#aafth ,,congress #ast ,session ,h4 ,r4 #bfi ,,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 to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,division ,a--,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,sec4 #ajj4 ,references in division4 ,title ,i--,strengthening the national health security strategy ,sec4 #aja4 ,national ,health ,security ,strategy4 ,title ,,ii--,improving preparedness and response ,sec4 #bja4 ,improving benchmarks and standards for preparedness and response4 ,sec4 #bjb4 ,amendments to preparedness and response programs4 ,sec4 #bjc4 ,regional health care emergency preparedness and response systems4 ,sec4 #bjd4 ,military and civilian partnership for trauma readiness4 ,sec4 #bje4 ,public health and health care system situational awareness and biosurveillance capabilities4 ,sec4 #bjf4 ,strengthening and supporting the public health emergency rapid response fund4 ,sec4 #bjg4 ,improving all-hazards preparedness and response by public health emergency volunteers4 ,sec4 #bjh4 ,clarifying ,state liability law for volunteer health care professionals4 ,sec4 #bji4 ,report on adequate national blood supply4 ,sec4 #baj4 ,report on the public health preparedness and response capabilities and capacities of hospitals1 long-term care facilities1 and other health care facilities4 ,title ,,iii--,reaching all communities ,sec4 #cja4 ,strengthening and assessing the emergency response workforce4 ,sec4 #cjb4 ,health system infrastructure to improve preparedness and response4 ,sec4 #cjc4 ,considerations for at-risk individuals4 ,sec4 #cjd4 ,improving emergency preparedness and response considerations for children4 ,sec4 #cje4 ,national advisory committees on disasters4 ,sec4 #cjf4 ,guidance for participation in exercises and drills4 ,title ,,iv--,prioritizing a threat-based approach ,sec4 #dja4 ,assistant ,secretary for ,preparedness and ,response4 ,sec4 #djb4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise4 ,sec4 #djc4 ,strategic ,national ,stockpile4 ,sec4 #djd4 ,preparing for pandemic influenza1 antimicrobial resistance1 and other significant threats4 ,sec4 #dje4 ,reporting on the ,federal ,select ,agent ,program4 ,title ,v--,increasing communication in medical countermeasure advanced research and development ,sec4 #eja4 ,medical countermeasure budget plan4 ,sec4 #ejb4 ,material threat and medical countermeasure notifications4 ,sec4 #ejc4 ,availability of regulatory management plans4 ,sec4 #ejd4 ,the ,biomedical ,advanced ,research and ,development ,authority and the ,bio,shield ,special ,reserve ,fund4 ,sec4 #eje4 ,additional strategies for combating antibiotic resistance4 ,title ,,vi--,advancing technologies for medical countermeasures ,sec4 #fja4 ,administration of countermeasures4 ,sec4 #fjb4 ,updating definitions of other transactions4 ,sec4 #fjc4 ,medical countermeasure master files4 ,sec4 #fjd4 ,animal rule report4 ,sec4 #fje4 ,review of the benefits of genomic engineering technologies and their potential role in national security4 ,sec4 #fjf4 ,report on vaccines development4 ,sec4 #fjg4 ,strengthening mosquito abatement for safety and health4 ,title ,,vii--,miscellaneous provisions ,sec4 #gja4 ,reauthorizations and extensions4 ,sec4 #gjb4 ,location of materials in the stockpile4 ,sec4 #gjc4 ,cybersecurity4 ,sec4 #gjd4 ,strategy and report4 ,sec4 #gje4 ,technical amendments4 ,division ,b--,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,sec4 #ajjj4 ,short title2 references in division4 ,title ,i--,,otc ,drug ,review ,sec4 #ajja4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application4 ,sec4 #ajjb4 ,misbranding4 ,sec4 #ajjc4 ,drugs excluded from the over-the-counter drug review4 ,sec4 #ajjd4 ,treatment of ,sunscreen ,innovation ,act4 ,sec4 #ajje4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs4 ,sec4 #ajjf4 ,technical corrections4 ,title ,,ii--,user ,fees ,sec4 #bjja4 ,short title2 finding4 ,sec4 #bjjb4 ,fees relating to over-the-counter drugs4 ,a ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation #ajj4 ,references in division ,except as otherwise specified-- 7#a7 amendments made by this division to a section or other provision of law are amendments to such section or other provision of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq472 and 7#b7 any reference to this ,act contained in this division shall be treated as referring only to the provisions of this division4 ,i ,strengthening the national health security strategy #aja4 ,national ,health ,security ,strategy ,section #bhjb 7#db ,u4,s4,c4 #cjj;hh-#a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by striking #bjad and inserting #bjah2 and 7ii7 by striking the second sentence and inserting the following3 ,such ,national ,health ,security ,strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection 7b7 to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal 7as described in section #ejd7;a77#ai7 of the ,homeland ,security ,act of #bjjb71 the ,national ,incident ,management ,system 7as defined in section #eja7g7 of such ,act71 and the ,national ,response ,plan developed pursuant to section #ejd of such ,act1 or any successor plan42 7,b7 in paragraph 7#b71 by inserting before the period at the end of the second sentence the following3 1 and an analysis of any changes to the evidence-based benchmarks and objective standards under sections #cai;,c-#a and #cai;,c-#b2 and 7,c7 in paragraph 7#c7-- 7i7 by striking #bjji and inserting #bjbb2 7ii7 by inserting 7including gaps in the environmental health and animal health workforces1 as applicable71 describing the status of such workforce after gaps in such workforce2 7iii7 by striking and identifying strategies and inserting identifying strategies2 and 7iv7 by inserting before the period at the end 1 and identifying current capabilities to meet the requirements of section #bhjc2 and 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking and investigation and inserting investigation1 and related information technology activities2 7ii7 in subparagraph 7,b71 by striking and decontamination and inserting decontamination1 relevant health care services and supplies1 and transportation and disposal of medical waste2 and 7iii7 by adding at the end the following3 7,e7 ,response to environmental hazards4 2 7,b7 in paragraph 7#c7-- 7i7 in the matter preceding subparagraph 7,a71 by striking including mental health and inserting including pharmacies1 mental health facilities12 and 7ii7 in subparagraph 7,f71 by inserting or exposures to agents that could cause a public health emergency before the period2 7,c7 in paragraph 7#e71 by inserting and other applicable compacts after ,compact2 and 7,d7 by adding at the end the following3 7#i7 ,zoonotic disease1 food1 and agriculture ,improving coordination among ,federal1 ,state1 local1 ,tribal1 and territorial entities 7including through consultation with the ,secretary of ,agriculture7 to prevent1 detect1 and respond to outbreaks of plant or animal disease 7including zoonotic disease7 that could compromise national security resulting from a deliberate attack1 a naturally occurring threat1 the intentional adulteration of food1 or other public health threats1 taking into account interactions between animal health1 human health1 and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities1 as applicable4 7#aj7 ,global health security ,assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities4 4 ,,ii ,improving preparedness and response #bja4 ,improving benchmarks and standards for preparedness and response 7a7 ,evaluating measurable evidence-,based benchmarks and objective standards ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended by inserting after subsection 7j7 the following3 7k7 ,evaluation 7#a7 ,in general ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai and every #b years thereafter1 the ,secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection 7g74 ,such evaluation shall be submitted to the congressional committees of jurisdiction together with the ,national ,health ,security ,strategy under section #bhjb1 at such time as such strategy is submitted4 7#b7 ,content ,the evaluation under this paragraph shall include-- 7,a7 a review of evidence-based benchmarks and objective standards1 and associated metrics and targets2 7,b7 a discussion of changes to any evidence-based benchmarks and objective standards1 and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and1 to the extent practicable1 the applicable goals of the ,national ,health ,security ,strategy under section #bhjb2 7,c7 a description of amounts received by eligible entities described in subsection 7b7 and section #cai;,c-#b7;b71 and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards2 and 7,d7 recommendations1 as applicable and appropriate1 to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section #bhjb4 4 7b7 ,evaluating the partnership for ,state and regional hospital preparedness ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg-c;b7i77#a77 is amended by striking section #cai;,c-#a7;g71 7i71 and 7j7 and inserting section #cai;,c-#a7;g71 7i71 7j71 and 7k74 #bjb4 ,amendments to preparedness and response programs 7a7 ,cooperative agreement applications for improving ,state and local public health security ,section #cai;,c-#a 7#db ,u4,s4,c4 #bdg;d-#c;a7 is amended-- 7#a7 in subsection 7a71 by inserting 1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 after the ,secretary2 and 7#b7 in subsection 7b77#b77;,a7-- 7,a7 in clause 7vi71 by inserting 1 including public health agencies with specific expertise that may be relevant to public health security1 such as environmental health agencies1 after stakeholders2 7,b7 by redesignating clauses 7vii7 through 7ix7 as clauses 7viii7 through 7x72 7,c7 by inserting after clause 7vi7 the following3 7vii7 a description of how1 as applicable1 such entity may integrate information to account for individuals with behavioral health needs following a public health emergency2 2 7,d7 in clause 7ix71 as so redesignated1 by striking 2 and and inserting a semicolon2 and 7,e7 by adding at the end the following3 7xi7 a description of how the entity will partner with health care facilities1 including hospitals and nursing homes and other long-term care facilities1 to promote and improve public health preparedness and response2 and 7xii7 a description of how1 as appropriate and practicable1 the entity will include critical infrastructure partners1 such as utility companies within the entity's jurisdiction1 in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during1 or return to function as soon as practicable after1 a public health emergency2 4 7b7 ,exception relating to application of certain requirements 7#a7 ,in general ,section #cai;,c-#a7;g7 7#db ,u4,s4,c4 #bdg;d-#c;a7g77 is amended-- 7,a7 in paragraph 7#e7-- 7i7 in the matter preceding subparagraph 7,a71 by striking ,beginning with fiscal year #bjji and inserting ,beginning with fiscal year #bjai2 and 7ii7 in subparagraph 7,a7-- 7,i7 by striking for the immediately preceding fiscal year and inserting for either of the #b immediately preceding fiscal years2 and 7,,ii7 by striking #bjjh and inserting #bjah2 and 7,b7 in paragraph 7#f71 by amending subparagraph 7,a7 to read as follows3 7,a7 ,in general ,the amounts described in this paragraph are the following amounts that are payable to an entity for activities described in this section or section #cai;,c-#b3 7i7 ,for no more than #a of each of the first #b fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph 7,a7 or 7,b7 of paragraph 7#e71 an amount equal to #aj percent of the amount the entity was eligible to receive for the respective fiscal year4 7ii7 ,for no more than #a of the first #b fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure1 in lieu of applying clause 7i71 an amount equal to #ae percent of the amount the entity was eligible to receive for the respective fiscal year4 4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply with respect to cooperative agreements awarded on or after the date of enactment of this ,act4 7c7 ,partnership for ,state and regional hospital preparedness ,to improve surge capacity ,section #cai;,c-#b 7#db ,u4,s4,c4 #bdg;d-#c;b7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 1 acting through the ,assistant ,secretary for ,preparedness and ,response1 after ,the ,secretary2 and 7,b7 by striking preparedness for public health emergencies and inserting preparedness for1 and response to1 public health emergencies in accordance with subsection 7c72 7#b7 in subsection 7b77#a77;,a7-- 7,a7 by striking partnership consisting of and inserting coalition that includes2 7,b7 in clause 7ii71 by striking 2 and and inserting a semicolon2 and 7,c7 by adding at the end the following3 7iv7 one or more emergency medical service organizations or emergency management organizations2 and 2 7#c7 in subsection 7d7-- 7,a7 in paragraph 7#a77;,b71 by striking partnership each place it appears and inserting coalition2 and 7,b7 in paragraph 7#b77;,c71 by striking medical preparedness and inserting preparedness and response2 7#d7 in subsection 7f71 by striking partnership and inserting coalition2 7#e7 in subsection 7g77#b7-- 7,a7 by striking ,partnerships and inserting ,coalitions2 7,b7 by striking partnerships and inserting coalitions2 and 7,c7 by inserting and response after preparedness2 and 7#f7 in subsection 7i77#a7-- 7,a7 by striking ,an entity and inserting ,a coalition2 and 7,b7 by striking such partnership and inserting such coalition4 7d7 ,public health security grants authorization of appropriations ,section #cai;,c-#a7;h77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;a7h77#a77;,a77 is amended by striking #fda1ijj1jjj for fiscal year #bjad and all that follows through the period at the end and inserting #fhe1jjj1jjj for each of fiscal years #bjai through #bjbc for awards pursuant to paragraph 7#c7 7subject to the authority of the ,secretary to make awards pursuant to paragraphs 7#d7 and 7#e7744 7e7 ,partnership for ,state and regional hospital preparedness authorization of appropriations ,section #cai;,c-#b7;j7 7#db ,u4,s4,c4 #bdg;d-#c;b7j77 is amended-- 7#a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,in general 7,a7 ,authorization of appropriations ,for purposes of carrying out this section and section #cai;,c-#c1 in accordance with subparagraph 7,b71 there is authorized to be appropriated #che1jjj1jjj for each of fiscal years #bjai through #bjbc4 7,b7 ,reservation of amounts for regional systems 7i7 ,in general ,subject to clause 7ii71 of the amount appropriated under subparagraph 7,a7 for a fiscal year1 the ,secretary may reserve up to #e percent for the purpose of carrying out section #cai;,c-#c4 7ii7 ,reservation contingent on continued appropriations for this section ,if for fiscal year #bjai or a subsequent fiscal year1 the amount appropriated under