,,ii #aaeth ,,congress #b;d ,session ,s4 #bheb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #ae1 #bjah,mr4 ,burr 7for himself1 ,mr4 ,casey1 ,mr4 ,alexander1 and ,mrs4 ,murray7 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 ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,references in ,act4 ,,title ,i--,strengthening the national health security strategy ,sec4 #aja4 ,national ,health ,security ,strategy4 ,,title ,,ii--,improving preparedness and response ,sec4 #bja4 ,improving benchmarks and standards for preparedness and response4 ,sec4 #bjb4 ,amendments to preparedness and response programs4 ,sec4 #bjc4 ,regional health care emergency preparedness and response systems4 ,sec4 #bjd4 ,public health and health care system situational awareness and biosurveillance capabilities4 ,sec4 #bje4 ,strengthening and supporting the public health emergency rapid response fund4 ,sec4 #bjf4 ,improving preparedness for and response to all-hazards by public health emergency volunteers4 ,,title ,,iii--,reaching all communities ,sec4 #cja4 ,strengthening and assessing the emergency response workforce4 ,sec4 #cjb4 ,health system infrastructure to improve preparedness and response4 ,sec4 #cjc4 ,considerations for at-risk individuals4 ,sec4 #cjd4 ,improving emergency preparedness and response considerations for children4 ,sec4 #cje4 ,reauthorizing the ,national ,advisory ,committee on ,children and ,disasters4 ,sec4 #cjf4 ,guidance for participation in exercises and drills4 ,,title ,,iv--,prioritizing a threat-based approach ,sec4 #dja4 ,assistant ,secretary for ,preparedness and ,response4 ,sec4 #djb4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise4 ,sec4 #djc4 ,strategic ,national ,stockpile4 ,sec4 #djd4 ,preparing for pandemic influenza1 antimicrobial resistance1 and other significant threats4 ,sec4 #dje4 ,reporting on the ,federal ,select ,agent ,program4 ,,title ,v--,increasing communication in medical countermeasure advanced research and development ,sec4 #eja4 ,medical countermeasure budget plan4 ,sec4 #ejb4 ,material threat and medical countermeasure notifications4 ,sec4 #ejc4 ,availability of regulatory management plans4 ,sec4 #ejd4 ,the ,biomedical ,advanced ,research and ,development ,authority and the ,bio,shield ,special ,reserve ,fund4 ,,title ,,vi--,advancing technologies for medical countermeasures ,sec4 #fja4 ,administration of countermeasures4 ,sec4 #fjb4 ,medical countermeasure master files4 ,sec4 #fjc4 ,animal rule report4 ,,title ,,vii--,miscellaneous provisions ,sec4 #gja4 ,reauthorizations and extensions4 ,sec4 #gjb4 ,technical amendments4 #b4 ,references in ,act ,except as otherwise specified1 amendments made by this ,act to a section or other provision of law are amendments to such section or other provision of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 ,i ,strengthening the national health security strategy #aja4 ,national ,health ,security ,strategy ,section #bhjb 7#db ,u4,s4,c4 #cjj;hh-#a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by striking #bjad and inserting #bjah2 and 7ii7 by striking the second sentence and inserting the following3 ,such ,national ,health ,security ,strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection 7b7 to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal 7as described in section #ejd7;a77#ai7 of the ,homeland ,security ,act of #bjjb71 the ,national ,incident ,management ,system 7as defined in section #eja7g7 of such ,act71 and the ,national ,response ,plan developed pursuant to section #ejd of such ,act1 or any successor plan42 7,b7 in paragraph 7#b71 by inserting before the period at the end of the second sentence the following3 1 and an analysis of any changes to the evidence-based benchmarks and objective standards under sections #cai;,c-#a and #cai;,c-#b2 and 7,c7 in paragraph 7#c7-- 7i7 by striking #bjji and inserting #bjbb2 7ii7 by inserting 7including gaps in the environmental health workforce71 describing the status of such workforce after gaps in such workforce2 7iii7 by striking and identifying strategies and inserting identifying strategies2 and 7iv7 by inserting before the period at the end 1 and identifying current capabilities to meet the requirements of section #bhjc2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking and investigation and inserting investigation1 and related information technology activities2 7ii7 in subparagraph 7,b71 by striking and decontamination and inserting decontamination1 relevant health care services and supplies1 and transportation and disposal of medical waste2 and 7iii7 by adding at the end the following3 7,e7 ,response to environmental hazards4 2 7,b7 in paragraph 7#c77;,f71 by inserting or exposures to agents that could cause a public health emergency before the period2 7,c7 in paragraph 7#e71 by inserting and other applicable compacts after ,compact2 and 7,d7 by adding at the end the following3 7#i7 ,zoonotic disease1 food1 and agriculture ,in consultation with the ,secretary of ,agriculture1 improving coordination among ,federal1 ,state1 local1 tribal1 and territorial entities to prevent1 detect1 and respond to outbreaks of plant or animal disease 7including zoonotic disease7 that could compromise national security resulting from a deliberate attack1 a naturally occurring threat1 the intentional adulteration of food1 or other public health threats1 taking into account interactions between animal health1 human health1 and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities1 as applicable4 7#aj7 ,global health security ,assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities4 4 ,,ii ,improving preparedness and response #bja4 ,improving benchmarks and standards for preparedness and response 7a7 ,evaluating measurable evidence-,based benchmarks and objective standards ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended by inserting after subsection 7j7 the following3 7k7 ,evaluation 7#a7 ,in general ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah and every #b years thereafter1 the ,secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection 7g74 ,such evaluation shall be submitted to the congressional committees of jurisdiction together with the ,national ,health ,security ,strategy under section #bhjb1 at such time as such strategy is submitted4 7#b7 ,content ,the evaluation under this paragraph shall include-- 7,a7 a review of evidence-based benchmarks and objective standards1 and associated metrics and targets2 7,b7 a discussion of changes to any evidence-based benchmarks and objective standards1 and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and1 to the extent practicable1 the applicable goals of the ,national ,health ,security ,strategy under section #bhjb2 7,c7 a description of amounts received by eligible entities1 as described in subsection 7b7 and section #cai;,c-#b7;b71 and amounts received by sub-recipients and the effect of such funding on meeting evidence-based benchmarks and objective standards2 and 7,d7 recommendations1 as applicable and appropriate1 to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section #bhjb4 4 7b7 ,evaluating the partnership for ,state and regional hospital preparedness ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg-c;b7i77#a77 is amended by striking section #cai;,c-#a7;g71 7i71 and 7j7 and inserting section #cai;,c-#a7;g71 7i71 7j71 and 7k74 #bjb4 ,amendments to preparedness and response programs 7a7 ,cooperative agreement applications for improving ,state and local public health security ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended-- 7#a7 in subsection 7a71 by inserting 1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 after the ,secretary2 and 7#b7 in subsection 7b77#b77;,a7-- 7,a7 in clause 7vi71 by inserting 1 including public health agencies with specific expertise that may be relevant to public health security1 such as environmental health agencies1 after stakeholders2 7,b7 by redesignating clauses 7vii7 through 7ix7 as clauses 7viii7 through 7x72 and 7,c7 by inserting after clause 7vi7 the following3 7vii7 a description of how1 as applicable1 such entity may integrate information to account for individuals with behavioral health needs following a public health emergency2 4 7b7 ,partnership for ,state and regional hospital preparedness ,to improve surge capacity ,section #cai;,c-#b 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 1 acting through the ,assistant ,secretary for ,preparedness and ,response1 after ,the ,secretary2 and 7,b7 by striking preparedness for public health emergencies and inserting preparedness for1 and response to1 public health emergencies in accordance with subsection 7c72 and 7#b7 in subsection 7b77#a77;,a7-- 7,a7 in clause 7iii71 by redesignating subclauses 7,i7 through 7,,iii7 as items 7aa7 through 7cc71 respectively1 and adjusting the margins accordingly2 7,b7 by redesignating clauses 7i7 through 7iii7 as subclauses 7,i7 through 7,,iii7 respectively1 and adjusting the margins accordingly2 7,c7 by striking partnership consisting of-- and inserting 8partnership-- 7i7 consisting of-- 2 and 7,d7 by adding at the end the following3 7ii7 that may include one or more emergency medical service organizations or emergency management organizations2 and 4 7c7 ,public health security grants authorization of appropriations ,section #cai;,c-#a7;h77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;a7h77#a77;,a77 is amended by striking #fda1ijj1jjj for fiscal year #bjad and all that follows through the period at the end and inserting #fhe1jjj1jjj for each of fiscal years #bjai through #bjbc for awards pursuant to paragraph 7#c7 7subject to the authority of the ,secretary to make awards pursuant to paragraphs 7#d7 and 7#e7744 7d7 ,partnership for ,state and regional hospital preparedness authorization of appropriations ,section #cai;,c-#b7;j7 7#db ,u4,s4,c4 #bdg;d-#c;b7j77 is amended-- 7#a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general 7,a7 ,authorization of appropriations ,for purposes of carrying out this section and section #cai;,c-#c1 in accordance with subparagraph 7,b71 there is authorized to be appropriated #che1jjj1jjj for each of fiscal years #bjai through #bjbc4 7,b7 ,reservations of amounts for regional systems 7i7 ,in general ,subject to clause 7ii71 of the amount appropriated under subparagraph 7,a7 for a fiscal year1 the ,secretary may reserve up to #e percent for the purpose of carrying out section #cai;,c-#c4 7ii7 ,reservations contingent on continued appropriations ,if the amount appropriated under subparagraph 7,a7 for fiscal year #bjai or a subsequent fiscal year is less than or equal the amount so appropriated for the previous fiscal year1 the amount that may be reserved under clause 7i7 shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year4 2 7#b7 in paragraph 7#b71 by striking paragraph 7#a7 for a fiscal year and inserting