb4bfb88f4cf3bda3"><enum>(1)</enum><text>in subsection (b)(2)—</text><subparagraph id="id6c80e183f7fb4efea0fa2129e2b9bc8e"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>and</quote> at the end;</text></subparagraph><subparagraph id="id65b51758f0dd454d8f1e27b304462826"><enum>(B)</enum><text>in subparagraph (B), by striking the period and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="id78af7ab8f17c4198a73a358227e0e45d"><enum>(C)</enum><text>by inserting at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id1b978518aef14324a6ffdc5443b21e38"><subparagraph id="id98e145cf6fe34763868ad44297e1ba4b" indent="up1"><enum>(C)</enum><text>designate a lead entity to administer such award and support coordination between entities described in this subsection.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="id0fd4521d732d4322afc0f68425f658b5"><enum>(2)</enum><text>in subsection (g)(1), as amended by section 102(a)(2), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idcb82608938ae4150ac360dfb40781757"><subparagraph id="id6c1479609673468ca4fc214c93d09b1d"><enum>(B)</enum><header>Regional operations</header><text>An eligible entity shall establish and maintain, or leverage an existing, capability to enable coordination of regional medical operations, which may include systems to facilitate information sharing and coordination, within a coalition described under subsection (b)(1)(A) and, as appropriate, between multiple coalitions that are in close geographic proximity to each other.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc0a4db3bcfde4d94b9a9d205ac2e3912"><enum>(3)</enum><text>in subsection (j)(1)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id1774c8f3347b4902adf1518e46a30d1d"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id49a5b2f619804874a31487350993b938"><enum>(B)</enum><text>in subparagraph (B)(iii), by striking <quote>2023</quote> and inserting <quote>2028</quote>.</text></subparagraph></paragraph></section><section id="ida11837cb2f2a4dbb9c6d36b57c1e6c58"><enum>105.</enum><header>Pilot program to support State medical stockpiles</header><subsection commented="no" display-inline="no-display-inline" id="id63db2e09e451449c8949764388ec145f"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 319F–2(i) of the Public Health Service Act (42 U.S.C. 247d–6b(i)) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="idf06df698891f47d5bbaf44ef0cf93879"><enum>(1)</enum><text>in paragraph (2)(B)(i)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id28bdc5b77c4e4411aabdbc8d910b5884"><enum>(A)</enum><text>in subclause (I), by striking <quote>and 2024</quote> and inserting <quote>through 2025</quote>; and</text></subparagraph><subparagraph id="ide1b0f1d7622242b5b836a902ea7f8f31"><enum>(B)</enum><text>in subclause (II), by striking <quote>2025</quote> and inserting <quote>2026</quote>; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb9fb712ab91e46419dc27faccf418ca0"><enum>(2)</enum><text>in paragraph (4)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id75c86ee527f7480292a34afe720d4e3e"><enum>(A)</enum><text>in subparagraph (G), by striking <quote>; and</quote> at the end and inserting a semicolon;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb6fec68cdd1d438da362ccb84916df4c"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (H) as subparagraph (I); </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb998368fb49540b698091ec1577a1771"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (G) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id71F884FDF8AE4D85975A333669107804"><subparagraph id="id08d448a448124f81923419249421e2f9"><enum>(H)</enum><text>facilitate the sharing of best practices between States within a consortia of States in receipt of funding related to establishing and maintaining a stockpile of medical products; and </text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1ec240c18dad4dba9e77c9c6d627dbb5"><enum>(D)</enum><text>in subparagraph (I), as so redesignated, by striking <quote>State efforts</quote> and inserting <quote>State or regional efforts</quote>; </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide1a337342f4547e3b8be5332886486fa"><enum>(3)</enum><text>by redesignating paragraphs (5) through (9) as paragraphs (6) through (10), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id550766634bb54d0cb7cd8724a59ae5f1"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting after paragraph (4) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id83FB57BE5EF74657B8D64901BED54D43"><paragraph id="id31c242249e364a1287432312affc6d11"><enum>(5)</enum><header>Coordination</header><text>An entity in receipt of an award under paragraph (1), in carrying out the activities under this subsection, shall coordinate with appropriate health care entities, health officials, and emergency management officials within the jurisdiction of such State or States.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="ide7931e573db84257beedb6e813495085"><enum>(5)</enum><text>in paragraph (10), as so redesignated, by striking <quote>$3,500,000,000 for each of fiscal years 2023 and 2024</quote> and inserting <quote>such sums as may be necessary for each of fiscal years 2024 through 2028</quote>.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ide03df67c445741a48b0bac35e26f483c"><enum>(b)</enum><header>GAO report</header><text>Section 2409(b) of the PREVENT Pandemics Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id8ee163e2c67b4977b764fa3dc83dda41"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>; and</quote> and inserting a semicolon;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id58f7f53f39a14bf18c238db793b5c465"><enum>(2)</enum><text>in paragraph (3), by striking the period and inserting <quote>; and</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id060ec20c0eec459f84ccd6ed1c5e6150"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id5F32139EB6F4454CB7899D599B889262"><paragraph id="id0f725fad9b0f4c459d2a0fabb78e5c8c"><enum>(4)</enum><text>the impact of any regional stockpiling approaches carried out under such subsection (i)(1) of section 319F–2 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>).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="ide9ef8a174c2d4a1aa49204e26681ca56"><enum>106.</enum><header>Enhancing domestic wastewater surveillance for pathogen detection</header><subsection commented="no" display-inline="no-display-inline" id="id5a86170f378a4eeca7d4299bb6201492"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subtitle C of title XXVIII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idA38BBEF82DF0442C9355ADE295369D11"><section id="id88c612268a29469baaf3646c535b53ef"><enum>2827.</enum><header>Wastewater surveillance for pathogen detection</header><subsection commented="no" display-inline="no-display-inline" id="id8615187b7b7c48828de0a42219b6cd73"><enum>(a)</enum><header display-inline="yes-display-inline">Wastewater surveillance system</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other Federal departments and agencies, shall award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes.</text></subsection><subsection commented="no" display-inline="no-display-inline" id="id5f1bd3f31ff448aa8799e4f9657a67fa"><enum>(b)</enum><header>Eligible entities</header><text>To be eligible to receive an award under this section, an entity shall—</text><paragraph commented="no" display-inline="no-display-inline" id="idfbb15fe2aaee4fc78e187e0aae3781b9"><enum>(1)</enum><text display-inline="yes-display-inline">be a State, Tribal, or local health department, or a partnership between such a health department and other public and private entities; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id58f1c6e435234f0093b4f4761341780d"><enum>(2)</enum><text display-inline="yes-display-inline">submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require, which shall include—</text><subparagraph id="id0eb190eea46c48caac892bdd98a242d0"><enum>(A)</enum><text>a description of activities proposed to be carried out pursuant to an award under subsection (a);</text></subparagraph><subparagraph id="id7ce1426631ac4e8c92c53fac0055a158"><enum>(B)</enum><text>factors such entity proposes to use to select wastewater sampling sites;</text></subparagraph><subparagraph id="ida19f26b5cbbd49de93b60c4ffd5d4de2"><enum>(C)</enum><text>a plan for responding, as appropriate, to findings from such wastewater sampling, consistent with applicable plans developed by such entity pursuant to section 319C–1;</text></subparagraph><subparagraph id="id2f021c4487bd46bab52e53c37f475c44"><enum>(D)</enum><text>a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period; and</text></subparagraph><subparagraph id="idd9950f53a569486aa60ab6374f165992"><enum>(E)</enum><text>any additional information the Secretary may require.</text></subparagraph></paragraph></subsection><subsection id="ide0736fd51dd546e5b7a2624dac480537"><enum>(c)</enum><header>Consideration</header><text>In making awards under subsection (a), the Secretary may give priority to eligible entities that have submitted an application that—</text><paragraph id="idc4f2bdba4ff1450b91e24d597f053b0e"><enum>(1)</enum><text>details plans to provide public access to data generated through such wastewater surveillance activities in a manner that enables comparison to such data generated by other recipients of an award under subsection (a); and</text></paragraph><paragraph id="id69d1309049eb48de8aee067615ccd427"><enum>(2)</enum><text>provides an assessment of community needs related to ongoing infectious disease monitoring, including burden of infectious diseases that can be detected in wastewater and availability of other forms of infectious disease surveillance.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id032515bf38b24ff8bde04af388ed5896"><enum>(d)</enum><header>Use of funds</header><text display-inline="yes-display-inline">An eligible entity shall, as appropriate, use amounts awarded under this section to—</text><paragraph id="id765cc67e5caa4396b91a3fbaa9e15057"><enum>(1)</enum><text>establish, or enhance existing, capacity and capabilities to conduct wastewater sampling, testing, and related analysis;</text></paragraph><paragraph id="iddcdf07766401478488cd9634106efb35"><enum>(2)</enum><text>conduct wastewater surveillance, as appropriate, at individual facilities, institutions, and locations in rural areas, in which there is an increased risk of infectious disease outbreaks, or areas in which wastewater is not treated through the relevant local utility of the jurisdiction; and</text></paragraph><paragraph id="id37e1e81cba0b475392735ec331ac71ea"><enum>(3)</enum><text>implement projects that use evidence-based or promising practices to conduct wastewater surveillance activities.</text></paragraph></subsection><subsection id="id6584d405a70545d78152ca2e4bc25218"><enum>(e)</enum><header>Partnerships</header><text>In carrying out activities under this section, eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities, as appropriate and consistent with this section.</text></subsection><subsection id="id4178e0c87d994e74b3ce596a78003ec3"><enum>(f)</enum><header>Technical assistance</header><text>The Secretary, in consultation with the heads of other applicable Federal agencies and departments, as appropriate, shall provide technical assistance to recipients of awards under this section to facilitate the planning, development, and implementation of activities described in subsection (d).</text></subsection><subsection id="ida2e660d75f8f4ff99804b29930c636a3"><enum>(g)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2024 through 2028.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="id022d9c5af1e84fa8a35ddf1431756195" commented="no"><enum>(b)</enum><header>Wastewater surveillance research</header><paragraph id="idf90d9ed601a84e68b5a59f822d4b30b0" commented="no"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this subsection referred to as the <quote>Secretary</quote>) shall continue to conduct or support research on the use of wastewater surveillance to detect and monitor emerging infectious diseases, which may include—</text><subparagraph id="idba6009d2f3fb4746b2ac13f94009617e" commented="no"><enum>(A)</enum><text>research to improve the efficiency of wastewater sample collection and analysis and increase the sensitivity and specificity of wastewater testing methods; and</text></subparagraph><subparagraph id="id7372e80858894121aebab3483886682e" commented="no"><enum>(B)</enum><text>implementation and development of evidence-based practices to facilitate the estimation of population-level data within a community.</text></subparagraph></paragraph><paragraph id="id18de93a9e5184ec9bb8b8eb14f1e75b9" commented="no"><enum>(2)</enum><header>Non-duplication of effort</header><text>The Secretary shall ensure that activities carried out under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the Department of Health and Human Services related to wastewater surveillance.</text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id31c02fec-943d-4c0e-85b3-f10a9a2da75d"><enum>107.</enum><header display-inline="yes-display-inline">Reauthorization of Mosquito Abatement for Safety and Health program</header><text display-inline="no-display-inline">Section 317S of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-21">42 U.S.C. 247b–21</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id0d063ed93ffd495997eca4485a1998d2"><enum>(1)</enum><text>in subsection (a)(3)(A), by striking <quote>subsection (b)(3)</quote> and inserting <quote>subsection (b)(4)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida0734573e7464301a918cc902c41199e"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id267f945c841940c388625711b511a56d"><enum>(A)</enum><text>by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1cc862cedece4c8a9654418c5d2a28cd"><enum>(B)</enum><text>by inserting after paragraph (2) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id16E5B2CF2ABD4122A4ECD4E50344BDD7"><paragraph id="id2252b4e640f440cd93b68229071052f0"><enum>(3)</enum><header>Considerations</header><text>The Secretary may consider the use of innovative and novel technology for mosquito prevention and control in making grants under paragraph (1).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="ida96f23d64e4149779e0eb098f9bd8f6a"><enum>(3)</enum><text>by amending subsection (d) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id7EB36B97EFB240A68EA21A6FB214533B"><subsection id="id85a832af232f4b53b1cd74040bd71e55"><enum>(d)</enum><header>Uses of funds</header><text>Amounts appropriated under subsection (f) may be used by the Secretary to provide training and technical assistance with respect to the planning, development, and operation of assessments and plans under subsection (a) and control programs under subsection (b). The Secretary may provide such training and technical assistance directly or through awards of grants or contracts to public and private entities.</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id585ebc8644544c91a146b888ff6db4a5"><enum>(4)</enum><text>in subsection (f)(1), by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></paragraph></section><enum>II</enum><header>Federal planning and coordination</header><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id0af39f6a820c4a35abc696bb19913f8c"><enum>201.</enum><header display-inline="yes-display-inline">All-Hazards Emergency Preparedness and Response</header><text display-inline="no-display-inline">Section 2811 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10">42 U.S.C. 300hh–10</external-xref>) is amended—</text><paragraph id="idad15fba1fa0843ec888e028b268ec7ee"><enum>(1)</enum><text>in subsection (b)—</text><subparagraph id="id16ec5a29e3074b149799f2cbc3dbcac6"><enum>(A)</enum><text>in paragraph (3)—</text><clause commented="no" display-inline="no-display-inline" id="idd3e0ff64fa524e6f96c72cc7dda47153"><enum>(i)</enum><text>by striking <quote>Oversee advanced</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idB54FB8C607DB4FC0B33C75655A200599"><subparagraph id="id90da1646c40c40adbaa9c729a1bee663"><enum>(A)</enum><header>In general</header><text>Oversee advanced</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause commented="no" display-inline="no-display-inline" id="id0fc4d9810081420eb7a2c07970031c60"><enum>(ii)</enum><text>by adding at the end following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idA286EA8ECA10487BB960495BFD8762F9"><subparagraph id="id744ae192565c4d67bdd17d93aef18a35"><enum>(B)</enum><header>Development of requirements</header><text>Lead the development and approval, and, on a routine basis, the review and update, of requirements for such countermeasures and products, including related capabilities, to inform the advanced research, development, procurement, and replenishment decisions of the Department of Health and Human Services.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb528de40a17d43f09cc4a8e77087a8d6"><enum>(B)</enum><text>in paragraph (4)—</text><clause commented="no" display-inline="no-display-inline" id="idb903594be8f64404ae90bb38a5c9fae8"><enum>(i)</enum><text>in subparagraph (F)—</text><subclause commented="no" display-inline="no-display-inline" id="id7961b960c3144d48b71418674a50fa73"><enum>(I)</enum><text>in the matter preceding clause (i), by striking <quote>and in consultation with the Secretary of Homeland Security,</quote>; and</text></subclause><subclause id="idd65d7c1dbf964933a74c679fb8424cb2"><enum>(II)</enum><text>in clause (i), by inserting <quote>enhance</quote> after <quote>capabilities and</quote>; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id4b3902ec32f0442fbea0c2b8cbcf0b85"><enum>(ii)</enum><text>in subparagraph (G)—</text><subclause commented="no" display-inline="no-display-inline" id="idef4234685adf4776ab7ded2a6c3380bd"><enum>(I)</enum><text>in clause (i), by striking <quote>based on</quote> and inserting <quote>based on—</quote>; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="ida8b87ef6ae9845659f09ec45ba1cc78b"><enum>(II)</enum><text display-inline="yes-display-inline">in clause (ii), by striking <quote>; and</quote> at the end and inserting a semicolon;</text></subclause><subclause commented="no" display-inline="no-display-inline" id="idd4b7764f703a4ebca79075573e470783"><enum>(III)</enum><text>in clause (iii), by striking the period and inserting <quote>; and</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="id4358010d3e964639864a77b92b16bd02"><enum>(IV)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id4FC7954D04EE4342BFEE82C3E4BFF63A"><clause id="id92dc7881a4414ee3ad0fe6de8fc3e8ae"><enum>(iv)</enum><text>that include, as appropriate, participation by relevant industry, academia, professional societies, and other stakeholders.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subclause></clause><clause commented="no" display-inline="no-display-inline" id="idb788be66989449809317db6ccf2855f3"><enum>(iii)</enum><text>in subparagraph (H)—</text><subclause commented="no" display-inline="no-display-inline" id="idafa8d62f945d46e29f436e1a375043e6"><enum>(I)</enum><text>by inserting <quote>and the Director of the Office of Pandemic Preparedness and Response</quote> after <quote>Security Affairs</quote>; and</text></subclause><subclause id="id00a072eb7cc74b2e9a29582cafdbc127"><enum>(II)</enum><text>by inserting <quote>and medical product and supply capacity planning pursuant to subparagraph (J), including discussion of any relevant identified supply chain vulnerabilities</quote> before the period at the end; </text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id64060720de5649b0aea67f0bf8b03cd4"><enum>(iv)</enum><text display-inline="yes-display-inline">in subparagraph (I), by inserting <quote>the Director of the Office of Pandemic Preparedness and Response Policy,</quote> after <quote>Security Affairs,</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id912faa7106a348d094f0f0b6b389bdc7"><enum>(v)</enum><text>in subparagraph (J)(i), in the matter preceding subclause (I), by inserting <quote>(including ancillary medical supplies and components of medical products, such as active pharmaceutical ingredients, key starting materials, and medical device components)</quote> after <quote>supply needs</quote>; and</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb9fe473178df40b79d4c1898e67872f7"><enum>(C)</enum><text>in paragraph (7)—</text><clause commented="no" display-inline="no-display-inline" id="id74d1aba009fb4cfd837ae6c0fcf19d88"><enum>(i)</enum><text>in the matter preceding subparagraph (A), by inserting <quote>and the requirements developed pursuant to paragraph (3)(B)</quote> after <quote>subsection (d)</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="id11c9a22056434fca8e1212a5c2f99363"><enum>(ii)</enum><text>by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id83d586d28f1f471992c00d4017a5c5c0"><enum>(iii)</enum><text>by inserting after subparagraph (D) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idE8568EE5DC62496A83D364200B419CCE"><subparagraph id="ide1a04de8828c4605867d4908a202d7db"><enum>(E)</enum><text>include a professional judgment of anticipated budget needs for each future fiscal year accounted for in such plan to account for the full range of anticipated medical countermeasure needs and life-cycle costs to address such priorities and requirements;</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="id5fd5027348154898b6f11253c42624bf"><enum>(2)</enum><text>in subsection (d)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ida9c30783bc7f4b74a31a691de9e6fbc8"><enum>(A)</enum><text>by amending paragraph (1) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id0C0B60115C1E488F991634295603D38B"><paragraph id="idc5b88947e83349e28a6a550e7e9ebcfd"><enum>(1)</enum><header>In general</header><text>Not later than March 15, 2020, and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop and 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 coordinated strategy for medical countermeasures to address chemical, biological, radiological, and nuclear threats, informed by the requirements developed pursuant to subsection (b)(3)(B). Not later than 180 days after the submission of such strategy to such committees, the Assistant Secretary for Preparedness and Response shall submit an accompanying implementation plan to such committees. In developing such a strategy and plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb86b4d7893cb429893151882ec607a1b"><enum>(B)</enum><text>in paragraph (2), in the matter preceding subparagraph (A), by inserting <quote>strategy and</quote> before <quote>plan</quote>; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfc6e29af4fb347e1a7f1799234018827"><enum>(3)</enum><text>in subsection (f)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id941a285edc2446248e149397509fb4a6"><enum>(A)</enum><text>in paragraph (1), in the matter preceding subparagraph (A), by inserting <quote>, including an emerging infectious disease,</quote> after <quote>any such agent</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf8e11c4dc24742798dc909ee91b6fd6f"><enum>(B)</enum><text>in paragraph (2)(A), by striking <quote>$250,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$335,000,000 for each of fiscal years 2024 through 2028</quote>. </text></subparagraph></paragraph></section><section id="id19e5ffd86cd543d1bb5783073250a7a1"><enum>202.