,,ii #aahth ,,congress #ast ,session ,s4 #bccc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ah1 #bjbc,mr4 ,casey 7for himself1 ,mr4 ,romney1 ,mr4 ,sanders1 and ,mr4 ,cassidy7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to reauthorize certain programs under the ,public ,health ,service ,act with respect to public health security and all-hazards preparedness and response1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,pandemic and ,all-,hazards ,preparedness and ,response ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,state and local readiness and response,sec4 #aja4 ,temporary reassignment of ,state and local personnel during a public health emergency4,sec4 #ajb4 ,public ,health ,emergency ,preparedness program4,sec4 #ajc4 ,improving and enhancing participation of ,,ems organizations in the hospital preparedness program4,sec4 #ajd4 ,improving medical readiness and response capabilities4,sec4 #aje4 ,pilot program to support ,state medical stockpiles4,sec4 #ajf4 ,enhancing domestic wastewater surveillance for pathogen detection4,sec4 #ajg4 ,reauthorization of ,mosquito ,abatement for ,safety and ,health program4,,title ,,ii--,federal planning and coordination,sec4 #bja4 ,all-,hazards ,emergency ,preparedness and ,response4,sec4 #bjb4 ,national ,health ,security ,strategy4,sec4 #bjc4 ,improving development and distribution of diagnostic tests4,sec4 #bjd4 ,pilot program for public health data availability4,sec4 #bje4 ,combating antimicrobial resistance4,sec4 #bjf4 ,strategic ,national ,stockpile and material threats4,sec4 #bjg4 ,medical countermeasures for viral threats with pandemic potential4,sec4 #bjh4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise4,sec4 #bji4 ,strengthening public health communication4,sec4 #baj4 ,fellowship and training programs4,sec4 #baa4 ,assessment of ,,covid-#ai mitigation policies4,,title ,,iii--,addressing the needs of all individuals,sec4 #cja4 ,transition of certain countermeasures between compensation programs4,sec4 #cjb4 ,accelerating injury compensation program administration and ensuring program integrity4,sec4 #cjc4 ,compensation for injuries relating to the public health emergency caused by ,,sars-,co,v-#b4,sec4 #cjd4 ,review of regulations4,sec4 #cje4 ,supporting individuals with disabilities1 older adults1 and other at-risk individuals during emergency responses4,sec4 #cjf4 ,national advisory committees4,sec4 #cjg4 ,research and coordination of activities concerning the long-term health effects of ,,sars-,co,v-#b infection4,sec4 #cjh4 ,national ,academies study on prizes4,,title ,,iv--,strengthening biosecurity,sec4 #dja4 ,treatment of genetic variants and synthetic products of select agents and toxins4,sec4 #djb4 ,establishment of no-fault reporting system4,sec4 #djc4 ,evaluation of the ,federal ,select ,agent ,program and related policies4,sec4 #djd4 ,supporting research and laboratory surge capacity4,sec4 #dje4 ,gene synthesis4,sec4 #djf4 ,limitation related to countries of concern conducting certain research4,sec4 #djg4 ,assessment of artificial intelligence threats to health security4,,title ,v--,preventing drug shortages,sec4 #eja4 ,improving notification procedures in case of increased demand for critical drugs4,sec4 #ejb4 ,reporting on supply chains4,sec4 #ejc4 ,reporting on use of new authorities and requirements with respect to drug shortages4,,title ,,vi--,additional reauthorizations and technical amendments,sec4 #fja4 ,medical countermeasure priority review voucher4,sec4 #fjb4 ,epidemic ,intelligence ,service loan repayment program4,sec4 #fjc4 ,vaccine tracking and distribution4,sec4 #fjd4 ,regional health care emergency preparedness and response systems4,sec4 #fje4 ,emergency system for advance registration of volunteer health professional4,sec4 #fjf4 ,limited antitrust exemption4,sec4 #fjg4 ,trauma care4,sec4 #fjh4 ,military and civilian partnership for trauma readiness4,sec4 #fji4 ,national ,disaster ,medical ,system4,sec4 #faj4 ,volunteer ,medical ,reserve ,corps4,sec4 #faa4 ,epidemiology-laboratory capacity grants4,sec4 #fab4 ,veterans ,affairs4,sec4 #fac4 ,technical amendments4 ,i ,state and local readiness and response #aja4 ,temporary reassignment of ,state and local personnel during a public health emergency ,section #cai7;e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7e77 is amended-- 7#a7 in paragraph 7#a71 by striking such ,governor or tribal organization's designee and inserting the designee of the ,governor or ,tribal organization1 or the ,state or ,tribal health official2 7#b7 in paragraph 7#b77;,b7-- 7,a7 in the matter preceding clause 7i71 by striking tribal organization and inserting ,tribal organization1 or the ,state or ,tribal health official2 and 7,b7 in clause 7v71 by striking tribal organization and inserting ,tribal organization or ,state or ,tribal health official2 7#c7 in paragraph 7#f7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking ,reauthorization ,act of #bjac and inserting and ,response ,act2 and 7ii7 by striking appropriate committees of the ,congress and inserting ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7,b7 in subparagraph 7,a71 by inserting 1 including requests from ,state or ,tribal health officials before the semicolon2 7#d7 in paragraph 7#g77;,a71 by striking tribal organization and inserting ,tribal organization2 and 7#e7 in paragraph 7#h71 by striking #bjbc and inserting #bjbh4 #ajb4 ,public ,health ,emergency ,preparedness program ,section #cai;,c-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a77ii71 by striking influenza and inserting response planning2 and 7,b7 in subparagraph 7,h71 by inserting 1 such as community-based organizations1 including faith-based organizations1 and other public and private entities after stakeholders2 7#b7 in subsection 7g7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting and the ability of each entity receiving an award under subsection 7a7 to respond to all-hazards threats before the period at the end of the first sentence2 7,b7 in paragraph 7#b7-- 7i7 in the paragraph heading1 by striking influenza and inserting response2 and 7ii7 in subparagraph 7,a7-- 7,i7 by striking to pandemic influenza and inserting to a pathogen causing a pandemic1 including pandemic influenza2 and 7,,ii7 by striking such pandemic influenza and inserting such pandemic response2 7,c7 in paragraph 7#e7-- 7i7 in the paragraph heading1 by striking influenza and inserting pandemic response2 7ii7 in the matter preceding subparagraph 7,a71 by striking #bjai and inserting #bjbe2 7iii7 in clause 7i71 by striking #bjah and inserting #bjbd2 and 7iv7 in subparagraph 7,b71 by striking pandemic influenza and inserting a pathogen causing a pandemic2 and 7,d7 in paragraph 7#f7-- 7i7 in subparagraph 7,a71 in the matter preceding clause 7i71 by striking ,the amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section of section #cai;,c-#b and inserting ,the ,secretary shall withhold from an entity pursuant to paragraph 7#e7 for noncompliance with the requirements of this section or section #cai;,c-#b as follows2 and 7ii7 in subparagraph 7,b71 by inserting with respect to the requirements of this section or section #cai;,c-#b after paragraph 7#e72 and 7#c7 in subsection 7h7-- 7,a7 in paragraph 7#a77;,a71 by striking #fhe1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #gce1jjj1jjj for each of fiscal years #bjbd through #bjbh2 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,a71 by striking ,for fiscal year #bjbg1 the ,secretary and inserting ,the ,secretary2 and 7ii7 in subparagraph 7,d71 by striking for fiscal year #bjbf2 and 7,c7 in paragraph 7#e77;,a71 by striking ,for fiscal year #bjjg1 the ,secretary and inserting ,the ,secretary4 #ajc4 ,improving and enhancing participation of ,,ems organizations in the hospital preparedness program 7a7 ,increasing participation by ,,ems in the hospital preparedness program ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7b77#a77;,a7-- 7,a7 in clause 7iii77,,iii71 by striking 2 and and inserting semicolon2 and 7,b7 by striking clause 7iv7 and inserting the following3 7iv7 one or more emergency medical service organizations2 and 7v7 to the extent practicable1 one or more emergency management organizations2 and 2 and 7#b7 in subsection 7g77#a7-- 7,a7 by striking the heading and inserting3 7#a7 ,local response capabilities 7,a7 ,program coordination 2 7,b7 by striking extent practicable1 ensure and inserting the following3 8extent practicable-- 7i7 ensure 2 7,c7 by striking the period and inserting 2 and2 and 7,d7 by adding at the end the following3 7ii7 seek to increase participation of eligible entities described in subsection 7b77#a77;,a7 with lower participation rates relative to coalitions of other eligible entities1 such as coalitions that include emergency medical services organizations and health care facilities in underserved areas4 4 7b7 ,preferences ,section #cai;,c-#b7;d77#a77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77iii77 is amended by striking subsection 7b77#a77;,a77ii7 and inserting clauses 7ii7 and 7iv7 of subsection 7b77#a77;,a74 #ajd4 ,improving medical readiness and response capabilities ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 7,b7 in subparagraph 7,b71 by striking the period and inserting 2 and2 and 7,c7 by inserting at the end the following3 7,c7 designate a lead entity to administer such award and support coordination between entities described in this subsection4 2 7#b7 in subsection 7g77#a71 as amended by section #ajb7;a77#b71 by adding at the end the following3 7,b7 ,regional operations ,an eligible entity shall establish and maintain1 or leverage an existing1 capability to enable coordination of regional medical operations1 which may include systems to facilitate information sharing and coordination1 within a coalition described under subsection 7b77#a77;,a7 and1 as appropriate1 between multiple coalitions that are in close geographic proximity to each other4 2 and 7#c7 in subsection 7j77#a7-- 7,a7 in subparagraph 7,a71 by striking #bjai through #bjbc and inserting #bjbd through #bjbh2 and 7,b7 in subparagraph 7,b77iii71 by striking #bjbc and inserting #bjbh4 #aje4 ,pilot program to support ,state medical stockpiles 7a7 ,in general ,section #cai;,f-#b7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7i77 is amended-- 7#a7 in paragraph 7#b77;,b77i7-- 7,a7 in subclause 7,i71 by striking and #bjbd and inserting through #bjbe2 and 7,b7 in subclause 7,,ii71 by striking #bjbe and inserting #bjbf2 7#b7 in paragraph 7#d7-- 7,a7 in subparagraph 7,g71 by striking 2 and at the end and inserting a semicolon2 7,b7 by redesignating subparagraph 7,h7 as subparagraph 7,i72 7,c7 by inserting after subparagraph 7,g7 the following3 7,h7 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 products2 and 2 and 7,d7 in subparagraph 7,i71 as so redesignated1 by striking ,state efforts and inserting ,state or regional efforts2 7#c7 by redesignating paragraphs 7#e7 through 7#i7 as paragraphs 7#f7 through 7#aj71 respectively2 7#d7 by inserting after paragraph 7#d7 the following3 7#e7 ,coordination ,an entity in receipt of an award under paragraph 7#a71 in carrying out the activities under this subsection1 shall coordinate with appropriate health care entities1 health officials1 and emergency management officials within the jurisdiction of such ,state or ,states4 2 and 7#e7 in paragraph 7#aj71 as so redesignated1 by striking #c1ejj1jjj1jjj for each of fiscal years #bjbc and #bjbd and inserting such sums as may be necessary for each of fiscal years #bjbd through #bjbh4 7b7 ,,gao report ,section #bdji7;b7 of the ,,prevent ,pandemics ,act 7,public ,law #aag-cbh7 is amended-- 7#a7 in paragraph 7#b71 by striking 2 and and inserting a semicolon2 7#b7 in paragraph 7#c71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7#d7 the impact of any regional stockpiling approaches carried out under such subsection 7i77#a7 of section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 4 #ajf4 ,enhancing domestic wastewater surveillance for pathogen detection 7a7 ,in general ,subtitle ,c of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca et seq47 is amended by adding at the end the following3 #bhbg4 ,wastewater surveillance for pathogen detection 7a7 ,wastewater surveillance system ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with other ,federal departments and agencies1 shall award