subparagraph 7,a7 is such that1 after application of clause 7i71 the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year1 the amount that may be reserved under clause 7i7 shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year4 7iii7 ,sunset ,the authority to reserve amounts under clause 7i7 shall expire on ,september #cj1 #bjbc4 2 7#b7 in paragraph 7#b71 by striking paragraph 7#a7 for a fiscal year and inserting paragraph 7#a77;,a7 for a fiscal year and not reserved for the purpose described in paragraph 7#a77;,b77i72 and 7#c7 in paragraph 7#c77;,a71 by striking paragraph 7#a7 and not reserved under paragraph 7#b7 and inserting paragraph 7#a77;,a7 and not reserved under paragraph 7#a77;,b77i7 or 7#b74 #bjc4 ,regional health care emergency preparedness and response systems 7a7 ,in general ,part ,b of title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai;,c-#b the following3 #cai;,c-#c4 ,guidelines for regional health care emergency preparedness and response systems 7a7 ,purpose ,it is the purpose of this section to identify and provide guidelines for regional systems of hospitals1 health care facilities1 and other public and private sector entities1 with varying levels of capability to treat patients and increase medical surge capacity during1 in advance of1 and immediately following a public health emergency1 including threats posed by one or more chemical1 biological1 radiological1 or nuclear agents1 including emerging infectious diseases4 7b7 ,guidelines ,the ,assistant ,secretary for ,preparedness and ,response1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,administrator of the ,health ,resources and ,services ,administration1 the ,commissioner of ,food and ,drugs1 the ,assistant ,secretary for ,mental ,health and ,substance ,use1 the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health1 the ,secretary of ,veterans ,affairs1 the heads of such other ,federal agencies as the ,secretary determines to be appropriate1 and ,state1 local1 ,tribal1 and territorial public health officials1 shall1 not later than #b years after the date of enactment of this section-- 7#a7 identify and develop a set of guidelines relating to practices and protocols for all-hazards public health emergency preparedness and response for hospitals and health care facilities to provide appropriate patient care during1 in advance of1 or immediately following1 a public health emergency1 resulting from one or more chemical1 biological1 radiological1 or nuclear agents1 including emerging infectious diseases 7which may include existing practices1 such as trauma care and medical surge capacity and capabilities71 with respect to-- 7,a7 a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency1 including-- 7i7 the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under section #cai;,c-#b7;b72 and 7ii7 informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community2 7,b7 physical and technological infrastructure1 laboratory capacity1 staffing1 blood supply1 and other supply chain needs1 taking into account resiliency1 geographic considerations1 and rural considerations2 7,c7 protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers 7including with respect to protective equipment and supplies1 waste management processes1 and decontamination71 sharing of specialized experience among the health care workforce1 behavioral health1 psychological resilience1 and training of the workforce1 as applicable2 7,d7 in a manner that allows for disease containment 7within the meaning of section #bhjb7;b77#b77;,b771 coordinated medical triage1 treatment1 and transportation of patients1 based on patient medical need 7including patients in rural areas71 to the appropriate hospitals or health care facilities within the regional system or1 as applicable and appropriate1 between systems in different ,states or regions2 and 7,e7 the needs of children and other at-risk individuals2 7#b7 make such guidelines available on the internet website of the ,department of ,health and ,human ,services in a manner that does not compromise national security2 and 7#c7 update such guidelines as appropriate1 including based on input received pursuant to subsections 7c7 and 7e7 and information resulting from applicable reports required under the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai 7including any amendments made by such ,act71 to address new and emerging public health threats4 7c7 ,considerations ,in identifying1 developing1 and updating guidelines under subsection 7b71 the ,assistant ,secretary for ,preparedness and ,response shall-- 7#a7 include input from hospitals and health care facilities 7including health care coalitions under section #cai;,c-#b71 ,state1 local1 ,tribal1 and territorial public health departments1 and health care or subject matter experts 7including experts with relevant expertise in chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases71 as the ,assistant ,secretary determines appropriate1 to meet the goals under section #bhjb7;b77#c72 7#b7 consult and engage with appropriate health care providers and professionals1 including physicians1 nurses1 first responders1 health care facilities 7including hospitals1 primary care clinics1 community health centers1 mental health facilities1 ambulatory care facilities1 and dental health facilities71 pharmacies1 emergency medical providers1 trauma care providers1 environmental health agencies1 public health laboratories1 poison control centers1 blood banks1 tissue banks1 and other experts that the ,assistant ,secretary determines appropriate1 to meet the goals under section #bhjb7;b77#c72 7#c7 consider feedback related to financial implications for hospitals1 health care facilities1 public health agencies1 laboratories1 blood banks1 tissue banks1 and other entities engaged in regional preparedness planning to implement and follow such guidelines1 as applicable2 and 7#d7 consider financial requirements and potential incentives for entities to prepare for1 and respond to1 public health emergencies as part of the regional health care emergency preparedness and response system4 7d7 ,technical assistance ,the ,assistant ,secretary for ,preparedness and ,response1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention and the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health1 may provide technical assistance and consultation toward meeting the guidelines described in subsection 7b74 7e7 ,demonstration project for regional health care preparedness and response systems 7#a7 ,in general ,the ,assistant ,secretary for ,preparedness and ,response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection 7b7 to award grants to improve medical surge capacity for all hazards1 build and integrate regional medical response capabilities1 improve specialty care expertise for all-hazards response1 and coordinate medical preparedness and response across ,state1 local1 ,tribal1 territorial1 and regional jurisdictions4 7#b7 ,sunset ,the authority under this subsection shall expire on ,september #cj1 #bjbc4 4 7b7 ,,gao report to ,congress 7#a7 ,report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states 7referred to in this subsection as the ,comptroller ,general7 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,finance of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives1 a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under section #cai;,c-#c7;b7 of the ,public ,health ,service ,act 7as added by subsection 7a771 including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines4 7#b7 ,content ,the ,comptroller ,general shall include in the report under paragraph 7#a7-- 7,a7 data on the preparedness and response capabilities that have been informed by the guidelines under section #cai;,c-#c7;b7 of the ,public ,health ,service ,act to improve regional emergency health care preparedness and response capability1 including hospital and health care facility capacity and medical surge capabilities to prepare for1 and respond to1 public health emergencies2 and 7,b7 recommendations to reduce gaps in incentives for regional health partners1 including hospitals and health care facilities1 to improve capacity and medical surge capabilities to prepare for1 and respond to1 public health emergencies1 consistent with subsection 7a71 which may include consideration of facilities participating in programs under section #cai;,c-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#c;b7 or in programs under the ,centers for ,medicare ,medicaid ,services 7including innovative health care delivery and payment models71 and input from private sector financial institutions4 7#c7 ,consultation ,in carrying out paragraphs 7#a7 and 7#b71 the ,comptroller ,general shall consult with the heads of appropriate ,federal agencies1 including-- 7,a7 the ,assistant ,secretary for ,preparedness and ,response2 7,b7 the ,director of the ,centers for ,disease ,control and ,prevention2 7,c7 the ,administrator of the ,centers for ,medicare ,medicaid ,services2 7,d7 the ,assistant ,secretary for ,mental ,health and ,substance ,use2 7,e7 the ,assistant ,secretary of ,labor for ,occupational ,safety and ,health2 and 7,f7 the ,secretary of ,veterans ,affairs4 7c7 ,annual reports ,section #cai;,c-#b7;i77#a7 7#db ,u4,s4,c4 #bdg;d-#c;b7i77#a77 is amended by inserting after the first sentence the following3 ,in submitting reports under this paragraph1 a coalition shall include information on the progress that the coalition has made toward the implementation of section #cai;,c-#c 7or barriers to progress1 if any744 7d7 ,national health security strategy incorporation of regionalized emergency preparedness and response ,subparagraph 7,g7 of section #bhjb7;b77#c7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#c77 is amended to read as follows3 7,g7 ,optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals1 other health care facilities1 critical care1 trauma care 7which may include trauma centers71 and emergency medical systems4 4 7e7 ,improving ,state and local public health security 7#a7 ,state and local security ,section #cai;,c-#a7;e7 7#db ,u4,s4,c4 #bdg;d-#c;a7e77 is amended by striking 1 and local emergency plans4 and inserting 1 local emergency plans1 and any regional health care emergency preparedness and response system established pursuant to the applicable guidelines under section #cai;,c-#c44 7#b7 ,partnerships ,section #cai;,c-#b7;d77#a77;,a7 7#db ,u4,s4,c4 #bdg;d-#c;b7d77#a77;,a77 is amended-- 7,a7 in clause 7i71 by striking 2 and and inserting 22 7,b7 by redesignating clause 7ii7 as clause 7iii72 and 7,c7 by inserting after clause 7i7 the following3 7ii7 among one or more facilities in a regional health care emergency system under section #cai;,c-#c2 and 4 #bjd4 ,military and civilian partnership for trauma readiness ,title ,,xii 7#db ,u4,s4,c4 #cjj;d et seq47 is amended by adding at the end the following new part3 ,i ,military and ,civilian ,partnership for ,trauma ,readiness ,grant ,program #abia4 ,military and ,civilian ,partnership for ,trauma ,readiness ,grant ,program 7a7 ,military trauma team placement program 7#a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response and in consultation with the ,secretary of ,defense1 shall award grants to not more than #bj eligible high-acuity trauma centers to enable military trauma teams to provide1 on a full-time basis1 trauma care and related acute care at such trauma centers4 7#b7 ,limitations ,in the case of a grant awarded under paragraph 7#a7 to an eligible high-acuity trauma center1 such grant-- 7,a7 shall be for a period of at least #c years and not more than #e years 7and may be renewed at the end of such period72 and 7,b7 shall be in an amount that does not exceed #a1jjj1jjj per year4 7#c7 ,availability of funds ,notwithstanding section #aeeb of title #ca1 ,united ,states ,code1 or any other provision of law1 funds available to the ,secretary for obligation for a grant under this subsection shall remain available for expenditure for #ajj days after the last day of the performance period of such grant4 7b7 ,military trauma care provider placement program 7#a7 ,in general ,the ,secretary1 acting through the ,assistant ,secretary for ,preparedness and ,response and in consultation with the ,secretary of ,defense1 shall award grants to eligible trauma centers to enable military trauma care providers to provide trauma care and related acute care at such trauma centers4 7#b7 ,limitations ,in the case of a grant awarded under paragraph 7#a7 to an eligible trauma center1 such grant-- 7,a7 shall be for a period of at least #a year and not more than #c years 7and may be renewed at the end of such period72 and 7,b7 shall be in an amount that does not exceed1 in a year-- 7i7 #ajj1jjj for each military trauma care provider that is a physician at such eligible trauma center2 and 7ii7 #ej1jjj for each other military trauma care provider at such eligible trauma center4 7c7 ,grant requirements 7#a7 ,deployment and public health emergencies ,as a condition of receipt of a grant under this section1 a grant recipient shall agree to allow military trauma care providers providing care pursuant to such grant to-- 7,a7 be deployed by the ,secretary of ,defense for military operations1 for training1 or for response to a mass casualty incident2 and 7,b7 be deployed by the ,secretary of ,defense1 in consultation with the ,secretary of ,health and ,human ,services1 for response to a public health emergency pursuant to section #cai4 7#b7 ,use of funds ,grants awarded under this section to an eligible trauma center may be used to train and incorporate military trauma care providers into such trauma center1 including incorporation into operational exercises and training drills related to public health emergencies1 expenditures for malpractice insurance1 office space1 information technology1 specialty education and supervision1 trauma programs1 research1 and applicable license fees for such military trauma care providers4 7d7 ,rule of construction ,nothing in this section shall be construed to affect any other provision of law that preempts ,state licensing requirements for health care professionals1 including with respect to military trauma care providers4 7e7 ,reporting requirements 7#a7 ,report to the secretary and the secretary of defense ,each eligible trauma center or eligible high-acuity trauma center awarded a grant under subsection 7a7 or 7b7 for a year shall submit to the ,secretary and the ,secretary of ,defense a report for such year that includes information on-- 7,a7 the number and types of trauma cases managed by military trauma teams or military trauma care providers pursuant to such grant during such year2 7,b7 the ability to maintain the integration of the military trauma providers or teams of providers as part of the trauma center1 including the financial effect of such grant on the