</enum><header>National Health Security Strategy</header><text display-inline="no-display-inline">Section 2802 of the Public Health Service Act is amended—</text><paragraph id="ide5d69a868c2d449199a722e36163dc97"><enum>(1)</enum><text>in subsection (a)(3)—</text><subparagraph id="id101059a0e529437bbd01336cc52e9da3"><enum>(A)</enum><text>by striking <quote>In 2022, the</quote> and inserting <quote>The</quote>; and</text></subparagraph><subparagraph id="idb6929fdcceab439bb2f7832c7f56a64b"><enum>(B)</enum><text>by inserting <quote>, maintaining, and sustaining</quote> after <quote>establishing</quote>; and</text></subparagraph></paragraph><paragraph id="id89a1db059c10459c81fd5761efed7be0"><enum>(2)</enum><text>in subsection (b)—</text><subparagraph id="id71b691b078d44f9ca9dff650f8d2e406"><enum>(A)</enum><text>in paragraph (2)—</text><clause id="id23d4bb3e736143e28da232bde01a84df"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>that support interagency coordination and availability of information, as appropriate</quote> before the period;</text></clause><clause id="ide3320652305647dd8be6c99d7df79d68"><enum>(ii)</enum><text>in subparagraph (B), by inserting <quote>rapid testing,</quote> after <quote>and supplies,</quote>;</text></clause></subparagraph><subparagraph id="id4c011a582ca04b5b86a493678a8f5c08"><enum>(B)</enum><text>in paragraph (3)—</text><clause id="id738a8be4fc6c4633a54f35be52bee0de"><enum>(i)</enum><text>in subparagraph (C), by inserting <quote>and current capacity of facilities within such systems, as applicable</quote> before the period;</text></clause><clause id="iddf060260d570404288e5c058e477c836"><enum>(ii)</enum><text>in subparagraph (D), by inserting <quote>and other medical products and medical supplies directly related to responding to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and incidents covered by the National Response Framework, as applicable and consistent with the activities carried out under section 2811(b)(4)(J)</quote> before the period; and</text></clause><clause id="id75ce4677fe554ffab804fe56eefc455d"><enum>(iii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ide94b3c84fe4b49368e55d73bc258894b"><subparagraph id="idf091fe33088347f786a4e386be4f9999"><enum>(H)</enum><text>Supporting the availability of blood and blood products with respect to public health emergencies.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="idf85afec2a0d04e2db59358157a53a08f"><enum>(C)</enum><text>in paragraph (5), by inserting <quote>applicable federally-funded activities and</quote> after <quote>(including</quote>;</text></subparagraph><subparagraph id="id1b5dc169ab98483fa546baf2b72282ef"><enum>(D)</enum><text>in paragraph (8)—</text><clause id="id510f4c6b1df34f9cb3039aad1cc9b9ce"><enum>(i)</enum><text>in subparagraph (A), by inserting <quote>public health and medical</quote> before <quote>activities</quote>; and</text></clause><clause id="ide62619a952c14a2aa5bef80e65f6bee1"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>familiarity with</quote> and inserting <quote>understanding of, and coordination between,</quote>;</text></clause></subparagraph><subparagraph id="idfbf7f99fac3744d78bd929b19f04d658"><enum>(E)</enum><text>by redesignating paragraphs (9) and (10) as paragraphs (10) and (12), respectively;</text></subparagraph><subparagraph id="id743af2b2974d4bb8b429e2ab22f60ad3"><enum>(F)</enum><text>by inserting after paragraph (8) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idc0a5141746ac4daba9593d4f6b58a52c"><paragraph id="id45caccfc0a9c47d89c9ee0d3a6e589cf"><enum>(9)</enum><header>Other settings</header><text>Supporting Federal, State, local, and Tribal coordination and planning with respect to facilities in which there is an increased risk of infectious disease outbreaks, including such facilities that address the needs of at-risk individuals, in the event of a public health emergency declared under section 319.</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph id="id24f55f9bbe254d75aad5baa1ae8f927a"><enum>(G)</enum><text>by inserting after subparagraph (10), as so redesignated, the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idd75a82eee9354552a703899e0004cf9e"><paragraph id="id3b3ad4d7f7024ed4ab2248cb7b9cf67b"><enum>(11)</enum><header>Other hazards</header><text>Assessing current and potential health security threats from natural disasters or other extreme weather events with respect to public health and medical preparedness and response.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="idff36ac7e25884d369d713deb12cdb63b"><enum>(H)</enum><text>by striking <quote>tribal</quote> each place it appears and inserting <quote>Tribal</quote>. </text></subparagraph></paragraph></section><section id="ide02e64925e0242888b2c138cd8e0a240"><enum>203.</enum><header>Improving development and distribution of diagnostic tests</header><text display-inline="no-display-inline">Section 319B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-2">42 U.S.C. 247d–2</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idBB68919D7FF246BABF35397BC00616A3"><section id="idbd65ae85122b4860b2155163f6024635"><enum>319B.</enum><header>Improving development and distribution of diagnostic tests</header><subsection id="idcee4a2b97792406bb32a74120d7f54b8"><enum>(a)</enum><header>Framework</header><text>The Secretary shall develop, make publicly available not later than 1 year after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Response Act</short-title>, and update not less frequently than every 3 years thereafter, a strategic framework for the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, and for rapid scaling of testing capacity, in response to chemical, biological, radiological, or nuclear threats, including infectious diseases for which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency. Such strategic framework shall take into consideration—</text><paragraph id="id8a6ef2cc3f0d49f7b6af8f7b58a43f03"><enum>(1)</enum><text>domestic capacity, including any such capacity established through partnerships with public and private entities pursuant to subsection (c), to support the development, validation, authorization, manufacture, procurement, and distribution of tests;</text></paragraph><paragraph id="idd462bdf0ed1a437fb65aa4e4ea32133e"><enum>(2)</enum><text>novel technologies and platforms that may be used to improve testing capabilities, including high-throughput laboratory diagnostics, and point-of-care diagnostics, and any such technologies to improve the accessibility of such tests, and facilitate the development and manufacture of diagnostic tests;</text></paragraph><paragraph id="id9bbb372101624883af4feabcef4460bf"><enum>(3)</enum><text>medical supply needs related to testing, including diagnostic testing, equipment, supplies, and component parts, and any potential vulnerabilities related to the availability of such medical supplies and related planning, consistent with section 2811(b)(4)(J);</text></paragraph><paragraph id="id31a9313cd68a4793bce94aac99039b06"><enum>(4)</enum><text>strategies for the rapid and efficient distribution of tests locally, regionally, or nationwide and scaling laboratory testing capacity; and</text></paragraph><paragraph id="idad4b38b6adbd41b28f56746f3a340a6e"><enum>(5)</enum><text>assessing such strategies through drills and operational exercises carried out under section 2811(b)(4)(G), as appropriate.</text></paragraph></subsection><subsection id="idea891e27bdc5419fbab82b1258658f62"><enum>(b)</enum><header>Coordination</header><text>To inform the development and update of the framework under subsection (a), and in carrying out activities to implement such framework, the Secretary shall coordinate with industry, States, local governmental entities, Indian Tribes and Tribal organizations, and other relevant public and private entities.</text></subsection><subsection id="id6080fbc63ace43f7b19350d8a5b3d2ad"><enum>(c)</enum><header>Capacity building</header><text>The Secretary may contract with public and private entities, as appropriate, to increase domestic capacity in the rapid development, validation, authorization, manufacture, procurement, and distribution of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency.</text></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></section><section id="ida5df5cee0e654818be048ccf4d937967"><enum>204.</enum><header>Pilot program for public health data availability</header><subsection commented="no" display-inline="no-display-inline" id="idc0b58d8b87484d12a178bcf90cb00489"><enum>(a)</enum><header display-inline="yes-display-inline">Situational awareness system</header><text display-inline="yes-display-inline">Section 319D of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id71e7eb0c15c64586aa9351590608c60d"><enum>(1)</enum><text>in subsection (c)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7f3a11d8d3be4c99ba0f3e58e4ed1b43"><enum>(A)</enum><text>in paragraph (1), by inserting <quote>, and facilitate the leveraging of relevant public health data across the Department of Health and Human Services</quote> after <quote>extent practicable</quote>; and</text></subparagraph><subparagraph id="id9dfb5b1c8d314ac5843a7b3c6cba35d1"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="id0f0f95eafd2e4cc2845d6d18c1e8f4c7"><enum>(i)</enum><text>in subparagraph (A)—</text><subclause commented="no" display-inline="no-display-inline" id="id3294e491234f41ffa7d03c04e05f150d"><enum>(I)</enum><text>by striking <quote>among agencies</quote> and inserting <quote>among, and direct communication between, agencies</quote>; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id847c4d6c36b74d1ba55294157409cecf"><enum>(II)</enum><text>by inserting <quote>the sharing of information from applicable public health data systems,</quote> after <quote>Technology),</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="id4707be5f74d84d1abd63586c8555fc2b"><enum>(III)</enum><text>by striking <quote>; and</quote> at the end and inserting a semicolon;</text></subclause></clause><clause id="id1f69d4a7402f417c9af44ae5fcfc0e0b"><enum>(ii)</enum><text>in subparagraph (B), by striking the period at the end and inserting <quote>; and</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id5ecbb40f4ab34bdc93f60d9c28712aaf"><enum>(iii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id0F062262E94D468E9E0554F04082D014"><subparagraph id="id9ee689ceb1c64ed1b9d93aad5e23a591"><enum>(C)</enum><text>facilitate communication, including bidirectional communication or other means of communication, to enable timely information sharing with State, local, and Tribal public health officials, between agencies and offices of the Department of Health and Human Services, and with health care providers, as applicable and appropriate.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcd49c97dda6347a593d69684e6211b2c"><enum>(2)</enum><text>in subsection (d)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id9aeedda68dc2455eb77ffbb25a324ac5"><enum>(A)</enum><text>in paragraph (1)—</text><clause id="idb1a56bf0031448078d9a76336a2c93c9"><enum>(i)</enum><text>by striking <quote>, the Secretary may</quote> and inserting <quote>and support the near real-time public availability of data, as appropriate, pursuant to section 319D–2, the Secretary shall establish a pilot program to</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id44f2eea0adeb41ac973499c525a2872a"><enum>(ii)</enum><text>by striking <quote>, in collaboration with appropriate</quote> and inserting <quote>. Such States or consortia of States shall carry out such activities in collaboration with appropriate stakeholders, such as health information exchanges, laboratory information systems,</quote>;</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8bf65d9af39a4485a26e92d71f314023"><enum>(B)</enum><text>in paragraph (2)(A), by inserting <quote>pursuant to paragraph (3)</quote> after <quote>may require</quote>;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id22b4b0cdb215477594593291dc7e6c36"><enum>(C)</enum><text>by striking paragraph (6);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id02608d7b815e44c6b9121f44e0259492"><enum>(D)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id11c98b4475b14dd8bc06395521df0a55"><enum>(E)</enum><text>by inserting after paragraph (2) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id883657264766400195A28EE84CB4B2CF"><paragraph id="id6c59a23d801a4e4581eb1805db9f59f0"><enum>(3)</enum><header>Data plan</header><text>For purposes of this subsection, the Secretary shall develop a plan for data elements to be reported to the Secretary pertaining to potentially catastrophic infectious disease outbreaks, in such form and manner and at such timing and frequency as determined by the Secretary. When developing the plan under this subsection, the Secretary shall—</text><subparagraph id="id40c995ee62b64a8e9a82cefd50b9e9a4"><enum>(A)</enum><text>align with the standards and implementation specifications adopted by the Secretary under section 3004, where applicable, and update, as necessary and consistent with applicable requirements of subsection (b)(3) and section 2823, uniform standards for applicable entities to report data elements; </text></subparagraph><subparagraph id="id912226cc68a1462fa67ec4939895c7aa"><enum>(B)</enum><text>consider the use of technologies that enable fast bulk exchange of data; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc0eeac30a21e46b3aa6e3c8ab9f0789f"><enum>(C)</enum><text display-inline="yes-display-inline">ensure the data elements reported under this subsection and made publicly available pursuant to section 319D–2 are made available consistent with applicable Federal and State privacy law, at a minimum.</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ideaf991126d994e70b9f0b2ce032b48bc"><enum>(F)</enum><text>in paragraph (4), as so redesignated—</text><clause commented="no" display-inline="no-display-inline" id="idffc54f736437450c92b3ebf421153c17"><enum>(i)</enum><text>in subparagraph (A), by striking <quote>emergencies;</quote> and inserting <quote>emergencies, including such diseases recommended by the National Public Health Data Board established under section 319D–2; and</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="id107669185a1c4662b4ab691bf9736a56"><enum>(ii)</enum><text>in subparagraph (B), by striking <quote>; and</quote> and inserting a period; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id106d69fad49b4786a4977757df380404"><enum>(iii)</enum><text>by striking subparagraph (C); and</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcb6d81daf1c04df3927f46545bc4a595"><enum>(3)</enum><text>in subsection (h)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id5b81581cb8834cc6b2843504e7b158bd"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>2022 and 2023</quote> and inserting <quote>2024 through 2028</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idccaa220da74c4f6fbf10e5d37d09835f"><enum>(B)</enum><text>in paragraph (2), by striking <quote>2022 and 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8ba278569bce4da5a58c582ede71847a"><enum>(b)</enum><header>Data selection and access</header><text display-inline="yes-display-inline">Title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241 et seq.</external-xref>) is amended by inserting after section 319D–1 the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id581004657C7F46D3B12825ADD00C9BA6"><section id="id2d5ac5e79dfd42eaa99d5f70e2460d23"><enum>319D–2.</enum><header>Public health data pilot program</header><subsection commented="no" display-inline="no-display-inline" id="idd1538216e55d4219be22ffde6ba861a0"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text>The Secretary shall—</text><paragraph commented="no" display-inline="no-display-inline" id="idaf8a5f77aa1c4312bf4419d9e00c8bdf"><enum>(1)</enum><text display-inline="yes-display-inline">establish and maintain a near real-time, open source, public-facing, and publicly available website to provide deidentified, aggregated data on potentially catastrophic disease outbreaks, in accordance with subsection (b); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc47c023d0af44eee8abd59cca0371269"><enum>(2)</enum><text display-inline="yes-display-inline">collect the data elements pertaining to such diseases recommended pursuant to subsection (b)(1)(B), using existing processes or any new processes established pursuant to section 319D(d).</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idcabdc795294a4681bd9e3dd5801d7258"><enum>(b)</enum><header>National Public Health Data Board</header><paragraph commented="no" display-inline="no-display-inline" id="id9704e48a554645b0987ecd70a53232d4"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish a National Public Health Data Board to advise, and make recommendations to the Secretary with respect to potentially catastrophic infectious diseases appropriate for inclusion in the public health situational awareness system pilot program established pursuant to section 319D(d) and the website established under subsection (a)(1).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9ab83fd2878e4c44ae18a91a50f075c7"><enum>(2)</enum><header>Membership</header><text display-inline="yes-display-inline">The Board established under paragraph (1) shall consist of the following members:</text><subparagraph commented="no" display-inline="no-display-inline" id="id81dd8b57d88b402eaf035d6bd88fff56"><enum>(A)</enum><header>Federal members</header><text display-inline="yes-display-inline">The following Federal members:</text><clause commented="no" display-inline="no-display-inline" id="id03967c024e6749c3872f1d0e7666b307"><enum>(i)</enum><text>The Secretary of Health and Human Services.</text></clause><clause commented="no" display-inline="no-display-inline" id="id7a7e29056bcf4565a5dedbfd1a0fc753"><enum>(ii)</enum><text display-inline="yes-display-inline">The Secretary of Defense.</text></clause><clause commented="no" display-inline="no-display-inline" id="idca304c3d58994df8b2dff6c390f6e6af"><enum>(iii)</enum><text display-inline="yes-display-inline">The Secretary of Veterans Affairs.</text></clause><clause commented="no" display-inline="no-display-inline" id="ide6cb1fb167d54a6e8b5366a62abb7433"><enum>(iv)</enum><text display-inline="yes-display-inline">The National Coordinator for Health Information Technology.</text></clause><clause commented="no" display-inline="no-display-inline" id="id20c3487ec964426b934ad73e163e1a03"><enum>(v)</enum><text display-inline="yes-display-inline">The Director of the National Institutes of Health.</text></clause><clause commented="no" display-inline="no-display-inline" id="idf59c2b3e179d48b4aec08dfe9e6449ea"><enum>(vi)</enum><text display-inline="yes-display-inline">The Director of the Centers for Disease Control and Prevention.