grants1 contracts1 or cooperative agreements to eligible entities to establish1 maintain1 or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes4 7b7 ,eligible entities ,to be eligible to receive an award under this section1 an entity shall-- 7#a7 be a ,state1 ,tribal1 or local health department1 or a partnership between such a health department and other public and private entities2 and 7#b7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may reasonably require1 which shall include-- 7,a7 a description of activities proposed to be carried out pursuant to an award under subsection 7a72 7,b7 factors such entity proposes to use to select wastewater sampling sites2 7,c7 a plan for responding1 as appropriate1 to findings from such wastewater sampling1 consistent with applicable plans developed by such entity pursuant to section #cai;,c-#a2 7,d7 a plan to sustain such wastewater surveillance activities described in such application following the conclusion of the award period2 and 7,e7 any additional information the ,secretary may require4 7c7 ,consideration ,in making awards under subsection 7a71 the ,secretary may give priority to eligible entities that have submitted an application that-- 7#a7 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 7a72 and 7#b7 provides an assessment of community needs related to ongoing infectious disease monitoring1 including burden of infectious diseases that can be detected in wastewater and availability of other forms of infectious disease surveillance4 7d7 ,use of funds ,an eligible entity shall1 as appropriate1 use amounts awarded under this section to-- 7#a7 establish1 or enhance existing1 capacity and capabilities to conduct wastewater sampling1 testing1 and related analysis2 7#b7 conduct wastewater surveillance1 as appropriate1 at individual facilities1 institutions1 and locations in rural areas1 in which there is an increased risk of infectious disease outbreaks1 or areas in which wastewater is not treated through the relevant local utility of the jurisdiction2 and 7#c7 implement projects that use evidence-based or promising practices to conduct wastewater surveillance activities4 7e7 ,partnerships ,in carrying out activities under this section1 eligible entities shall identify opportunities to partner with other public or private entities to leverage relevant capabilities maintained by such entities1 as appropriate and consistent with this section4 7f7 ,technical assistance ,the ,secretary1 in consultation with the heads of other applicable ,federal agencies and departments1 as appropriate1 shall provide technical assistance to recipients of awards under this section to facilitate the planning1 development1 and implementation of activities described in subsection 7d74 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbd through #bjbh4 4 7b7 ,wastewater surveillance research 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this subsection referred to as the ,secretary7 shall continue to conduct or support research on the use of wastewater surveillance to detect and monitor emerging infectious diseases1 which may include-- 7,a7 research to improve the efficiency of wastewater sample collection and analysis and increase the sensitivity and specificity of wastewater testing methods2 and 7,b7 implementation and development of evidence-based practices to facilitate the estimation of population-level data within a community4 7#b7 ,non-duplication of effort ,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 surveillance4 #ajg4 ,reauthorization of ,mosquito ,abatement for ,safety and ,health program ,section #cag,s of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#ba7 is amended-- 7#a7 in subsection 7a77#c77;,a71 by striking subsection 7b77#c7 and inserting subsection 7b77#d72 7#b7 in subsection 7b7-- 7,a7 by redesignating paragraphs 7#c7 through 7#f7 as paragraphs 7#d7 through 7#g71 respectively2 and 7,b7 by inserting after paragraph 7#b7 the following3 7#c7 ,considerations ,the ,secretary may consider the use of innovative and novel technology for mosquito prevention and control in making grants under paragraph 7#a74 2 7#c7 by amending subsection 7d7 to read as follows3 7d7 ,uses of funds ,amounts appropriated under subsection 7f7 may be used by the ,secretary to provide training and technical assistance with respect to the planning1 development1 and operation of assessments and plans under subsection 7a7 and control programs under subsection 7b74 ,the ,secretary may provide such training and technical assistance directly or through awards of grants or contracts to public and private entities4 2 and 7#d7 in subsection 7f77#a71 by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 ,,ii ,federal planning and coordination #bja4 ,all-,hazards ,emergency ,preparedness and ,response ,section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#c7-- 7i7 by striking ,oversee advanced and inserting the following3 7,a7 ,in general ,oversee advanced 2 and 7ii7 by adding at the end following3 7,b7 ,development of requirements ,lead the development and approval1 and1 on a routine basis1 the review and update1 of requirements for such countermeasures and products1 including related capabilities1 to inform the advanced research1 development1 procurement1 and replenishment decisions of the ,department of ,health and ,human ,services4 2 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,f7-- 7,i7 in the matter preceding clause 7i71 by striking and in consultation with the ,secretary of ,homeland ,security12 and 7,,ii7 in clause 7i71 by inserting enhance after capabilities and2 and 7ii7 in subparagraph 7,g7-- 7,i7 in clause 7i71 by striking based on and inserting based on--2 7,,ii7 in clause 7ii71 by striking 2 and at the end and inserting a semicolon2 7,,iii7 in clause 7iii71 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7iv7 that include1 as appropriate1 participation by relevant industry1 academia1 professional societies1 and other stakeholders4 2 7iii7 in subparagraph 7,h7-- 7,i7 by inserting and the ,director of the ,office of ,pandemic ,preparedness and ,response after ,security ,affairs2 and 7,,ii7 by inserting and medical product and supply capacity planning pursuant to subparagraph 7,j71 including discussion of any relevant identified supply chain vulnerabilities before the period at the end2 7iv7 in subparagraph 7,i71 by inserting the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy1 after ,security ,affairs12 and 7v7 in subparagraph 7,j77i71 in the matter preceding subclause 7,i71 by inserting 7including ancillary medical supplies and components of medical products1 such as active pharmaceutical ingredients1 key starting materials1 and medical device components7 after supply needs2 and 7,c7 in paragraph 7#g7-- 7i7 in the matter preceding subparagraph 7,a71 by inserting and the requirements developed pursuant to paragraph 7#c77;,b7 after subsection 7d72 7ii7 by redesignating subparagraphs 7,e7 and 7,f7 as subparagraphs 7,f7 and 7,g71 respectively2 and 7iii7 by inserting after subparagraph 7,d7 the following3 7,e7 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 requirements2 2 7#b7 in subsection 7d7-- 7,a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general ,not later than ,march #ae1 #bjbj1 and biennially thereafter1 the ,assistant ,secretary for ,preparedness and ,response shall develop and submit to the ,committee on ,health1 ,education1 ,labor1 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 chemical1 biological1 radiological1 and nuclear threats1 informed by the requirements developed pursuant to subsection 7b77#c77;,b74 ,not later than #ahj days after the submission of such strategy to such committees1 the ,assistant ,secretary for ,preparedness and ,response shall submit an accompanying implementation plan to such committees4 ,in developing such a strategy and plan1 the ,assistant ,secretary for ,preparedness and ,response shall consult with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a4 2 and 7,b7 in paragraph 7#b71 in the matter preceding subparagraph 7,a71 by inserting strategy and before plan2 and 7#c7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting 1 including an emerging infectious disease1 after any such agent2 and 7,b7 in paragraph 7#b77;,a71 by striking #bej1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #cce1jjj1jjj for each of fiscal years #bjbd through #bjbh4 #bjb4 ,national ,health ,security ,strategy ,section #bhjb of the ,public ,health ,service ,act is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 by striking ,in #bjbb1 the and inserting ,the2 and 7,b7 by inserting 1 maintaining1 and sustaining after establishing2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting that support interagency coordination and availability of information1 as appropriate before the period2 7ii7 in subparagraph 7,b71 by inserting rapid testing1 after and supplies12 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,c71 by inserting and current capacity of facilities within such systems1 as applicable before the period2 7ii7 in subparagraph 7,d71 by inserting and other medical products and medical supplies directly related to responding to chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases1 and incidents covered by the ,national ,response ,framework1 as applicable and consistent with the activities carried out under section #bhaa7;b77#d77;,j7 before the period2 and 7iii7 by adding at the end the following3 7,h7 ,supporting the availability of blood and blood products with respect to public health emergencies4 2 7,c7 in paragraph 7#e71 by inserting applicable federally-funded activities and after 7including2 7,d7 in paragraph 7#h7-- 7i7 in subparagraph 7,a71 by inserting public health and medical before activities2 and 7ii7 in subparagraph 7,b71 by striking familiarity with and inserting understanding of1 and coordination between12 7,e7 by redesignating paragraphs 7#i7 and 7#aj7 as paragraphs 7#aj7 and 7#ab71 respectively2 7,f7 by inserting after paragraph 7#h7 the following3 7#i7 ,other settings ,supporting ,federal1 ,state1 local1 and ,tribal coordination and planning with respect to facilities in which there is an increased risk of infectious disease outbreaks1 including such facilities that address the needs of at-risk individuals1 in the event of a public health emergency declared under section #cai4 2 7,g7 by inserting after subparagraph 7#aj71 as so redesignated1 the following3 7#aa7 ,other hazards ,assessing current and potential health security threats from natural disasters or other extreme weather events with respect to public health and medical preparedness and response4 2 and 7,h7 by striking tribal each place it appears and inserting ,tribal4 #bjc4 ,improving development and distribution of diagnostic tests ,section #cai;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#b7 is amended to read as follows3 #cai;,b4 ,improving development and distribution of diagnostic tests 7a7 ,framework ,the ,secretary shall develop1 make publicly available not later than #a year after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,response ,act1 and update not less frequently than every #c years thereafter1 a strategic framework for the rapid development1 validation1 authorization1 manufacture1 procurement1 and distribution of diagnostic tests1 and for rapid scaling of testing capacity1 in response to chemical1 biological1 radiological1 or nuclear threats1 including infectious diseases for which a public health emergency is declared under section #cai1 or that has significant potential to cause such a public health emergency4 ,such strategic framework shall take into consideration-- 7#a7 domestic capacity1 including any such capacity established through partnerships with public and private entities pursuant to subsection 7c71 to support the development1 validation1 authorization1 manufacture1 procurement1 and distribution of tests2 7#b7 novel technologies and platforms that may be used to improve testing capabilities1 including high-throughput laboratory diagnostics1 and point-of-care diagnostics1 and any such technologies to improve the accessibility of such tests1 and facilitate the development and manufacture of diagnostic tests2 7#c7 medical supply needs related to testing1 including diagnostic testing1 equipment1 supplies1 and component parts1 and any potential vulnerabilities