,,ii #aagth ,,congress #b;d ,session ,s4 #cgii ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #aj 7legislative day1 ,march #g71 #bjbb ,mrs4 ,murray 7for herself and ,mr4 ,burr7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to prepare for1 and respond to1 existing viruses1 emerging new threats1 and pandemics4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,prepare for and ,respond to ,existing ,viruses1 ,emerging ,new ,threats1 and ,pandemics ,act or the ,,prevent ,pandemics ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,,title ,i--,strengthening ,federal and ,state preparedness ,subtitle ,a--,federal leadership and accountability ,sec4 #aja4 ,comprehensive review of the ,,covid-#ai response4 ,sec4 #ajb4 ,appointment and authority of the ,director of the ,centers for ,disease ,control and ,prevention4 ,sec4 #ajc4 ,additional provisions related to the ,centers for ,disease ,control and ,prevention4 ,sec4 #ajd4 ,public health and medical preparedness and response coordination4 ,sec4 #aje4 ,strengthening public health communication4 ,sec4 #ajf4 ,office of ,pandemic ,preparedness and ,response ,policy4 ,subtitle ,b--,state and local readiness ,sec4 #aaa4 ,improving ,state and local public health security4 ,sec4 #aab4 ,supporting access to mental health and substance use disorder services during public health emergencies4 ,sec4 #aac4 ,trauma care reauthorization4 ,sec4 #aad4 ,assessment of containment and mitigation of infectious diseases4 ,,title ,,ii--,improving public health preparedness and response capacity ,subtitle ,a--,addressing disparities and improving public health emergency responses ,sec4 #bja4 ,addressing social determinants of health and improving health outcomes4 ,sec4 #bjb4 ,national ,academies of ,sciences1 ,engineering1 and ,medicine report4 ,subtitle ,b--,improving public health data ,sec4 #baa4 ,modernizing biosurveillance capabilities and infectious disease data collection4 ,sec4 #bab4 ,genomic sequencing1 analytics1 and public health surveillance of pathogens4 ,sec4 #bac4 ,supporting public health data availability and access4 ,sec4 #bad4 ,epidemic forecasting and outbreak analytics4 ,sec4 #bae4 ,report on ,,cdc data portal4 ,sec4 #baf4 ,public health data transparency4 ,subtitle ,c--,revitalizing the public health workforce ,sec4 #bba4 ,improving recruitment and retention of the frontline public health workforce4 ,sec4 #bbb4 ,awards to support community health workers and community health4 ,sec4 #bbc4 ,improving public health emergency response capacity4 ,sec4 #bbd4 ,extension of authorities to support health professional volunteers at community health centers4 ,sec4 #bbe4 ,increasing educational opportunities for allied health professions4 ,sec4 #bbf4 ,public ,health ,service ,corps annual and sick leave4 ,subtitle ,d--,improving public health responses ,sec4 #bca4 ,centers for public health preparedness and response4 ,sec4 #bcb4 ,vaccine distribution plans4 ,sec4 #bcc4 ,coordination and collaboration regarding blood supply4 ,,title ,,iii--,accelerating research and countermeasure discovery ,subtitle ,a--,fostering research and development and improving coordination ,sec4 #cja4 ,research and activities related to long-term health effects of ,,sars-,co,v-#b infection4 ,sec4 #cjb4 ,research centers for pathogens of pandemic concern4 ,sec4 #cjc4 ,improving medical countermeasure research coordination4 ,sec4 #cjd4 ,accessing specimen samples and diagnostic tests4 ,subtitle ,b--,improving biosafety and biosecurity ,sec4 #caa4 ,improving control and oversight of select biological agents and toxins4 ,sec4 #cab4 ,strategy for ,federal high-containment laboratories4 ,sec4 #cac4 ,national ,science ,advisory ,board for ,biosecurity4 ,sec4 #cad4 ,research to improve biosafety4 ,sec4 #cae4 ,federally-funded research with enhanced pathogens of pandemic potential4 ,subtitle ,c--,preventing undue foreign influence in biomedical research ,sec4 #cba4 ,foreign talent programs4 ,sec4 #cbb4 ,securing identifiable1 sensitive information4 ,sec4 #cbc4 ,duties of the ,director4 ,sec4 #cbd4 ,protecting ,america's biomedical research enterprise4 ,sec4 #cbe4 ,,gao ,study4 ,sec4 #cbf4 ,report on progress to address undue foreign influence4 ,,title ,,iv--,modernizing and strengthening the supply chain for vital medical products ,sec4 #dja4 ,warm base manufacturing capacity for medical countermeasures4 ,sec4 #djb4 ,supply chain considerations for the ,strategic ,national ,stockpile4 ,sec4 #djc4 ,strategic ,national ,stockpile equipment maintenance4 ,sec4 #djd4 ,improving transparency and predictability of processes of the ,strategic ,national ,stockpile4 ,sec4 #dje4 ,improving supply chain flexibility for the ,strategic ,national ,stockpile4 ,sec4 #djf4 ,reimbursement for certain supplies4 ,sec4 #djg4 ,action reporting on stockpile depletion4 ,sec4 #djh4 ,provision of medical countermeasures to ,indian programs and facilities4 ,sec4 #dji4 ,grants for ,state strategic stockpiles4 ,,title ,v--,enhancing development and combating shortages of medical products ,subtitle ,a--,development and review ,sec4 #eja4 ,advancing qualified infectious disease product innovation4 ,sec4 #ejb4 ,modernizing clinical trials4 ,sec4 #ejc4 ,accelerating countermeasure development and review4 ,sec4 #ejd4 ,third party test evaluation during emergencies4 ,sec4 #eje4 ,facilitating the use of real world evidence4 ,sec4 #ejf4 ,platform technologies4 ,sec4 #ejg4 ,increasing ,,eua decision transparency4 ,sec4 #ejh4 ,improving ,,fda guidance and communication4 ,sec4 #eji4 ,,gao study and report on hiring challenges at ,,fda4 ,subtitle ,b--,mitigating shortages ,sec4 #eaa4 ,ensuring registration of foreign drug and device manufacturers4 ,sec4 #eab4 ,extending expiration dates for certain drugs4 ,sec4 #eac4 ,unannounced foreign facility inspections pilot program4 ,sec4 #ead4 ,combating counterfeit devices4 ,sec4 #eae4 ,strengthening medical device supply chains4 ,sec4 #eaf4 ,preventing medical device shortages4 ,sec4 #eag4 ,remote records assessments for medical devices4 ,sec4 #eah4 ,advanced manufacturing technologies designation pilot program4 ,sec4 #eai4 ,technical corrections4 ,i ,strengthening ,federal and ,state preparedness ,a ,federal leadership and accountability #aja4 ,comprehensive review of the ,,covid-#ai response 7a7 ,establishment of task force ,there is established in the legislative branch a task force to be known as the ,national ,task ,force on the ,response of the ,united ,states to the ,,covid-#ai ,pandemic 7referred to in this section as the ,task ,force74 7b7 ,purposes ,the purposes of the ,task ,force are to-- 7#a7 examine1 assess1 and report upon the ,united ,states' preparedness for1 and response to1 the ,,covid-#ai pandemic1 including-- 7,a7 the initial ,federal1 ,state1 local1 and territorial responses in the ,united ,states2 7,b7 the ongoing ,federal1 ,state1 local1 and territorial responses in the ,united ,states1 including the activities1 policies1 and decisions of the ,trump ,administration and the ,biden ,administration2 7,c7 the impact of the pandemic on public health and health care systems2 and 7,d7 the initial outbreak in ,wuhan1 ,china1 including efforts to determine the potential causes for the emergence of the ,,sars-,co,v-#b virus1 and ,federal actions to mitigate its spread internationally2 7#b7 build upon existing or ongoing evaluations and avoid unnecessary duplication1 by reviewing the findings1 conclusions1 and recommendations of other appropriate task forces1 committees1 commissions1 or entities established by other public or nonprofit private entities related to the ,united ,states' preparedness for1 and response to1 the ,,covid-#ai pandemic2 7#c7 identify gaps in public health preparedness and medical response policies1 processes1 and activities1 including disparities in ,,covid-#ai infection and mortality rates among people of color1 older adults1 people with disabilities1 and other vulnerable or at-risk groups1 and how such gaps impacted the ability of the ,united ,states to respond to the ,,covid-#ai pandemic2 and 7#d7 submit a report to the ,president and to ,congress on its findings1 conclusions1 and recommendations to improve the ,united ,states preparedness for1 and response to1 future public health emergencies1 including a public health emergency resulting from an emerging infectious disease4 7c7 ,composition of ,task ,force2 meetings 7#a7 ,members ,the ,task ,force shall be composed of #ab members1 of whom-- 7,a7 #a member shall be appointed by the majority leader of the ,senate2 7,b7 #a member shall be appointed by the minority leader of the ,senate2 7,c7 #b members shall be appointed by the chair of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,d7 #b members shall be appointed by the ranking member of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,e7 #a member shall be appointed by the ,speaker of the ,house of ,representatives2 7,f7 #a member shall be appointed by the minority leader of the ,house of ,representatives2 7,g7 #b members shall be appointed by the chair of the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7,h7 #b members shall be appointed by the ranking member of the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7#b7 ,chair and vice chair ,not later than #cj days after the date on which all members of the ,task ,force are appointed under paragraph 7#a71 such members shall meet to elect a ,chair and ,vice ,chair from among such members4 ,the ,chair and ,vice ,chair shall each be elected to serve upon an affirmative vote from #h members of the ,task ,force4 ,the ,chair and ,vice ,chair shall not be registered members of the same political party4 7#c7 ,qualifications 7,a7 ,political party affiliation ,not more than #f members of the ,task ,force shall be registered members of the same political party4 7,b7 ,nongovernmental appointees ,an individual appointed to the ,task ,force may not be an officer or employee of the ,federal ,government or any ,state1 local1 ,tribal1 or territorial government4 7,c7 ,qualifications ,it is the sense of ,congress that individuals appointed to the ,task ,force should be highly qualified citizens of the ,united ,states4 ,members appointed under paragraph 7#a7 may include individuals with expertise in-- 7i7 public health1 health disparities and at-risk populations1 medicine1 and related fields2 7ii7 ,state1 local1 ,tribal1 or territorial government1 including public health and medical preparedness and response and emergency management and other relevant public administration2 7iii7 research regarding1 or the development1 manufacturing1 distribution1 and regulation of1 medical products2 7iv7 national security and foreign relations1 including global health2 and 7v7 commerce1 including transportation1 supply chains1 and small business4 7#d7 ,deadline for appointment ,all members of the ,task ,force shall be appointed not later than #ij days after the date of enactment of this ,act4 7#e7 ,meetings ,the ,task ,force shall meet and begin the operations of the ,task ,force as soon as practicable4 ,after its initial meeting1 the ,task ,force shall meet upon the call of the ,chair and ,vice ,chair or #h of its members4 7#f7 ,quorum2 vacancies 7,a7 ,quorum ,eight members of the ,task ,force shall constitute a quorum4 7,b7 ,vacancies ,any vacancy in the ,task ,force shall not affect its powers1 but shall be filled in the same manner in which the original appointment was made4 7d7 ,functions of ,task ,force ,the functions of the ,task ,force are to-- 7#a7 conduct a review that-- 7,a7 examines the initial outbreak of the ,,sars-,co,v-#b virus in ,wuhan1 ,china1 including-- 7i7 engaging with willing partner governments and global experts2 7ii7 seeking access to relevant records2 and 7iii7 examining the potential causes of the emergence and source of the virus2 7,b7 examines the ,united ,states preparation for1 and response to1 the ,,covid-#ai pandemic1 including-- 7i7 relevant laws1 policies1 regulations1 and processes that were in place prior to1 or put into place during1 the public health emergency declared by the ,secretary of ,health and ,human ,services under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 with respect to ,,covid-#ai1 including any that are put into place related to such public health emergency after the date of enactment of this ,act and prior to the issuance of the final report pursuant to subsection 7j77#b72 7ii7 relevant actions taken by1 and coordination between1 ,federal1 ,state1 local1 ,tribal1 and territorial governments1 nongovernmental organizations1 and international organizations on preparedness and response efforts1 including coordination between governments and other public and private entities1 during the-- 7,i7 initial response in the ,united ,states2 7,,ii7 response during the ,trump ,administration2 and 7,,iii7 ongoing response during the ,biden ,administration2 7iii7 communication of public health and scientific information related to the ,,covid-#ai pandemic1 including processes for the development1 approval1 and dissemination of ,federal public health and other relevant public health or scientific guidance2 7iv7 actions taken to support the development1 manufacturing1 and distribution of medical countermeasures and related medical supplies to prevent1 detect1 and treat ,,covid-#ai2 and 7,c7 may include assessments relating to-- 7i7 the capacity and capabilities of ,federal1 ,state1 local1 ,tribal1 and territorial governments to respond to the ,,covid-#ai pandemic2 7ii7 the capacity and capabilities of health care facilities and the health care workforce to respond to the ,,covid-#ai pandemic2 7iii7 medical countermeasure research and development and the supply chains of medical products necessary to respond to the ,,covid-#ai pandemic2 7iv7 international preparedness for and response to ,,covid-#ai1 and ,federal decision-making processes related to new global health threats2 7v7 containment and mitigation measures related to domestic and international travel in response to ,,covid-#ai2 and 7vi7 the impact of the ,,covid-#ai pandemic and related mitigation efforts on hard-to-reach and at-risk or underserved populations1 including related health disparities2 7#b7 identify1 review1 and evaluate the lessons learned from the ,,covid-#ai pandemic1 including activities to prepare for1 and respond to1 future potential pandemics and related public health emergencies2 and 7#c7 submit to the ,president and ,congress such reports as are required by this ,act containing such findings1 conclusions1 and recommendations as the ,task ,force shall determine4 7e7 ,powers of ,task ,force 7#a7 ,hearings ,the ,task ,force may-- 7,a7 hold such hearings and sit and act at such times and places1 take such testimony1 receive such evidence as determined by the ,chair and ,vice ,chair1 and administer such oaths as the ,task ,force or a designated member1 as determined by the ,chair or ,vice ,chair1 may determine advisable to be necessary to carry out the functions of the ,task ,force2 and 7,b7 subject to paragraph 7#b77;,a71 require1 by subpoena or otherwise1 the attendance and testimony of such witnesses and the production of such books1 records1 correspondence1 memoranda1 papers1 and documents1 as the person described in paragraph 7#b77;,a77i7 may determine advisable4 7#b7 ,subpoenas 7,a7 ,issuance 7i7 ,in general ,a subpoena may be issued under this subsection only-- 7,i7 by the agreement of the ,chair and the ,vice ,chair2 or 7,,ii7 by the affirmative vote of #i members of the ,task ,force4 7ii7 ,signature ,subpoenas issued under this subsection may be issued under the signature of the ,chair or any member designated by a majority of the ,task ,force1 and may be served by any person designated by the ,chair or by a member designated by agreement of the majority of the ,task ,force4 7,b7 ,enforcement ,in the case of contumacy or failure to obey a subpoena issued under subsection1 the ,united ,states district court for the judicial district in which the subpoenaed person resides1 is served1 or may be found1 or where the subpoena is returnable1 may issue an order requiring such person to appear at any designated place to testify or to produce documentary or other evidence4 ,any failure to obey the order of the court may be punished by the court as a contempt of that court4 7#c7 ,contracting ,the ,task ,force may1 to such extent and in such amounts as are provided in appropriation ,acts1 enter into contracts to enable the ,task ,force to discharge its duties under this ,act4 7#d7 ,information from federal agencies 7,a7 ,in general ,the ,task ,force may access from any executive department1 bureau1 agency1 board1 commission1 office1 independent establishment1 or instrumentality of the ,federal ,government1 such information1 documents1 suggestions1 estimates1 and statistics as the ,task ,force considers necessary to carry out this section4 7,b7 ,provision of information ,on written request of the ,chair1 each department1 bureau1 agency1 board1 commission1 office1 independent establishment1 or instrumentality shall1 to the extent authorized by law1 provide such information to the ,task ,force4 7,c7 ,receipt1 handling1 storage1 and dissemination ,information shall only be received1 handled1 stored1 and disseminated by members of the ,task ,force and its staff consistent with all applicable statutes1 regulations1 and executive orders4 7#e7 ,assistance from ,federal agencies 7,a7 ,general services administration ,on request of the ,chair and ,vice ,chair1 the ,administrator of ,general ,services ,administration shall provide to the ,task ,force1 on a reimbursable basis1 administrative support and other assistance necessary for the ,task ,force to carry out its duties4 7,b7 ,other departments and agencies ,in addition to the assistance provided for in subparagraph 7,a71 departments and agencies of the ,united ,states may provide to the ,task ,force such assistance as such departments and agencies may determine advisable and as authorized by law4 7#f7 ,donations ,the ,task ,force may accept1 use1 and dispose of gifts or donations of services or property4 ,not later than #e days after the acceptance of a donation under this subsection1 the ,task ,force shall publicly disclose-- 7,a7 the name of the entity that provided such donation2 7,b7 the service or property provided through such donation2 7,c7 the value of such donation2 and 7,d7 how the ,task ,force plans to use such donation4 7#g7 ,postal services ,the ,task ,force may use the ,united ,states mails in the same manner and under the same conditions as a department or agency of the ,united ,states4 7f7 ,applicability of ,federal ,advisory ,committee ,act 7#a7 ,in general ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,task ,force4 7#b7 ,public meetings and release of public versions of reports ,the ,task ,force shall-- 7,a7 hold public hearings and meetings to the extent appropriate2 and 7,b7 release public versions of the reports required under paragraph 7#a7 and 7#b7 of subsection 7j74 7#c7 ,public hearings ,any public hearings of the ,task ,force shall be conducted in a manner consistent with the protection of information provided to or developed for or by the ,task ,force as required by any applicable statute1 regulation1 or ,executive order4 7g7 ,staff of ,task ,force 7#a7 ,in general 7,a7 ,appointment and compensation ,the ,chair of the ,task ,force1 in agreement with the ,vice ,chair1 in accordance with rules agreed upon by the ,task ,force1 may appoint and fix the compensation of a staff director and such other personnel as may be necessary to enable the ,task ,force to carry out its functions1 without regard to the provisions of title #e1 ,united ,states ,code1 governing appointments in the competitive service1 and without regard to the provisions of chapter #ea and subchapter ,,iii of chapter #ec of such title relating to classification and ,general ,schedule pay rates1 except that no rate of pay fixed under this subsection may exceed the equivalent of that payable for a position at level ,v of the ,executive ,schedule under section #ecaf of title #e1 ,united ,states ,code4 7,b7 ,personnel as ,federal employees 7i7 ,in general ,the staff director and any personnel of the ,task ,force who are employees shall be employees under section #baje of title #e1 ,united ,states ,code1 for purposes of chapters #fc1 #ha1 #hc1 #hd1 #he1 #hg1 #hi1 and #ij of that title4 7ii7 ,members of task force ,clause 7i7 shall not be construed to apply to members of the ,task ,force4 7#b7 ,detailees ,upon request of the ,chair and ,vice ,chair of the ,task ,force1 the head of any executive department1 bureau1 agency1 board1 commission1 office1 independent establishment1 or instrumentality of the ,federal ,government employee may detail1 without reimbursement1 any of its personnel to the ,task ,force to assist in carrying out its duties under this section4 ,any such detailee shall be without interruption or loss of civil service status or privilege4 7#c7 ,consultant services ,the ,task ,force is authorized to procure the services of experts and consultants in accordance with section #caji of title #e1 ,united ,states ,code1 but at rates not to exceed the daily rate paid a person occupying a position at level ,,iv of the ,executive ,schedule under section #ecae of title #e1 ,united ,states ,code4 7h7 ,compensation and travel expenses ,each member of the ,task ,force shall serve without compensation1 but shall receive travel expenses1 including per diem in lieu of subsistence1 at rates authorized for an employee of an agency under subchapter ,i of chapter #eg of title #e1 ,united ,states ,code4 7i7 ,security clearances for task force members and staff ,the appropriate ,federal agencies or departments shall cooperate with the ,task ,force in expeditiously providing to the ,task ,force members and staff appropriate security clearances1 consistent with existing procedures and requirements4 ,no person shall be provided with access to classified information under this section without the appropriate security clearances4 7j7 ,reports of ,task ,force2 termination 7#a7 ,interim report ,not later than #ahj days after the date of enactment of this ,act1 the ,task ,force shall submit to the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives an interim report containing such findings1 conclusions1 and recommendations as have been agreed to by #h members of the ,task ,force4 ,such interim report shall be made available online in a manner that does not compromise national security4 7#b7 ,final ,report 7,a7 ,in general ,not later than #ah months after the date on which the last member of the ,task ,force is appointed1 the ,task ,force shall submit to the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a final report containing such findings1 conclusions1 and recommendations as have been agreed to by #h members of the ,task ,force4 ,the final report shall be made available online in a manner that does not compromise national security4 7,b7 ,extensions 7i7 ,in general ,the submission and publication of the final report1 as described in subparagraph 7,a71 may be delayed by #f months upon the agreement of #h members of the ,task ,force4 7ii7 ,notification ,the ,task ,force shall notify the ,president1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the public of any extension granted under clause 7i74 7,c7 ,special rules and considerations 7i7 ,rule of construction ,nothing in this subsection shall be construed as authorizing the ,task ,force to publicly disclose information otherwise prohibited from disclosure by law4 7ii7 ,special timing considerations ,notwithstanding any other provision of this section1 the ,task ,force shall not publish or make available any interim or final report during the during the #fj-;day periods ending ,november #h1 #bjbb1 and ,november #e1 #bjbd4 7#c7 ,termination 7,a7 ,in general ,the ,task ,force1 and all the authorities of this section1 shall terminate #fj days after the date on which the final report is submitted under paragraph 7#b74 7,b7 ,administrative activities before termination ,the ,task ,force may use the #fj-;day period referred to in subparagraph 7,a7 for the purpose of concluding its activities1 including providing testimony to committees of ,congress concerning its reports and disseminating the final report4 7k7 ,funding 7#a7 ,authorization of appropriations ,there is authorized to be appropriated to carry out this section1 a total of #c1jjj1jjj for fiscal years #bjbc and #bjbd4 7#b7 ,duration of availability ,amounts made available to the ,task ,force under paragraph 7#a7 shall remain available until the termination of the ,task ,force4 #ajb4 ,appointment and authority of the ,director of the ,centers for ,disease ,control and ,prevention 7a7 ,in general ,part ,a of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cjd the following3 #cje4 ,appointment and authority of the ,director of the ,centers for ,disease ,control and ,prevention 7a7 ,in general ,the ,centers for ,disease ,control and ,prevention 7referred to in this section as the ,,cdc7 shall be headed by the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this section as the ,director71 who shall be appointed by the ,president1 by and with the advice and consent of the ,senate4 ,such individual shall also serve as the ,administrator of the ,agency for ,toxic ,substances and ,disease ,registry consistent with section #ajd7;i7 of the ,comprehensive ,environmental ,response1 ,compensation1 and ,liability ,act4 ,the ,director shall perform functions provided for in subsection 7b7 and such other functions as the ,secretary may prescribe4 7b7 ,functions ,the ,secretary1 acting through the ,director1 shall-- 7#a7 implement and exercise applicable authorities and responsibilities provided for in this ,act or other applicable law related to the investigation1 detection1 identification1 prevention1 or control of diseases or conditions to preserve and improve public health domestically and globally and address injuries and occupational and environmental hazards1 as appropriate2 7#b7 be responsible for the overall direction of the ,,cdc and for the establishment and implementation of policies related to the management and operation of programs and activities within the ,,cdc2 7#c7 coordinate and oversee the operation of centers1 institutes1 and offices within the ,,cdc2 7#d7 support1 in consultation with the heads of such centers1 institutes1 and offices1 program coordination across such centers1 institutes1 and offices1 including through priority setting reviews and the development of strategic plans1 to reduce unnecessary duplication and encourage collaboration between programs2 7#e7 oversee the development1 implementation1 and updating of the strategic plan established pursuant to subsection 7c72 7#f7 ensure that appropriate strategic planning1 including the use of performance metrics1 is conducted by such centers1 institutes1 and offices to facilitate and improve ,,cdc programs and activities2 7#g7 communicate1 including through convening annual meetings1 with public and private entities regarding relevant public health programs and activities1 and1 as applicable1 the strategic plan established pursuant to subsection 7c74 7c7 ,strategic plan 7#a7 ,in general ,not later than #a year after the date of enactment of the ,,prevent ,pandemics ,act1 and at least every #d years thereafter1 the ,director shall develop and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 and post on the website of the ,,cdc1 a coordinated strategy to provide strategic direction and facilitate collaboration across the centers1 institutes1 and offices within the ,,cdc4 ,such strategy shall be known as the ,,cdc ,strategic ,plan4 7#b7 ,requirements ,the ,,cdc ,strategic ,plan shall-- 7,a7 identify strategic priorities and objectives related to-- 7i7 preventing1 reducing1 and eliminating the spread of communicable and noncommunicable diseases or conditions1 and addressing injuries1 and occupational and environmental hazards2 7ii7 supporting the efforts of ,state1 local1 and ,tribal health departments to prevent and reduce the prevalence of the diseases or conditions under clause 7i72 7iii7 containing1 mitigating1 and ending disease outbreaks2 7iv7 enhancing global and domestic public health capacity1 capabilities1 and preparedness1 including public health data1 surveillance1 workforce1 and laboratory capacity and safety2 and 7v7 other priorities1 as established by the ,director2 7,b7 describe the capacity and capabilities necessary to achieve the priorities and objectives under subparagraph 7,a71 and progress towards achieving such capacity and capabilities1 as appropriate2 and 7,c7 include a description of how the ,,cdc ,strategic ,plan incorporates-- 7i7 strategic communications2 7ii7 partnerships with private sector entities1 and ,state1 local1 and ,tribal health departments1 and other public sector entities1 as appropriate2 and 7iii7 coordination with other agencies and offices of the ,department of ,health and ,human ,services and other ,federal departments and agencies1 as appropriate4 7#c7 ,use of plans ,strategic plans developed and updated by the centers1 institutes1 and offices of the ,,cdc shall be prepared regularly and in such a manner that such plans will be informed by the ,,cdc ,strategic ,plan developed and updated under this subsection4 7d7 ,appearances before ,congress 7#a7 ,in general ,each fiscal year1 the ,director shall appear before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives at hearings on topics such as-- 7,a7 support for ,state1 local1 and ,tribal public health preparedness and responses to any recent or ongoing public health emergency1 including-- 7i7 any objectives1 activities1 or initiatives that have been carried out1 or are planned1 by the ,director to prepare for1 or respond to1 the public health emergency1 including relevant strategic communications or partnerships and any gaps or challenges identified in such objectives1 activities1 or initiatives2 7ii7 any objectives and planned activities for the upcoming fiscal year to address gaps in1 or otherwise improve1 ,state1 local1 and ,tribal public health preparedness2 and 7iii7 other potential all-hazard threats that the ,director is preparing to address2 7,b7 activities related to public health and functions of the ,director described in subsection 7b72 and 7,c7 updates on other relevant activities supported or conducted by the ,,cdc1 or in collaboration or coordination with the heads of other ,federal departments1 agencies1 or stakeholders1 as appropriate4 7#b7 ,clarifications 7,a7 ,waiver authority ,the ,chair of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate or the ,chair of the ,committee on ,energy and ,commerce of the ,house of ,representatives may waive the requirements of paragraph 7#a7 for the applicable fiscal year with respect to the applicable ,committee4 7,b7 ,scope of requirements ,the requirements of this subsection shall not be construed to impact the appearance of other ,federal officials or the ,director at hearings of either ,committee described in paragraph 7#a7 at other times and for purposes other than the times and purposes described in paragraph 7#a74 7#c7 ,closed hearings ,information that is not appropriate for disclosure during an open hearing under paragraph 7#a7 in order to protect national security may instead be discussed in a closed hearing that immediately follows the open hearing4 4 7b7 ,application ,the first sentence of section #cje7;a7 of the ,public ,health ,service ,act1 as added by subsection 