,in the ,senate of the ,united ,states1 ,february #bg1 #bjac4 ,amendment3 ,that the bill from the ,house of ,representatives 7,h4,r4 #cjg7 entitled ,an ,act to reauthorize certain programs under the ,public ,health ,service ,act and the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to public health security and all-hazards preparedness and response1 and for other purposes41 do pass with the following ,strike out all after the enacting clause and insert3 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,,title ,i--,strengthening national preparedness and response for public health emergencies ,sec4 #aja4 ,national ,health ,security ,strategy4 ,sec4 #ajb4 ,assistant ,secretary for ,preparedness and ,response4 ,sec4 #ajc4 ,national ,advisory ,committee on ,children and ,disasters4 ,sec4 #ajd4 ,modernization of the ,national ,disaster ,medical ,system4 ,sec4 #aje4 ,continuing the role of the ,department of ,veterans ,affairs4 ,,title ,,ii--,optimizing ,state and local all-hazards preparedness and response ,sec4 #bja4 ,temporary reassignment of ,state and local personnel during a public health emergency4 ,sec4 #bjb4 ,improving ,state and local public health security4 ,sec4 #bjc4 ,hospital preparedness and medical surge capacity4 ,sec4 #bjd4 ,enhancing situational awareness and biosurveillance4 ,sec4 #bje4 ,eliminating duplicative ,project ,bioshield reports4 ,,title ,,iii--,enhancing ,medical ,countermeasure ,review ,sec4 #cja4 ,special protocol assessment4 ,sec4 #cjb4 ,authorization for medical products for use in emergencies4 ,sec4 #cjc4 ,definitions4 ,sec4 #cjd4 ,enhancing medical countermeasure activities4 ,sec4 #cje4 ,regulatory management plans4 ,sec4 #cjf4 ,report4 ,sec4 #cjg4 ,pediatric medical countermeasures4 ,,title ,,iv--,accelerating medical countermeasure advanced research and development ,sec4 #dja4 ,bio,shield4 ,sec4 #djb4 ,biomedical ,advanced ,research and ,development ,authority4 ,sec4 #djc4 ,strategic ,national ,stockpile4 ,sec4 #djd4 ,national ,biodefense ,science ,board4 ,i ,strengthening national preparedness and response for public health emergencies #aja4 ,national ,health ,security ,strategy 7a7 ,in general ,section #bhjb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7 is amended-- 7#a7 in subsection 7a77#a71 by striking #bjji and inserting #bjad2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a77;,a71 by inserting 1 including drills and exercises to ensure medical surge capacity for events without notice after exercises2 and 7,b7 in paragraph 7#c7-- 7i7 in the matter preceding subparagraph 7,a7-- 7,i7 by striking facilities71 and trauma care and inserting and ambulatory care facilities and which may include dental health facilities71 and trauma care1 critical care12 and 7,,ii7 by inserting 7including related availability1 accessibility1 and coordination7 after public health emergencies2 7ii7 in subparagraph 7,a71 by inserting and trauma after medical2 7iii7 in subparagraph 7,b71 by striking ,medical evacuation and fatality management and inserting ,fatality management2 7iv7 by redesignating subparagraphs 7,c71 7,d71 and 7,e7 as subparagraphs 7,d71 7,e71 and 7,f71 respectively2 7v7 by inserting after subparagraph 7,b71 the following the new subparagraph3 7,c7 ,coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need1 taking into account regionalized systems of care4 2 7vi7 in subparagraph 7,e71 as redesignated by clause 7iv71 by inserting 7which may include such dental health assets7 after medical assets2 and 7vii7 by adding at the end the following3 7,g7 ,optimizing a coordinated and flexible approach to the medical surge capacity of hospitals1 other health care facilities1 critical care1 trauma care 7which may include trauma centers71 and emergency medical systems4 2 7,c7 in paragraph 7#d7-- 7i7 in subparagraph 7,a71 by inserting 1 including the unique needs and considerations of individuals with disabilities1 after medical needs of at-risk individuals2 and 7ii7 in subparagraph 7,b71 by inserting the before purpose of this section2 and 7,d7 by adding at the end the following3 7#g7 ,countermeasures 7,a7 ,promoting strategic initiatives to advance countermeasures to diagnose1 mitigate1 prevent1 or treat harm from any biological agent or toxin1 chemical1 radiological1 or nuclear agent or agents1 whether naturally occurring1 unintentional1 or deliberate4 7,b7 ,for purposes of this paragraph1 the term countermeasures has the same meaning as the terms qualified countermeasures under section #cai;,f-#a1 qualified pandemic and epidemic products under section #cai;,f-#c1 and security countermeasures under section #cai;,f-#b4 7#h7 ,medical and public health community resiliency ,strengthening the ability of ,states1 local communities1 and tribal communities to prepare for1 respond to1 and be resilient in the event of public health emergencies1 whether naturally occurring1 unintentional1 or deliberate by-- 7,a7 optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities2 and 7,b7 promoting familiarity with local medical and public health systems4 4 7b7 ,at-,risk individuals ,section #bhad of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#af7 is amended-- 7#a7 by striking paragraphs 7#e71 7#g71 and 7#h72 7#b7 in paragraph 7#d71 by striking #bhaa7;b77#c77;,b7 and inserting #bhjb7;b77#d77;,b72 7#c7 by redesignating paragraphs 7#a7 through 7#d7 as paragraphs 7#b7 through 7#e71 respectively2 7#d7 by inserting before paragraph 7#b7 7as so redesignated71 the following3 7#a7 monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency declared by the ,secretary under section #cai2 2 7#e7 by amending paragraph 7#b7 7as so redesignated7 to read as follows3 7#b7 oversee the implementation of the preparedness goals described in section #bhjb7;b7 with respect to the public health and medical needs of at-risk individuals in the event of a public health emergency1 as described in section #bhjb7;b77#d72 2 and 7#f7 by inserting after paragraph 7#f71 the following3 7#g7 disseminate and1 as appropriate1 update novel and best practices of outreach to and care of at-risk individuals before1 during1 and following public health emergencies in as timely a manner as is practicable1 including from the time a public health threat is identified2 and 7#h7 ensure that public health and medical information distributed by the ,department of ,health and ,human ,services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients1 including at-risk individuals4 4 #ajb4 ,assistant ,secretary for ,preparedness and ,response 7a7 ,in general ,section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#c71 by inserting 1 security countermeasures 7as defined in section #cai;,f-#b71 after qualified countermeasures 7as defined in section #cai;,f-#a72 7,b7 in paragraph 7#d71 by adding at the end the following3 7,d7 ,policy coordination and strategic direction ,provide integrated policy coordination and strategic direction with respect to all matters related to ,federal public health and medical preparedness and execution and deployment of the ,federal response for public health emergencies and incidents covered by the ,national ,response ,plan developed pursuant to section #ejd7f7 of the ,homeland ,security ,act of #bjjb1 or any successor plan1 before1 during1 and following public health emergencies4 7,e7 ,identification of inefficiencies ,identify and minimize gaps1 duplication1 and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles4 7,f7 ,coordination of grants and agreements ,align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this ,act1 to the extent possible1 including program requirements1 timelines1 and measurable goals1 and in consultation with the ,secretary of ,homeland ,security1 to-- 7i7 optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies2 and 7ii7 gather and disseminate best practices among grant and cooperative agreement recipients1 as appropriate4 7,g7 ,drill and operational exercises ,carry out drills and operational exercises1 in consultation with the ,department of ,homeland ,security1 the ,department of ,defense1 the ,department of ,veterans ,affairs1 and other applicable ,federal departments and agencies1 as necessary and appropriate1 to identify1 inform1 and address gaps in and policies related to all-hazards medical and public health preparedness and response1 including exercises based on-- 7i7 identified threats for which countermeasures are available and for which no countermeasures are available2 and 7ii7 unknown threats for which no countermeasures are available4 7,h7 ,national security priority ,on a periodic basis consult with1 as applicable and appropriate1 the ,assistant to the ,president for ,national ,security ,affairs1 to provide an update on1 and discuss1 medical and public health preparedness and response activities pursuant to this ,act and the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including progress on the development1 approval1 clearance1 and licensure of medical countermeasures4 2 and 7,c7 by adding at the end the following3 7#g7 ,countermeasures budget plan ,develop1 and update on an annual basis1 a coordinated #e-year budget plan based on the medical countermeasure priorities described in subsection 7d74 ,each such plan shall-- 7,a7 include consideration of the entire medical countermeasures enterprise1 including-- 7i7 basic research and advanced research and development2 7ii7 approval1 clearance1 licensure1 and authorized uses of products2 and 7iii7 procurement1 stockpiling1 maintenance1 and replenishment of all products in the ,strategic ,national ,stockpile2 7,b7 inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities2 7,c7 identify medical countermeasure life-cycle costs to inform planning1 budgeting1 and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section #cai;,f-#b2 and 7,d7 be made available to the appropriate committees of ,congress upon request4 2 7#b7 by striking subsection 7c7 and inserting the following3 7c7 ,functions ,the ,assistant ,secretary for ,preparedness and ,response shall-- 7#a7 have lead responsibility within the ,department of ,health and ,human ,services for emergency preparedness and response policy coordination and strategic direction2 7#b7 have authority over and responsibility for-- 7,a7 the ,national ,disaster ,medical ,system pursuant to section #bhab2 7,b7 the ,hospital ,preparedness ,cooperative ,agreement ,program pursuant to section #cai;,c-#b2 7,c7 the ,biomedical ,advanced ,research and ,development ,authority pursuant to section #cai,l2 7,d7 the ,medical ,reserve ,corps pursuant to section #bhac2 7,e7 the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals pursuant to section #cai;,i2 and 7,f7 administering grants and related authorities related to trauma care under parts ,a through ,c of title ,,xii1 such authority to be transferred by the ,secretary from the ,administrator of the ,health ,resources and ,services ,administration to such ,assistant ,secretary2 7#c7 exercise the responsibilities and authorities of the ,secretary with respect to the coordination of-- 7,a7 the ,public ,health ,emergency ,preparedness ,cooperative ,agreement ,program pursuant to section #cai;,c-#a2 7,b7 the ,strategic ,national ,stockpile pursuant to section #cai;,f-#b2 and 7,c7 the ,cities ,readiness ,initiative2 and 7#d7 assume other duties as determined appropriate by the ,secretary4 2 and 7#c7 by adding at the end the following3 7d7 ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan 7#a7 ,in general ,not later than #ahj days after the date of enactment of this subsection1 and every year thereafter1 the ,assistant ,secretary for ,preparedness and ,response shall develop and submit to the appropriate committees of ,congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical1 biological1 radiological1 and nuclear threats4 ,in developing such a plan1 the ,assistant ,secretary for ,preparedness and ,response shall consult with the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 the ,director of the ,national ,institutes of ,health1 the ,director of the ,centers for ,disease ,control and ,prevention1 and the ,commissioner of ,food and ,drugs4 ,such strategy and plan shall be known as the ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan4 7#b7 ,requirements ,the plan under paragraph 7#a7 shall-- 7,a7 describe the chemical1 biological1 radiological1 and nuclear agent or agents that may present a threat to the ,nation and the corresponding efforts to develop qualified countermeasures 7as defined in section #cai;,f-#a71 security countermeasures 7as defined in section #cai;,f-#b71 or qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7 for each threat2 7,b7 evaluate the progress of all activities with respect to such countermeasures or products1 including research1 advanced research1 development1 procurement1 stockpiling1 deployment1 distribution1 and utilization2 7,c7 identify and prioritize near-1 mid-1 and long-term needs with respect to such countermeasures or products to address a chemical1 biological1 radiological1 and nuclear threat or threats2 7,d7 identify1 with respect to each category of threat1 a summary of all awards and contracts1 including advanced research and development and procurement1 that includes-- 7i7 the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication 7such as the award1 denial of award1 or solicitation termination72 and 7ii7 an identification of projected timelines1 anticipated funding allocations1 benchmarks1 and milestones for each medical countermeasure priority under subparagraph 7,c71 including projected needs with regard to replenishment of the ,strategic ,national ,stockpile2 7,e7 be informed by the recommendations of the ,national ,biodefense ,science ,board pursuant to section #cai,m2 7,f7 evaluate progress made in meeting timelines1 allocations1 benchmarks1 and milestones identified under subparagraph 7,d77ii72 7,g7 report on the amount of funds available for procurement in the special reserve fund as defined in section #cai;,f-#b7;h7 and the impact this funding will have on meeting the requirements under section #cai;,f-#b2 7,h7 incorporate input from ,federal1 ,state1 local1 and tribal stakeholders2 7,i7 identify the progress made in meeting the medical countermeasure priorities for at-risk individuals 7as defined in #bhjb7;b77#d77;,b771 as applicable under subparagraph 7,c71 including with regard to the projected needs for related stockpiling and replenishment of the ,strategic ,national ,stockpile1 including by addressing the needs of pediatric populations with respect to such countermeasures and products in the ,strategic ,national ,stockpile1 including-- 7i7 a list of such countermeasures and products necessary to address the needs of pediatric populations2 7ii7 a description of measures taken to coordinate with the ,office of ,pediatric ,therapeutics of the ,food and ,drug ,administration to maximize the labeling1 dosages1 and formulations of such countermeasures and products for pediatric populations2 7iii7 a description of existing gaps in the ,strategic ,national ,stockpile and the development of such countermeasures and products to address the needs of pediatric populations2 and 7iv7 an evaluation of the progress made in addressing priorities identified pursuant to subparagraph 7,c72 7,j7 identify the use of authority and activities undertaken pursuant to sections #cai;,f-#a7;b77#a71 #cai;,f-#a7;b77#b71 #cai;,f-#a7;b77#c71 #cai;,f-#a7;c71 #cai;,f-#a7;d71 #cai;,f-#a7;e71 #cai;,f-#b7;c77#g77;,c77iii71 #cai;,f-#b7;c77#g77;,c77iv71 and #cai;,f-#b7;c77#g77;,c77v7 of this ,act1 and subsections 7a77#a71 7b77#a71 and 7e7 of section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 by summarizing-- 7i7 the particular actions that were taken under the authorities specified1 including1 as applicable1 the identification of the threat agent1 emergency1 or the biomedical countermeasure with respect to which the authority was used2 7ii7 the reasons underlying the decision to use such authorities1 including1 as applicable1 the options that were considered and rejected with respect to the use of such authorities2 7iii7 the number of1 nature of1 and other information concerning the persons and entities that received a grant1 cooperative agreement1 or contract pursuant to the use of such authorities1 and the persons and entities that were considered and rejected for such a grant1 cooperative agreement1 or contract1 except that the report need not disclose the identity of any such person or entity2 7iv7 whether1 with respect to each procurement that is approved by the ,president under section #cai;,f-#b7;c77#f71 a contract was entered into within one year after such approval by the ,president2 and 7v7 with respect to section #cai;,f-#a7;d71 for the one-year period for which the report is submitted1 the number of persons who were paid amounts totaling #ajj1jjj or greater and the number of persons who were paid amounts totaling at least #ej1jjj but less than #ajj1jjj2 and 7,k7 be made publicly available4 7#c7 ,,gao report 7,a7 ,in general ,not later than #a year after the date of the submission to the ,congress of the first ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the appropriate committees of ,congress a report1 concerning such ,strategy and ,implementation ,plan4 7,b7 ,content ,the report described in subparagraph 7,a7 shall review and assess-- 7i7 the near-term1 mid-term1 and long-term medical countermeasure needs and identified priorities of the ,federal ,government pursuant to paragraph 7#b77;,c72 7ii7 the activities of the ,department of ,health and ,human ,services with respect to advanced research and development pursuant to section #cai,l2 and 7iii7 the progress made toward meeting the timelines1 allocations1 benchmarks1 and milestones identified in the ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan under this subsection4 7e7 ,protection of national security ,in carrying out subsections 7b77#g7 and 7d71 the ,secretary shall ensure that information and items that could compromise national security1 contain confidential commercial information1 or contain proprietary information are not disclosed4 4 7b7 ,interagency coordination plan ,in the first ,public ,health ,emergency ,countermeasures ,enterprise ,strategy and ,implementation ,plan submitted under subsection 7d7 of section #bhaa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aj7 7as added by subsection 7a77#c771 the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary of ,defense1 shall include a description of the manner in which the ,department of ,health and ,human ,services is coordinating with the ,department of ,defense regarding countermeasure activities to address chemical1 biological1 radiological1 and nuclear threats4 ,such report shall include information with respect to-- 7#a7 the research1 advanced research1 development1 procurement1 stockpiling1 and distribution of countermeasures to meet identified needs2 and 7#b7 the coordination of efforts between the ,department of ,health and ,human ,services and the ,department of ,defense to address countermeasure needs for various segments of the population4 #ajc4 ,national ,advisory ,committee on ,children and ,disasters ,subtitle ,b of title ,,xxviii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh et seq47 is amended by inserting after section #bhaa the following3 #bhaa;,a4 ,national ,advisory ,committee on ,children and ,disasters 7a7 ,establishment ,the ,secretary1 in consultation with the ,secretary of ,homeland ,security1 shall establish an advisory committee to be known as the ,national ,advisory ,committee on ,children and ,disasters 7referred to in this section as the ,advisory ,committee74 7b7 ,duties ,the ,advisory ,committee shall-- 7#a7 provide advice and consultation with respect to the activities carried out pursuant to section #bhad1 as applicable and appropriate2 7#b7 evaluate and provide input with respect to the medical and public health needs of children as they relate to preparation for1 response to1 and recovery from all-hazards emergencies2 and 7#c7 provide advice and consultation with respect to ,state emergency preparedness and response activities and children1 including related drills and exercises pursuant to the preparedness goals under section #bhjb7;b74 7c7 ,additional duties ,the ,advisory ,committee may provide advice and recommendations to the ,secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this title and title ,,iii4 7d7 ,membership 7#a7 ,in general ,the ,secretary1 in consultation with such other ,secretaries as may be appropriate1 shall appoint not to exceed #ae members to the ,advisory ,committee4 ,in appointing such members1 the ,secretary shall ensure that the total membership of the ,advisory ,committee is an odd number4 7#b7 ,required members ,the ,secretary1 in consultation with such other ,secretaries as may be appropriate1 may appoint to the ,advisory ,committee under paragraph 7#a7 such individuals as may be appropriate to perform the duties described in subsections 7b7 and 7c71 which may include-- 7,a7 the ,assistant ,secretary for ,preparedness and ,response2 7,b7 the ,director of the ,biomedical ,advanced ,research and ,development ,authority2 7,c7 the ,director of the ,centers for ,disease ,control and ,prevention2 7,d7 the ,commissioner of ,food and ,drugs2 7,e7 the ,director of the ,national ,institutes of ,health2 7,f7 the ,assistant ,secretary of the ,administration for ,children and ,families2 7,g7 the ,administrator of the ,federal ,emergency ,management ,agency2 7,h7 at least two non-,federal health care professionals with expertise in pediatric medical disaster planning1 preparedness1 response1 or recovery2 7,i7 at least two representatives from ,state1 local1 territorial1 or tribal agencies with expertise in pediatric disaster planning1 preparedness1 response1 or recovery2 and 7,j7 representatives from such ,federal agencies 7such as the ,department of ,education and the ,department of ,homeland ,security7 as determined necessary to fulfill the duties of the ,advisory ,committee1 as established under subsections 7b7 and 7c74 7e7 ,meetings ,the ,advisory ,committee shall meet not less than biannually4 7f7 ,sunset ,the ,advisory ,committee shall terminate on ,september #cj1 #bjah4 4 #ajd4 ,modernization of the ,national ,disaster ,medical ,system ,section #bhab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,a71 in clause 7i7 by inserting 1 including at-risk individuals as applicable after victims of a public health emergency2 7,b7 by redesignating subparagraph 7,c7 as subparagraph 7,e72 and 7,c7 by inserting after subparagraph 7,b71 the following3 7,c7 ,considerations for at-risk populations ,the ,secretary shall take steps to ensure that an appropriate specialized and focused range of public health and medical capabilities are represented in the ,national ,disaster ,medical ,system1 which take into account the needs of at-risk individuals1 in the event of a public health emergency4 4 7,d7 ,administration ,the ,secretary may determine and pay claims for reimbursement for services under subparagraph 7,a7 directly or through contracts that provide for payment in advance or by way of reimbursement4 2 and 7#b7 in subsection 7g71 by striking such sums as