related to the availability of such medical supplies and related planning1 consistent with section #bhaa7;b77#d77;,j72 7#d7 strategies for the rapid and efficient distribution of tests locally1 regionally1 or nationwide and scaling laboratory testing capacity2 and 7#e7 assessing such strategies through drills and operational exercises carried out under section #bhaa7;b77#d77;,g71 as appropriate4 7b7 ,coordination ,to inform the development and update of the framework under subsection 7a71 and in carrying out activities to implement such framework1 the ,secretary shall coordinate with industry1 ,states1 local governmental entities1 ,indian ,tribes and ,tribal organizations1 and other relevant public and private entities4 7c7 ,capacity building ,the ,secretary may contract with public and private entities1 as appropriate1 to increase domestic capacity in the rapid development1 validation1 authorization1 manufacture1 procurement1 and distribution of diagnostic tests1 as appropriate1 to ,state1 local1 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 #cai1 or that has significant potential to cause such a public health emergency4 4 #bjd4 ,pilot program for public health data availability 7a7 ,situational awareness system ,section #cai;,d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by inserting 1 and facilitate the leveraging of relevant public health data across the ,department of ,health and ,human ,services after extent practicable2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking among agencies and inserting among1 and direct communication between1 agencies2 7,,ii7 by inserting the sharing of information from applicable public health data systems1 after ,technology712 and 7,,iii7 by striking 2 and at the end and inserting a semicolon2 7ii7 in subparagraph 7,b71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following3 7,c7 facilitate communication1 including bidirectional communication or other means of communication1 to enable timely information sharing with ,state1 local1 and ,tribal public health officials1 between agencies and offices of the ,department of ,health and ,human ,services1 and with health care providers1 as applicable and appropriate4 2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by striking 1 the ,secretary may and inserting and support the near real-time public availability of data1 as appropriate1 pursuant to section #cai;,d-#b1 the ,secretary shall establish a pilot program to2 and 7ii7 by striking 1 in collaboration with appropriate and inserting 4 ,such ,states or consortia of ,states shall carry out such activities in collaboration with appropriate stakeholders1 such as health information exchanges1 laboratory information systems12 7,b7 in paragraph 7#b77;,a71 by inserting pursuant to paragraph 7#c7 after may require2 7,c7 by striking paragraph 7#f72 7,d7 by redesignating paragraphs 7#c7 through 7#e7 as paragraphs 7#d7 through 7#f71 respectively2 7,e7 by inserting after paragraph 7#b7 the following3 7#c7 ,data plan ,for purposes of this subsection1 the ,secretary shall develop a plan for data elements to be reported to the ,secretary pertaining to potentially catastrophic infectious disease outbreaks1 in such form and manner and at such timing and frequency as determined by the ,secretary4 ,when developing the plan under this subsection1 the ,secretary shall-- 7,a7 align with the standards and implementation specifications adopted by the ,secretary under section #cjjd1 where applicable1 and update1 as necessary and consistent with applicable requirements of subsection 7b77#c7 and section #bhbc1 uniform standards for applicable entities to report data elements2 7,b7 consider the use of technologies that enable fast bulk exchange of data2 and 7,c7 ensure the data elements reported under this subsection and made publicly available pursuant to section #cai;,d-#b are made available consistent with applicable ,federal and ,state privacy law1 at a minimum4 2 and 7,f7 in paragraph 7#d71 as so redesignated-- 7i7 in subparagraph 7,a71 by striking emergencies2 and inserting emergencies1 including such diseases recommended by the ,national ,public ,health ,data ,board established under section #cai;,d-#b2 and2 7ii7 in subparagraph 7,b71 by striking 2 and and inserting a period2 and 7iii7 by striking subparagraph 7,c72 and 7#c7 in subsection 7h7-- 7,a7 in paragraph 7#a71 by striking #bjbb and #bjbc and inserting #bjbd through #bjbh2 and 7,b7 in paragraph 7#b71 by striking #bjbb and #bjbc and inserting #bjbd through #bjbh4 7b7 ,data selection and access ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cai;,d-#a the following3 #cai;,d-#b4 ,public health data pilot program 7a7 ,in general ,the ,secretary shall-- 7#a7 establish and maintain a near real-time1 open source1 public-facing1 and publicly available website to provide deidentified1 aggregated data on potentially catastrophic disease outbreaks1 in accordance with subsection 7b72 and 7#b7 collect the data elements pertaining to such diseases recommended pursuant to subsection 7b77#a77;,b71 using existing processes or any new processes established pursuant to section #cai;,d7d74 7b7 ,national ,public ,health ,data ,board 7#a7 ,in general ,the ,secretary shall establish a ,national ,public ,health ,data ,board to advise1 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 #cai;,d7d7 and the website established under subsection 7a77#a74 7#b7 ,membership ,the ,board established under paragraph 7#a7 shall consist of the following members3 7,a7 ,federal members ,the following ,federal members3 7i7 ,the ,secretary of ,health and ,human ,services4 7ii7 ,the ,secretary of ,defense4 7iii7 ,the ,secretary of ,veterans ,affairs4 7iv7 ,the ,national ,coordinator for ,health ,information ,technology4 7v7 ,the ,director of the ,national ,institutes of ,health4 7vi7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7vii7 ,the ,assistant ,secretary for ,preparedness and ,response4 7viii7 ,the ,director of the ,indian ,health ,service4 7ix7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7x7 ,the ,commissioner of ,food and ,drugs4 7xi7 ,such other heads of departments1 agencies1 and offices as the ,secretary determines appropriate4 7,b7 ,non-,federal members ,such other individuals appointed by the ,secretary-- 7i7 who have relevant public health1 medical1 or scientific expertise1 including-- 7,i7 individuals with expertise or experience in-- 7aa7 ,state1 local1 or ,tribal health data systems or practices2 or 7bb7 health data standards and technology systems1 which may include hospital1 pharmacy1 laboratory information systems and health information exchanges2 and 7,,ii7 representatives of national public health organizations2 and 7ii7 individuals with such other specific expertise as the ,secretary determines appropriate4 7c7 ,rule of construction ,nothing in this section shall be construed to alter existing obligations under regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 and this section shall be applied in a manner that is consistent with applicable ,federal and ,state privacy law1 at a minimum4 7d7 ,nonduplication of efforts ,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 ,secretary4 7e7 ,sunset ,this section shall cease to have force or effect on ,september #cj1 #bjbh4 4 #bje4 ,combating antimicrobial resistance ,section #cai;,e of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by inserting and activities after ,federal programs2 7,b7 in paragraph 7#b7-- 7i7 by striking public health constituencies1 manufacturers1 veterinary and medical professional societies and others and inserting the ,advisory ,council described in subsection 7b7 and relevant public and private entities2 and 7ii7 by inserting 1 pursuant to paragraph 7#d71 after comprehensive plan2 7,c7 by amending paragraph 7#c7 to read as follow3 7#c7 ,agenda ,the task force described in paragraph 7#a7 shall consider factors the ,secretary considers appropriate1 including factors to-- 7,a7 slow the emergence of resistant bacteria and fungi and prevent the spread of resistant infections2 7,b7 strengthen activities to combat resistance with respect to zoonotic diseases2 7,c7 advance development and use of rapid and innovative capabilities1 including diagnostic tests1 for identification and characterization of resistant bacteria and fungi2 7,d7 accelerate basic and applied research and development for new antibiotics1 antifungals1 and other related therapeutics and vaccines2 and 7,e7 support international collaboration and capacities for antimicrobial-resistance prevention1 detection1 and control4 2 7,d7 by redesignating paragraph 7#d7 as paragraph 7#e72 and 7,e7 by inserting after paragraph 7#c7 the following3 7#d7 ,action plan ,not later than ,october #a1 #bjbe1 and every #e years thereafter1 the task force described in paragraph 7#a7 shall develop and submit to the ,committee on ,health1 ,education1 ,labor1 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 resistance1 including measurable outcomes1 as appropriate1 informed by the agenda described in paragraph 7#c7 and input provided by the ,advisory ,council described in subsection 7b7 and other relevant stakeholders provided pursuant to paragraph 7#b74 2 7#b7 by redesignating subsections 7b7 through 7o7 as subsections 7c7 through 7p71 respectively2 7#c7 by inserting after subsection 7a7 the following3 7b7 ,advisory council 7#a7 ,in general ,the ,secretary may continue the ,presidential ,advisory ,council on ,combating ,antibiotic-,resistant ,bacteria1 referred to in this subsection as the ,advisory ,council4 7#b7 ,duties ,the ,advisory ,council shall advise and provide information and recommendations to the ,secretary1 acting through the ,task ,force established under subsection 7a71 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 prevent1 diagnose1 mitigate1 or treat such resistance4 ,such advice1 information1 and recommendations may be related to improving ,federal efforts related to factors described in subsection 7a77#c7 and other topics related to antimicrobial resistance1 as appropriate4 7#c7 ,meetings and coordination 7,a7 ,meetings ,the ,advisory ,council shall meet not less than biannually and1 to the extent practicable1 in coordination with meetings of the task force established under subsection 7a74 7,b7 ,coordination ,the ,advisory ,council shall1 to the greatest extent practicable1 coordinate activities carried out by the ,council with the task force established under subsection 7a74 7#d7 ,,faca ,chapter #aj of title #e1 ,united ,states ,code1 shall apply to the activities and duties of the ,advisory ,council4 2 and 7#d7 in subsection 7n71 as so redesignated1 by striking 7f7 through 7j7 and inserting 7g7 through 7k74 #bjf4 ,strategic ,national ,stockpile and material threats ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#b77;,b77i71 by striking subclause 7,,iv7 and inserting the following3 7,,iv7 the emergency health security threat or threats such countermeasure procurement is intended to address1 including-- 7aa7 whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats2 and 7bb7 in the case of a countermeasure that addresses a biological agent1 whether such agent has an increased likelihood to become resistant to1 more resistant to1 or evade1 such countermeasure relative to other available medical countermeasures2 2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,b71 by striking are followed1 regularly reviewed1 and updated with respect to such stockpile and inserting with respect to such stockpile are followed1 regularly reviewed1 and updated to reflect best practices2 7ii7 by redesignating subparagraphs 7,h7 through 7,k7 as subparagraphs 7,i7 through 7,l71 respectively2 and 7iii7 by inserting after subparagraph 7,g7 the following3 7,h7 utilize tools to enable the timely and accurate tracking1 including the location and geographic distribution and utilization1 of the contents of the stockpile throughout the deployment of such contents2 2 7#b7 in subsection 7c77#b77;,c7-- 7,a7 by striking promptly2 and 7,b7 by inserting 1 not later than #fj days after such determination2 7#c7 in subsection 7f77#a71 by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjba1 and #gej1jjj1jjj for each of fiscal years #bjbb and #bjbc and inserting #ife1jjj1jjj for each of fiscal years #bjbd through #bjbh2 and 7#d7 in subsection 7g77#a71 by striking #bjai through #bjbh and inserting #bjbd through #bjcc4 #bjg4 ,medical countermeasures for viral threats with pandemic potential ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7c77#d7-- 7,a7 in subparagraph 7,d71 by amending clause 7iii7 to read as follows3 7iii7 conduct research to promote strategic initiatives1 such as-- 7,i7 rapid diagnostics2 7,,ii7 broad spectrum antimicrobials2 7,,iii7 medical countermeasures for virus families that have significant potential to cause a pandemic1 including such countermeasures that take either pathogen-specific or broad spectrum approaches2 and 7,,iv7 technologies to improve the production and use of medical countermeasures1 which may include vaccine-manufacturing technologies1 dose-sparing technologies1 efficacy-increasing technologies1 platform technologies1 technologies to administer countermeasures1 and technologies to improve storage and transportation of countermeasures4 2 and 7,b7 in subparagraph 7,f71 by amending clause 7ii7 to read as follows3 7ii7 threats that-- 7,i7 7aa7 consistently exist or continually circulate and have a significant potential to become a pandemic1 such as pandemic influenza2 or 7bb7 include priority virus families and other viral pathogens with a significant potential to cause a pandemic2 and 7,,ii7 may include the advanced research and development1 manufacturing1 and appropriate stockpiling of qualified pandemic or epidemic products1 and products1 technologies1 or processes to support the advanced research and development of such countermeasures 7including multiuse platform technologies for diagnostics1 vaccines1 and therapeutics2 virus seeds2 clinical trial lots2 novel virus strains2 and antigen and adjuvant material72 2 7#b7 in subsection 7d77#b71 by striking #faa1gjj1jjj for each of fiscal years #bjai through #bjbc and inserting #iej1jjj1jjj for each of fiscal years #bjbd through #bjbh2 and 7#c7 in subsection 7e77#a71 by amending subparagraph 7,d7 to read as follows3 7,d7 ,sunset ,this paragraph shall cease to have force or effect after ,september #cj1 #bjbh4 4 #bjh4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,section #bhaa-a7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by redesignating subparagraph 7,d7 as subparagraph 7,e72 and 7,b7 by inserting after subparagraph 7,c7 the following3 7,d7 ,assist the ,secretary in developing strategies for appropriate and evidence-based allocation and distribution of countermeasures to jurisdictions1 in a manner that supports the availability and use of such countermeasures1 for public health and medical preparedness and response needs4 2 7#b7 in paragraph 7#b71 by striking 1 as appropriate2 and 7#c7 by adding at the end the following3 7#c7 ,information sharing ,the ,secretary shall1 as appropriate and in a manner that does not compromise national security1 share information related to recommendations made and strategies developed under subparagraphs 7,a7 and 7,c7 of paragraph 7#a7 with relevant stakeholders1 including industry and ,state1 local1 and ,tribal public health departments4 4 #bji4 ,strengthening public health communication 7a7 ,public health communications advisory committee ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish an advisory committee to be known as the ,public ,health ,communications ,advisory ,committee 7referred to in this subsection as the ,advisory ,committee74 7b7 ,duties ,the ,advisory ,committee shall make recommendations to the ,secretary and report on-- 7#a7 critical aspects of communication and dissemination of scientific and evidence-based public health information during public health emergencies2 7#b7 research from relevant external stakeholders related to evidence-based or evidence-informed strategies and best practices to effectively communicate and disseminate such information2 and 7#c7 strategies to improve communication and dissemination of scientific and evidence-based public health information to the public and to improve communication between ,federal1 ,state1 local1 and ,tribal health officials4 7c7 ,composition ,the ,advisory ,committee shall be composed of-- 7#a7 appropriate ,federal officials1 appointed by the ,secretary1 who shall serve as nonvoting members2 and 7#b7 individuals1 appointed by the ,secretary1 representing a variety of ,states and rural and urban areas1 and each of whom that has-- 7,a7 expertise in public health1 including individuals with experience in ,state1 local1 and ,tribal health departments1 medicine1 communications1 related technology1 psychology1 mental health and substance use disorders1 national security2 7,b7 experience in leading community outreach2 or 7,c7 expertise in other areas1 as the ,secretary determines appropriate4 7d7 ,dissemination ,the ,secretary shall review the recommendations of the ,advisory ,committee and1 not later than #ahj days after receipt of the report under subsection 7b71 shall submit to the ,committee on ,health1 ,education1 ,labor1 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 section4 7e7 ,termination ,the ,advisory ,committee shall terminate #b years after the date of enactment of this ,act4 #baj4 ,fellowship and training programs ,section #cag;,g of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#h7 is amended-- 7#a7 by striking ,the ,secretary1 and inserting the following3 7a7 ,in general ,the ,secretary1 2 and 7#b7 by adding at the end the following3 7b7 ,noncompetitive conversion 7#a7 ,in general ,the ,secretary may noncompetitively convert an individual who has completed an epidemiology1 surveillance1 or laboratory fellowship or training program under subsection 7a7 to a career-conditional appointment without regard to the provisions of subchapter ,i of chapter #cc of title #e1 ,united ,states ,code1 provided that individual meets qualification requirements for the appointment4 4 #baa4 ,assessment of ,,covid-#ai mitigation policies 7a7 ,,gao study ,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-#ai pandemic in the ,united ,states4 ,such study shall include-- 7#a7 a summary of strategies used by local governmental entities1 ,states1 and the ,federal ,government to contain and mitigate the spread of ,,covid-#ai during the public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 on ,january #ca1 #bjbj1 including-- 7,a7 limitations on large gatherings of people2 7,b7 the closure of schools1 businesses1 houses of worship1 and other facilities2 7,c7 masking policies2 7,d7 testing policies2 and 7,e7 vaccination policies2 7#b7 an analysis and review of the scientific evidence related to the effectiveness of such strategies in preventing or mitigating the spread of ,,covid-#ai1 including estimates of the burden of disease and death that were avoided through such interventions2 7#c7 an analysis and review of the economic and health impacts of such strategies1 including impacts related to mental and physical health and student learning loss2 and 7#d7 an accounting of ,federal funding used to implement such strategies4 7b7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report on the study under subsection 7a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,such report shall include recommendations based on the findings of the study conducted under subsection 7a7 regarding the impact of such strategies during the ,,covid-#ai public health emergency1 including how to improve future responses4 ,,iii ,addressing the needs of all individuals #cja4 ,transition of certain countermeasures between compensation programs 7a7 ,treatment of certain ineligible requests related to ,,covid-#ai countermeasures 7#a7 ,requests initially submitted under ,,cicp 7,a7 ,in general ,in the case of a request for compensation submitted under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 for an injury or death related to a ,,covid-#ai vaccine that the ,secretary determines to be ineligible pursuant to subparagraph 7,b7 of such section #cai;,f-#d7;b77#d71 as added by subsection 7b77#a71 the ,secretary shall1 not later than #cj days after such determination1 notify the individual submitting the request of such determination4 7,b7 ,submission of petition ,an individual who receives a notification described in subparagraph 7,a7 shall be eligible to submit a petition to the ,united ,states ,court of ,federal ,claims under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 with respect to the same vaccine administration claimed in the request submitted under section #cai;,f-#d of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 provided that such petition is submitted not later than the later of-- 7i7 #a year after receiving such notification under subparagraph 7,a72 or 7ii7 the last date on which the individual otherwise would be eligible to submit a petition relating to such injury1 as specified in section #baaf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#af74 7,c7 ,eligibility ,to be eligible to submit a petition in accordance with subparagraph 7,b71 the petitioner shall have submitted the request for compensation under section #cai;,f-#d of the ,public ,health ,service ,act that was determined to be ineligible not later than the deadline for filing a petition under section #baaf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#af7 that applies with respect to the administration of such vaccine4 7#b7 ,requests initially submitted under ,,vicp 7,a7 ,in general ,if a special master determines that-- 7i7 a petition submitted under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 related to a ,,covid-#ai vaccine is ineligible for the ,national ,vaccine ,injury ,compensation ,program under subtitle #b of title ,,xxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 because it relates to a vaccine administered at a time when the vaccine was not included in the ,vaccine ,injury ,table under section #baad of such ,act 7#db ,u4,s4,c4 #cjj;aa-#ad72 and 7ii7 the vaccine was administered when it was a covered countermeasure subject to a declaration under section #cai;,f-#c7;b7 of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b771 the special master shall1 not later than #cj days after such determination1 notify the petitioner of such determination4 7,b7 ,submission of request ,an individual who receives a notification described in subparagraph 7,a7 shall be eligible to submit a request for compensation under section #cai;,f-#d7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 with respect to the same vaccine administration claimed in the petition submitted under section #baaa of such ,act-- 7i7 not later than #a year after receiving such notification2 or 7ii7 in the case that the notification is issued after judicial review of the petition under subsection 7e7 or 7f7 of section #baab of such ,act 7#db ,u4,s4,c4 #cjj;aa-#ab71 not later than #a 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 7e7 or 7f74 7,c7 ,eligibility ,to be eligible to submit a request for compensation in accordance with subparagraph 7,b71 the individual submitting the request shall have submitted the petition under section #baaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7 that was determined to be ineligible not later than one year after the date of administration of the vaccine4 7b7 ,changes to certain programs 7#a7 ,,cicp ,section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is amended-- 7,a7 in subsection 7b77#d7-- 7i7 by striking ,except as provided and inserting the following3 7,a7 ,in general ,except as provided 2 and 7ii7 by adding at the end the following3 7,b7 ,exclusion of injuries caused by vaccines on the vaccine injury table ,notwithstanding any other provision of this section1 no individual may be eligible for compensation under this section with respect to a vaccine that1 at the time it was administered1 was included in the ,vaccine ,injury ,table under section #baad4 2 and 7,b7 in subsection 7d77#c7-- 7i7 by striking ,this section and inserting the following3 7,a7 ,in general ,this section 2 and 7ii7 by adding at the end the following3 7,b7 ,exhaustion of remedies ,a covered individual shall not be considered to have exhausted remedies as described in paragraph 7#a71 nor be eligible to seek remedy under section #cai;,f-#c7;d71 unless such individual has provided to the ,secretary all supporting documentation necessary to facilitate the determinations required under subsection 7b77#d74 4 7#b7 ,,vicp ,title ,,xxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is amended-- 7,a7 in