paragraph 7#a77;,a7 for a fiscal year and not reserved for the purpose described in paragraph 7#a77;,b77i72 and 7#c7 in paragraph 7#c77;,a71 by striking paragraph 7#a7 and not reserved under paragraph 7#b7 and inserting paragraph 7#a77;,a7 and not reserved under paragraph 7#a77;,b77i7 or 7#b74 #bjc4 ,regional health care emergency preparedness and response systems 7a7 ,in general ,part ,b of title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai;,c-#b the following3 #cai;,c-#c4 ,guidelines for regional health care emergency preparedness and response systems 7a7 ,purpose ,it is the purpose of this section to identify and provide guidelines for regional systems of hospitals1 health care facilities1 and other public and private sector entities1 with varying levels of capability to treat patients and increase medical surge capacity during1 and in advance of1 a public health emergency1 including threats posed by one or more chemical1 biological1 radiological1 and nuclear agents1 including emerging infectious diseases4 7b7 ,guidelines ,the ,assistant ,secretary for ,preparedness and ,response1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,administrator of the ,health ,resources and ,services ,administration1 the ,commissioner of ,food and ,drugs1 the ,assistant ,secretary for ,mental ,health and ,substance ,use1 the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health1 the ,secretary of ,veterans ,affairs1 heads of such other ,federal agencies as the ,secretary determines to be appropriate1 and ,state1 local1 tribal1 and territorial public health officials1 shall1 not later than #b years after the date of enactment of this section-- 7#a7 identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during1 in advance of1 or immediately following1 a public health emergency1 resulting from one or more chemical1 biological1 radiological1 or nuclear agents1 including emerging infectious diseases 7which may include existing practices1 such as trauma care and medical surge capacity and capabilities71 with respect to-- 7,a7 a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency1 including-- 7i7 the manner in which the system will coordinate with and integrate the partnerships established under section #cai;,c-#b7;b72 and 7ii7 informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community2 7,b7 physical and technological infrastructure1 laboratory capacity1 staffing1 blood supply1 and other supply chain needs1 taking into account resiliency1 geographic considerations1 and rural considerations2 7,c7 protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers 7including with respect to protective equipment and supplies1 waste management processes1 and decontamination71 sharing of specialized experience among the health care workforce1 behavioral health1 psychological resilience1 and training of the workforce1 as applicable2 7,d7 in a manner that allows for disease containment 7within the meaning of section #bhjb7;b77#b77;,b771 coordinated medical triage1 treatment1 and transportation of patients1 based on patient medical need 7including patients in rural areas71 to the appropriate hospitals or health care facilities within the regional system or1 as applicable and appropriate1 between systems in different ,states or regions2 and 7,e7 the needs of children and other at-risk individuals2 7#b7 make such guidelines available on the internet website of the ,department of ,health and ,human ,services in a manner that does not compromise national security2 and 7#c7 update such guidelines as appropriate1 including based on input received pursuant to subsections 7c71 7e71 and 7f71 to address new and emerging public health threats4 7c7 ,considerations ,in identifying1 developing1 and updating guidelines under subsection 7b71 the ,assistant ,secretary for ,preparedness and ,response shall-- 7#a7 include input from hospitals and health care facilities1 including health care coalitions under section #cai;,c-#b1 ,state1 local1 tribal1 and territorial public health departments1 and health care or subject matter experts1 including experts with relevant expertise in chemical1 biological1 radiological1 or nuclear threats1 and emerging infectious disease as the ,assistant ,secretary determines appropriate1 to meet the goals under section #bhjb7;b77#c72 7#b7 consult and engage with appropriate health care providers and professionals1 including physicians1 nurses1 first responders1 health care facilities 7including hospitals1 primary care clinics1 community health centers1 mental health facilities1 ambulatory care facilities1 and dental health facilities71 pharmacies1 emergency medical providers1 trauma care providers1 environmental health agencies1 public health laboratories1 poison control centers1 blood banks1 and other experts that the ,assistant ,secretary determines appropriate1 to meet the goals under section #bhjb7;b77#c72 7#c7 consider feedback related to financial implications for hospitals1 health care facilities1 public health agencies1 laboratories1 and other entities engaged in regional preparedness planning to implement and follow such guidelines1 as applicable2 and 7#d7 consider financial requirements and potential incentives for entities to prepare for1 and respond to1 public health emergencies as part of the regional health care emergency preparedness and response system4 7d7 ,technical assistance ,the ,assistant ,secretary for ,preparedness and ,response1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention and the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health1 may provide technical assistance and consultation towards meeting the guidelines described in subsection 7b74 7e7 ,demonstration project for regional health care preparedness and response systems 7#a7 ,in general ,the ,assistant ,secretary for ,preparedness and ,response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection 7b7 to improve medical surge capacity for all hazards1 build and integrate regional medical response capabilities1 improve specialty care expertise for all-hazards response1 and coordinate medical preparedness and response across ,state1 local1 tribal1 territorial1 and regional jurisdictions4 7#b7 ,sunset ,the authority under this subsection shall expire on ,september #cj1 #bjbc4 7f7 ,,gao report to ,congress 7#a7 ,report ,not later than #c years after the date of enactment of this section1 the ,comptroller ,general of the ,united ,states 7referred to in this subsection as the ,comptroller ,general7 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,finance of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives1 a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under subsection 7b71 including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines4 7#b7 ,content ,the ,comptroller ,general shall include in the report under paragraph 7#a7-- 7,a7 data on the preparedness and response capabilities that have been informed by the guidelines under subsection 7b7 to improve regional emergency health care preparedness and response capability1 including hospital and health care facility capacity and medical surge capabilities to prepare for1 and respond to1 public health emergencies2 and 7,b7 recommendations to reduce gaps in incentives for regional health partners1 including hospitals and health care facilities to improve capacity and medical surge capabilities to prepare for1 and respond to1 public health emergencies1 consistent with subsection 7a71 which may include consideration of facilities participating in programs under section #cai;,c-#b1 programs under the ,centers for ,medicare ,medicaid ,services 7including innovative health care delivery and payment models71 and input from private sector financial institutions4 7#c7 ,consultation ,in carrying out paragraphs 7#a7 and 7#b71 the ,comptroller ,general shall consult with the heads of appropriate ,federal agencies1 including-- 7,a7 the ,assistant ,secretary for ,preparedness and ,response2 7,b7 the ,director of the ,centers for ,disease ,control and ,prevention2 7,c7 the ,administrator of the ,centers for ,medicare ,medicaid ,services2 7,d7 the ,assistant ,secretary for ,mental ,health and ,substance ,use2 7,e7 the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health2 7,f7 the ,secretary of ,veterans ,affairs2 and 7,g7 the heads of such other ,federal agencies as the ,secretary determines appropriate4 4 7b7 ,annual reports ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg;d-#c;b7i77#a77 is amended by inserting after the first sentence the following ,the reports submitted under this paragraph shall also include progress towards the implementation of section #cai;,c-#c44 7c7 ,national health security strategy incorporation of regionalized emergency preparedness and response ,section #bhjb7;b77#c7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#c77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by striking including mental health and inserting 8including pharmacies1 mental health facilities102 and 7#b7 by amending subparagraph 7,g7 to read as follows3 7,g7 ,optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals1 other health care facilities1 critical care1 trauma care 7which may include trauma centers71 and emergency medical systems1 which may include the implementation of guidelines for regional health care emergency preparedness and response systems under section #cai;,c-#c4 4 7d7 ,improving ,state and local public health security 7#a7 ,state and local security ,section #cai;,c-#a7;e7 7#db ,u4,s4,c4 #bdg;d-#c;a7e77 is amended by striking 1 and local emergency plans4 and inserting 1 local emergency plans1 and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section #cai;,c-#c44 7#b7 ,partnerships ,section #cai;,c-#b7;d77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77 is amended-- 7,a7 in clause 7i71 by striking 2 and and inserting 22 7,b7 by redesignating clause 7ii7 as clause 7iii72 and 7,c7 inserting after clause 7i71 the following3 7ii7 among one or more facilities in a regional health care emergency system under section #cai;,c-#c2 and 4 #bjd4 ,public health and health care system situational awareness and biosurveillance capabilities 7a7 ,facilities1 capacities1 and biosurveillance capabilities ,section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in the section heading1 by striking ,revitalizing and inserting ,facilities and capacities of2 7#b7 in subsection 7a7-- 7,a7 in the subsection heading1 by striking ,facilities2 capacities and inserting ,in general2 7,b7 in paragraph 7#a71 by striking and improved and inserting 1 improved1 and appropriately maintained2 7,c7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by striking expand1 enhance1 and improve and inserting expand1 improve1 enhance1 and appropriately maintain2 and 7,d7 by adding at the end the following3 7#d7 ,study of resources for facilities and capacities ,not