may be necessary for each of the fiscal years #bjjg through #bjaa and inserting #eb1gjj1jjj for each of fiscal years #bjad through #bjah4 #aje4 ,continuing the role of the ,department of ,veterans ,affairs ,section #haag7;g7 of title #ch1 ,united ,states ,code1 is amended by striking such sums as may be necessary to carry out this section for each of fiscal years #bjjg through #bjaa and inserting #aee1cjj1jjj for each of fiscal years #bjad through #bjah to carry out this section4 ,,ii ,optimizing ,state and local all-hazards preparedness and response #bja4 ,temporary reassignment of ,state and local personnel during a public health emergency ,section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d7 is amended by adding at the end the following3 7e7 ,temporary reassignment of state and local personnel during a public health emergency 7#a7 ,emergency reassignment of federally funded personnel ,notwithstanding any other provision of law1 and subject to paragraph 7#b71 upon request by the ,governor of a ,state or a tribal organization or such ,governor or tribal organization's designee1 the ,secretary may authorize the requesting ,state or ,indian tribe to temporarily reassign1 for purposes of immediately addressing a public health emergency in the ,state or ,indian tribe1 ,state and local public health department or agency personnel funded in whole or in part through programs authorized under this ,act1 as appropriate4 7#b7 ,activation of emergency reassignment 7,a7 ,public health emergency ,the ,secretary may authorize a temporary reassignment of personnel under paragraph 7#a7 only during the period of a public health emergency determined pursuant to subsection 7a74 7,b7 ,contents of request ,to seek authority for a temporary reassignment of personnel under paragraph 7#a71 the ,governor of a ,state or a tribal organization shall submit to the ,secretary a request for such reassignment flexibility and shall include in the request each of the following3 7i7 ,an assurance that the public health emergency in the geographic area of the requesting ,state or ,indian tribe cannot be adequately and appropriately addressed by the public health workforce otherwise available4 7ii7 ,an assurance that the public health emergency would be addressed more efficiently and effectively through the requested temporary reassignment of ,state and local personnel described in paragraph 7#a74 7iii7 ,an assurance that the requested temporary reassignment of personnel is consistent with any applicable ,all-,hazards ,public ,health ,emergency ,preparedness and ,response ,plan under section #cai;,c-#a4 7iv7 ,an identification of-- 7,i7 each ,federal program from which personnel would be temporarily reassigned pursuant to the requested authority2 and 7,,ii7 the number of personnel who would be so reassigned from each such program4 7v7 ,such other information and assurances upon which the ,secretary and ,governor of a ,state or tribal organization agree4 7,c7 ,consideration ,in reviewing a request for temporary reassignment under paragraph 7#a71 the ,secretary shall consider the degree to which the program or programs funded in whole or in part by programs authorized under this ,act would be adversely affected by the reassignment4 7,d7 ,termination and extension 7i7 ,termination ,a ,state or ,indian tribe's temporary reassignment of personnel under paragraph 7#a7 shall terminate upon the earlier of the following3 7,i7 ,the ,secretary's determination that the public health emergency no longer exists4 7,,ii7 ,subject to clause 7ii71 the expiration of the #cj-;day period following the date on which the ,secretary approved the ,state or ,indian tribe's request for such reassignment flexibility4 7ii7 ,extension of reassignment flexibility ,the ,secretary may extend reassignment flexibility of personnel under paragraph 7#a7 beyond the date otherwise applicable under clause 7i77,,ii7 if the public health emergency still exists as of such date1 but only if-- 7,i7 the ,state or ,indian tribe that submitted the initial request for a temporary reassignment of personnel submits a request for an extension of such temporary reassignment2 and 7,,ii7 the request for an extension contains the same information and assurances necessary for the approval of an initial request for such temporary reassignment pursuant to subparagraph 7,b74 7#c7 ,voluntary nature of temporary reassignment of state and local personnel 7,a7 ,in general ,unless otherwise provided under the law or regulation of the ,state or ,indian tribe that receives authorization for temporary reassignment of personnel under paragraph 7#a71 personnel eligible for reassignment pursuant to such authorization-- 7i7 shall have the opportunity to volunteer for temporary reassignment2 and 7ii7 shall not be required to agree to a temporary reassignment4 7,b7 ,prohibition on conditioning ,federal awards ,the ,secretary may not condition the award of a grant1 contract1 or cooperative agreement under this ,act on the requirement that a ,state or ,indian tribe require that personnel eligible for reassignment pursuant to an authorization under paragraph 7#a7 agree to such reassignment4 7#d7 ,notice to congress ,the ,secretary shall give notice to the ,congress in conjunction with the approval under this subsection of-- 7,a7 any initial request for temporary reassignment of personnel2 and 7,b7 any request for an extension of such temporary reassignment4 7#e7 ,guidance ,the ,secretary shall-- 7,a7 not later than #f months after the enactment of this subsection1 issue proposed guidance on the temporary reassignment of personnel under this subsection2 and 7,b7 after providing notice and a #fj-;day period for public comment1 finalize such guidance4 7#f7 ,report to congress ,not later than #d years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the appropriate committees of the ,congress a report1 on temporary reassignment under this subsection1 including-- 7,a7 a description of how1 and under what circumstances1 such temporary reassignment has been used by ,states and ,indian tribes2 7,b7 an analysis of how such temporary reassignment has assisted ,states and ,indian tribes in responding to public health emergencies2 7,c7 an evaluation of how such temporary reassignment has improved operational efficiencies in responding to public health emergencies2 7,d7 an analysis of the extent to which1 if any1 ,federal programs from which personnel have been temporarily reassigned have been adversely affected by the reassignment2 and 7,e7 recommendations on how medical surge capacity could be improved in responding to public health emergencies and the impact of the reassignment flexibility under this section on such surge capacity4 7#g7 ,definitions ,in this subsection-- 7,a7 the terms ,indian tribe and tribal organization have the meanings given such terms in section #d of the ,indian ,self-,determination and ,education ,assistance ,act2 and 7,b7 the term ,state includes1 in addition to the entities listed in the definition of such term in section #b1 the ,freely ,associated ,states4 7#h7 ,sunset ,this subsection shall terminate on ,september #cj1 #bjah4 4 #bjb4 ,improving ,state and local public health security 7a7 ,cooperative agreements ,section #cai;,c-#a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended-- 7#a7 in subsection 7b77#a77;,c71 by striking consortium of entities described in subparagraph 7,a7 and inserting consortium of ,states2 7#b7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking clauses 7i7 and 7ii7 and inserting the following3 7i7 a description of the activities such entity will carry out under the agreement to meet the goals identified under section #bhjb1 including with respect to chemical1 biological1 radiological1 or nuclear threats1 whether naturally occurring1 unintentional1 or deliberate2 7ii7 a description of the activities such entity will carry out with respect to pandemic influenza1 as a component of the activities carried out under clause 7i71 and consistent with the requirements of paragraphs 7#b7 and 7#e7 of subsection 7g72 2 7ii7 in clause 7iv71 by striking and at the end2 and 7iii7 by adding at the end the following3 7vi7 a description of how1 as appropriate1 the entity may partner with relevant public and private stakeholders in public health emergency preparedness and response2 7vii7 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 educational agencies 7as defined in section #iaja7da7 of the ,elementary and ,secondary ,education ,act of #aife7 and ,state child care lead agencies 7designated under section #feh;,d of the ,child ,care and ,development ,block ,grant ,act of #aiij72 7viii7 in the case of entities that operate on the ,united ,states-,mexico border or the ,united ,states-,canada border1 a description of the activities such entity will carry out under the agreement that are specific to the border area including disease detection1 identification1 investigation1 and preparedness and response activities related to emerging diseases and infectious disease outbreaks whether naturally occurring or due to bioterrorism1 consistent with the requirements of this section2 and 7ix7 a description of any activities that such entity will use to analyze real-time clinical specimens for pathogens of public health or bioterrorism significance1 including any utilization of poison control centers2 2 and 7,b7 in subparagraph 7,c71 by inserting 1 including addressing the needs of at-risk individuals1 after capabilities of such entity2 7#c7 in subsection 7f7-- 7,a7 in paragraph 7#b71 by adding and at the end2 7,b7 in paragraph 7#c71 by striking 2 and and inserting a period2 and 7,c7 by striking paragraph 7#d72 7#d7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by striking subparagraph 7,a7 and inserting the following3 7,a7 include outcome goals representing operational achievements of the ,national ,preparedness ,goals developed under section #bhjb7;b7 with respect to all-hazards1 including chemical1 biological1 radiological1 or nuclear threats2 and 2 and 7,b7 in paragraph 7#b77;,a71 by adding at the end the following3 ,the ,secretary shall periodically update1 as necessary and appropriate1 such pandemic influenza plan criteria and shall require the integration of such criteria into the benchmarks and standards described in paragraph 7#a742 7#e7 by striking subsection 7h72 7#f7 by redesignating subsections 7i71 7j71 and 7k7 as subsections 7h71 7i71 and 7j71 respectively2 7#g7 in subsection 7h71 as so redesignated-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking #hbd1jjj1jjj for fiscal year #bjjg1 of which #ce1jjj1jjj shall be used to carry out subsection 7h71 and inserting #fda1ijj1jjj for fiscal year #bjad2 and 7,,ii7 by striking such sums as may be necessary for each of fiscal years #bjjh through #bjaa and inserting #fda1ijj1jjj for each of fiscal years #bjae through #bjah2 7ii7 by striking subparagraph 7,b72 7iii7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7iv7 in subparagraph 7,c71 as so redesignated1 by striking subparagraph 7,c7 and inserting subparagraph 7,b72 7,b7 in subparagraphs 7,c7 and 7,d7 of paragraph 7#c71 by striking 7#a77;,a77i77,i7 each place it appears and inserting 7#a77;,a72 7,c7 in paragraph 7#d77;,b71 by striking subsection 7c7 and inserting subsection 7b72 and 7,d7 by adding at the end the following3 7#g7 ,availability of cooperative agreement funds 7,a7 ,in general ,amounts provided to an eligible entity under a cooperative agreement under subsection 7a7 for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided4 7,b7 ,funds contingent on achieving benchmarks ,the continued