section #baaa7;a77#b77;,a7 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a771 in the matter preceding clause 7i71 by inserting containing the information required under subsection 7c7 after unless a petition2 7,b7 in section #baab7;d7 7#db ,u4,s4,c4 #cjj;aa-#ab7;d77-- 7i7 by adding at the end of paragraph 7#a7 the following3 ,such designation shall not occur until the petitioner has filed all materials required under section #baaa7;c742 and 7ii7 in paragraph 7#c77;,a77ii71 by striking the petition was filed and inserting on which the chief special master makes the designation pursuant to paragraph 7#a72 7,c7 in section #baad7;e7 7#db ,u4,s4,c4 #cjj;aa-#ad7;e77-- 7i7 in paragraph 7#b71 in the matter preceding subparagraph 7,a71 by striking #b years and inserting #f months2 and 7ii7 by adding at the end the following3 7#d7 ,licensure requirement ,notwithstanding paragraphs 7#b7 and 7#c71 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 #cea4 ,upon such revision of the ,vaccine ,injury ,table1 all vaccines to prevent the same infectious disease1 including vaccines authorized under emergency use pursuant to section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 shall be considered included in the ,vaccine ,injury ,table4 2 and 7,d7 in section #baaf 7#db ,u4,s4,c4 #cjj;aa-#af71 by adding at the end the following3 7d7 ,clarification ,notwithstanding subsections 7a7 and 7b71 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 #cai;,f-#c7;b7 shall not be eligible for compensation under the ,program4 4 #cjb4 ,accelerating injury compensation program administration and ensuring program integrity 7a7 ,in general ,section #baab7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa#ab7;c77 is amended-- 7#a7 in paragraph 7#a71 by striking not more than #h special masters and inserting not fewer than #aj special masters2 and 7#b7 in paragraph 7#d7-- 7,a7 by striking a term of #d years and inserting an initial term of #d years2 7,b7 by striking the second and third sentences2 and 7,c7 by adding at the end the following3 ,an individual appointed as special master may be reappointed to serve one or more additional terms of up to #h years each1 pursuant to paragraph 7#a71 and subject to termination under paragraphs 7#b7 and 7#c744 7b7 ,petitions for compensation ,section #baaa7;a77#b77;,a77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#aa7;a77#b77;,a77i77 is amended-- 7#a7 in subclause 7,i71 by striking 1 and and inserting a semicolon2 7#b7 in subclause 7,,ii7-- 7,a7 by moving the margin #b ems to the right2 and 7,b7 by striking 1 or and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 the judgment described in subclause 7,i7 does not result from a petitioner's motion to dismiss the case2 or 4 7c7 ,compensation ,section #baae7;e77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ae7;e77#a77 is amended by adding at the end the following3 ,when making a determination of good faith under this paragraph1 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 #baba7;b744 #cjc4 ,compensation for injuries relating to the public health emergency caused by ,,sars-,co,v-#b 7a7 ,in general ,with respect to claims filed under the ,countermeasure ,injury ,compensation ,program 7referred to in this section as the ,program7 under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 alleging a covered injury caused by the administration or use of a covered countermeasure pursuant to a declaration under section #cai;,f-#c7;b7 of such ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7b77 relating to ,,covid-#ai1 the following shall apply3 7#a7 ,notwithstanding the filing deadline applicable under section #cai;,f-#d1 the claim shall be filed within #c years of the administration or use of the covered countermeasure1 or one year after enactment of this section1 whichever is later1 and1 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 7b77#d7 of such section #cai;,f-#d1 such claim may be refiled pursuant to this paragraph4 7#b7 ,with respect to a claim relating to the administration of a ,,covid-#ai vaccine1 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 #baad of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#ad74 7#c7 ,not later than #i months after the date of enactment of this section1 the ,secretary of ,health and ,human ,services shall promulgate a covered countermeasure injury table pursuant to subsection 7b77#e7 of section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7b77#e774 7b7 ,professional judgment budget 7#a7 ,in general ,the ,secretary of ,health and ,human ,services-- 7,a7 in consultation with the ,attorney ,general1 shall submit a budget outlining the resource needs for each agency for purposes of carrying out the ,national ,vaccine ,injury ,compensation ,program under subtitle #b of title ,,xxi of such ,act 7#db ,u4,s4,c4 #cjj;aa-#aj et seq47 for fiscal years #bjbd through #bjbh2 and 7,b7 shall submit a budget outlining resource needs for purposes of carrying out the ,countermeasures ,injury ,compensation ,program under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 for fiscal years #bjbd through #bjbh4 7#b7 ,inclusions ,the budgets described in subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 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 judgments4 7c7 ,,nasem report ,the ,secretary of ,health and ,human ,services shall seek to enter into a contract with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine under which such ,national ,academies shall report1 not later than #c years after the date of enactment of this ,act1 on the ,countermeasure ,injury ,compensation ,program under section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e71 including recommendations to improve the administration of such program and whether ,congress should adjust the compensation payments available under such program4 #cjd4 ,review of regulations ,the ,secretary of ,health and ,human ,services shall update regulations1 as needed for purposes of carrying out the amendments made by sections #cja and #cjb4 #cje4 ,supporting individuals with disabilities1 older adults1 and other at-risk individuals during emergency responses 7a7 ,technical assistance centers on at-,risk individuals and disasters 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 may1 through grants1 contracts1 or cooperative agreements to eligible entities1 establish more than one research1 training1 and technical assistance centers to provide appropriate information1 training1 and technical assistance to ,states1 localities1 ,tribes1 and other applicable entities related to addressing the unique needs and considerations of at-risk individuals1 as defined in section #bhjb7;b77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d771 in the event of a public health emergency declared by the ,secretary pursuant to section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d74 7#b7 ,responsibilities of the centers ,the centers established under paragraph 7#a7 shall conduct activities for the purpose of-- 7,a7 developing1 identifying1 evaluating1 and disseminating evidence-based or evidence-informed strategies to improve health and other related outcomes for at-risk individuals related to public health emergencies1 including by addressing such unique needs and considerations in carrying out public health and medical activities to prepare for1 respond to1 and recover from1 such public health emergencies2 and 7,b7 assisting applicable entities in the implementation of such evidence-based strategies1 including through sub-grants1 contracts1 or cooperative agreements4 7#c7 ,priority ,in awarding grants for activities described in this subsection1 the ,secretary shall give priority to eligible entities with demonstrated expertise in1 and ability to carry out1 the activities described in paragraph 7#b74 7#d7 ,consultation ,in carrying out activities under paragraph 7#b71 the centers established under paragraph 7#a7 shall take into consideration relevant findings and recommendations of1 and1 as appropriate1 consult with1 the ,national ,advisory ,committee on ,individuals with ,disabilities and ,disasters established under section #bhaa;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d71 the ,national ,advisory ,committee on ,children and ,disasters under section #bhaa;,a of such ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b71 and the ,national ,advisory ,committee on ,seniors and ,disasters under section #bhaa;,b of such ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c74 7#e7 ,reports ,not later than #b years after the date of enactment of this ,act and every #b years thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 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 #b fiscal years4 7#f7 ,sunset ,this subsection shall cease to have force or effort on ,september #cj1 #bjbh4 7b7 ,crisis standards of care ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 acting through the ,director of the ,office for ,civil ,rights of the ,department of ,health and ,human ,services1 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 #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d71 or a major disaster or emergency declared by the ,president under section #dja or #eja1 respectively1 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eagj1 #eaia7 to ensure that such standards of care are consistent with the nondiscrimination requirements of section #ejd of the ,rehabilitation ,act of #aigc 7#bi ,u4,s4,c4 #gid71 title ,,ii of the ,americans with ,disabilities ,act of #aiij 7#db ,u4,s4,c4 #abaca et seq471 and the ,age ,discrimination ,act of #aige 7#db ,u4,s4,c4 #faja et seq474 #cjf4 ,national advisory committees 7a7 ,national advisory committee on children and disasters ,section #bhaa;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;b7 is amended-- 7#a7 in subsection 7c7-- 7,a7 by striking may provide advice and inserting the following3 8may provide-- 7#a7 advice 2 7,b7 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7#b7 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 children4 2 and 7#b7 in subsection 7g71 by striking #bjbc and inserting #bjbh4 7b7 ,national advisory committee on seniors and disasters ,section #bhaa;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;c7 is amended-- 7#a7 in subsection 7c7-- 7,a7 by striking may provide advice and inserting the following3 8may provide-- 7#a7 advice 2 7,b7 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7#b7 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 seniors4 2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking #ag members and inserting #be members2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,j71 by striking #b and inserting #c2 7ii7 in subparagraph 7,k71 by striking #b and inserting #c2 7iii7 by redesignating subparagraphs 7,k7 through 7,l7 as subparagraphs 7,l7 through 7,m71 respectively2 and 7iv7 by inserting after subparagraph 7,j7 the following3 7,k7 ,at least #b non-,federal health care professionals with expertise in gerontology4 2 and 7#c7 by amending subsection 7g7 to read as follows3 7g7 ,sunset ,the ,advisory ,committee shall terminate on ,september #cj1 #bjbh4 4 7c7 ,national advisory committee on individuals with disabilities and disasters ,section #bhaa;,c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;d7 is amended-- 7#a7 by redesignating subsections 7c7 through 7g7 as subsections 7d7 through 7h71 respectively2 7#b7 by inserting after subsection 7b7 the following3 7c7 ,additional duties ,the ,advisory ,committee may provide-- 7#a7 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 ,,iii2 and 7#b7 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 disabilities4 2 7#c7 in subsection 7d71 as so redesignated-- 7,a7 in paragraph 7#a71 by striking #ag members and inserting #be members2 7,b7 in paragraph 7#b7-- 7i7 by striking subparagraphs 7,k7 through 7,m72 and 7ii7 by inserting after subparagraph 7,j7 the following3 7,k7 #ae non-,federal members 7at least #d of whom shall be individuals with disabilities7 from diverse backgrounds1 including the following3 7i7 ,one representative from each of the following3 7,i7 ,a nongovernmental organization that provides disaster preparedness and response services4 7,,ii7 ,a community-based organization that represents individuals with multiple types of disabilities4 7,,iii7 ,a ,state-based organization that represents individuals with