trauma center2 7,c7 the educational effect on resident trainees in centers where military trauma teams are assigned2 7,d7 any research conducted during such year supported by such grant2 and 7,e7 any other information required by the ,secretaries for the purpose of evaluating the effect of such grant4 7#b7 ,report to congress ,not less than once every #b years1 the ,secretary1 in consultation with the ,secretary of ,defense1 shall submit a report to the congressional committees of jurisdiction that includes information on the effect of placing military trauma care providers in trauma centers awarded grants under this section on-- 7,a7 maintaining military trauma care providers' readiness and ability to respond to and treat battlefield injuries2 7,b7 providing health care to civilian trauma patients in urban and rural settings2 7,c7 the capability of trauma centers and military trauma care providers to increase medical surge capacity1 including as a result of a large-scale event2 7,d7 the ability of grant recipients to maintain the integration of the military trauma providers or teams of providers as part of the trauma center2 7,e7 efforts to incorporate military trauma care providers into operational exercises and training and drills for public health emergencies2 and 7,f7 the capability of military trauma care providers to participate as part of a medical response during or in advance of a public health emergency1 as determined by the ,secretary1 or a mass casualty incident4 7f7 ,definitions ,for purposes of this part3 7#a7 ,eligible high-acuity trauma center ,the term eligible high-acuity trauma center means a ,level ,i trauma center that satisfies each of the following3 7,a7 ,such trauma center has an agreement with the ,secretary of ,defense to enable military trauma teams to provide trauma care and related acute care at such trauma center4 7,b7 ,at least #bj percent of patients treated at such trauma center in the most recent #c-month period for which data are available are treated for a major trauma at such trauma center4 7,c7 ,such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure performance1 quality1 and patient outcomes4 7,d7 ,such trauma center is an academic training center-- 7i7 affiliated with a medical school2 7ii7 that maintains residency programs and fellowships in critical trauma specialties and subspecialties1 and provides education and supervision of military trauma team members according to those specialties and subspecialties2 and 7iii7 that undertakes research in the prevention and treatment of traumatic injury4 7,e7 ,such trauma center serves as a medical and public health preparedness and response leader for its community1 such as by participating in a partnership for ,state and regional hospital preparedness established under section #cai;,c-#b or #cai;,c-#c4 7#b7 ,eligible trauma center ,the term eligible trauma center means a ,level ,i1 ,,ii1 or ,,iii trauma center that satisfies each of the following3 7,a7 ,such trauma center has an agreement with the ,secretary of ,defense to enable military trauma care providers to provide trauma care and related acute care at such trauma center4 7,b7 ,such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure performance1 quality1 and patient outcomes4 7,c7 ,such trauma center demonstrates a need for integrated military trauma care providers to maintain or improve the trauma clinical capability of such trauma center4 7#c7 ,major trauma ,the term major trauma means an injury that is greater than or equal to #ae on the injury severity score4 7#d7 ,military trauma team ,the term military trauma team means a complete military trauma team consisting of military trauma care providers4 7#e7 ,military trauma care provider ,the term military trauma care provider means a member of the ,armed ,forces who furnishes emergency1 critical care1 and other trauma acute care services 7including a physician1 surgeon1 physician assistant1 nurse1 nurse practitioner1 respiratory therapist1 flight paramedic1 combat medic1 or enlisted medical technician7 or other military trauma care provider as the ,secretary determines appropriate4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #aa1ejj1jjj for each of fiscal years #bjai through #bjbc4 4 #bje4 ,public health and health care system situational awareness and biosurveillance capabilities 7a7 ,facilities1 capacities1 and biosurveillance capabilities ,section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d7 is amended-- 7#a7 in the section heading1 by striking ,revitalizing and inserting ,facilities and capacities of2 7#b7 in subsection 7a7-- 7,a7 in the subsection heading1 by striking ,facilities2 capacities and inserting ,in general2 7,b7 in paragraph 7#a71 by striking and improved and inserting 1 improved1 and appropriately maintained2 7,c7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by striking expand1 enhance1 and improve and inserting expand1 improve1 enhance1 and appropriately maintain2 and 7,d7 by adding at the end the following3 7#d7 ,study of resources for facilities and capacities ,not later than ,june #a1 #bjbb1 the ,comptroller ,general of the ,united ,states shall conduct a study on ,federal spending in fiscal years #bjac through #bjah for activities authorized under this subsection4 ,such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs 7#b7 and 7#c71 including a specific accounting of1 and delineation between1 obligations and expenditures incurred for the construction1 renovation1 equipping1 and security upgrades of facilities and associated contracts under this subsection1 and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection 7b71 and shall identify the agency or agencies incurring such obligations and expenditures4 2 7#c7 in subsection 7b7-- 7,a7 in the subsection heading1 by striking national and inserting ,establishment of systems of public health2 7,b7 in paragraph 7#a77;,b71 by inserting immunization information systems1 after centers12 7,c7 in paragraph 7#b7-- 7i7 by inserting develop a plan to1 and after ,the ,secretary shall2 and 7ii7 by inserting and in a form readily usable for analytical approaches after in a secure manner2 and 7,d7 by amending paragraph 7#c7 to read as follows3 7#c7 ,standards 7,a7 ,in general ,not later than #a year after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary1 in cooperation with health care providers1 ,state1 local1 ,tribal1 and territorial public health officials1 and relevant ,federal agencies 7including the ,office of the ,national ,coordinator for ,health ,information ,technology and the ,national ,institute of ,standards and ,technology71 shall1 as necessary1 adopt technical and reporting standards1 including standards for interoperability as defined by section #cjjj1 for networks under paragraph 7#a7 and update such standards as necessary4 ,such standards shall be made available on the internet website of the ,department of ,health and ,human ,services1 in a manner that does not compromise national security4 7,b7 ,deference to standards development organizations ,in adopting and implementing standards under this subsection and subsection 7c71 the ,secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities4 2 7#d7 in subsection 7c7-- 7,a7 in paragraph 7#a7-- 7i7 by striking ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness ,reauthorization ,act of #bjac1 the ,secretary and inserting ,the ,secretary2 7ii7 by inserting 1 and improve as applicable and appropriate1 after shall establish2 7iii7 by striking of rapid and inserting of1 rapid2 and 7iv7 by striking such connectivity and inserting such interoperability2 7,b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,coordination and consultation ,in establishing and improving the network under paragraph 7#a71 the ,secretary shall-- 7,a7 facilitate coordination among agencies within the ,department of ,health and ,human ,services that provide1 or have the potential to provide1 information and data to1 and analyses for1 the situational awareness and biosurveillance network under paragraph 7#a71 including coordination among relevant agencies related to health care services1 the facilitation of health information exchange 7including the ,office of the ,national ,coordinator for ,health ,information ,technology71 and public health emergency preparedness and response2 and 7,b7 consult with the ,secretary of ,agriculture1 the ,secretary of ,commerce 7and the ,director of the ,national ,institute of ,standards and ,technology71 the ,secretary of ,defense1 the ,secretary of ,homeland ,security1 the ,secretary of ,veterans ,affairs1 and the heads of other ,federal agencies1 as the ,secretary determines appropriate4 2 7,c7 in paragraph 7#c7-- 7i7 by redesignating subparagraphs 7,a7 through 7,e7 as clauses 7i7 through 7v71 respectively1 and adjusting the margins accordingly2 7ii7 in clause 7iv71 as so redesignated-- 7,i7 by inserting immunization information systems1 after poison control12 and 7,,ii7 by striking and clinical laboratories and inserting 1 clinical laboratories1 and public environmental health agencies2 7iii7 by striking ,the network and inserting the following3 7,a7 ,in general ,the network 2 and 7iv7 by adding at the end the following3 7,b7 ,review ,not later than #b years after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai and every #f years thereafter1 the ,secretary shall conduct a review of the elements described in subparagraph 7,a74 ,such review shall include a discussion of the addition of any elements pursuant to clause 7v71 including elements added to advancing new technologies1 and identify any challenges in the incorporation of elements under subparagraph 7,a74 ,the ,secretary shall provide such review to the congressional committees of jurisdiction4 2 7,d7 in paragraph 7#e7-- 7i7 by redesignating subparagraphs 7,a7 through 7,d7 as clauses 7i7 through 7iv71 respectively1 and adjusting the margins accordingly2 7ii7 by striking ,in establishing and inserting the following3 7,a7 ,in general ,in establishing 2 7iii7 by adding at the end the following3 7,b7 ,public meeting 7i7 ,in general ,not later than #ahj days after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals1 functions1 and uses of the network described in paragraph 7#a7 and incorporating the elements described in paragraph 7#c77;,a74 7ii7 ,experts ,the public meeting shall include representatives of relevant ,federal agencies 7including representatives from the ,office of the ,national ,coordinator for ,health ,information ,technology and the ,national ,institute of ,standards and ,technology72 ,state1 local1 ,tribal1 and territorial public health officials2 stakeholders with expertise in biosurveillance and situational awareness2 stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness1 such as experts in informatics and data analytics 7including experts in prediction1 modeling1 or forecasting72 and other representatives as the ,secretary determines appropriate4 7iii7 ,topics ,such public meeting shall include a discussion of-- 7,i7 data elements1 including minimal or essential data elements1 that are voluntarily provided for such network1 which may include elements from public health and public and private health care entities1 to the extent practicable2 7,,ii7 standards and implementation specifications that may improve the collection1 analysis1 and interpretation of data during a public health emergency2 7,,iii7 strategies to encourage the access1 exchange1 and use of information2 7,,iv7 considerations for ,state1 local1 ,tribal1 and territorial capabilities and infrastructure related to data exchange and interoperability2 7,v7 privacy and security protections provided at the ,federal1 ,state1 local1 ,tribal1 and territorial levels1 and by nongovernmental stakeholders2 and 7,,vi7 opportunities for the incorporation of innovative technologies to improve the network4 2 and 7iv7 in subparagraph 7,a71 as so designated by clause 7ii7-- 7,i7 in clause 7i71 as so redesignated-- 7aa7 by striking as determined and inserting as adopted2 and 7bb7 by inserting and the ,national ,institute of ,standards and ,technology after ,office of the ,national ,coordinator for ,health ,information ,technology2 7,,ii7 in clause 7iii71 as so redesignated1 by striking 2 and and inserting a semicolon2 7,,iii7 in clause 7iv71 as so redesignated1 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7v7 pilot test standards and implementation specifications1 consistent with the process described in section #cjjb7;b77#c77;,c71 which ,state1 local1 ,tribal1 and territorial public health entities may utilize1 on a voluntary basis1 as a part of the network4 2 7,e7 by redesignating paragraph 7#f7 as paragraph 7#g72 7,f7 by inserting after paragraph 7#e7 the following3 7#f7 ,strategy and implementation plan 7,a7 ,in general ,not later than #ah months after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that-- 7i7 is informed by the public meeting under paragraph 7#e77;,b72 7ii7 includes a review and assessment of existing capabilities of the network and related infrastructure1 including input provided by the public meeting under paragraph 7#e77;,b72 7iii7 identifies and demonstrates the measurable steps the ,secretary will carry out to-- 7,i7 develop1 implement1 and evaluate the network described in paragraph 7#a71 utilizing elements described in paragraph 7#c77;,a72 7,,ii7 modernize and enhance biosurveillance activities1 including strategies to include innovative technologies and analytical approaches 7including prediction and forecasting for pandemics and all-hazards7 from public and private entities2 7,,iii7 improve information sharing1 coordination1 and communication among disparate biosurveillance systems supported by the ,department of ,health and ,human ,services1 including the identification of methods to improve accountability1 better utilize resources and workforce capabilities1 and incorporate innovative technologies within and across agencies2 and 7,,iv7 test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities2 7iv7 includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause 7iii72 and 7v7 establishes dates by which each measurable step under clause 7iii7 will be implemented4 7,b7 ,annual budget plan ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai and on an annual basis thereafter1 in accordance with the strategy and implementation plan under this paragraph1 the ,secretary shall1 taking into account recommendations provided by the ,national ,biodefense ,science ,board1 develop a budget plan based on the strategy and implementation plan under this section4 ,such budget plan shall include-- 7i7 a summary of resources previously expended to establish1 improve1 and utilize the nationwide public health situational awareness and biosurveillance network under paragraph 7#a72 7ii7 estimates of costs and resources