later than ,june #a1 #bjbb1 the ,comptroller ,general of the ,united ,states shall conduct a study on ,federal spending in fiscal years #bjac through #bjah for activities authorized under this subsection4 ,such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs 7#b7 and 7#c71 including a specific accounting of1 and delineation between1 obligations and expenditures incurred for the construction1 renovation1 equipping1 and security upgrades of facilities and associated contracts under this subsection1 and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection 7b71 and shall identify the agency or agencies incurring such obligations and expenditures4 2 7#c7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking national and inserting ,establishment of systems of public health 2 7,b7 in paragraph 7#a77;,b71 by inserting immunization information systems1 after centers12 7,c7 in paragraph 7#b7-- 7i7 by inserting develop a plan to1 and after ,the ,secretary shall2 and 7ii7 by inserting and in a form readily usable for analytical approaches after in a secure manner2 and 7,d7 by amending paragraph 7#c7 to read as follows3 7#c7 ,standards 7,a7 ,in general ,not later than #a year after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary1 in cooperation with health care providers1 ,state1 local1 tribal1 and territorial public health officials1 and relevant ,federal agencies 7including the ,office of the ,national ,coordinator for ,health ,information ,technology and the ,national ,institute of ,standards and ,technology71 shall1 as necessary1 adopt technical and reporting standards1 including standards for interoperability as defined by section #cjjj1 for networks under paragraph 7#a7 and update such standards as necessary4 ,such standards shall be made available on the internet website of the ,department of ,health and ,human ,services1 in a manner that does not compromise national security4 7,b7 ,deference to standards development organizations ,in adopting and implementing standards under this subsection and subsection 7c71 the ,secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities4 2 7#d7 in subsection 7c7-- 7,a7 in paragraph 7#a7-- 7i7 by striking ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,secretary and inserting ,the ,secretary2 7ii7 by inserting 1 and improve as applicable and appropriate1 after shall establish2 7iii7 by striking of rapid and inserting of1 rapid2 and 7iv7 by striking such connectivity and inserting such interoperability2 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,coordination and consultation ,in establishing and improving the network under paragraph 7#a7 the ,secretary shall-- 7,a7 facilitate coordination among agencies within the ,department of ,health and ,human ,services that provide or have the potential to provide information and data to1 and analyses for1 the situational awareness and biosurveillance network under paragraph 7#a71 including coordination among relevant agencies related to health care services1 the facilitation of health information exchange 7including the ,office of the ,national ,coordinator for ,health ,information ,technology71 and public health emergency preparedness and response2 and 7,b7 consult with the ,secretary of ,agriculture1 the ,secretary of ,commerce 7and the ,director of the ,national ,institute of ,standards and ,technology71 the ,secretary of ,defense1 the ,secretary of ,homeland ,security1 and the ,secretary of ,veterans ,affairs1 and the heads of other ,federal agencies1 as the ,secretary determines appropriate4 2 7,c7 in paragraph 7#c7-- 7i7 by redesignating subparagraphs 7,a7 through 7,e7 as clauses 7i7 through 7v71 respectively1 and adjusting the margins accordingly2 7ii7 in clause 7iv71 as so redesignated-- 7,i7 by inserting immunization information programs1 after poison control12 and 7,,ii7 by striking and clinical laboratories and inserting 1 clinical laboratories1 and public environmental health agencies2 7iii7 by striking ,the network and inserting the following3 7,a7 ,in general ,the network 2 and 7iv7 by adding at the end the following3 7,b7 ,review ,not later than #b years after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah and every #f years thereafter1 the ,secretary shall conduct a review of the elements described in subparagraph 7,a74 ,such review shall include a discussion of the addition of any elements pursuant to clause 7v71 including elements added to advancing new technologies1 and identify any challenges in the incorporation of elements under subparagraph 7,a74 ,the ,secretary shall provide such review to the congressional committees of jurisdiction4 2 7,d7 in paragraph 7#e7-- 7i7 by redesignating subparagraphs 7,a7 through 7,d7 as clauses 7i7 through 7iv71 respectively1 and adjusting the margins accordingly2 7ii7 by striking ,in establishing and inserting the following3 7,a7 ,in general ,in establishing 2 7iii7 by adding at the end the following3 7,b7 ,public meeting 7i7 ,in general ,not later than #ahj days after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals1 functions1 and uses of the network described in paragraph 7#a7 and incorporating the elements described in paragraph 7#c77;,a74 7ii7 ,experts ,the public meeting shall include representatives of relevant ,federal agencies 7including representatives from the ,office of the ,national ,coordinator for ,health ,information ,technology and the ,national ,institute of ,standards and ,technology71 ,state1 local1 tribal1 and territorial public health officials1 stakeholders with expertise in biosurveillance and situational awareness1 and stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness1 such as experts in informatics and data analytics 7including experts in prediction and forecasting71 and other representatives as the ,secretary determines appropriate4 7iii7 ,topics ,such public meeting shall include a discussion of-- 7,i7 data elements1 including minimal or essential data elements1 that are voluntarily provided for such network1 which may include elements from public health and public and private health care entities1 to the extent practicable2 7,,ii7 standards and implementation specifications that may improve the collection1 analysis1 and interpretation of data during a public health emergency2 7,,iii7 strategies to encourage the access1 exchange1 and use of information2 7,,iv7 considerations for ,state1 local1 tribal1 and territorial capabilities and infrastructure related to data exchange and interoperability2 7,v7 privacy and security protections provided at the ,federal1 ,state1 local1 tribal1 and territorial levels1 and by nongovernmental stakeholders2 and 7,,vi7 opportunities for the incorporation of innovative technologies to improve the network4 2 and 7iv7 in subparagraph 7,a71 as so designated by clause 7ii7-- 7,i7 in clause 7i71 as so redesignated-- 7aa7 by striking as determined and inserting as adopted2 and 7bb7 by inserting and the ,national ,institute of ,standards and ,technology after ,office of the ,national ,coordinator for ,health ,information ,technology2 7,,ii7 in clause 7iii71 as so redesignated1 by striking 2 and and inserting a semicolon2 7,,iii7 in clause 7iv71 as so redesignated1 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7v7 pilot test standards and implementation specifications1 consistent with the process described in section #cjjb7;b77#c77;,c71 which ,state1 local1 tribal1 and territorial public health entities may utilize1 on a voluntary basis1 as a part of the network4 2 7,e7 by redesignating paragraph 7#f7 as paragraph 7#g72 7,f7 by inserting after paragraph 7#e7 the following3 7#f7 ,strategy and implementation plan 7,a7 ,in general ,not later than #ah months after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary shall submit to the appropriate committees of ,congress a coordinated strategy and an accompanying implementation plan that-- 7i7 is informed by the public meeting under paragraph 7#e77;,b72 7ii7 includes a review and assessment of existing capabilities of the network and related infrastructure1 including input provided by the public meeting under paragraph 7#e77;,b72 7iii7 identifies and demonstrates the measurable steps the ,secretary will carry out to-- 7,i7 develop1 implement1 and evaluate the network described in paragraph 7#a71 utilizing elements described in paragraph 7#c77;,a72 7,,ii7 modernize and enhance biosurveillance activities1 including strategies to include innovative technologies and analytical approaches 7including prediction and forecasting for pandemics and all-hazards7 from public and private entities2 7,,iii7 improve information sharing1 coordination1 and communication among disparate biosurveillance systems supported by the ,department of ,health and ,human ,services1 including the identification of methods to improve accountability1 better utilize resources and workforce capabilities1 and incorporate innovative technologies within and across agencies2 and 7,,iv7 test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities2 7iv7 includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause 7iii72 and 7v7 establishes dates by which each measurable step under clause 7iii7 will be implemented4 4 7,b7 ,annual budget plan ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah and on an annual basis thereafter1 in accordance with the strategy and implementation plan under this paragraph1 the ,secretary shall1 taking into account recommendations provided by the ,national ,biodefense ,science ,board1 develop a budget plan based on the strategy and implementation plan under this section4 ,such budget plan shall include-- 7i7 a summary of resources previously expended to establish1 improve1 and utilize the nationwide public health situational awareness and biosurveillance network under paragraph 7#a72 7ii7 estimates of costs and resources needed to establish and improve the network under paragraph 7#a7 according to the strategy and implementation plan under subparagraph 7,a72 7iii7 the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities1 resources1 and authorities needed to address such gaps2 and 7iv7 a strategy to minimize and address such gaps and improve inefficiencies4 2 7,g7 in paragraph 7#g71 as so redesignated-- 7i7 in subparagraph 7,a71 by inserting 7taking into account zoonotic disease1 including gaps in scientific understanding of the interactions between human1 animal1 and environmental health7 after human health2 7ii7 in subparagraph 7,b7-- 7,i7 by inserting and gaps in surveillance programs after surveillance programs2 and 7,,ii7 by striking 2 and and inserting a semicolon2 7iii7 in subparagraph 7,c7-- 7,i7 by inserting 1 animal health organizations related to zoonotic disease1 after health care entities2 and 7,,ii7 by striking the period and inserting 2 and2 and 7iv7 by adding at the end the following3 7,d7 provide recommendations to the ,secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section #bhjb4 2 and 7,h7 by adding at the end the following3 7#h7 ,situational awareness and biosurveillance as a national security priority ,the ,secretary1 on a periodic basis as applicable and appropriate1 shall meet with the ,director of ,national ,intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network4 2 7#e7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting environmental health agencies1 after public health agencies12 and 7ii7 by inserting immunization programs1 after poison control centers12 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7iii7 by adding after subparagraph 7,c7 the following3 7,d7 an implementation plan that may include measurable steps to achieve the purposes described in paragraph 7#a74 2 and 7,c7 by striking paragraph 7#e7 and inserting the following3 7#e7 ,technical assistance ,the ,secretary may provide technical assistance to ,states1 localities1 tribes1 and territories or a consortium of ,states1 localities1 tribes1 and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the ,secretary4 2 7#f7 by redesignating subsections 7f7 and 7g7 as subsections 7h7 and 7i71 respectively2 and 7#g7 by inserting after subsection 7e7 the following3 7f7 ,timeline ,the ,secretary shall accomplish the purposes under subsections 7b7 and 7c7 no later than ,september #cj1 #bjbc1 and shall provide a justification to ,congress for any missed or delayed implementation of measurable steps identified under subsection 7c77#f77;,a77iii74 7g7 ,independent evaluation ,not later than #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the ,secretary and the appropriate committees of ,congress a report concerning the activities conducted under subsections 7b7 and 7c71 and provide recommendations1 as applicable and appropriate1 on necessary improvements to the biosurveillance and situational awareness network4 4 7b7 ,authorization of appropriations ,subsection 7h7 of section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d71 as redesignated by subsection 7a77#f71 is amended by striking #ach1cjj1jjj for each of fiscal years #bjad through #bjah and inserting #afa1hjj1jjj for each of fiscal years #bjai through #bjbc4 #bje4 ,strengthening and supporting the public health emergency rapid response fund ,section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#a7-- 7i7 in the first sentence1 by inserting or if the ,secretary determines there is the significant potential for a public health emergency1 to allow the ,secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency before the period2 and 7ii7 by inserting ,the ,secretary shall plan for the expedited distribution of funds to appropriate agencies and entities4 after the first sentence2 7,b7 by redesignating paragraph 7#b7 as paragraph 7#c72 7,c7 by inserting after paragraph 7#a7 the following3 7#b7 ,uses ,the ,secretary may use amounts in the ,fund established under paragraph 7#a71 to-- 7,a7 facilitate coordination between and among ,federal1 ,state1 local1 tribal1 and territorial entities and public and private health care entities that the ,secretary determines may be affected by a public health emergency or potential public health emergency 7including communication of such entities with relevant international entities1 as applicable72 7,b7 make grants1 provide for awards1 enter into contracts1 and conduct supportive investigations pertaining to a public health emergency or potential public health emergency1 including further supporting programs under section #cai;,c-#a or #cai;,c-#b2 7,c7 facilitate and accelerate1 as applicable1 advanced research and development of security countermeasures 7as defined in section #cai;,f-#b71 qualified countermeasures 7as defined in section #cai;,f-#a71 or qualified pandemic or epidemic products 7as defined in section #cai;,f-#c71 that are applicable to the public health emergency or potential public health emergency under paragraph 7#a72 7,d7 strengthen biosurveillance capabilities and laboratory capacity to identify1 collect1 and analyze information on such public health emergency or potential public health emergency1 including the systems under section #cai;,d2 7,e7 support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel expenses under section #bhab1 and the ,medical ,reserve ,corps under section #bhac2 and 7,f7 other activities1 as the ,secretary determines applicable and appropriate4 2 and 7,d7 by inserting after paragraph 7#c71 as so redesignated1 the following3 7#d7 ,review ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary1 in coordination with the ,assistant ,secretary for ,preparedness and ,response1 shall conduct a review of the ,fund under this section1 and provide recommendations 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 on policies to improve such ,fund for the uses described in paragraph 7#b74 7#e7 ,,gao report ,not later than #d years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,comptroller ,general of the ,united ,states shall conduct a review of the ,fund under this section1 including the uses and the resources available in the ,fund4 2 and 7#b7 in subsection 7c7-- 7,a7 by inserting rapidly respond to public health emergencies or potential public health emergencies and after used to2 and 7,b7 by striking section4 and inserting ,act or funds otherwise provided for emergency response44 #bjf4 ,improving preparedness for and response to all-hazards by public health emergency volunteers ,section #cai;,i 7#db ,u4,s4,c4 #bdg;d-#g;b7 is amended3 7#a7 in subsection 7a71 by adding at the end the following3 ,such health care professionals may include members of the ,national ,disaster ,medical ,system1 members of the ,medical ,reserve ,corps1 and individual health care professionals42 7#b7 in subsection 7i7 by adding at the end ,in order to inform the development of such mechanisms by ,states1 the ,secretary shall make available information and material provided by ,states that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical services during a public health emergency4 ,such information shall be made publicly available in a manner that does not jeopardize national security42 and 7#c7 in subsection 7k7 by striking #bjad through #bjah and inserting #bjai through #bjbc4 ,,iii ,reaching all communities #cja4 ,strengthening and assessing the emergency response workforce 7a7 ,national ,disaster ,medical ,system ,clause 7ii7 of section #bhab7;a77#c77;,a7 7#db ,u4,s4,c4 #cjj;hh-#aa7;a77#c77;,a77 is amended to read as follows3 7ii7 be present at locations1 and for limited periods of time1 specified by the ,secretary on the basis that the ,secretary has determined that a location is at risk of a public health emergency during the time specified1 or there is a significant potential for a public health emergency4 4 7b7 ,volunteer ,medical ,reserve ,corps ,section #bhac7;a7 7#db ,u4,s4,c4 #db ,u4,s4,c4 #cjj;hh-#ae7;a77 is amended by striking the second sentence and inserting ,the ,secretary may appoint a ,director to head the ,corps and oversee the activities of the ,corps chapters that exist at the ,state1 local1 and tribal levels4 7c7 ,review of the national disaster medical system ,section #bhab7;b77#b7 7#db ,u4,s4,c4 #cjj;hh-#aa7;b77#b77 is amended to read as follows3 7#b7 ,joint review and medical surge capacity strategic plan 7,a7 ,review ,not later than #ahj days after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary1 in coordination with the ,secretary of ,homeland ,security1 the ,secretary of ,defense1 and the ,secretary of ,veterans ,affairs1 shall conduct a joint review of the ,national ,disaster ,medical ,system4 ,such review shall include-- 7i7 an evaluation of medical surge capacity1 as described in section #bhjc7;a72 7ii7 an assessment of the available workforce of the intermittent disaster response personnel described in subsection 7c72 7iii7 the capacity of the workforce described in clause 7ii7 to respond to all hazards1 including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency2 7iv7 the effectiveness of efforts to recruit1 retain1 and train such workforce2 and 7v7 gaps that may exist in such workforce and recommendations for addressing such gaps4 7,b7 ,updates ,as part of the ,national ,health ,security ,strategy under section #bhjb1 the ,secretary shall update the findings from the review under subparagraph 7,a7 and provide recommendations to modify the policies of the ,national ,disaster ,medical ,system as necessary4 4 7d7 ,notification of ,,ndms ,shortage ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c77 is amended by adding at the end the following3 7#c7 ,service benefit ,individuals appointed to serve under this subsection shall be considered public safety officers under part ,l of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh4 ,the ,secretary shall provide notification to eligible individuals of any effect such designation may have on other benefits for which such individuals are eligible1 including benefits from private entities4 7#d7 ,notification ,not later than #cj days after the date on which the ,secretary determines the number of intermittent disaster response personnel of such ,system is insufficient to address a public health emergency or potential public health emergency1 the ,secretary shall submit to the congressional committees of jurisdiction a notification detailing the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency1 and any identified measures to address such shortage4 7#e7 ,certain appointments 7,a7 ,in general ,if the ,secretary determines that the number of intermittent disaster response personnel within the ,national ,disaster ,medical ,system under this section is insufficient to address a public health emergency or potential public health emergency1 the ,secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system4 ,the ,secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect4 7,b7 ,sunset ,the authority under this paragraph shall expire on ,september #cj1 #bjba4 4 7e7 ,public safety officer benefits ,section #abjd7i7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd7i77 is amended-- 7#a7 in subparagraph 7,c77ii71 by striking or at the end2 7#b7 in subparagraph 7,d71 by striking the period and inserting 2 or2 and 7#c7 by inserting after subparagraph 7,d7 the following3 7,e7 an individual appointed to the ,national ,disaster ,medical ,system under section #bhab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 who is performing official duties of the ,department of ,health and ,human ,services1 if those official duties are related to responding to a public health emergency or potential public health emergency1 or other activities for which the ,secretary of ,health and ,human ,services has activated such ,national ,disaster ,medical ,system4 4 7f7 ,national disaster medical system authorization of appropriations ,section #bhab7;g7 