multiple types of disabilities4 7,,iv7 ,a national organization that represents individuals with multiple types of disabilities4 7,v7 ,a national organization that represents older adults4 7,,vi7 ,an organization that provides relevant housing services1 including during the response to1 and recovery from1 disasters4 7,,vii7 ,an organization that represents disabled veterans4 7ii7 ,four individuals with geographically diverse expertise in emergency management4 7iii7 ,two non-,federal health care professionals with expertise in disability accessibility before1 during1 and after disasters1 medical and mass care disaster planning1 preparedness1 response1 or recovery4 2 and 7,c7 by adding at the end the following3 7#c7 ,consideration ,in appointing members1 including the ,chair1 to the ,committee under this subsection1 the ,secretary may give consideration to disability status4 2 and 7#d7 by amending subsection 7h71 as so redesignated1 to read as follows3 7h7 ,sunset ,the ,advisory ,committee shall terminate on ,september #cj1 #bjbh4 4 #cjg4 ,research and coordination of activities concerning the long-term health effects of ,,sars-,co,v-#b infection 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 as appropriate-- 7#a7 coordinate activities among relevant ,federal departments and agencies with respect to addressing the long-term health effects of ,,sars-,co,v-#b infection1 which may include conditions that arise as a result of such infection2 7#b7 continue to conduct or support basic1 clinical1 epidemiological1 behavioral1 and translational research and public health surveillance related to the pathogenesis1 prevention1 diagnosis1 and treatment of the long-term health effects of ,,sars-,co,v-#b infection and re-infection1 which may include conditions and any effects on development1 cognition1 and neural structure and function that arise as a result of such infection2 and 7#c7 consistent with the findings of studies and research under paragraph 7#a71 in consultation with health and public health professional associations1 scientific and medical researchers1 and other relevant experts1 develop and inform recommendations1 guidance1 and educational materials on the long-term effects of ,,sars-,co,v-#b infection1 which may include conditions that arise as a result of such infection1 and provide such recommendations1 guidance1 and educational materials to health care providers and the general public4 7b7 ,considerations ,in conducting or supporting research under this section1 the ,secretary shall consider the diversity of research participants or cohorts to ensure inclusion of a broad range of participants1 as applicable and appropriate4 7c7 ,additional activities ,the ,secretary may-- 7#a7 acting through the ,director of the ,agency for ,healthcare ,research and ,quality1 conduct or support research related to-- 7,a7 the improvement of health care delivery for individuals experiencing long-term health effects of ,,sars-,co,v-#b1 which may include conditions that arise as a result of such infection2 7,b7 the identification of any trends associated with differences in diagnosis and treatment of the long-term health effects of ,,sars-,co,v-#b infection and related conditions2 and 7,c7 the development or identification of tools and strategies to help health care entities and providers care for such populations1 which may include addressing any differences identified pursuant to subparagraph 7,b72 7#b7 publicly disseminate the results of such research2 and 7#c7 establish a primary care technical assistance initiative to convene primary care providers and organizations1 which may include support for continuing training and education for such providers1 as applicable and appropriate1 in order to collect and disseminate best practices related to the care of individuals with long-term health effects of ,,sars-,co,v-#b infection1 which may include conditions that arise as a result of such infection4 7d7 ,annual reports ,not later than #a year after the date of enactment of this ,act1 and annually thereafter for the next #d years1 the ,secretary shall prepare and submit a report to the ,committee on ,health1 ,education1 ,labor1 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 findings4 ,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 entities4 7e7 ,public availability of information ,in making information or reports publicly available under this section1 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 recipients1 including at-risk individuals4 #cjh4 ,national ,academies study on prizes 7a7 ,in general ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall seek to enter into an agreement with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7referred to in this section as the ,national ,academies7 to conduct a study to examine-- 7#a7 alternative models for directly funding1 or stimulating investment in1 biomedical research and development that delink research and development costs from the prices of drugs1 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 milestones2 7#b7 the dollar amount of innovation prizes for different stages of research and development of different classes or types of drugs1 and total annual funding1 that would be necessary to stimulate investment sufficient to achieve such successful drug development and related milestones2 7#c7 the relative effectiveness and efficiency of such alternative models in stimulating innovation1 compared to the status quo that includes patents and regulatory exclusivities2 7#d7 strategies to implement such alternative models described in paragraph 7#a71 including a phased transition over time2 and 7#e7 the anticipated economic and societal impacts of such alternative models1 including an assessment of impact on-- 7,a7 the number and variety of new drugs that would be developed1 approved1 and marketed in the ,united ,states1 including such new drugs intended to prevent1 diagnose1 or treat a rare disease or condition2 7,b7 the rate at which new drugs would be developed1 approved1 and marketed in the ,united ,states2 7,c7 access to medication and health outcomes2 7,d7 average lifespan and disease burden in the ,united ,states2 7,e7 the number of manufacturers that would be seeking approval for a drug or bringing a drug to market for the first time2 7,f7 ,federal discretionary and mandatory spending2 and 7,g7 public and private insurance markets4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #c1jjj1jjj for fiscal year #bjbd4 7c7 ,requirements ,in conducting the study pursuant to subsection 7a71 the ,national ,academies shall hold not fewer than #b public listening sessions to solicit feedback from interested parties1 including representatives of academia1 professional societies1 patient advocates1 public health organizations1 relevant ,federal departments and agencies1 drug developers1 representatives of other relevant industries1 and subject matter experts4 7d7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,national ,academies shall submit to the ,committee on ,health1 ,education1 ,labor1 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 7a74 ,,iv ,strengthening biosecurity #dja4 ,treatment of genetic variants and synthetic products of select agents and toxins ,section #cea;,a7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7a77#a77 is amended by adding at the end the following3 7,c7 ,inclusions 7i7 ,in general ,for purposes of the list under this paragraph1 the following shall be considered to be a biological agent or toxin included on the list3 7,i7 ,any biological agent that incorporates nucleic acids coding for a virulence factor from a listed agent or toxin4 7,,ii7 ,any biological agent or toxin that is genetically homologous to a listed agent or toxin with respect to nucleotides coding for virulence factors or toxicity4 7,,iii7 ,any biological agent or toxin that is synthetically derived with virulence or toxicity characteristics of a listed agent or toxin4 7,,iv7 ,any nucleic acid that encodes for components contributing to pathogenicity1 transmissibility1 or toxicity of a listed agent or toxin4 7ii7 ,exemptions ,the ,secretary may exempt from inclusion on the list under this paragraph any biological agent1 toxin1 or nucleic acid described in clause 7i71 if such agent1 toxin1 or nucleic acid does not meet the criteria under subparagraph 7,b74 4 #djb4 ,establishment of no-fault reporting system ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cea;,a 7#db ,u4,s4,c4 #bfb;a7 the following3 #cea;,b4 ,no-fault reporting system 7a7 ,definitions ,in this section3 7#a7 ,the term listed agents and toxins has the meaning given the term in section #cea;,a7l74 7#b7 ,the term reporting system means the reporting system established under subsection 7b77#a74 7b7 ,establishment 7#a7 ,in general ,not later than #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,response ,act1 the ,secretary shall establish a confidential1 anonymous1 voluntary1 no-fault reporting system related to accidents1 near-accidents1 or other safety incidents involving biological agents and toxins1 in order to support continuous improvement and sharing of lessons learned related to such incidents4 7#b7 ,availability ,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 ,states1 or at federally-funded entities outside the ,united ,states1 that conduct research involving biological agents and toxins4 7#c7 ,data ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,response ,act1 the ,secretary shall publish a notice in the ,federal ,register on plans for the reporting system1 including-- 7,a7 data elements that will be included in the submission of reports2 7,b7 procedures and processes for the submission of reports2 7,c7 criteria for incidents that may be reported to such system2 and 7,d7 procedures for privacy and anonymization4 7#d7 ,prototyping and testing ,the ,secretary shall test and prototype the reporting system for not less than #a year before finalizing the reporting system4 7#e7 ,external feedback ,the ,secretary shall seek feedback on development of the reporting system from external stakeholders1 including prior to publication of the information under paragraph 7#c7 and prior to introduction of prototypes and finalization of such system under paragraph 7#d74 7c7 ,,foia 7#a7 ,in general ,information submitted to1 or derived from1 the reporting system shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code4 7#b7 ,applicability ,for purposes of paragraph 7#a71 this section shall be considered a statute described in section #eeb7;b77#c77;,b7 of title #e1 ,united ,states ,code4 7d7 ,prohibition on use as evidence ,information submitted to1 or derived from1 the reporting system shall not be used in any ,federal or ,state enforcement action or criminal prosecution4 7e7 ,privacy2 disciplinary action for unauthorized disclosure ,an individual or entity that submits information to the reporting system under subsection 7b7 shall not be required to provide their name4 7f7 ,relationship to other reporting systems ,the voluntary reporting system established under this section shall supplement1 and not supplant1 any other requirements to submit reports under any other reporting system4 4 #djc4 ,evaluation of the ,federal ,select ,agent ,program and related policies 7a7 ,in general ,not later than #d years after the date of enactment of this ,act1 the ,national ,science ,advisory ,board for ,biosecurity 7referred to in this section as the ,board7 established pursuant to section #djd,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhcr7 shall be charged with assessing the framework for biosafety and biosecurity oversight1 particularly with respect to mitigating risks to the ,united ,states population with respect to biological threats4 ,the findings of the ,board shall address scientific advancements and integration of the ,program and other related ,federal policies and frameworks for biosafety and biosecurity4 ,the findings of the ,board shall be transmitted to the ,president4 7b7 ,framework 7#a7 ,in general ,the recommendations developed under subsection 7a7 shall include a proposed framework for an integrated approach to the oversight of biological research that raises significant biosafety and biosecurity concerns1 which may include proposals to harmonize and modernize relevant ,federal policies such as the following3 7,a7 ,the ,federal ,select ,agent ,program4 