availability of funds under subparagraph 7,a7 with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as described in subsection 7g74 2 and 7#h7 in subsection 7i71 as so redesignated-- 7,a7 in paragraph 7#a77;,e71 by striking subsection 7k7 and inserting subsection 7j72 7,b7 by striking paragraph 7#c74 7b7 ,vaccine tracking and distribution ,section #cai;,a7e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking such sums for each of fiscal years #bjjg through #bjaa and inserting #cj1hjj1jjj for each of fiscal years #bjad through #bjah4 7c7 ,technical and conforming amendments 7#a7 ,section #cai;,c-#a7;b77#a77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#a77;,b77 is amended by striking subsection 7i77#d7 and inserting subsection 7h77#d74 7#b7 ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7,a7 in subsection 7i71 by striking 7j71 and 7k7 and inserting 7i71 and 7j72 and 7,b7 in subsection 7j77#c71 by striking #cai;,c-#a7;i7 and inserting #cai;,c-#a7;h74 #bjc4 ,hospital preparedness and medical surge capacity 7a7 ,all-,hazards public health and medical response curricula and training ,section #cai;,f7a77#e77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f7;a77#e77;,b77 is amended by striking public health or medical and inserting public health1 medical1 or dental4 7b7 ,encouraging health professional volunteers 7#a7 ,emergency system for advance registration of volunteer health professionals ,section #cai;,i7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7k77 is amended by striking #b1jjj1jjj for fiscal year #bjjb1 and such sums as may be necessary for each of the fiscal years #bjjc through #bjaa and inserting #e1jjj1jjj for each of fiscal years #bjad through #bjah4 7#b7 ,volunteers ,section #bhac of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#ae7 is amended-- 7,a7 in subsection 7d77#b71 by adding at the end the following3 ,such training exercises shall1 as appropriate and applicable1 incorporate the needs of at-risk individuals in the event of a public health emergency42 and 7,b7 in subsection 7i71 by striking #bb1jjj1jjj for fiscal year #bjjg1 and such sums as may be necessary for each of fiscal years #bjjh through #bjaa and inserting #aa1bjj1jjj for each of fiscal years #bjad through #bjah4 7c7 ,partnerships for ,state and regional preparedness ,to improve surge capacity ,section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7a71 by inserting 1 including1 as appropriate1 capacity and preparedness to address the needs of children and other at-risk individuals before the period at the end2 7#b7 in subsection 7b77#a77;,a77ii71 by striking centers1 primary and inserting centers1 community health centers1 primary2 7#c7 by striking subsection 7c7 and inserting the following3 7c7 ,use of funds ,an award under subsection 7a7 shall be expended for activities to achieve the preparedness goals described under paragraphs 7#a71 7#c71 7#d71 7#e71 and 7#f7 of section #bhjb7;b7 with respect to all-hazards1 including chemical1 biological1 radiological1 or nuclear threats4 2 7#d7 by striking subsection 7g7 and inserting the following3 7g7 ,coordination 7#a7 ,local response capabilities ,an eligible entity shall1 to the extent practicable1 ensure that activities carried out under an award under subsection 7a7 are coordinated with activities of relevant local ,metropolitan ,medical ,response ,systems1 local ,medical ,reserve ,corps1 the local ,cities ,readiness ,initiative1 and local emergency plans4 7#b7 ,national collaboration ,partnerships consisting of one or more eligible entities under this section may1 to the extent practicable1 collaborate with other partnerships consisting of one or more eligible entities under this section for purposes of national coordination and collaboration with respect to activities to achieve the preparedness goals described under paragraphs 7#a71 7#c71 7#d71 7#e71 and 7#f7 of section #bhjb7;b74 2 7#e7 in subsection 7i7-- 7,a7 by striking ,the requirements of and inserting the following3 7#a7 ,in general ,the requirements of 2 and 7,b7 by adding at the end the following3 7#b7 ,meeting goals of ,national ,health ,security ,strategy ,the ,secretary shall implement objective1 evidence-based metrics to ensure that entities receiving awards under this section are meeting1 to the extent practicable1 the applicable goals of the ,national ,health ,security ,strategy under section #bhjb4 2 and 7#f7 in subsection 7j7-- 7,a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general ,for purposes of carrying out this section1 there is authorized to be appropriated #cgd1gjj1jjj for each of fiscal years #bjad through #bjah4 2 and 7,b7 by adding at the end the following3 7#d7 ,availability of cooperative agreement funds 7,a7 ,in general ,amounts provided to an eligible entity under a cooperative agreement under subsection 7a7 for a fiscal year and remaining unobligated at the end of such year shall remain available to such entity for the next fiscal year for the purposes for which such funds were provided4 7,b7 ,funds contingent on achieving benchmarks ,the continued availability of funds under subparagraph 7,a7 with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the pandemic influenza plan as required under subsection 7i74 4 #bjd4 ,enhancing situational awareness and biosurveillance 7a7 ,in general ,section #cai;,d of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#a77;,b71 by inserting poison control centers1 after hospitals12 7,b7 in paragraph 7#b71 by inserting before the period at the end the following3 1 allowing for coordination to maximize all-hazards medical and public health preparedness and response and to minimize duplication of effort2 and 7,c7 in paragraph 7#c71 by inserting before the period at the end the following3 and update such standards as necessary2 7#b7 by striking subsection 7c72 7#c7 by redesignating subsections 7d7 through 7g7 as subsections 7c7 through 7f71 respectively2 7#d7 in subsection 7c71 as so redesignated-- 7,a7 in the subsection heading1 by striking ,public ,health ,situational ,awareness and inserting ,modernizing ,public ,health ,situational ,awareness and ,biosurveillance2 7,b7 in paragraph 7#a7-- 7i7 by striking ,pandemic and ,all-,hazards ,preparedness ,act and inserting ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac2 and 7ii7 by inserting 1 novel emerging threats1 after disease outbreaks2 7,c7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,strategy and implementation plan ,not later than #ahj days after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,secretary shall submit to the appropriate committees of ,congress a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measurable steps the ,secretary will carry out to-- 7,a7 develop1 implement1 and evaluate the network described in paragraph 7#a71 utilizing the elements described in paragraph 7#c72 7,b7 modernize and enhance biosurveillance activities2 and 7,c7 improve information sharing1 coordination1 and communication among disparate biosurveillance systems supported by the ,department of ,health and ,human ,services4 2 7,d7 in paragraph 7#c77;,d71 by inserting community health centers1 health centers after poison control12 7,e7 in paragraph 7#e71 by striking subparagraph 7,a7 and inserting the following3 7,a7 utilize applicable interoperability standards as determined by the ,secretary1 and in consultation with the ,office of the ,national ,coordinator for ,health ,information ,technology1 through a joint public and private sector process2 2 and 7,f7 by adding at the end the following3 7#f7 ,consultation with the ,national ,biodefense ,science ,board ,in carrying out this section and consistent with section #cai,m1 the ,national ,biodefense ,science ,board shall provide expert advice and guidance1 including recommendations1 regarding the measurable steps the ,secretary should take to modernize and enhance biosurveillance activities pursuant to the efforts of the ,department of ,health and ,human ,services to ensure comprehensive1 real-time1 all-hazards biosurveillance capabilities4 ,in complying with the preceding sentence1 the ,national ,biodefense ,science ,board shall-- 7,a7 identify the steps necessary to achieve a national biosurveillance system for human health1 with international connectivity1 where appropriate1 that is predicated on ,state1 regional1 and community level capabilities and creates a networked system to allow for two-way information flow between and among ,federal1 ,state1 and local government public health authorities and clinical health care providers2 7,b7 identify any duplicative surveillance programs under the authority of the ,secretary1 or changes that are necessary to existing programs1 in order to enhance and modernize such activities1 minimize duplication1 strengthen and streamline such activities under the authority of the ,secretary1 and achieve real-time and appropriate data that relate to disease activity1 both human and zoonotic2 and 7,c7 coordinate with applicable existing advisory committees of the ,director of the ,centers for ,disease ,control and ,prevention1 including such advisory committees consisting of representatives from ,state1 local1 and tribal public health authorities and appropriate public and private sector health care entities and academic institutions1 in order to provide guidance on public health surveillance activities4 2 7#e7 in subsection 7d71 as so redesignated-- 7,a7 in paragraph 7#a71 by striking subsection 7d7 and inserting subsection 7c72 7,b7 in paragraph 7#d77;,b71 by striking subsection 7d7 and inserting subsection 7c72 and 7,c7 in paragraph 7#e7-- 7i7 by striking #d years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,act and inserting #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac2 and 7ii7 by striking subsection 7d7 and inserting subsection 7c72 7#f7 in subsection 7f71 as so redesignated1 by striking such sums as may be necessary in each of fiscal years #bjjg through #bjaa and inserting #ach1cjj1jjj for each of fiscal years #bjad through #bjah2 and 7#g7 by adding at the end the following3 7g7 ,definition ,for purposes of this section the term biosurveillance means the process of gathering near real-time biological data that relates to human and zoonotic disease activity and threats to human or animal health1 in order to achieve early warning and identification of such health threats1 early detection and prompt ongoing tracking of health events1 and overall situational awareness of disease activity4 4 7b7 ,technical and conforming amendment ,section #cai;,c-#a7;b77#b77;,d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77;,d77 is amended by striking section #cai;,d7d77#c7 and inserting section #cai;,d7c77#c74 #bje4 ,eliminating duplicative ,project ,bioshield reports ,section #e of the ,project ,bioshield ,act of #bjjd 7#db ,u4,s4,c4 #bdg;d-#f;c7 is repealed4 ,,iii ,enhancing ,medical ,countermeasure ,review #cja4 ,special protocol assessment ,section #eje7;b77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#e77;,b77 is amended by striking size of clinical trials intended and all that follows through 4 ,the sponsor or applicant and inserting the following3 8size-- 7i7 7,i7 of clinical trials intended to form the primary basis of an effectiveness claim2 or 7,,ii7 in the case where human efficacy studies are not ethical or feasible1 of animal and any associated clinical trials which1 in combination1 are intended to form the primary basis of an effectiveness claim2 or 7ii7 with respect to an application for approval of a biological product under section #cea7k7 of the ,public ,health ,service ,act1 of any necessary