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is amended by striking #eb1gjj1jjj for each of fiscal years #bjad through #bjah and inserting #eg1djj1jjj for each of fiscal years #bjai through #bjbc4 7g7 ,medical ,reserve ,corps ,authorization of ,appropriations ,section #bhac7;i7 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 #cjb4 ,health system infrastructure to improve preparedness and response 7a7 ,coordination of preparedness ,section #bhaa7;b77#e7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#e77 is amended by adding at the end the following3 ,such logistical support shall include working with other relevant ,federal1 ,state1 local1 tribal1 and territorial public health officials and private sector partners to identify the critical infrastructure assets1 systems1 and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster1 including entities capable of assisting with1 responding to1 and mitigating the effect of a public health emergency1 including an emergency under section #cai1 an emergency or major disaster under the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act1 or the ,national ,emergencies ,act1 including by establishing methods to exchange critical information and deliver products consumed or used to preserve1 protect1 or sustain life1 health1 or safety1 and sharing of specialized expertise44 7b7 ,manufacturing ,capacity ,section #bhaa7;d77#b77;,c7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77;,c77 is amended by inserting 1 and ancillary medical supplies to assist with the utilization of such products1 after products4 #cjc4 ,considerations for at-risk individuals 7a7 ,at-,risk individuals in the ,national ,health ,security ,strategy ,section #bhjb7;b77#d77;,b7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b77 is amended-- 7#a7 by striking this section and sections #cai;,c-#a1 #cai;,f1 and #cai,l1 and inserting this ,act 2 and 7#b7 by striking special and inserting access or functional4 7b7 ,countermeasure considerations ,section #cai,l7c77#f7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#f77 is amended-- 7#a7 by striking elderly and inserting senior citizens2 and 7#b7 by inserting with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products before the period4 #cjd4 ,improving emergency preparedness and response considerations for children ,part ,b of title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai;,d the following3 #cai;,d-#a4 ,children's preparedness unit 7a7 ,enhancing emergency preparedness for children ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this subsection as the ,director71 shall maintain an internal team of experts1 to be known as the ,children's ,preparedness ,unit 7referred to in this subsection as the ,unit71 to work collaboratively to provide guidance on the considerations for1 and the specific needs of1 children before1 during1 and after public health emergencies4 ,the ,unit shall inform the ,director regarding emergency preparedness and response efforts pertaining to children at the ,centers for ,disease ,control and ,prevention4 7b7 ,expertise ,the team described in subsection 7a7 shall include one or more pediatricians1 which may be a developmental-behavior pediatrician1 and may also include behavioral scientists1 child psychologists1 epidemiologists1 biostatisticians1 health communications staff1 and individuals with other areas of expertise1 as the ,secretary determines appropriate4 7c7 ,duties ,the team described in subsection 7a7 may-- 7#a7 assist ,state1 local1 tribal1 and territorial emergency planning and response activities related to children1 which may include developing1 identifying1 and sharing best practices2 7#b7 provide technical assistance1 training1 and consultation to ,federal1 ,state1 local1 tribal1 and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children1 including providing such technical assistance1 training1 and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections #cai;,c-#a and #cai;,c-#b2 7#c7 improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency1 including public awareness of such methods2 7#d7 coordinate with1 and improve1 public-private partnerships1 such as health care coalitions pursuant to sections #cai;,c-#b and #cai;,c-#c1 to address gaps and inefficiencies in emergency preparedness and response efforts for children2 7#e7 provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for1 and responding to1 public health emergencies2 and 7#f7 carry out other duties related to preparedness and response activities for children1 as the ,secretary determines appropriate4 4 #cje4 ,reauthorizing the ,national ,advisory ,committee on ,children and ,disasters ,section #bhaa;,a 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is amended-- 7#a7 in subsection 7b77#b71 by inserting 1 mental and behavioral1 after medical2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking #ae and inserting #be2 and 7,b7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,required non-,federal members ,the ,secretary1 in consultation with such other heads of ,federal agencies as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals to perform the duties described in subsections 7b7 and 7c71 including-- 7,a7 at least #b non-,federal professionals with expertise in pediatric medical disaster planning1 preparedness1 response1 or recovery2 7,b7 at least #b representatives from ,state1 local1 tribal1 or territorial agencies with expertise in pediatric disaster planning1 preparedness1 response1 or recovery2 7,c7 at least #d members representing health care professionals1 which may include members with expertise in pediatric emergency medicine2 pediatric trauma1 critical care1 or surgery2 the treatment of pediatric patients affected by chemical1 biological1 radiological1 or nuclear agents and emerging infectious diseases2 pediatric mental or behavioral health related to children affected by a public health emergency2 or pediatric primary care2 and 7,d7 other members as the ,secretary determines appropriate1 of whom-- 7i7 at least one such member shall represent a children's hospital2 7ii7 at least one such member shall be an individual with expertise in schools or child care settings2 7iii7 at least one such member shall be an individual with expertise in children and youth with special health care needs2 and 7iv7 at least one such member shall be an individual with expertise in the needs of parents or family caregivers1 including the parents or caregivers of children with disabilities4 4 7#c7 ,federal members ,the ,advisory ,committee under paragraph 7#a7 shall include the following ,federal members or their designees3 7,a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7,b7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7,c7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,d7 ,the ,commissioner of ,food and ,drugs4 7,e7 ,the ,director of the ,national ,institutes of ,health4 7,f7 ,the ,assistant ,secretary of the ,administration for ,children and ,families4 7,g7 ,the ,administrator of the ,health ,resources and ,services ,administration4 7,h7 ,the ,administrator of the ,federal ,emergency ,management ,agency4 7,i7 ,the ,administrator of the ,administration for ,community ,living4 7,j7 ,the ,secretary of ,education4 7,k7 ,representatives from such ,federal agencies 7such as the ,substance ,abuse and ,mental ,health ,services ,administration and the ,department of ,homeland ,security7 as the ,secretary determines appropriate to fulfill the duties of the ,advisory ,committee under subsections 7b7 and 7c74 4 7#d7 ,term of appointment ,each member of the ,advisory ,committee appointed under paragraph 7#b7 shall serve for a term of #c years1 except that the ,secretary may adjust the terms of the ,advisory ,committee appointees serving on the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 or appointees who are initially appointed after such date of enactment1 in order to provide for a staggered term of appointment for all members4 7#e7 ,consecutive appointments2 maximum terms ,a member appointed under paragraph 7#b7 may serve not more than #c terms on the ,advisory ,committee1 and not more than #b of which may be served consecutively4 2 7#c7 in subsection 7e71 by adding at the end ,at least one meeting per year shall be an in-person meeting42 and 7#d7 in subsection 7f7 by striking #bjah and inserting #bjbc4 #cjf4 ,guidance for participation in exercises and drills ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final guidance regarding the participation of ,state1 local1 tribal1 and territorial public health department or agency personnel funded in whole or in part through programs authorized under this ,act in drills and operational exercises in order to identify1 inform1 and address the gaps in and policies related to all-hazards medical and public health preparedness and response1 which may include drills and operational exercises that incorporate medical surge capacity planning1 medical countermeasure distribution and administration1 and preparing for and responding to identified threats for that region4 ,the ,secretary shall consult with the ,department of ,homeland ,security1 the ,department of ,defense1 the ,department of ,veterans ,affairs1 and other applicable ,federal departments and agencies as necessary and appropriate in the development of such guidance4 ,the ,secretary shall make the guidance available on the internet website of the ,department of ,health and ,human ,services4 ,,iv ,prioritizing a threat-based approach #dja4 ,assistant ,secretary for ,preparedness and ,response ,section #bhaa7;b7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is amended-- 7#a7 in the matter preceding paragraph 7#a7 by inserting utilize experience related to public health emergency preparedness and response1 biodefense1 medical countermeasures1 and other relevant topics to after shall2 and 7#b7 in paragraph 7#d7 by adding at the end the following3 7,i7 ,threat awareness ,coordinate with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of ,national ,intelligence1 the ,secretary of ,homeland ,security1 the ,assistant to the ,president for ,national ,security ,affairs1 the ,secretary of ,defense1 and other relevant ,federal officials1 to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency4 4 #djb4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise 7a7 ,in general ,title ,,xxviii is amended by inserting after section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 the following3 #bhaa-a4 ,public health emergency medical countermeasures enterprise 7a7 ,in general ,the ,secretary shall establish the ,public ,health ,emergency ,medical ,countermeasures ,enterprise 7referred to in this section as the ,,phemce74 ,the ,assistant ,secretary for ,preparedness and ,response shall serve as chair of the ,,phemce4 7b7 ,members ,the ,,phemce shall include each of the following members1 or the designee