needed to establish and improve the network under paragraph 7#a7 according to the strategy and implementation plan under subparagraph 7,a72 7iii7 the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities1 resources1 and authorities needed to address such gaps2 and 7iv7 a strategy to minimize and address such gaps and improve inefficiencies4 2 7,g7 in paragraph 7#g71 as so redesignated-- 7i7 in subparagraph 7,a71 by inserting 7taking into account zoonotic disease1 including gaps in scientific understanding of the interactions between human1 animal1 and environmental health7 after human health2 7ii7 in subparagraph 7,b7-- 7,i7 by inserting and gaps in surveillance programs after surveillance programs2 and 7,,ii7 by striking 2 and and inserting a semicolon2 7iii7 in subparagraph 7,c7-- 7,i7 by inserting 1 animal health organizations related to zoonotic disease1 after health care entities2 and 7,,ii7 by striking the period and inserting 2 and2 and 7iv7 by adding at the end the following3 7,d7 provide recommendations to the ,secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section #bhjb4 2 and 7,h7 by adding at the end the following3 7#h7 ,situational awareness and biosurveillance as a national security priority ,the ,secretary1 on a periodic basis as applicable and appropriate1 shall meet with the ,director of ,national ,intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network4 2 7#e7 in subsection 7d7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting environmental health agencies1 after public health agencies12 and 7ii7 by inserting immunization programs1 after poison control centers12 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7iii7 by adding after subparagraph 7,c7 the following3 7,d7 an implementation plan that may include measurable steps to achieve the purposes described in paragraph 7#a74 2 and 7,c7 by striking paragraph 7#e7 and inserting the following3 7#e7 ,technical assistance ,the ,secretary may provide technical assistance to ,states1 localities1 ,tribes1 and territories or a consortium of ,states1 localities1 ,tribes1 and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the ,secretary4 2 7#f7 by redesignating subsections 7f7 and 7g7 as subsections 7i7 and 7j71 respectively2 and 7#g7 by inserting after subsection 7e7 the following3 7f7 ,personnel authorities 7#a7 ,specially qualified personnel ,in addition to any other personnel authorities1 to carry out subsections 7b7 and 7c71 the ,secretary may-- 7,a7 appoint highly qualified individuals to scientific or professional positions at the ,centers for ,disease ,control and ,prevention1 not to exceed #cj such employees at any time 7specific to positions authorized by this subsection71 with expertise in capabilities relevant to biosurveillance and situational awareness1 such as experts in informatics and data analytics 7including experts in prediction1 modeling1 or forecasting71 and other related scientific or technical fields2 and 7,b7 compensate individuals appointed under subparagraph 7,a7 in the same manner and subject to the same terms and conditions in which individuals appointed under #iijc of title #e1 ,united ,states ,code1 are compensated1 without regard to the provisions of chapter #ea and subchapter ,,iii of chapter #ec of such title relating to classification and ,general ,schedule pay rates4 7#b7 ,limitations ,the ,secretary shall exercise the authority under paragraph 7#a7 in a manner that is consistent with the limitations described in section #cai;,f-#a7;e77#b74 7g7 ,timeline ,the ,secretary shall accomplish the purposes under subsections 7b7 and 7c7 no later than ,september #cj1 #bjbc1 and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection 7c77#f77;,a77iii74 7h7 ,independent evaluation ,not later than #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation and submit to the ,secretary and the congressional committees of jurisdiction a report concerning the activities conducted under subsections 7b7 and 7c71 and provide recommendations1 as applicable and appropriate1 on necessary improvements to the biosurveillance and situational awareness network4 4 7b7 ,authorization of appropriations ,subsection 7i7 of section #cai;,d 7#db ,u4,s4,c4 #bdg;d-#d71 as redesignated by subsection 7a77#f71 is amended by striking #ach1cjj1jjj for each of fiscal years #bjad through #bjah and inserting #afa1hjj1jjj for each of fiscal years #bjai through #bjbc4 7c7 ,biological threat detection report ,the ,secretary of ,health and ,human ,services shall1 in coordination with the ,secretary of ,defense and the ,secretary of ,homeland ,security1 not later than #ahj days after the date of enactment of this ,act1 report to the ,committee on ,energy and ,commerce1 the ,committee on ,armed ,services1 and the ,committee on ,homeland ,security of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,armed ,services1 and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate on the state of ,federal biological threat detection efforts1 including the following3 7#a7 ,an identification of technological1 operational1 and programmatic successes and failures of domestic detection programs supported by ,federal departments and agencies for intentionally introduced or accidentally released biological threat agents and naturally occurring infectious diseases4 7#b7 ,a description of ,federal efforts to facilitate the exchange of information related to the information described in paragraph 7#a7 among ,federal departments and agencies that utilize biological threat detection technology4 7#c7 ,a description of the capabilities of detection systems in use by ,federal departments and agencies including the capability to-- 7,a7 rapidly detect1 identify1 characterize1 and confirm the presence of biological threat agents2 7,b7 recover live biological agents from collection devices2 7,c7 determine the geographical distribution of biological agents2 7,d7 determine the extent of environmental contamination and persistence of biological agents2 and 7,e7 provide advanced molecular diagnostics to ,state1 local1 ,tribal1 and territorial public health and other laboratories that support biological threat detection activities4 7#d7 ,a description of ,federal interagency coordination related to biological threat detection4 7#e7 ,a description of efforts by ,federal departments and agencies that utilize biological threat detection technology to collaborate with ,state1 local1 ,tribal1 and territorial public health laboratories and other users of biological threat detection systems1 including collaboration regarding the development of-- 7,a7 biological threat detection requirements or standards2 7,b7 a standardized integration strategy2 7,c7 training requirements or guidelines2 7,d7 guidelines for a coordinated public health response1 including preparedness capabilities1 and1 as applicable1 for coordination with public health surveillance systems2 and 7,e7 a coordinated environmental remediation plan1 as applicable4 7#f7 ,recommendations related to research1 advanced research1 development1 and procurement for ,federal departments and agencies to improve and enhance biological threat detection systems1 including recommendations on the transfer of biological threat detection technology among ,federal departments and agencies1 as necessary and appropriate4 #bjf4 ,strengthening and supporting the public health emergency rapid response fund ,section #cai 7#db ,u4,s4,c4 #bdg;d7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#a7-- 7i7 in the first sentence1 by inserting or if the ,secretary determines there is the significant potential for a public health emergency1 to allow the ,secretary to rapidly respond to the immediate needs resulting from such public health emergency or potential public health emergency before the period2 and 7ii7 by inserting ,the ,secretary shall plan for the expedited distribution of funds to appropriate agencies and entities4 after the first sentence2 7,b7 by redesignating paragraph 7#b7 as paragraph 7#c72 7,c7 by inserting after paragraph 7#a7 the following3 7#b7 ,uses ,the ,secretary may use amounts in the ,fund established under paragraph 7#a71 to-- 7,a7 facilitate coordination between and among ,federal1 ,state1 local1 ,tribal1 and territorial entities and public and private health care entities that the ,secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph 7#a7 7including communication of such entities with relevant international entities1 as applicable72 7,b7 make grants1 provide for awards1 enter into contracts1 and conduct supportive investigations pertaining to a public health emergency or potential public health emergency1 including further supporting programs under section #cai;,c-#a1 #cai;,c-#b1 or #cai;,c-#c2 7,c7 facilitate and accelerate1 as applicable1 advanced research and development of security countermeasures 7as defined in section #cai;,f-#b71 qualified countermeasures 7as defined in section #cai;,f-#a71 or qualified pandemic or epidemic products 7as defined in section #cai;,f-#c71 that are applicable to the public health emergency or potential public health emergency under paragraph 7#a72 7,d7 strengthen biosurveillance capabilities and laboratory capacity to identify1 collect1 and analyze information regarding such public health emergency or potential public health emergency1 including the systems under section #cai;,d2 7,e7 support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section #bhab and the ,medical ,reserve ,corps under section #bhac2 and 7,f7 carry out other activities1 as the ,secretary determines applicable and appropriate4 2 and 7,d7 by inserting after paragraph 7#c71 as so redesignated1 the following3 7#d7 ,review ,not later than #b years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary1 in coordination with the ,assistant ,secretary for ,preparedness and ,response1 shall conduct a review of the ,fund under this section and provide recommendations to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives on policies to improve such ,fund for the uses described in paragraph 7#b74 7#e7 ,,gao report ,not later than #d years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,comptroller ,general of the ,united ,states shall-- 7,a7 conduct a review of the ,fund under this section1 including its uses and the resources available in the ,fund2 and 7,b7 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on such review1 including recommendations related to such review1 as applicable4 2 and 7#b7 in subsection 7c7-- 7,a7 by inserting rapidly respond to public health emergencies or potential public health emergencies and after used to2 and 7,b7 by striking section4 and inserting ,act or funds otherwise provided for emergency response44 #bjg4 ,improving all-hazards preparedness and response by public health emergency volunteers 7a7 ,in general ,section #cai;,i 7#db ,u4,s4,c4 #bdg;d-#g;b7 is amended-- 7#a7 in the section heading1 by striking ,health ,professions ,volunteers and inserting ,volunteer ,health ,professional2 7#b7 in subsection 7a71 by adding at the end the following3 ,such health care professionals may include members of the ,national ,disaster ,medical ,system1 members of the ,medical ,reserve ,corps1 and individual health care professionals42 7#c7 in subsection 7i71 by adding at the end the following3 ,in order to inform the development of such mechanisms by ,states1 the ,secretary shall make available information and material provided by ,states that have developed mechanisms to waive the application of licensing requirements to applicable health professionals seeking to provide medical services during a public health emergency4 ,such information shall be made publicly available in a manner that does not compromise national security42 and 7#d7 in subsection 7k71 by striking #bjad through #bjah and inserting #bjai through #bjbc4 7b7 ,all-,hazards ,public ,health ,emergency ,preparedness and ,response ,plan ,section #cai;,c-#a7;b77#b77;,a77iv7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77;,a77iv77 is amended to read as follows3 7iv7 a description of the mechanism the entity will implement to utilize the ,emergency ,management ,assistance ,compact1 or other mutual aid agreement1 for medical and public health mutual aid1 and1 as appropriate1 the activities such entity will implement pursuant to section #cai;,i to improve enrollment and coordination of volunteer health care professionals seeking to provide medical services during a public health emergency1 which may include-- 7,i7 providing a public method of communication for purposes of volunteer coordination 7such as a phone number72 7,,ii7 providing for optional registration to participate in volunteer services during processes related to ,state medical licensing1 registration1 or certification or renewal of such licensing1 registration1 or certification2 or 7,,iii7 other mechanisms as the ,state determines appropriate2 4 #bjh4 ,clarifying ,state liability law for volunteer health care professionals 7a7 ,in general ,title ,,ii 7#db ,u4,s4,c4 #bjb et seq47 is amended by inserting after section #bbd the following3 #bbe4 ,health care professionals assisting during a public health emergency 7a7 ,limitation on liability ,notwithstanding any other provision of law1 a health care professional who is a member of the ,medical ,reserve ,corps under section #bhac or who is included in the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals under section #cai;,i and who-- 7#a7 is responding-- 7,a7 to a public health emergency determined under section #cai7;a71 during the initial period of not more than #ij days 7as determined by the ,secretary7 of the public health emergency determination 7excluding any period covered by a renewal of such determination72 or 7,b7 to a major disaster or an emergency as declared by the ,president under section #dja of the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act 7#db ,u4,s4,c4 #eagj7 or under section #bja of the ,national ,emergencies ,act 7#ej ,u4,s4,c4 #afba7 during the initial period of such declaration2 7#b7 is alleged to be liable for an act or omission-- 7,a7 during the initial period of a determination or declaration described in paragraph 7#a7 and related to the treatment of individuals in need of health care services due to such public health emergency1 major disaster1 or emergency2 7,b7 in the ,state or ,states for which such determination or declaration is made2 7,c7 in the health care professional's capacity as a member of the ,medical ,reserve ,corps or a professional included in the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals under section #cai;,i2 and 7,d7 in the course of providing services that are within the scope of the license1 registration1 or certification of the professional1 as defined by the ,state of licensure1 registration1 or certification2 and 7#c7 prior to the rendering