</text></clause><clause commented="no" display-inline="no-display-inline" id="id0e25b4c466484027843e9296065be5a3"><enum>(vii)</enum><text display-inline="yes-display-inline">The Assistant Secretary for Preparedness and Response.</text></clause><clause commented="no" display-inline="no-display-inline" id="idc6807f7cbbb64333b323435faea4a822"><enum>(viii)</enum><text display-inline="yes-display-inline">The Director of the Indian Health Service.</text></clause><clause commented="no" display-inline="no-display-inline" id="id0b29e57e1eea4e1cb3e299674056c5cb"><enum>(ix)</enum><text display-inline="yes-display-inline">The Administrator of the Centers for Medicare & Medicaid Services.</text></clause><clause commented="no" display-inline="no-display-inline" id="id8279c3b504e340cc882b569cc862ce31"><enum>(x)</enum><text>The Commissioner of Food and Drugs.</text></clause><clause commented="no" display-inline="no-display-inline" id="idcf349c924a104ff6b73f02714e856f8c"><enum>(xi)</enum><text>Such other heads of departments, agencies, and offices as the Secretary determines appropriate.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb0d121ea3f7a4828863f812befa1501d"><enum>(B)</enum><header>Non-Federal members</header><text display-inline="yes-display-inline">Such other individuals appointed by the Secretary—</text><clause commented="no" display-inline="no-display-inline" id="ida292ef3388104058b113ab4f700254e0"><enum>(i)</enum><text display-inline="yes-display-inline">who have relevant public health, medical, or scientific expertise, including—</text><subclause commented="no" display-inline="no-display-inline" id="idf7f3273413984fdca0b5d7f6d84ac6c0"><enum>(I)</enum><text display-inline="yes-display-inline">individuals with expertise or experience in—</text><item commented="no" display-inline="no-display-inline" id="id2ee863ecfccb4ec3bdda75f90c423969"><enum>(aa)</enum><text>State, local, or Tribal health data systems or practices; or</text></item><item commented="no" display-inline="no-display-inline" id="idb0e3c477449c45e4bf5667f743b71efc"><enum>(bb)</enum><text display-inline="yes-display-inline">health data standards and technology systems, which may include hospital, pharmacy, laboratory information systems and health information exchanges; and</text></item></subclause><subclause commented="no" display-inline="no-display-inline" id="id93d2212447dd4288b16ef14a88c5b459"><enum>(II)</enum><text display-inline="yes-display-inline">representatives of national public health organizations; and</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="iddd90b5e4ddcd4dee8193b09bcafe44b9"><enum>(ii)</enum><text display-inline="yes-display-inline">individuals with such other specific expertise as the Secretary determines appropriate. </text></clause></subparagraph></paragraph></subsection><subsection id="id3f66faf3a57c4068b3b42ad0b7f79a23"><enum>(c)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to alter existing obligations under regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and this section shall be applied in a manner that is consistent with applicable Federal and State privacy law, at a minimum.</text></subsection><subsection id="id5c24b9b9a1624f7788e2b743f61ab02a"><enum>(d)</enum><header>Nonduplication of efforts</header><text>The Secretary shall ensure that the activities carried out by the Board under this section do not duplicate the efforts of other Federal advisory committees that advise and make recommendations to the Secretary. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="id891a8bafc0654f0faddd38dfcd2e7cc8"><enum>(e)</enum><header>Sunset</header><text display-inline="yes-display-inline">This section shall cease to have force or effect on September 30, 2028.</text></subsection></section><after-quoted-block>. </after-quoted-block></quoted-block></subsection></section><section id="id232b05ea448145ac98143c9c5c7c9f01"><enum>205.</enum><header>Combating antimicrobial resistance</header><text display-inline="no-display-inline">Section 319E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-5">42 U.S.C. 247d–5</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id2854024f52c94607bf25eb16d21e9830"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph commented="no" display-inline="no-display-inline" id="idf8277732b8b34e47998cb81a3e344807"><enum>(A)</enum><text>in paragraph (1), by inserting <quote>and activities</quote> after <quote>Federal programs</quote>;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6442afe273eb4a2f9c434b5233f7b41e"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="id5222669115034af98f29620a761e6f71"><enum>(i)</enum><text>by striking <quote>public health constituencies, manufacturers, veterinary and medical professional societies and others</quote> and inserting <quote>the Advisory Council described in subsection (b) and relevant public and private entities</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id8009429f24b64f6bb2b3dcafc0ddbd52"><enum>(ii)</enum><text>by inserting <quote>, pursuant to paragraph (4),</quote> after <quote>comprehensive plan</quote>;</text></clause></subparagraph><subparagraph id="id679bae5a6a6a4e748eac47444616411d"><enum>(C)</enum><text>by amending paragraph (3) to read as follow:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id886B151E5CBA4FF38D3CC5BA4F2F75A8"><paragraph id="id09b68d7a697a4ef48452cb2412f84b89"><enum>(3)</enum><header>Agenda</header><text>The task force described in paragraph (1) shall consider factors the Secretary considers appropriate, including factors to—</text><subparagraph id="id3df804040da748faab36ba9a270ccc35"><enum>(A)</enum><text>slow the emergence of resistant bacteria and fungi and prevent the spread of resistant infections;</text></subparagraph><subparagraph id="id62170e40832044d8be8eec01480e49e8"><enum>(B)</enum><text>strengthen activities to combat resistance with respect to zoonotic diseases;</text></subparagraph><subparagraph id="ide9d6ee3836694c5bad1dfd100ecbcac8"><enum>(C)</enum><text>advance development and use of rapid and innovative capabilities, including diagnostic tests, for identification and characterization of resistant bacteria and fungi;</text></subparagraph><subparagraph id="id929df260abc447748553b5a6b5845a10"><enum>(D)</enum><text>accelerate basic and applied research and development for new antibiotics, antifungals, and other related therapeutics and vaccines; and</text></subparagraph><subparagraph id="id948a7ab84c6446aea9d012d61d2f1375"><enum>(E)</enum><text>support international collaboration and capacities for antimicrobial-resistance prevention, detection, and control.</text></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3636be89e59248968a123259411069c3"><enum>(D)</enum><text>by redesignating paragraph (4) as paragraph (5); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id34fb03575c024bb6bc82d29a5e50e540"><enum>(E)</enum><text>by inserting after paragraph (3) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id209891A2A9834CB2A455E853075DBD28"><paragraph id="id1cfc7e548a8e4676b4761025e764cd7d"><enum>(4)</enum><header>Action plan</header><text>Not later than October 1, 2025, and every 5 years thereafter, the task force described in paragraph (1) shall develop and submit 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 a plan regarding Federal programs and activities to combat antimicrobial resistance, including measurable outcomes, as appropriate, informed by the agenda described in paragraph (3) and input provided by the Advisory Council described in subsection (b) and other relevant stakeholders provided pursuant to paragraph (2).</text></paragraph><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb3c0c64d4da1422a878eeac0f27df1df"><enum>(2)</enum><text>by redesignating subsections (b) through (o) as subsections (c) through (p), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc261e85458de4870a2cbdbdc63174186"><enum>(3)</enum><text>by inserting after subsection (a) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idD2898370E1F24A53A9DDB05C3F4A8CFD"><subsection commented="no" display-inline="no-display-inline" id="id85bc65a775d140718532d5d993802e3b"><enum>(b)</enum><header>Advisory council</header><paragraph commented="no" display-inline="no-display-inline" id="id4b2c1848dbf347eeb9da9f35bf9063ee"><enum>(1)</enum><header>In general</header><text>The Secretary may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this subsection as the <quote>Advisory Council</quote>.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb3f8a914a36a440596365e90560d51cb"><enum>(2)</enum><header>Duties</header><text>The Advisory Council shall advise and provide information and recommendations to the Secretary, acting through the Task Force established under subsection (a), regarding Federal programs and activities intended to reduce or combat antimicrobial-resistant bacteria or fungi that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. Such advice, information, and recommendations may be related to improving Federal efforts related to factors described in subsection (a)(3) and other topics related to antimicrobial resistance, as appropriate.</text></paragraph><paragraph id="id9a7788d28fde44dab9f38908836e5b58"><enum>(3)</enum><header>Meetings and coordination</header><subparagraph id="id9ce1720fc8a349b99ca761ad396af8b6"><enum>(A)</enum><header>Meetings</header><text>The Advisory Council shall meet not less than biannually and, to the extent practicable, in coordination with meetings of the task force established under subsection (a).</text></subparagraph><subparagraph id="iddf321ef40da043cb8a5a28c09b8c2fd3"><enum>(B)</enum><header>Coordination</header><text>The Advisory Council shall, to the greatest extent practicable, coordinate activities carried out by the Council with the task force established under subsection (a).</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="iddcea1f0e786a44e7b1fdd96dd84a441a"><enum>(4)</enum><header>FACA</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/10">Chapter 10</external-xref> of title 5, United States Code, shall apply to the activities and duties of the Advisory Council.</text></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc8cc6d9ae0664beeb0271a149dcadc2f"><enum>(4)</enum><text>in subsection (n), as so redesignated, by striking <quote>(f) through (j)</quote> and inserting <quote>(g) through (k)</quote>.</text></paragraph></section><section id="id196510b42af54475b837e1e5695a009c"><enum>206.</enum><header>Strategic National Stockpile and material threats</header><text display-inline="no-display-inline">Section 319F–2 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>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="ida1b3eee1253549fd97627e3b2bb9fae9"><enum>(1)</enum><text>in subsection (a)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id95d8cd0daf3b4fe6bba59743d9cd86af"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (2)(B)(i), by striking subclause (IV) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id59a0fe286c04486993155f7263ef9296"><subclause id="id5535a6856f9c451fbb2ed049b25cd4b6"><enum>(IV)</enum><text>the emergency health security threat or threats such countermeasure procurement is intended to address, including—</text><item id="id9dbd177a4c084a8b99347418025b3f4e"><enum>(aa)</enum><text>whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats; and</text></item><item id="id382e484fafe64cac97eed5ec03199049"><enum>(bb)</enum><text>in the case of a countermeasure that addresses a biological agent, whether such agent has an increased likelihood to become resistant to, more resistant to, or evade, such countermeasure relative to other available medical countermeasures;</text></item></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8b3230496d9242a5a59cf96216556a0b"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (3)—</text><clause commented="no" display-inline="no-display-inline" id="id75cd0a9fab5244039fb9622123753afa"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>are followed, regularly reviewed, and updated with respect to such stockpile</quote> and inserting <quote>with respect to such stockpile are followed, regularly reviewed, and updated to reflect best practices</quote>;</text></clause><clause id="id09bab4d8823f4b998558a84708ea7dea"><enum>(ii)</enum><text>by redesignating subparagraphs (H) through (K) as subparagraphs (I) through (L), respectively; and</text></clause><clause commented="no" display-inline="no-display-inline" id="idb62909d2a92b4d01875fbc096f022d44"><enum>(iii)</enum><text>by inserting after subparagraph (G) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id8CC82508B35F4E6BAB7D0EA1A3DBC38D"><subparagraph id="id932efce0b61d44db9bc3153351318b9c"><enum>(H)</enum><text>utilize tools to enable the timely and accurate tracking, including the location and geographic distribution and utilization, of the contents of the stockpile throughout the deployment of such contents;</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3bbdd870ebf546f483b594c8823eac26"><enum>(2)</enum><text>in subsection (c)(2)(C)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ide18abfdb46bd4dd284825c2516d667cc"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>promptly</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id20b04ee810e64bdeb7e145c3658d6c30"><enum>(B)</enum><text>by inserting <quote>, not later than 60 days after such determination</quote>;</text></subparagraph></paragraph><paragraph id="id8f184020df20441eac57cde4d9139e82"><enum>(3)</enum><text>in subsection (f)(1), by striking <quote>$610,000,000 for each of fiscal years 2019 through 2021, and $750,000,000 for each of fiscal years 2022 and 2023</quote> and inserting <quote>$965,000,000 for each of fiscal years 2024 through 2028</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0c869ae6796042b2838e714a4565b7be"><enum>(4)</enum><text>in subsection (g)(1), by striking <quote>2019 through 2028</quote> and inserting <quote>2024 through 2033</quote>.</text></paragraph></section><section id="id9234b8d05e5545d0a6ccf2e54c697c0b"><enum>207.</enum><header>Medical countermeasures for viral threats with pandemic potential</header><text display-inline="no-display-inline">Section 319L of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7e">42 U.S.C. 247d–7e</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id184b36a67e854775ae42bd7e31a09c69"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (c)(4)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id0addf6383aa3421ea840f4ed6fb9e762"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (D), by amending clause (iii) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idec54e6d5a6a74ffe84fe1debd6f04f09"><clause id="id118aa0b0ec1849feabd790bfeaa8082c"><enum>(iii)</enum><text>conduct research to promote strategic initiatives, such as— </text><subclause commented="no" display-inline="no-display-inline" id="idb1296ca2dcec4188ac85193aea3039f0"><enum>(I)</enum><text display-inline="yes-display-inline">rapid diagnostics; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id2c645d59084a4b6cb7c390517c063ea3"><enum>(II)</enum><text display-inline="yes-display-inline">broad spectrum antimicrobials; </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id8800c4ef57a240c788de9f57c79aadf7"><enum>(III)</enum><text display-inline="yes-display-inline">medical countermeasures for virus families that have significant potential to cause a pandemic, including such countermeasures that take either pathogen-specific or broad spectrum approaches; and </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id1d384be1ac83433fa91385482521693c"><enum>(IV)</enum><text display-inline="yes-display-inline">technologies to improve the production and use of medical countermeasures, which may include vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures.</text></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="id74d6f179de0641daa63c4ab3a2f66644"><enum>(B)</enum><text>in subparagraph (F), by amending clause (ii) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id67F90375557D453E8A459BA22398E91C"><clause commented="no" display-inline="no-display-inline" id="id8c1804d54e544cf0b6bb1dac5f4d18a9"><enum>(ii)</enum><text>threats that—</text><subclause id="id680c43bb637f4584bc2b7f0917fea70f"><enum>(I)</enum><item commented="no" display-inline="yes-display-inline" id="id0620424332f64e6cb5fa43ec221a6c32"><enum>(aa)</enum><text>consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza; or</text></item><item commented="no" display-inline="no-display-inline" id="id3fdeb41ad36a4e4aa523259075e07068" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">include priority virus families and other viral pathogens with a significant potential to cause a pandemic; and</text></item></subclause><subclause id="idab4cbbb654494ffdbf3be36426bf89b4"><enum>(II)</enum><text>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);</text></subclause></clause><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5e789db8087944669ce1f50e448ea36f"><enum>(2)</enum><text>in subsection (d)(2), by striking <quote>$611,700,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$950,000,000 for each of fiscal years 2024 through 2028</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idbbfee1bd4da24b90a1c7ae5b120cffce"><enum>(3)</enum><text>in subsection (e)(1), by amending subparagraph (D) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id434EDF7D7C0D491186373B2374F0BF7D"><subparagraph id="id49db20bb31514f639f416a9105f2cdc5"><enum>(D)</enum><header>Sunset</header><text>This paragraph shall cease to have force or effect after September 30, 2028.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="idf91b7465f6204ed8ac7a31609ebe0685"><enum>208.</enum><header>Public Health Emergency Medical Countermeasures Enterprise</header><text display-inline="no-display-inline">Section 2811–1(c) of the Public Health Service Act (42 U.S.C. 300hh–10a(c)) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id5b9f27d1e71c48b6bef486c98f65a508"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ide9b4ea6c4e4541edbe11ad87202c6e39"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (D) as subparagraph (E); and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcfddc1d6066442559bf939fdbeddf933"><enum>(B)</enum><text>by inserting after subparagraph (C) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id923B259612F04A7888CFD34C40861BE0"><subparagraph id="id37dc38f4d963431d99db1224793dc000"><enum>(D)</enum><text>Assist the Secretary in developing strategies for appropriate and evidence-based allocation and distribution of countermeasures to jurisdictions, in a manner that supports the availability and use of such countermeasures, for public health and medical preparedness and response needs.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6df010474c7b49d4894763efcda4b0e4"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>, as appropriate</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida8f20d1de3204afba22cfcc6f286a9e3"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id3E3C6DDC1DC44BF6BEEE51955BA1863F"><paragraph id="id86F92246398744A1826AD1A8681523F0"><enum>(3)</enum><header>Information sharing</header><text>The Secretary shall, as appropriate and in a manner that does not compromise national security, share information related to recommendations made and strategies developed under subparagraphs (A) and (C) of paragraph (1) with relevant stakeholders, including industry and State, local, and Tribal public health departments.</text></paragraph><after-quoted-block>. </after-quoted-block></quoted-block></paragraph></section><section id="id75b749af990a4839b42d9ad99ed72e7c"><enum>209.</enum><header>Strengthening public health communication</header><subsection id="id47b65a1bd8d0497b9a51d1af2ff83a15"><enum>(a)</enum><header>Public health communications advisory committee</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall establish an advisory committee to be known as the Public Health Communications Advisory Committee (referred to in this subsection as the <quote>Advisory Committee</quote>).</text></subsection><subsection id="id41248f556c1845acb364e91ccc0d4581"><enum>(b)</enum><header>Duties</header><text>The Advisory Committee shall make recommendations to the Secretary and report on—</text><paragraph id="id3a428634966a427a8f652c24fc355c62"><enum>(1)</enum><text>critical aspects of communication and dissemination of scientific and evidence-based public health information during public health emergencies;</text></paragraph><paragraph id="idd8d96366d0c64e2db995b36b56fa9bbe"><enum>(2)</enum><text>research from relevant external stakeholders related to evidence-based or evidence-informed strategies and best practices to effectively communicate and disseminate such information; and</text></paragraph><paragraph id="id9a7754c6d4cf4f91b58d688b75fcbce9"><enum>(3)</enum><text>strategies to improve communication and dissemination of scientific and evidence-based public health information to the public and to improve communication between Federal, State, local, and Tribal health officials.