of such members3 7#a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7#b7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7#c7 ,the ,director of the ,national ,institutes of ,health4 7#d7 ,the ,commissioner of ,food and ,drugs4 7#e7 ,the ,secretary of ,defense4 7#f7 ,the ,secretary of ,homeland ,security4 7#g7 ,the ,secretary of ,agriculture4 7#h7 ,the ,secretary of ,veterans ,affairs4 7#i7 ,representatives of any other ,federal agency1 which may include the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 and the ,director of the ,strategic ,national ,stockpile1 as the ,secretary determines appropriate4 7c7 ,functions 7#a7 ,in general ,the functions of the ,,phemce shall include the following3 7,a7 ,establish a process pursuant to section #bhaa7;d77#b77;,b7 to make recommendations to the ,secretary regarding the prioritization of research1 development1 and procurement of countermeasures1 as defined in section #cai;,f-#b7;c71 based on the health security needs of the ,united ,states4 ,such recommendations shall be informed by the ,national ,health ,security ,strategy pursuant to section #bhjb1 the ,strategic ,national ,stockpile review required under section #cai;,f-#b7;a77#b71 the countermeasures budget plan pursuant to section #bhaa7;b77#g71 and an assessment of current national security threats1 including chemical1 biological1 radiological and nuclear threats1 including emerging infectious diseases4 ,in the event that members of the ,,phemce do not agree upon a recommendation1 the ,secretary shall provide a determination regarding such recommendation4 7,b7 ,identify national health security needs1 including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs 7including any regulatory challenges71 and provide for alignment of countermeasure procurement with recommendations under subparagraph 7,a74 7,c7 ,develop strategies related to logistics1 deployment1 distribution1 dispensing1 and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section #cai;,f-#b7;a74 7,d7 ,provide consultation for the development of the strategy and implementation plan under section #bhaa7;d74 7#b7 ,input ,in carrying out subparagraphs 7,b7 and 7,c7 of paragraph 7#a71 the ,,phemce shall solicit and consider input from ,state1 local1 tribal1 and territorial public health departments1 as appropriate4 4 7b7 ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan ,section #bhaa7;d77#a7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#a77 is amended-- 7#a7 by striking ,not later than #ahj days after the date of enactment of this subsection1 and every year thereafter and inserting ,not later than ,march #ae1 #bjbj1 and biennially thereafter2 and 7#b7 by striking ,director of ,biomedical and all that follows through ,food and ,drugs and inserting ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a4 #djc4 ,strategic ,national ,stockpile 7a7 ,section #cai;,f-#b7;a7 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended-- 7#a7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#c7 and 7#d71 respectively2 and 7#b7 in paragraph 7#a7-- 7,a7 by inserting and optimize after provide for2 7,b7 by inserting and1 as informed by existing recommendations of1 or consultations with1 the ,public ,health ,emergency ,medical ,countermeasure ,enterprise established under section #bhaa-a1 make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph 7#b7 before the period of the first sentence2 and 7,c7 by striking the second sentence2 7#c7 by inserting after paragraph 7#a7 the following3 7#b7 ,threat-based review 7,a7 ,in general ,the ,secretary shall conduct a biennial threat-based review 7taking into account at-risk individuals7 of the contents of the stockpile under paragraph 7#a71 including non-pharmaceutical supplies1 and1 in consultation with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a1 review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section #bhaa-a7;c77#a77;,a74 ,such review shall be submitted biennially1 beginning on ,march #ae1 #bjai1 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 ,representatives1 in a manner that does not compromise national security4 7,b7 ,additions1 modifications1 and replenishments ,each biennial threat-based review under subparagraph 7,a7 shall1 for each new or modified countermeasure procurement or replenishment1 provide-- 7i7 information regarding-- 7,i7 the quantities of the additional or modified countermeasure procured for1 or contracted to be procured for1 the stockpile2 7,,ii7 planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications 7without disclosing proprietary information71 including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system2 7,,iii7 the presence or lack of a commercial market for the countermeasure at the time of procurement2 7,,iv7 the emergency health security threat or threats such countermeasure procurement is intended to address1 including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats2 7,v7 an assessment of whether the emergency health security threat or threats described in subclause 7,,iv7 could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats2 7,,vi7 whether such countermeasure is replenishing an expired countermeasure1 is a different countermeasure with the same indication that is replacing an expired countermeasure1 or is a new addition to the stockpile2 7,,vii7 a description of how such additions or modifications align with the countermeasures budget plan as required under section #bhaa7;b77#g71 including expected life-cycle costs1 expenditures related to countermeasure procurement to address the threat or threats described in subclause 7,,iv71 replenishment dates 7including the ability to extend the maximum shelf life of a countermeasure71 and the manufacturing capacity required to replenish such countermeasure2 and 7,,viii7 appropriate protocols and processes for the deployment1 distribution1 or dispensing of the countermeasure at the ,state and local level1 including plans for relevant capabilities of ,state and local entities to dispense1 distribute1 and administer the countermeasure2 and 7ii7 an assurance that for each countermeasure produced or replenished under this subsection1 the ,secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment1 which need not be provided in advance of procurement4 2 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a71 by inserting and the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a before the semicolon2 7,b7 in subparagraph 7,c71 by inserting 1 and the availability1 deployment1 dispensing1 and administration of countermeasures before the semicolon2 and 7,c7 by amending subparagraph 7,e7 to read as follows3 7,e7 devise plans for effective and timely supply-chain management of the stockpile1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,assistant ,secretary for ,preparedness and ,response1 the ,secretary of ,transportation1 the ,secretary of ,homeland ,security1 the ,secretary of ,veterans ,affairs1 and the heads of other appropriate ,federal agencies1 ,state1 local1 tribal1 and territorial agencies1 and the public and private health care infrastructure1 as applicable1 taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile 2 and 7#e7 by adding at the end the following3 7#e7 ,,gao report 7,a7 ,in general ,not later than #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 and every #e years thereafter1 the ,comptroller ,general of the ,united ,states shall conduct a review of any changes to the contents or management of the stockpile since ,january #a1 #bjae4 ,such review shall include-- 7i7 an assessment of the comprehensiveness and completeness of each biennial threat-based review under paragraph 7#b71 including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review1 and whether1 consistent with paragraph 7#b77;,b71 the ,secretary conducted the necessary internal review in advance of such procurement or replenishment2 7ii7 an assessment of whether the ,secretary established health security and science-based justifications1 and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat1 for additions or modifications to the stockpile based on the information provided in such reviews under paragraph 7#b77;,b71 including whether such review was conducted prior to procurement1 modification1 or replenishment2 7iii7 an assessment of the plans developed by the ,secretary for the deployment1 distribution1 and dispensing of countermeasures procured1 modified1 or replenished under paragraph 7#a71 including whether such plans were developed prior to procurement1 modification1 or replenishment2 7iv7 an accounting of countermeasures procured1 modified1 or replenished under paragraph 7#a7 that received advanced research and development funding from the ,biomedical ,advanced ,research and ,development ,authority2 7v7 an analysis of how such procurement decisions made progress towards meeting emergency health security needs related to the identified threats for countermeasures added1 modified1 or replenished under paragraph 7#a72 7vi7 a description of the resources expended related to the procurement of countermeasures 7including additions1 modifications1 and replenishments7 in the stockpile1 and how such expenditures relate to the emergency health security needs of the stockpile2 7vii7 an assessment of the extent to which additions1 modifications1 and replenishments reviewed under paragraph 7#b7 align with previous relevant reports or reviews by the ,secretary or the ,comptroller ,general2 and 7viii7 with respect to any change in the ,federal organizational management of the stockpile1 an assessment and comparison of the processes affected by such change1 including planning for potential countermeasure deployment1 distribution1 or dispensing capabilities and processes related to procurement decisions1 use of stockpiled countermeasures1 and use of resources for such activities4 7,b7 ,submission ,not later than #f months after completing a classified version of the review under subparagraph 7,a71 the ,comptroller ,general shall submit an unclassified version of the review to the appropriate committees of ,congress4 4 7b7 ,authorization of appropriations1 strategic national stockpile ,section #cai;,f-#b7;f77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is amended by striking #ecc1hjj1jjj for each of fiscal years #bjad through #bjah and inserting #faj1jjj1jjj for each of fiscal years #bjai through #bjbc4 #djd4 ,preparing for pandemic influenza1 antimicrobial resistance1 and other significant threats ,section #cai,l7c77#d7 7#bdg;d-#g;e7c77#d77 is amended by adding at the end the following3 7,f7 ,strategic initiatives ,the ,secretary1 acting through the ,director of ,,barda1 may implement strategic initiatives1 including by building on existing programs1 supporting innovative candidate products in preclinical and clinical development1 to address priority1 naturally occurring and man-made