of such act or omission1 was authorized by the ,state's authorization of deploying such ,state's ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals described in section #cai;,i or the ,medical ,reserve ,corps established under section #bhac1 to provide health care services1 shall be subject only to the ,state liability laws of the ,state in which such act or omission occurred1 in the same manner and to the same extent as a similar health care professional who is a resident of such ,state would be subject to such ,state laws1 except with respect to the licensure1 registration1 and certification of such individual4 7b7 ,volunteer protection act ,nothing in this section shall be construed to affect an individual's right to protections under the ,volunteer ,protection ,act of #aiig4 7c7 ,preemption ,this section shall supersede the laws of any ,state that would subject a health care professional described in subsection 7a7 to the liability laws of any ,state other than the ,state liability laws to which such individual is subject pursuant to such subsection4 7d7 ,definitions ,in this section3 7#a7 ,the term health care professional means an individual licensed1 registered1 or certified under ,federal or ,state laws or regulations to provide health care services4 7#b7 ,the term health care services means any services provided by a health care professional1 or by any individual working under the supervision of a health care professional1 that relate to-- 7,a7 the diagnosis1 prevention1 or treatment of any human disease or impairment2 or 7,b7 the assessment or care of the health of human beings4 7e7 ,effective date 7#a7 ,in general ,this section shall take effect #ij days after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai4 7#b7 ,application ,this section shall apply to a claim for harm only if the act or omission that caused such harm occurred on or after the effective date described in paragraph 7#a74 4 7b7 ,,gao study ,not later than one year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a review of-- 7#a7 the number of health care providers who register under the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals under section #cai;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b7 in advance to provide services during a public health emergency2 7#b7 the number of health care providers who are credentialed to provide services during the period of a public health emergency declaration1 including those who are credentialed though programs established in the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals under such section #cai;,i and those credentialed by authorities within the ,state in which the emergency occurred2 7#c7 the average time to verify the credentials of a health care provider during the period of a public health emergency declaration1 including the average time pursuant to the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals under such section #cai;,i and for an individual's credentials to be verified by an authority within the ,state2 and 7#d7 the ,emergency ,system for ,advance ,registration of ,volunteer ,health ,professionals program in ,states1 including whether physician or medical groups1 associations1 or other relevant provider organizations utilize such program for purposes of volunteering during public health emergencies4 #bji4 ,report on adequate national blood supply ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report containing recommendations related to maintaining an adequate national blood supply1 including-- 7#a7 challenges associated with the continuous recruitment of blood donors 7including those newly eligible to donate72 7#b7 ensuring the adequacy of the blood supply in the case of public health emergencies2 7#c7 implementation of the transfusion transmission monitoring system2 and 7#d7 other measures to promote safety and innovation1 such as the development1 use1 or implementation of new technologies1 processes1 and procedures to improve the safety and reliability of the blood supply4 #baj4 ,report on the public health preparedness and response capabilities and capacities of hospitals1 long-term care facilities1 and other health care facilities 7a7 ,study 7#a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall enter into an agreement with an appropriate entity to conduct a study regarding the public health preparedness and response capabilities and medical surge capacities of hospitals1 long-term care facilities1 and other health care facilities to prepare for1 and respond to1 public health emergencies1 including natural disasters4 7#b7 ,consultation ,in conducting the study under paragraph 7#a71 the entity shall consult with ,federal1 ,state1 local1 ,tribal1 and territorial public health officials 7as appropriate71 and health care providers and facilities with experience in public health preparedness and response activities4 7#c7 ,evaluation ,the study under paragraph 7#a7 shall include-- 7,a7 an evaluation of the current benchmarks and objective standards1 as applicable1 related to programs that support hospitals1 long-term care facilities1 and other health care facilities1 and their effect on improving public health preparedness and response capabilities and medical surge capacities1 including the ,hospital ,preparedness ,program1 the ,public ,health ,emergency ,preparedness cooperative agreements1 and the ,regional ,health ,care ,emergency ,preparedness and ,response ,systems under section #cai;,c-#c of the ,public ,health ,service ,act 7as added by section #bjc72 7,b7 the identification of gaps in preparedness1 including with respect to such benchmarks and objective standards1 such as those identified during recent public health emergencies1 for hospitals1 long-term care facilities1 and other health care facilities to address future potential public health threats2 7,c7 an evaluation of coordination efforts between the recipients of ,federal funding for programs described in subparagraph 7,a7 and entities with expertise in emergency power systems and other critical infrastructure partners during a public health emergency1 to ensure a functioning critical infrastructure1 to the greatest extent practicable1 during a public health emergency2 7,d7 an evaluation of coordination efforts between the recipients of ,federal funding for programs described in subparagraph 7,a7 and environmental health agencies with expertise in emergency preparedness and response planning for hospitals1 long-term care facilities1 and other health care facilities2 and 7,e7 an evaluation of current public health preparedness and response capabilities and medical surge capacities related to at-risk individuals during public health emergencies1 including an identification of gaps in such preparedness as they relate to such individuals4 7b7 ,report 7#a7 ,in general ,the agreement under subsection 7a7 shall require the entity to submit to the ,secretary of ,health and ,human ,services and the congressional committees of jurisdiction1 not later than #c years after the date of enactment of this ,act1 a report on the results of the study conducted pursuant to this section4 7#b7 ,contents ,the report under paragraph 7#a7 shall-- 7,a7 describe the findings and conclusions of the evaluation conducted pursuant to subsection 7a72 and 7,b7 provide recommendations for improving public health preparedness and response capability and medical surge capacity for hospitals1 long-term care facilities1 and other health care facilities1 including-- 7i7 improving the existing benchmarks and objective standards for the ,federal grant programs described in subsection 7a77#c77;,a7 or developing new benchmarks and standards for such programs2 and 7ii7 identifying best practices for improving public health preparedness and response programs and medical surge capacity at hospitals1 long-term care facilities1 and other health care facilities1 including recommendations for the evaluation under subparagraphs 7,c7 and 7,d7 of subsection 7a77#c74 ,,iii ,reaching all communities #cja4 ,strengthening and assessing the emergency response workforce 7a7 ,national ,disaster ,medical ,system 7#a7 ,strengthening the ,national ,disaster ,medical ,system ,clause 7ii7 of section #bhab7;a77#c77;,a7 7#db ,u4,s4,c4 #cjj;hh-#aa7;a77#c77;,a77 is amended to read as follows3 7ii7 be present at locations1 and for limited periods of time1 specified by the ,secretary on the basis that the ,secretary has determined that a location is at risk of a public health emergency during the time specified1 or there is a significant potential for a public health emergency4 4 7#b7 ,review of the national disaster medical system ,section #bhab7;b77#b7 7#db ,u4,s4,c4 #cjj;hh-#aa7;b77#b77 is amended to read as follows3 7#b7 ,joint review and medical surge capacity strategic plan 7,a7 ,review ,not later than #ahj days after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary1 in coordination with the ,secretary of ,homeland ,security1 the ,secretary of ,defense1 and the ,secretary of ,veterans ,affairs1 shall conduct a joint review of the ,national ,disaster ,medical ,system4 ,such review shall include-- 7i7 an evaluation of medical surge capacity1 as described in section #bhjc7;a72 7ii7 an assessment of the available workforce of the intermittent disaster response personnel described in subsection 7c72 7iii7 the capacity of the workforce described in clause 7ii7 to respond to all hazards1 including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency2 7iv7 the effectiveness of efforts to recruit1 retain1 and train such workforce2 and 7v7 gaps that may exist in such workforce and recommendations for addressing such gaps4 7,b7 ,updates ,as part of the ,national ,health ,security ,strategy under section #bhjb1 the ,secretary shall update the findings from the review under subparagraph 7,a7 and provide recommendations to modify the policies of the ,national ,disaster ,medical ,system as necessary4 4 7#c7 ,notification of shortage ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c77 is amended by adding at the end the following3 7#c7 ,notification ,not later than #cj days after the date on which the ,secretary determines the number of intermittent disaster-response personnel of the ,national ,disaster ,medical ,system is insufficient to address a public health emergency or potential public health emergency1 the ,secretary shall submit to the congressional committees of jurisdiction a notification detailing-- 7,a7 the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency2 and 7,b7 any identified measures to address such shortage4 7#d7 ,certain appointments 7,a7 ,in general ,if the ,secretary determines that the number of intermittent disaster response personnel within the ,national ,disaster ,medical ,system under this section is insufficient to address a public health emergency or potential public health emergency1 the ,secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system4 ,the ,secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect4 7,b7 ,sunset ,the authority under this paragraph shall expire on ,september #cj1 #bjba4 4 7#d7 ,authorization of appropriations ,section #bhab7;g7 7#db ,u4,s4,c4 #cjj;hh-#aa7;g77 is amended by striking #eb1gjj1jjj for each of fiscal years #bjad through #bjah and inserting #eg1djj1jjj for each of fiscal years #bjai through #bjbc4 7b7 ,volunteer medical reserve corps 7#a7 ,in general ,section #bhac7;a7 7#db ,u4,s4,c4 #db ,u4,s4,c4 #cjj;hh-#ae7;a77 is amended by striking the second sentence and inserting ,the ,secretary may appoint a ,director to head the ,corps and oversee the activities of the ,corps chapters that exist at the ,state1 local1 ,tribal1 and territorial levels44 7#b7 ,authorization of appropriations ,section #bhac7;i7 7#db ,u4,s4,c4 #cjj;hh-#ae7;i77 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 7c7 ,strengthening the ,epidemic ,intelligence ,service ,section #cag;,f 7#db ,u4,s4,c4 ,sec4 #bdg;b-#g7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by inserting or preparedness and response activities1 including rapid response to public health emergencies and significant public health threats after conduct prevention activities2 and 7ii7 by striking #ce1jjj and inserting #ej1jjj2 and 7,b7 in paragraph 7#b77;,b71 by striking #c years and inserting #b years2 and 7#b7 in subsection 7c7-- 7,a7 by striking ,for the purpose of carrying out this section and inserting the following3 7#a7 ,in general ,for the purpose of carrying out this section1 except as described in paragraph 7#b7 2 and 7,b7 by adding at the end the following3 7#b7 ,epidemic intelligence service program ,for purposes of carrying out this section with respect to qualified health professionals serving in the ,epidemic ,intelligence ,service1 as authorized under section #cag;,g1 there is authorized to be appropriated #a1jjj1jjj for each of fiscal years #bjai through #bjbc4 4 7d7 ,service benefit for ,national ,disaster ,medical ,system volunteers 7#a7 ,in general ,section #bhab7;c7 7#db ,u4,s4,c4 #cjj;hh-#aa7;c771 as amended by subsection 7a77#c71 is further amended by adding at the end the following3 7#e7 ,service benefit ,individuals appointed to serve under this subsection shall be considered eligible for benefits under part ,l of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh4 ,the ,secretary shall provide notification to any eligible individual of any effect such designation may have on other benefits for which such individual is eligible1 including benefits from private entities4 4 7#b7 ,public safety officer benefits ,section #abjd7i7 of title ,i of the ,omnibus ,crime ,control and ,safe ,streets ,act of #aifh 7#cd ,u4,s4,c4 #ajbhd7i77 is amended-- 7,a7 in subparagraph 7,c77ii71 by striking or at the end2 7,b7 in subparagraph 7,d71 by striking the period and inserting 2 or2 and 7,c7 by inserting after subparagraph 7,d7 the following3 7,e7 an individual appointed to the ,national ,disaster ,medical ,system under section #bhab of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#aa7 who is performing official duties of the ,department of ,health and ,human ,services1 if those official duties are-- 7i7 related to responding to a public health emergency or potential public health emergency1 or other activities for which the ,secretary of ,health and ,human ,services has activated such ,national ,disaster ,medical ,system2 and 7ii7 determined by the ,secretary of ,health and ,human ,services to be hazardous4 4 7#c7 ,sunset ,the amendments made by paragraphs 7#a7 and 7#b7 shall cease to have force or effect on ,october #a1 #bjba4 7e7 ,mission readiness report to ,congress 7#a7 ,report ,not later than one year after the date of enactment of this section1 the ,comptroller ,general of the ,united ,states 7referred to in this subsection as the ,comptroller ,general7 shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the