</text></paragraph></subsection><subsection id="ideb1efc793b2f471abdec01ff2be86c51"><enum>(c)</enum><header>Composition</header><text>The Advisory Committee shall be composed of—</text><paragraph id="idff62bbc3e0f84fe89b760715f1711db5"><enum>(1)</enum><text>appropriate Federal officials, appointed by the Secretary, who shall serve as nonvoting members; and</text></paragraph><paragraph id="ideac2942fa4434fc59b739e9bf99bbeb7"><enum>(2)</enum><text>individuals, appointed by the Secretary, representing a variety of States and rural and urban areas, and each of whom that has—</text><subparagraph id="ide0287aeb5c0e47c8a4abf73b553f3344"><enum>(A)</enum><text>expertise in public health, including individuals with experience in State, local, and Tribal health departments, medicine, communications, related technology, psychology, mental health and substance use disorders, national security;</text></subparagraph><subparagraph id="idda5a62d6877d4da29c20a4dd2ec076c8"><enum>(B)</enum><text>experience in leading community outreach; or</text></subparagraph><subparagraph id="id86ddf72c1d694f4f9baee8cf872fc558"><enum>(C)</enum><text>expertise in other areas, as the Secretary determines appropriate.</text></subparagraph></paragraph></subsection><subsection id="id06f37c240b124c62b8a636e9d0bb08a9"><enum>(d)</enum><header>Dissemination</header><text>The Secretary shall review the recommendations of the Advisory Committee and, not later than 180 days after receipt of the report under subsection (b), 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 describing any actions planned by the Secretary related to this section.</text></subsection><subsection id="idaff093fea2f144ce9383142587d90892"><enum>(e)</enum><header>Termination</header><text>The Advisory Committee shall terminate 2 years after the date of enactment of this Act.</text></subsection></section><section id="id3dc649f3fda542f1b0aad63d48b19e68"><enum>210.</enum><header>Fellowship and training programs</header><text display-inline="no-display-inline">Section 317G of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-8">42 U.S.C. 247b–8</external-xref>) is amended—</text><paragraph id="idb1216f2207e340748d47557176404309"><enum>(1)</enum><text>by striking <quote>The Secretary,</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id40cc46b1339440b9a3508623d7f71c46"><subsection id="id9f4008b1540c4562acd7309ce944d59e"><enum>(a)</enum><header>In general</header><text>The Secretary,</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="id0d82d8dd56b840cc9419ad376785e938"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id0958a4c62f384462a45a48748e66f475"><subsection id="id8b13b61c74114695805d5a854c58b8f2"><enum>(b)</enum><header>Noncompetitive conversion</header><paragraph id="id104313f1a9cd4590a277468eeb32053b"><enum>(1)</enum><header>In general</header><text>The Secretary may noncompetitively convert an individual who has completed an epidemiology, surveillance, or laboratory fellowship or training program under subsection (a) to a career-conditional appointment without regard to the provisions of subchapter I of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/33">chapter 33</external-xref> of title 5, United States Code, provided that individual meets qualification requirements for the appointment.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="id8141EA22CF6943D6A9016CF9B699C06C"><enum>211.</enum><header>Assessment of COVID–19 mitigation policies</header><subsection id="ide9ade1b41f39441badbae3aa259b6ce7"><enum>(a)</enum><header>GAO study</header><text>The Comptroller General of the United States shall conduct a study on the economic impact and health outcomes associated with the response to the COVID–19 pandemic in the United States. Such study shall include—</text><paragraph id="id77b4631b1f28478996b5233cd6d57b08"><enum>(1)</enum><text>a summary of strategies used by local governmental entities, States, and the Federal Government to contain and mitigate the spread of COVID–19 during the public health emergency declared under 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>) on January 31, 2020, including—</text><subparagraph id="id46b1583da68849d887cfb9b768646fdc"><enum>(A)</enum><text>limitations on large gatherings of people;</text></subparagraph><subparagraph id="id0d9af95747d14f0d83846760ecbd7926"><enum>(B)</enum><text>the closure of schools, businesses, houses of worship, and other facilities;</text></subparagraph><subparagraph id="id885064025c004addb2ded1878e1c1e1a"><enum>(C)</enum><text>masking policies;</text></subparagraph><subparagraph id="id76a5021ba9ba4bc6a53bbd3103e70f32"><enum>(D)</enum><text>testing policies; and</text></subparagraph><subparagraph id="idb6ddaf66b6c14cb49692bee896ffed13"><enum>(E)</enum><text>vaccination policies; </text></subparagraph></paragraph><paragraph id="ide65d48eb8a644d778bc9bd9da3fbaf36"><enum>(2)</enum><text>an analysis and review of the scientific evidence related to the effectiveness of such strategies in preventing or mitigating the spread of COVID–19, including estimates of the burden of disease and death that were avoided through such interventions;</text></paragraph><paragraph id="id0156d33d994f47588238d206e3154d85"><enum>(3)</enum><text>an analysis and review of the economic and health impacts of such strategies, including impacts related to mental and physical health and student learning loss; and</text></paragraph><paragraph id="id08f92b5c2d054a879ffb3d91d97127b2"><enum>(4)</enum><text>an accounting of Federal funding used to implement such strategies.</text></paragraph></subsection><subsection id="id26daeb992cc4420db3940d83aa11f694"><enum>(b)</enum><header>Report</header><text>Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit a report on the study under subsection (a) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. Such report shall include recommendations based on the findings of the study conducted under subsection (a) regarding the impact of such strategies during the COVID–19 public health emergency, including how to improve future responses.</text></subsection></section><enum>III</enum><header>Addressing the needs of all individuals</header><section id="idF125D2ADC7B84BA6847B3C0D1B14EA1D"><enum>301.</enum><header>Transition of certain countermeasures between compensation programs</header><subsection id="idC84D67AFF95647D5A03B674CDEA45A5F"><enum>(a)</enum><header>Treatment of certain ineligible requests related to COVID–19 countermeasures</header><paragraph commented="no" display-inline="no-display-inline" id="id0DE96577AB564643A5FB461F5611BE31"><enum>(1)</enum><header>Requests initially submitted under CICP</header><subparagraph commented="no" display-inline="no-display-inline" id="idd5a3b0bb3c9641998fbf6cbaeeaaf1dd"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of a request for compensation submitted under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) for an injury or death related to a COVID–19 vaccine that the Secretary determines to be ineligible pursuant to subparagraph (B) of such section 319F–4(b)(4), as added by subsection (b)(1), the Secretary shall, not later than 30 days after such determination, notify the individual submitting the request of such determination. </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id42AD5F5755104D87A5265FB545D398AF"><enum>(B)</enum><header>Submission of petition</header><text display-inline="yes-display-inline">An individual who receives a notification described in subparagraph (A) shall be eligible to submit a petition to the United States Court of Federal Claims under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) with respect to the same vaccine administration claimed in the request submitted under section 319F–4 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>), provided that such petition is submitted not later than the later of—</text><clause commented="no" display-inline="no-display-inline" id="id49488AA1D3A740129907D808F4154704"><enum>(i)</enum><text display-inline="yes-display-inline">1 year after receiving such notification under subparagraph (A); or </text></clause><clause commented="no" display-inline="no-display-inline" id="idBD713D93AEC34280A47A053139B96D13"><enum>(ii)</enum><text display-inline="yes-display-inline">the last date on which the individual otherwise would be eligible to submit a petition relating to such injury, as specified in section 2116 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-16">42 U.S.C. 300aa–16</external-xref>).</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8053acded3c84bd9861131722f610805"><enum>(C)</enum><header>Eligibility</header><text>To be eligible to submit a petition in accordance with subparagraph (B), the petitioner shall have submitted the request for compensation under section 319F–4 of the Public Health Service Act that was determined to be ineligible not later than the deadline for filing a petition under section 2116 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-16">42 U.S.C. 300aa–16</external-xref>) that applies with respect to the administration of such vaccine. </text></subparagraph></paragraph><paragraph id="ide3ec3cda1fb745d2946fe063d5cd1cf1"><enum>(2)</enum><header>Requests initially submitted under VICP</header><subparagraph id="id9d59f8db3a7a4d92a66e3bbf83add32d"><enum>(A)</enum><header>In general</header><text>If a special master determines that—</text><clause commented="no" display-inline="no-display-inline" id="idae5b2ffe51dd4f168f145540b419587f"><enum>(i)</enum><text display-inline="yes-display-inline">a petition submitted under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) related to a COVID–19 vaccine is ineligible for the National Vaccine Injury Compensation Program under subtitle 2 of title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-10">42 U.S.C. 300aa–10 et seq.</external-xref>) because it relates to a vaccine administered at a time when the vaccine was not included in the Vaccine Injury Table under section 2114 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14</external-xref>); and</text></clause><clause commented="no" display-inline="no-display-inline" id="id3b4d90a6a11942b69f1f02c673acf69b"><enum>(ii)</enum><text display-inline="yes-display-inline">the vaccine was administered when it was a covered countermeasure subject to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)), </text></clause><continuation-text continuation-text-level="subparagraph">the special master shall, not later than 30 days after such determination, notify the petitioner of such determination.</continuation-text></subparagraph><subparagraph id="idf6b10aa8d800435e8cee40b293f9c561"><enum>(B)</enum><header>Submission of request</header><text display-inline="yes-display-inline">An individual who receives a notification described in subparagraph (A) shall be eligible to submit a request for compensation under section 319F–4(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) with respect to the same vaccine administration claimed in the petition submitted under section 2111 of such Act—</text><clause commented="no" display-inline="no-display-inline" id="id043fc6d0b1b0487d81124bdadc22cc8b"><enum>(i)</enum><text display-inline="yes-display-inline">not later than 1 year after receiving such notification; or</text></clause><clause commented="no" display-inline="no-display-inline" id="id9e355343e6784ffeb1206a48cb8d9e4b"><enum>(ii)</enum><text>in the case that the notification is issued after judicial review of the petition under subsection (e) or (f) of section 2112 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-12">42 U.S.C. 300aa–12</external-xref>), not later than 1 year after the decision of the United States Court of Federal Claim or the mandate is issued by the United States Court of Appeals for the Federal Circuit pursuant to such subsection (e) or (f).</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id764f7f3f468c42fba00d236f16232344"><enum>(C)</enum><header>Eligibility</header><text>To be eligible to submit a request for compensation in accordance with subparagraph (B), the individual submitting the request shall have submitted the petition under section 2111 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11</external-xref>) that was determined to be ineligible not later than one year after the date of administration of the vaccine. </text></subparagraph></paragraph></subsection><subsection id="idC9C53B3E3D72444BAF7A84556FB172A1"><enum>(b)</enum><header>Changes to certain programs</header><paragraph commented="no" display-inline="no-display-inline" id="id3e4a214d416d4501b061d7b4363438e7"><enum>(1)</enum><header>CICP</header><text display-inline="yes-display-inline">Section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) is amended—</text><subparagraph commented="no" display-inline="no-display-inline" id="id2e0184e12a6142d8b5073d12ea90c3fd"><enum>(A)</enum><text>in subsection (b)(4)—</text><clause id="idD209F1D715404232B7AA77488621BD77"><enum>(i)</enum><text>by striking <quote>Except as provided</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idF0207D2D0F0347069D03352D2DE512AA"><subparagraph id="idA4BFB16BB3DE464BAC8D4B239572750D"><enum>(A)</enum><header>In general</header><text>Except as provided</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="idA7E56F7F148C4DC288FD8B9C0109CCF6"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idCEC93769F4BD4FBF979A9A8B673F4B10"><subparagraph id="idDC5CC30034A94E728E92926FB141E5D6"><enum>(B)</enum><header>Exclusion of injuries caused by vaccines on the vaccine injury table</header><text>Notwithstanding any other provision of this section, no individual may be eligible for compensation under this section with respect to a vaccine that, at the time it was administered, was included in the Vaccine Injury Table under section 2114.</text></subparagraph><after-quoted-block>; and </after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="id98D23E4C63A14B2CBB05DD3CBB18D6C0"><enum>(B)</enum><text>in subsection (d)(3)—</text><clause id="idf8fabc8a2ab84b1b95a0ac80a5db7d73"><enum>(i)</enum><text>by striking <quote>This section</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id7c5fb0d4ca744a3b92c9ddd1b4c3f1cc"><subparagraph id="id998485ed49364682b5f0ff297b48325a"><enum>(A)</enum><header>In general</header><text>This section</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="id7b70ea0fa5ef4ddb95fc8a0ef1cdbebf"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id964c3de08ec944f290104f45dabc7904"><subparagraph id="id08a3a1e787e248cf98cbe7cf3cddc31c"><enum>(B)</enum><header>Exhaustion of remedies</header><text>A covered individual shall not be considered to have exhausted remedies as described in paragraph (1), nor be eligible to seek remedy under section 319F–3(d), unless such individual has provided to the Secretary all supporting documentation necessary to facilitate the determinations required under subsection (b)(4).</text></subparagraph><after-quoted-block>. </after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="idE1392C7B472B4EE098671A8C16D27975"><enum>(2)</enum><header>VICP</header><text>Title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-1">42 U.S.C. 300aa–1 et seq.</external-xref>) is amended—</text><subparagraph id="id0DC500EFA665456C87039607B633D689"><enum>(A)</enum><text>in section 2111(a)(2)(A) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11(a)(2)(A)</external-xref>), in the matter preceding clause (i), by inserting <quote>containing the information required under subsection (c)</quote> after <quote>unless a petition</quote>; </text></subparagraph><subparagraph id="id22818C1B90A4465E89B2788E81714746"><enum>(B)</enum><text>in section 2112(d) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-12">42 U.S.C. 300aa–12(d)</external-xref>)— </text><clause id="id0D6BDCC6CBE34A7AAA4D669E40915B01"><enum>(i)</enum><text>by adding at the end of paragraph (1) the following: <quote>Such designation shall not occur until the petitioner has filed all materials required under section 2111(c).</quote>; and </text></clause><clause id="id09388CB8BBEC4BDCB3EA1228C68BD08F"><enum>(ii)</enum><text>in paragraph (3)(A)(ii), by striking <quote>the petition was filed</quote> and inserting <quote>on which the chief special master makes the designation pursuant to paragraph (1)</quote>; </text></clause></subparagraph><subparagraph id="iddabbe498b5a942a89c213643c4db290a" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">in section 2114(e) (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14(e)</external-xref>)—</text><clause id="id052875a826fb48d79336a090680f1b01" commented="no"><enum>(i)</enum><text>in paragraph (2), in the matter preceding subparagraph (A), by striking <quote>2 years</quote> and inserting <quote>6 months</quote>; and</text></clause><clause id="idd67334137ce94403ab256fa0aef5dc73" commented="no"><enum>(ii)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idCF9C11EC5C984FA98F42336A6D54ECE7"><paragraph id="id6E2E2C192EC9476FB635B8B216F3D5FF" commented="no"><enum>(4)</enum><header>Licensure requirement</header><text>Notwithstanding paragraphs (2) and (3), the Secretary may not revise the Vaccine Injury Table to include a vaccine for which the Centers for Disease Control and Prevention has issued a recommendation for routine use in children or pregnant women until at least one application for such vaccine has been approved under section 351. Upon such revision of the Vaccine Injury Table, all vaccines to prevent the same infectious disease, including vaccines authorized under emergency use pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, shall be considered included in the Vaccine Injury Table.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="idD5B54996840640019E27B6B210A1D5C1" commented="no"><enum>(D)</enum><text>in section 2116 (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-16">42 U.S.C. 300aa–16</external-xref>), by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id23f8b794148a4e22b6c805040d66e961"><subsection id="id2f74de3eee78455c9bbdba54e1032f61" commented="no"><enum>(d)</enum><header>Clarification</header><text>Notwithstanding subsections (a) and (b), an injury or death related to a vaccine administered at a time when the vaccine was a covered countermeasure subject to a declaration under section 319F–3(b) shall not be eligible for compensation under the Program.</text></subsection><after-quoted-block>. </after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section><section id="idCC433919817641229087A890CA71972D"><enum>302.</enum><header>Accelerating injury compensation program administration and ensuring program integrity</header><subsection id="id872544b01c42474aa7b34ec8a1624f34" commented="no"><enum>(a)</enum><header>In general</header><text>Section 2112(c) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa12">42 U.S.C. 300aa12(c)</external-xref>) is amended—</text><paragraph id="id7c5df2b56a4e49e3846e39d1062bc4ee" commented="no"><enum>(1)</enum><text>in paragraph (1), by striking <quote>not more than 8 special masters</quote> and inserting <quote>not fewer than 10 special masters</quote>; and</text></paragraph><paragraph id="id575278d17468467a9502d63263d217cf" commented="no"><enum>(2)</enum><text>in paragraph (4)—</text><subparagraph id="id4a19e21534dc41cd9056bb9e16f92cdb" commented="no"><enum>(A)</enum><text>by striking <quote>a term of 4 years</quote> and inserting <quote>an initial term of 4 years</quote>;</text></subparagraph><subparagraph id="id18b23dd18c594d6584ea4d8c8a8d5b32" commented="no"><enum>(B)</enum><text>by striking the second and third sentences; and</text></subparagraph><subparagraph id="id4cff0f72e78c47868388ff9f98efccea" commented="no"><enum>(C)</enum><text>by adding at the end the following: <quote>An individual appointed as special master may be reappointed to serve one or more additional terms of up to 8 years each, pursuant to paragraph (1), and subject to termination under paragraphs (2) and (3).</quote>.</text></subparagraph></paragraph></subsection><subsection id="idD61859CEC964493E8CB203B3090EBA37"><enum>(b)</enum><header>Petitions for compensation</header><text>Section 2111(a)(2)(A)(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-11">42 U.S.C. 300aa–11(a)(2)(A)(i)</external-xref>) is amended—</text><paragraph id="idE06DAD4C87084C188ED74BE8F9DBA9AE"><enum>(1)</enum><text>in subclause (I), by striking <quote>, and</quote> and inserting a semicolon;</text></paragraph><paragraph id="id65B1C348528840AC9EE58D599560C50C"><enum>(2)</enum><text>in subclause (II)—</text><subparagraph id="id751555F7D27F466C96C5400F5154AA5F"><enum>(A)</enum><text>by moving the margin 2 ems to the right; and</text></subparagraph><subparagraph id="idD03F82A21B584BA08527D35AB600DBDF"><enum>(B)</enum><text>by striking <quote>, or</quote> and inserting <quote>; and</quote>; and</text></subparagraph></paragraph><paragraph id="idC2B8320CBFE840E798F686456A2F5502"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id38BEEDB873064303BE0E27B1CBFEE250"><subclause id="id72A4307D2BD6494296105AF95C82B4A9" indent="up2"><enum>(III)</enum><text>the judgment described in subclause (I) does not result from a petitioner's motion to dismiss the case; or</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id3531920B5FB74A0CB1ADF6CE10822D0E"><enum>(c)</enum><header>Compensation</header><text>Section 2115(e)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-15">42 U.S.C. 300aa–15(e)(1)</external-xref>) is amended by adding at the end the following: <quote>When making a determination of good faith under this paragraph, the special master or court may consider whether the petitioner demonstrated an intention to obtain compensation on such petition and was not merely seeking to satisfy the exhaustion requirement under section 2121(b).