clinical study or studies4 ,the sponsor or applicant 4 #cjb4 ,authorization for medical products for use in emergencies 7a7 ,in general ,section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a71 by striking sections #eje1 #eaj7k71 and #eae of this ,act and inserting any provision of this ,act2 7,b7 in paragraph 7#b77;,a71 by striking under a provision of law referred to in such paragraph and inserting under section #eje1 #eaj7k71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 and 7,c7 in paragraph 7#c71 by striking a provision of law referred to in such paragraph and inserting a section of this ,act or the ,public ,health ,service ,act referred to in paragraph 7#b77;,a72 7#b7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking ,emergency and inserting ,emergency or ,threat ,justifying ,emergency ,authorized ,use2 7,b7 in paragraph 7#a7-- 7i7 in the matter preceding subparagraph 7,a71 by striking may declare an emergency and inserting may make a declaration that the circumstances exist2 7ii7 in subparagraph 7,a71 by striking specified2 7iii7 in subparagraph 7,b7-- 7,i7 by striking specified2 and 7,,ii7 by striking 2 or and inserting a semicolon2 7iv7 by amending subparagraph 7,c7 to read as follows3 7,c7 a determination by the ,secretary that there is a public health emergency1 or a significant potential for a public health emergency1 that affects1 or has a significant potential to affect1 national security or the health and security of ,united ,states citizens living abroad1 and that involves a biological1 chemical1 radiological1 or nuclear agent or agents1 or a disease or condition that may be attributable to such agent or agents2 or 2 and 7v7 by adding at the end the following3 7,d7 the identification of a material threat pursuant to section #cai;,f-#b of the ,public ,health ,service ,act sufficient to affect national security or the health and security of ,united ,states citizens living abroad4 2 7,c7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by amending clause 7ii7 to read as follows3 7ii7 a change in the approval status of the product such that the circumstances described in subsection 7a77#b7 have ceased to exist4 2 7ii7 by striking subparagraph 7,b72 and 7iii7 by redesignating subparagraph 7,c7 as subparagraph 7,b72 7,d7 in paragraph 7#d71 by striking advance notice of termination1 and renewal under this subsection4 and inserting 1 and advance notice of termination under this subsection42 and 7,e7 by adding at the end the following3 7#e7 ,explanation by ,secretary ,if an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than #a year1 the ,secretary shall provide in writing to the sponsor of such product an explanation of the scientific1 regulatory1 or other obstacles to approval1 licensure1 or clearance of such product or use1 including specific actions to be taken by the ,secretary and the sponsor to overcome such obstacles4 2 7#c7 in subsection 7c7-- 7,a7 in the matter preceding paragraph 7#a7-- 7i7 by inserting the ,assistant ,secretary for ,preparedness and ,response1 after consultation with2 7ii7 by striking ,health and and inserting ,health1 and2 and 7iii7 by striking circumstances of the emergency involved and inserting applicable circumstances described in subsection 7b77#a72 7,b7 in paragraph 7#a71 by striking specified and inserting referred to2 and 7,c7 in paragraph 7#b77;,b71 by inserting 1 taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection 7b77#a77;,d71 if applicable after risks of the product2 7#d7 in subsection 7d77#c71 by inserting 1 to the extent practicable given the circumstances of the emergency1 after including2 7#e7 in subsection 7e7-- 7,a7 in paragraph 7#a77;,a71 by striking circumstances of the emergency and inserting applicable circumstances described in subsection 7b77#a72 7,b7 in paragraph 7#a77;,b71 by amending clause 7iii7 to read as follows3 7iii7 ,appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period4 2 7,c7 in paragraph 7#b7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking manufacturer of the product and inserting person2 7,,ii7 by striking circumstances of the emergency and inserting applicable circumstances described in subsection 7b77#a72 and 7,,iii7 by inserting at the end before the period or in paragraph 7#a77;,b72 7ii7 in subparagraph 7,b77i71 by inserting before the period at the end 1 except as provided in section #efd;,a with respect to authorized changes to the product expiration date2 and 7iii7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,in establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use1 the ,secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use4 2 and 7,d7 by amending paragraph 7#c7 to read as follows3 7#c7 ,good manufacturing practice2 prescription ,with respect to the emergency use of a product for which an authorization under this section is issued 7whether an unapproved product or an unapproved use of an approved product71 the ,secretary may waive or limit1 to the extent appropriate given the applicable circumstances described in subsection 7b77#a7-- 7,a7 requirements regarding current good manufacturing practice otherwise applicable to the manufacture1 processing1 packing1 or holding of products subject to regulation under this ,act1 including such requirements established under section #eja or #ebj7;f77#a71 and including relevant conditions prescribed with respect to the product by an order under section #ebj7;f77#b72 7,b7 requirements established under section #ejc7;b72 and 7,c7 requirements established under section #ebj7;e74 2 7#f7 in subsection 7g7-- 7,a7 in the subsection heading1 by inserting ,review and before ,revocation2 7,b7 in paragraph 7#a71 by inserting after the period at the end the following3 8,as part of such review1 the ,secretary shall regularly review the progress made with respect to the approval1 licensure1 or clearance of-- 7,a7 an unapproved product for which an authorization was issued under this section2 or 7,b7 an unapproved use of an approved product for which an authorization was issued under this section4 2 and 7,c7 by amending paragraph 7#b7 to read as follows3 7#b7 ,revision and revocation ,the ,secretary may revise or revoke an authorization under this section if-- 7,a7 the circumstances described under subsection 7b77#a7 no longer exist2 7,b7 the criteria under subsection 7c7 for issuance of such authorization are no longer met2 or 7,c7 other circumstances make such revision or revocation appropriate to protect the public health or safety4 2 7#g7 in subsection 7h77#a71 by adding after the period at the end the following3 ,the ,secretary shall make any revisions to an authorization under this section available on the ,internet ,web site of the ,food and ,drug ,administration42 7#h7 by adding at the end of subsection 7j7 the following3 7#d7 ,nothing in this section shall be construed as authorizing a delay in the review or other consideration by the ,secretary of any application or submission pending before the ,food and ,drug ,administration for a product for which an authorization under this section is issued4 2 and 7#i7 by adding at the end the following3 7m7 ,categorization of laboratory tests associated with devices subject to authorization 7#a7 ,in general ,in issuing an authorization under this section with respect to a device1 the ,secretary may1 subject to the provisions of this section1 determine that a laboratory examination or procedure associated with such device shall be deemed1 for purposes of section #cec of the ,public ,health ,service ,act1 to be in a particular category of examinations and procedures 7including the category described by subsection 7d77#c7 of such section7 if1 based on the totality of scientific evidence available to the ,secretary-- 7,a7 such categorization would be beneficial to protecting the public health2 and 7,b7 the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization4 7#b7 ,conditions of determination ,the ,secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination4 7#c7 ,effective period ,a determination under this subsection shall be effective for purposes of section #cec of the ,public ,health ,service ,act notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection 7b74 4 7b7 ,emergency use of medical products ,subchapter ,e of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb et seq47 is amended by inserting after section #efd the following3 #efd;,a4 ,emergency use of medical products 7a7 ,definitions ,in this section3 7#a7 ,eligible product ,the term eligible product means a product that-- 7,a7 is approved or cleared under this chapter or licensed under section #cea of the ,public ,health ,service ,act2 7,b7 7i7 is intended for use to prevent1 diagnose1 or treat a disease or condition involving a biological1 chemical1 radiological1 or nuclear agent or agents2 or 7ii7 is intended for use to prevent1 diagnose1 or treat a serious or life-threatening disease or condition caused by a product described in clause 7i72 and 7,c7 is intended for use during the circumstances under which-- 7i7 a determination described in subparagraph 7,a71 7,b71 or 7,c7 of section #efd7;b77#a7 has been made by the ,secretary of ,homeland ,security1 the ,secretary of ,defense1 or the ,secretary1 respectively2 or 7ii7 the identification of a material threat described in subparagraph 7,d7 of section #efd7;b77#a7 has been made pursuant to section #cai;,f-#b of the ,public ,health ,service ,act4 7#b7 ,product ,the term product means a drug1 device1 or biological product4 7b7 ,expiration dating 7#a7 ,in general ,the ,secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if-- 7,a7 the expiration date extension is intended to support the ,united ,states ability to protect-- 7i7 the public health2 or 7ii7 military preparedness and effectiveness2 and 7,b7 the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the ,secretary4 7#b7 ,requirements and conditions ,any extension of an expiration date under paragraph 7#a7 shall1 as part of the extension1 identify-- 7,a7 each specific lot1 batch1 or other unit of the product for which extended expiration is authorized2 7,b7 the duration of the extension2 and 7,c7 any other requirements or conditions as the ,secretary may deem appropriate for the protection of the public health1 which may include requirements for1 or conditions on1 product sampling1 storage1 packaging or repackaging1 transport1 labeling1 notice to product recipients1 recordkeeping1 periodic testing or retesting1 or product disposition4 7#c7 ,effect ,notwithstanding any other provision of this ,act or the ,public ,health ,service ,act1 an eligible product shall not be considered an unapproved product 7as defined in section #efd7;a77#b77;,a77 and shall not be deemed adulterated or misbranded under this ,act because1 with respect to such product1 the ,secretary has1 under paragraph 7#a71 extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer4 7#d7 ,expiration date ,for purposes of this subsection1 the term expiration date means the date established through appropriate stability testing required by the regulations issued by the ,secretary to ensure that the product meets applicable standards of identity1 strength1 quality1 and purity at the time of use4 7c7 ,current good manufacturing practice 7#a7 ,in general ,the ,secretary may1 when the circumstances of a domestic1 military1 or public health emergency or material threat described in subsection 7a77#a77;,c7 so warrant1 authorize1 with respect to an eligible product1 deviations from current good manufacturing practice requirements otherwise applicable to the manufacture1 processing1 packing1 or holding