7a71 shall not apply to the ,director of the ,centers for ,disease ,control and ,prevention who is serving on the date of enactment of this ,act4 #ajc4 ,additional provisions related to the ,centers for ,disease ,control and ,prevention ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cje1 as added by section #ajb1 the following3 #cje;,a4 ,additional provisions related to the ,centers for ,disease ,control and ,prevention 7a7 ,appointments 7#a7 ,in general ,unless otherwise specified in statute1 the heads of the centers or institutes of the ,centers for ,disease ,control and ,prevention shall be appointed by the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this section as the ,director74 ,each such individual shall be appointed for #e years4 7#b7 ,reappointments ,at the end of a #e-year term1 an individual appointed under paragraph 7#a7 shall be reappointed in accordance with standards applicable to the relevant appointment mechanism and as determined by the ,secretary1 as applicable4 7#c7 ,no limit on terms ,there shall be no limit on the number of terms that any individual appointed under this subsection may serve4 7#d7 ,vacancies ,if the position of a head of a center or institute described in paragraph 7#a7 becomes vacant before the end of a term1 the head of such center or institute appointed to fill the vacancy shall be appointed for a #e-year term starting on the date of such appointment4 7#e7 ,current positions and exemptions 7,a7 ,in general ,each such individual who is serving on the date of enactment of the ,,prevent ,pandemics ,act shall be deemed to be appointed for a #e-year term under this subsection beginning on such date of enactment4 7,b7 ,exemptions ,the ,secretary may exempt the head of a center or institute from the #e-year term described in subparagraph 7,a7 if such ,secretary determines such exemption is necessary in order to hire or retain talented individuals4 7#f7 ,rule of construction ,nothing in this subsection shall be construed to limit the authority of the ,secretary or the ,director to terminate the appointment of a head of a center or institute described in paragraph 7#a7 before the expiration of such individual's #e-year term4 7#g7 ,nature of appointment ,appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the ,centers for ,disease ,control and ,prevention and its components1 including compliance with relevant legal requirements4 7b7 ,other transactions 7#a7 ,in general ,in carrying out activities of the ,centers for ,disease ,control and ,prevention1 the ,director may enter into transactions other than a contract1 grant1 or cooperative agreement for purposes of biosurveillance1 infectious disease modeling1 and public health preparedness and response1 including related research4 7#b7 ,written determination ,with respect to a project that is expected to cost the ,centers for ,disease ,control and ,prevention more than #e1jjj1jjj1 the ,director may exercise the authority under paragraph 7#a7 only upon a written determination by the ,assistant ,secretary for ,financial ,resources of the ,department of ,health and ,human ,services1 that the use of such authority is essential to promoting the success of the project4 ,the authority of the ,assistant ,secretary for ,financial ,resources under this paragraph may not be delegated4 7#c7 ,guidelines ,the ,director1 in consultation with the ,secretary1 shall establish guidelines regarding the use of the authority under paragraph 7#a74 ,such guidelines shall include auditing requirements4 4 #ajd4 ,public health and medical preparedness and response coordination 7a7 ,public ,health ,emergency ,fund ,section #cai7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,e71 by striking and at the end2 7,b7 by redesignating subparagraph 7,f7 as subparagraph 7,g72 and 7,c7 by inserting after subparagraph 7,e71 the following3 7,f7 support the initial deployment and distribution of contents of the ,strategic ,national ,stockpile1 as appropriate2 and 2 and 7#b7 by amending paragraph 7#c77;,a7 to read as follows3 7,a7 the expenditures made from the ,public ,health ,emergency ,fund in such fiscal year1 including-- 7i7 the amount obligated2 7ii7 the recipient or recipients of such obligated funds2 7iii7 the specific response activities such obligated funds will support2 and 7iv7 the declared or potential public health emergency for which such funds were obligated2 and 4 7b7 ,improving public health and medical preparedness and response coordination 7#a7 ,coordination with ,federal agencies ,section #bhja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh7 is amended by adding at the end the following3 7c7 ,coordination with ,federal agencies ,in leading the ,federal public health and medical response to a declared or potential public health emergency1 consistent with this section1 the ,secretary shall coordinate with1 and may request support from1 other ,federal departments and agencies1 as appropriate in order to carry out necessary activities and leverage the expertise of such departments and agencies1 which may include the provision of assistance at the direction of the ,secretary related to supporting the public health and medical response for ,states1 localities1 and ,tribes4 4 7#b7 ,,aspr duties ,section #bhaa7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is amended-- 7,a7 in paragraph 7#a71 by inserting and1 consistent with the ,national ,response ,framework and other applicable provisions of law1 assist the ,secretary in carrying out the functions under section #bhja before the period2 and 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,e7 by striking the actions necessary to overcome these obstacles4 and inserting 8recommend actions necessary to overcome these obstacles1 such as-- 7i7 improving coordination with relevant ,federal officials2 7ii7 partnering with other public or private entities to leverage capabilities maintained by such entities1 as appropriate and consistent with this subsection2 and 7iii7 coordinating efforts to support or establish new capabilities1 as appropriate4 2 and 7ii7 in subparagraph 7,g7-- 7,i7 by redesignating clauses 7i7 and 7ii7 as subclauses 7,i7 and 7,,ii7 and adjusting the margins accordingly2 7,,ii7 in the matter preceding subclause 7,i71 as so redesignated-- 7aa7 by inserting each year1 including national-level and ,state-level full-scale exercises not less than once every #e years after operational exercises2 and 7bb7 by striking exercises based on-- and inserting 8exercises-- 7i7 based on 2 7,,iii7 by striking the period and inserting a semicolon2 and 7,,iv7 by adding at the end the following3 7ii7 that assess the ability of the ,strategic ,national ,stockpile1 as appropriate1 to provide medical countermeasures1 medical products1 and other supplies1 including ancillary medical supplies1 to support the response to a public health emergency or potential public health emergency1 including a threat that requires the large-scale and simultaneous deployment of stockpiles and a long-term public health and medical response2 and 7iii7 conducted in coordination with ,state and local health officials4 4 7c7 ,appearances before and reports to ,congress ,section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended by adding at the end the following3 7g7 ,appearances before ,congress 7#a7 ,in general ,each fiscal year1 the ,assistant ,secretary for ,preparedness and ,response shall appear before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives at hearings1 on topics such as-- 7,a7 coordination of ,federal activities to prepare for1 and respond to1 public health emergencies2 7,b7 activities and capabilities of the ,strategic ,national ,stockpile1 including whether1 and the degree to which1 recommendations made pursuant to section #bhaa-a7;c77#a77;,a7 have been met2 7,c7 support for ,state1 local1 and ,tribal public health and medical preparedness2 7,d7 activities implementing the countermeasures budget plan described under subsection 7b77#g71 including-- 7i7 any challenges in meeting the full range of identified medical countermeasure needs2 and 7ii7 progress in supporting advanced research1 development1 and procurement of medical countermeasures1 pursuant to subsection 7b77#c72 7,e7 the strategic direction of1 and activities related to1 the sustainment of manufacturing surge capacity and capabilities for medical countermeasures pursuant to section #cai,l and the distribution and deployment of such countermeasures2 7,f7 any additional objectives1 activities1 or initiatives that have been carried out or are planned by the ,assistant ,secretary for ,preparedness and ,response and associated challenges1 as appropriate2 7,g7 the specific all-hazards threats that the ,assistant ,secretary for ,preparedness and ,response is preparing to address1 or that are being addressed1 through the activities described in subparagraphs 7,a7 through 7,f72 and 7,h7 objectives1 activities1 or initiatives related to the coordination and consultation required under subsections 7b77#d77;,h7 and 7b77#d77;,i71 in a manner consistent with paragraph 7#c71 as appropriate4 7#b7 ,clarifications 7,a7 ,waiver authority ,the ,chair of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate or the ,chair of the ,committee on ,energy and ,commerce of the ,house of ,representatives may waive the requirements of paragraph 7#a7 for the applicable fiscal year with respect to the applicable ,committee4 7,b7 ,scope of requirements ,the requirements of this subsection shall not be construed to impact the appearance of other ,federal officials or the ,assistant ,secretary at hearings of either ,committee described in paragraph 7#a7 at other times and for purposes other than the times and purposes described in paragraph 7#a74 7#c7 ,closed hearings ,information that is not appropriate for disclosure during an open hearing under paragraph 7#a7 in order to protect national security may instead be discussed in a closed hearing that immediately follows such open hearing4 4 7d7 ,annual report on emergency response and preparedness ,section #bhja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh71 as amended by subsection 7b71 is further amended by adding at the end the following3 7d7 ,annual report on emergency response and preparedness ,the ,secretary shall submit a written report each fiscal year to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 containing-- 7#a7 updated information related to an assessment of the response to any public health emergency declared1 or otherwise in effect1 during the previous fiscal year2 7#b7 findings related to drills and operational exercises completed in the previous fiscal year pursuant to section #bhaa7;b77#d77;,g72 7#c7 the state of public health preparedness and response capabilities for chemical1 biological1 radiological1 and nuclear threats1 including emerging infectious diseases2 and 7#d7 any challenges in preparing for or responding to such threats1 as appropriate4 4 7e7 ,,gao report on interagency agreements and coordination ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct a review of previous and current interagency agreements established between the ,secretary of ,health and ,human ,services and the heads of other relevant ,federal departments or agencies pursuant to section #bhja7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh7b771 including-- 7,a7 the specific roles and responsibilities of each ,federal department or agency that is a party to any such interagency agreement2 7,b7 the manner in which specific capabilities of each such ,federal department or agency may be utilized under such interagency agreements2 7,c7 the frequency with which such interagency agreements have been utilized2 7,d7 gaps1 if any1 in interagency agreements that prevent the ,secretary from carrying out the goals under section #bhjb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a72 7,e7 barriers1 if any1 to establishing or utilizing such interagency agreements2 and 7,f7 recommendations1 if any1 on the ways in which such interagency agreements can be improved to address the gaps and barriers identified under subparagraphs 7,d7 and 7,e72 7#b7 conduct a review of the implementation and utilization of the authorities described under section #bhja7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh7c772 and 7#c7 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the reviews under paragraphs 7#a7 and 7#b71 including related recommendations1 as applicable4 #aje4 ,strengthening public health communication ,subsection 7b7 of section #cai;,f of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f7 is amended to read as follows3 7b7 ,public health information and communications advisory committee 7#a7 ,in general ,the ,secretary shall establish an advisory committee to be known as the ,public ,health ,information and ,communications ,advisory ,committee 7referred to in this subsection as the ,advisory ,committee74 7#b7 ,duties ,the ,advisory ,committee shall make recommendations to the ,secretary and report on-- 7,a7 critical aspects of communication and dissemination of scientific and evidence-based public health information during public health emergencies1 including-- 7i7 the role and impact of misinformation on the response to such public health emergencies2 7ii7 the role of risk communication before and during such public health emergencies2 and 7iii7 other relevant factors1 as the ,secretary determines appropriate2 7,b7 information from academic institutions1 community-based organizations1 and other nongovernmental organizations related to evidence-based or evidence-informed strategies and best practices to effectively communicate and disseminate such information2 7,c7 strategies to improve communication and dissemination of scientific and evidence-based public health information to the public1 to improve such communication between ,federal1 ,state1 local1 and ,tribal health officials1 and1 as appropriate1 to address misinformation during public health emergencies1 including strategies to-- 7i7 identify the most effective methods for the dissemination of information during a public health emergency1 with consideration of the needs of at-risk populations2 7ii7 determine best practices and communicate information to populations that may be impacted by such misinformation2 and 7iii7 adapt approaches for the dissemination of information1 as appropriate1 to address emerging trends related to misinformation4 7#c7 ,composition ,the ,advisory ,committee shall be composed of-- 7,a7 appropriate ,federal officials1 appointed by the ,secretary1 who shall serve as nonvoting members2 and 7,b7 individuals1 appointed by the ,secretary1 with expertise in public health 7including individuals with experience in ,state1 local1 and ,tribal health departments71 medicine1 communications1 related technology1 psychology1 mental health and substance use disorders1 national security1 and other areas1 as the ,secretary determines appropriate1 who shall serve as voting members4 7#d7 ,dissemination ,the ,secretary shall review the recommendations of the ,advisory ,committee and1 not later than #ahj days after receipt of the report under paragraph 7#b71 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report describing any actions planned by the ,secretary related to the communication and dissemination of scientific and evidence-based public health information1 including addressing misinformation1 as appropriate4 7#e7 ,termination ,the ,advisory ,committee shall terminate #d years after the date of enactment of the ,,prevent ,pandemics ,act4 4 #ajf4 ,office of ,pandemic ,preparedness and ,response ,policy 7a7 ,in general ,there is established in the ,executive ,office of the ,president an ,office of ,pandemic ,preparedness and ,response ,policy 7referred to in this section as the ,office71 which shall be headed by a ,director 7referred to in this section as the ,director7 appointed by the ,president and who shall be compensated at the rate provided for level ,,ii of the ,executive ,schedule in section #ecac of title #e1 ,united ,states ,code4 ,the ,president is authorized to appoint not more than #b ,associate ,directors1 who shall be compensated at a rate not to exceed that provided for level ,,iii of the ,executive ,schedule in section #ecad of such title4 ,associate ,directors shall perform such functions as the ,director may prescribe4 7b7 ,functions of the ,director ,the primary function of the ,director is to provide advice1 within the ,executive ,office of the ,president1 on pandemic preparedness and response policy1 and support strategic coordination and communication with respect to relevant activities across the ,federal ,government4 ,in addition to such other functions and activities as the ,president may assign1 the ,director1 consistent with applicable laws and the ,national ,response ,framework1 shall-- 7#a7 serve as the principal advisor to the ,president on all matters related to pandemic preparedness and response policy and make recommendations to the ,president regarding pandemic and other biological threats that may impact national security2 7#b7 coordinate ,federal activities to prepare for1 and respond to1 pandemic and other biological threats1 by-- 7,a7 providing strategic direction to the heads of applicable ,federal departments1 agencies1 and offices1 including-- 7i7 the establishment1 implementation1 prioritization1 and assessment of policy goals and objectives across the ,executive ,office of the ,president and such departments1 agencies1 and offices2 7ii7 supporting the assessment and clarification of roles and responsibilities related to such ,federal activities2 and 7iii7 supporting the development and implementation of metrics and performance measures to evaluate the extent to which applicable activities meet such goals and objectives2 7,b7 providing1 in consultation with the ,secretary of ,health and ,human ,services and the heads of other relevant ,federal departments1 agencies1 and offices1 leadership with respect to the ,national ,biodefense ,strategy and related activities pursuant to section #ajhf of the ,national ,defense ,authorization ,act for ,fiscal ,year #bjag 7#f ,u4,s4,c4 #ajd7 and section #cfc of the ,william ,m4 7,mac7 ,thornberry ,national ,defense ,authorization ,act for ,fiscal ,year #bjba 7#f ,u4,s4,c4 #aje72 7,c7 facilitating coordination and communication between such ,federal departments1 agencies1 and offices to improve preparedness for1 and response to1 such threats2 7,d7 ensuring that the authorities1 capabilities1 and expertise of each such department1 agency1 and office are appropriately leveraged to facilitate the whole-of-,government response to such threats2 7,e7 overseeing coordination of ,federal efforts to prepare for and support the production1 supply1 and distribution of relevant medical products and supplies during a response to a pandemic or other biological threat1 as applicable and appropriate1 including supporting ,federal efforts to assess any relevant vulnerabilities in the supply chain of such products and supplies2 7,f7 overseeing coordination of ,federal efforts for the basic and advanced research1 development1 manufacture1 and procurement of medical countermeasures1 including by-- 7i7 serving1 with the ,secretary of ,health and ,human ,services1 as co-,chair of the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established pursuant to section #bhaa-a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a72 and 7ii7 promoting coordination between the medical countermeasure research1 development1 and procurement activities of respective ,federal departments and agencies1 including to advance the discovery and development of new medical products and technologies2 7,g7 convening heads of ,federal departments and agencies1 as appropriate1 on topics related to capabilities to prepare for1 and respond to1 such threats2 7,h7 assessing and advising on international cooperation in preparing for1 and responding to1 such threats to advance the national security objectives of the ,united ,states2 and 7,i7 overseeing other ,federal activities to assess preparedness for1 and responses to1 such threats1 including-- 7i7 drills and operational exercises conducted pursuant to applicable provisions of law2 and 7ii7 ,federal after-action reports developed following such drills and exercises or a response to a pandemic or other biological threat2 7#c7 promote and support the development of relevant expertise and capabilities within the ,federal ,government to ensure that the ,united ,states can quickly detect1 identify1 and respond to such threats1 and provide recommendations1 as appropriate1 to the ,president2 7#d7 consult with the ,director of the ,office of ,management and ,budget and other relevant officials within the ,executive ,office of the ,president1 including the ,assistant to the ,president for ,national ,security ,affairs and the ,director of the ,office of ,science and ,technology ,policy1 regarding activities related to preparing for1 and responding to1 such threats and relevant research and emerging technologies that may advance the biosecurity and preparedness and response goals of the ,federal ,government2 7#e7 identify opportunities to leverage current and emerging technologies1 including through public-private partnerships1 as appropriate1 to address such threats and advance the preparedness and response goals of the ,federal ,government2 and 7#f7 ensure that findings of ,federal after-action reports conducted pursuant to paragraph 7#b77;,i77ii7 are implemented to the maximum extent feasible within the ,federal ,government4 7c7 ,support from other agencies ,each department1 agency1 and instrumentality of the executive branch of the ,federal ,government1 including any independent agency1 is authorized to support the ,director by providing the ,director such information as the ,director determines necessary to carry out the functions of the ,director under this section4 7d7 ,preparedness outlook report 7#a7 ,in general ,within its first year of operation1 the ,director1 in consultation with the heads of relevant ,federal departments and agencies and other officials within the ,executive ,office of the ,president1 shall through a report submitted to the ,president and made available to the public1 to the extent practicable1 identify and describe situations and conditions which warrant special attention within the next #e years1 involving current and emerging problems of national significance related to pandemic or other biological threats1 and opportunities for1 and the barriers to1 the research1 development1 and procurement of medical countermeasures to adequately respond to such threats4 7#b7 ,revisions ,the ,office shall revise the report under paragraph 7#a7 not less than once every #e years and work with relevant ,federal officials to address the problems1 barriers1 opportunities1 and actions identified under this report through the development of the ,president's ,budgets and programs4 7e7 ,interdepartmental working group ,the ,director shall lead an interdepartmental working group that will meet on a regular basis to evaluate national biosecurity and pandemic preparedness issues and make recommendations to the heads of applicable ,federal departments1 agencies and offices4 ,the working group shall consist of representatives from-- 7#a7 the ,office of ,pandemic ,preparedness and ,response ,policy1 to serve as the chair2 7#b7 the ,department of ,health and ,human ,services2 7#c7 the ,department of ,homeland ,security2 7#d7 the ,department of ,defense2 7#e7 the ,office of ,management and ,budget2 and 7#f7 other ,federal ,departments and agencies4 7f7 ,additional functions of the director ,the ,director1 in addition to the other duties and functions set forth in this section-- 7#a7 shall-- 7,a7 serve as a member of the ,domestic ,policy ,council and the ,national ,security ,council2 7,b7 serve as a member of the ,intergovernmental ,science1 ,engineering1 and ,technology ,advisory ,panel under section #bje7;b7 of the ,national ,science and ,technology ,policy1 ,organization1 and ,priorities ,act of #aigf 7#db ,u4,s4,c4 #ffad7;b77 and the ,federal ,coordinating ,council for ,science1 ,engineering and ,technology under section #dja of such ,act 7#db ,u4,s4,c4 #ffea72 7,c7 consult with ,state1 ,tribal1 local1 and territorial governments1 industry1 academia1 professional societies1 and other stakeholders1 as appropriate2 7,d7 use for administrative purposes1 on a reimbursable basis1 the available services1 equipment1 personnel1 and facilities of ,federal1 ,state1 and local agencies2 and 7,e7 at the ,president's request1 perform such other duties and functions and enter into contracts and other arrangements for studies1 analyses1 and related services with public or private entities1 as applicable and appropriate2 and 7#b7 may hold such hearings in various parts of the ,united ,states as necessary to determine the views of the entities and individuals referred to in paragraph 7#a7 and of the general public1 concerning national needs and trends in pandemic preparedness and response4 7g7 ,staffing and detailees ,in carrying out functions under this section1 the ,director may-- 7#a7 appoint not more than #be individuals to serve as employees of the ,office as necessary to carry out this section2 7#b7 fix the compensation of such personnel at a rate to be determined by the ,director1 up to the amount of annual compensation 7excluding expenses7 specified in section #ajb of title #c1 ,united ,states ,code2 7#c7 utilize the services of consultants1 which may include by obtaining services described under section #caji7;b7 of title #e1 ,united ,states ,code1 at rates not to exceed the rate of basic pay for level ,,iv of the ,executive ,schedule2 and 7#d7 direct1 with the concurrence of the ,secretary of a department or head of an agency1 the temporary reassignment within the ,federal ,government of personnel employed by such department or agency1 in order to carry out the functions of the ,office4 7h7 ,preparedness review and report ,the ,director1 in consultation with the heads of applicable ,federal departments1 agencies1 and offices1 shall-- 7#a7 not later than #a year after the date of enactment of this ,act1 conduct a review of applicable ,federal strategies1 policies1 procedures1 and after-action reports to identify gaps and inefficiencies related to pandemic preparedness and response2 7#b7 not later than #ah months after the date of enactment of this ,act1 and every #b years thereafter1 submit to the ,president and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report describing-- 7,a7 current and emerging pandemic and other biological threats that pose a significant level of risk to national security2 7,b7 the roles and responsibilities of the ,federal ,government in preparing for1 and responding to1 such threats2 7,c7 the findings of the review conducted under paragraph 7#a72 7,d7 any barriers or limitations related to addressing such findings2 7,e7 current and planned activities to update ,federal strategies1 policies1 and procedures to address such findings1 consistent with applicable laws and the ,national ,response ,framework2 7,f7 current and planned activities to support the development of expertise within the ,federal ,government pursuant to subsection 7b77#c72 and 7,g7 opportunities to improve ,federal preparedness and response capacities and capabilities through the use of current and emerging technologies4 7i7 ,nonduplication of effort ,the ,director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other ,federal departments1 agencies1 and offices4 7j7 ,conforming amendments 7#a7 ,section #bhaa-a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is amended-- 7,a7 in the second sentence of subsection 7a71 by striking shall serve as chair and inserting and the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy shall serve as co-chairs2 and 7,b7 in subsection 7b7-- 7i7 by redesignating paragraph 7#aj7 as paragraph 7#aa72 and 7ii7 by inserting after paragraph 7#i7 the following3 7#aj7 ,the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy4 4 7#b7 ,section #aja7;c77#a7 of the ,national ,security ,act of #aidg 7#ej ,u4,s4,c4 #cjba7;c77#a77 is amended by inserting the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy after ,treasury14 7#c7 ,the ,national ,science and ,technology ,policy1 ,organization1 and ,priorities ,act of #aigf 7#db ,u4,s4,c4 #ffja et seq47 is amended-- 7,a7 in section #bje7;b77#b7 7#db ,u4,s4,c4 #ffad7;b77#b77-- 7i7 by striking and 7,c7 and inserting 7,c72 and 7ii7 by striking the period at the end and inserting 2 and 7,d7 the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy42 and 7,b7 in section #dja7;b7 7#db ,u4,s4,c4 #ffea7;b771 by inserting 1 the ,director of the ,office of ,pandemic ,preparedness and ,response ,policy1 after ,technology ,policy4 ,b ,state and local readiness #aaa4 ,improving ,state and local public health security 7a7 ,in general ,section #cai;,c-#a7;b77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is amended-- 7#a7 in subparagraph 7,a7-- 7,a7 in clause 7vii71 by inserting during and before following a public health emergency2 7,b7 by amending clause 7viii7 to read as follows3 7viii7 a description of how the entity1 as applicable and appropriate1 will coordinate with ,state emergency preparedness and response plans in public health emergency preparedness1 including ,state education agencies 7as defined in section #haja of the ,elementary and ,secondary ,education ,act of #aife71 ,state child care lead agencies 7designated under section #feh;,d of the ,child ,care and ,development ,block ,grant ,act of #aiij71 and other relevant ,state agencies 2 7,c7 in clause 7xi71 by striking 2 and and inserting a semicolon2 7,d7 by redesignating clause 7xii7 as clause 7xiii72 and 7,e7 by inserting after clause 7xi7 the following3 7xii7 a description of how the entity will provide technical assistance to improve public health preparedness and response1 as appropriate1 to agencies or other entities that operate facilities within the entity's jurisdiction in which there is an increased risk of infectious disease outbreaks in the event of a public health emergency declared under section #cai1 such as residential care facilities1 group homes1 and other similar settings2 and 2 7#b7 by redesignating subparagraphs 7,d7 through 7,h7 as subparagraphs 7,e7 through 7,i71 respectively2 and 7#c7 by inserting after subparagraph 7,c7 the following3 7,d7 an assurance that the entity will require relevant staff to complete relevant preparedness and response trainings1 including trainings related to efficient and effective operation during an incident or event within an ,incident ,command ,system2 4 7b7 ,applicability ,the amendments made by subsection 7a7 shall not apply with respect to any cooperative agreement entered into prior to the date of enactment of this ,act4 #aab4 ,supporting access to mental health and substance use disorder services during public health emergencies 7a7 ,authorities ,section #eja7;d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa7d77 is amended-- 7#a7 by redesignating paragraphs 7#bd7 and 7#be7 as paragraphs 7#be7 and 7#bf71 respectively2 and 7#b7 by inserting after paragraph 7#bc7 the following3 7#bd7 support the continued access to1 or availability of1 mental health and substance use disorder services during1 or in response to1 a public health emergency declared under section #cai1 including in consultation with1 as appropriate1 the ,assistant ,secretary for ,preparedness and ,response