threats that1 as determined by the ,secretary1 pose a significant level of risk to national security based on the characteristics of a chemical1 biological1 radiological or nuclear threat1 or existing capabilities to respond to such a threat 7including medical response and treatment capabilities and manufacturing infrastructure74 ,such initiatives shall accelerate and support the advanced research1 development1 and procurement of1 countermeasures and products1 as applicable1 to address areas including-- 7i7 chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases1 for which insufficient approved1 licensed1 or authorized countermeasures exist1 or for which such threat1 or the result of an exposure to such threat1 may become resistant to countermeasures or existing countermeasures may be rendered ineffective2 7ii7 threats that consistently exist or continually circulate and have significant potential to become a pandemic1 such as pandemic influenza1 which 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 and 7iii7 threats that may result primarily or secondarily from a chemical1 biological1 radiological1 or nuclear agent1 or emerging infectious disease1 and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures1 including antimicrobial resistant pathogens4 4 #dje4 ,reporting on the ,federal ,select ,agent ,program ,section #cea;,a7k7 7#db ,u4,s4,c4 #bfb;a7 is amended-- 7#a7 by striking ,the ,secretary and inserting the following3 7#a7 ,in general ,the ,secretary 2 and 7#b7 by adding at the end the following3 7#b7 ,implementation of recommendations of the ,federal experts security advisory panel and the fast track action committee on select agent regulations 7,a7 ,in general ,not later than #a year after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah1 the ,secretary shall provide an update to the appropriate committees of ,congress on the implementation of recommendations of the ,federal ,experts ,security ,advisory ,panel concerning the select agent program4 7,b7 ,continued updates ,the ,secretary shall provide status updates at #f-month intervals following the submission of the update under subparagraph 7,a7 until the recommendations described in such subparagraph are fully implemented1 or a justification is provided for the delay in1 or lack of1 implementation4 4 ,v ,increasing communication in medical countermeasure advanced research and development #eja4 ,medical countermeasure budget plan ,section #bhaa7;b77#g7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by striking ,march #a of each year and inserting ,march #ae1 #bjbj and every #b years thereafter2 7#b7 by striking subparagraph 7,a7 and inserting the following3 7,a7 include consideration of the entire medical countermeasures enterprise1 including-- 7i7 basic research and advanced research and development2 7ii7 approval1 clearance1 licensure1 and authorized uses of products2 7iii7 procurement1 stockpiling1 maintenance1 and potential replenishment 7including manufacturing capabilities7 of all products in the ,strategic ,national ,stockpile2 and 7iv7 the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development2 4 7#c7 by redesignating subparagraphs 7,d7 and 7,e7 as subparagraphs 7,e7 and 7,f71 respectively2 7#d7 by inserting after subparagraph 7,c71 the following3 7,d7 identify the full range of anticipated medical countermeasure needs related to research and development1 procurement1 and stockpiling1 including the potential need for indications1 dosing1 and administration technologies1 and other countermeasure needs as applicable and appropriate2 2 and 7#e7 in subparagraph 7,e71 as so redesignated1 by striking ,march #ae of each year and inserting ,march #ae1 #bjbj1 and every #b years thereafter4 #ejb4 ,material threat and medical countermeasure notifications 7a7 ,congressional notification of material threat determination ,section #cai;,f-#b7;c77#b77;,c7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#b77;,c77 is amended by striking ,the ,secretary and the ,homeland ,security ,secretary shall promptly notify the appropriate committees of ,congress and inserting ,the ,secretary and the ,secretary of ,homeland ,security shall send to ,congress1 on an annual basis1 all current material threat determinations and shall promptly notify the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,homeland ,security and ,government ,affairs of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,homeland ,security of the ,house of ,representatives4 7b7 ,contracting communications 7#a7 ,contract duration ,section #cai;,f-#b7;c77#g77;,b77ii77,,iii7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#g77;,b77ii77,,iii77 is amended by adding at the end the following3 ,the ,secretary shall notify the vendor within #ij days of a determination by the ,secretary to renew such contract44 7#b7 ,expedited authorities ,section #cai,l7c77#e77;,b77i7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77;,b77i77 is amended by adding at the end the following3 ,upon award1 extension1 or termination of any such contract1 grant1 cooperative agreement1 and other transaction1 the ,secretary shall provide a written notification to the receiving entity that includes a justification for such award1 extension1 or termination44 #ejc4 ,availability of regulatory management plans ,section #efe7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;f77 is amended-- 7#a7 by redesignating paragraphs 7#c7 through 7#f7 as paragraphs 7#d7 through 7#g71 respectively2 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 ,publication ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration information regarding regulatory management plans1 including-- 7,a7 the process by which an applicant may submit a request for a regulatory management plan2 7,b7 the timeframe by which the ,secretary is required to respond to such request2 7,c7 the information required for the submission of such request2 7,d7 a description of the types of development milestones and performance targets that could be discussed and included in such plans2 and 7,e7 contact information for beginning the regulatory management plan process4 2 7#c7 in paragraph 7#f71 as so redesignated1 in the matter preceding subparagraph 7,a7-- 7,a7 by striking paragraph 7#d77;,a7 and inserting paragraph 7#e77;,a72 and 7,b7 by striking paragraph 7#d77;,b7 and inserting paragraph 7#e77;,b72 and 7#d7 in paragraph 7#g77;,a71 as so redesignated1 by striking paragraph 7#c77;,a7 and inserting paragraph 7#d77;,a74 #ejd4 ,the ,biomedical ,advanced ,research and ,development ,authority and the ,bio,shield ,special ,reserve ,fund 7a7 ,bioshield special reserve fund ,section #cai;,f-#b7;g77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7g77#a77 is amended-- 7#a7 by striking #b1hjj1jjj1jjj for the period of fiscal years #bjad through #bjah and inserting #c1ejj1jjj1jjj for the period of fiscal years #bjai through #bjbc1 to remain available until expended2 and 7#b7 by striking the second sentence4 7b7 ,the ,biomedical ,advanced ,research and ,development ,authority ,section #cai,l7d77#b7 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is amended by striking #dae1jjj1jjj for each of fiscal years #bjad through #bjah and inserting #faa1gjj1jjj for each of fiscal years #bjai through #bjbc4 ,,vi ,advancing technologies for medical countermeasures #fja4 ,administration of countermeasures ,section #cai,l7c77#d77;,d77iii7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,d77iii77 is amended by striking and platform technologies inserting platform technologies1 technologies to administer countermeasures1 technologies to improve storage1 and transportation of countermeasures4 #fjb4 ,medical countermeasure master files 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #efe;,a the following3 #efe;,b4 ,medical countermeasure master files 7a7 ,purpose ,the purpose of this section is to support and accelerate the development or manufacture of security countermeasures1 qualified countermeasures1 and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support such products to master files1 and through clarifying the authority to cross-reference to data and information previously submitted to the ,secretary4 7b7 ,applicability of reference 7#a7 ,in general ,a person may submit data and information to the ,secretary with the intent to reference1 or to authorize1 in writing1 another person to reference1 such data or information1 in accordance with subsections 7d7 and 7e7 of section #cad4dbj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 to support a medical countermeasure submission 7including a supplement or amendment to any such submission71 without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file4 7#b7 ,master file holder ,in this section1 the term master file holder means a person who submits data and information to the ,secretary with the intent to reference or authorize to reference such data or information to support a medical countermeasure submission1 as described in paragraph 7#a74 7c7 ,medical countermeasure master file content 7#a7 ,in general ,a master file under this section may include information to support and accelerate-- 7,a7 the development of medical countermeasure submissions to support the approval1 licensure1 classification1 clearance1 conditional approval1 or authorization of one or more security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products2 and 7,b7 the manufacture of security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products4 7#b7 ,required updates ,the ,secretary may require1 as appropriate1 that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission4 7d7 ,sponsor reference 7#a7 ,in general ,each incorporation of information or data contained in a master file by reference shall describe the incorporated material in a manner in which the ,secretary determines appropriate and that permits the review of such information without necessitating resubmission of such information or data4 ,master files shall be submitted in an electronic format in accordance with section #gde;,a and as specified in applicable guidance4 7#b7 ,reference by a master file holder ,a master file holder that is the sponsor of a medical countermeasure submission shall notify the ,secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission4 7#c7 ,reference by an authorized person ,a sponsor of a medical countermeasure submission may1 where the ,secretary determines appropriate1 incorporate by reference all or part of the contents of a medical countermeasure master file1 if the master file holder authorizes the incorporation in writing4 7e7 ,acknowledgement of master file by the ,secretary ,the ,secretary shall provide the master file holder with a written notification indicating that the ,secretary has reviewed and relied upon specified information or data within a master file and the purposes for which such information or data