of products subject to regulation under this ,act1 including requirements under section #eja or #ebj7;f77#a7 or applicable conditions prescribed with respect to the eligible product by an order under section #ebj7;f77#b74 7#b7 ,effect ,notwithstanding any other provision of this ,act or the ,public ,health ,service ,act1 an eligible product shall not be considered an unapproved product 7as defined in section #efd7;a77#b77;,a77 and shall not be deemed adulterated or misbranded under this ,act because1 with respect to such product1 the ,secretary has authorized deviations from current good manufacturing practices under paragraph 7#a74 7d7 ,emergency dispensing ,the requirements of sections #ejc7;b7 and #ebj7;e7 shall not apply to an eligible product1 and the product shall not be considered an unapproved product 7as defined in section #efd7;a77#b77;,a77 and shall not be deemed adulterated or misbranded under this ,act because it is dispensed without an individual prescription1 if-- 7#a7 the product is dispensed during the circumstances described in subsection 7a77#a77;,c72 and 7#b7 such dispensing without an individual prescription occurs-- 7,a7 as permitted under the law of the ,state in which the product is dispensed2 or 7,b7 in accordance with an order issued by the ,secretary1 for the purposes and duration of the circumstances described in subsection 7a77#a77;,c74 7e7 ,emergency use instructions 7#a7 ,in general ,the ,secretary1 acting through an appropriate official within the ,department of ,health and ,human ,services1 may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product's approved1 licensed1 or cleared conditions of use4 7#b7 ,effect ,notwithstanding any other provisions of this ,act or the ,public ,health ,service ,act1 a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this ,act because of the issuance of emergency use instructions under paragraph 7#a7 with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions-- 7,a7 during an emergency response to an actual emergency that is the basis for a determination described in subsection 7a77#a77;,c77i72 or 7,b7 by a government entity 7including a ,federal1 ,state1 local1 or tribal government entity71 or a person acting on behalf of such a government entity1 in preparation for an emergency response4 4 7c7 ,risk evaluation and mitigation strategies ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 is amended-- 7#a7 in subsection 7f71 by striking paragraph 7#g72 and 7#b7 by adding at the end the following3 7k7 ,waiver in public health emergencies ,the ,secretary may waive any requirement of this section with respect to a qualified countermeasure 7as defined in section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act7 to which a requirement under this section has been applied1 if the ,secretary determines that such waiver is required to mitigate the effects of1 or reduce the severity of1 the circumstances under which-- 7#a7 a determination described in subparagraph 7,a71 7,b71 or 7,c7 of section #efd7;b77#a7 has been made by the ,secretary of ,homeland ,security1 the ,secretary of ,defense1 or the ,secretary1 respectively2 or 7#b7 the identification of a material threat described in subparagraph 7,d7 of section #efd7;b77#a7 has been made pursuant to section #cai;,f-#b of the ,public ,health ,service ,act4 4 7d7 ,products held for emergency use ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended by inserting after section #efd;,a1 as added by subsection 7b71 the following3 #efd;,b4 ,products held for emergency use ,it is not a violation of any section of this ,act or of the ,public ,health ,service ,act for a government entity 7including a ,federal1 ,state1 local1 or tribal government entity71 or a person acting on behalf of such a government entity1 to introduce into interstate commerce a product 7as defined in section #efd7;a77#d77 intended for emergency use1 if that product-- 7#a7 is intended to be held and not used2 and 7#b7 is held and not used1 unless and until that product-- 7,a7 is approved1 cleared1 or licensed under section #eje1 #eaj7k71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 7,b7 is authorized for investigational use under section #eje or #ebj of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,c7 is authorized for use under section #efd4 4 #cjc4 ,definitions ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 is amended by striking ,the ,secretary1 in consultation and inserting the following3 7a7 ,definitions ,in this section-- 7#a7 the term countermeasure means a qualified countermeasure1 a security countermeasure1 and a qualified pandemic or epidemic product2 7#b7 the term qualified countermeasure has the meaning given such term in section #cai;,f-#a of the ,public ,health ,service ,act2 7#c7 the term security countermeasure has the meaning given such term in section #cai;,f-#b of such ,act2 and 7#d7 the term qualified pandemic or epidemic product means a product that meets the definition given such term in section #cai;,f-#c of the ,public ,health ,service ,act and-- 7,a7 that has been identified by the ,department of ,health and ,human ,services or the ,department of ,defense as receiving funding directly related to addressing chemical1 biological1 radiological1 or nuclear threats1 including pandemic influenza2 or 7,b7 is included under this paragraph pursuant to a determination by the ,secretary4 7b7 ,general duties ,the ,secretary1 in consultation 4 #cjd4 ,enhancing medical countermeasure activities ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 as amended by section #cjc1 is further amended-- 7#a7 in the section heading1 by striking ,technical ,assistance and inserting ,countermeasure ,development1 ,review1 and ,technical ,assistance2 7#b7 in subsection 7b71 by striking the subsection enumerator and all that follows through shall establish and inserting the following3 7b7 ,general duties ,in order to accelerate the development1 stockpiling1 approval1 licensure1 and clearance of qualified countermeasures1 security countermeasures1 and qualified pandemic or epidemic products1 the ,secretary1 in consultation with the ,assistant ,secretary for ,preparedness and ,response1 shall-- 7#a7 ensure the appropriate involvement of ,food and ,drug ,administration personnel in interagency activities related to countermeasure advanced research and development1 consistent with sections #cai;,f1 #cai;,f-#a1 #cai;,f-#b1 #cai;,f-#c1 #cai,l1 and #bhaa of the ,public ,health ,service ,act2 7#b7 ensure the appropriate involvement and consultation of ,food and ,drug ,administration personnel in any flexible manufacturing activities carried out under section #cai,l of the ,public ,health ,service ,act1 including with respect to meeting regulatory requirements set forth in this ,act2 7#c7 promote countermeasure expertise within the ,food and ,drug ,administration by-- 7,a7 ensuring that ,food and ,drug ,administration personnel involved in reviewing countermeasures for approval1 licensure1 or clearance are informed by the ,assistant ,secretary for ,preparedness and ,response on the material threat assessment conducted under section #cai;,f-#b of the ,public ,health ,service ,act for the agent or agents for which the countermeasure under review is intended2 7,b7 training ,food and ,drug ,administration personnel regarding review of countermeasures for approval1 licensure1 or clearance2 7,c7 holding public meetings at least twice annually to encourage the exchange of scientific ideas2 and 7,d7 establishing protocols to ensure that countermeasure reviewers have sufficient training or experience with countermeasures2 7#d7 maintain teams1 composed of ,food and ,drug ,administration personnel with expertise on countermeasures1 including specific countermeasures1 populations with special clinical needs 7including children and pregnant women that may use countermeasures1 as applicable and appropriate71 classes or groups of countermeasures1 or other countermeasure-related technologies and capabilities1 that shall-- 7,a7 consult with countermeasure experts1 including countermeasure sponsors and applicants1 to identify and help resolve scientific issues related to the approval1 licensure1 or clearance of countermeasures1 through workshops or public meetings2 and 7,b7 improve and advance the science relating to the development of new tools1 standards1 and approaches to assessing and evaluating countermeasures-- 7i7 in order to inform the process for countermeasure approval1 clearance1 and licensure2 and 7ii7 with respect to the development of countermeasures for populations with special clinical needs1 including children and pregnant women1 in order to meet the needs of such populations1 as necessary and appropriate2 and 7#e7 establish 2 and 7#c7 by adding at the end the following3 7c7 ,final ,guidance on development of animal models 7#a7 ,in general ,not later than #a year after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,secretary shall provide final guidance to industry regarding the development of animal models to support approval1 clearance1 or licensure of countermeasures referred to in subsection 7a7 when human efficacy studies are not ethical or feasible4 7#b7 ,authority to extend deadline ,the ,secretary may extend the deadline for providing final guidance under paragraph 7#a7 by not more than #f months upon submission by the ,secretary of a report on the status of such guidance to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7d7 ,development and animal modeling procedures 7#a7 ,availability of animal model meetings ,to facilitate the timely development of animal models and support the development1 stockpiling1 licensure1 approval1 and clearance of countermeasures1 the ,secretary shall1 not later than #ahj days after the enactment of this subsection1 establish a procedure by which a sponsor or applicant that is developing a countermeasure for which human efficacy studies are not ethical or practicable1 and that has an approved investigational new drug application or investigational device exemption1 may request and receive-- 7,a7 a meeting to discuss proposed animal model development activities2 and 7,b7 a meeting prior to initiating pivotal animal studies4 7#b7 ,pediatric models ,to facilitate the development and selection of animal models that could translate to pediatric studies1 any meeting conducted under paragraph 7#a7 shall include discussion of animal models for pediatric populations1 as appropriate4 7e7 ,review and approval of countermeasures 7#a7 ,material threat ,when evaluating an application or submission for approval1 licensure1 or clearance of a countermeasure1 the ,secretary shall take into account the material threat posed by the chemical1 biological1 radiological1 or nuclear agent or agents identified under section #cai;,f-#b of the ,public ,health ,service ,act for which the countermeasure under review is intended4 7#b7 ,review expertise ,when practicable and appropriate1 teams of ,food and ,drug ,administration personnel reviewing applications or submissions described under paragraph 7#a7 shall include a reviewer with sufficient training or experience with countermeasures pursuant to the protocols established under subsection 7b77#c77;,d74 4 #cje4 ,regulatory management plans ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 as amended by section #cjd1 is further amended by adding at the end the following3 7f7 ,regulatory management plan 7#a7 ,definition ,in this subsection1 the term eligible countermeasure means-- 7,a7 a security countermeasure with respect to which the ,secretary has entered into a procurement contract under