and the heads of other relevant agencies1 in preparing for1 and responding to1 a public health emergency2 4 7b7 ,strategic plan ,section #eja7l77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa7l77#d77 is amended-- 7#a7 in subparagraph 7,e71 by striking and at the end2 7#b7 in subparagraph 7,f71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,g7 specify a strategy to support the continued access to1 or availability of1 mental health and substance use disorder services1 including to at-risk individuals 7as defined in section #bhjb7;b77#d771 during1 or in response to1 public health emergencies declared pursuant to section #cai4 4 7c7 ,biennial report concerning activities and progress ,section #eja7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa7m77 is amended-- 7#a7 by redesignating paragraphs 7#d7 through 7#g7 as paragraphs 7#e7 through 7#h71 respectively2 7#b7 by inserting after paragraph 7#c7 the following3 7#d7 a description of the ,administration's activities to support the continued provision of mental health and substance use disorder services1 as applicable1 in response to public health emergencies declared pursuant to section #cai2 2 and 7#c7 in paragraph 7#e71 as so redesignated-- 7,a7 by redesignating subparagraphs 7,d7 and 7,e7 as subparagraphs 7,e7 and 7,f71 respectively2 and 7,b7 by inserting after subparagraph 7,c7 the following3 7,d7 relevant preparedness and response activities2 4 7d7 ,advisory councils ,not later than #a year after the date of enactment of this ,act1 the ,assistant ,secretary for ,mental ,health and ,substance ,use shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 reflecting the feedback of the advisory councils for the ,center for ,substance ,abuse ,treatment1 the ,center for ,substance ,abuse ,prevention1 and the ,center for ,mental ,health ,services1 pursuant to section #ejb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#a71 with recommendations to improve the continued provision of mental health and substance use disorder services during a public health emergency declared under section #cai of such ,act 7#db ,u4,s4,c4 #bdg;d71 and the provision of such services as part of the public health and medical response to such an emergency1 consistent with title ,,xxviii of such ,act 7#db ,u4,s4,c4 #cjj;hh et seq471 including related to the capacity of the mental health and substance use disorder workforce and flexibilities provided to awardees of mental health and substance use disorder programs4 7e7 ,,gao 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 on programs and activities of the ,substance ,abuse and ,mental ,health ,services ,administration to support the provision of mental health and substance use disorder services and related activities during the ,,covid-#ai pandemic1 including the provision of such services as part of the medical and public health response to such pandemic4 ,such report shall-- 7#a7 examine the role played by the advisory councils described in section #ejb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bij;aa-#a7 and the ,national ,mental ,health and ,substance ,use ,policy ,laboratory established under section #eja;,a of such ,act 7#db ,u4,s4,c4 #bij;aa-#j7 in providing technical assistance and recommendations to the ,substance ,abuse and ,mental ,health ,services ,administration to support the response of such agency to the public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 with respect to ,,covid-#ai2 7#b7 describe the manner in which existing awardees of mental health and substance use disorder programs provided and altered delivery of services during such public health emergency1 including information on the populations served by such awardees and any barriers faced in delivering services2 and 7#c7 describe activities of the ,substance ,abuse and ,mental ,health ,services ,administration to support the response to such public health emergency1 including through technical assistance1 provision of services1 and any flexibilities provided to such existing awardees1 and any barriers faced in implementing such activities4 #aac4 ,trauma care reauthorization 7a7 ,in general ,section #abja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c7-- 7i7 by inserting analyze1 after compile12 and 7ii7 by inserting and medically underserved areas before the semicolon2 7,b7 in paragraph 7#d71 by adding and after the semicolon2 7,c7 by striking paragraph 7#e72 and 7,d7 by redesignating paragraph 7#f7 as paragraph 7#e72 7#b7 by redesignating subsection 7b7 as subsection 7c72 and 7#c7 by inserting after subsection 7a7 the following3 7b7 ,trauma care readiness and coordination ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response1 shall support the efforts of ,states and consortia of ,states to coordinate and improve emergency medical services and trauma care during a public health emergency declared by the ,secretary pursuant to section #cai or a major disaster or emergency declared by the ,president under section #dja or #eja1 respectively1 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act4 ,such support may include-- 7#a7 developing1 issuing1 and updating guidance1 as appropriate1 to support the coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need1 taking into account regionalized systems of care2 7#b7 disseminating1 as appropriate1 information on evidence-based or evidence-informed trauma care practices1 taking into consideration emergency medical services and trauma care systems1 including such practices identified through activities conducted under subsection 7a7 and which may include the identification and dissemination of performance metrics1 as applicable and appropriate2 and 7#c7 other activities1 as appropriate1 to optimize a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals1 other health care facilities1 critical care1 and emergency medical systems4 4 7b7 ,grants ,to improve trauma care in rural areas ,section #abjb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#c7 is amended-- 7#a7 by amending the section heading to read as follows3 ,grants to improve trauma care in rural areas2 7#b7 by amending subsections 7a7 and 7b7 to read as follows3 7a7 ,in general ,the ,secretary shall award grants to eligible entities for the purpose of carrying out research and demonstration projects to support the improvement of emergency medical services and trauma care in rural areas through the development of innovative uses of technology1 training and education1 transportation of seriously injured patients for the purposes of receiving such emergency medical services1 access to prehospital care1 evaluation of protocols for the purposes of improvement of outcomes and dissemination of any related best practices1 activities to facilitate clinical research1 as applicable and appropriate1 and increasing communication and coordination with applicable ,state or ,tribal trauma systems4 7b7 ,eligible entities 7#a7 ,in general ,to be eligible to receive a grant under this section1 an entity shall be a public or private entity that provides trauma care in a rural area4 7#b7 ,priority ,in awarding grants under this section1 the ,secretary shall give priority to eligible entities that will provide services under the grant in any rural area identified by a ,state under section #abad7;d77#a74 2 and 7#c7 by adding at the end the following3 7d7 ,reports ,an entity that receives a grant under this section shall submit to the ,secretary such reports as the ,secretary may require to inform administration of the program under this section4 4 7c7 ,pilot grants for trauma centers ,section #abjd of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#f7 is amended-- 7#a7 by amending the section heading to read as follows3 ,pilot grants for trauma centers2 7#b7 in subsection 7a7-- 7,a7 by striking not fewer than #d and inserting #aj2 7,b7 by striking that design1 implement1 and evaluate and inserting to design1 implement1 and evaluate new or existing2 7,c7 by striking emergency care and inserting emergency medical2 and 7,d7 by inserting 1 and improve access to trauma care within such systems before the period2 7#c7 in subsection 7b77#a71 by striking subparagraphs 7,a7 and 7,b7 and inserting the following3 7,a7 a ,state or consortia of ,states2 7,b7 an ,indian ,tribe or ,tribal organization 7as defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act72 7,c7 a consortium of level ,i1 ,,ii1 or ,,iii trauma centers designated by applicable ,state or local agencies within an applicable ,state or region1 and1 as applicable1 other emergency services providers2 or 7,d7 a consortium or partnership of nonprofit ,indian ,health ,service1 ,indian ,tribal1 and urban ,indian trauma centers4 2 7#d7 in subsection 7c7-- 7,a7 in the matter preceding paragraph 7#a7-- 7i7 by striking that proposes a pilot project2 7ii7 by striking an emergency medical and trauma system that-- and inserting a new or existing emergency medical and trauma system4 ,such eligible entity shall use amounts awarded under this subsection to carry out #b or more of the following activities32 7,b7 in paragraph 7#a7 -- 7i7 by striking coordinates and inserting ,strengthening coordination and communication2 and 7ii7 by striking an approach to emergency medical and trauma system access throughout the region1 including #i-a-a ,public ,safety ,answering ,points and emergency medical dispatch2 and inserting approaches to improve situational awareness and emergency medical and trauma system access1 including distribution of patients during a mass casualty incident1 throughout the region42 7,c7 in paragraph 7#b7-- 7i7 by striking includes and inserting ,providing2 7ii7 by inserting support patient movement to after region to2 and 7iii7 by striking the semicolon and inserting a period2 7,d7 in paragraph 7#c7-- 7i7 by striking allows for and inserting ,improving2 and 7ii7 by striking 2 and and inserting a period2 7,e7 in paragraph 7#d71 by striking includes a consistent and inserting ,supporting a consistent2 and 7,f7 by adding at the end the following3 7#e7 ,establishing1 implementing1 and disseminating1 or utilizing existing1 as applicable1 evidence-based or evidence-informed practices across facilities within such emergency medical and trauma system to improve health outcomes1 including such practices related to management of injuries1 and the ability of such facilities to surge4 7#f7 ,conducting activities to facilitate clinical research1 as applicable and appropriate4 2 7#e7 in subsection 7d77#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking the proposed and inserting the applicable emergency medical and trauma system2 7ii7 in clause 7i71 by inserting or ,tribal entity after equivalent ,state office2 and 7iii7 in clause 7vi71 by striking 2 and and inserting a semicolon2 7,b7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 and 7,c7 by inserting after subparagraph 7,a7 the following3 7,b7 for eligible entities described in subparagraph 7,c7 or 7,d7 of subsection 7b77#a71 a description of1 and evidence of1 coordination with the applicable ,state ,office of ,emergency ,medical ,services 7or equivalent ,state ,office7 or applicable such office for a ,tribe or ,tribal organization2 and 2 7#f7 in subsection 7e7-- 7,a7 in paragraph 7#a71 by striking #a for each #c and inserting #a for each #e2 and 7,b7 by adding at the end the following3 7#c7 ,waiver ,the ,secretary may waive all or part of the matching requirement described in paragraph 7#a7 for any fiscal year for a ,state1 consortia of ,states1 ,indian ,tribe or ,tribal organization1 or trauma center1 if the ,secretary determines that applying such matching requirement would result in serious hardship or an inability to carry out the purposes of the pilot program4 2 7#g7 in subsection 7f71 by striking population in a medically underserved area and inserting medically underserved population2 7#h7 in subsection 7g7-- 7,a7 in the matter preceding paragraph 7#a71 by striking described in2 7,b7 in paragraph 7#b71 by striking the system characteristics that contribute to and inserting opportunities for improvement1 including recommendations for how to improve2 7,c7 by striking paragraph 7#d72 7,d7 by redesignating paragraphs 7#e7 and 7#f7 as paragraphs 7#d7 and 7#e71 respectively2 7,e7 in paragraph 7#d71 as so redesignated1 by striking 2 and and inserting a semicolon2 7,f7 in paragraph 7#e71 as so redesignated1 by striking the period and inserting 2 and2 and 7,g7 by adding at the end the following3 7#f7 any evidence-based or evidence-informed strategies developed or utilized pursuant to subsection 7c77#e74 2 and 7#i7 by amending subsection 7h7 to read as follows3 7h7 ,dissemination of findings ,not later than #a year after the completion of the final project under subsection 7a71 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report describing the information contained in each report submitted pursuant to subsection 7g7 and any additional actions planned by the ,secretary related to regionalized emergency care and trauma systems4 4 7d7 ,program funding ,section #abcb7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;d-#cb7;a77 is amended by striking #bjaj through #bjad and inserting #bjbc through #bjbg4 #aad4 ,assessment of containment and mitigation of infectious diseases 7a7 ,,gao study ,the ,comptroller ,general of the ,united ,states shall conduct a study that reviews a geographically diverse sample of ,states and territories that1 in response to the ,,covid-#ai pandemic1 implemented preparedness and response plans that included isolation and quarantine recommendations or requirements4 ,such study shall include-- 7#a7 a review of such ,state and territorial preparedness and response plans in place during the ,,covid-#ai pandemic1 an assessment of the extent to which such plans facilitated or presented challenges to ,state and territorial responses to such public health emergency1 including response activities relating to isolation and quarantine to prevent the spread of ,,covid-#ai2 and 7#b7 a description of the technical assistance provided by the ,federal ,government to help ,states and territories facilitate such response activities during responses to relevant public health emergencies declared by the ,secretary of ,health and ,human ,services pursuant to section #cai of the ,public ,health ,service ,act1 including the public health emergency with respect to ,,covid-#ai1 and a review of the degree to which such ,state and territorial plans were implemented and subsequently revised in response to the ,,covid-#ai pandemic to address any challenges4 7b7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report on the study under subsection 7a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,,ii ,improving public health preparedness and response capacity ,a ,addressing disparities and improving public health emergency responses #bja4 ,addressing social determinants of health and improving health outcomes 7a7 ,in general ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended-- 7#a7 by inserting after section #cag,u the following3 #cag,v4 ,addressing social determinants of health and improving health outcomes 7a7 ,in general ,the ,secretary shall1 as appropriate1 award grants1 contracts1 or cooperative agreements to eligible entities for the conduct of evidence-based or evidence-informed projects1 which may include the development of networks to improve health outcomes and reduce health disparities by improving the capacity of such entities to address social determinants of health in communities4 7b7 ,eligible entities ,to be eligible to receive an award under this section1 an entity shall-- 7#a7 7,a7 be a ,state1 local1 or ,tribal health department1 community-based organization1 ,indian ,tribe or ,tribal organization 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act71 or other public or private entity1 as the ,secretary determines appropriate2 or 7,b7 be a consortia or public-private partnership of entities described in subparagraph 7,a72 7#b7 submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary shall require2 7#c7 in the case of an entity other than a community-based organization1 demonstrate a history of successfully working with an established community-based organization to address health disparities2 7#d7 submit a plan to conduct activities described in subsection 7a7 based on a community needs assessment that takes into account community input2 and 7#e7 demonstrate the capacity to effectively implement evidence-based or evidence-informed strategies to address health disparities among underserved populations1 which may include rural1 racial1 and ethnic minority populations and people with disabilities1 in a timely manner4 7c7 ,use of funds ,an entity described in subsection 7b7 shall use funds received under subsection 7a71 in consultation with ,state1 local1 and ,tribal health departments1 community-based organizations1 and other entities with experience addressing social determinants of health or reducing health disparities1 as applicable1 for one or more of the following purposes3 7#a7 ,supporting the implementation1 evaluation1 and dissemination of strategies1 including culturally-appropriate strategies1 to address social determinants of health1 based on the identified needs of the community that is the subject of the assessment submitted under subsection 7b77#d71 through evidence-informed or evidence-based programs and through the support and use of public health and health care professionals to address such social determinants of health4 7#b7 ,establishing1 maintaining1 or improving1 in consultation with ,state1 local1 or ,tribal health departments1 technology platforms or networks to support coordination among appropriate entities1 and providing information on health and related social services1 which may include activities to improve data collection for public health purposes1 in a manner that is consistent with applicable ,federal and ,state privacy law4 7#c7 ,implementing best practices for improving health outcomes and reducing disease among underserved populations1 including rural or racial and ethnic minority populations4 7#d7 ,supporting consideration of social determinants of health in preparing for1 and responding to1 public health emergencies1 through outreach1 education1 research1 and other relevant activities4 7d7 ,best practices and technical assistance ,the ,secretary1 in consultation with the ,director of the ,office of ,minority ,health1 may award grants1 contracts1 and cooperative agreements to public or nonprofit private entities1 including minority serving institutions 7defined1 for purposes of this subsection1 as institutions and programs described in section #cbf7;e77#a7 of the ,higher ,education ,act of #aife and institutions described in section #cga7;a7 of such ,act of #aife71 to-- 7#a7 identify or facilitate the development of best practices to support improved health outcomes and reduce health disparities by addressing social determinants of health2 7#b7 provide technical assistance1 training1 and evaluation assistance to award recipients under subsection 7a72 7#c7 disseminate best practices1 including to award recipients under subsection 7a72 and 7#d7 establish or operate regional centers to develop1 evaluate1 and disseminate effective strategies on the utilization of preventive health care services to address social determinants of health1 including supporting research and training related to such strategies4 7e7 ,award periods ,the ,secretary shall issue awards under this section for periods of not more than #e years and may issue extensions of such award periods for an additional period of up to #c years4 7f7 ,report ,not later than ,september #cj1 #bjbf1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes information on activities funded under this section4 ,such report shall include a description of-- 7#a7 changes in the capacity of public health entities to address social determinants of health in communities1 including any applicable platforms or networks developed or utilized to coordinate health and related social services and any changes in workforce capacity or capabilities2 7#b7 improvements in health outcomes and in reducing health disparities in medically underserved communities2 7#c7 activities conducted to support consideration of social determinants of health in preparing for1 and responding to1 public health emergencies1 through outreach1 education1 and other relevant activities2 7#d7 communities and populations served by recipients of awards under subsection 7a72 7#e7 activities supported under subsection 7e72 and 7#f7 other relevant activities and outcomes1 as determined by the ,secretary4 7g7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #gj1jjj1jjj for each of fiscal years #bjbc through #bjbg4 2 and 7#b7 by striking section #ccj;,d 7#db ,u4,s4,c4 #bed;c-#d74 7b7 ,,gao study and report ,not later than #d 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 ,energy and ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the program authorized under section #cag,v of the ,public ,health ,service ,act1 as added by subsection 7a71 including a review of the outcomes and effectiveness of the program and coordination with other programs in the ,department of ,health and ,human ,services with similar goals to ensure that there was no unnecessary duplication of efforts4 #bjb4 ,national ,academies of ,sciences1 ,engineering1 and ,medicine report 7a7 ,in general ,not later than #de days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall seek to enter into a contract with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine 7referred to in this section as the ,national ,academies7 to conduct a study to examine health disparities and the effect of such disparities on health outcomes1 which may include health outcomes related to pandemic and other public health emergencies4 7b7 ,report ,pursuant to the contract under subsection 7a71 the ,national ,academies shall1 not later than #c years after the date of enactment of this ,act1 issue a report informed by the study conducted under such subsection that includes-- 7#a7 consideration of previous recommendations made by the ,national ,academies related to health disparities1 including in the report titled ,unequal ,treatment3 ,confronting ,racial and ,ethnic ,disparities in ,healthcare2 7#b7 recommendations for strategies to improve health outcomes by reducing health disparities1 which may include education and training2 and 7#c7 an assessment of ongoing research and strategies to reduce health disparities and improve health outcomes1 including effective service delivery models4 7c7 ,clarification ,in completing the requirements of the contract under this section1 the ,national ,academies may leverage relevant ongoing work of the ,national ,academies1 including ongoing work related to the impact of ,federal policies on health disparities4 7d7 ,authorization of appropriations ,there is authorized to be appropriated #b1jjj1jjj for fiscal year #bjbc to carry out this section4 ,b ,improving public health data #baa4 ,modernizing biosurveillance capabilities and infectious disease data collection ,section #cai;,d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in subsection 7b77#a77;,a71 by striking 1 and local and inserting 1 local1 and ,tribal2 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by inserting modernize1 after establish12 7,b7 in paragraph 7#c77;,b71 by inserting 1 and make recommendations to improve the quality of data collected pursuant to subparagraph 7,a7 to ensure complete1 accurate1 and timely sharing of such data1 as appropriate1 across such elements as described in subparagraph 7,a7 after under subparagraph 7,a72 7,c7 in paragraph 7#e7-- 7i7 in subparagraph 7,a7-- 7,i7 in the matter preceding clause 7i71 by striking and operating and inserting 1 operating1 and updating1 as appropriate12 7,,ii7 in clause 7iv71 by striking and at the end2 7,,iii7 in clause 7v71 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7vi7 in collaboration with ,state1 local1 and ,tribal public health officials1 integrate and update applicable existing public health data systems and networks of the ,department of ,health and ,human ,services to reflect technological advancements1 consistent with section #bhbc1 as applicable4 2 and 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7i71 by inserting and #ahj days after the date of enactment of the ,,prevent ,pandemics ,act1 after ,innovation ,act of #bjai12 7,,ii7 in clause 7ii71 by inserting experts in privacy and data security2 after forecasting722 and 7,,iii7 in clause 7iii7-- 7aa7 in subclause 7,v71 by striking and at the end2 7bb7 in subclause 7,,vi71 by striking the period and inserting a semicolon2 and 7cc7 by adding at the end the following3 7,,vii7 strategies to integrate laboratory and public health data systems and capabilities to support rapid and accurate reporting of laboratory test results and associated relevant data2 7,,viii7 strategies to improve the collection and reporting of relevant1 aggregated1 deidentified demographic data to inform responses to public health emergencies1 including identification of at-risk populations and to address potential health disparities2 and 7,,ix7 strategies to improve the electronic exchange of health information between ,state and local health departments and health care providers and facilities to improve public health surveillance4 2 and 7,d7 in paragraph 7#f77;,a7-- 7i7 in the matter preceding clause 7i71 by inserting and every #e years thereafter1 after ,innovation ,act of #bjai1 7ii7 in clause 7iii7-- 7,i7 in subclause 7,,iii71 by striking and at the end2 and 7,,ii7 by adding at the end the following3 7,v7 improve coordination and collaboration1 as appropriate1 with other ,federal departments2 and 7,,vi7 implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities2 2 7iii7 in clause 7iv71 by striking and at the end2 7iv7 in clause 7v71 by striking the period and inserting 1 including a description of how such steps will further the goals of the network1 consistent with paragraph 7#a72 and2 and 7v7 by adding at the end the following3 7vi7 identifies and demonstrates measurable steps the ,secretary will take to further develop and integrate infectious disease detection1 support rapid and accurate reporting of laboratory test results during a public health emergency1 and improve coordination and collaboration with ,state1 local1 and ,tribal public health officials1 clinical laboratories1 and other entities with expertise in public health surveillance4 2 7#c7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by inserting 1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with the heads of other appropriate agencies and offices within the ,department of ,health and ,human ,services1 after the ,secretary2 7,b7 in paragraph 7#b77;,c71 by inserting 1 including any public-private partnerships or other partnerships entered into to improve such capacity before the semicolon2 and 7,c7 by adding at the end the following3 7#f7 ,non-duplication of effort ,the ,secretary shall ensure that activities carried out under an award under this subsection do not unnecessarily duplicate efforts of other agencies and offices within the ,department of ,health and ,human ,services4 2 7#d7 by amending subsection 7i7 to read as follows3 7i7 ,authorization of appropriations ,there are authorized to be appropriated-- 7#a7 to carry out subsection 7a71 #be1jjj1jjj for each of fiscal years #bjbb and #bjbc2 and 7#b7 to carry out subsections 7b71 7c71 and 7d71 #acf1hjj1jjj for each of fiscal years #bjbb and #bjbc4 2 and 7#e7 by striking tribal each place it appears and inserting ,tribal4 #bab4 ,genomic sequencing1 analytics1 and public health surveillance of pathogens 7a7 ,guidance supporting genomic sequencing of pathogens collaboration ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with the heads of other ,federal departments or agencies1 as appropriate1 shall issue guidance to support collaboration relating to genomic sequencing of pathogens1 including the use of new and innovative approaches and technology for the detection1 characterization1 and sequencing of pathogens1 to improve public health surveillance and preparedness and response activities1 consistent with section #bhbd of the ,public ,health ,service ,act1 as added by subsection 7b74 ,such guidance shall address the secure sharing1 for public health surveillance purposes1 of specimens of such pathogens1 between appropriate entities and public health authorities1 consistent with the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 as applicable1 and in a manner that protects personal privacy to the extent required by applicable privacy law1 at a minimum1 and the appropriate use of sequence data derived from such specimens4 7b7 ,genomic sequencing program ,title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh et seq47 is amended by adding at the end the following #bhbd4 ,genomic sequencing1 analytics1 and public health surveillance of pathogens program 7a7 ,genomic sequencing1 analytics1 and public health surveillance of pathogens program ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in consultation with the ,director of the ,national ,institutes of ,health and heads of other departments and agencies1 as appropriate1 shall strengthen and expand activities related to genomic sequencing of pathogens1 including new and innovative approaches and technology for the detection1 characterization1 and sequencing of pathogens1 analytics1 and public health surveillance1 including-- 7#a7 continuing and expanding activities1 which may include existing genomic sequencing activities related to advanced molecular detection1 to-- 7,a7 identify and respond to emerging infectious disease threats2 and 7,b7 identify the potential use of genomic sequencing technologies1 advanced computing1 and other advanced technology to inform surveillance activities and incorporate the use of such technologies1 as appropriate1 into related activities2 7#b7 providing technical assistance and guidance to ,state1 ,tribal1 local1 and territorial public health departments to increase the capacity of such departments to perform genomic sequencing of pathogens1 including recipients of funding under section #bhba2 7#c7 carrying out activities to enhance the capabilities of the public health workforce with respect to pathogen genomics1 epidemiology1 and bioinformatics1 including through training2 and 7#d7 continuing and expanding activities1 as applicable1 with public and private entities1 including relevant departments and agencies1 laboratories1 academic institutions1 and industry4 7b7 ,partnerships ,for the purposes of carrying out the activities described in subsection 7a71 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 may award grants1 contracts1 or cooperative agreements to entities1 including academic and other laboratories1 with expertise in genomic sequencing for public health purposes1 including new and innovative approaches to1 and related technology for1 the detection1 characterization1 and sequencing of pathogens4 7c7 ,centers of excellence 7#a7 ,in general ,the ,secretary shall1 as appropriate1 award grants1 contracts1 or cooperative agreements to public health agencies for the establishment or operation of centers of excellence to promote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emergency4 ,such centers shall1 as appropriate-- 7,a7 identify and evaluate the use of genomics1 or other related technologies that may advance public health preparedness and