</quote>. </text></subsection></section><section id="id2e7c7bb210b54dc195bdf07a08cda690"><enum>303.</enum><header>Compensation for injuries relating to the public health emergency caused by SARS–CoV–2</header><subsection id="id12bb0d6ca4b24631a715affc5b2d1b2c"><enum>(a)</enum><header>In general</header><text>With respect to claims filed under the Countermeasure Injury Compensation Program (referred to in this section as <quote>the Program</quote>) under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) alleging a covered injury caused by the administration or use of a covered countermeasure pursuant to a declaration under section 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) relating to COVID–19, the following shall apply:</text><paragraph id="idd7330c8bac8343bbae966aff0f688366"><enum>(1)</enum><text>Notwithstanding the filing deadline applicable under section 319F–4, the claim shall be filed within 3 years of the administration or use of the covered countermeasure, or one year after enactment of this section, whichever is later, and, if a claim filed under the Program with respect to such administration or use was filed before the date of enactment of this Act and denied on the basis of having not been filed within the time period required under subsection (b)(4) of such section 319F–4, such claim may be refiled pursuant to this paragraph.</text></paragraph><paragraph id="idc143b83a1c3f430882210bf3942a4681"><enum>(2)</enum><text>With respect to a claim relating to the administration of a COVID–19 vaccine, such a claim may be filed under the Program only if the administration of such vaccine occurred prior to the addition of the vaccine to the Vaccine Injury Table under section 2114 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-14">42 U.S.C. 300aa–14</external-xref>).</text></paragraph><paragraph id="id6e61be495ea54c139c4b5b8361d790a0"><enum>(3)</enum><text>Not later than 9 months after the date of enactment of this section, the Secretary of Health and Human Services shall promulgate a covered countermeasure injury table pursuant to subsection (b)(5) of section 319F–4 of the Public Health Service Act (42 U.S.C. 247d–6e(b)(5)).</text></paragraph></subsection><subsection id="idfcb9767ecba44a9cba852a49af6040a0"><enum>(b)</enum><header>Professional judgment budget</header><paragraph commented="no" display-inline="no-display-inline" id="id4467c3e6f78e4cfc8a64157e24b05777"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services—</text><subparagraph commented="no" display-inline="no-display-inline" id="idef0694d94a0d47a18c286f206cdd5b09"><enum>(A)</enum><text display-inline="yes-display-inline">in consultation with the Attorney General, shall submit a budget outlining the resource needs for each agency for purposes of carrying out the National Vaccine Injury Compensation Program under subtitle 2 of title XXI of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-10">42 U.S.C. 300aa–10 et seq.</external-xref>) for fiscal years 2024 through 2028; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id74a06b16c810421784534713f6e8ea47"><enum>(B)</enum><text display-inline="yes-display-inline">shall submit a budget outlining resource needs for purposes of carrying out the Countermeasures Injury Compensation Program under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) for fiscal years 2024 through 2028. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf7599342797747babf53ee0f19271b04"><enum>(2)</enum><header>Inclusions</header><text display-inline="yes-display-inline">The budgets described in subparagraphs (A) and (B) of paragraph (1) shall include estimates of both the resources necessary to process current backlogs and each program’s ability to reduce processing times with respect to such professional judgments.</text></paragraph></subsection><subsection id="id6efeb3e00751479a8ae6d6bee6070736"><enum>(c)</enum><header>NASEM report</header><text>The Secretary of Health and Human Services shall seek to enter into a contract with the National Academies of Sciences, Engineering, and Medicine under which such National Academies shall report, not later than 3 years after the date of enactment of this Act, on the Countermeasure Injury Compensation Program under section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>), including recommendations to improve the administration of such program and whether Congress should adjust the compensation payments available under such program. </text></subsection></section><section id="id6E87653066AE4234959E948FA17DDEF0"><enum>304.</enum><header>Review of regulations</header><text display-inline="no-display-inline">The Secretary of Health and Human Services shall update regulations, as needed for purposes of carrying out the amendments made by sections 301 and 302.</text></section><section id="iddd8de51561a944a69a5f2276f152cb5e" commented="no"><enum>305.</enum><header>Supporting individuals with disabilities, older adults, and other at-risk individuals during emergency responses</header><subsection commented="no" display-inline="no-display-inline" id="id669cfb20f2aa4ac7807829116ef2e4e4"><enum>(a)</enum><header display-inline="yes-display-inline">Technical assistance centers on at-Risk individuals and disasters</header><paragraph id="id7e969a7578aa4c6f8ffe2552c3572cc0"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) may, through grants, contracts, or cooperative agreements to eligible entities, establish more than one research, training, and technical assistance centers to provide appropriate information, training, and technical assistance to States, localities, Tribes, and other applicable entities related to addressing the unique needs and considerations of at-risk individuals, as defined in section 2802(b)(4) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1(b)(4)</external-xref>), in the event of a public health emergency declared by the Secretary pursuant to 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>).</text></paragraph><paragraph id="idab755ac257924d40b28b161c193a0eb1"><enum>(2)</enum><header>Responsibilities of the centers</header><text>The centers established under paragraph (1) shall conduct activities for the purpose of—</text><subparagraph id="idd7b7fed676a144b7a21580a6e8ae86d1"><enum>(A)</enum><text>developing, identifying, evaluating, and disseminating evidence-based or evidence-informed strategies to improve health and other related outcomes for at-risk individuals related to public health emergencies, including by addressing such unique needs and considerations in carrying out public health and medical activities to prepare for, respond to, and recover from, such public health emergencies; and</text></subparagraph><subparagraph id="ida3da6a1588ea4e709eda51f2e49f1e62"><enum>(B)</enum><text>assisting applicable entities in the implementation of such evidence-based strategies, including through sub-grants, contracts, or cooperative agreements.</text></subparagraph></paragraph><paragraph id="iddab32ee35e2e4db9a21e2ee9989176f3"><enum>(3)</enum><header>Priority</header><text>In awarding grants for activities described in this subsection, the Secretary shall give priority to eligible entities with demonstrated expertise in, and ability to carry out, the activities described in paragraph (2).</text></paragraph><paragraph id="id71f27f509e2943f79321801e27c46fed"><enum>(4)</enum><header>Consultation</header><text>In carrying out activities under paragraph (2), the centers established under paragraph (1) shall take into consideration relevant findings and recommendations of, and, as appropriate, consult with, the National Advisory Committee on Individuals with Disabilities and Disasters established under section 2811C of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10d">42 U.S.C. 300hh–10d</external-xref>), the National Advisory Committee on Children and Disasters under section 2811A of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10b">42 U.S.C. 300hh–10b</external-xref>), and the National Advisory Committee on Seniors and Disasters under section 2811B of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10c">42 U.S.C. 300hh–10c</external-xref>).</text></paragraph><paragraph id="id26a6487ae5f94af88d64b6571378b3f5"><enum>(5)</enum><header>Reports</header><text>Not later than 2 years after the date of enactment of this Act and every 2 years thereafter, the Secretary 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 describing the activities carried out under this subsection during the preceding 2 fiscal years.</text></paragraph><paragraph id="ide3a0e78646314f8397fc363f3ef7085c"><enum>(6)</enum><header>Sunset</header><text>This subsection shall cease to have force or effort on September 30, 2028. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id02362907303e46e69bd067ebcec55441"><enum>(b)</enum><header>Crisis standards of care</header><text>Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Director of the Office for Civil Rights of the Department of Health and Human Services, shall issue guidance to States and localities on the development or modification of State and local crisis standards of care for use during the response to a public health emergency declared by the governor of a State or by the Secretary under 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>), or a major disaster or emergency declared by the President under section 401 or 501, respectively, of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/42/5170">42 U.S.C. 5170</external-xref>, 5191) to ensure that such standards of care are consistent with the nondiscrimination requirements of section 504 of the Rehabilitation Act of 1973 (<external-xref legal-doc="usc" parsable-cite="usc/29/794">29 U.S.C. 794</external-xref>), title II of the Americans with Disabilities Act of 1990 (<external-xref legal-doc="usc" parsable-cite="usc/42/12131">42 U.S.C. 12131 et seq.</external-xref>), and the Age Discrimination Act of 1975 (<external-xref legal-doc="usc" parsable-cite="usc/42/6101">42 U.S.C. 6101 et seq.</external-xref>). </text></subsection></section><section id="id58b5335429b2406a8087484c3edb9f4a"><enum>306.</enum><header>National advisory committees</header><subsection commented="no" display-inline="no-display-inline" id="id15c6111350d14f7993e5738abce9b099"><enum>(a)</enum><header>National advisory committee on children and disasters</header><text>Section 2811A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10b">42 U.S.C. 300hh–10b</external-xref>) is amended—</text><paragraph id="id16b4b64a44e641d9be2d952f2b185785"><enum>(1)</enum><text>in subsection (c)—</text><subparagraph commented="no" display-inline="no-display-inline" id="idef42ee6c4a75463eb1d1970ab48495b1"><enum>(A)</enum><text>by striking <quote>may provide advice</quote> and inserting the following: “may provide—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id6D39E277B4D74DADBA86A88B99D3BEF4"><paragraph commented="no" display-inline="no-display-inline" id="id2ffd86f30be7473390e5c28eaa2bde9f"><enum>(1)</enum><text>advice</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id98fa5c2e96184033a1d1159964f2e00a"><enum>(B)</enum><text>by striking the period and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0e5c882230b044cb90951528b28ef859"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idCCF1634A525541F2ACA23D6483535374"><paragraph id="id7e0baf5cd0014def819c97ff17fb4c54"><enum>(2)</enum><text>recommendations to the Director of the Office of Pandemic Preparedness and Response Policy and to Congress with respect to the public health and emergency preparedness needs of children.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id726c6bd60578486b99cf8c00451bb227"><enum>(2)</enum><text>in subsection (g), by striking <quote>2023</quote> and inserting <quote>2028</quote>.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3ae82cb1ff204ec98a41c2c34b02412d"><enum>(b)</enum><header>National advisory committee on seniors and disasters</header><text>Section 2811B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10c">42 U.S.C. 300hh–10c</external-xref>) is amended—</text><paragraph id="id765A07E37E22486A9CE9BF10290C808C"><enum>(1)</enum><text>in subsection (c)—</text><subparagraph commented="no" display-inline="no-display-inline" id="id8CBD2AD756F148AAB296933120D1A6AD"><enum>(A)</enum><text>by striking <quote>may provide advice</quote> and inserting the following: “may provide—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id140971FA1E9941288CC2193F23BA1112"><paragraph commented="no" display-inline="no-display-inline" id="id7F1A58B0225A4DE69B5AB45ACE4144C8"><enum>(1)</enum><text>advice</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2462871EE7224FE6A218A82596FC4986"><enum>(B)</enum><text>by striking the period and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA79ECECA3F704F318BE74D70C945FF74"><enum>(C)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id2D419D29E8774648B70BD13553EF3FB1"><paragraph id="id230B45EB8BC34EC7B366764C946C63DF"><enum>(2)</enum><text>recommendations to the Director of the Office of Pandemic Preparedness and Response Policy and to Congress with respect to the public health and emergency preparedness needs of seniors.</text></paragraph><after-quoted-block>; </after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5465d66128e542df929862f96693724f"><enum>(2)</enum><text>in subsection (d)—</text><subparagraph commented="no" display-inline="no-display-inline" id="idbfe3c16950db46d4ba97c39286fe8334"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>17 members</quote> and inserting <quote>25 members</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2e6c493471f241b799e6bfe7a047c2bd"><enum>(B)</enum><text>in paragraph (2)—</text><clause commented="no" display-inline="no-display-inline" id="idfdc1f25738d5499fa1ebb2705b70cb5d"><enum>(i)</enum><text>in subparagraph (J), by striking <quote>2</quote> and inserting <quote>3</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="id37ab60c135d141408586f0560e2a567e"><enum>(ii)</enum><text>in subparagraph (K), by striking <quote>2</quote> and inserting <quote>3</quote>;</text></clause><clause commented="no" display-inline="no-display-inline" id="idcb75d316d0ed4f8fb8a0d666bf6c7825"><enum>(iii)</enum><text>by redesignating subparagraphs (K) through (L) as subparagraphs (L) through (M), respectively; and</text></clause><clause commented="no" display-inline="no-display-inline" id="idc0d81ef68add49b995df429d1722dca4"><enum>(iv)</enum><text>by inserting after subparagraph (J) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id68A0F7D3338F4ED1A77667D9019AC7D5"><subparagraph id="idc07440cc9fe04a77b27be1809b010e4b"><enum>(K)</enum><text>At least 2 non-Federal health care professionals with expertise in gerontology.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfb505d4beeb94fce941fb441e047ea43"><enum>(3)</enum><text>by amending subsection (g) to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idF88B8ACBBA694995A865BF5A8238D022"><subsection id="id2ec7ddb602f14fe7b11116148b4645f1"><enum>(g)</enum><header>Sunset</header><text>The Advisory Committee shall terminate on September 30, 2028.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id69e3018433b1439ab18fa9b1da2c284e"><enum>(c)</enum><header>National advisory committee on individuals with disabilities and disasters</header><text>Section 2811C of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-10d">42 U.S.C. 300hh–10d</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id25c93336fc154e4a9558c501d340ee1b"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subsections (c) through (g) as subsections (d) through (h), respectively;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idae38d2f38eee479bb3568025c343dc28"><enum>(2)</enum><text>by inserting after subsection (b) the following: </text><quoted-block style="OLC" display-inline="no-display-inline" id="idC74B25BDE2AB455FB7B031680B26B88B"><subsection id="idf12b1f0b86d44fd69d81913ad907f5bc"><enum>(c)</enum><header>Additional duties</header><text>The Advisory Committee may provide—</text><paragraph id="id63831e9f601b422385042b8474679f00"><enum>(1)</enum><text>advice and recommendations to the Secretary and to Congress with respect to individuals with disabilities and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this title and title III; and</text></paragraph><paragraph id="idab7897c7b63a42b2af617d1c54e04d09"><enum>(2)</enum><text>recommendations to the Director of the Office of Pandemic Preparedness and Response Policy and to Congress with respect to the public health and emergency preparedness needs of individuals with disabilities. </text></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id723d7b4d2456443a8c9b2aa1bdbc3be9"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (d), as so redesignated—</text><subparagraph commented="no" display-inline="no-display-inline" id="idfa84b00220b14d3fbe71c26a0da01a0e"><enum>(A)</enum><text>in paragraph (1), by striking <quote>17 members</quote> and inserting <quote>25 members</quote>; </text></subparagraph><subparagraph id="id793720c8229342be801246d6ff9f9724"><enum>(B)</enum><text>in paragraph (2)—</text><clause id="idd5bfc29076b6464498e6b48b6026ac1f"><enum>(i)</enum><text>by striking subparagraphs (K) through (M); and</text></clause><clause commented="no" display-inline="no-display-inline" id="ide603f442779c474db57b7986bd201875"><enum>(ii)</enum><text>by inserting after subparagraph (J) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idB5D3983D649D44E8A8DD1489789F505E"><subparagraph id="ida343ab38aa494b2a81a513350130a577"><enum>(K)</enum><text>15 non-Federal members (at least 4 of whom shall be individuals with disabilities) from diverse backgrounds, including the following:</text><clause commented="no" display-inline="no-display-inline" id="id4c27a2ed5033416b8ff9e6c267cf3e0b"><enum>(i)</enum><text display-inline="yes-display-inline">One representative from each of the following:</text><subclause commented="no" display-inline="no-display-inline" id="id9094d3153a224c179dcfc1828a89564f"><enum>(I)</enum><text display-inline="yes-display-inline">A nongovernmental organization that provides disaster preparedness and response services.</text></subclause><subclause commented="no" display-inline="no-display-inline" id="idea103be6fc8646f7a2a22e0e237ae02f"><enum>(II)</enum><text>A community-based organization that represents individuals with multiple types of disabilities. </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id16f5d2e477874d8297422f992e43b977"><enum>(III)</enum><text display-inline="yes-display-inline">A State-based organization that represents individuals with multiple types of disabilities.</text></subclause><subclause commented="no" display-inline="no-display-inline" id="idc9c1df9fdb284ad6a272f6667df4bcd2"><enum>(IV)</enum><text display-inline="yes-display-inline">A national organization that represents individuals with multiple types of disabilities.</text></subclause><subclause commented="no" display-inline="no-display-inline" id="idc47d9b3bb5724e2081b2306280626c79"><enum>(V)</enum><text display-inline="yes-display-inline">A national organization that represents older adults. </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id491caa825cdb4e10ab0cc606ae91ce05"><enum>(VI)</enum><text display-inline="yes-display-inline">An organization that provides relevant housing services, including during the response to, and recovery from, disasters. </text></subclause><subclause commented="no" display-inline="no-display-inline" id="id408677825a4d4048aeb54c8f5b69bcdc"><enum>(VII)</enum><text display-inline="yes-display-inline">An organization that represents disabled veterans.</text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id59119c88317448108630552bacd50f32"><enum>(ii)</enum><text display-inline="yes-display-inline">Four individuals with geographically diverse expertise in emergency management.</text></clause><clause commented="no" display-inline="no-display-inline" id="id3ae479c59fbe49d780ea40329a672194"><enum>(iii)</enum><text display-inline="yes-display-inline">Two non-Federal health care professionals with expertise in disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="id5ceac759cec440d0be09ede6215b6538"><enum>(C)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id27c8f0dc4c0849eca32b875c017f2601"><paragraph id="idfd8cbca0a2de4936b993129b6158b542"><enum>(3)</enum><header>Consideration</header><text>In appointing members, including the Chair, to the Committee under this subsection, the Secretary may give consideration to disability status.