7,b7 ,federal policies relating to dual-use research of concern4 7,c7 ,federal policies related to federally funded research involving enhanced pathogens of pandemic potential4 7,d7 ,the ,biosafety in ,microbiological and ,biomedical ,laboratories ,manual of the ,department of ,health and ,human ,services1 and other related guidance documents4 7,e7 ,the ,guidelines for ,research ,involving ,recombinant or ,synthetic ,nucleic ,acid ,molecules of the ,national ,institutes of ,health4 7#b7 ,requirements for framework ,the framework proposed under paragraph 7#a7 shall-- 7,a7 be developed in consultation with stakeholders and experts from institutions of higher education1 industry1 and other government agencies2 and 7,b7 make recommendations related to mitigating any identified risks associated with existing gaps in oversight of such research1 which may include research that does not receive ,federal funding1 taking into consideration any national security concerns1 the potential benefits of such research1 considerations related to the research community1 transparency1 and public availability of information1 and international research collaboration4 7c7 ,reorganization ,in carrying out this section1 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 agencies4 7d7 ,report ,not later than #a year after the issuance of recommendations under subsection 7a71 the ,president shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and1 as applicable1 other appropriate committees of ,congress1 a report that describes plans to consider and implement such recommendations1 including the identification of-- 7#a7 any barriers to implementation2 and 7#b7 any areas in which the ,president disagrees with the findings or recommendations of the ,board4 #djd4 ,supporting research and laboratory surge capacity 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall make awards to establish or maintain1 as applicable1 not fewer than #ab regional biocontainment laboratories1 for purposes of-- 7#a7 conducting biomedical research to support public health and medical preparedness for1 and rapid response to1 biological agents1 including emerging infectious diseases2 7#b7 ensuring the availability of surge capacity for purposes of responding to such biological agents2 7#c7 supporting information-sharing between1 and the dissemination of findings to1 researchers and other relevant individuals to facilitate collaboration between industry and academia2 and 7#d7 providing1 as appropriate and applicable1 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 agents4 7b7 ,requirements ,as a condition of receiving a grant under this section1 a regional biocontainment laboratory shall agree-- 7#a7 to such oversight activities as the ,secretary determines appropriate1 including periodic meetings with relevant officials of the ,department of ,health and ,human ,services1 facility inspections1 and other activities as necessary and appropriate to ensure compliance with the terms and conditions of such award2 and 7#b7 to report accidents1 near-accidents1 or other safety incidents involving biological agents and toxins into the no-fault reporting system established pursuant to section #cea;,b of the ,public ,health ,service ,act1 as added by section #djb4 7c7 ,board ,the ,secretary shall establish a ,board consisting of a representative from each entity in receipt of an award under subsection 7a71 which shall be headed by an executive committee of #c members elected upon an affirmative vote from a majority of such representatives4 ,the ,board shall make recommendations to the ,secretary in administering awards under this section1 for purposes of-- 7#a7 improving the quality and consistency of applicable procedures and practices within laboratories funded pursuant to subsection 7a72 and 7#b7 ensuring coordination1 as appropriate1 of federally funded activities carried out at such laboratories4 7d7 ,definition ,in this section1 the term regional biocontainment laboratory means a ,biosafety or ,animal ,biosafety ,level-#c and ,level-#b facility located at an institution in the ,united ,states that is designated by the ,secretary to carry out the activities described in subsection 7a74 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #eb1jjj1jjj for each of fiscal years #bjbd through #bjbh4 7f7 ,administrative expenses ,of the amount available to carry out this section for a fiscal year1 the ,secretary may use not more than #e percent for the administrative expenses of carrying out this section1 including expenses related to carrying out subsection 7c74 7g7 ,report to ,congress ,not later than #a year after the date of the enactment of this ,act1 and biannually thereafter1 the ,secretary1 in consultation with the heads of applicable ,federal departments and agencies shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on-- 7#a7 the activities and accomplishments of the regional biocontainment laboratories2 7#b7 any published or disseminated research findings based on research conducted in such laboratories in the applicable year2 7#c7 oversight activities carried out by the ,secretary pursuant to subsection 7b72 7#d7 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 agents1 which may include leveraging such capacity and capabilities to support the ,laboratory ,response ,network1 as applicable and appropriate2 7#e7 plans for the maintenance and sustainment of federally funded activities conducted at the regional biocontainment laboratories1 consistent with the strategy required under section #bcab of the ,,prevent ,pandemics ,act 7,public ,law #aag-cbh72 and 7#f7 activities undertaken by the ,secretary to coordinate with applicable agencies to ensure work carried out by such facilities is prioritized and complementary to one another1 and avoiding unnecessary duplication4 #dje4 ,gene synthesis 7a7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 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 concern4 ,such guidance shall include recommendations related to-- 7#a7 screening for sequences that the ,secretary determines may contribute to toxicity1 pathogenicity1 or virulence2 7#b7 screening and verification of the identity and legitimacy of customers2 7#c7 the identification1 evaluation1 and use of appropriate software or other tools to enable the screening described in paragraphs 7#a7 and 7#b72 7#d7 ensuring nucleic acid synthesis activities are carried out in compliance with existing regulations under part #gc of title #db1 ,code of ,federal ,regulations1 part #cca of title #g1 ,code of ,federal ,regulations1 part #aba of title #i1 ,code of ,federal ,regulations1 and part #ggd of title #ae ,code of ,federal ,regulations 7or successor regulations72 7#e7 implementing appropriate safeguards1 which may include the use of such software or other tools1 in gene synthesis equipment to facilitate screening of nucleic acid sequences and1 as applicable1 customers2 7#f7 maintaining records of customer orders1 metadata1 and screening system or protocol performance in specified formats1 which may include standardized machine-readable and interoperable data formats2 and 7#g7 other recommendations as determined appropriate by the ,secretary4 7b7 ,sequences of concern ,the ,secretary shall maintain a public docket to solicit recommendations on potential sequences of concern and1 in consultation with other ,federal departments and agencies and non-,federal experts1 as appropriate1 review and update1 on a regular basis1 a list of sequences of concern to facilitate screening under subsection 7a77#a74 7c7 ,landscape review ,the ,secretary1 in coordination with other ,federal departments and agencies1 as appropriate1 shall conduct a landscape review of providers and manufacturers of gene synthesis equipment1 products1 software1 and other tools with the purpose of understanding the number1 types1 and capabilities of products and equipment that exist domestically and to inform the development of any updates to the guidance under subsection 7a74 7d7 ,technical assistance ,the ,secretary1 in consultation with other ,federal departments and agencies1 shall provide technical assistance upon request of a gene synthesis provider1 manufacturer of gene synthesis equipment1 or developer of software or other screening tools to support implementation of the recommendations included in the guidance under subsection 7a74 7e7 ,definitions ,for purposes of this section3 7#a7 ,the term gene synthesis equipment means equipment needed to produce gene synthesis products4 7#b7 ,the term gene synthesis product-- 7,a7 means custom single-stranded or double-stranded ,,dna1 or single-stranded or double-stranded ,,rna1 which has been chemically or enzymatically synthesized or otherwise manufactured de novo and is of a length exceeding the screening threshold1 as determined by the ,secretary2 and 7,b7 does not include-- 7i7 base chemical subunits1 such as individual nucleotides or nucleosides1 or oligonucleotides shorter than the screening threshold typically used as polymerase chain reaction primers1 as determined by the ,secretary2 7ii7 by-products generated during sequencing that are not useful for assembly or cloning1 as determined by the ,secretary2 or 7iii7 products generated from cloning or assembling of existing gene or gene fragment material1 in circumstances in which the gene synthesis provider has no access or notice to the sequence design1 as determined by the ,secretary4 7#c7 ,the term gene synthesis provider means an entity that synthesizes and distributes gene synthesis products1 including bacteria1 viruses1 or fungi containing recombinant or synthetic nucleic acid molecules1 for delivery to a customer4 7#d7 ,the term manufacturers of gene synthesis equipment means an entity that produces and sells equipment for synthesizing gene synthesis products4 #djf4 ,limitation related to countries of concern conducting certain research ,section #bcae7;c7 of the ,,prevent ,pandemics ,act 7,public ,law #aag-cbh7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by inserting that may reasonably be anticipated to involve the creation1 transfer1 and use of enhanced pathogens of pandemic potential or biological agents or toxins listed pursuant to section #cea;,a7a77#a7 if such research is after not fund research2 and 7,b7 by striking 1 involving pathogens of pandemic potential and all that follows through the period at the end and inserting a period2 7#b7 in paragraph 7#b7-- 7,a7 in the heading1 by striking ,conditions for listing or suspending prohibition and inserting ,limitations2 and 7,b7 in the matter preceding subparagraph 7,a7-- 7i7 by striking ,the ,secretary and inserting ,beginning #e years after an initial determination of a country of concern1 the ,director of ,national ,intelligence or the ,secretary2 and 7ii7 by inserting with respect to such country of concern after paragraph 7#a72 and 7#c7 by adding at the end the following3 7#c7 ,clarification 7,a7 ,in general ,the requirement of paragraph 7#a7 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 outbreak4 7,b7 ,notification ,the ,president shall notify ,congress not later than #dh hours after exercising the waiver under subparagraph 7,a71 and shall provide updates to ,congress related to the use of such waiver every #ae days thereafter4 4 #djg4 ,assessment of artificial intelligence threats to health security 7a7 ,in general ,not later than #de days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall seek to enter into a contract with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7referred to in this section as the ,national ,academies7 to conduct a study assessing the potential vulnerabilities to health security presented by the current or prospective use or misuse of artificial intelligence1 including with respect to open-source artificial intelligence models1 such as large language models4 7b7 ,inclusions ,the study conducted pursuant to the contract under subsection 7a7 shall include-- 7#a7 an assessment of the potential vulnerabilities posed by technical advancements in artificial intelligence to health security1 including any risks related to the development of1 enhancement of1 or protection from1 chemical1 biological1 radiological1 or nuclear threats2 7#b7 a description of roles1 responsibilities1 and capabilities of agencies and offices of the ,department of ,health and ,human ,services1 and1 as applicable and