response2 7,b7 improve the identification1 development1 and use of tools for integrating and analyzing genomic and epidemiologic data2 7,c7 assist with genomic surveillance of1 and response to1 infectious diseases1 including analysis of pathogen genomic data2 7,d7 conduct applied research to improve public health surveillance of1 and response to1 infectious diseases through innovation in pathogen genomics and molecular epidemiology2 and 7,e7 develop and provide training materials for experts in the fields of genomics1 microbiology1 bioinformatics1 epidemiology1 and other fields1 as appropriate4 7#b7 ,requirements ,to be eligible for an award under paragraph 7#a71 an entity shall submit to the ,secretary an application containing such information as the ,secretary may require1 including a description of how the entity will partner1 as applicable1 with academic institutions or a consortium of academic partners that have relevant expertise1 such as microbial genomics1 molecular epidemiology1 or the application of bioinformatics or statistics4 7d7 ,authorization ,for purposes of carrying out this section1 there are authorized to be appropriated #age1jjj1jjj for each of fiscal years #bjbc through #bjbg4 4 #bac4 ,supporting public health data availability and access 7a7 ,designation of public health data standards ,section #bhbc7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#cc7;a77#b77 is amended-- 7#a7 by striking ,in carrying out and inserting the following3 7,a7 ,in general ,in carrying out 2 and 7#b7 by striking shall1 as appropriate and and inserting shall1 not later than #b years after the date of enactment of the ,,prevent ,pandemics ,act12 and 7#c7 by adding at the end the following3 7,b7 ,selection of data and technology standards ,the standards designated as described in subparagraph 7,a7 may include standards to improve-- 7i7 the exchange of electronic health information for-- 7,i7 electronic case reporting2 7,,ii7 syndromic surveillance2 7,,iii7 reporting of vital statistics2 and 7,,iv7 reporting test orders and results electronically1 including from laboratories2 7ii7 automated electronic reporting to relevant public health data systems of the ,centers for ,disease ,control and ,prevention2 and 7iii7 such other use cases as the ,secretary determines appropriate4 7,c7 ,no duplicative efforts 7i7 ,in general ,in carrying out the requirements of this paragraph1 the ,secretary1 in consultation with the ,office of the ,national ,coordinator for ,health ,information ,technology1 may use input gathered 7including input and recommendations gathered from the ,health ,information ,technology ,advisory ,committee71 and materials developed1 prior to the date of enactment of the ,,prevent ,pandemics ,act4 7ii7 ,previously adopted standards ,the data and technology standards designated pursuant to this paragraph may include the adoption of standards previously adopted by the ,secretary pursuant to section #cjjd4 7,d7 ,privacy and security ,nothing in this paragraph shall be construed as modifying applicable ,federal or ,state information privacy or security law4 4 7b7 ,study on laboratory information standards 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,office of the ,national ,coordinator for ,health ,information ,technology shall conduct a study to review the use of standards for electronic ordering and reporting of laboratory test results4 7#b7 ,areas of concentration ,in conducting the study under paragraph 7#a71 the ,office of the ,national ,coordinator for ,health ,information ,technology shall-- 7,a7 determine the extent to which clinical laboratories are using standards for electronic ordering and reporting of laboratory test results2 7,b7 assess trends in laboratory compliance with standards for ordering and reporting laboratory test results and the effect of such trends on the interoperability of laboratory data with public health data systems2 7,c7 identify challenges related to collection and reporting of demographic and other data elements with respect to laboratory test results2 7,d7 identify any challenges associated with using or complying with standards and reporting laboratory test results with data elements identified in standards for electronic ordering and reporting of such results2 and 7,e7 review other relevant areas determined appropriate by the ,office of the ,national ,coordinator for ,health ,information ,technology4 7#c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,office of the ,national ,coordinator for ,health ,information ,technology 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 concerning the findings of the study conducted under paragraph 7#a74 7c7 ,supporting information sharing through data use agreements 7#a7 ,interagency data use agreements within the ,department of ,health and ,human ,services for public health emergencies 7,a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall1 as appropriate1 facilitate the development of1 or updates to1 memoranda of understanding1 data use agreements1 or other applicable interagency agreements regarding appropriate access1 exchange1 and use of public health data between the ,centers for ,disease ,control and ,prevention1 the ,office of the ,assistant ,secretary for ,preparedness and ,response1 other relevant agencies or offices within the ,department of ,health and ,human ,services1 and other relevant ,federal agencies1 in order to prepare for1 identify1 monitor1 and respond to declared or potential public health emergencies4 7,b7 ,requirements ,in carrying out activities pursuant to subparagraph 7,a71 the ,secretary shall-- 7i7 ensure that the agreements and memoranda of understanding described in such subparagraph-- 7,i7 address the methods of granting access to data held by one agency or office with another to support the respective missions of such agencies or offices2 7,,ii7 consider minimum necessary principles of data sharing for appropriate use2 7,,iii7 include appropriate privacy and cybersecurity protections2 and 7,,iv7 are subject to regular updates1 as appropriate2 7ii7 collaborate with the ,centers for ,disease ,control and ,prevention1 the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,office of the ,chief ,information ,officer1 and1 as appropriate1 the ,office of the ,national ,coordinator for ,health ,information ,technology1 and other entities within the ,department of ,health and ,human ,services2 and 7iii7 consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agreements1 consistent with paragraph 7#b74 7#b7 ,data use agreements with external entities ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and the ,assistant ,secretary for ,preparedness and ,response1 may update memoranda of understanding1 data use agreements1 or other applicable agreements and contracts to improve appropriate access1 exchange1 and use of public health data between the ,centers for ,disease ,control and ,prevention and the ,office of the ,assistant ,secretary for ,preparedness and ,response and external entities1 including ,state1 ,tribal1 and territorial health departments1 laboratories1 hospitals and other health care providers1 electronic health records vendors1 and other entities1 as applicable and appropriate1 in order to prepare for1 identify1 monitor1 and respond to declared or potential public health emergencies4 7#c7 ,report ,not later than #ij days after the date of enactment of this ,act1 the ,secretary shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the status of the agreements under this subsection4 7d7 ,improving information sharing and availability of public health data ,part ,a of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 #caj;,b4 ,improving information sharing and availability of public health data 7a7 ,in general ,the ,secretary may1 in consultation with ,state1 local1 and ,tribal public health officials1 carry out activities to improve the availability of appropriate and applicable public health data related to communicable diseases1 and information sharing between1 the ,director of the ,centers for ,disease ,control and ,prevention1 the ,assistant ,secretary for ,preparedness and ,response1 and such ,state1 local1 and ,tribal public health officials1 which may include such data from-- 7#a7 health care providers and facilities2 7#b7 public health and clinical laboratories2 and 7#c7 ,state1 local1 and ,tribal health departments4 7b7 ,content1 form1 and manner ,the ,secretary shall1 consistent with the requirements of this section1 work with such officials and relevant stakeholders to provide information on the content1 form1 and manner in which such data may most effectively support the ability of ,state1 local1 and ,tribal health departments to respond to such communicable diseases1 including related to the collection and reporting of demographic and other relevant data elements4 7c7 ,decreased burden ,in facilitating the coordination of efforts under subsection 7a71 the ,secretary shall make reasonable efforts to limit reported public health data to the minimum necessary information needed to accomplish the intended public health surveillance purpose4 7d7 ,exemption of certain public health data from disclosure ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 may exempt from disclosure under section #eeb7;b77#c7 of title #e1 ,united ,states ,code1 public health data that are gathered under this section if-- 7#a7 an individual is identified through such data2 or 7#b7 there is at least a very small risk1 as determined by current scientific practices or statistical methods1 that some combination of the information1 the request1 and other available data sources or the application of technology could be used to deduce the identity of an individual4 4 7e7 ,improving public health data collection 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall award grants1 contracts1 or cooperative agreements to eligible entities for purposes of identifying1 developing1 or disseminating best practices in the collection of electronic health information and the use of designated data standards and implementation specifications to improve the quality and completeness of data1 including demographic data1 collected1 accessed1 or used for public health purposes and to address health disparities and related health outcomes4 7#b7 ,eligible entities ,to be eligible to receive an award under this subsection an entity shall-- 7,a7 be a health care provider1 academic medical center1 community-based organization1 ,state1 local governmental entity1 ,indian ,tribe or ,tribal organization 7as such terms are defined in section #d of the ,indian ,self ,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd771 urban ,indian organization 7as defined in section #d of the ,indian ,health ,care ,improvement ,act 7#be ,u4,s4,c4 #afjc771 or other appropriate public or private nonprofit entity1 or a consortia of any such entities2 and 7,b7 submit an application to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 7#c7 ,activities ,entities receiving awards under this subsection shall use such award to develop and test best practices for training health care providers to use standards and implementation specifications that assist in the capture1 access1 exchange1 and use of electronic health information1 including demographic information1 disability status1 veteran status1 housing status1 functional status1 and other data elements4 ,such activities shall include1 at a minimum-- 7,a7 improving1 understanding1 and using data standards and implementation specifications2 7,b7 developing or identifying methods to improve communication with patients in a culturally- and linguistically-appropriate manner1 including to better capture information related to demographics of such individuals2 7,c7 developing methods for accurately categorizing and recording patient responses using available data standards2 7,d7 educating providers regarding the utility of such information for public health purposes and the importance of accurate collection and recording of such data2 and 7,e7 other activities1 as the ,secretary determines appropriate4 7#d7 ,reporting 7,a7 ,reporting by award recipients ,each recipient of an award under this subsection shall submit to the ,secretary a report on the results of best practices identified1 developed1 or disseminated through such award4 7,b7 ,report to congress ,not later than #a year after the completion of the program under this subsection1 the ,secretary shall submit a report to ,congress on the success of best practices developed under such program1 opportunities for further dissemination of such best practices1 and recommendations for improving the capture1 access1 exchange1 and use of information to improve public health and reduce health disparities4 7#e7 ,non-duplication of efforts ,the ,secretary shall ensure that the activities and programs carried out under this subsection are free of unnecessary duplication of effort4 7#f7 ,authorization of appropriations ,there are authorized to be appropriated #aj1jjj1jjj for each of fiscal years #bjbc through #bjbe to carry out this subsection4 #bad4 ,epidemic forecasting and outbreak analytics ,title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh et seq471 as amended by section #bab1 is further amended by adding at the end the following3 #bhbe4 ,epidemic forecasting and outbreak analytics 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall continue activities related to the development of infectious disease outbreak analysis capabilities to enhance the prediction1 modeling1 and forecasting of potential public health emergencies and other infectious disease outbreaks1 which may include activities to support preparedness for1 and response to1 such emergencies and outbreaks4 ,in carrying out this subsection1 the ,secretary shall identify strategies to include and leverage1 as appropriate1 the capabilities to public and private entities1 which may include conducting such activities through collaborative partnerships with public and private entities1 including academic institutions1 and other ,federal agencies1 consistent with section #cai;,d1 as applicable4 7b7 ,considerations ,in carrying out subsection 7a71 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 may consider public health data and1 as appropriate1 other data sources related to the transmission of such infectious diseases that affect preparedness for1 or response to1 public health emergencies and infectious disease outbreaks4 7c7 ,annual reports ,not later than #a year after the date of enactment of this section1 and annually thereafter for each of the subsequent #d years1 the ,secretary shall prepare and submit a report1 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 regarding an update on progress on activities conducted under this section to develop infectious disease outbreak analysis capabilities and any additional information relevant to such efforts4 4 #bae4 ,report on ,,cdc data portal 7a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding public health data modernization initiatives1 surveillance investments1 and public health data reporting modernization initiatives under this ,act 7including the amendments made by this ,act7 and the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 and provide recommendations on the feasibility of the use of a web-based information technology platform 7referred to in this section as the platform7 for the streamlining of existing voluntary submissions of public health data for all ,state1 local1 ,tribal1 and territorial entities that report such data to the ,centers for ,disease ,control and ,prevention1 and whether such platform would reduce the reporting burden for such entities4 7b7 ,requirements ,the report under subsection 7a7 shall address the extent to which the submission of such data to the platform may-- 7#a7 support coordination within the ,department of ,health and ,human ,services2 7#b7 provide appropriate information among and between ,state1 ,tribal1 local1 and territorial public health officials2 7#c7 leverage private sector technologies2 and 7#d7 provide for the streamlining of data reporting to the greatest extent possible4 #baf4 ,public health data transparency 7a7 ,report ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue a report assessing practices1 objectives1 and associated progress and challenges in achieving such objectives1 of the ,centers of ,disease ,control and ,prevention with respect to the collection and dissemination of public health data related to a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 or a potential public health emergency4 7b7 ,plan ,not later than #ahj days following the issuance of the report pursuant to paragraph 7#a71 the ,director of the ,centers for ,disease ,control and ,prevention 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 plan that shall include-- 7#a7 steps to improve the timely reporting and dissemination of public health data related to a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 or a potential public health emergency that is collected by the ,centers for ,disease ,control and ,prevention1 including any associated barriers2 7#b7 recommendations to ,congress regarding gaps in such practices and objectives described in subsection 7a72 and 7#c7 considerations regarding the requirements and limitations of data use agreements for such purposes1 as applicable4 ,c ,revitalizing the public health workforce #bba4 ,improving recruitment and retention of the frontline public health workforce 7a7 ,in general ,section #ggf of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bie;f-#a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking supply of and inserting supply of1 and encourage recruitment and retention of12 and 7,b7 by striking ,federal12 7#b7 in subsection 7b7-- 7,a7 by amending paragraph 7#a77;,a7 to read as follows3 7#a7 7,a7 7i7 be accepted for enrollment1 or be enrolled1 as a student in an accredited institution of higher education or school of public health in the final semester 7or equivalent7 of a program leading to a certificate or degree1 including a master's or doctoral degree1 in public health1 epidemiology1 laboratory sciences1 data systems1 data science1 data analytics1 informatics1 statistics1 or another subject matter related to public health2 and 7ii7 be employed by1 or have accepted employment with1 a ,state1 local1 or ,tribal public health agency1 or a related training fellowship at such ,state1 local1 or ,tribal public health agency1 as recognized by the ,secretary1 to commence upon graduation2 or 2 and 7,b7 in paragraph 7#a77;,b7-- 7i7 in clause 7i7-- 7,i7 by striking accredited educational institution in a ,state or territory and inserting accredited institution of higher education or school of public health2 and 7,,ii7 by striking a public health or health professions degree or certificate and inserting a certificate or degree1 including a master's or doctoral degree1 in public health1 epidemiology1 laboratory sciences1 data systems1 data science1 data analytics1 informatics1 statistics1 or another subject matter related to public health2 and 7ii7 in clause 7ii7-- 7,i7 by striking ,federal12 and 7,,ii7 by striking fellowship1 and inserting fellowship at such ,state1 local1 or ,tribal public health agency12 7#c7 in subsection 7c77#b7-- 7,a7 by striking ,federal12 and 7,b7 by striking equal to the greater of-- and all that follows through the end of subparagraph 7,b7 and inserting of at least #c consecutive years22 7#d7 in subsection 7d7-- 7,a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general ,a loan repayment provided for an individual under a written contract under the ,program shall consist of payment1 in accordance with paragraph 7#b71 for the individual toward the outstanding principal and interest on education loans incurred by the individual in the pursuit of the relevant degree or certificate described in subsection 7b77#a7 in accordance with the terms of the contract4 2 and 7,b7 in paragraph 7#b7-- 7i7 by striking ,for each year and inserting the following3 7,a7 ,in general ,for each year 2 7ii7 by striking #ce1jjj and inserting #ej1jjj2 7iii7 by striking #aje1jjj and inserting #aej1jjj2 and 7iv7 by adding at the end the following3 7,b7 ,considerations ,the ,secretary may take action in making awards under this section to ensure that-- 7i7 an appropriate proportion of contracts are awarded to individuals who are eligible to participate in the program pursuant to subsection 7b77#a77;,a72 and 7ii7 contracts awarded under this section are equitably distributed among-- 7,i7 the geographical regions of the ,united ,states2 7,,ii7 local1 ,state1 and ,tribal public health departments2 and 7,,iii7 such public health departments under subclause 7,,ii7 serving rural and urban areas4 2 7#e7 in subsection 7e71 by striking receiving a degree or certificate from a health professions or other related school and inserting with a contract to serve under subsection 7c72 7#f7 in subsection 7f71 by adding at the end the following3 ,in the event that a participant fails to either begin or complete the obligated service requirement of the loan repayment contract under this section1 the ,secretary may waive or suspend either the unfulfilled service or the assessed damages as provided for under section #cch;,e7d71 as appropriate42 7#g7 by redesignating subsection 7g7 as subsection 7h72 7#h7 by inserting after subsection 7f7 the following3 7g7 ,eligible loans ,the loans eligible for repayment under this section are each of the following3 7#a7 ,any loan for education or training for employment by a health department4 7#b7 ,any loan under part ,e of title ,,viii 7relating to nursing student loans74 7#c7 ,any ,federal ,direct ,stafford ,loan1 ,federal ,direct ,,plus ,loan1 ,federal ,direct ,unsubsidized ,stafford ,loan1 or ,federal ,direct ,consolidation ,loan 7as such terms are used in section #dee of the ,higher ,education ,act of #aife74 7#d7 ,any ,federal ,perkins ,loan under part ,e of title ,i of the ,higher ,education ,act of #aife4 7#e7 ,any other ,federal loan1 as the ,secretary determines appropriate4 2 7#i7 in subsection 7h71 as so redesignated1 by striking #aie1jjj1jjj for fiscal year #bjaj1 and such sums as may be necessary for each of fiscal years #bjaa through #bjae and inserting such sums as may be necessary for each of fiscal years #bjbb through #bjbe2 and 7#aj7 by striking tribal each place such term appears and inserting ,tribal4 7b7 ,,gao study on public health workforce ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 conduct an evaluation of what is known about the public health workforce in the ,united ,states1 which shall address-- 7,a7 existing gaps in the ,federal1 ,state1 local1 ,tribal1 and territorial public health workforce1 including positions that may be required to prepare for1 and respond to1 a public health emergency such as ,,covid-#ai2 7,b7 challenges associated with the hiring1 recruitment1 and retention of the ,federal1 ,state1 local1 ,tribal1 and territorial public health workforce2 and 7,c7 ,federal efforts to improve hiring1 recruitment1 and retention of the public health workforce2 and 7#b7 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on such review4 #bbb4 ,awards to support community health workers and community health 7a7 ,in general ,section #cii,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#aa7 is amended-- 7#a7 by amending the section heading to read as follows3 ,awards to support community health workers and community health2 7#b7 by amending subsection 7a7 to read as follows3 7a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and in coordination with the ,administrator of the ,health ,resources and ,services ,administration1 shall award grants1 contracts1 or cooperative agreements to eligible entities to promote positive health behaviors and outcomes for populations in medically underserved communities by leveraging community health workers1 including by addressing ongoing and longer-term community health needs1 and by building the capacity of the community health worker workforce4 ,such grants1 contracts1 and cooperative agreements shall be awarded in alignment and coordination with existing funding arrangements supporting community health workers4 2 7#c7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a7-- 7i7 by striking ,grants awarded and inserting ,subject to any requirements for the scope of licensure1 registration1 or certification of a community health worker under applicable ,state law1 grants1 contracts1 and cooperative agreements awarded2 and 7ii7 by striking support community health workers2 7,b7 by redesignating paragraphs 7#c7 through 7#e7 as paragraphs 7#d7 through 7#f71 respectively2 7,c7 by striking paragraphs 7#a7 and 7#b7 and inserting the following3 7#a7 recruit1 hire1 train1 and retain community health workers that reflect the needs of the community2 7#b7 support community health workers in providing education and outreach1 in a community setting1 regarding-- 7,a7 health conditions prevalent in-- 7i7 medically underserved communities 7as defined in section #gii;,b71 particularly racial and ethnic minority populations2 and 7ii7 other such at-risk populations or geographic areas that may require additional support during public health emergencies1 which may include counties identified by the ,secretary using applicable measures developed by the ,centers for ,disease ,control and ,prevention or other ,federal agencies2 and 7,b7 addressing social determinants of health and eliminating health disparities1 including by-- 7i7 promoting awareness of services and resources to increase access to health care1 mental health and substance use disorder services1 child services1 technology1 housing services1 educational services1 nutrition services1 employment services1 and other services2 and 7ii7 assisting in conducting individual and community needs assessments2 7#c7 educate community members1 including regarding effective strategies to promote healthy behaviors2 2 7,d7 in paragraph 7#d71 as so redesignated1 by striking to educate and inserting educate2 7,e7 in paragraph 7#e71 as so redesignated-- 7i7 by striking to identify and inserting identify2 7ii7 by striking healthcare agencies and inserting health care agencies2 and 7iii7 by striking healthcare services and to eliminate duplicative care2 or and inserting health care services and to streamline care1 including serving as a liaison between communities and health care agencies2 and2 and 7,f7 in paragraph 7#f71 as so redesignated-- 7i7 by striking to educate1 guide1 and provide and inserting support community health workers in educating1 guiding1 or providing2 and 7ii7 by striking maternal health and prenatal care and inserting chronic diseases1 maternal health1 prenatal1 and postpartum care in order to improve maternal and infant health outcomes2 7#d7 in subsection 7c71 by striking ,each eligible entity and all that follows through accompanied by and inserting ,to be eligible to receive an award under subsection 7a71 an entity shall prepare and submit to the ,secretary an application at such time1 in such manner1 and containing2 7#e7 in subsection 7d7-- 7,a7 in the matter preceding paragraph 7#a71 by striking awarding grants and inserting making awards2 7,b7 by amending paragraph 7#a7 to read as follows3 7#a7 propose to serve-- 7,a7 areas with populations that have a high rate of chronic disease1 infant mortality1 or maternal morbidity and mortality2 7,b7 low-income populations1 including medically underserved populations 7as defined in section #ccj7;b77#c772 7,c7 populations residing in health professional shortage areas 7as defined in section #ccb7;a772 7,d7 populations residing in maternity care health professional target areas identified under section #ccb7k72 or 7,e7 rural or traditionally underserved populations1 including racial and ethnic minority populations or low-income populations2 2 7,c7 in paragraph 7#b71 by striking 2 and and inserting 1 including rural populations and racial and ethnic minority populations22 7,d7 in paragraph 7#c71 by striking with community health workers4 and inserting and established relationships with community health workers in the communities expected to be served by the program2 and 7,e7 by adding at the end the following3 7#d7 develop a plan for providing services to the extent practicable1 in the language and cultural context most appropriate to individuals expected to be served by the program2 and 7#e7 propose to use evidence-informed or evidence-based practices1 as applicable and appropriate4 2 7#f7 in subsection 7e7-- 7,a7 by striking community health worker programs and inserting eligible entities2 and 7,b7 by striking and one-stop delivery systems under section #aba7;e7 and inserting 1 health professions schools1 minority-serving institutions 7defined1 for purposes of this subsection1 as institutions and programs described in section #cbf7;e77#a7 of the ,higher ,education ,act of #aife and institutions described in section #cga7;a7 of such ,act71 area health education centers under section #gea of this ,act1 and one-stop delivery systems under section #aba2 7#g7 by striking subsections 7f71 7g71 7h71 7i71 and 7j7 and inserting the following3 7f7 ,technical assistance ,the ,secretary may provide to eligible entities that receive awards under subsection 7a7 technical assistance with respect to planning1 development1 and operation of community health worker programs authorized or supported under this section4 7g7 ,dissemination of best practices ,not later than #d years after the date of enactment of the ,,prevent ,pandemics ,act1 the ,secretary shall1 based on activities carried out under this section and in consultation with relevant stakeholders1 identify and disseminate evidence-based or evidence-informed practices regarding recruitment and retention of community health workers and paraprofessionals to address ongoing public health and community health needs1 and to prepare for1 and respond to1 future public health emergencies4 7h7 ,report to ,congress ,not later than #d years after the date of enactment of the ,,prevent ,pandemics ,act1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report concerning the effectiveness of the program under this section in addressing ongoing public health and community health needs4 ,such report shall include recommendations regarding any improvements to such program1 including recommendations for how to improve recruitment1 training1 and retention of the community health workforce4 7i7 ,authorization of appropriations ,for purposes of carrying out this section1 there are authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbc through #bjbg4 2 7#h7 by redesignating subsection 7k7 as subsection 7j72 and 7#i7 in subsection 7j71 as so redesignated-- 7,a7 by striking paragraphs 7#a71 7#b71 and 7#d72 7,b7 by redesignating paragraph 7#c7 as paragraph 7#a72 7,c7 in paragraph 7#a71 as so redesignated-- 7i7 by striking entity 7including a ,state or public subdivision of a ,state and inserting entity1 including a ,state or political subdivision of a ,state1 an ,indian ,tribe or ,tribal organization1 an urban ,indian organization1 a community-based organization2 and 7ii7 by striking as defined in section #ahfa7;aa7 of the ,social ,security ,act77 and inserting 7as defined in section #ahfa7;aa77#d7 of the ,social ,security ,act72 and 7,d7 by adding at the end the following3 7#b7 ,indian ,tribe2 ,tribal organization ,the terms ,indian ,tribe and ,tribal organization have the meanings given the terms ,indian tribe