</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id647e2430d4fe4d1998d26ed838881208"><enum>(4)</enum><text>by amending subsection (h), as so redesignated, to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id94389050A3E84084AF488FBCC88429D2"><subsection id="ide398c60fb8c74d0ebbceef305a82b22c"><enum>(h)</enum><header>Sunset</header><text>The Advisory Committee shall terminate on September 30, 2028.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section id="id494D5DBE82464E15B0F1EAF5D96A147A"><enum>307.</enum><header>Research and coordination of activities concerning the long-term health effects of SARS–CoV–2 infection</header><subsection id="id6effebb1657449538a60bbc57eb74b82"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall, as appropriate—</text><paragraph id="id05cc5c3c1c2246308684aed1d9b2aa2a"><enum>(1)</enum><text>coordinate activities among relevant Federal departments and agencies with respect to addressing the long-term health effects of SARS–CoV–2 infection, which may include conditions that arise as a result of such infection;</text></paragraph><paragraph id="id75baa5139982458f9d0c7ed3ae29c722"><enum>(2)</enum><text>continue to conduct or support basic, clinical, epidemiological, behavioral, and translational research and public health surveillance related to the pathogenesis, prevention, diagnosis, and treatment of the long-term health effects of SARS–CoV–2 infection and re-infection, which may include conditions and any effects on development, cognition, and neural structure and function that arise as a result of such infection; and</text></paragraph><paragraph id="id39dc809a7c8d425f9f6bbaa3c061f9ea"><enum>(3)</enum><text>consistent with the findings of studies and research under paragraph (1), in consultation with health and public health professional associations, scientific and medical researchers, and other relevant experts, develop and inform recommendations, guidance, and educational materials on the long-term effects of SARS–CoV–2 infection, which may include conditions that arise as a result of such infection, and provide such recommendations, guidance, and educational materials to health care providers and the general public.</text></paragraph></subsection><subsection id="ida8d61ccd1f394fd9bfe65e067adef8a3"><enum>(b)</enum><header>Considerations</header><text>In conducting or supporting research under this section, the Secretary shall consider the diversity of research participants or cohorts to ensure inclusion of a broad range of participants, as applicable and appropriate.</text></subsection><subsection id="idc51849988daf4f8580da74112fc6f943"><enum>(c)</enum><header>Additional activities</header><text>The Secretary may—</text><paragraph id="id098379009e62466f973eeae0ba2699ca"><enum>(1)</enum><text>acting through the Director of the Agency for Healthcare Research and Quality, conduct or support research related to—</text><subparagraph id="idd890e30d23fb4abf8baac90193ed79ec"><enum>(A)</enum><text>the improvement of health care delivery for individuals experiencing long-term health effects of SARS–CoV–2, which may include conditions that arise as a result of such infection; </text></subparagraph><subparagraph id="idd1dc626887e54bed8f4f9e665b44f76b"><enum>(B)</enum><text>the identification of any trends associated with differences in diagnosis and treatment of the long-term health effects of SARS–CoV–2 infection and related conditions; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc5c7773517ea47b2b02c8f39a8e9b1e7"><enum>(C)</enum><text>the development or identification of tools and strategies to help health care entities and providers care for such populations, which may include addressing any differences identified pursuant to subparagraph (B); </text></subparagraph></paragraph><paragraph id="id77c9e554fc9e41bfbf99198de9baf551"><enum>(2)</enum><text>publicly disseminate the results of such research; and</text></paragraph><paragraph id="id7500a4c7b4b045eab63a9f0808c76b6f"><enum>(3)</enum><text>establish a primary care technical assistance initiative to convene primary care providers and organizations, which may include support for continuing training and education for such providers, as applicable and appropriate, in order to collect and disseminate best practices related to the care of individuals with long-term health effects of SARS–CoV–2 infection, which may include conditions that arise as a result of such infection.</text></paragraph></subsection><subsection id="id3ee7f8dce51f4a20a3b9e8c5ef9695be"><enum>(d)</enum><header>Annual reports</header><text>Not later than 1 year after the date of enactment of this Act, and annually thereafter for the next 4 years, the Secretary shall prepare and submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding an overview of the research conducted or supported under this section and any relevant findings. Such reports may include information about how the research and relevant findings under this section relate to other research efforts supported by other public or private entities.</text></subsection><subsection id="idd48ce62ab3014e4caf3b9e15631b1f74" commented="no" display-inline="no-display-inline"><enum>(e)</enum><header>Public availability of information</header><text>In making information or reports publicly available under this section, the Secretary shall take into consideration the delivery of such information in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.</text></subsection></section><section id="id4e73663e9aee4b9587a1c5500f48c7c7"><enum>308.</enum><header>National Academies study on prizes</header><subsection id="idc7b59d80583348f8b51f3774700db72e"><enum>(a)</enum><header>In general</header><text>Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the <quote>National Academies</quote>) to conduct a study to examine—</text><paragraph id="id94536e656f374ede85c4abdb9b8dc592"><enum>(1)</enum><text>alternative models for directly funding, or stimulating investment in, biomedical research and development that delink research and development costs from the prices of drugs, including the progressive replacement of patents and regulatory exclusivities on new drugs with a combination of expanded support for research and innovation prizes to reward the successful development of drugs or achievement of related milestones;</text></paragraph><paragraph id="iddac2b9c98a8640ffadd9c0f6816135ce"><enum>(2)</enum><text>the dollar amount of innovation prizes for different stages of research and development of different classes or types of drugs, and total annual funding, that would be necessary to stimulate investment sufficient to achieve such successful drug development and related milestones;</text></paragraph><paragraph id="ideb9d10c76055493aa5d8863963b07445"><enum>(3)</enum><text>the relative effectiveness and efficiency of such alternative models in stimulating innovation, compared to the status quo that includes patents and regulatory exclusivities;</text></paragraph><paragraph id="id62e09e5e02b04d0bafc3fb41a01530b7"><enum>(4)</enum><text>strategies to implement such alternative models described in paragraph (1), including a phased transition over time; and</text></paragraph><paragraph id="idd4ddfb4a306044c983dda15f8e96d0aa"><enum>(5)</enum><text>the anticipated economic and societal impacts of such alternative models, including an assessment of impact on—</text><subparagraph id="id3ec062f224dd4d628caf972d3d8965df"><enum>(A)</enum><text>the number and variety of new drugs that would be developed, approved, and marketed in the United States, including such new drugs intended to prevent, diagnose, or treat a rare disease or condition;</text></subparagraph><subparagraph id="id85c39230886245adbde06bb9fa29abe9"><enum>(B)</enum><text>the rate at which new drugs would be developed, approved, and marketed in the United States;</text></subparagraph><subparagraph id="id1c5c8beef88645668afe070d12cf3df8"><enum>(C)</enum><text>access to medication and health outcomes;</text></subparagraph><subparagraph id="idb2384b0003bc494582cd68423d796837"><enum>(D)</enum><text>average lifespan and disease burden in the United States;</text></subparagraph><subparagraph id="idc9ee5a1c0ae44785adecae9d200774d9"><enum>(E)</enum><text>the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time;</text></subparagraph><subparagraph id="idc276a864dc4448309857dc3ebc8bbd4d"><enum>(F)</enum><text>Federal discretionary and mandatory spending; and</text></subparagraph><subparagraph id="id8ca359fd2987441ca533fe858cb76d27"><enum>(G)</enum><text>public and private insurance markets.</text></subparagraph></paragraph></subsection><subsection id="id58f041a811d441f38d76b6536f4e8bc6"><enum>(b)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $3,000,000 for fiscal year 2024.</text></subsection><subsection id="id850729a4ac564c5f88a9152a73bc3743"><enum>(c)</enum><header>Requirements</header><text>In conducting the study pursuant to subsection (a), the National Academies shall hold not fewer than 2 public listening sessions to solicit feedback from interested parties, including representatives of academia, professional societies, patient advocates, public health organizations, relevant Federal departments and agencies, drug developers, representatives of other relevant industries, and subject matter experts.</text></subsection><subsection id="id0358dcc000de43b5b83dfcb931f32237"><enum>(d)</enum><header>Report</header><text>Not later than 2 years after the date of enactment of this Act, the National Academies shall submit 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 a report on the study conducted pursuant to subsection (a). </text></subsection></section><enum>IV</enum><header>Strengthening biosecurity</header><section id="id2fc644a1dc4a4345a2c01363ea7169d3"><enum>401.</enum><header>Treatment of genetic variants and synthetic products of select agents and toxins</header><text display-inline="no-display-inline">Section 351A(a)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262a">42 U.S.C. 262a(a)(1)</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idbb5f148ebd1a4d0d822ec2315df1fe8e"><subparagraph id="id0d9bcbd229ae46c6838ba79d74aa5958"><enum>(C)</enum><header>Inclusions</header><clause id="idf695ecc78b71498a91de02f6f046680e"><enum>(i)</enum><header>In general</header><text>For purposes of the list under this paragraph, the following shall be considered to be a biological agent or toxin included on the list:</text><subclause id="id19ad0e536d5f4660ad56c76bd0422981"><enum>(I)</enum><text>Any biological agent that incorporates nucleic acids coding for a virulence factor from a listed agent or toxin.</text></subclause><subclause id="idd46e402651814f7b8da94a7b9026e113"><enum>(II)</enum><text>Any biological agent or toxin that is genetically homologous to a listed agent or toxin with respect to nucleotides coding for virulence factors or toxicity.</text></subclause><subclause id="ide660078c1441468c963bc48ccafd6488"><enum>(III)</enum><text>Any biological agent or toxin that is synthetically derived with virulence or toxicity characteristics of a listed agent or toxin.</text></subclause><subclause id="id708ae40dcd9c4277b6606978c244411e"><enum>(IV)</enum><text>Any nucleic acid that encodes for components contributing to pathogenicity, transmissibility, or toxicity of a listed agent or toxin.</text></subclause></clause><clause id="ide18b80c3cf04466db15e67ebeb3e0cb1"><enum>(ii)</enum><header>Exemptions</header><text>The Secretary may exempt from inclusion on the list under this paragraph any biological agent, toxin, or nucleic acid described in clause (i), if such agent, toxin, or nucleic acid does not meet the criteria under subparagraph (B).</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="id7dcba6d0cc9445d0b7204c4c53552258"><enum>402.</enum><header>Establishment of no-fault reporting system</header><text display-inline="no-display-inline">Title III of the Public Health Service Act is amended by inserting after section 351A (<external-xref legal-doc="usc" parsable-cite="usc/42/262a">42 U.S.C. 262a</external-xref>) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id976E76DFDC8D4608B0243C89A2855B89"><section id="id423ee86348874bec8656c662e4c9b25f"><enum>351B.</enum><header>No-fault reporting system</header><subsection commented="no" display-inline="no-display-inline" id="id92C5B7A28D4645EAB8FFEAE1D0AD9960"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text>In this section:</text><paragraph commented="no" display-inline="no-display-inline" id="iddbcaf10077ab4d6c8dfa6b200eed3214"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>listed agents and toxins</term> has the meaning given the term in section 351A(l). </text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1558d46abd904d8fa57df854369a7f98"><enum>(2)</enum><text>The term <term>reporting system</term> means the reporting system established under subsection (b)(1).</text></paragraph></subsection><subsection id="ide2ecc6e26fb8446fab1694c6eee73bd5"><enum>(b)</enum><header>Establishment</header><paragraph id="iddf1206f3a4674ede889c08f7cab162cf"><enum>(1)</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 Response Act</short-title>, the Secretary shall establish a confidential, anonymous, voluntary, no-fault reporting system related to accidents, near-accidents, or other safety incidents involving biological agents and toxins, in order to support continuous improvement and sharing of lessons learned related to such incidents.</text></paragraph><paragraph id="id665e1964ae2246589ee10ea837cbd854"><enum>(2)</enum><header>Availability</header><text>The ability to submit reports on a voluntary basis to the reporting system shall be made available to individuals affiliated with laboratories located in the United States, or at federally-funded entities outside the United States, that conduct research involving biological agents and toxins.</text></paragraph><paragraph id="id3ea378c0824e494492d9761268bdfac7"><enum>(3)</enum><header>Data</header><text>Not later than 2 years after the date of enactment of the <short-title>Pandemic and All-Hazards Preparedness and Response Act</short-title>, the Secretary shall publish a notice in the Federal Register on plans for the reporting system, including—</text><subparagraph id="id7d559b12abc4422d9cd49d59e1575f0a"><enum>(A)</enum><text>data elements that will be included in the submission of reports;</text></subparagraph><subparagraph id="idb63438e4eb5f4de0a3a2e89fbb680ae6"><enum>(B)</enum><text>procedures and processes for the submission of reports;</text></subparagraph><subparagraph id="idac216ba497ec4bb6819c363db5a9b961"><enum>(C)</enum><text>criteria for incidents that may be reported to such system; and</text></subparagraph><subparagraph id="id7e73c8b2175b47f0bf2d5fea14e4e639"><enum>(D)</enum><text>procedures for privacy and anonymization.</text></subparagraph></paragraph><paragraph id="idf9bf55f51b77410ca206e70e63bd9016"><enum>(4)</enum><header>Prototyping and testing</header><text>The Secretary shall test and prototype the reporting system for not less than 1 year before finalizing the reporting system.</text></paragraph><paragraph id="idc8ebe56258564ff6a951d5656b8dc5b6"><enum>(5)</enum><header>External feedback</header><text>The Secretary shall seek feedback on development of the reporting system from external stakeholders, including prior to publication of the information under paragraph (3) and prior to introduction of prototypes and finalization of such system under paragraph (4).</text></paragraph></subsection><subsection id="idd6f517751d904a98a756b69418a87ea9"><enum>(c)</enum><header>FOIA</header><paragraph id="id21265611a00749dea6acdb12d8927f55"><enum>(1)</enum><header>In general</header><text>Information submitted to, or derived from, the reporting system shall be exempt from disclosure under section 552 of title 5, United States Code.</text></paragraph><paragraph id="id8608e7e396364bf8a35535f5ff46379d"><enum>(2)</enum><header>Applicability</header><text>For purposes of paragraph (1), this section shall be considered a statute described in section 552(b)(3)(B) of title 5, United States Code.</text></paragraph></subsection><subsection id="ideca19d8596e448439666cc8c8d883703"><enum>(d)</enum><header>Prohibition on use as evidence</header><text>Information submitted to, or derived from, the reporting system shall not be used in any Federal or State enforcement action or criminal prosecution.</text></subsection><subsection id="id2dc17fe8f1404354a0b240663e2c1c3b"><enum>(e)</enum><header>Privacy; disciplinary action for unauthorized disclosure</header><text>An individual or entity that submits information to the reporting system under subsection (b) shall not be required to provide their name.</text></subsection><subsection id="idb20d54da11074b16a17b738d1fa80af2"><enum>(f)</enum><header>Relationship to other reporting systems</header><text>The voluntary reporting system established under this section shall supplement, and not supplant, any other requirements to submit reports under any other reporting system.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section><section id="id7b64b38ec8d1450f91ed37a59bcf596c"><enum>403.</enum><header>Evaluation of the Federal Select Agent Program and related policies</header><subsection id="idc27c458d229f4e909c28175c8ee8496a"><enum>(a)</enum><header>In general</header><text>Not later than 4 years after the date of enactment of this Act, the National Science Advisory Board for Biosecurity (referred to in this section as the <quote>Board</quote>) established pursuant to section 404O of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/283r">42 U.S.C. 283r</external-xref>) shall be charged with assessing the framework for biosafety and biosecurity oversight, particularly with respect to mitigating risks to the United States population with respect to biological threats. The findings of the Board shall address scientific advancements and integration of the Program and other related Federal policies and frameworks for biosafety and biosecurity. The findings of the Board shall be transmitted to the President.</text></subsection><subsection id="id39ab6380604244ee987bc9bcb9e32e27"><enum>(b)</enum><header>Framework</header><paragraph id="id70006ca6b2fc4106a49fc66bf470337f"><enum>(1)</enum><header>In general</header><text>The recommendations developed under subsection (a) shall include a proposed framework for an integrated approach to the oversight of biological research that raises significant biosafety and biosecurity concerns, which may include proposals to harmonize and modernize relevant Federal policies such as the following: </text><subparagraph id="id2c9258bfaab847f7959b8439996f1f03"><enum>(A)</enum><text>The Federal Select Agent Program.</text></subparagraph><subparagraph id="id815ee11a07ab47dc91f758b19cde426e"><enum>(B)</enum><text>Federal policies relating to dual-use research of concern.</text></subparagraph><subparagraph id="id2a2d5197a07b42cea716bf144a7188b7"><enum>(C)</enum><text>Federal policies related to federally funded research involving enhanced pathogens of pandemic potential.</text></subparagraph><subparagraph id="idd59044bab0064794a53997ae0bbfeb4a"><enum>(D)</enum><text>The Biosafety in Microbiological and Biomedical Laboratories Manual of the Department of Health and Human Services, and other related guidance documents.</text></subparagraph><subparagraph id="idfd1b6174bac14f368929720309eac72e"><enum>(E)</enum><text>The Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules of the National Institutes of Health.</text></subparagraph></paragraph><paragraph id="idc694aafdb1d843289f95c24de68e7e9f"><enum>(2)</enum><header>Requirements for framework</header><text>The framework proposed under paragraph (1) shall—</text><subparagraph id="idca8277b5c9224c5abc55d6ac3b62b9d3"><enum>(A)</enum><text>be developed in consultation with stakeholders and experts from institutions of higher education, industry, and other government agencies; and</text></subparagraph><subparagraph id="id2c215f465d0649909c1e5690e9057ed6"><enum>(B)</enum><text>make recommendations related to mitigating any identified risks associated with existing gaps in oversight of such research, which may include research that does not receive Federal funding, taking into consideration any national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration.</text></subparagraph></paragraph></subsection><subsection id="id87a3c078d70b4d2d89756def1f1734a2"><enum>(c)</enum><header>Reorganization</header><text>In carrying out this section, the Board may make recommendations related to the clarification of the authorities and responsibilities of relevant Federal departments and agencies and any necessary reorganization of such authorities and responsibilities among such departments and agencies.</text></subsection><subsection id="idf2ba0ab19e844f59aabb8abcc8abd3c0"><enum>(d)</enum><header>Report</header><text>Not later than 1 year after the issuance of recommendations under subsection (a), the President 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, and, as applicable, other appropriate committees of Congress, a report that describes plans to consider and implement such recommendations, including the identification of—</text><paragraph id="id07e85ef7c8e24101a63d0f0362c2b9e1"><enum>(1)</enum><text>any barriers to implementation; and</text></paragraph><paragraph id="id4849878b10844e17a35df3f0f50e0a55"><enum>(2)</enum><text>any areas in which the President disagrees with the findings or recommendations of the Board.