appropriate1 other ,federal departments and agencies1 with respect to the identification and mitigation of such potential vulnerabilities2 7#c7 a summary of any ongoing ,federal activities related to the identification1 understanding1 and mitigation of such potential risks2 7#d7 the identification of any potential gaps1 whether current or anticipated1 related to such roles1 responsibilities1 and capabilities2 and 7#e7 recommendations to improve ,federal efforts to identify1 prepare for1 and mitigate such potential vulnerabilities4 7c7 ,reports 7#a7 ,national ,academies report ,not later than #b years after the date of the contract under subsection 7a71 the ,national ,academies shall submit to the ,committee on ,health1 ,education1 ,labor1 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 7a74 7#b7 ,,hhs report ,not later than #a year after the issuance of the report required under paragraph 7#a71 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 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 intelligence1 as detailed in the report under paragraph 7#a74 ,v ,preventing drug shortages #eja4 ,improving notification procedures in case of increased demand for critical drugs 7a7 ,in general ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the section heading1 by striking ,discontinuance or interruption in the production of life-saving drugs and inserting ,notification of issues affecting domestic supply of critical drugs2 7#b7 by striking subsections 7a71 7b71 and 7c71 and inserting the following3 7a7 ,notification required 7#a7 ,in general ,a manufacturer of a covered drug shall notify the ,secretary1 in accordance with subsection 7b71 of-- 7,a7 7i7 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 ,states2 7ii7 a permanent discontinuance in the manufacture of an active pharmaceutical ingredient of such drug1 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 drug2 or 7iii7 any other circumstance1 such as an increase in demand or export restriction1 that is likely to leave the manufacturer unable to meet demand for the drug without a meaningful shortfall or delay2 and 7,b7 the reasons for such discontinuance1 interruption1 or other circumstance1 if known4 7#b7 ,contents ,notification under this subsection with respect to a covered drug shall include-- 7,a7 with respect to the reasons for the discontinuation1 interruption1 or other circumstance described in paragraph 7#a77;,a77iii71 if an active pharmaceutical ingredient is a reason for1 or risk factor in1 such discontinuation1 interruption1 or other circumstance1 the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known to the manufacturer2 7,b7 whether any associated device used for preparation or administration included in the drug is a reason for1 or a risk factor in1 such discontinuation1 interruption1 or other circumstance described in paragraph 7#a77;,a77iii72 7,c7 the expected duration of the interruption2 and 7,d7 such other information as the ,secretary may require4 7b7 ,timing ,a notice required under subsection 7a7 shall be submitted to the ,secretary-- 7#a7 at least #f months prior to the date of the discontinuance or interruption2 7#b7 in the case of such a notice with respect to a circumstance described in subsection 7a77#a77;,a77iii71 as soon as practicable1 or not later than #aj business days after the onset of the circumstance2 or 7#c7 if compliance with paragraph 7#a7 or 7#b7 is not possible1 as soon as practicable4 7c7 ,distribution ,to the maximum extent practicable1 the ,secretary shall distribute1 through such means as the ,secretary determines appropriate1 information on the discontinuance or interruption of the manufacture of1 or other circumstance described in subsection 7a77#a77;,a77iii7 that is likely to lead to a shortage or meaningful disruption in the supply of1 covered drugs to appropriate organizations1 including physician1 health provider1 and patient organizations1 as described in section #ejf;,e4 2 7#c7 in subsection 7g71 in the matter preceding paragraph 7#a71 by striking drug described in subsection 7a7 and inserting covered drug2 and 7#d7 in subsection 7j71 by striking drug described in subsection 7a7 and inserting covered drug4 7b7 ,definitions ,paragraph 7#a7 of section #ejf;,c7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7h77 is amended to read as follows3 7#a7 the term covered drug means a drug that is intended for human use and that-- 7,a7 is-- 7i7 life-supporting2 7ii7 life-sustaining2 or 7iii7 intended for use in the prevention or treatment of a debilitating disease or condition1 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 #cai of the ,public ,health ,service ,act2 7,b7 is not a radio pharmaceutical drug product or any other product as designated by the ,secretary2 and 7,c7 is not a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act71 unless otherwise provided by the ,secretary in the regulations promulgated under subsection 7i72 4 #ejb4 ,reporting on supply chains ,section #eaj7;j77#c77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j77#c77;,a77 is amended-- 7#a7 by inserting 1 and the names and unique facility identifiers of the manufacturers of the active pharmaceutical ingredients such person used for the manufacture1 preparation1 propagation1 compounding1 or processing of such drug1 and the amount of such drug manufactured1 prepared1 propagated1 compounded1 or processed using each such active pharmaceutical ingredient from each such manufacturer before the period at the end of the first sentence2 and 7#b7 by inserting after the first sentence the following3 ,in addition to the reporting required under the preceding sentence1 the ,secretary may receive voluntary submissions of such information at more frequent intervals44 #ejc4 ,reporting on use of new authorities and requirements with respect to drug shortages ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on-- 7#a7 the extent to which the ,secretary has implemented the authorities and requirements under sections #ejf;,c7g71 #ejf;,c7j71 #ejf;,e7d71 #eaj7;j77#c71 and #gjd7;b77#b7 7#ba ,u4,s4,c4 #cef;c7g71 #cef;c7j71 #cef;e7d71 #cfj7;j77#c71 #cgd7;b77#b77 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #caaa and #caab of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf71 including-- 7,a7 specific examples of uses of such authorities and requirements2 and 7,b7 an assessment of the extent to which such authorities and requirements have helped mitigate drug shortages2 and 7#b7 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 ingredients1 pursuant to the amendments made to section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 by subsections 7a7 and 7b7 of section #caab of the ,coronavirus ,aid1 ,relief1 and ,economic ,security ,act 7,public ,law #aaf-acf74 ,,vi ,additional reauthorizations and technical amendments #fja4 ,medical countermeasure priority review voucher ,section #efe;,a7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7 is amended by striking #bjbc and inserting #bjbh4 #fjb4 ,epidemic ,intelligence ,service loan repayment program ,section #cag;,f7c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;b-#g7;c77#b77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fjc4 ,vaccine tracking and distribution ,section #cai;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fjd4 ,regional health care emergency preparedness and response systems ,section #cai;,c-#c7;e77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;c7e77#b77 is amended by striking #bjbc and inserting #bjbh4 #fje4 ,emergency system for advance registration of volunteer health professional ,section #cai;,i7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7k77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fjf4 ,limited antitrust exemption ,section #cai,l-#a7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;f7b77 is amended by striking at the end of the #ag-year period that begins on the date of enactment of this ,act and inserting on ,september #cj1 #bjbh4 #fjg4 ,trauma care ,section #abcb7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#cb7;a77 is amended by striking #bd1jjj1jjj for each of fiscal years #bjbc through #bjbg and inserting #ci1jjj1jjj for each of fiscal years #bjbd through #bjbh4 #fjh4 ,military and civilian partnership for trauma readiness ,section #abia7;g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#ia7;g77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fji4 ,national ,disaster ,medical ,system 7a7 ,in general ,section #bhab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 is amended-- 7#a7 in subsection 7c77#d77;,b71 by striking #bjbc and inserting #bjbh2 and 7#b7 in subsection 7g71 by striking #eg1djj1jjj for each of fiscal years #bjai through #bjbc and inserting #fe1ijj1jjj for each of fiscal years #bjbd through #bjbh4 7b7 ,repeal of sunset 7#a7 ,in general ,section #cja7;d77#c7 of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai 7,public ,law #aaf-bb2 #cd ,u4,s4,c4 #ajbhd note7 is repealed4 7#b7 ,effective date ,paragraph 7#a7 shall take effect as if enacted on ,september #cj1 #bjba4 #faj4 ,volunteer ,medical ,reserve ,corps ,section #bhac7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #faa4 ,epidemiology-laboratory capacity grants ,section #bhba7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ca7;b77 is amended1 in the matter preceding paragraph 7#a71 by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fab4 ,veterans ,affairs ,section #haag7;g7 of title #ch1 ,united ,states ,code is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 #fac4 ,technical amendments 7a7 ,title ,,xxi of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;aa-#a et seq47 is amended-- 7#a7 in section #baje7;b71 by striking 1 #bajc1 and #bajd each place it appears and inserting and #bajc2 7#b7 in section #baaj7;b71 by striking the program and inserting ,the ,program2 7#c7 in section #baaa7;a7-- 7,a7 in paragraph 7#f71 by striking #aihh for and inserting #aihh1 for2 and 7,b7 in paragraph 7#aj71 by striking ,united ,states ,claims ,court and inserting ,united ,states ,court of ,federal ,claims2 7#d7 in section #baab-- 7,a7 in subsection 7c77#f77;,a71 by striking ,united ,states ,claims ,courts and inserting ,united ,states ,court of ,federal ,claims2 and 7,b7 in subsection 7f7-- 7i7 by striking ,united ,states ,claims ,court on and inserting ,united ,states ,court of ,federal ,claims on2 and 7ii7 by striking ,united ,states ,claims ,court's judgment and inserting judgment of the ,united ,states ,court of ,federal ,claims2 7#e7 in section #baae7;b77#c71 by striking subsection 7e7 and inserting subsection 7e772 7#f7 in section #baag-- 7,a7 in the section heading1 by striking ,subrogration and inserting ,subrogation2 and 7,b7 in subsection 7a71 by striking subrograted and inserting subrogated2 and 7#g7 in section #babg-- 7,a7 in subsection 7b77#a71 by inserting and ,prevention before the period2 and 7,b7 in subsection 7c71 by striking ,committee on ,labor and ,human ,resources and inserting ,committee on ,health1 ,education1 ,labor1 and ,pensions4 7b7 ,section #cai;,f-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7 is amended-- 7#a7 in subsection 7c77#e77;,b77ii77,i71 by striking chapter #e and inserting chapter ,v2 and 7#b7 in subsection 7i77#g7-- 7,a7 by striking #cba7;g77#a77 and inserting #cba7;g77#a7772 and 7,b7 by striking #cba7;h77 and inserting #cba7;h7774 7c7 ,section #cai;,f-#d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;e7 is amended-- 7#a7 in subsection 7b77#a71 by striking under #cai;,f-#c7;b7 and inserting under section #cai;,f-#c7;b72 and 7#b7 in subsection 7d77#e71 by striking under subsection 7a7 the ,secretary determines that a covered individual qualifies for compensation and inserting a covered individual is determined under subsection 7a7 to be eligible for compensation under this section4 7d7 ,part ,c of title ,,ii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bci et seq47 is amended-- 7#a7 in section #bfa7;a77#b77;,a71 by striking specialities and inserting specialties2 7#b7 in section #bfe7;c77#e71 by striking involves and inserting involved2 7#c7 in section #bff7;b77#c77;,b77ii71 by striking to with respect to an eligible and inserting with respect to an eligible2 and 7#d7 in section #bfg7;b71 by striking such ,act and inserting such part4 7e7 ,section #cea;,a7e77#g77;,b77ii7 is amended by striking judical and inserting judicial4