and tribal organization1 respectively1 in section #d of the ,indian ,self-,determination and ,education ,assistance ,act4 7#c7 ,urban ,indian organization ,the term urban ,indian organization has the meaning given such term in section #d of the ,indian ,health ,care ,improvement ,act4 4 7b7 ,,gao study and report ,not later than #a year after the date of submission of the report under subsection 7h7 of section #cii,v of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#aa71 as amended by subsection 7a71 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 on the program authorized under such section #cii,v1 including a review of the efforts of the ,secretary of ,health and ,human ,services to coordinate such program with applicable programs of the ,health ,resources and ,services ,administration to ensure there is no unnecessary duplication of efforts among such programs1 and identification of any areas of duplication4 #bbc4 ,improving public health emergency response capacity 7a7 ,certain appointments to support public health emergency responses ,section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 is amended by adding at the end the following3 7g7 ,certain appointments ,to support public health emergency responses 7#a7 ,in general ,in order to support the initial response to a public health emergency declared by the ,secretary under this section1 the ,secretary may1 subject to paragraph 7#b7 and without regard to sections #ccji through #ccah of title #e1 ,united ,states ,code1 appoint individuals directly to positions in the ,department of ,health and ,human ,services for which the ,secretary has provided public notice in order to-- 7,a7 address a critical hiring need directly related to responding to a public health emergency declared by the ,secretary under this section2 or 7,b7 address a severe shortage of candidates that impacts the operational capacity of the ,department of ,health and ,human ,services to respond in the event of a public health emergency declared by the ,secretary under this section4 7#b7 ,number of appointments ,each fiscal year in which the ,secretary makes a determination of a public health emergency under subsection 7a7 7not including a renewal71 the ,secretary may directly appoint not more than-- 7,a7 #djj individuals under paragraph 7#a77;,a72 and 7,b7 #ajj individuals under paragraph 7#a77;,b74 7#c7 ,compensation ,the annual rate of basic pay of an individual appointed under this subsection shall be determined in accordance with chapter #ea and subchapter ,,iii of chapter #ec of title #e1 ,united ,states ,code4 7#d7 ,reporting ,the ,secretary shall establish and maintain records regarding the use of the authority under this subsection1 including-- 7,a7 the number of positions filled through such authority2 7,b7 the types of appointments of such positions2 7,c7 the titles1 occupational series1 and grades of such positions2 7,d7 the number of positions publicly noticed to be filled under such authority2 7,e7 the number of qualified applicants who apply for such positions2 7,f7 the qualification criteria for such positions2 and 7,g7 the demographic information of individuals appointed to such positions4 7#e7 ,notification to ,congress ,in the event the ,secretary1 within a single fiscal year1 directly appoints more than #ej percent of the individuals allowable under either subparagraph 7,a7 or 7,b7 of paragraph 7#b71 the ,secretary shall1 not later than #ae days after the date of such action1 notify the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 ,such notification shall1 in a manner that protects personal privacy1 to the extent required by applicable ,federal and ,state privacy law1 at a minimum1 include-- 7,a7 information on each such appointment within such fiscal year2 7,b7 a description of how each such position relates to the requirements of subparagraph 7,a7 or 7,b7 of paragraph 7#a72 and 7,c7 the additional number of personnel1 if any1 the ,secretary anticipates to be necessary to adequately support a response to a public health emergency declared under this section using the authorities described in paragraph 7#a7 within such fiscal year4 7#f7 ,reports to ,congress ,not later than ,september #cj1 #bjbc1 and annually thereafter for each fiscal year in which the authority under this subsection is used1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report describing the total number of appointments filled under this subsection within the fiscal year and a description of how the positions relate to the requirements of subparagraph 7,a7 or 7,b7 of paragraph 7#a74 7#g7 ,sunset ,the authority under this subsection shall expire on ,september #cj1 #bjbh4 4 7b7 ,,gao report ,not later than #a year after the issuance of the initial report under subsection 7g77#f7 of section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d71 as added by subsection 7a71 and again #ahj days after the date on which the authority provided under section #cai7;g7 of such ,act expires pursuant to paragraph 7#g7 of such section1 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 on the use of the authority provided under such section4 ,such report shall1 in a manner that protects personal privacy1 at a minimum1 include information on-- 7#a7 the number of positions publicly noticed and filled under the authority of each of subparagraphs 7,a7 and 7,b7 of such section #cai7;g77#a72 7#b7 the occupational series1 grades1 and types of appointments of such positions2 7#c7 how such positions related to addressing a need or shortage described in subparagraph 7,a7 or 7,b7 of such section2 7#d7 how the ,secretary of ,health and ,human ,services made appointment decisions under each of subparagraphs 7,a7 and 7,b7 of such section2 7#e7 sources used to identify candidates for filling such positions2 7#f7 the number of individuals appointed under each such subparagraph2 7#g7 aggregated demographic information related to individuals appointed under each such subparagraph2 and 7#h7 any challenges1 limitations1 or gaps related to the use of the authority under each such subparagraph and any related recommendations to address such challenges1 limitations1 or gaps4 #bbd4 ,extension of authorities to support health professional volunteers at community health centers ,section #bbd7q7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bcc7q77 is amended by striking paragraph 7#f74 #bbe4 ,increasing educational opportunities for allied health professions ,section #gee7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bid;e7b77 is amended by adding at the end the following3 7#d7 ,increasing educational opportunities in physical therapy1 occupational therapy1 respiratory therapy1 audiology1 and speech-language pathology professions1 which may include offering scholarships or stipends and carrying out other activities to improve retention1 for individuals from disadvantaged backgrounds or individuals who are underrepresented in such professions4 4 #bbf4 ,public ,health ,service ,corps annual and sick leave 7a7 ,in general ,section #bai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #baj-a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking ,reserve ,corps and inserting ,ready ,reserve ,corps2 and 7,b7 by striking 3 ,provided1 ,that such regulations shall not authorize annual leave to be accumulated in excess of sixty days2 7#b7 by inserting after subsection 7a7 the following3 7b7 ,the regulations described in subsection 7a7 may authorize accumulated annual leave of not more than #abj days for any commissioned officer of the ,regular ,corps or officer of the ,ready ,reserve ,corps on active duty4 2 and 7#c7 by redesignating subsection 7d7 as subsection 7c74 7b7 ,application ,the amendments made by subsection 7a7 shall apply with respect to accumulated annual leave 7as defined in section #bai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #baj-a77 that a commissioned officer of the ,regular ,corps or officer of the ,ready ,reserve ,corps on active duty would1 but for the regulations described in such section1 lose at the end of fiscal year #bjbb or a subsequent fiscal year4 ,d ,improving public health responses #bca4 ,centers for public health preparedness and response 7a7 ,in general ,section #cai;,f of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f7 is amended-- 7#a7 by striking subsection 7d7 and inserting the following3 7d7 ,centers for ,public ,health ,preparedness and ,response 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 may award grants1 contracts1 or cooperative agreements to institutions of higher education1 including accredited schools of public health1 or other nonprofit private entities to establish or maintain a network of ,centers for ,public ,health ,preparedness and ,response 7referred to in this subsection as ,centers74 7#b7 ,eligibility ,to be eligible to receive an award under this subsection1 an entity shall submit to the ,secretary an application containing such information as the ,secretary may require1 including a description of how the entity will-- 7,a7 coordinate relevant activities with applicable ,state1 local1 and ,tribal health departments and officials1 health care facilities1 and health care coalitions to improve public health preparedness and response1 as informed by the public health preparedness and response needs of the community1 or communities1 involved2 7,b7 prioritize efforts to implement evidence-informed or evidence-based practices to improve public health preparedness and response1 including by helping to reduce the transmission of emerging infectious diseases2 and 7,c7 use funds awarded under this subsection1 including by carrying out any activities described in paragraph 7#c74 7#c7 ,use of funds ,the ,centers established or maintained under this subsection shall use funds awarded under this subsection to carry out activities to advance public health preparedness and response capabilities1 which may include-- 7,a7 identifying1 translating1 and disseminating promising research findings or strategies into evidence-informed or evidence-based practices to inform preparedness for1 and responses to1 chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases1 and other public health emergencies1 which may include conducting research related to public health preparedness and response systems2 7,b7 improving awareness of such evidence-informed or evidence-based practices and other relevant scientific or public health information among health care professionals1 public health professionals1 other stakeholders1 and the public1 including through the development1 evaluation1 and dissemination of trainings and training materials1 consistent with section #bhjb7;b77#b71 as applicable and appropriate1 and with consideration given to existing training materials1 to support preparedness for1 and responses to1 such threats2 7,c7 utilizing and expanding relevant technological and analytical capabilities to inform public health and medical preparedness and response efforts2 7,d7 expanding activities1 including through public-private partnerships1 related to public health preparedness and response1 including participation in drills and exercises and training public health experts1 as appropriate2 and 7,e7 providing technical assistance and expertise that relies on evidence-based practices1 as applicable1 related to responses to public health emergencies1 as appropriate1 to ,state1 local1 and ,tribal health departments and other entities pursuant to paragraph 7#b77;,a74 7#d7 ,distribution of awards ,in awarding grants1 contracts1 or cooperative agreements under this subsection1 the ,secretary shall support not fewer than #aj ,centers1 subject to the availability of appropriations1 and ensure that such awards are equitably distributed among the geographical regions of the ,united ,states4 2 and 7#b7 in subsection 7f77#a77;,c71 by striking 1 of which #e1jjj1jjj shall be used to carry out paragraphs 7#c7 through 7#e7 of such subsection4 7b7 ,repeal ,section #cai;,g of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g7 is repealed4 #bcb4 ,vaccine distribution plans ,section #cai;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 1 or other federally purchased vaccine to address another pandemic before the period at the end of the first sentence2 and 7,b7 by inserting or other pandemic before the period at the end of the second sentence2 and 7#b7 in subsection 7d71 by inserting or other pandemics after influenza pandemics4 #bcc4 ,coordination and collaboration regarding blood supply 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 or the ,secretary's designee1 shall-- 7#a7 ensure coordination and collaboration between relevant ,federal departments and agencies related to the safety and availability of the blood supply1 including-- 7,a7 the ,department of ,health and ,human ,services1 including the ,office of the ,assistant ,secretary for ,health1 the ,centers for ,disease ,control and ,prevention1 the ,food and ,drug ,administration1 the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,national ,institutes of ,health1 the ,centers for ,medicare ,medicaid ,services1 and the ,health ,resources and ,services ,administration2 7,b7 the ,department of ,defense2 and 7,c7 the ,department of ,veterans ,affairs2 and 7#b7 consult and communicate with private stakeholders1 including blood collection establishments1 health care providers1 accreditation organizations1 researchers1 and patients1 regarding issues related to the safety and availability of the blood supply4 7b7 ,streamlining blood donor input ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection of information to which a response is voluntary and that is initiated by the ,secretary of ,health and ,human ,services to solicit information from blood donors or potential blood donors to support the development of recommendations by the ,secretary concerning blood donation4 ,,iii ,accelerating research and countermeasure discovery ,a ,fostering research and development and improving coordination #cja4 ,research and activities related to long-term health effects of ,,sars-,co,v-#b infection 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 as appropriate-- 7#a7 continue to conduct or support basic1 clinical1 epidemiological1 behavioral1 and translational research and public health surveillance related to the pathogenesis1 prevention1 diagnosis1 and treatment of the long-term health effects of ,,sars-,co,v-#b infection2 and 7#b7 in consultation with health professional associations1 researchers1 and other relevant experts1 develop and inform recommendations1 guidance1 and provide educational materials for health care providers and the general public on the long-term effects of ,,sars-,co,v-#b infection1 consistent with the findings of studies and research under paragraph 7#a74 7b7 ,considerations ,in conducting or supporting research under this section1 the ,secretary shall consider the diversity of research participants or cohorts to ensure inclusion of a broad range of participants1 as applicable and appropriate4 7c7 ,annual reports ,not later than #a year after the date of enactment of this ,act1 and annually thereafter for the next #d years1 the ,secretary shall prepare and submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding an overview of the research conducted or supported under this section and any relevant findings4 ,such reports may include information about how the research and relevant findings under this section relate to other research efforts supported by other public or private entities4 #cjb4 ,research centers for pathogens of pandemic concern ,subpart #f of part ,c of title ,,iv of the ,public ,health ,service ,act is amended by inserting after section #ddg;,c 7#db ,u4,s4,c4 #bhe;f-#d7 the following3 #ddg;,d4 ,research centers for pathogens of pandemic concern 7a7 ,in general ,the ,director of the ,institute1 in collaboration1 as appropriate1 with the directors of applicable institutes1 centers1 and divisions of the ,national ,institutes of ,health1 the ,assistant ,secretary for ,preparedness and ,response1 and the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 shall establish or continue a multidisciplinary research program to advance the discovery and preclinical development of medical products for priority virus families and other viral pathogens with a significant potential to cause a pandemic1 through support for research centers4 7b7 ,uses of funds ,the ,director of the ,institute shall award funding through grants1 contracts1 or cooperative agreements to public or private entities to provide support for research centers described in subsection 7a7 for the purpose of-- 7#a7 conducting basic research through preclinical development of new medical products or technologies1 including platform technologies1 to address pathogens of pandemic concern2 7#b7 identifying potential targets for therapeutic candidates1 including antivirals1 to treat such pathogens2 7#c7 identifying existing medical products with the potential to address such pathogens1 including candidates that could be used in outpatient settings2 and 7#d7 carrying out or supporting other research related to medical products to address such pathogens1 as determined appropriate by the ,director4 7c7 ,coordination ,the ,director of the ,institute shall1 as appropriate1 provide for the coordination of activities among the centers described in subsection 7a71 including through-- 7#a7 facilitating the exchange of information and regular communication among the centers1 as appropriate2 and 7#b7 requiring the periodic preparation and submission to the ,director of reports on the activities of each center4 7d7 ,priority ,in awarding funding through grants1 contracts1 or cooperative agreements under subsection 7a71 the ,director of the ,institute shall1 as appropriate1 give priority to applicants with existing frameworks and partnerships1 as applicable1 to support the advancement of such research4 7e7 ,collaboration ,the ,director of the ,institute shall-- 7#a7 collaborate with the heads of other appropriate ,federal departments1 agencies1 and offices with respect to the identification of additional priority virus families and other viral pathogens with a significant potential to cause a pandemic2 and 7#b7 collaborate with the ,director of the ,biomedical ,advanced ,research and ,development ,authority with respect to the research conducted by centers described in subsection 7a71 including1 as appropriate1 providing any updates on the research advancements made by such centers1 identifying any advanced research and development needs for such countermeasures1 consistent with section #cai,l7a77#f71 and taking into consideration existing manufacturing capacity and future capacity needs for such medical products or technologies1 including platform technologies1 supported by the centers described in subsection 7a74 7f7 ,supplement1 not supplant ,any support received by a center described in subsection 7a7 under this section shall be used to supplement1 and not supplant1 other public or private support for activities authorized to be supported4 4 #cjc4 ,improving medical countermeasure research coordination ,section #djb7;b7 in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b77 is amended-- 7#a7 in paragraph 7#bd71 by striking and at the end2 7#b7 in paragraph 7#be71 by striking the period and inserting a semicolon2 and 7#c7 by inserting after paragraph 7#be7 the following3 7#bf7 shall consult with the ,assistant ,secretary for ,preparedness and ,response1 the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 the ,director of the ,centers for ,disease ,control and ,prevention1 and the heads of other ,federal agencies and offices1 as appropriate1 regarding research needs to advance medical countermeasures to diagnose1 mitigate1 prevent1 or treat harm from any biological agent or toxin1 including emerging infectious diseases1 chemical1 radiological1 or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats2 4 #cjd4 ,accessing specimen samples and diagnostic tests 7a7 ,improving research and development of medical countermeasures for novel pathogens 7#a7 ,sample access ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall make publicly available policies and procedures related to public and private entities accessing specimens of1 or specimens containing1 pathogens or suitable surrogates for1 or alternatives to1 such pathogens as the ,secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation1 as applicable1 of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases4 ,such policies and procedures shall take into account1 as appropriate1 any applicable existing ,federal resources4 7#b7 ,guidance ,the ,secretary shall issue guidance regarding the procedures for carrying out paragraph 7#a71 including-- 7,a7 the method for requesting such samples2 7,b7 considerations for sample availability and use of suitable surrogates or alternatives to such pathogens1 as appropriate1 including applicable safeguard and security measures2 and 7,c7 information required to be provided in order to receive such samples or suitable surrogates or alternatives4 7b7 ,earlier development of diagnostic tests ,title ,,iii of the ,public ,health ,service ,act is amended by inserting after section #cai;,a 7#db ,u4,s4,c4 #bdg;d-#a7 the following3 #cai;,b4 ,earlier development of diagnostic tests ,the ,secretary may contract with public and private entities1 as appropriate1 to increase capacity in the rapid development1 validation1 manufacture1 and dissemination of diagnostic tests1 as appropriate1 to ,state1 local1 and ,tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under section #cai1 or that has significant potential to cause such a public health emergency4 4 ,b ,improving biosafety and biosecurity #caa4 ,improving control and oversight of select biological agents and toxins ,section #cea;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7 is amended-- 7#a7 in subsection 7b77#a71 by amending subparagraph 7,a7 to read as follows3 7,a7 proper training1 including with respect to notification requirements under this section1 of-- 7i7 individuals who are involved in the handling and use of such agents and toxins1 including appropriate skills to handle such agents and toxins2 7ii7 individuals whose responsibilities routinely place them in close proximity to laboratory facilities in which such agents and toxins are being transferred1 possessed1 or used2 and 7iii7 individuals who perform administrative or oversight functions of the facility related to the transfer1 possession1 or use of such agents and toxins on behalf of registered persons2 2 7#b7 in subsection 7e77#a71 by striking 7including the risk of use in domestic or international terrorism7 and inserting 7including risks posed by the release1 theft1 or loss of such agent or toxin1 or use in domestic or international terrorism72 7#c7 in subsection 7k7-- 7,a7 by redesignating paragraphs 7#a7 and 7#b7 as paragraphs 7#b7 and 7#c71 respectively2 7,b7 by inserting before paragraph 7#b71 as so redesignated1 the following3 7#a7 ,notification with respect to federal facilities ,in the event of the release1 loss1 or theft of an agent or toxin listed by the ,secretary pursuant to subsection 7a77#a71 or by the ,secretary of ,agriculture pursuant to section #bab7;a77#a7 of the ,agricultural ,bioterrorism ,protection ,act of #bjjb1 from or within a laboratory facility owned or operated by the ,department of ,health and ,human ,services1 or other ,federal laboratory facility subject to the requirements of this section1 the ,secretary1 in a manner that does not compromise national security1 shall-- 7,a7 not later than #gb hours after such event is reported to the ,secretary1 notify the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives of such event1 including-- 7i7 the ,federal laboratory facility in which such release1 loss1 or theft occurred2 and 7ii7 the circumstances of such release1 loss1 or theft2 and 7,b7 not later than #ad days after such notification1 update such ,committees on-- 7i7 any actions taken or planned by the ,secretary to mitigate any potential threat such release1 loss1 or theft may pose to public health and safety2 and 7ii7 any actions taken or planned by the ,secretary to review the circumstances of such release1 loss1 or theft1 and prevent similar events4 2 and 7,c7 by amending paragraph 7#b71 as so redesignated1 to read as follows3 7#b7 ,annual report ,the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on an annual basis a report-- 7,a7 summarizing the number and nature of notifications received under subsection 7e77#h7 7relating to theft or loss7 and subsection 7j7 7relating to releases71 during the preceding fiscal year2 7,b7 describing actions taken by the ,secretary to address such incidents1 such as any corrective action plans required and steps taken to promote adherence to1 and compliance with1 safety and security best practices1 standards1 and regulations2 and 7,c7 describing any gaps1 challenges1 or limitations with respect to ensuring that such safety and security practices are consistently applied and adhered to1 and actions taken to address such gaps1 challenges1 or limitations4 2 and 7#d7 in subsection 7m71 by striking fiscal years #bjjb through #bjjg and inserting fiscal years #bjbc through #bjbg4 #cab4 ,strategy for ,federal high-containment laboratories 7a7 ,strategy for ,federal high-,containment laboratories ,not later than #a year after the date of enactment of this ,act1 the ,director of the ,office of ,science and ,technology ,policy1 in consultation with relevant ,federal agencies and departments1 shall establish a strategy for the management1 maintenance1 and oversight of federally-owned laboratory facilities capable of operating at ,biosafety ,level #c or #d1 including equivalent classification levels4 ,such strategy shall include-- 7#a7 a description of the roles and responsibilities of relevant ,federal departments and agencies with respect to the management1 maintenance1 and oversight of ,biosafety ,level #c or #d laboratory facilities2 7#b7 an assessment of the needs of the ,federal ,government with respect to ,biosafety ,level #c or #d laboratory facilities2 7#c7 a summary of existing federally-owned ,biosafety ,level #c or #d laboratory facility capacity2 7#d7 a summary of other ,biosafety ,level #c or #d laboratory facility capacity established through ,federal funds2 7#e7 a description of how the capacity described in paragraphs 7#c7 and 7#d7 addresses the needs of the ,federal ,government1 including-- 7,a7 how relevant ,federal departments and agencies coordinate to provide access to appropriate laboratory facilities to reduce unnecessary duplication2 and 7,b7 any gaps in such capacity related to such needs2 7#f7 a summary of plans that are in place for the maintenance of such capacity1 as applicable and appropriate1 including processes for determining whether to maintain or expand such capacity1 and a description of how the ,federal ,government will address rapid changes in the need for such capacity during a public health emergency2 and 7#g7 a description of how the heads of relevant ,federal departments and agencies will coordinate to ensure appropriate oversight of federally-owned laboratory facility capacity and leverage such capacity1 as appropriate1 to fulfill the needs of multiple ,federal departments and agencies in order to reduce unnecessary duplication and improve collaboration within the ,federal ,government4 #cac4 ,national ,science ,advisory ,board for ,biosecurity 7a7 ,in general ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,o4 ,national ,science ,advisory ,board for ,biosecurity 7a7 ,establishment ,the ,secretary1 acting through the ,director of ,,nih1 shall establish an advisory committee1 to be known as the ,national ,science ,advisory ,board for ,biosecurity 7referred to in this section as the ,board74 7b7 ,duties 7#a7 ,in general ,the ,national ,science ,advisory ,board for ,biosecurity referred to in section #bje of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag7 7referred to in this section as the ,board7 shall provide technical advice1 guidance1 or recommendations1 to relevant ,federal departments and agencies related to biosafety and biosecurity oversight of biomedical research1 including-- 7,a7 oversight of federally-conducted or federally-supported dual use biomedical research1 such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research1 taking into consideration national security concerns1 the potential benefits of such research1 considerations related to the research community1 transparency1 and public availability of information1 and international research collaboration2 and 7,b7 continuing to carry out the activities required under section #bje of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag74 7c7 ,considerations ,in carrying out the duties under subsection 7b71 the ,board may consider strategies to improve the safety and security of biomedical research1 including through-- 7#a7 leveraging or using new technologies and scientific advancements to reduce safety and security risks associated with such research and improve containment of pathogens2 and 7#b7 outreach to1 and education and training of1 researchers1 laboratory personnel1 and other appropriate individuals with respect to safety and security risks associated with such research and mitigation of such risks4 7d7 ,membership ,the ,board shall be composed of the following3 7#a7 ,non-voting1 ex officio members1 including the following3 7,a7 ,at least one representative of each of the following3 7i7 ,the ,department of ,health and ,human ,services4 7ii7 ,the ,department of ,defense4 7iii7 ,the ,department of ,agriculture4 7iv7 ,the ,department of ,homeland ,security4 7v7 ,the ,department of ,energy4 7vi7 ,the ,department of ,state4 7vii7 ,the ,office of ,science and ,technology ,policy4 7viii7 ,the ,office of the ,director of ,national ,intelligence4 7,b7 ,representatives of such other ,federal departments or agencies as the ,secretary determines appropriate to carry out the requirements of this section4 7#b7 ,individuals1 appointed by the ,secretary1 with expertise in biology1 infectious diseases1 public health1 ethics1 national security1 and other fields1 as the ,secretary determines appropriate1 who shall serve as voting members4 4 7b7 ,orderly transition ,the ,secretary of ,health and ,human ,services shall take such steps as are necessary to provide for the orderly transition to the authority of the ,national ,science ,advisory ,board for ,biosecurity established under section #djd,o of the ,public ,health ,service ,act1 as added by subsection 7a71 from any authority of the ,board described in section #bje of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag71 as in effect on the day before the date of enactment of this ,act4 7c7 ,application ,the requirements under section #djd,o of the ,public ,health ,service ,act1 as added by subsection 7a71 related to the mission1 activities1 or functions of the ,national ,science ,advisory ,board for ,biosecurity shall not apply until the completion of any work undertaken by such ,board before the date of enactment of this ,act4 #cad4 ,research to improve biosafety 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall1 as appropriate1 conduct or support research to improve the safe conduct of biomedical research activities involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section #cea;,a7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7a77#a774 7b7 ,report ,not later than #e