</text></paragraph></subsection></section><section id="id7fc90f3e987a4a96924265be2953d13c"><enum>404.</enum><header>Supporting research and laboratory surge capacity</header><subsection id="idd691286d8c214fc6a60fedd21718f3d4"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall make awards to establish or maintain, as applicable, not fewer than 12 regional biocontainment laboratories, for purposes of—</text><paragraph commented="no" display-inline="no-display-inline" id="idf555a337986e4abf8dbdf679579b6701"><enum>(1)</enum><text display-inline="yes-display-inline">conducting biomedical research to support public health and medical preparedness for, and rapid response to, biological agents, including emerging infectious diseases;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0a9f0ebb9d0f40d8813c82f435c71346"><enum>(2)</enum><text display-inline="yes-display-inline">ensuring the availability of surge capacity for purposes of responding to such biological agents;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id10bc9a1a345b4157a76f035947d450c3"><enum>(3)</enum><text display-inline="yes-display-inline">supporting information-sharing between, and the dissemination of findings to, researchers and other relevant individuals to facilitate collaboration between industry and academia; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id52d06192b9f2441a967795ef8300956a"><enum>(4)</enum><text display-inline="yes-display-inline">providing, as appropriate and applicable, technical assistance and training to researchers and other relevant individuals to support the biomedical research workforce in improving the management and mitigation of safety and security risks in the conduct of research involving such biological agents.</text></paragraph></subsection><subsection id="idc34a693b44da47e8b41a9660d5bd81f7"><enum>(b)</enum><header>Requirements</header><text display-inline="yes-display-inline">As a condition of receiving a grant under this section, a regional biocontainment laboratory shall agree—</text><paragraph commented="no" display-inline="no-display-inline" id="idf493191c92ba48b48d80bfca308126a8"><enum>(1)</enum><text display-inline="yes-display-inline">to such oversight activities as the Secretary determines appropriate, including periodic meetings with relevant officials of the Department of Health and Human Services, facility inspections, and other activities as necessary and appropriate to ensure compliance with the terms and conditions of such award; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idaa6bbd7e3cd7409aa0836b763e75cb44"><enum>(2)</enum><text>to report accidents, near-accidents, or other safety incidents involving biological agents and toxins into the no-fault reporting system established pursuant to section 351B of the Public Health Service Act, as added by section 402. </text></paragraph></subsection><subsection id="id4a481295abf6436bb93ad0e72e6bdca7"><enum>(c)</enum><header>Board</header><text>The Secretary shall establish a Board consisting of a representative from each entity in receipt of an award under subsection (a), which shall be headed by an executive committee of 3 members elected upon an affirmative vote from a majority of such representatives. The Board shall make recommendations to the Secretary in administering awards under this section, for purposes of—</text><paragraph id="id284092fb0f2e479589197856e1c28a8b"><enum>(1)</enum><text>improving the quality and consistency of applicable procedures and practices within laboratories funded pursuant to subsection (a); and</text></paragraph><paragraph id="id65ba19d0bdba4c1dac91868e75520282"><enum>(2)</enum><text>ensuring coordination, as appropriate, of federally funded activities carried out at such laboratories. </text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id95104c5887f54b93b9ef7ae59145749a"><enum>(d)</enum><header display-inline="yes-display-inline">Definition</header><text>In this section, the term <term>regional biocontainment laboratory</term> means a Biosafety or Animal Biosafety Level-3 and Level-2 facility located at an institution in the United States that is designated by the Secretary to carry out the activities described in subsection (a).</text></subsection><subsection commented="no" display-inline="no-display-inline" id="idd1e3d2ef758e454a9de72b9c8ec45215"><enum>(e)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there are authorized to be appropriated $52,000,000 for each of fiscal years 2024 through 2028. </text></subsection><subsection commented="no" display-inline="no-display-inline" id="ida93a6f949cbb42beb67cb8268fd99d2c"><enum>(f)</enum><header>Administrative expenses</header><text>Of the amount available to carry out this section for a fiscal year, the Secretary may use not more than 5 percent for the administrative expenses of carrying out this section, including expenses related to carrying out subsection (c).</text></subsection><subsection id="id9338286c99a2497f966cb45494615454"><enum>(g)</enum><header>Report to Congress</header><text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, and biannually thereafter, the Secretary, in consultation with the heads of applicable Federal departments and agencies shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—</text><paragraph id="idad50db30d01d4d0c89b60d5f4e8311fe"><enum>(1)</enum><text>the activities and accomplishments of the regional biocontainment laboratories;</text></paragraph><paragraph id="idfc677ce41f12473494d6668638145930"><enum>(2)</enum><text>any published or disseminated research findings based on research conducted in such laboratories in the applicable year;</text></paragraph><paragraph id="id8a01fb6abf7945dfbd931c909cac86f7"><enum>(3)</enum><text>oversight activities carried out by the Secretary pursuant to subsection (b);</text></paragraph><paragraph id="idc7356bdb303b4ed78aacc18fc9f1cfab"><enum>(4)</enum><text>activities undertaken by the Secretary to take into consideration the capacity and capabilities of the network of regional biocontainment laboratories in activities to prepare for and respond to biological agents, which may include leveraging such capacity and capabilities to support the Laboratory Response Network, as applicable and appropriate;</text></paragraph><paragraph id="id5c328e9b6caa4b01926622fbf678b2d5"><enum>(5)</enum><text>plans for the maintenance and sustainment of federally funded activities conducted at the regional biocontainment laboratories, consistent with the strategy required under section 2312 of the PREVENT Pandemics Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>); and</text></paragraph><paragraph id="id2d0d45c5f6bf48169342d6efdfbc3f98" commented="no" display-inline="no-display-inline"><enum>(6)</enum><text>activities undertaken by the Secretary to coordinate with applicable agencies to ensure work carried out by such facilities is prioritized and complementary to one another, and avoiding unnecessary duplication. </text></paragraph></subsection></section><section id="id49331ac25ad142a8825fa36eec397771"><enum>405.</enum><header>Gene synthesis</header><subsection id="idb3d614172c934d39a88a652a6752e161"><enum>(a)</enum><header>Guidance</header><text>Not later than 1 year 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>) shall update the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA to account for scientific and technological advancements with respect to mitigating risk of unauthorized individuals or individuals with malicious intent from using nucleic acid synthesis technologies to obtain biological agents or toxins of concern. Such guidance shall include recommendations related to—</text><paragraph id="id257aab09a22d41d782735956689500fa"><enum>(1)</enum><text>screening for sequences that the Secretary determines may contribute to toxicity, pathogenicity, or virulence;</text></paragraph><paragraph id="idcbe95f29f4a84388aea29a45833a76b9"><enum>(2)</enum><text>screening and verification of the identity and legitimacy of customers;</text></paragraph><paragraph id="id30839a2325d84a77ab69f218a9cffd7e"><enum>(3)</enum><text>the identification, evaluation, and use of appropriate software or other tools to enable the screening described in paragraphs (1) and (2);</text></paragraph><paragraph id="id2bdbd04ecd0e400ea51aae7f3de3ae58"><enum>(4)</enum><text>ensuring nucleic acid synthesis activities are carried out in compliance with existing regulations under part 73 of title 42, Code of Federal Regulations, part 331 of title 7, Code of Federal Regulations, part 121 of title 9, Code of Federal Regulations, and part 774 of title 15 Code of Federal Regulations (or successor regulations);</text></paragraph><paragraph id="id83a93af1328942a0be01ea531de64369"><enum>(5)</enum><text>implementing appropriate safeguards, which may include the use of such software or other tools, in gene synthesis equipment to facilitate screening of nucleic acid sequences and, as applicable, customers;</text></paragraph><paragraph id="ide169a80a568e4a9593ed4c9f92951874"><enum>(6)</enum><text>maintaining records of customer orders, metadata, and screening system or protocol performance in specified formats, which may include standardized machine-readable and interoperable data formats; and</text></paragraph><paragraph id="id6538d4323f1f43ad8f83312472df286f"><enum>(7)</enum><text>other recommendations as determined appropriate by the Secretary.</text></paragraph></subsection><subsection id="id44a12ecfed6940bb896ac34332457087"><enum>(b)</enum><header>Sequences of concern</header><text>The Secretary shall maintain a public docket to solicit recommendations on potential sequences of concern and, in consultation with other Federal departments and agencies and non-Federal experts, as appropriate, review and update, on a regular basis, a list of sequences of concern to facilitate screening under subsection (a)(1).</text></subsection><subsection id="id7952af8a1fa148eaab78873676cdae4a"><enum>(c)</enum><header>Landscape review</header><text>The Secretary, in coordination with other Federal departments and agencies, as appropriate, shall conduct a landscape review of providers and manufacturers of gene synthesis equipment, products, software, and other tools with the purpose of understanding the number, types, and capabilities of products and equipment that exist domestically and to inform the development of any updates to the guidance under subsection (a).</text></subsection><subsection id="idfaf1ada6252344fc947094e023ee67fa"><enum>(d)</enum><header>Technical assistance</header><text>The Secretary, in consultation with other Federal departments and agencies, shall provide technical assistance upon request of a gene synthesis provider, manufacturer of gene synthesis equipment, or developer of software or other screening tools to support implementation of the recommendations included in the guidance under subsection (a).</text></subsection><subsection id="iddb977c55b2fe45b48dfb0e811942934e"><enum>(e)</enum><header>Definitions</header><text>For purposes of this section:</text><paragraph id="id74eb669564bd4d40b3ba1be5f496adf8"><enum>(1)</enum><text>The term <term>gene synthesis equipment</term> means equipment needed to produce gene synthesis products.</text></paragraph><paragraph id="idd323a83bd8aa49afa4e8b8867d2a79bf"><enum>(2)</enum><text>The term <term>gene synthesis product</term>—</text><subparagraph id="id042d5d91ac2047ff93c1319bbbe1046b"><enum>(A)</enum><text>means custom single-stranded or double-stranded DNA, or single-stranded or double-stranded RNA, which has been chemically or enzymatically synthesized or otherwise manufactured de novo and is of a length exceeding the screening threshold, as determined by the Secretary; and</text></subparagraph><subparagraph id="id49aa32d1de9f488aa7e05ad75f560b06"><enum>(B)</enum><text>does not include—</text><clause id="id1d7620c88d9c4089ba7e8cbb960b5420"><enum>(i)</enum><text>base chemical subunits, such as individual nucleotides or nucleosides, or oligonucleotides shorter than the screening threshold typically used as polymerase chain reaction primers, as determined by the Secretary;</text></clause><clause id="idf153798708f54a4991d447f90bb41229"><enum>(ii)</enum><text>by-products generated during sequencing that are not useful for assembly or cloning, as determined by the Secretary; or</text></clause><clause id="id89272623c47247b6bac2d64df5632d47"><enum>(iii)</enum><text>products generated from cloning or assembling of existing gene or gene fragment material, in circumstances in which the gene synthesis provider has no access or notice to the sequence design, as determined by the Secretary.</text></clause></subparagraph></paragraph><paragraph id="idd10614a44257428394e4bfa34eb31041"><enum>(3)</enum><text>The term <term>gene synthesis provider</term> means an entity that synthesizes and distributes gene synthesis products, including bacteria, viruses, or fungi containing recombinant or synthetic nucleic acid molecules, for delivery to a customer.</text></paragraph><paragraph id="id067e006dd0274e93b51ae1c1505c61b8"><enum>(4)</enum><text>The term <term>manufacturers of gene synthesis equipment</term> means an entity that produces and sells equipment for synthesizing gene synthesis products. </text></paragraph></subsection></section><section id="ida1b67177e53c42dab83595e45d6011f2"><enum>406.</enum><header>Limitation related to countries of concern conducting certain research</header><text display-inline="no-display-inline">Section 2315(c) of the PREVENT Pandemics Act (<external-xref legal-doc="public-law" parsable-cite="pl/117/328">Public Law 117–328</external-xref>) is amended—</text><paragraph id="id9b0b06e12782459bb450282a51128b2b"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph commented="no" display-inline="no-display-inline" id="idb1709b1f1342486ba421a38d1155f519"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>that may reasonably be anticipated to involve the creation, transfer, and use of enhanced pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) if such research is</quote> after <quote>not fund research</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc6ee86a16ad64b8eb90f864717176768"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>, involving pathogens of pandemic potential</quote> and all that follows through the period at the end and inserting a period; </text></subparagraph></paragraph><paragraph id="id50c90c5899e74e68aec1429a50487c16"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="ida3fe55b5bdc54b72a2198294222f7e50"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text style="OLC" level="paragraph">Conditions for listing or suspending prohibition</header-in-text></quote> and inserting <quote><header-in-text style="OLC" level="paragraph">Limitations</header-in-text></quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide9476c10c25e47ada5ca17df110d5688"><enum>(B)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A)—</text><clause commented="no" display-inline="no-display-inline" id="ide4fa11fc925e4a5782a2d58908bdbb89"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary</quote> and inserting <quote>Beginning 5 years after an initial determination of a country of concern, the Director of National Intelligence or the Secretary</quote>; and</text></clause><clause commented="no" display-inline="no-display-inline" id="id03b5db448ff54ca29b46aaad87f7346b"><enum>(ii)</enum><text>by inserting <quote>with respect to such country of concern</quote> after <quote>paragraph (1)</quote>; and</text></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id994024e190b3463d8cd757ca4d82eed3"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id156AF355D1BD41D395D20A82BFD86AA2"><paragraph id="id7edfc7fb332349abb2c64a4f28fd54dc"><enum>(3)</enum><header>Clarification</header><subparagraph id="id86055fcafbb94b4198e21ffed8f44525"><enum>(A)</enum><header>In general</header><text>The requirement of paragraph (1) may be waived by the President for the duration of the initial response to an outbreak of a novel emerging infectious disease if the President determines that such requirement impedes the ability of the Federal Government to immediately respond to such outbreak.</text></subparagraph><subparagraph id="idb58c052ea28147ec9686c97c0763736f"><enum>(B)</enum><header>Notification</header><text>The President shall notify Congress not later than 48 hours after exercising the waiver under subparagraph (A), and shall provide updates to Congress related to the use of such waiver every 15 days thereafter.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="id06ebee8d7ebe4559aa9c7d3efd897aef"><enum>407.</enum><header>Assessment of artificial intelligence threats to health security</header><subsection id="idf29bb6a9ef1549b080de5f96d1c83170"><enum>(a)</enum><header>In general</header><text>Not later than 45 days 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>) shall seek to enter into a contract with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the <quote>National Academies</quote>) to conduct a study assessing the potential vulnerabilities to health security presented by the current or prospective use or misuse of artificial intelligence, including with respect to open-source artificial intelligence models, such as large language models.</text></subsection><subsection id="id5a80d0ff6b2b4636bf3d14844d343dfe"><enum>(b)</enum><header>Inclusions</header><text>The study conducted pursuant to the contract under subsection (a) shall include—</text><paragraph id="id991309ce98a04dc6838bf3d80d8b5f88"><enum>(1)</enum><text>an assessment of the potential vulnerabilities posed by technical advancements in artificial intelligence to health security, including any risks related to the development of, enhancement of, or protection from, chemical, biological, radiological, or nuclear threats;</text></paragraph><paragraph id="ide084e387fd2f4fc2871c77c05e6a793e"><enum>(2)</enum><text>a description of roles, responsibilities, and capabilities of agencies and offices of the Department of Health and Human Services, and, as applicable and appropriate, other Federal departments and agencies, with respect to the identification and mitigation of such potential vulnerabilities;</text></paragraph><paragraph id="id1a52e8855f2f480d87e6ac4a63e25d1d"><enum>(3)</enum><text>a summary of any ongoing Federal activities related to the identification, understanding, and mitigation of such potential risks;</text></paragraph><paragraph id="id3e50661e4bb44c2c98762c8e009ec13e"><enum>(4)</enum><text>the identification of any potential gaps, whether current or anticipated, related to such roles, responsibilities, and capabilities; and</text></paragraph><paragraph id="idd20b7b9a7e9d480892df76a6e5fb9dbc"><enum>(5)</enum><text>recommendations to improve Federal efforts to identify, prepare for, and mitigate such potential vulnerabilities.</text></paragraph></subsection><subsection id="id8950a6427cec48c782329e66666fbafb"><enum>(c)</enum><header>Reports</header><paragraph id="id0daeb8ec18b44cb79797f073319d555e"><enum>(1)</enum><header>National Academies report</header><text>Not later than 2 years after the date of the contract under subsection (a), the National Academies 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 on the study conducted pursuant to subsection (a).</text></paragraph><paragraph id="id264da75f49644c46a2a7e5f770fcfcf1"><enum>(2)</enum><header>HHS report</header><text>Not later than 1 year after the issuance of the report required under paragraph (1), the Secretary 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 detailing actions taken to mitigate and monitor risks to health security posed by misuse of artificial intelligence, as detailed in the report under paragraph (1). </text></paragraph></subsection></section><enum>V</enum><header>Preventing drug shortages</header><section id="HB4B8D0CA4F464D79B71EE5001C24A44E"><enum>501.