section #cai;,f-#b7;c7 of the ,public ,health ,service ,act2 or 7,b7 a countermeasure with respect to which the ,biomedical ,advanced ,research and ,development ,authority has provided funding under section #cai,l of the ,public ,health ,service ,act for advanced research and development4 7#b7 ,regulatory management plan process ,the ,secretary1 in consultation with the ,assistant ,secretary for ,preparedness and ,response and the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 shall establish a formal process for obtaining scientific feedback and interactions regarding the development and regulatory review of eligible countermeasures by facilitating the development of written regulatory management plans in accordance with this subsection4 7#c7 ,submission of request and proposed plan by sponsor or applicant 7,a7 ,in general ,a sponsor or applicant of an eligible countermeasure may initiate the process described under paragraph 7#b7 upon submission of a written request to the ,secretary4 ,such request shall include a proposed regulatory management plan4 7,b7 ,timing of submission ,a sponsor or applicant may submit a written request under subparagraph 7,a7 after the eligible countermeasure has an investigational new drug or investigational device exemption in effect4 7,c7 ,response by ,secretary ,the ,secretary shall direct the ,food and ,drug ,administration1 upon submission of a written request by a sponsor or applicant under subparagraph 7,a71 to work with the sponsor or applicant to agree on a regulatory management plan within a reasonable time not to exceed #ij days4 ,if the ,secretary determines that no plan can be agreed upon1 the ,secretary shall provide to the sponsor or applicant1 in writing1 the scientific or regulatory rationale why such agreement cannot be reached4 7#d7 ,plan ,the content of a regulatory management plan agreed to by the ,secretary and a sponsor or applicant shall include-- 7,a7 an agreement between the ,secretary and the sponsor or applicant regarding developmental milestones that will trigger responses by the ,secretary as described in subparagraph 7,b72 7,b7 performance targets and goals for timely and appropriate responses by the ,secretary to the triggers described under subparagraph 7,a71 including meetings between the ,secretary and the sponsor or applicant1 written feedback1 decisions by the ,secretary1 and other activities carried out as part of the development and review process2 and 7,c7 an agreement on how the plan shall be modified1 if needed4 7#e7 ,milestones and performance targets ,the developmental milestones described in paragraph 7#d77;,a7 and the performance targets and goals described in paragraph 7#d77;,b7 shall include-- 7,a7 feedback from the ,secretary regarding the data required to support the approval1 clearance1 or licensure of the eligible countermeasure involved2 7,b7 feedback from the ,secretary regarding the data necessary to inform any authorization under section #efd2 7,c7 feedback from the ,secretary regarding the data necessary to support the positioning and delivery of the eligible countermeasure1 including to the ,strategic ,national ,stockpile2 7,d7 feedback from the ,secretary regarding the data necessary to support the submission of protocols for review under section #eje7;b77#e77;,b72 7,e7 feedback from the ,secretary regarding any gaps in scientific knowledge that will need resolution prior to approval1 licensure1 or clearance of the eligible countermeasure and plans for conducting the necessary scientific research2 7,f7 identification of the population for which the countermeasure sponsor or applicant seeks approval1 licensure1 or clearance and the population for which desired labeling would not be appropriate1 if known2 and 7,g7 as necessary and appropriate1 and to the extent practicable1 a plan for demonstrating safety and effectiveness in pediatric populations1 and for developing pediatric dosing1 formulation1 and administration with respect to the eligible countermeasure1 provided that such plan would not delay authorization under section #efd1 approval1 licensure1 or clearance for adults4 7#f7 ,prioritization 7,a7 ,plans for security countermeasures ,the ,secretary shall establish regulatory management plans for all security countermeasures for which a request is submitted under paragraph 7#c77;,a74 7,b7 ,plans for other eligible countermeasures ,the ,secretary shall determine whether resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures4 ,if resources are available to establish regulatory management plans for eligible countermeasures that are not security countermeasures1 and if resources are not available to establish regulatory management plans for all eligible countermeasures for which requests have been submitted1 the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 in consultation with the ,commissioner1 shall prioritize which eligible countermeasures may receive regulatory management plans4 4 #cjf4 ,report ,section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d71 as amended by section #cje1 is further amended by adding at the end the following3 7g7 ,annual report ,not later than #ahj days after the date of enactment of this subsection1 and annually thereafter1 the ,secretary shall make publicly available on the ,web site of the ,food and ,drug ,administration a report that details the countermeasure development and review activities of the ,food and ,drug ,administration1 including-- 7#a7 with respect to the development of new tools1 standards1 and approaches to assess and evaluate countermeasures-- 7,a7 the identification of the priorities of the ,food and ,drug ,administration and the progress made on such priorities2 and 7,b7 the identification of scientific gaps that impede the development1 approval1 licensure1 or clearance of countermeasures for populations with special clinical needs1 including children and pregnant women1 and the progress made on resolving these challenges2 7#b7 with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection 7f71 the extent to which the performance targets and goals set forth in subsection 7f77#d77;,b7 and the regulatory management plan have been met1 including1 for each such countermeasure-- 7,a7 whether the regulatory management plan was completed within the required timeframe1 and the length of time taken to complete such plan2 7,b7 whether the ,secretary adhered to the timely and appropriate response times set forth in such plan2 and 7,c7 explanations for any failure to meet such performance targets and goals2 7#c7 the number of regulatory teams established pursuant to subsection 7b77#d71 the number of products1 classes of products1 or technologies assigned to each such team1 and the number of1 type of1 and any progress made as a result of consultations carried out under subsection 7b77#d77;,a72 7#d7 an estimate of resources obligated to countermeasure development and regulatory assessment1 including-- 7,a7 ,center-specific objectives and accomplishments2 and 7,b7 the number of full-time equivalent employees of the ,food and ,drug ,administration who directly support the review of countermeasures2 7#e7 the number of countermeasure applications and submissions submitted1 the number of countermeasures approved1 licensed1 or cleared1 the status of remaining submitted applications and submissions1 and the number of each type of authorization issued pursuant to section #efd2 7#f7 the number of written requests for a regulatory management plan submitted under subsection 7f77#c77;,a71 the number of regulatory management plans developed1 and the number of such plans developed for security countermeasures2 and 7#g7 the number1 type1 and frequency of meetings between the ,food and ,drug ,administration and-- 7,a7 sponsors of a countermeasure as defined in subsection 7a72 or 7,b7 another agency engaged in development or management of portfolios for such countermeasures1 including the ,centers for ,disease ,control and ,prevention1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,national ,institutes of ,health1 and the appropriate agencies of the ,department of ,defense4 4 #cjg4 ,pediatric medical countermeasures 7a7 ,pediatric studies of drugs ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 is amended-- 7#a7 in subsection 7d71 by adding at the end the following3 7#e7 ,consultation ,with respect to a drug that is a qualified countermeasure 7as defined in section #cai;,f-#a of the ,public ,health ,service ,act71 a security countermeasure 7as defined in section #cai;,f-#b of the ,public ,health ,service ,act71 or a qualified pandemic or epidemic product 7as defined in section #cai;,f-#c of the ,public ,health ,service ,act71 the ,secretary shall solicit input from the ,assistant ,secretary for ,preparedness and ,response regarding the need for and1 from the ,director of the ,biomedical ,advanced ,research and ,development ,authority regarding the conduct of1 pediatric studies under this section4 2 and 7#b7 in subsection 7n77#a71 by adding at the end the following3 7,c7 ,for a drug that is a qualified countermeasure 7as defined in section #cai;,f-#a of the ,public ,health ,service ,act71 a security countermeasure 7as defined in section #cai;,f-#b of the ,public ,health ,service ,act71 or a qualified pandemic or epidemic product 7as defined in section #cai;,f-#c of such ,act71 in addition to any action with respect to such drug under subparagraph 7,a7 or 7,b71 the ,secretary shall notify the ,assistant ,secretary for ,preparedness and ,response and the ,director of the ,biomedical ,advanced ,research and ,development ,authority of all pediatric studies in the written request issued by the ,commissioner of ,food and ,drugs4 4 7b7 ,addition to priority list considerations ,section #dji;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7 is amended-- 7#a7 by striking subsection 7a77#b7 and inserting the following3 7#b7 ,consideration of available information ,in developing and prioritizing the list under paragraph 7#a71 the ,secretary-- 7,a7 shall consider-- 7i7 therapeutic gaps in pediatrics that may include developmental pharmacology1 pharmacogenetic determinants of drug response1 metabolism of drugs and biologics in children1 and pediatric clinical trials2 7ii7 particular pediatric diseases1 disorders or conditions where more complete knowledge and testing of therapeutics1 including drugs and biologics1 may be beneficial in pediatric populations2 and 7iii7 the adequacy of necessary infrastructure to conduct pediatric pharmacological research1 including research networks and trained pediatric investigators2 and 7,b7 may consider the availability of qualified countermeasures 7as defined in section #cai;,f-#a71 security countermeasures 7as defined in section #cai;,f-#b71 and qualified pandemic or epidemic products 7as defined in section #cai;,f-#c7 to address the needs of pediatric populations1 in consultation with the ,assistant ,secretary for ,preparedness and ,response1 consistent with the purposes of this section4 2 and 7#b7 in subsection 7b71 by striking subsection 7a7 and inserting paragraphs 7#a7 and 7#b77;,a7 of subsection 7a74 7c7 ,advice and recommendations of the pediatric advisory committee regarding countermeasures for pediatric populations ,subsection 7b77#b7 of section #ad of the ,best ,pharmaceuticals for ,children ,act 7#db ,u4,s4,c4 #bhdm note7 is amended-- 7#a7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7#b7 by adding at the end the following3 7,d7 the development of countermeasures 7as defined in section #efe7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 for pediatric populations4 4 ,,iv ,accelerating medical countermeasure advanced research and development #dja4 ,bio,shield 7a7 ,procurement of countermeasures ,section #cai;,f-#b7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7c77 is amended-- 7#a7 in paragraph 7#a77;,b77i77,,iii77bb71 by striking eight years and inserting #aj years2 7#b7 in paragraph 7#b77;,c71 by striking the designated congressional committees 7as defined in paragraph 7#aj77 and inserting the appropriate committees of ,congress2 7#c7 in paragraph 7#e77;,b77ii71 by striking eight years and inserting #aj years2 7#d7 in subparagraph 7,c7 of paragraph 7#f7-- 7,a7 in the subparagraph heading1 by striking designated congressional committees and inserting appropriate congressional committees2 and 7,b7 by striking the designated congressional committees and inserting the appropriate congressional committees2 and 7#e7 in paragraph 7#g77;,c7-- 7,a7 in clause 7i77,i71 by inserting including advanced research and development1 after as may reasonably be required12 7,b7 in clause 7ii7-- 7i7 in subclause 7,,iii71 by striking eight years and inserting #aj years2 and 7ii7 by striking subclause 7,,ix7 and inserting the following3 7,,ix7 ,contract terms ,the ,secretary1 in any contract for procurement under this section-- 7aa7 may specify-- 7,,aa7 the dosing and administration requirements for the countermeasure to be developed and procured2 7,,bb7 the amount of funding that will be dedicated by the ,secretary for advanced research1 development1 and procurement of the countermeasure2 and 7,,cc7 the specifications the countermeasure must meet to qualify for procurement under a contract under this section2 and 7bb7 shall provide a clear statement of defined ,government purpose limited to uses related to a security countermeasure1 as defined in paragraph 7#a77;,b74 2 and 7,c7 by adding at the end the following3 7viii7 ,flexibility ,in carrying out this section1 the ,secretary may1 consistent with the applicable provisions of this section1 enter into contracts and other agreements that are in the best interest of the ,government in meeting identified security countermeasure needs1 including with respect to reimbursement of the cost of advanced research and development as a reasonable1 allowable1 and allocable direct cost of the contract involved4 4 7b7 ,reauthorization of the special reserve fund ,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 7c7-- 7,a7 by striking special reserve fund under paragraph 7#aj7 each place it appears and inserting special reserve fund as defined in subsection 7h72 and 7,b7 by striking paragraphs 7#i7 and 7#aj72 and 7#b7 by adding at the end the following3 7g7 ,special reserve fund 7#a7 ,authorization of appropriations ,in addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection1 there is authorized to be appropriated1 for the procurement of security countermeasures under subsection 7c7 and for carrying out section #cai,l 7relating to the ,biomedical ,advanced ,research and ,development ,authority71 #b1hjj1jjj1jjj for the period of fiscal years #bjad through #bjah4 ,amounts appropriated pursuant to the preceding sentence are authorized to remain available until ,september #cj1 #bjai4 7#b7 ,use of special reserve fund for advanced research and development ,the ,secretary may utilize not more than #ej percent of the amounts authorized to be appropriated under paragraph 7#a7 to carry out section #cai,l 7related to the ,biomedical ,advanced ,research and ,development ,authority74 ,amounts authorized to be appropriated under this subsection to carry out section #cai,l are in addition to amounts otherwise authorized to be appropriated to carry out such section4 7#c7 ,restrictions on use of funds ,amounts in the special reserve fund shall not be used to pay costs other than payments made by the ,secretary to a vendor for advanced development 7under section #cai,l7 or for procurement of a security countermeasure under subsection 7c77#g74 7#d7 ,report ,not later than #cj days after any date on which the ,secretary determines that the amount of funds in the special reserve fund available for procurement is less than #a1ejj1jjj1jjj1 the ,secretary shall submit to the appropriate committees of ,congress a report detailing the amount of such funds available for procurement and the impact such reduction in funding will have-- 7,a7 in meeting the security countermeasure needs identified under this section2 and 7,b7 on the annual ,public ,health ,emergency ,medical ,countermeasures ,enterprise and ,strategy ,implementation ,plan 7pursuant to section #bhaa7;d774 7h7 ,definitions ,in this section3 7#a7 ,the term advanced research and development has the meaning given such term in section #cai,l7a74 7#b7 ,the term special reserve fund means the ,biodefense ,countermeasures appropriations account1 any appropriation made available pursuant to section #eba7;a7 of the ,homeland ,security ,act of #bjjb1 and any appropriation made available pursuant to subsection 7g77#a74 4 #djb4 ,biomedical ,advanced ,research and ,development ,authority 7a7 ,duties ,section #cai,l7c77#d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77 is amended-- 7#a7 in subparagraph 7,b77iii71 by inserting 7which may include advanced research and development for purposes of fulfilling requirements under the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act7 after development2 and 7#b7 in subparagraph 7,d77iii71 by striking and vaccine manufacturing technologies and inserting vaccine-manufacturing technologies1 dose-sparing technologies1 efficacy-increasing technologies1 and platform technologies4 7b7 ,transaction authorities ,section #cai,l7c77#e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77 is amended by adding at the end the following3 7,g7 ,government purpose ,in awarding contracts1 grants1 and cooperative agreements under this section1 the ,secretary shall provide a clear statement of defined ,government purpose related to activities included in subsection 7a77#f77;,b7 for a qualified countermeasure or qualified pandemic or epidemic product4 4 7c7 ,fund ,paragraph 7#b7 of section #cai,l7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is amended to read as follows3 7#b7 ,funding ,to carry out the purposes of this section1 there is authorized to be appropriated to the ,fund #dae1jjj1jjj for each of fiscal years #bjad through #bjah1 such amounts to remain available until expended4 4 7d7 ,continued ,inapplicability of ,certain ,provisions ,section #cai,l7e77#a77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77;,c77 is amended by striking #g years and inserting #ab years4 7e7 ,extension of limited antitrust exemption 7#a7 ,in general ,section #dje7;b7 of the ,pandemic and ,all-,hazards ,preparedness ,act 7#db ,u4,s4,c4 #bdg;d-#f;a note7 is amended by striking #f-year and inserting #ab-year4 7#b7 ,effective date ,this subsection shall take effect as if enacted on ,december #ag1 #bjab4 7f7 ,independent evaluation ,section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended by adding at the end the following3 7f7 ,independent evaluation 7#a7 ,in general ,not later than #ahj days after the date of enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section4 7#b7 ,report ,not later than #a year after the date of enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall submit to the appropriate committees of ,congress a report concerning the results of the evaluation conducted under paragraph 7#a74 ,such report shall review and assess-- 7,a7 the extent to which flexible manufacturing capacity under this section is dedicated to chemical1 biological1 radiological1 and nuclear threats2 7,b7 the activities supported by flexible manufacturing initiatives2 and 7,c7 the ability of flexible manufacturing activities carried out under this section to-- 7i7 secure and leverage leading technical expertise with respect to countermeasure advanced research1 development1 and manufacturing processes2 and 7ii7 meet the surge manufacturing capacity needs presented by novel and emerging threats1 including chemical1 biological1 radiological1 and nuclear agents4 4 7g7 ,definitions 7#a7 ,qualified countermeasure ,section #cai;,f-#a7;a77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77;,a77 is amended-- 7,a7 in the matter preceding clause 7i71 by striking to-- and inserting --2 7,b7 in clause 7i7-- 7i7 by striking diagnose and inserting to diagnose2 and 7ii7 by striking 2 or and inserting a semicolon2 7,c7 in clause 7ii7-- 7i7 by striking diagnose and inserting to diagnose2 and 7ii7 by striking the period at the end and inserting 2 or2 and 7,d7 by adding at the end the following3 7iii7 is a product or technology intended to enhance the use or effect of a drug1 biological product1 or device described in clause 7i7 or 7ii74 4 7#b7 ,qualified pandemic or epidemic product ,section #cai;,f-#c7;i77#g77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g77;,a77 is amended-- 7,a7 in clause 7i77,,ii71 by striking 2 or and inserting 22 7,b7 in clause 7ii71 by striking 2 and and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 a product or technology intended to enhance the use or effect of a drug1 biological product1 or device described in clause 7i7 or 7ii72 and 4 7#c7 ,technical amendments ,section #cai;,f-#c7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d7i77 is amended-- 7,a7 in paragraph 7#a77;,c71 by inserting 1 #efd;,a1 or #efd;,b after #efd2 and 7,b7 in paragraph 7#g77;,b77iii71 by inserting 1 #efd;,a1 or #efd;,b after #efd4 #djc4 ,strategic ,national ,stockpile ,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#a7-- 7i7 by inserting consistent with section #bhaa before by the ,secretary to be appropriate2 and 7ii7 by inserting before the period at the end of the second sentence the following3 and shall submit such review annually to the appropriate congressional committees of jurisdiction to the extent that disclosure of such information does not compromise national security2 and 7,b7 in paragraph 7#b77;,d71 by inserting before the semicolon at the end the following3 and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed1 including through necessary replenishment2 and 7#b7 in subsection 7f77#a71 by striking #fdj1jjj1jjj for fiscal year #bjjb1 and such sums as may be necessary for each of fiscal years #bjjc through #bjjf4 ,such authorization is in addition to amounts in the special reserve fund referred to in subsection 7c77#aj77;,a74 and inserting #ecc1hjj1jjj for each of fiscal years #bjad through #bjah4 ,such authorization is in addition to amounts in the special reserve fund referred to in subsection 7h744 #djd4 ,national ,biodefense ,science ,board ,section #cai,m7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-f7a77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,d7-- 7i7 in clause 7i71 by striking and at the end2 7ii7 in clause 7ii71 by striking the period and inserting a semicolon2 and 7iii7 by adding at the end the following3 7iii7 one such member shall be an individual with pediatric subject matter expertise2 and 7iv7 one such member shall be a ,state1 tribal1 territorial1 or local public health official4 2 and 7,b7 by adding at the end the following flush sentence3 ,nothing in this paragraph shall preclude a member of the ,board from satisfying two or more of the requirements described in subparagraph 7,d742 and 7#b7 in paragraph 7#e7-- 7,a7 in subparagraph 7,b71 by striking and at the end2 7,b7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7,d7 provide any recommendation1 finding1 or report provided to the ,secretary under this paragraph to the appropriate committees of ,congress4 4 ,secretary