years after the date of enactment of this ,act1 the ,secretary shall prepare and submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding an overview of any research conducted or supported under this section1 any relevant findings1 and steps the ,secretary is taking to disseminate any such findings to support the reduction of risks associated with biomedical research involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section #cea;,a7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7a77#a774 #cae4 ,federally-funded research with enhanced pathogens of pandemic potential 7a7 ,review and oversight of enhanced pathogens of pandemic potential 7#a7 ,in general ,the ,director of the ,office of ,science and ,technology ,policy 7referred to in this section as the ,director71 in consultation with the heads of relevant ,federal departments and agencies1 shall-- 7,a7 not later than #a years after the date of enactment of this ,act-- 7i7 continue or conduct a review of existing ,federal policies related to research proposed for ,federal funding that may be reasonably anticipated to involve the creation1 transfer1 or use of pathogens of pandemic potential2 and 7ii7 establish or update a ,federal policy for the consistent review and oversight of such proposed research that appropriately considers the risks associated with1 and potential benefits of1 such research2 and 7,b7 not less than every #d years thereafter1 review and update such policy1 as necessary and appropriate1 to ensure that such policy fully accounts for relevant research that may be reasonably anticipated to involve the creation1 transfer1 or use of enhanced pathogens of pandemic potential1 takes into consideration the benefits of such research1 and supports the mitigation of related risks4 7#b7 ,requirements ,the policy established pursuant to paragraph 7#a7 shall include-- 7,a7 a clear scope to support the consistent identification of research proposals subject to such policy by relevant ,federal departments and agencies2 7,b7 a framework for such reviews that accounts for safety1 security1 and ethical considerations related to the creation1 transfer1 or use of enhanced pathogens of pandemic potential2 7,c7 measures to enhance the transparency and public availability of information related to such research activities in a manner that does not compromise national security1 the safety and security of such research activities1 or any identifiable1 sensitive information of relevant individuals2 and 7,d7 consistent procedures across relevant ,federal department and agencies to ensure that-- 7i7 proposed research that has been determined to have scientific and technical merit and may be subject to such policy is identified and referred for review2 7ii7 subjected research activities conducted under an award1 including activities undertaken by any subrecipients of such award1 are monitored regularly throughout the project period to ensure compliance with such policy and the terms and conditions of such award2 and 7iii7 in the event that federally-funded research activities not subject to such policy produce unanticipated results related to the creation1 transfer1 or use of enhanced pathogens of pandemic potential1 such research activities are identified and appropriately reviewed under such policy4 7#c7 ,clarification ,reviews required pursuant to this section shall be in addition to any applicable requirements for research project applications required under the ,public ,health ,service ,act1 including reviews required under section #dib of such ,act 7#db ,u4,s4,c4 #bhi;a71 as applicable1 or other applicable laws4 7b7 ,implementation 7#a7 ,in general ,the ,director shall direct all heads of relevant ,federal departments and agencies to update1 modernize1 or promulgate applicable implementing regulations and guidance to implement the requirements of this section4 7#b7 ,updates ,consistent with the requirements under subsection 7a77#a77;,b71 the ,director shall require all heads of relevant ,federal departments and agencies to update such policies consistent with any changes to the policy established pursuant to subsection 7a77#a74 ,c ,preventing undue foreign influence in biomedical research #cba4 ,foreign talent programs ,the ,secretary of ,health and ,human ,services shall require disclosure of participation in foreign talent programs1 including the provision of copies of all grants1 contracts1 or other agreements related to such programs1 and other supporting documentation related to such programs1 as a condition of receipt of ,federal extramural biomedical research funding awarded through the ,department of ,health and ,human ,services4 #cbb4 ,securing identifiable1 sensitive information 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in consultation with the ,director of ,national ,intelligence1 the ,secretary of ,state1 the ,secretary of ,defense1 and other national security experts1 as appropriate1 shall ensure that biomedical research supported or conducted by the ,national ,institutes of ,health and other relevant agencies and offices within the ,department of ,health and ,human ,services involving the sequencing of human genomic information1 and collection1 analysis1 or storage of identifiable1 sensitive information1 as defined in section #cja7;d77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda7;d77#d771 is conducted in a manner that appropriately considers national security risks1 including national security implications related to potential misuse of such data4 ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall ensure that the ,national ,institutes of ,health and other relevant agencies and offices within the ,department of ,health and ,human ,services1 working with the heads of agencies and national security experts1 including the ,office of the ,national ,security within the ,department of ,health and ,human ,services-- 7#a7 develop a comprehensive framework for assessing and managing such national security risks that includes-- 7,a7 criteria for how and when to conduct risk assessments for projects that may have national security implications2 7,b7 security controls and training for researchers or entities1 including peer reviewers1 that manage or have access to such data2 and 7,c7 methods to incorporate risk-reduction in the process for funding such projects that may have national security implications2 7#b7 not later than #a year after the risk framework is developed under paragraph 7#a71 develop and implement controls to-- 7,a7 ensure that researchers or entities that manage or have access to such data have complied with the requirements of paragraph 7#a7 and ongoing requirements with such paragraph2 and 7,b7 ensure that data access committees reviewing data access requests for projects that may have national security risks1 as appropriate1 include members with expertise in current and emerging national security threats1 in order to make appropriate decisions related to access to such identifiable1 sensitive information2 and 7#c7 not later than #b years after the risk framework is developed under paragraph 7#a71 update data access and sharing policies related to human genomic data1 as appropriate1 based on current and emerging national security threats4 7b7 ,congressional briefing ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall provide a briefing to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,select ,committee on ,intelligence of the ,senate and the ,committee on ,energy and ,commerce and the ,permanent ,select ,committee on ,intelligence of the ,house of ,representatives on the activities required under subsection 7a74 #cbc4 ,duties of the ,director ,section #djb7;b7 in the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b771 as amended by section #cjc1 is further amended by inserting after paragraph 7#bf7 7as added by section #cjc7 the following3 7#bg7 shall consult with the ,director of the ,office of ,national ,security within the ,department of ,health and ,human ,services1 the ,assistant ,secretary for ,preparedness and ,response1 the ,director of ,national ,intelligence1 the ,director of the ,federal ,bureau of ,investigation1 and the heads of other appropriate agencies on a regular basis1 regarding biomedical research conducted or supported by the ,national ,institutes of ,health that may affect or be affected by matters of national security2 7#bh7 shall ensure that recipients of awards from the ,national ,institutes of ,health1 and1 as appropriate and practicable1 entities collaborating with such recipients1 have in place and are adhering to appropriate technology practices and policies for the security of identifiable1 sensitive information1 including information collected1 stored1 or analyzed by domestic and non-domestic entities2 and 7#bi7 shall ensure that recipients of awards from the ,national ,institutes of ,health are in compliance with the terms and conditions of such award1 which may include activities to support awareness of1 and compliance with1 such terms and conditions by any subrecipients of the award4 4 #cbd4 ,protecting ,america's biomedical research enterprise 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 in collaboration with ,assistant to the ,president for ,national ,security ,affairs1 the ,director of ,national ,intelligence1 the ,director of the ,federal ,bureau of ,investigation1 and the heads of other relevant departments and agencies1 and in consultation with research institutions and research advocacy organizations or other relevant experts1 as appropriate1 shall-- 7#a7 identify ways to improve the protection of intellectual property and other proprietary information1 as well as identifiable1 sensitive information of participants in biomedical research and development1 from national security risks and other applicable threats1 including the identification of gaps in policies and procedures in such areas related to biomedical research and development supported by the ,department of ,health and ,human ,services and biomedical research supported by other agencies as applicable1 and make recommendations to institutions of higher education or other entities that have traditionally received ,federal funding for biomedical research to protect such information2 7#b7 identify or develop strategies to prevent1 mitigate1 and address national security threats in biomedical research and development supported by the ,federal ,government1 including such threats associated with foreign talent programs1 by countries seeking to exploit ,united ,states technology and other proprietary information as it relates to such biomedical research and development2 7#c7 identify national security risks and potential misuse of proprietary information1 and identifiable1 sensitive information of biomedical research participants and other applicable risks1 including with respect to peer review1 and make recommendations for additional policies and procedures to protect such information2 7#d7 develop a framework to identify areas of biomedical research and development supported by the ,federal ,government that are emerging areas of interest for state actors and would compromise national security if they were to be subjected to undue foreign influence2 and 7#e7 regularly review recommendations or policies developed under this section and make additional recommendations or updates1 as appropriate4 7b7 ,report to ,president and to ,congress ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall prepare and submit1 in a manner that does not compromise national security1 to the ,president and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,select ,committee on ,intelligence of the ,senate1 the ,committee on ,energy and ,commerce and the ,permanent ,select ,committee on ,intelligence of the ,house of ,representatives1 and other congressional committees as appropriate1 a report on the findings and recommendations pursuant to subsection 7a74 #cbe4 ,,gao ,study 7a7 ,in general ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall conduct a study to assess the extent to which the ,department of ,health and ,human ,services 7referred to in this section as the ,department7 utilizes or provides funding to entities that utilize such funds for human genomic sequencing services or genetic services 7as such term is defined in section #bja7f7 of the ,genetic ,information ,nondiscrimination ,act of #bjjh 7#db ,u4,s4,c4 #bjjj;ff7#f777 provided by entities1 or subsidiaries of such entities1 organized under the laws of a country or countries of concern1 in the estimation of the ,director of ,national ,intelligence or the head of another ,federal department or agency1 as appropriate4 7b7 ,considerations ,in carrying out the study under this section1 the ,comptroller ,general shall-- 7#a7 consider-- 7,a7 the extent to which the country or countries of concern could obtain human genomic information of citizens and residents of the ,united ,states from such entities that sequence1 analyze1 collect1 or store human genomic information and which the ,director of ,national ,intelligence or the head of another ,federal department or agency reasonably anticipates may use such information in a manner inconsistent with the national security interests of the ,united ,states2 7,b7 whether the ,department or recipient of such funds from the ,department sought to provide funding to1 or to use1 domestic entities with no such ties to the country or countries of concern for such purposes and any barriers to the use of domestic entities2 and 7,c7 whether data use agreements1 data security measures1 and other such measures taken by the ,department or recipient of such funds from the ,department are sufficient to protect the identifiable1 sensitive information of the people of the ,united ,states and the national security interests of the ,united ,states2 and 7#b7 make recommendations to address any vulnerabilities to the ,united ,states national security identified1 as appropriate4 7c7 ,estimation ,in conducting the study under this section1 the ,comptroller ,general may1 as appropriate and necessary to complete such study1 investigate specific instances of such utilization of genetic sequencing services or genetic services1 as described in subsection 7a71 to produce estimates of the potential prevalence of such utilization among entities in receipt of ,departmental funds4 7d7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general shall submit a report on the study under this section1 in a manner that does not compromise national security1 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,select ,committee on ,intelligence of the ,senate1 and the ,committee on ,energy and ,commerce and the ,permanent ,select ,committee on ,intelligence of the ,house of ,representatives4 ,the report shall be submitted in unclassified form1 to the extent practicable1 but may include a classified annex4 #cbf4 ,report on progress to address undue foreign influence ,not later than #a year after the date of enactment of this ,act and annually thereafter1 the ,secretary of ,health and ,human ,services shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce in the ,house of ,representatives1 in a manner that does not compromise national security1 a report on actions taken by such ,secretary-- 7#a7 to address cases of noncompliance with disclosure requirements or research misconduct related to foreign influence1 including-- 7,a7 the number of potential noncompliance cases investigated by the ,national ,institutes of ,health or reported to the ,national ,institutes of ,health by a research institution1 including relating to undisclosed research support1 undisclosed conflicts of interest or other conflicts of commitment1 and peer review violations2 7,b7 the number of cases referred to the ,office of ,inspector ,general of the ,department of ,health and ,human ,services1 the ,office of ,national ,security of the ,department of ,health and ,human ,services1 the ,federal ,bureau of ,investigation1 or other law enforcement agencies2 7,c7 a description of enforcement actions taken for noncompliance related to undue foreign influence2 and 7,d7 any other relevant information2 and 7#b7 to prevent1 address1 and mitigate instances of noncompliance with disclosure requirements or research misconduct related to foreign influence4 ,,iv ,modernizing and strengthening the supply chain for vital medical products #dja4 ,warm base manufacturing capacity for medical countermeasures 7a7 ,in general ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7a77#f77;,b7-- 7,a7 by redesignating clauses 7iv7 and 7v7 as clauses 7v7 and 7vi71 respectively2 7,b7 by inserting after clause 7iii71 the following3 7iv7 activities to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 as appropriate1 including through the utilization of advanced manufacturing and platform technologies1 to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products2 2 and 7,c7 in clause 7vi7 7as so redesignated71 by inserting manufacturing1 after improvement12 7#b7 in subsection 7b7-- 7,a7 in the first sentence of paragraph 7#a71 by inserting support for domestic manufacturing surge capacity and capabilities1 after initiatives for innovation12 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7iii7 by inserting after subparagraph 7,b71 the following3 7,c7 activities to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 as appropriate1 including through the utilization of advanced manufacturing and platform technologies1 to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products2 and 2 7#c7 in subsection 7c7-- 7,a7 in paragraph 7#b77;,b71 by inserting before the semicolon 1 including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities1 consistent with subsection 7a77#f77;,b77iv72 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,a7-- 7,i7 in clause 7i7-- 7aa7 in subclause 7,i71 by striking and at the end2 and 7bb7 by adding at the end the following3 7,,iii7 facilitating such communication1 as appropriate1 regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for1 or respond to1 a public health emergency or potential public health emergency2 and 7,,iv7 facilitating such communication1 as appropriate and in a manner that does not compromise national security1 with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section #efe;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 2 7,,ii7 in clause 7ii77,,iii71 by striking and at the end2 7,,iii7 by redesignating clause 7iii7 as clause 7iv72 and 7,,iv7 by inserting after clause 7ii71 the following3 7iii7 communicate regularly with entities in receipt of an award pursuant to subparagraph 7,b77v71 and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph 7,b77iv71 as appropriate1 for purposes of planning and response regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities1 including any planned uses of such capacity and capabilities in the near- and mid-term1 and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities2 and 2 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7iii71 by striking and at the end2 7,,ii7 in clause 7iv71 by striking the period and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7v7 award contracts1 grants1 and cooperative agreements and enter into other transactions to support1 maintain1 and improve domestic manufacturing surge capacity and capabilities1 including through supporting flexible or advanced manufacturing1 to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency4 2 7iii7 in subparagraph 7,c7-- 7,i7 in clause 7i71 by striking and at the end2 7,,ii7 in clause 7ii71 by striking the period at the end and inserting 2 and2 and 7,,iii7 by adding at the end the following3 7iii7 consult with the ,commissioner of ,food and ,drugs1 pursuant to section #efe7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 to ensure that facilities performing manufacturing1 pursuant to an award under subparagraph 7,b77v71 are in compliance with applicable requirements under such ,act and this ,act1 as appropriate1 including current good manufacturing practice pursuant to section #eja7;a77#b77;,b7 of the ,food1 ,drug1 and ,cosmetic ,act2 and 2 7iv7 in subparagraph 7,d77i71 by inserting 1 including to improve manufacturing capacities and capabilities for medical countermeasures before the semicolon2 7v7 in subparagraph 7,e77ix71 by striking #bjbc and inserting #bjbh2 and 7vi7 by adding at the end the following3 7,g7 ,annual reports by award recipients ,as a condition of receiving an award under subparagraph 7,b77v71 a recipient shall develop and submit to the ,secretary annual reports related to the maintenance of such capacity and capabilities1 including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the ,secretary4 2 and 7,c7 in paragraph 7#e71 by adding at the end the following3 7,h7 ,supporting warm-base and surge capacity and capabilities ,pursuant to an award under subparagraph 7,b77v71 the ,secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the ,secretary to prepare for1 or respond to1 an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security4 ,the ,secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development1 as appropriate1 to provide for the maintenance of such capacity and capabilities4 2 and 7#d7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking ,not later than #ahj days after the date of enactment of this subsection and inserting ,not later than #ahj days after the date of enactment of the ,,prevent ,pandemics ,act2 7,b7 in paragraph 7#b7-- 7i7 in the matter preceding subparagraph 7,a71 by striking this subsection and inserting the ,,prevent ,pandemics ,act2 7ii7 in subparagraph 7,b71 by striking and at the end2 and 7iii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7,d7 plans for the near-1 mid-1 and long-term sustainment of manufacturing activities carried out under this section1 including such activities pursuant to subsection 7c77#e77;,h71 specific actions to regularly assess the ability of recipients of an award under subsection 7c77#d77;,b77v7 to rapidly manufacture countermeasures as required by the ,secretary1 and recommendations to address challenges1 if any1 related to such activities4 4 #djb4 ,supply chain considerations for the ,strategic ,national ,stockpile ,subclause 7,,ii7 of section #cai;,f-#b7;a77#b77;,b77i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#b77;,b77i77 is amended to read as follows3 7,,ii7 planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications 7without disclosing proprietary information71 including-- 7aa7 consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies on the health care system2 and 7bb7 an assessment of the current supply chain for such products1 including information on supply chain redundancies1 any known domestic manufacturing capacity for such products1 and any related vulnerabilities2 4 #djc4 ,strategic ,national ,stockpile equipment maintenance ,subparagraph 7,d7 of section #cai;,f-#b7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is amended to read as follows3 7,d7 review and revise1 as appropriate1 the contents of the stockpile on a regular basis to ensure that-- 7i7 emerging threats1 advanced technologies1 and new countermeasures are adequately considered2 7ii7 the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed1 including through necessary replenishment2 and 7iii7 such contents are in working condition or usable1 as applicable1 and are ready for deployment1 which may include conducting maintenance services on such contents of the stockpile and disposing of such contents that are no longer in working condition1 or usable1 as applicable2 4 #djd4 ,improving transparency and predictability of processes of the ,strategic ,national ,stockpile 7a7 ,guidance ,not later than #fj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue guidance describing the processes by which the ,secretary deploys the contents of the ,strategic ,national ,stockpile under section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 or otherwise distributes medical countermeasures1 as applicable1 to ,states1 territories1 ,indian ,tribes and ,tribal organizations 7as such terms are defined under section #d of the ,indian ,self-,determination and ,education ,assistance ,act71 and other applicable entities4 ,such guidance shall include information related to processes by which to request access to the contents of the ,strategic ,national ,stockpile1 factors considered by the ,secretary when making deployment or distribution decisions1 and processes and points of contact through which entities may contact the ,secretary to address any issues related to products requested or received by such entity from the stockpile1 and on other relevant topics4 7b7 ,annual meetings ,section #cai;,f-#b7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is amended-- 7#a7 in subparagraph 7,i71 by striking and at the end2 7#b7 in subparagraph 7,j71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,k7 convene meetings1 not less than once per year1 with representatives from ,state1 local1 and ,tribal health departments or officials1 relevant industries1 other ,federal agencies1 and other appropriate stakeholders1 in a manner that does not compromise national security1 to coordinate and share information related to maintenance and use of the stockpile1 including a description of future countermeasure needs and additions1 modifications1 and replenishments of the contents of the stockpile1 and considerations related to the manufacturing and procurement of products consistent with the requirements of the ,buy ,american ,act of #aicc1 as appropriate4 4 #dje4 ,improving supply chain flexibility for the ,strategic ,national ,stockpile 7a7 ,in general ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c77;,f71 by striking as required by the ,secretary of ,homeland ,security and inserting at the discretion of the ,secretary1 in consultation with1 or at the request of1 the ,secretary of ,homeland ,security12 7,b7 by redesignating paragraphs 7#e7 and 7#f7 as paragraphs 7#f7 and 7#g71 respectively2 7,c7 by inserting after paragraph 7#d7 the following3 7#e7 ,vendor-managed inventory and warm-base surge capacity 7,a7 ,in general ,for the purposes of maintaining the stockpile under paragraph 7#a7 and carrying out procedures under paragraph 7#c71 the ,secretary may enter into contracts or cooperative agreements with vendors1 which may include manufacturers or distributors of medical products1 with respect to medical products intended to be delivered to the ownership of the ,federal ,government4 ,each such contract or cooperative agreement shall be subject to such terms and conditions as the ,secretary may specify1 including terms and conditions with respect to-- 7i7 procurement1 maintenance1 storage1 and delivery of reserve amounts of products under such contract or cooperative agreement1 which may consider1 as appropriate1 costs of transporting and handling such products2 and 7ii7 maintenance of domestic manufacturing capacity and capabilities of such products to ensure additional reserved production capacity and capabilities are available1 and that such capacity and capabilities are able to support the rapid manufacture1 purchase1 storage1 and delivery of such products1 as required by the ,secretary to prepare for1 or respond to1 an existing or potential public health emergency4 7,b7 ,report ,not later than #b years after the date of enactment of the ,,prevent ,pandemics ,act1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on any contracts or cooperative agreements entered into under subparagraph 7,a7 for purposes of establishing and maintaining vendor-managed inventory or reserve manufacturing capacity and capabilities for products intended for the stockpile1 including a description of-- 7i7 the amount of each award2 7ii7 the recipient of each award2 7iii7 the product or products covered through each award2 and 7iv7 how the ,secretary works with each recipient to ensure situational awareness related to the manufacturing capacity for1 or inventory of1 such products and coordinates the distribution and deployment of such products1 as appropriate and applicable4 2 and 7,d7 in subparagraph 7,a7 of paragraph 7#f71 as so redesignated-- 7i7 in clause 7viii71 by striking 2 and and inserting a semicolon2 7ii7 in clause 7ix71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7x7 with respect to reports issued in #bjbg or any subsequent year1 an assessment of selected contracts or cooperative agreements entered into pursuant to paragraph 7#e74 2 and 7#b7 in subsection 7c77#b77;,c71 by striking on an annual basis and inserting not later than ,march #ae of each year4 7b7 ,authorization of appropriations ,section #cai;,f-#b7;f77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is amended by striking #faj1jjj1jjj for each of fiscal years #bjai through #bjbc and inserting #faj1jjj1jjj for each of fiscal year #bjai through #bjba1 and #gej1jjj1jjj for each of fiscal years #bjbb and #bjbc4 #djf4 ,reimbursement for certain supplies ,paragraph 7#g7 of section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 as so redesignated by section #dje7;a77#a77;,b71 is amended to read as follows3 7#g7 ,reimbursement for certain supplies 7,a7 ,in general ,the ,secretary may1 at appropriate intervals1 make available for purchase excess contents procured for1 and maintained within1 the stockpile under paragraph 7#a7 to any ,federal agency or ,state1 local1 or ,tribal government4 ,the ,secretary shall make such contents available for purchase only if-- 7i7 such contents are in excess of what is required for appropriate maintenance of such stockpile2 7ii7 the ,secretary determines that the costs for maintaining such excess contents are not appropriate to expend to meet the needs of the stockpile2 and 7iii7 the ,secretary determines that such action does not compromise national security and is in the national interest4 7,b7 ,reimbursement and collection ,the ,secretary may require reimbursement for contents that are made available under subparagraph 7,a71 in an amount that reflects the cost of acquiring and maintaining such contents and the costs incurred to make available such contents in the time and manner specified by the ,secretary4 ,amounts collected under this subsection shall be credited to the appropriations account or fund that incurred the costs to procure such contents1 and shall remain available1 without further appropriation1 until expended1 for the purposes of the appropriation account or fund so credited4 7,c7 ,rule of construction ,this paragraph shall not be construed to preclude transfers of contents in the stockpile under other authorities4 7,d7 ,report ,not later than #b years after the date of enactment of the ,,prevent ,pandemics ,act1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives a report on the use of the authority provided under this paragraph1 including details of each action taken pursuant to this paragraph1 the account or fund to which any collected amounts have been credited1 and how the ,secretary has used such amounts4 7,e7 ,sunset ,the authority under this paragraph shall terminate on ,september #cj1 #bjbe4 4 #djg4 ,action reporting on stockpile depletion ,section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d71 as amended by section #bbc1 is further amended by adding at the end the following3 7h7 ,stockpile depletion reporting ,the ,secretary shall1 not later than #cj days after the deployment of contents of the ,strategic ,national ,stockpile under section #cai;,f-#b7;a7 to respond to a public health emergency declared by the ,secretary under this section or an emergency or major disaster declared by the ,president under the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act1 and every #cj days thereafter until the expiration or termination of such public health emergency1 emergency1 or major disaster1 submit a report 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-- 7#a7 the deployment of the contents of the stockpile in response to ,state1 local1 and ,tribal requests2 7#b7 the amount of such products that remain within the stockpile following such deployment2 and 7#c7 plans to replenish such products1 as appropriate1 including related timeframes and any barriers or limitations to replenishment4 4 #djh4 ,provision of medical countermeasures to ,indian programs and facilities 7a7 ,clarification ,section #cai;,f-#b7;a77#c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a77#c77 is amended-- 7#a7 in subparagraph 7,c71 by striking and local and inserting local1 and ,tribal2 and 7#b7 in subparagraph 7 ,j71 by striking and local and inserting local1 and ,tribal4 7b7 ,distribution of medical countermeasures to ,indian ,tribes ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cai;,f-#d the following3 #cai;,f-#e4 ,provision of medical countermeasures to ,indian programs and facilities ,in the event that the ,secretary deploys the contents of the ,strategic ,national ,stockpile under section #cai;,f-#b7;a71 or otherwise distributes medical countermeasures to ,states to respond to a public health emergency declared by the ,secretary under section #cai1 the ,secretary shall1 in consultation with the applicable ,states1 make such contents or countermeasures directly available to ,indian ,tribes and ,tribal organizations 7as such terms are defined in section #d of the ,indian ,self-,determination and ,education ,assistance ,act 7#be ,u4,s4,c4 #ecjd71 which may include through health programs or facilities operated by the ,indian ,health ,service1 that are affected by such public health emergency4 4 #dji4 ,grants for ,state strategic stockpiles 7a7 ,section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended by adding at the end the following3 7i7 ,pilot program ,to support ,state medical stockpiles 7#a7 ,in general ,the ,secretary1 in consultation with the ,assistant ,secretary for ,preparedness and ,response and the ,director of the ,centers for ,disease ,control and ,prevention1 shall award grants or cooperative agreements to not fewer than #e ,states1 or consortia of ,states1 with consideration given to distribution among the geographical regions of the ,united ,states1 to establish1 expand1 or maintain a stockpile of appropriate drugs1 vaccines and other biological products1 medical devices1 and other medical supplies determined by the ,state to be necessary to respond to a public health emergency declared by the ,governor of a ,state or by the ,secretary under section #cai1 or a major disaster or emergency declared by the ,president under section #dja or #eja1 respectively1 of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act1 in order to support the preparedness goals described in paragraphs 7#b7 through 7#f7 and 7#h7 of section #bhjb7;b74 7#b7 ,requirements 7,a7 ,application ,to be eligible to receive an award under paragraph 7#a71 an entity shall prepare1 in consultation with appropriate health care entities and health officials within the jurisdiction of such ,state or ,states1 and submit to the ,secretary an application that contains such information as the ,secretary may require1 including-- 7i7 a plan for such stockpile1 consistent with paragraph 7#d71 including a description of the activities such entity will carry out under the agreement and an outline of proposed expenses2 and 7ii7 a description of how such entity will coordinate with relevant entities in receipt of an award under section #cai;,c-#a or #cai;,c-#b pursuant to paragraph 7#d71 including through promoting alignment between the stockpile plan established pursuant to clause 7i7 and applicable plans that are established by such entity pursuant to section #cai;,c-#a or #cai;,c-#b4 7,b7 ,matching funds 7i7 ,subject to clause 7ii71 the ,secretary may not make an award under this subsection unless the applicant agrees1 with respect to the costs to be incurred by the applicant in carrying out the purpose described in this subsection1 to make available non-,federal contributions toward such costs in an amount equal to-- 7,i7 for each of fiscal years #bjbc and #bjbd1 not less than #a for each #bj of ,federal funds provided in the award2 and 7,,ii7 for fiscal year #bjbe and each fiscal year thereafter1 not less than #a for each #aj of ,federal funds provided in the award4 7ii7 ,waiver ,the ,secretary may1 upon the request of a ,state1 waive the requirement under clause 7i71 in whole or in part1 if the ,secretary determines that extraordinary economic conditions in the ,state in the fiscal year involved or in the previous fiscal year justify the waiver4 ,a waiver provided by the ,secretary under this subparagraph shall apply only to the fiscal year involved4 7,c7 ,administrative expenses ,not more than #aj percent of amounts received by an entity pursuant to an award under this subsection may be used for administrative expenses4 7#c7 ,lead entity ,an entity in receipt of an award under paragraph 7#a7 may designate a lead entity1 which may be a public or private entity1 as appropriate1 to manage the stockpile at the direction of the ,state or consortium of ,states4 7#d7 ,use of funds ,an entity in receipt of an award under paragraph 7#a7 shall use such funds to-- 7,a7 purchase1 store1 and maintain a stockpile of appropriate drugs1 vaccines and other biological products1 medical devices1 and other medical supplies to be used during a public health emergency1 major disaster1 or emergency described in paragraph 7#a71 in such numbers1 types1 and amounts as the entity determines necessary1 consistent with such entity's stockpile plan established pursuant to paragraph 7#b77;,a77i72 7,b7 deploy the stockpile as required by the entity to respond to an actual or potential public health emergency1 major disaster1 or other emergency described in paragraph 7#a72 7,c7 replenish and make necessary additions or modifications to the contents of such stockpile1 including to address potential depletion2 7,d7 in consultation with ,federal1 ,state1 and local officials1 take into consideration the availability1 deployment1 dispensing1 and administration requirements of medical products within the stockpile2 7,e7 ensure that procedures are followed for inventory management and accounting1 and for the physical security of the stockpile1 as appropriate2 7,f7 review and revise1 as appropriate1 the contents of the stockpile on a regular basis to ensure that1 to the extent practicable1 new technologies and medical products are considered2 7,g7 carry out exercises1 drills1 and other training for purposes of stockpile deployment1 dispensing1 and administration of medical products1 and for purposes of assessing the capability of such stockpile to address the medical supply needs of public health emergencies1 major disasters1 or other emergencies described in paragraph 7#a7 of varying types and scales1 which may be conducted in accordance with requirements related to exercises1 drills1 and other training for recipients of awards under section #cai;,c-#a or #cai;,c-#b1 as applicable2 and 7,h7 carry out other activities related to the ,state strategic stockpile as the entity determines appropriate1 to support ,state efforts to prepare for1 and respond to1 public health threats4 7#e7 ,supplement not supplant ,awards under paragraph 7#a7 shall supplement1 not supplant1 the maintenance and use of the ,strategic ,national ,stockpile by the ,secretary under subsection 7a74 7#f7 ,guidance for ,states ,not later than #ahj days after the date of enactment of this subsection1 the ,secretary1 in consultation with ,states1 health officials1 and other relevant stakeholders1 as appropriate1 shall issue guidance1 and update such guidance as appropriate1 for ,states related to maintaining and replenishing a stockpile of medical products1 which may include strategies and best practices related to-- 7,a7 types of medical products and medical supplies that are critical to respond to public health emergencies1 and may be appropriate for inclusion in a stockpile by ,states1 with consideration of threats that require the large-scale and simultaneous deployment of stockpiles1 including the stockpile maintained by the ,secretary pursuant to subsection 7a71 and long-term public health and medical response needs2 7,b7 appropriate management of the contents of a stockpile1 including management by vendors of reserve amounts of medical products and supplies intended to be delivered to the ownership of the ,state and appropriate disposition of excess products1 as applicable2 and 7,c7 the procurement of medical products and medical supplies consistent with the ,buy ,american ,act of #aicc4 7#g7 ,technical assistance ,the ,secretary shall provide assistance to ,states1 including technical assistance1 as appropriate1 in establishing1 maintaining1 improving1 and utilizing a medical stockpile1 including appropriate inventory management and disposition of products4 7#h7 ,reporting 7,a7 ,state reports ,each entity receiving an award under paragraph 7#a7 shall update1 as appropriate1 the plan established pursuant to paragraph 7#b77;,a77i7 and submit to the ,secretary an annual report on implementation of such plan1 including any changes to the contents of the stockpile supported under such award4 ,the ,secretary shall use information obtained from such reports to inform the maintenance and management of the ,strategic ,national ,stockpile pursuant to subsection 7a74 7,b7 ,reports to congress ,not later than #a year after the initial issuance of awards pursuant to paragraph 7#a71 and annually thereafter for the duration of the program established under this subsection1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on such program1 including-- 7i7 ,federal and ,state expenditures to support stockpiles under such program2 7ii7 activities conducted pursuant to paragraph 7#d72 and 7iii7 any additional information from the ,states that the ,secretary determines relevant4 7#i7 ,authorization of appropriations ,to carry out this subsection1 there is authorized to be appropriated such sums as may be necessary for each of fiscal years #bjbc through #bjbh4 4 7b7 ,,gao report ,not later than #c years after the date on which awards are first issued pursuant to subsection 7i77#a7 of section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b71 as added by subsection 7a71 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 on the ,state stockpiles established or maintained pursuant to this section4 ,such report shall include an assessment of-- 7#a7 coordination and communication between the ,secretary of ,health and ,human ,services and entities in receipt of an award under this section1 or a lead entity designated by such entity2 7#b7 technical assistance provided by the ,secretary of ,health and ,human ,services to such entities2 and 7#c7 the impact of such stockpiles on the ability of the ,state to prepare for and respond to a public health emergency1 major disaster1 or other emergency described in subsection 7i77#a7 of section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b71 as added by subsection 7a71 including the availability and distribution of items from such ,state stockpile to health care entities and other applicable entities4 ,v ,enhancing development and combating shortages of medical products ,a ,development and review #eja4 ,advancing qualified infectious disease product innovation 7a7 ,in general ,section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#b71 by striking 2 or and inserting 22 7,b7 in paragraph 7#c71 by striking the period and inserting 2 or2 and 7,c7 by adding at the end the following3 7#d7 an application pursuant to section #cea7;a7 of the ,public ,health ,service ,act4 2 7#b7 in subsection 7d77#a71 by inserting of this ,act or section #cea7;a7 of the ,public ,health ,service ,act after section #eje7;b72 and 7#c7 by amending subsection 7g7 to read as follows3 7g7 ,qualified infectious disease product ,the term qualified infectious disease product means a drug1 including an antibacterial or antifungal drug or a biological product1 for human use that-- 7#a7 acts directly on bacteria or fungi or on substances produced by such bacteria or fungi2 and 7#b7 is intended to treat a serious or life-threatening infection1 including such an infection caused by-- 7,a7 an antibacterial or antifungal resistant pathogen1 including novel or emerging infectious pathogens2 or 7,b7 qualifying pathogens listed by the ,secretary under subsection 7f74 4 7b7 ,priority review ,section #ebd;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is amended by inserting of this ,act1 or section #cea7;a7 of the ,public ,health ,service ,act1 that requires clinical data 7other than bioavailability studies7 to demonstrate safety or effectiveness before the period4 #ejb4 ,modernizing clinical trials 7a7 ,clarifying the use of ,digital ,health ,technologies in ,clinical ,trials 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue or revise draft guidance regarding the appropriate use of validated digital health technologies in clinical trials to help improve recruitment for1 retention in1 participation in1 and data collection during1 clinical trials1 and provide for novel clinical trial designs utilizing such technology for purposes of supporting the development of1 and review of applications for1 drugs and devices4 ,not later than #ah months after the public comment period on such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7#b7 ,content ,the guidance described in paragraph 7#a7 shall include-- 7,a7 recommendations for data collection methodologies by which sponsors may incorporate the use of digital health technologies in clinical trials to collect data remotely from trial participants2 7,b7 considerations for privacy and security protections for data collected during a clinical trial1 including-- 7i7 recommendations for the protection of trial participant data that is collected or used in research1 using digital health technologies2 7ii7 compliance with the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note71 subpart ,b of part #ej of title #ba1 ,code of ,federal ,regulations1 subpart ,c of part #ef of title #ba1 ,code of ,federal ,regulations1 the ,federal policy for the protection of human subjects under subpart ,a of part #df of title #de1 ,code of ,federal ,regulations 7commonly known as the ,common ,rule71 and part #b of title #db1 ,code of ,federal ,regulations 7or any successor regulations72 and 7iii7 recommendations for protection of clinical trial participant data against cybersecurity threats1 as applicable2 7,c7 considerations on data collection methods to help increase recruitment of clinical trial participants and the level of participation of such participants1 reduce burden on clinical trial participants1 and optimize data quality2 7,d7 recommendations for the use of electronic methods to obtain informed consent from clinical trial participants1 taking into consideration applicable ,federal law1 including subpart ,b of part #ej of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 and1 as appropriate1 ,state law2 7,e7 best practices for communication and early engagement between sponsors and the ,secretary on the development of data collection methods2 7,f7 the appropriate format to submit such data to the ,secretary2 7,g7 a description of the manner in which the ,secretary may assess or evaluate data collected through digital health technologies to support the development of the drug or device2 7,h7 recommendations regarding the data and information needed to demonstrate that a digital health technology is fit-for-purpose for a clinical trial1 and a description of how the ,secretary will evaluate such data and information2 and 7,i7 recommendations for increasing access to1 and the use of1 digital health technologies in clinical trials to facilitate the inclusion of diverse and underrepresented populations1 as appropriate1 including considerations for access to1 and the use of1 digital health technologies in clinical trials by people with disabilities and pediatric populations4 7b7 ,advancing decentralized clinical trials 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue or revise draft guidance to provide recommendations to clarify and advance the use of decentralized clinical trials to support the development of drugs and devices and help improve trial participant engagement and advance the use of flexible and novel clinical trial designs4 ,not later than #ah months after the public comment period on such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7#b7 ,content ,the guidance described in paragraph 7#a7 shall include-- 7,a7 recommendations for methods of remote data collection1 including trial participant experience data1 though the use of digital health technologies1 telemedicine1 local laboratories1 local health care providers1 or other options for data collection2 7,b7 considerations for sponsors to minimize or reduce burdens for clinical trial participants associated with participating in a clinical trial1 such as the use of digital technologies1 telemedicine1 local laboratories1 local health care providers1 or other data collection or assessment options1 health care provider home visits1 direct-to-participant shipping of investigational drugs and devices1 and electronic informed consent1 as appropriate2 7,c7 recommendations regarding conducting decentralized clinical trials to facilitate and encourage diversity among the clinical trial participants1 as appropriate2 7,d7 recommendations for strategies and methods for recruiting1 retaining1 and engaging with clinical trial participants1 including communication regarding the role of trial participants and community partners to facilitate clinical trial recruitment and engagement1 including with respect to diverse and underrepresented populations1 as appropriate2 7,e7 considerations for review and oversight by sponsors and institutional review boards1 including remote trial oversight2 7,f7 recommendations for decentralized clinical trial protocol designs and processes for evaluating such proposed trial designs2 7,g7 recommendations for digital health technology and other remote assessment tools that may support decentralized clinical trials1 including guidance on appropriate technological platforms and tools1 data collection and use1 data integrity1 and communication to clinical trial participants through such technology2 7,h7 a description of the manner in which the ,secretary will assess or evaluate data collected within a decentralized clinical trial to support the development of the drug or device1 if the manner is different from that used for a non-decentralized trial2 7,i7 considerations for sponsors to validate digital technologies and establish appropriate clinical endpoints for use in decentralized trials2 7,j7 considerations for privacy and security of personally identifiable information of trial participants2 and 7,k7 considerations for conducting clinical trials using centralized approaches in conjunction with decentralized approaches4 7c7 ,seamless and concurrent clinical trials 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue or revise draft guidance on the use of seamless1 concurrent1 and other innovative clinical trial designs to support the expedited development and review of applications for drugs1 as appropriate4 ,not later than #ah months after the public comment period on such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7#b7 ,content ,the guidance described in paragraph 7#a7 shall include-- 7,a7 recommendations on the use of expansion cohorts and other seamless clinical trial designs to assess different aspects of product candidates in one continuous trial1 including how such clinical trial designs can be used as part of meeting the substantial evidence standard under section #eje7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;d772 7,b7 recommendations on the use of clinical trial designs that involve the concurrent conduct of different or multiple clinical trial phases1 and the concurrent conduct of preclinical testing1 to expedite the development of new drugs and facilitate the timely collection of data2 7,c7 recommendations for how to streamline trial logistics and facilitate the efficient collection and analysis of clinical trial data1 including any planned interim analyses and how such analyses could be used to streamline the product development and review processes2 7,d7 considerations to assist sponsors in ensuring the rights1 safety1 and welfare of clinical trial participants1 maintaining compliance with good clinical practice regulations1 minimizing risks to clinical trial data integrity1 and ensuring the reliability of clinical trial results2 7,e7 recommendations for communication and early engagement between sponsors and the ,food and ,drug ,administration on the development of seamless1 concurrent1 or other adaptive trial designs1 including review of1 and feedback on1 clinical trial protocols2 and 7,f7 a description of the manner in which the ,secretary will assess or evaluate data collected through seamless1 concurrent1 or other adaptive trial designs to support the development of the drug4 7d7 ,international harmonization ,the ,secretary shall work with foreign regulators pursuant to memoranda of understanding or other arrangements governing the exchange of information to facilitate international harmonization of the regulation and use of decentralized clinical trials1 digital technology in clinical trials1 and seamless1 concurrent1 and other adaptive or innovative clinical trial designs4 #ejc4 ,accelerating countermeasure development and review ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 is amended by adding at the end the following3 7h7 ,accelerating countermeasure development and review during an emergency 7#a7 ,acceleration of countermeasure development and review ,the ,secretary may1 at the request of the sponsor of a countermeasure1 during a domestic1 military1 or public health emergency or material threat described in section #efd;,a7a77#a77;,c71 expedite the development and review of countermeasures that are intended to address such domestic1 military1 or public health emergency or material threat for approval1 licensure1 clearance1 or authorization under this title or section #cea of the ,public ,health ,service ,act4 7#b7 ,actions ,the actions to expedite the development and review of a countermeasure under paragraph 7#a7 may include the following3 7,a7 ,expedited review of submissions made by sponsors of countermeasures to the ,food and ,drug ,administration1 including rolling submissions of countermeasure applications and other submissions4 7,b7 ,expedited and increased engagement with sponsors regarding countermeasure development and manufacturing1 including-- 7i7 holding meetings with the sponsor and the review team and providing timely advice to1 and interactive communication with1 the sponsor regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval1 licensure1 clearance1 or authorization is as efficient as practicable2 7ii7 involving senior managers and experienced review staff1 as appropriate1 in a collaborative1 cross-disciplinary review2 7iii7 assigning a cross-disciplinary project lead for the review team to facilitate2 7iv7 taking steps to ensure that the design of the clinical trials is as efficient as practicable1 when scientifically appropriate1 such as by minimizing the number of patients exposed to a potentially less efficacious treatment2 and 7v7 streamlining the review of approved1 licensed1 cleared1 or authorized countermeasures to treat or prevent new or emerging threats1 including the review of any changes to such countermeasures4 7,c7 ,expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing4 7,d7 ,other steps to expedite the development and review of a countermeasure application submitted for approval1 licensure1 clearance1 or authorization1 as the ,secretary determines appropriate4 7#c7 ,limitation of effect ,nothing in this subsection shall be construed to require the ,secretary to grant1 or take any other action related to1 a request of a sponsor to expedite the development and review of a countermeasure for approval1 licensure1 clearance1 or authorization under paragraph 7#a74 4 #ejd4 ,third party test evaluation during emergencies 7a7 ,in general ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 as amended by section #ejc1 is further amended by adding at the end the following3 7i7 ,third party evaluation of tests used during an emergency 7#a7 ,in general ,for purposes of conducting evaluations regarding whether an in vitro diagnostic product 7as defined in section #hji4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 for which a request for emergency use authorization is submitted under section #efd meets the criteria for issuance of such authorization1 the ,secretary may1 as appropriate1 consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations1 including1 as appropriate1 evaluations and recommendations regarding the scope of authorization and conditions of authorization4 7#b7 ,requirements regarding evaluations and recommendations 7,a7 ,in general ,in evaluating and making recommendations to the ,secretary regarding the validity1 accuracy1 and reliability of in vitro diagnostic products1 as described in paragraph 7#a71 a person shall consider and document whether the relevant criteria under subsection 7c77#b7 of section #efd for issuance of authorization under such section are met with respect to the in vitro diagnostic product4 7,b7 ,written recommendations ,recommendations made by a person under this subsection shall be submitted to the ,secretary in writing1 and shall include the reasons for such recommendation and other information that may be requested by the ,secretary4 7#c7 ,rule of construction ,nothing in this subsection shall be construed to require the ,secretary to consult with1 or enter into cooperative agreements or contracts with1 persons as described in paragraph 7#a7 for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section #efd4 4 7b7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall issue draft guidance on consultations with persons under subsection 7i7 of section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 as added by subsection 7a71 including considerations concerning conflicts of interest1 compensation arrangements1 and information sharing4 ,not later than #a year after the public comment period on such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 #eje4 ,facilitating the use of real world evidence ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue or revise existing guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making1 as follows3 7#a7 ,with respect to drugs1 such guidance shall address the use of such data and evidence to support the approval of a drug application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product application under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 or to support an investigational use exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act4 ,such guidance shall include considerations for the inclusion1 in such applications1 of real world data and real world evidence obtained as a result of the use of drugs authorized for emergency use under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications1 submissions1 or requests1 as appropriate4 7#b7 ,with respect to devices1 such guidance shall address the use of such data and evidence to support the approval1 clearance1 or classification of a device pursuant to an application or submission submitted under section #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f77#b71 #cfj;e71 or to support an investigational use exemption under section #ebj7;g7 of such ,act 7#ba ,u4,s4,c4 #cfj;j7g774 ,such guidance shall include considerations for the inclusion1 in such applications1 submissions1 or requests1 of real world data and real world evidence obtained as a result of the use of devices authorized for emergency use under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 and considerations for standards and methodologies for collection and analysis of real world evidence included in such applications1 submissions1 or requests1 as appropriate4 #ejf4 ,platform technologies 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ejf;,j of such ,act 7#ba ,u4,s4,c4 #cef;j7 the following3 #ejf,k4 ,platform technologies 7a7 ,in general ,the ,secretary shall establish a process for the designation of platform technologies that meet the criteria described in subsection 7b74 7b7 ,criteria ,a platform technology incorporated within or utilized by a drug is eligible for designation as a designated platform technology under this section if-- 7#a7 the platform technology is incorporated in1 or utilized by1 a drug approved under section #eje of this ,act or a biological product licensed under section #cea of the ,public ,health ,service ,act2 7#b7 preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph 7#a71 or a sponsor that has been granted a right of reference to data submitted in the application for such drug1 demonstrates that the platform technology has the potential to be incorporated in1 or utilized by1 more than one drug without an adverse effect on quality1 manufacturing1 or safety2 and 7#c7 data or information submitted by the applicable person under paragraph 7#b7 indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review processes4 7c7 ,request for designation ,a person may request the ,secretary designate a platform technology as a designated platform technology concurrently with1 or at any time after1 submission under section #eje7;i7 of this ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request4 7d7 ,designation 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7c71 the ,secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection 7b74 7#b7 ,designation ,if the ,secretary determines that the platform technology meets the criteria described in subsection 7b71 the ,secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for a drug that uses or incorporates the platform technology pursuant to subsection 7e71 as appropriate4 7#c7 ,determination not to designate ,if the ,secretary determines that the platform technology does not meet the criteria under subsection 7b71 the ,secretary shall include with the determination not to designate the technology a written description of the rationale for such determination4 7#d7 ,revocation of designation ,the ,secretary may revoke a designation made under paragraph 7#b71 if the ,secretary determines that the designated platform technology no longer meets the criteria described in subsection 7b74 ,the ,secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing1 including a description of the rationale for such determination4 7#e7 ,applicability ,nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this ,act or the ,public ,health ,service ,act4 7e7 ,actions ,the ,secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology1 including-- 7#a7 engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology1 including data previously submitted that is relevant to establishing1 as applicable1 safety or efficacy under