</enum><header>Improving notification procedures in case of increased demand for critical drugs</header><subsection id="H3AC993FAE4D644CBB7547A2AE46BD401"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 506C of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C. 356c</external-xref>) is amended—</text><paragraph id="HD385368EE7B44181B161E9B673E4A231"><enum>(1)</enum><text>in the section heading, by striking <quote><header-in-text level="section" style="OLC">Discontinuance or interruption in the production of life-saving drugs</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">Notification of issues affecting domestic supply of critical drugs</header-in-text></quote>;</text></paragraph><paragraph id="HCEDED83B383243688F7FD0F325A7DF0D"><enum>(2)</enum><text>by striking subsections (a), (b), and (c), and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HCCF9698C0A6A4E349C22C949962B4520"><subsection id="H87E6A28172974AA3B8A5867F8CA1B69D"><enum>(a)</enum><header>Notification required</header><paragraph id="H85BA1F8210FE457EB5DDEF7FCA67D26A"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">A manufacturer of a covered drug shall notify the Secretary, in accordance with subsection (b), of—</text><subparagraph id="H9CF68966A2E84D36A9C7F465736A5889"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="H39F1917FDFE6470D86119C423262E81D"><enum>(i)</enum><text>a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of such drug in the United States; </text></clause><clause id="HF177FEF7CF2744A2BD6CB030AAC18539" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">a permanent discontinuance in the manufacture of an active pharmaceutical ingredient of such drug, or an interruption in the manufacture of an active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug; or</text></clause><clause id="HB29C8709041244F0A29389ADC1A371C7" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">any other circumstance, such as an increase in demand or export restriction, that is likely to leave the manufacturer unable to meet demand for the drug without a meaningful shortfall or delay; and</text></clause></subparagraph><subparagraph id="H531B8DD84AED49FC839D1AC05E9B743F"><enum>(B)</enum><text display-inline="yes-display-inline">the reasons for such discontinuance, interruption, or other circumstance, if known.</text></subparagraph></paragraph><paragraph id="HBF0D6B27CADF43679F37D577FDDDBD8B"><enum>(2)</enum><header>Contents</header><text>Notification under this subsection with respect to a covered drug shall include—</text><subparagraph id="HC27F9A0948BA404C84720232F738694F"><enum>(A)</enum><text display-inline="yes-display-inline">with respect to the reasons for the discontinuation, interruption, or other circumstance described in paragraph (1)(A)(iii), if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation, interruption, or other circumstance, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known to the manufacturer;</text></subparagraph><subparagraph id="HDAF137B2CBBB496282CE67E21A480CB7"><enum>(B)</enum><text>whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation, interruption, or other circumstance described in paragraph (1)(A)(iii); </text></subparagraph><subparagraph id="H55AAD1E4AFE747EE8D42D422BFF47546"><enum>(C)</enum><text>the expected duration of the interruption; and</text></subparagraph><subparagraph id="HEE556F859A9A423097C0FC54AE590360"><enum>(D)</enum><text>such other information as the Secretary may require.</text></subparagraph></paragraph></subsection><subsection id="H01C75821983D429C848E4C83CEF56F13"><enum>(b)</enum><header>Timing</header><text>A notice required under subsection (a) shall be submitted to the Secretary—</text><paragraph id="H5BC6CA01FF104319B9E753C0D30A53E4"><enum>(1)</enum><text>at least 6 months prior to the date of the discontinuance or interruption; </text></paragraph><paragraph id="HC714F3EFA8D54823BB83AAE01E931327"><enum>(2)</enum><text display-inline="yes-display-inline">in the case of such a notice with respect to a circumstance described in subsection (a)(1)(A)(iii), as soon as practicable, or not later than 10 business days after the onset of the circumstance; or</text></paragraph><paragraph id="H946C5C1B15754562BDDA7BF39E2748ED"><enum>(3)</enum><text>if compliance with paragraph (1) or (2) is not possible, as soon as practicable.</text></paragraph></subsection><subsection id="H903DDB085CC346DB85E8B9370B2CE62D"><enum>(c)</enum><header>Distribution</header><text>To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary determines appropriate, information on the discontinuance or interruption of the manufacture of, or other circumstance described in subsection (a)(1)(A)(iii) that is likely to lead to a shortage or meaningful disruption in the supply of, covered drugs to appropriate organizations, including physician, health provider, and patient organizations, as described in section 506E.</text></subsection><after-quoted-block>; </after-quoted-block></quoted-block></paragraph><paragraph id="HBC031525A43341F2BD3218E5E7EC3582"><enum>(3)</enum><text>in subsection (g), in the matter preceding paragraph (1), by striking <quote>drug described in subsection (a)</quote> and inserting <quote>covered drug</quote>; and</text></paragraph><paragraph id="HB3E547A127D24D74B5AE55F650665706"><enum>(4)</enum><text>in subsection (j), by striking <quote>drug described in subsection (a)</quote> and inserting <quote>covered drug</quote>.</text></paragraph></subsection><subsection id="H71A34195FB0B49C084E373879C66E39A"><enum>(b)</enum><header>Definitions</header><text display-inline="yes-display-inline">Paragraph (1) of section 506C(h) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C. 356c(h)</external-xref>) is amended to read as follows:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H438D521AABCC4427BB86AD6301FE2AB4"><paragraph id="HDB5335E68570432A9975DCD8BECCC8A3"><enum>(1)</enum><text>the term <term>covered drug</term> means a drug that is intended for human use and that—</text><subparagraph id="HC8F2563CA36C4764B65A5D1676D972D7"><enum>(A)</enum><text display-inline="yes-display-inline">is—</text><clause id="HDC025392127247A1A1CBC94347F653CA"><enum>(i)</enum><text>life-supporting; </text></clause><clause id="H4060941E5E8643BABDC18E457E6A1C8E"><enum>(ii)</enum><text>life-sustaining; or </text></clause><clause id="H1E19DC0090A84C349BB84390029050D6"><enum>(iii)</enum><text>intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act; </text></clause></subparagraph><subparagraph id="H99E75F58CCD74A55AAC0AEB99F7FE0A5"><enum>(B)</enum><text>is not a radio pharmaceutical drug product or any other product as designated by the Secretary; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide4583a7b798d498ebcd8106adfd8b714"><enum>(C)</enum><text display-inline="yes-display-inline">is not a biological product (as defined in section 351(i) of the Public Health Service Act), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section commented="no" display-inline="no-display-inline" id="id1c5cc281c0814475a4c8a76be06e9862"><enum>502.</enum><header>Reporting on supply chains</header><text display-inline="no-display-inline">Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(j)(3)(A)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="id750e0d3f7c4b41629fafd1a7e7fe629d"><enum>(1)</enum><text display-inline="yes-display-inline">by inserting <quote>, and the names and unique facility identifiers of the manufacturers of the active pharmaceutical ingredients such person used for the manufacture, preparation, propagation, compounding, or processing of such drug, and the amount of such drug manufactured, prepared, propagated, compounded, or processed using each such active pharmaceutical ingredient from each such manufacturer</quote> before the period at the end of the first sentence; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc49ee2f5eaab4951a20be75869d53c36"><enum>(2)</enum><text>by inserting after the first sentence the following: <quote>In addition to the reporting required under the preceding sentence, the Secretary may receive voluntary submissions of such information at more frequent intervals.</quote>.</text></paragraph></section><section id="id945a050acdbc42be98b65d5016931c93"><enum>503.</enum><header>Reporting on use of new authorities and requirements with respect to drug shortages</header><text display-inline="no-display-inline">Not later than 90 days 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>) shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—</text><paragraph id="ida3d43541783d4e5bbacdd073691abe20"><enum>(1)</enum><text>the extent to which the Secretary has implemented the authorities and requirements under sections 506C(g), 506C(j), 506E(d), 510(j)(3), and 704(b)(2) (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C. 356c(g)</external-xref>, 356c(j), 356e(d), 360(j)(3), 374(b)(2)) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3111 and 3112 of the Coronavirus Aid, Relief, and Economic Security Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/136">Public Law 116–136</external-xref>), including—</text><subparagraph commented="no" display-inline="no-display-inline" id="id7c3d58906164466bb2621c20cd71a8da"><enum>(A)</enum><text display-inline="yes-display-inline">specific examples of uses of such authorities and requirements; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id24c68d406bb8461d9b920175795439c2"><enum>(B)</enum><text>an assessment of the extent to which such authorities and requirements have helped mitigate drug shortages; and</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5e03b669a5ba48c190548b7dbaae09cf"><enum>(2)</enum><text>the status of the guidance documents that the Secretary intends to issue with respect to reporting and risk management plan requirements applicable to manufacturers of drugs and active pharmaceutical ingredients, pursuant to the amendments made to section 506C of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C. 356c</external-xref>) by subsections (a) and (b) of section 3112 of the Coronavirus Aid, Relief, and Economic Security Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/136">Public Law 116–136</external-xref>). </text></paragraph></section><enum>VI</enum><header>Additional reauthorizations and technical amendments</header><section id="ide97ad6bbcac14ecfb1cc09bbdba3f9d7"><enum>601.</enum><header>Medical countermeasure priority review voucher</header><text display-inline="no-display-inline">Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4a">21 U.S.C. 360bbb–4a</external-xref>) is amended by striking <quote>2023</quote> and inserting <quote>2028</quote>.</text></section><section id="id163ec49178094a53b5b8b4e6fde088ba"><enum>602.</enum><header>Epidemic Intelligence Service loan repayment program</header><text display-inline="no-display-inline">Section 317F(c)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-7">42 U.S.C. 247b–7(c)(2)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id4f434537adae4feea70fca7ddda64e2b"><enum>603.</enum><header>Vaccine tracking and distribution</header><text display-inline="no-display-inline">Section 319A(e) of the Public Health Service Act (<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>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id5585037f316344e89164311e637c3355"><enum>604.</enum><header>Regional health care emergency preparedness and response systems</header><text display-inline="no-display-inline">Section 319C–3(e)(2) of the Public Health Service Act (42 U.S.C. 247d–3c(e)(2)) is amended by striking <quote>2023</quote> and inserting <quote>2028</quote>.</text></section><section id="ida121ff18184a4e329b5e4979679bf5f5"><enum>605.</enum><header>Emergency system for advance registration of volunteer health professional</header><text display-inline="no-display-inline">Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d–7b(k)) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>. </text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id906ffed69b904ac59a39e5b772ede443"><enum>606.</enum><header>Limited antitrust exemption</header><text display-inline="no-display-inline">Section 319L–1(b) of the Public Health Service Act (42 U.S.C. 247d–7f(b)) is amended by striking <quote>at the end of the 17-year period that begins on the date of enactment of this Act</quote> and inserting <quote>on September 30, 2028</quote>. </text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id5e95d09313074e42ac80401e6c51bdb4"><enum>607.</enum><header>Trauma care</header><text display-inline="no-display-inline">Section 1232(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300d-32">42 U.S.C. 300d–32(a)</external-xref>) is amended by striking <quote>$24,000,000 for each of fiscal years 2023 through 2027</quote> and inserting <quote>$39,000,000 for each of fiscal years 2024 through 2028</quote>. </text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="ide741632c4eec449daddcd82176f5df3c"><enum>608.</enum><header>Military and civilian partnership for trauma readiness</header><text display-inline="no-display-inline">Section 1291(g) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300d-91">42 U.S.C. 300d–91(g)</external-xref>) is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section id="id588fe6b8f02d44a5b58502b0eddaf7cd"><enum>609.</enum><header>National Disaster Medical System</header><subsection commented="no" display-inline="no-display-inline" id="id106e593542ea42e5b17785e4b4065c5a"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="idb3f5030190b54952a07cb0e8e19f14e7"><enum>(1)</enum><text>in subsection (c)(4)(B), by striking <quote>2023</quote> and inserting <quote>2028</quote>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf4f6a30d25544327bc88864a089a819e"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (g), by striking <quote>$57,400,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$65,900,000 for each of fiscal years 2024 through 2028</quote>.</text></paragraph></subsection><subsection id="ide488c4f4130043509ca1b2b27c94190f"><enum>(b)</enum><header>Repeal of sunset</header><paragraph commented="no" display-inline="no-display-inline" id="idbd2e1f92019a4a019612dbf17af22c17"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 301(d)(3) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (<external-xref legal-doc="public-law" parsable-cite="pl/116/22">Public Law 116–22</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/34/10284">34 U.S.C. 10284</external-xref> note) is repealed.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4a685e56b84748559015c7df90ac62a5"><enum>(2)</enum><header>Effective date</header><text display-inline="yes-display-inline"> Paragraph (1) shall take effect as if enacted on September 30, 2021.</text></paragraph></subsection></section><section id="idc938b6104c914e2cb478ca12bee7fe87"><enum>610.</enum><header>Volunteer Medical Reserve Corps</header><text display-inline="no-display-inline">Section 2813(i) of the Public Health Service Act (<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>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id8bb7224986454af1b4925f054d0116bb"><enum>611.</enum><header>Epidemiology-laboratory capacity grants</header><text display-inline="no-display-inline">Section 2821(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31(b)</external-xref>) is amended, in the matter preceding paragraph (1), by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section commented="no" display-inline="no-display-inline" id="ida18dacd59b824953903b86705b63578f"><enum>612.</enum><header>Veterans Affairs</header><text display-inline="no-display-inline">Section 8117(g) of title 38, United States Code is amended by striking <quote>2019 through 2023</quote> and inserting <quote>2024 through 2028</quote>.</text></section><section id="idBFCAFD647E3844FA86F88C43DB64AC30"><enum>613.</enum><header>Technical amendments</header><subsection id="id5D413D5675D240309EB4472F5EEE3DBF"><enum>(a)</enum><text display-inline="yes-display-inline">Title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-1">42 U.S.C. 300aa–1 et seq.</external-xref>) is amended—</text><paragraph id="idD091FF760DC64862A01C84AD5362C2FD"><enum>(1)</enum><text>in section 2105(b), by striking <quote>, 2103, and 2104</quote> each place it appears and inserting <quote>and 2103</quote>;</text></paragraph><paragraph id="id425E20CD06CD4BE187AA9F4D07EB6871"><enum>(2)</enum><text>in section 2110(b), by striking <quote>the program</quote> and inserting <quote>The Program</quote>;</text></paragraph><paragraph id="id8AB03E9730884720B0EAA3A2C53C8097"><enum>(3)</enum><text>in section 2111(a)—</text><subparagraph id="id38695B8A5CBF45F4B744DE884FFEEA1B"><enum>(A)</enum><text>in paragraph (6), by striking <quote>1988 for</quote> and inserting <quote>1988, for</quote>; and</text></subparagraph><subparagraph id="idA04584249FE64F46B646B0D96181311A"><enum>(B)</enum><text>in paragraph (10), by striking <quote>United States Claims Court</quote> and inserting <quote>United States Court of Federal Claims</quote>;</text></subparagraph></paragraph><paragraph id="id8C11D6946BA54C91B599367D9B99B96B"><enum>(4)</enum><text>in section 2112—</text><subparagraph id="id382A4A7C30E3424F80A5C68058BBF359"><enum>(A)</enum><text>in subsection (c)(6)(A), by striking <quote>United States Claims Courts</quote> and inserting <quote>United States Court of Federal Claims</quote>; and</text></subparagraph><subparagraph id="id62CE5F4BF8A04B438F552344229C1582"><enum>(B)</enum><text>in subsection (f)—</text><clause id="id76DB5C3F2FCD4956887BD456C1556380"><enum>(i)</enum><text>by striking <quote>United States Claims Court on</quote> and inserting <quote>United States Court of Federal Claims on</quote>; and</text></clause><clause id="id43D026239D2045C3955F8B52203A4CA6"><enum>(ii)</enum><text>by striking <quote>United States Claims Court's judgment</quote> and inserting <quote>judgment of the United States Court of Federal Claims</quote>;</text></clause></subparagraph></paragraph><paragraph id="idF3C74DE79FAB4448B843ADD07EE03B78"><enum>(5)</enum><text>in section 2115(b)(3), by striking <quote>subsection (e)</quote> and inserting <quote>subsection (e))</quote>;</text></paragraph><paragraph id="id7F793866F88548FDA4AC6D81B4EEBB7B"><enum>(6)</enum><text>in section 2117—</text><subparagraph id="id702AEFF2D7904AE881769182E27FAE0A"><enum>(A)</enum><text>in the section heading, by striking <quote><header-in-text level="section" style="OLC">Subrogration</header-in-text></quote> and inserting <quote><header-in-text level="section" style="OLC">Subrogation</header-in-text></quote>; and</text></subparagraph><subparagraph id="id17E795DEF83441BEA581173EF865C0BC"><enum>(B)</enum><text>in subsection (a), by striking <quote>subrograted</quote> and inserting <quote>subrogated</quote>; and</text></subparagraph></paragraph><paragraph id="id5DF53F4D85484CFE94DE7FDD2956C959"><enum>(7)</enum><text>in section 2127—</text><subparagraph id="idFBB38A97F8774D6C8CB05786C0A71A1F"><enum>(A)</enum><text>in subsection (b)(1), by inserting <quote>and Prevention</quote> before the period; and</text></subparagraph><subparagraph id="id8B30FAE7D7A84B9B9FEC46A3A4B272D6"><enum>(B)</enum><text>in subsection (c), by striking <quote>Committee on Labor and Human Resources</quote> and inserting <quote>Committee on Health, Education, Labor, and Pensions</quote>.</text></subparagraph></paragraph></subsection><subsection id="idB2103641AD704DF8848127DEBB11ADCB"><enum>(b)</enum><text>Section 319F–3 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>) is amended—</text><paragraph id="id384418DB2B5C414DBA690BFA7642FB61"><enum>(1)</enum><text>in subsection (c)(5)(B)(ii)(I), by striking <quote>chapter 5</quote> and inserting <quote>chapter V</quote>; and</text></paragraph><paragraph id="id7567DCD182D74BA0AD8C7FD4D8179B03"><enum>(2)</enum><text>in subsection (i)(7)—</text><subparagraph id="id07673E1B0E6148ED88B8D2C57CDFA560"><enum>(A)</enum><text>by striking <quote>321(g)(1))</quote> and inserting <quote>321(g)(1)))</quote>; and</text></subparagraph><subparagraph id="idE194348CB06046D890DEC5AD493F76AC"><enum>(B)</enum><text>by striking <quote>321(h))</quote> and inserting <quote>321(h)))</quote>. </text></subparagraph></paragraph></subsection><subsection id="idd953172afa764c33b73c3255a58f945e"><enum>(c)</enum><text>Section 319F–4 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) is amended—</text><paragraph id="id09e786cb039b4002938ae7bd34003e02"><enum>(1)</enum><text>in subsection (b)(1), by striking <quote>under 319F–3(b)</quote> and inserting <quote>under section 319F–3(b)</quote>; and</text></paragraph><paragraph id="id278ee500d1a54b7d8022ba3f8a449bc5"><enum>(2)</enum><text>in subsection (d)(5), by striking <quote>under subsection (a) the Secretary determines that a covered individual qualifies for compensation</quote> and inserting <quote>a covered individual is determined under subsection (a) to be eligible for compensation under this section</quote>. </text></paragraph></subsection><subsection id="idFBA1158150B5426391971B9D2A3F2364"><enum>(d)</enum><text>Part C of title II of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/239">42 U.S.C. 239 et seq.</external-xref>) is amended—</text><paragraph id="id3FF4E2BECF3D4A7E940E44A5A6C50FA5"><enum>(1)</enum><text>in section 261(a)(2)(A), by striking <quote>specialities</quote> and inserting <quote>specialties</quote>;</text></paragraph><paragraph id="idB8C122DF827B477FBFCA6B4A76028FF9"><enum>(2)</enum><text>in section 265(c)(5), by striking <quote>involves</quote> and inserting <quote>involved</quote>;</text></paragraph><paragraph id="id02A679270BDE4B8CA3221A6BF2170AC1"><enum>(3)</enum><text>in section 266(b)(3)(B)(ii), by striking <quote>to with respect to an eligible</quote> and inserting <quote>with respect to an eligible</quote>; and</text></paragraph><paragraph id="id6CF2F04133E44716B411E6B7E6BA328E"><enum>(4)</enum><text>in section 267(b), by striking <quote>such Act</quote> and inserting <quote>such part</quote>. </text></paragraph></subsection><subsection id="id3b03b6e832e24e59941b8aa054d34417" commented="no" display-inline="no-display-inline"><enum>(e)</enum><text>Section 351A(e)(7)(B)(ii) is amended by striking <quote>judical</quote> and inserting <quote>judicial</quote>.</text></subsection></section>