medical surge capacity of the ,united ,states in the event of a public health emergency1 including the capacity and capability of the current health care workforce to prepare for1 and respond to1 the full range of public health emergencies or potential public health emergencies1 and recommendations to address any gaps identified in such workforce4 7#b7 ,contents ,the ,comptroller ,general shall include in the report under paragraph 7#a7-- 7,a7 the number of health care providers who have volunteered to provide health care services during a public health emergency1 including members of the ,national ,disaster ,medical ,system1 the ,disaster ,medical ,assistant ,teams1 the ,medical ,reserve ,corps1 and other volunteer health care professionals in the verification network pursuant to section #cai;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;b72 7,b7 the capacity of the workforce described in subparagraph 7,a7 to respond to a public health emergency or potential public health emergency1 including the capacity to respond to multiple concurrent public health emergencies and the capacity to respond to a nationwide public health emergency2 7,c7 the preparedness and response capabilities and mission readiness of the workforce described in subparagraph 7,a7 taking into account areas of health care expertise and considerations for at-risk individuals 7as defined in section #bhjb7;b77#d77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b7772 7,d7 an assessment of the effectiveness of efforts to recruit1 retain1 and train such workforce2 and 7,e7 identification of gaps that may exist in such workforce and recommendations for addressing such gaps1 the extent to which the ,assistant ,secretary for ,preparedness and ,response plans to address such gaps1 and any recommendations from the ,comptroller ,general to address such gaps4 #cjb4 ,health system infrastructure to improve preparedness and response 7a7 ,coordination of preparedness ,section #bhaa7;b77#e7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#e77 is amended by adding at the end the following3 ,such logistical support shall include working with other relevant ,federal1 ,state1 local1 ,tribal1 and territorial public health officials and private sector entities to identify the critical infrastructure assets1 systems1 and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster1 including entities capable of assisting with1 responding to1 and mitigating the effect of a public health emergency1 including a public health emergency determined by the ,secretary pursuant to section #cai7;a7 or an emergency or major disaster declared by the ,president under the ,robert ,t4 ,stafford ,disaster ,relief and ,emergency ,assistance ,act or the ,national ,emergencies ,act1 including by establishing methods to exchange critical information and deliver products consumed or used to preserve1 protect1 or sustain life1 health1 or safety1 and sharing of specialized expertise44 7b7 ,manufacturing ,capacity ,section #bhaa7;d77#b77;,c7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77#b77;,c77 is amended by inserting 1 and ancillary medical supplies to assist with the utilization of such countermeasures or products1 after products4 7c7 ,evaluation of barriers to rapid delivery of medical countermeasures 7#a7 ,rapid delivery study ,the ,assistant ,secretary for ,preparedness and ,response may conduct a study on issues that have the potential to adversely affect the handling and rapid delivery of medical countermeasures to individuals during public health emergencies occurring in the ,united ,states4 7#b7 ,notice to congress ,not later than #i months after the date of the enactment of this ,act1 the ,assistant ,secretary for ,preparedness and ,response shall notify the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate if the ,assistant ,secretary for ,preparedness and ,response does not plan to conduct the study under paragraph 7#a7 and shall provide such committees a summary explanation for such decision4 7#c7 ,report to ,congress ,not later than #a year after the ,assistant ,secretary for ,preparedness and ,response conducts the study under paragraph 7#a71 such ,assistant ,secretary shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate containing the findings of such study4 #cjc4 ,considerations for at-risk individuals 7a7 ,at-,risk individuals in the ,national ,health ,security ,strategy ,section #bhjb7;b77#d77;,b7 7#db ,u4,s4,c4 #cjj;hh-#a7;b77#d77;,b77 is amended-- 7#a7 by striking this section and sections #cai;,c-#a1 #cai;,f1 and #cai,l1 and inserting this ,act12 and 7#b7 by striking special and inserting access or functional4 7b7 ,countermeasure considerations ,section #cai,l7c77#f7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#f77 is amended-- 7#a7 by striking elderly and inserting older adults2 and 7#b7 by inserting with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products before the period4 7c7 ,biosurveillance of emerging public health threats ,section #bhad is amended-- 7#a7 in paragraph 7#g71 by striking 2 and and inserting a semicolon2 7#b7 in paragraph 7#h71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7#i7 facilitate coordination to ensure that1 in implementing the situational awareness and biosurveillance network under section #cai;,d1 the ,secretary considers incorporating data and information from ,federal1 ,state1 local1 ,tribal1 and territorial public health officials and entities relevant to detecting emerging public health threats that may affect at-risk individuals1 such as pregnant and postpartum women and infants1 including adverse health outcomes of such populations related to such emerging public health threats4 4 #cjd4 ,improving emergency preparedness and response considerations for children ,part ,b of title ,,iii 7#db ,u4,s4,c4 #bdc et seq47 is amended by inserting after section #cai;,d the following3 #cai;,d-#a4 ,children's preparedness unit 7a7 ,enhancing emergency preparedness for children ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention 7referred to in this subsection as the ,director71 shall maintain an internal team of experts1 to be known as the ,children's ,preparedness ,unit 7referred to in this subsection as the ,unit71 to work collaboratively to provide guidance on the considerations for1 and the specific needs of1 children before1 during1 and after public health emergencies4 ,the ,unit shall inform the ,director regarding emergency preparedness and response efforts pertaining to children at the ,centers for ,disease ,control and ,prevention4 7b7 ,expertise ,the team described in subsection 7a7 shall include one or more pediatricians1 which may be a developmental-behavioral pediatrician1 and may also include behavioral scientists1 child psychologists1 epidemiologists1 biostatisticians1 health communications staff1 and individuals with other areas of expertise1 as the ,secretary determines appropriate4 7c7 ,duties ,the team described in subsection 7a7 may-- 7#a7 assist ,state1 local1 ,tribal1 and territorial emergency planning and response activities related to children1 which may include developing1 identifying1 and sharing best practices2 7#b7 provide technical assistance1 training1 and consultation to ,federal1 ,state1 local1 ,tribal1 and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children1 including providing such technical assistance1 training1 and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections #cai;,c-#a and #cai;,c-#b2 7#c7 improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency1 including public awareness of such methods2 7#d7 coordinate with1 and improve1 public-private partnerships1 such as health care coalitions pursuant to sections #cai;,c-#b and #cai;,c-#c1 to address gaps and inefficiencies in emergency preparedness and response efforts for children2 7#e7 provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for1 and responding to1 public health emergencies1 including pursuant to section #cai;,c-#c2 and 7#f7 carry out other duties related to preparedness and response activities for children1 as the ,secretary determines appropriate4 4 #cje4 ,national advisory committees on disasters 7a7 ,reauthorizing the ,national ,advisory ,committee on ,children and ,disasters ,section #bhaa;,a 7#db ,u4,s4,c4 #cjj;hh-#aj;a7 is amended-- 7#a7 in subsection 7b77#b71 by inserting 1 mental and behavioral1 after medical2 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking #ae and inserting #be2 and 7,b7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,required non-,federal members ,the ,secretary1 in consultation with such other heads of ,federal agencies as may be appropriate1 shall appoint to the ,advisory ,committee under paragraph 7#a7 at least #ac individuals1 including-- 7,a7 at least #b non-,federal professionals with expertise in pediatric medical disaster planning1 preparedness1 response1 or recovery2 7,b7 at least #b representatives from ,state1 local1 ,tribal1 or territorial agencies with expertise in pediatric disaster planning1 preparedness1 response1 or recovery2 7,c7 at least #d members representing health care professionals1 which may include members with expertise in pediatric emergency medicine2 pediatric trauma1 critical care1 or surgery2 the treatment of pediatric patients affected by chemical1 biological1 radiological1 or nuclear agents1 including emerging infectious diseases2 pediatric mental or behavioral health related to children affected by a public health emergency2 or pediatric primary care2 and 7,d7 other members as the ,secretary determines appropriate1 of whom-- 7i7 at least one such member shall represent a children's hospital2 7ii7 at least one such member shall be an individual with expertise in schools or child care settings2 7iii7 at least one such member shall be an individual with expertise in children and youth with special health care needs2 and 7iv7 at least one such member shall be an individual with expertise in the needs of parents or family caregivers1 including the parents or caregivers of children with disabilities4 7#c7 ,federal members ,the ,advisory ,committee under paragraph 7#a7 shall include the following ,federal members or their designees 7who may be nonvoting members1 as determined by the ,secretary73 7,a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7,b7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7,c7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,d7 ,the ,commissioner of ,food and ,drugs4 7,e7 ,the ,director of the ,national ,institutes of ,health4 7,f7 ,the ,assistant ,secretary of the ,administration for ,children and ,families4 7,g7 ,the ,administrator of the ,health ,resources and ,services ,administration4 7,h7 ,the ,administrator of the ,federal ,emergency ,management ,agency4 7,i7 ,the ,administrator of the ,administration for ,community ,living4 7,j7 ,the ,secretary of ,education4 7,k7 ,representatives from such ,federal agencies 7such as the ,substance ,abuse and ,mental ,health ,services ,administration and the ,department of ,homeland ,security7 as the ,secretary determines appropriate to fulfill the duties of the ,advisory ,committee under subsections 7b7 and 7c74 7#d7 ,term of appointment ,each member of the ,advisory ,committee appointed under paragraph 7#b7 shall serve for a term of #c years1 except that the ,secretary may adjust the terms of the ,advisory ,committee appointees serving on the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 or appointees who are initially appointed after such date of enactment1 in order to provide for a staggered term of appointment for all members4 7#e7 ,consecutive appointments2 maximum terms ,a member appointed under paragraph 7#b7 may serve not more than #c terms on the ,advisory ,committee1 and not more than #b of such terms may be served consecutively4 2 7#c7 in subsection 7e71 by adding at the end ,at least one meeting per year shall be an in-person meeting42 7#d7 by redesignating subsection 7f7 as subsection 7g72 7#e7 by inserting after subsection 7e7 the following3 7f7 ,coordination ,the ,secretary shall coordinate duties and activities authorized under this section in accordance with section #bhaa;,d4 2 and 7#f7 in subsection 7g71 as so redesignated1 by striking #bjah and inserting #bjbc4 7b7 ,authorizing the ,national ,advisory ,committee on ,seniors and ,disasters ,subtitle ,b of title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq47 is amended by inserting after section #bhaa;,a the following3 #bhaa;,b4 ,national ,advisory ,committee on ,seniors and ,disasters 7a7 ,establishment ,the ,secretary1 in consultation with the ,secretary of ,homeland ,security and the ,secretary of ,veterans ,affairs1 shall establish an advisory committee to be known as the ,national ,advisory ,committee on ,seniors 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 seniors related 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 relating to seniors1 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 seniors and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this title and title ,,iii4 7d7 ,membership 7#a7 ,in general ,the ,secretary1 in consultation with such other heads of agencies as appropriate1 shall appoint not more than #ag 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 ,advisory ,committee shall include ,federal members or their designees 7who may be nonvoting members1 as determined by the ,secretary7 and non-,federal members1 as follows3 7,a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7,b7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7,c7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,d7 ,the ,commissioner of ,food and ,drugs4 7,e7 ,the ,director of the ,national ,institutes of ,health4 7,f7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7,g7 ,the ,administrator of the ,administration for ,community ,living4 7,h7 ,the ,administrator of the ,federal ,emergency ,management ,agency4 7,i7 ,the ,under ,secretary for ,health of the ,department of ,veterans ,affairs4 7,j7 ,at least #b non-,federal health care professionals with expertise in geriatric medical disaster planning1 preparedness1 response1 or recovery4 7,k7 ,at least #b representatives of ,state1 local1 ,tribal1 or territorial agencies with expertise in geriatric disaster planning1 preparedness1 response1 or recovery4 7,l7 ,representatives of such other ,federal agencies 7such as the ,department of ,energy and the ,department of ,homeland ,security7 as the ,secretary determines necessary to fulfill the duties of the ,advisory ,committee4 7e7 ,meetings ,the ,advisory ,committee shall meet not less frequently than biannually4 ,at least one meeting per year shall be an in-person meeting4 7f7 ,coordination ,the ,secretary shall coordinate duties and activities authorized under this section in accordance with section #bhaa;,d4 7g7 ,sunset 7#a7 ,in general ,the ,advisory ,committee shall terminate on ,september #cj1 #bjbc4 7#b7 ,extension of committee ,not later than ,october #a1 #bjbb1 the ,secretary shall submit to ,congress a recommendation on whether the ,advisory ,committee should be extended4 4 7c7 ,national advisory committee on individuals with disabilities and disasters ,subtitle ,b of title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq471 as amended by subsection 7b71 is further amended by inserting after section #bhaa;,b the following3 #bhaa;,c4 ,national advisory committee on individuals with disabilities and disasters 7a7 ,establishment ,the ,secretary1 in consultation with the ,secretary of ,homeland ,security1 shall establish a national advisory committee to be known as the ,national ,advisory ,committee on ,individuals with ,disabilities 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 activities carried out pursuant to section #bhad1 as applicable and appropriate2 7#b7 evaluate and provide input with respect to the medical1 public health1 and accessibility needs of individuals with disabilities related 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 activities1 including related drills and exercises pursuant to the preparedness goals under section #bhjb7;b74 7c7 ,membership 7#a7 ,in general ,the ,secretary1 in consultation with such other heads of agencies and departments as appropriate1 shall appoint not more than #ag 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 ,advisory ,committee shall include ,federal members or their designees 7who may be nonvoting members1 as determined by the ,secretary7 and non-,federal members1 as follows3 7,a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7,b7 ,the ,administrator of the ,administration for ,community ,living4 7,c7 ,the ,director of the ,biomedical ,advanced ,research and ,development ,authority4 7,d7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7,e7 ,the ,commissioner of ,food and ,drugs4 7,f7 ,the ,director of the ,national ,institutes of ,health4 7,g7 ,the ,administrator of the ,federal ,emergency ,management ,agency4 7,h7 ,the ,chair of the ,national ,council on ,disability4 7,i7 ,the ,chair of the ,united ,states ,access ,board4 7,j7 ,the ,under ,secretary for ,health of the ,department of ,veterans ,affairs4 7,k7 ,at least #b non-,federal health care professionals with expertise in disability accessibility before1 during1 and after disasters1 medical and mass care disaster planning1 preparedness1 response1 or recovery4 7,l7 ,at least #b representatives from ,state1 local1 ,tribal1 or territorial agencies with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities4 7,m7 ,at least #b individuals with a disability with expertise in disaster planning1 preparedness1 response1 or recovery for individuals with disabilities4 7d7 ,meetings ,the ,advisory ,committee shall meet not less frequently than biannually4 ,at least one meeting per year shall be an in-person meeting4 7e7 ,disability defined ,for purposes of this section1 the term disability has the meaning given such term in section #c of the ,americans with ,disabilities ,act of #aiij4 7f7 ,coordination ,the ,secretary shall coordinate duties and activities authorized under this section in accordance with section #bhaa;,d4 7g7 ,sunset 7#a7 ,in general ,the ,advisory ,committee shall terminate on ,september #cj1 #bjbc4 7#b7 ,recommendation ,not later than ,october #a1 #bjbb1 the ,secretary shall submit to ,congress a recommendation on whether the ,advisory ,committee should be extended4 4 7d7 ,advisory committee coordination ,subtitle ,b of title ,,xxviii 7#db ,u4,s4,c4 #cjj;hh et seq471 as amended by subsection 7c71 is further amended by inserting after section #bhaa;,c the following3 #bhaa;,d4 ,advisory committee coordination 7a7 ,in general ,the ,secretary shall coordinate duties and activities authorized under sections #bhaa;,a1 #bhaa;,b1 and #bhaa;,c1 and make efforts to reduce unnecessary or duplicative reporting1 or unnecessary duplicative meetings and recommendations under such sections1 as practicable4 ,members of the advisory committees authorized under such sections1 or their designees1 shall annually meet to coordinate any recommendations1 as appropriate1 that may be similar1 duplicative1 or overlapping with respect to addressing the needs of children1 seniors1 and individuals with disabilities during public health emergencies4 ,if such coordination occurs through an in-person meeting1 it shall not be considered the required in-person meetings under any of sections #bhaa;,a7e71 #bhaa;,b7e71 or #bhaa;,c7d74 7b7 ,coordination and alignment ,the ,secretary1 acting through the employee designated pursuant to section #bhad1 shall align preparedness and response programs or activities to address similar1 dual1 or overlapping needs of children1 seniors1 and individuals with disabilities1 and any challenges in preparing for and responding to such needs4 7c7 ,notification ,the ,secretary shall annually notify the congressional committees of jurisdiction regarding the steps taken to coordinate1 as appropriate1 the recommendations under this section1 and provide a summary description of such coordination4 4 #cjf4 ,guidance for participation in exercises and drills ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final guidance regarding the ability of personnel funded by programs authorized under this ,act 7including the amendments made by this ,act7 to participate in drills and operational exercises related to all-hazards medical and public health preparedness and response4 ,such drills and operational exercises may include activities that incorporate medical surge capacity planning1 medical countermeasure distribution and administration1 and preparing for and responding to identified threats for that region4 ,such personnel may include ,state1 local1 ,tribal1 and territorial public health department or agency personnel funded under this ,act 7including the amendments made by this ,act74 ,the ,secretary shall consult with the ,department of ,homeland ,security1 the ,department of ,defense1 the ,department of ,veterans ,affairs1 and other applicable ,federal departments and agencies as necessary and appropriate in the development of such guidance4 ,the ,secretary shall make the guidance available on the internet website of the ,department of ,health and ,human ,services4 ,,iv ,prioritizing a threat-based approach #dja4 ,assistant ,secretary for ,preparedness and ,response ,section #bhaa7;b7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by inserting utilize experience related to public health emergency preparedness and response1 biodefense1 medical countermeasures1 and other relevant topics to after shall2 and 7#b7 in paragraph 7#d71 by adding at the end the following3 7,i7 ,threat awareness ,coordinate with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of ,national ,intelligence1 the ,secretary of ,homeland ,security1 the ,assistant to the ,president for ,national ,security ,affairs1 the ,secretary of ,defense1 and other relevant ,federal officials1 such as the ,secretary of ,agriculture1 to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency4 4 #djb4 ,public ,health ,emergency ,medical ,countermeasures ,enterprise 7a7 ,in general ,title ,,xxviii is amended by inserting after section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 the following3 #bhaa-a4 ,public health emergency medical countermeasures enterprise 7a7 ,in general ,the ,secretary shall establish the ,public ,health ,emergency ,medical ,countermeasures ,enterprise 7referred to in this section as the ,,phemce74 ,the ,assistant ,secretary for ,preparedness and ,response shall serve as chair of the ,,phemce4 7b7 ,members ,the ,,phemce shall include each of the following members1 or the designee of such members3 7#a7 ,the ,assistant ,secretary for ,preparedness and ,response4 7#b7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7#c7 ,the ,director of the ,national ,institutes of ,health4 7#d7 ,the ,commissioner of ,food and ,drugs4 7#e7 ,the ,secretary of ,defense4 7#f7 ,the ,secretary of ,homeland ,security4 7#g7 ,the ,secretary of ,agriculture4 7#h7 ,the ,secretary of ,veterans ,affairs4 7#i7 ,the ,director of ,national ,intelligence4 7#aj7 ,representatives of any other ,federal agency1 which may include the ,director of the ,biomedical ,advanced ,research and ,development ,authority1 the ,director of the ,strategic ,national ,stockpile1 the ,director of the ,national ,institute of ,allergy and ,infectious ,diseases1 and the ,director of the ,office of ,public ,health ,preparedness and ,response1 as the ,secretary determines appropriate4 7c7 ,functions 7#a7 ,in general ,the functions of the ,,phemce shall include the following3 7,a7 ,utilize a process to make recommendations to the ,secretary regarding research1 advanced research1 development1 procurement1 stockpiling1 deployment1 distribution1 and utilization with respect to countermeasures1 as defined in section #cai;,f-#b7;c71 including prioritization based on the health security needs of the ,united ,states4 ,such recommendations shall be informed by1 when available and practicable1 the ,national ,health ,security ,strategy pursuant to section #bhjb1 the ,strategic ,national ,stockpile needs pursuant to section #cai;,f-#b1 and assessments of current national security threats1 including chemical1 biological1 radiological1 and nuclear threats1 including emerging infectious diseases4 ,in the event that members of the ,,phemce do not agree upon a recommendation1 the ,secretary shall provide a determination regarding such recommendation4 7,b7 ,identify national health security needs1 including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs 7including any regulatory challenges71 and support alignment of countermeasure procurement with recommendations to address such needs under subparagraph 7,a74 7,c7 ,assist the ,secretary in developing strategies related to logistics1 deployment1 distribution1 dispensing1 and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section #cai;,f-#b7;a74 7,d7 ,provide consultation for the development of the strategy and implementation plan under section #bhaa7;d74 7#b7 ,input ,in carrying out subparagraphs 7,b7 and 7,c7 of paragraph 7#a71 the ,,phemce shall solicit and consider input from ,state1 local1 ,tribal1 and territorial public health departments or officials1 as appropriate4 4 7b7 ,public ,health ,emergency ,medical ,countermeasures ,enterprise ,strategy and ,implementation ,plan ,section #bhaa7;d7 7#db ,u4,s4,c4 #cjj;hh-#aj7;d77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking ,not later than #ahj days after the date of enactment of this subsection1 and every year thereafter and inserting ,not later than ,march #ae1 #bjbj1 and biennially thereafter2 and 7,b7 by striking ,director of the ,biomedical and all that follows through ,food and ,drugs and inserting ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a2 and 7#b7 in paragraph 7#b77;,j77v71 by striking one-year period and inserting #b-year period4 #djc4 ,strategic ,national ,stockpile 7a7 ,in general ,section #cai;,f-#b7;a7 7#db ,u4,s4,c4 #bdg;d-#f;b7a77 is amended-- 7#a7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#c7 and 7#d71 respectively2 and 7#b7 in paragraph 7#a7-- 7,a7 by inserting the ,assistant ,secretary for ,preparedness and ,response and after collaboration with2 7,b7 by inserting and optimize after provide for2 7,c7 by inserting and1 as informed by existing recommendations of1 or consultations with1 the ,public ,health ,emergency ,medical ,countermeasure ,enterprise established under section #bhaa-a1 make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph 7#b7 before the period of the first sentence2 and 7,d7 by striking the second sentence2 7#c7 by inserting after paragraph 7#a7 the following3 7#b7 ,threat-based review 7,a7 ,in general ,the ,secretary shall conduct an annual threat-based review 7taking into account at-risk individuals7 of the contents of the stockpile under paragraph 7#a71 including non-pharmaceutical supplies1 and1 in consultation with the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a1 review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section #bhaa-a7;c77#a77;,a74 ,such review shall be submitted on ,june #ae1 #bjai1 and on ,march #ae of each year thereafter1 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives1 in a manner that does not compromise national security4 7,b7 ,additions1 modifications1 and replenishments ,each annual threat-based review under subparagraph 7,a7 shall1 for each new or modified countermeasure procurement or replenishment1 provide-- 7i7 information regarding-- 7,i7 the quantities of the additional or modified countermeasure procured for1 or contracted to be procured for1 the stockpile2 7,,ii7 planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications 7without disclosing proprietary information71 including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system2 7,,iii7 the presence or lack of a commercial market for the countermeasure at the time of procurement2 7,,iv7 the emergency health security threat or threats such countermeasure procurement is intended to address1 including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats2 7,v7 an assessment of whether the emergency health security threat or threats described in subclause 7,,iv7 could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats2 7,,vi7 whether such countermeasure is replenishing an expiring or expired countermeasure1 is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure1 or is a new addition to the stockpile2 7,,vii7 a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section #bhaa7;b77#g71 including expected life-cycle costs1 expenditures related to countermeasure procurement to address the threat or threats described in subclause 7,,iv71 replenishment dates 7including the ability to extend the maximum shelf life of a countermeasure71 and the manufacturing capacity required to replenish such countermeasure2 and 7,,viii7 appropriate protocols and processes for the deployment1 distribution1 or dispensing of the countermeasure at the ,state and local level1 including plans for relevant capabilities of ,state and local entities to dispense1 distribute1 and administer the countermeasure2 and 7ii7 an assurance1 which need not be provided in advance of procurement1 that for each countermeasure procured or replenished under this subsection1 the ,secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment4 2 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a71 by inserting and the ,public ,health ,emergency ,medical ,countermeasures ,enterprise established under section #bhaa-a before the semicolon2 7,b7 in subparagraph 7,c71 by inserting 1 and the availability1 deployment1 dispensing1 and administration of countermeasures before