section #eje7;b7 of this ,act or safety1 purity1 or potency under section #cea7;a7 of the ,public ,health ,service ,act2 7#b7 providing timely advice to1 and interactive communication with1 the sponsor regarding the development of the drug that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable1 which may include holding meetings with the sponsor and the review team throughout the development of the drug2 and 7#c7 considering inspectional findings1 including prior findings1 related to the manufacture of a drug that incorporates or utilizes the designated platform technology4 7f7 ,leveraging data from designated platform technologies ,the ,secretary shall1 consistent with applicable standards for approval1 authorization1 or licensure under this ,act and section #cea7;a7 of the ,public ,health ,service ,act1 allow the sponsor of an application under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act or a request for emergency use authorization under section #efd1 in order to support approval1 licensure1 or authorization1 to reference or rely upon data and information within such application or request that incorporates or utilizes the same or substantially similar platform technology designated under subsection 7d71 provided that-- 7#a7 such data and information was submitted by the same sponsor1 pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection 7d7 was granted2 or 7#b7 the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph 7#a74 7g7 ,changes to a designated platform technology ,a sponsor of one or more applications approved under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for a drug or biological product that incorporates or utilizes the same designated platform technology may submit a single supplemental application for the same proposed changes to the designated platform technology that is applicable to more than one drug or biological product that incorporates or utilizes such designated platform technology that may be cross referenced in other applications incorporating such change4 ,such application may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable application4 7h7 ,guidance ,not later than #a year after the date of enactment of this section1 the ,secretary shall issue draft guidance on the implementation of this section4 ,such guidance shall include examples of drugs that can be manufactured using platform technologies1 including drugs that contain or consist of vectors and nucleic acids1 information about the ,secretary's review of platform technologies1 information regarding submitting for designation1 consideration for persons submitting a request for designation who has been granted a right of reference1 the implementation of the designated platform technology designation program1 efficiencies that may be achieved in the development and review of products that incorporate or utilize designated platform technologies1 and recommendations and requirements for making and reporting manufacturing changes to a designated platform technology in accordance with section #ejf;,a4 7i7 ,definitions ,for purposes of this section3 7#a7 ,the term platform technology means-- 7,a7 a technology incorporated into a drug or biological product1 such as a nucleic acid sequence1 molecular structure1 mechanism of action1 delivery method1 or other technology the ,secretary determines to be appropriate1 or combination of any such technologies1 that-- 7i7 is essential to the characterization of the drug or biological product2 and 7ii7 can be adapted for1 or incorporated or utilized in1 more than one drug or biological product sharing common structural elements2 or 7,b7 a standardized production or manufacturing process that is used to create or develop more than one drug sharing common structural elements that can be incorporated into multiple different drugs4 7#b7 ,the term designated platform technology means a platform technology that is designated as a platform technology under subsection 7d74 7j7 ,rule of construction ,nothing in this section shall be construed to-- 7#a7 alter the authority of the ,secretary to approve drugs pursuant to section #eje of this ,act or license biological products pursuant to section #cea of the ,public ,health ,service ,act1 including standards of evidence and applicable conditions for approval or licensure under the applicable ,act2 or 7#b7 confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing information contained in another application submitted by the holder of an approved application under section #eje7;c7 of this ,act or of a license under section #cea7;a7 of the ,public ,health ,service ,act4 4 7b7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 on the platform technology designation program under section #ejf,k of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 ,such report shall include-- 7#a7 the number of requests for designation under such program2 7#b7 the number of designations under such program issued1 active1 and revoked2 7#c7 the resources required to carry out such program 7including the review time used for full-time equivalent employees72 7#d7 any efficiencies gained in the development1 manufacturing1 and review processes associated with such designations2 and 7#e7 recommendations1 if any1 to strengthen the program to better leverage platform technologies that can be used in more than one drug and meet patient needs in a manner as timely as possible1 taking into consideration the resources available to the ,secretary of ,health and ,human ,services for carrying out such program4 #ejg4 ,increasing ,,eua decision transparency ,section #efd7;h77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7;h77#a77 is amended-- 7#a7 by inserting on the internet website of the ,food and ,drug ,administration and after promptly publish2 and 7#b7 by striking application under section #eje7;i71 #eab7;j71 or #ebj7;g71 even if such summary may indirectly reveal the existence of such application and inserting application1 request1 or submission under this section or section #eje7;b71 #eje7;i71 #eje7;j71 #eab7;b71 #eab7;j71 #eab7n71 #eae1 #eaj7k71 #eac7;f77#b71 #ebj7;g71 #ebj7m71 #ega1 or #egb of this ,act1 or section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act1 even if such summary may reveal the existence of such an application1 request1 or submission1 or data contained in such application1 request1 or submission4 #ejh4 ,improving ,,fda guidance and communication 7a7 ,,fda report and implementation of good guidance practices ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall develop1 and publish on the website of the ,food and ,drug ,administration-- 7#a7 a report identifying best practices for the efficient prioritization1 development1 issuance1 and use of guidance documents1 within centers1 across the ,food and ,drug ,administration1 and across other applicable agencies2 and 7#b7 a plan for implementation of such best practices1 including across other applicable agencies1 which shall address-- 7,a7 streamlining development and review of guidance documents within centers and across the ,food and ,drug ,administration2 7,b7 streamlining processes for regulatory submissions to the ,food and ,drug ,administration1 including through the revision or issuance of guidance documents2 and 7,c7 implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the ,,covid-#ai public health emergency1 as appropriate4 7b7 ,report and implementation of ,,fda best practices for communicating with external stakeholders ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall develop and publish on the website of the ,food and ,drug ,administration a report on the practices of the ,food and ,drug ,administration to broadly communicate with external stakeholders1 other than through guidance documents1 which shall include-- 7#a7 a review of the types and methods of public communication that the ,food and ,drug ,administration uses to communicate and interact with medical product sponsors and other external stakeholders2 7#b7 the identification of best practices for the efficient development1 issuance1 and use of such communications2 and 7#c7 a plan for implementation of best practices for communication with external stakeholders1 which shall address-- 7,a7 advancing the use of innovative forms of communication1 including novel document types and formats1 to provide increased regulatory clarity to product sponsors and other stakeholders1 and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders1 including the use of tools such as product submission templates1 webinars1 and frequently asked questions communications2 7,b7 streamlining processes for regulatory submissions2 and 7,c7 implementing innovative communication development processes and transitioning or updating communication practices used during the ,,covid-#ai public health emergency1 as appropriate4 7c7 ,consultation ,in developing and publishing the report and implementation plan under this section1 the ,secretary shall consult with stakeholders1 including researchers1 academic organizations1 pharmaceutical1 biotechnology1 and medical device developers1 clinical research organizations1 clinical laboratories1 health care providers1 patient groups1 and other appropriate stakeholders4 7d7 ,manner of issuance ,for purposes of carrying out this section1 the ,secretary may update an existing report or plan1 and may combine the reports and implementation plans described in subsections 7a7 and 7b7 into one or more documents4 7e7 ,timing ,the ,secretary shall-- 7#a7 not later than #a year after the date of enactment of this ,act1 publish a draft of the reports and plans required under this section2 and 7#b7 not later than #ahj days after publication of the draft reports and plans under paragraph 7#a7-- 7,a7 publish a final report and plan2 and 7,b7 begin implementation of the best practices pursuant to such final plan4 #eji4 ,,gao study and report on hiring challenges at ,,fda 7a7 ,in general ,not later than #ah months 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 assessing the policies1 practices1 processes1 and programs of the ,food and ,drug ,administration with respect to hiring1 recruiting1 and retention1 and the impact of such policies1 practices1 processes1 and programs on the agency's ability to carry out its public health mission1 including the agency's ability to respond to the ,,covid-#ai public health emergency4 ,such report may involve policies1 practices1 processes1 and programs of the ,department of ,health and ,human ,services and other agencies1 as applicable4 7b7 ,content of report ,the report required under subsection 7a7 shall include an assessment of-- 7#a7 challenges related to the efficient hiring1 recruiting1 professional development1 and retention of the ,food and ,drug ,administration workforce1 including1 as applicable1 the end-to-end hiring process1 time to hire1 multiple hiring authorities1 salary levels1 vacancy rates1 and identification and availability of candidates with necessary expertise2 7#b7 causes of the challenges identified under paragraph 7#a71 including an analysis of relevant policies1 practices1 processes1 programs1 organizational structure1 resources1 training1 remote work capabilities1 and data systems2 7#c7 challenges facing the ,food and ,drug ,administration workforce1 including with respect to workload1 diversity1 employee engagement1 and morale2 7#d7 the impact of challenges identified under paragraphs 7#a7 and 7#c7 on operations of the ,food and ,drug ,administration1 including on meeting user fee agreement performance goals and inspection activities2 7#e7 any hiring or retention plans of the ,food and ,drug ,administration1 and progress towards implementation and the metrics to measure success of such plans2 7#f7 successful or efficient hiring policies or authorities1 including any relevant hiring authorities that resulted in efficient hiring for vacant positions1 such as temporary direct hiring authorities during the ,,covid-#ai public health emergency response2 7#g7 whether policies1 practices1 processes1 and programs related to hiring1 recruiting1 professional development1 and retention are implemented consistently across the ,food and ,drug ,administration2 7#h7 recommendations to address challenges identified1 including recommendations regarding improvements to policies1 practices1 processes1 and programs of the ,food and ,drug ,administration with respect to hiring1 recruiting1 professional development1 and retention2 and 7#i7 challenges related to hiring1 recruiting1 and retaining a qualified workforce to meet public health emergency response needs1 including any such challenges identified during the ,,covid-#ai public health emergency4 ,b ,mitigating shortages #eaa4 ,ensuring registration of foreign drug and device manufacturers 7a7 ,registration of certain foreign establishments ,section #eaj7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i77 is amended by adding at the end the following3 7#e7 ,the requirements of paragraphs 7#a7 and 7#b7 shall apply regardless of whether the drug or device undergoes further manufacture1 preparation1 propagation1 compounding1 or processing at a separate establishment outside the ,united ,states prior to being imported or offered for import into the ,united ,states4 4 7b7 ,updating regulations ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall update regulations1 as appropriate1 to implement the amendment made by subsection 7a74 #eab4 ,extending expiration dates for certain drugs 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue draft guidance1 or revise existing guidance1 to address recommendations for sponsors of applications submitted under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 regarding-- 7#a7 the submission of stability testing data in such applications1 including considerations for data requirements that could be streamlined or reduced to facilitate faster review of longer proposed expiration dates2 7#b7 establishing in the labeling of drugs the longest feasible expiration date scientifically supported by such data1 taking into consideration how extended expiration dates may-- 7,a7 help prevent or mitigate drug shortages2 and 7,b7 affect product quality2 and 7#c7 the use of innovative approaches for drug and combination product stability modeling to support initial product expiration dates and expiration date extensions4 7b7 ,report ,not later than #b years after the date of enactment of this ,act1 and again #b years thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes-- 7#a7 the number of drugs for which the ,secretary has requested the manufacturer make a labeling change regarding the expiration date2 and 7#b7 for each drug for which the ,secretary has requested a labeling change with respect to the expiration date1 information regarding the circumstances of such request1 including-- 7,a7 the name and dose of such drug2 7,b7 the rationale for the request2 7,c7 whether the drug1 at the time of the request1 was listed on the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 or was at risk of shortage2 7,d7 whether the request was made during a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d72 and 7,e7 whether the manufacturer made the requested change by the requested date1 and for instances where the manufacturer does not make the requested change1 the manufacturer's justification for not making the change1 if the manufacturer agrees to provide such justification for inclusion in the report4 #eac4 ,unannounced foreign facility inspections pilot program 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conduct a pilot program under which the ,secretary increases the conduct of unannounced inspections of foreign human drug facilities and evaluates the differences between inspections of domestic and foreign human drug facilities1 including the impact of announcing inspections to persons who own or operate foreign human drug facilities in advance of an inspection4 ,such pilot program shall evaluate-- 7#a7 differences in the number and type of violations of section #eja7;a77#b77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7;a77#b77;,b77 identified during unannounced and announced inspections of foreign human drug facilities and any other significant differences between each type of inspection2 7#b7 costs and benefits associated with conducting announced and unannounced inspections of foreign human drug facilities2 7#c7 barriers to conducting unannounced inspections of foreign human drug facilities and any challenges to achieving parity between domestic and foreign human drug facility inspections2 and 7#d7 approaches for mitigating any negative effects of conducting announced inspections of foreign human drug facilities4 7b7 ,pilot program initiation ,the ,secretary shall initiate the pilot program under this section not later than #ahj days after the date of enactment of this ,act4 7c7 ,report ,the ,secretary shall1 not later than #ahj days following the completion of the pilot program1 make available on the website of the ,food and ,drug ,administration a final report on the pilot program under this section1 including-- 7#a7 findings and any associated recommendations with respect to the evaluation under subsection 7a71 including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug facilities2 7#b7 findings and any associated recommendations regarding how the ,secretary may achieve parity between domestic and foreign human drug inspections2 and 7#c7 the number of unannounced inspections during the pilot that would not be unannounced under existing practices4 #ead4 ,combating counterfeit devices 7a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7fff7 7#a7 ,forging1 counterfeiting1 simulating1 or falsely representing1 or without proper authority using any mark1 stamp1 tag1 label1 or other identification upon any device or container1 packaging1 or labeling thereof so as to render such device a counterfeit device4 7#b7 ,making1 selling1 disposing of1 or keeping in possession1 control1 or custody1 or concealing any punch1 die1 plate1 stone1 or other thing designed to print1 imprint1 or reproduce the trademark1 trade name1 or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container1 packaging1 or labeling thereof so as to render such device a counterfeit device4 7#c7 ,the doing of any act which causes a device to be a counterfeit device1 or the sale or dispensing1 or the holding for sale or dispensing1 of a counterfeit device4 4 7b7 ,penalties ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended-- 7#a7 in subsection 7b77#h71 by inserting 1 or who violates section #cja7;fff77#c7 by knowingly making1 selling or dispensing1 or holding for sale or dispensing1 a counterfeit device1 after a counterfeit drug2 and 7#b7 in subsection 7c71 by inserting 2 or 7#f7 for having violated section #cja7;fff77#b7 if such person acted in good faith and had no reason to believe that use of the punch1 die1 plate1 stone1 or other thing involved would result in a device being a counterfeit device1 or for having violated section #cja7;fff77#c7 if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the device was a counterfeit device before the period4 7c7 ,seizure ,section #cjd7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7;a77#b77 is amended-- 7#a7 by striking 1 and 7,e7 and inserting 1 7,e72 and 7#b7 by inserting 1 7,f7 ,any device that is a counterfeit device1 7,g7 ,any container1 packaging1 or labeling of a counterfeit device1 and 7,h7 ,any punch1 die1 plate1 stone1 labeling1 container1 or other thing used or designed for use in making a counterfeit device or devices before the period4 #eae4 ,strengthening medical device supply chains 7a7 ,in general ,section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 is amended-- 7#a7 by redesignating subsections 7h7 and 7i7 as subsections 7j7 and 7k71 respectively2 and 7#b7 by inserting after subsection 7g7 the following3 7h7 ,risk management plans ,each manufacturer of a device that is critical to public health1 including devices that are life-supporting1 life-sustaining1 or intended for use in emergency medical care1 shall develop1 maintain1 and1 as appropriate1 implement a redundancy risk management plan that identifies and evaluates risks to the supply of the device1 as applicable1 for each establishment in which such device is manufactured4 ,a risk management plan under this subsection-- 7#a7 may identify and evaluate risks to the supply of more than one device1 or device category1 manufactured at the same establishment2 and 7#b7 shall be subject to inspection and copying by the ,secretary pursuant to section #gjd or at the request of the ,secretary4 4 7b7 ,report ,not later than #b years after the date of enactment of this ,act1 and annually for #d years thereafter1 the ,secretary of ,health and ,human ,services shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the use of information manufacturers submit pursuant to section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j7 and applicable guidance issued with respect to such section4 #eaf4 ,preventing medical device shortages 7a7 ,notifications ,section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j71 as amended by section #eae1 is further amended-- 7#a7 in the flush text at the end of subsection 7a71 by inserting or of any other circumstance that is likely to lead to a meaningful disruption in the supply of the device or a shortage of the device1 and there is no other available device that could reasonably be substituted for that device in the ,united ,states before the period2 7#b7 in subsection 7f71 by inserting or 7i7 after subsection 7a72 and 7#c7 by inserting after subsection 7h71 as added by section #eae1 the following3 7i7 ,additional notifications ,the ,secretary may receive notifications from a manufacturers of a device that is life-supporting1 life-sustaining1 or intended for use in emergency medical care or during surgery1 or any other device the ,secretary determines to be critical to the public health1 pertaining to a permanent discontinuance in the manufacture of the device 7except for any discontinuance as a result of an approved modification of the device7 or an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the ,united ,states1 and the reasons for such discontinuance or interruption4 4 7b7 ,guidance on voluntary notifications of discontinuance or interruption of device manufacture ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue draft guidance to facilitate voluntary notifications under subsection 7i7 of section #ejf;,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;j71 as added by subsection 7a74 ,such guidance shall include a description of circumstances in which a voluntary notification under such subsection 7i7 may be appropriate1 recommended timeframes within which sponsors should submit such a notification1 the process for receiving such notifications1 and actions the ,secretary may take to mitigate or prevent a shortage resulting from a discontinuance or interruption in the manufacture of a device for which such notification is received4 ,the ,secretary shall issue final guidance not later than #a year after the close of the comment period for the draft guidance4 #eag4 ,remote records assessments for medical devices 7a7 ,factory inspection ,section #gjd7;a77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is amended-- 7#a7 in the first sentence1 by inserting or device after processing of a drug2 and 7#b7 in the second sentence1 by striking shall include and all that follows through the period at the end and inserting the following3 8shall include-- 7,a7 a description of the records requested2 and 7,b7 a rationale for requesting such information in advance of1 or in lieu of1 an inspection4 4 7b7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary shall issue draft guidance describing circumstances in which the ,secretary intends to issue requests for records or other information in advance of1 or in lieu of1 an inspection1 processes for responding to such requests electronically or in physical form1 and factors the ,secretary intends to consider in evaluating whether such records are provided within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 accounting for resource and other limitations that may exist1 including for small businesses4 ,the ,secretary shall issue final guidance not later than #a year after the close of the comment period for the draft guidance4 #eah4 ,advanced manufacturing technologies designation pilot program ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 as amended by section #ejf1 is further amended by inserting after section #ejf,k the following3 #ejf,l4 ,advanced manufacturing technologies designation pilot program 7a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection 7b74 7b7 ,designation process ,the ,secretary shall establish a process for the designation under this section of methods of manufacturing drugs1 including biological products1 and active pharmaceutical ingredients of such drugs1 as advanced manufacturing technologies4 ,a method of manufacturing1 or a combination of manufacturing methods1 is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology1 or uses an established technique or technology in a novel way1 that will substantially-- 7#a7 enhance drug quality2 or 7#b7 improve the manufacturing process for a drug and maintain drug quality1 including by-- 7,a7 reducing development time for a drug using the designated manufacturing method2 or 7,b7 increasing or maintaining the supply of-- 7i7 a drug that is life-supporting1 life-sustaining1 or of critical importance to providing health care2 or 7ii7 a drug that is on the drug shortage list under section #ejf;,e4 7c7 ,evaluation and designation of an advanced manufacturing technology 7#a7 ,submission ,a person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the ,secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection 7b7 in a particular context of use4 ,the ,secretary may facilitate the development and review of such data or information by-- 7,a7 providing timely advice to1 and interactive communication with1 such person regarding the development of the method of manufacturing2 and 7,b7 involving senior managers and experienced staff of the ,food and ,drug ,administration1 as appropriate1 in a collaborative1 cross-disciplinary review of the method of manufacturing1 as applicable4 7#b7 ,evaluation and designation ,not later than #ahj calendar days after the receipt of a request under paragraph 7#a71 the ,secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology1 in a particular context of use1 based on the data and information submitted under paragraph 7#a7 and the criteria described in subsection 7b74 7d7 ,review of advanced manufacturing technologies ,if the ,secretary designates a method of manufacturing as an advanced manufacturing technology1 the ,secretary shall-- 7#a7 expedite the development and review of an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including supplemental applications1 for drugs that are manufactured using a designated advanced manufacturing technology2 and 7#b7 allow the holder of an advanced technology designation1 or a person authorized by the advanced manufacturing technology designation holder1 to reference or rely upon1 in an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including a supplemental application1 data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted4 7e7 ,implementation and evaluation of advanced manufacturing technologies pilot 7#a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting1 to be held not later than #ahj days after the date of enactment of this section1 to discuss1 and obtain input and recommendations from relevant stakeholders regarding-- 7,a7 the goals and scope of the pilot program1 and a suitable framework1 procedures1 and requirements for such program2 and 7,b7 ways in which the ,food and ,drug ,administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs4 7#b7 ,pilot program guidance 7,a7 ,in general ,the ,secretary shall-- 7i7 not later than #ahj days after the public meeting under paragraph 7#a71 issue draft guidance regarding the goals and implementation of the pilot program under this section2 and 7ii7 not later than #b years after the date of enactment of this section1 issue final guidance regarding the implementation of such program4 7,b7 ,content ,the guidance described in subparagraph 7,a7 shall address-- 7i7 the process by which a person may request a designation under subsection 7b72 7ii7 the data and information that a person requesting such a designation is required to submit under subsection 7c71 and how the ,secretary intends to evaluate such submissions2 7iii7 the process to expedite the development and review of applications under subsection 7d72 and 7iv7 the criteria described in subsection 7b7 for eligibility for such a designation4 7#c7 ,report ,not later than #c years after the date of enactment of this section and annually thereafter1 the ,secretary shall publish on the website of the ,food and ,drug ,administration and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing a description and evaluation of the pilot program being conducted under this section1 including the types of innovative manufacturing approaches supported under the program4 ,such report shall include the following3 7,a7 ,the number of persons that have requested designations and that have been granted designations4 7,b7 ,the number of methods of manufacturing that have been the subject of designation requests and that have been granted designations4 7,c7 ,the average number of calendar days for completion of evaluations under subsection 7c77#b74 7,d7 ,an analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection 7c77#b74 7,e7 ,the number of applications received under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including supplemental applications1 that have included an advanced manufacturing technology designated under this section1 and the number of such applications approved4 7f7 ,sunset ,the ,secretary-- 7#a7 may not consider any requests for designation submitted under subsection 7c7 after ,october #a1 #bjbi2 and 7#b7 may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection 7d7 prior to such date1 if the ,secretary determines such activities are in the interest of the public health4 4 #eai4 ,technical corrections 7a7 ,technical corrections to the ,,cares ,act ,division ,a of the ,,cares ,act 7,public ,law #aaf-acf7 is amended-- 7#a7 in section #caaa7a71 by striking in paragraph 7#a7 and inserting in the matter preceding paragraph 7#a72 7#b7 in section #caab7;d77#a71 by striking and subparagraphs 7,a7 and 7,b7 and inserting as subparagraphs 7,a7 and 7,b72 and 7#c7 in section #caab7;e71 by striking ,federal ,food1 ,drug1 ,cosmetic ,act and inserting ,federal ,food1 ,drug1 and ,cosmetic ,act4 7b7 ,technical corrections to the ,federal ,food1 ,drug1 and ,cosmetic ,act related to the ,,cares ,act 7#a7 ,section #ejf;,c ,section #ejf;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7a77 is amended1 in the flush text at the end1 by striking the second comma after in the ,united ,states4 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as if included in section #caab of division ,a of the ,,cares ,act 7,public ,law #aaf-acf74 7c7 ,other technical correction to the ,federal food1 drug1 and cosmetic act ,section #eje;,b7f77#f77;,i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7f77#f77;,i77 is amended by striking subsection 7a77#c77;,b7 and inserting subsection 7a77#d77;,c74