was incorporated by reference if the ,secretary has reviewed and relied upon such specified information or data to support the approval1 classification1 conditional approval1 clearance1 licensure1 or authorization of a security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product4 ,the ,secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications1 as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder4 7f7 ,rules of construction ,nothing in this section shall be construed to-- 7#a7 alter the authority of the ,secretary to approve1 license1 classify1 clear1 conditionally approve1 or authorize drugs1 biological products1 or devices pursuant to this ,act or section #cea of the ,public ,health ,service ,act 7as authorized prior to the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjah71 including the standards of evidence1 and applicable conditions1 for approval under the applicable ,act2 or 7#b7 alter the authority of the ,secretary under this ,act or the ,public ,health ,service ,act to determine the types of information or data previously submitted by a sponsor or any other person that may be incorporated by reference in an application1 request1 or notification for a drug1 biological product1 or device submitted under sections #eje7;i71 #eje7;b71 #eje7;j71 #eab7;b77#a71 #eab7;b77#b71 #efd1 #ega1 #ebj7;g71 #eae7;c71 #eac7;f77#b71 or #eaj7k7 of this ,act1 or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 including a supplement or amendment to any such submission1 and the requirements associated with such reference4 7g7 ,definitions ,in this section3 7#a7 ,the term medical countermeasure submission means an investigational new drug application under section #eje7;i71 a new drug application under section #eje7;b71 or an abbreviated new drug application under section #eje7;j7 of this ,act1 a biological product license application under section #cea7;a7 of the ,public ,health ,service ,act or a biosimilar biological product license application under section #cea7k7 of the ,public ,health ,service ,act1 a new animal drug application under section #eab7;b77#a7 or abbreviated new animal drug application under section #eab7;b77#b71 an application for conditional approval of a new animal drug under #ega1 an investigational device application under section #ebj7;g71 an application with respect to a device under section #eae7;c71 a request for classification of a device under section #eac7;f77#b71 a notification with respect to a device under section #eaj7k71 or request for an emergency use authorization under section #efd to support-- 7,a7 the approval1 licensure1 classification1 clearance1 conditional approval1 or authorization of a security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product2 or 7,b7 a new indication to an approved security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product4 7#b7 ,the terms qualified countermeasure1 security countermeasure1 and qualified pandemic or epidemic product have the meanings given such terms in sections #cai;,f-#a1 #cai;,f-#b1 and #cai;,f-#c1 respectively1 of the ,public ,health ,service ,act4 4 7b7 ,stakeholder ,input ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,assistant ,secretary for ,preparedness and ,response1 shall solicit input from stakeholders1 including stakeholders developing security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products1 and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the ,food and ,drug ,administration can advance the use of tools and technologies to support and accelerate the development or manufacture of security countermeasures1 qualified countermeasures1 and qualified pandemic or epidemic products1 including through the reliance on cross-referenced data and information contained within master files and submissions previously submitted to the ,secretary as set forth in section #efe;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 7c7 ,guidance ,not later than #b years after the after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section #efe;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a7 or submissions otherwise submitted to the ,secretary may be used for specific tools or technologies 7including platform technologies7 that have the potential to support and accelerate the development or manufacture of security countermeasures1 qualified countermeasures1 qualified pandemic or epidemic products4 ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall publish the final guidance not later than #c years after the enactment of this ,act4 #fjc4 ,animal rule report 7a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the application of the requirements under section #efe7;d7 of the of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;d77 7referred to in this section as the animal rule7 as a component of medical countermeasure advanced development under the ,biomedical ,advanced ,research and ,development ,authority and regulatory review by the ,food and ,drug ,administration4 ,in conducting such study1 the ,comptroller ,general shall examine the following3 7#a7 ,the extent to which advanced development and review of a medical countermeasure are coordinated between the ,biomedical ,advanced ,research and ,development ,authority and the ,food and ,drug ,administration1 including activities facilitate appropriate and efficient design of studies to support approval1 licensure1 and authorization under the animal rule1 consistent with the recommendations in the animal rule guidance1 issued pursuant to section #efe7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 and entitled ,product ,development ,under the ,animal ,rule ,guidance for ,industry 7issued in ,october #bjae71 to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved1 licensed1 or authorized under the animal rule4 7#b7 ,the consistency of the application of the animal rule among and between review divisions within the ,food and ,drug ,administration4 7#c7 ,the flexibilities pursuant to the animal rule to address variations in countermeasure development and review processes1 including the extent to which qualified animal models are adopted and used within the ,food and ,drug ,administration in regulatory decisionmaking with respect to medical countermeasures4 7#d7 ,the extent to which the guidance issued under section #efe7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c771 entitled1 ,product ,development ,under the ,animal ,rule ,guidance for ,industry 7issued in ,october #bjae71 has assisted in achieving the purposes described in paragraphs 7#a71 7#b71 and 7#c74 7b7 ,consultations ,in conducting the study under subsection 7a71 the ,comptroller ,general of the ,united ,states shall consult with-- 7#a7 the ,federal agencies responsible for advancing1 reviewing1 and procuring medical countermeasures1 including the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,food and ,drug ,administration1 and the ,department of ,defense2 7#b7 manufacturers involved in the research and development of medical countermeasures to address biological1 chemical1 radiological1 and nuclear threats2 and 7#c7 other biodefense stakeholders1 as applicable4 7c7 ,report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states 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 containing the results of the study conducted under subsection 7a7 and recommendations to improve the application and consistency of the requirements under subsections 7c7 and 7d7 of section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 to support and expedite the research and development of medical countermeasures1 as applicable4 7d7 ,protection of national security ,the ,comptroller ,general of the ,united ,states shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security4 ,,vii ,miscellaneous provisions #gja4 ,reauthorizations and extensions 7a7 ,veterans ,affairs ,section #haag7;g7 of title #ch1 ,united ,states ,code1 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 7b7 ,vaccine tracking and distribution ,section #cai;,a7e7 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 7c7 ,temporary reassignment ,section #cai7;e77#h7 7#db ,u4,s4,c4 #bdg;d7e77#h77 is amended by striking #bjah and inserting #bjbc4 7d7 ,strategic ,innovation ,partner ,section #cai,l7c77#d77;,e77ix7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e77ix77 is amended by striking #bjbb and inserting #bjbc4 7e7 ,public disclosure exemption ,section #cai,l7e77#a77;,c7 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77;,c77 is amended by striking #ab and inserting #ag4 7f7 ,limited antitrust exemption 7#a7 ,in general ,section #dje of the ,pandemic and ,all-,hazards ,preparedness ,act 7#db ,u4,s4,c4 #bdg;d-#f;a note7 is amended-- 7,a7 by redesignating such section as section #cai,l-#a2 7,b7 transferring such section to the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to appear after section #cai,l of such ,act 7#db ,u4,s4,c4 #bdg;d-#g;e72 7,c7 in subsection 7a77#a7-- 7i7 by striking ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 and inserting ,secretary2 7ii7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b77 7as amended by this ,act2 7iii7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a77 7as amended by this ,act2 and 7iv7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d72 and 7,d7 in subsection 7b71 by striking #ab-year and inserting #ag-year4 7#b7 ,effective date ,the amendment made by paragraph 7#a77;,d7 shall take effect as if enacted on ,december #ag1 #bjab4 7#c7 ,conforming amendment ,the table of contents in section #a7;b7 of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag7 is amended by striking the item related to section #dje4 #gjb4 ,technical amendments 7a7 ,public ,health ,service ,act ,title ,,iii 7#db ,u4,s4,c4 #bda et seq47 is amended-- 7#a7 in paragraphs 7#a7 and 7#e7 of section #cai;,f-#a7;a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a771 by striking section #cai;,f7h7 each place such term appears and inserting section #cai;,f7e72 and 7#b7 in section #cai,k7a7 7#db ,u4,s4,c4 #bdg;d-#g;d7a771 by striking section #cai;,f7h77#d7 and inserting section #cai;,f7e77#d74 7b7 ,public health security grants ,section #cai;,c-#a7;b77#b7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is amended-- 7#a7 in subparagraph 7,c71 by striking individuals11 and inserting individuals12 and 7#b7 in subparagraph 7,f71 by striking make satisfactory annual improvement and describe and inserting makes satisfactory annual improvement and describes4 7c7 ,federal ,food1 ,drug1 and ,cosmetic ,act ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #efd;,a7e77#b77;,a7 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7e77#b77;,a771 by striking subsection 7a77#a77;,c77i7 and inserting subsection 7a77#a77;,c72 and 7#b7 in section #efd;,b7#b77;,c7 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77;,c771 by inserting or section #efd;,a4