the semicolon2 7,c7 by amending subparagraph 7,e7 to read as follows3 7,e7 devise plans for effective and timely supply-chain management of the stockpile1 in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,assistant ,secretary for ,preparedness and ,response1 the ,secretary of ,transportation1 the ,secretary of ,homeland ,security1 the ,secretary of ,veterans ,affairs1 and the heads of other appropriate ,federal agencies2 ,state1 local1 ,tribal1 and territorial agencies2 and the public and private health care infrastructure1 as applicable1 taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile2 2 7,d7 in subparagraph 7,g71 by striking 2 and and inserting a semicolon2 7,e7 in subparagraph 7,h71 by striking the period and inserting a semicolon2 and 7,f7 by adding at the end the following3 7,i7 ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section #cai,l1 including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the ,united ,states2 and 7,j7 provide assistance1 including technical assistance1 to maintain and improve ,state and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile1 as appropriate4 2 and 7#e7 by adding at the end the following3 7#e7 ,,gao report 7,a7 ,in general ,not later than #c years after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 and every #e years thereafter1 the ,comptroller ,general of the ,united ,states shall conduct a review of any changes to the contents or management of the stockpile since ,january #a1 #bjae4 ,such review shall include-- 7i7 an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph 7#b71 including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review1 and whether1 consistent with paragraph 7#b77;,b71 the ,secretary conducted the necessary internal review in advance of such procurement or replenishment2 7ii7 an assessment of whether the ,secretary established health security and science-based justifications1 and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat1 for additions or modifications to the stockpile based on the information provided in such reviews under paragraph 7#b77;,b71 including whether such review was conducted prior to procurement1 modification1 or replenishment2 7iii7 an assessment of the plans developed by the ,secretary for the deployment1 distribution1 and dispensing of countermeasures procured1 modified1 or replenished under paragraph 7#a71 including whether such plans were developed prior to procurement1 modification1 or replenishment2 7iv7 an accounting of countermeasures procured1 modified1 or replenished under paragraph 7#a7 that received advanced research and development funding from the ,biomedical ,advanced ,research and ,development ,authority2 7v7 an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added1 modified1 or replenished under paragraph 7#a72 7vi7 a description of the resources expended related to the procurement of countermeasures 7including additions1 modifications1 and replenishments7 in the stockpile1 and how such expenditures relate to the ability of the stockpile to meet emergency health security needs2 7vii7 an assessment of the extent to which additions1 modifications1 and replenishments reviewed under paragraph 7#b7 align with previous relevant reports or reviews by the ,secretary or the ,comptroller ,general2 7viii7 with respect to any change in the ,federal organizational management of the stockpile1 an assessment and comparison of the processes affected by such change1 including planning for potential countermeasure deployment1 distribution1 or dispensing capabilities and processes related to procurement decisions1 use of stockpiled countermeasures1 and use of resources for such activities2 and 7ix7 an assessment of whether the processes and procedures described by the ,secretary pursuant to section #djc7;b7 of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection 7a7 receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section #cai,l1 including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the ,united ,states4 7,b7 ,submission ,not later than #f months after completing a classified version of the review under subparagraph 7,a71 the ,comptroller ,general shall submit an unclassified version of the review to the congressional committees of jurisdiction4 4 7b7 ,additional reporting ,in the first threat-based review submitted after the date of enactment of this ,act pursuant to paragraph 7#b7 of section #cai;,f-#b7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b7a771 as amended by subsection 7a71 the ,secretary shall include a description of the processes and procedures through which the ,director of the ,strategic ,national ,stockpile and the ,director of the ,biomedical ,advanced ,research and ,development ,authority coordinate with respect to countermeasures and products procured under such section #cai;,f-#b7;a71 including such processes and procedures in place to ensure countermeasures and products under consideration for procurement pursuant to such section #cai;,f-#b7;a7 receive the same consideration regardless of whether such countermeasures or products receive or had received funding under section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e71 and whether such countermeasures and products are the most appropriate to meet the emergency health security needs of the ,united ,states4 7c7 ,authorization of appropriations1 strategic national stockpile ,section #cai;,f-#b7;f77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7f77#a77 is amended by striking #ecc1hjj1jjj for each of fiscal years #bjad through #bjah and inserting #faj1jjj1jjj for each of fiscal years #bjai through #bjbc1 to remain available until expended4 #djd4 ,preparing for pandemic influenza1 antimicrobial resistance1 and other significant threats 7a7 ,strategic initiatives ,section #cai,l7c77#d7 7#bdg;d-#g;e7c77#d77 is amended by adding at the end the following3 7,f7 ,strategic initiatives ,the ,secretary1 acting through the ,director of ,,barda1 may implement strategic initiatives1 including by building on existing programs and by awarding contracts1 grants1 and cooperative agreements1 or entering into other transactions1 to support innovative candidate products in preclinical and clinical development that address priority1 naturally occurring and man-made threats that1 as determined by the ,secretary1 pose a significant level of risk to national security based on the characteristics of a chemical1 biological1 radiological or nuclear threat1 or existing capabilities to respond to such a threat 7including medical response and treatment capabilities and manufacturing infrastructure74 ,such initiatives shall accelerate and support the advanced research1 development1 and procurement of countermeasures and products1 as applicable1 to address areas including-- 7i7 chemical1 biological1 radiological1 or nuclear threats1 including emerging infectious diseases1 for which insufficient approved1 licensed1 or authorized countermeasures exist1 or for which such threat1 or the result of an exposure to such threat1 may become resistant to countermeasures or existing countermeasures may be rendered ineffective2 7ii7 threats that consistently exist or continually circulate and have a significant potential to become a pandemic1 such as pandemic influenza1 which may include the advanced research and development1 manufacturing1 and appropriate stockpiling of qualified pandemic or epidemic products1 and products1 technologies1 or processes to support the advanced research and development of such countermeasures 7including multiuse platform technologies for diagnostics1 vaccines1 and therapeutics2 virus seeds2 clinical trial lots2 novel virus strains2 and antigen and adjuvant material72 and 7iii7 threats that may result primarily or secondarily from a chemical1 biological1 radiological1 or nuclear agent1 or emerging infectious diseases1 and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures1 including antimicrobial resistant pathogens4 4 7b7 ,protection of national security from threats ,section #bhaa 7#db ,u4,s4,c4 #cjj;hh-#aj7 is amended by adding at the end the following3 7f7 ,protection of national security from threats 7#a7 ,in general ,in carrying out subsection 7b77#c71 the ,assistant ,secretary for ,preparedness and ,response shall implement strategic initiatives or activities to address threats1 including pandemic influenza and which may include a chemical1 biological1 radiological1 or nuclear agent 7including any such agent with a significant potential to become a pandemic71 that pose a significant level of risk to public health and national security based on the characteristics of such threat4 ,such initiatives shall include activities to-- 7,a7 accelerate and support the advanced research1 development1 manufacturing capacity1 procurement1 and stockpiling of countermeasures1 including initiatives under section #cai,l7c77#d77;,f72 7,b7 support the development and manufacturing of virus seeds1 clinical trial lots1 and stockpiles of novel virus strains2 and 7,c7 maintain or improve preparedness activities1 including for pandemic influenza4 7#b7 ,authorization of appropriations 7,a7 ,in general ,to carry out this subsection1 there is authorized to be appropriated #bej1jjj1jjj for each of fiscal years #bjai through #bjbc4 7,b7 ,supplement1 not supplant ,amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections #cai,l7d7 and #cai;,f-#b7;g74 7,c7 ,documentation required ,the ,assistant ,secretary for ,preparedness and ,response1 in accordance with subsection 7b77#g71 shall document amounts expended for purposes of carrying out this subsection1 including amounts appropriated under the heading ,public ,health and ,social ,services ,emergency ,fund under the heading ,office of the ,secretary under title ,,ii of division ,h of the ,consolidated ,appropriations ,act1 #bjah 7,public ,law #aae-ada7 and allocated to carrying out section #cai,l7c77#d77;,f74 4 #dje4 ,reporting on the ,federal ,select ,agent ,program ,section #cea;,a7k7 7#db ,u4,s4,c4 #bfb;a7k77 is amended-- 7#a7 by striking ,the ,secretary and inserting the following3 7#a7 ,in general ,the ,secretary 2 and 7#b7 by adding at the end the following3 7#b7 ,implementation of recommendations of the federal experts security advisory panel and the fast track action committee on select agent regulations 7,a7 ,in general ,not later than #a year after the date of the enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 the ,secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the ,federal ,experts ,security ,advisory ,panel concerning the select agent program4 7,b7 ,continued updates ,the ,secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph 7,a7 until the recommendations described in such subparagraph are fully implemented1 or a justification is provided for the delay in1 or lack of1 implementation4 4 ,v ,increasing communication in medical countermeasure advanced research and development #eja4 ,medical countermeasure budget plan ,section #bhaa7;b77#g7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#g77 is amended-- 7#a7 in the matter preceding subparagraph 7,a71 by striking ,march #a and inserting ,march #ae2 7#b7 in subparagraph 7,a7-- 7,a7 in clause 7ii71 by striking 2 and and inserting 22 and 7,b7 by striking clause 7iii7 and inserting the following3 7iii7 procurement1 stockpiling1 maintenance1 and potential replenishment 7including manufacturing capabilities7 of all products in the ,strategic ,national ,stockpile2 7iv7 the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development2 and 7v7 potential deployment1 distribution1 and utilization of medical countermeasures2 development of clinical guidance and emergency use instructions for the use of medical countermeasures2 and1 as applicable1 potential postdeployment activities related to medical countermeasures2 2 7#c7 by redesignating subparagraphs 7,d7 and 7,e7 as subparagraphs 7,e7 and 7,f71 respectively2 and 7#d7 by inserting after subparagraph 7,c71 the following3 7,d7 identify the full range of anticipated medical countermeasure needs related to research and development1 procurement1 and stockpiling1 including the potential need for indications1 dosing1 and administration technologies1 and other countermeasure needs as applicable and appropriate2 4 #ejb4 ,material threat and medical countermeasure notifications 7a7 ,congressional notification of material threat determination ,section #cai;,f-#b7;c77#b77;,c7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#b77;,c77 is amended by striking ,the ,secretary and the ,homeland ,security ,secretary shall promptly notify the appropriate committees of ,congress and inserting ,the ,secretary and the ,secretary of ,homeland ,security shall send to ,congress1 on an annual basis1 all current material threat determinations and shall promptly notify the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,homeland ,security and ,governmental ,affairs of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,homeland ,security of the ,house of ,representatives4 7b7 ,contracting communication ,section #cai;,f-#b7;c77#g77;,b77ii77,,iii7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#g77;,b77ii77,,iii77 is amended by adding at the end the following3 ,the ,secretary shall notify the vendor within #ij days of a determination by the ,secretary to renew1 extend1 or terminate such contract44 #ejc4 ,availability of regulatory management plans ,section #efe7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;f77 is amended-- 7#a7 by redesignating paragraphs 7#c7 through 7#f7 as paragraphs 7#d7 through 7#g71 respectively2 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 ,publication ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration information regarding regulatory management plans1 including-- 7,a7 the process by which an applicant may submit a request for a regulatory management plan2 7,b7 the timeframe by which the ,secretary is required to respond to such request2 7,c7 the information required for the submission of such request2 7,d7 a description of the types of development milestones and performance targets that could be discussed and included in such plans2 and 7,e7 contact information for beginning the regulatory management plan process4 2 7#c7 in paragraph 7#f71 as so redesignated1 in the matter preceding subparagraph 7,a7-- 7,a7 by striking paragraph 7#d77;,a7 and inserting paragraph 7#e77;,a72 and 7,b7 by striking paragraph 7#d77;,b7 and inserting paragraph 7#e77;,b72 and 7#d7 in paragraph 7#g77;,a71 as so redesignated1 by striking paragraph 7#c77;,a7 and inserting paragraph 7#d77;,a74 #ejd4 ,the ,biomedical ,advanced ,research and ,development ,authority and the ,bio,shield ,special ,reserve ,fund 7a7 ,bio,shield special reserve fund ,section #cai;,f-#b7;g77#a7 7#db ,u4,s4,c4 #bdg;d-#f;b7g77#a77 is amended-- 7#a7 by striking #b1hjj1jjj1jjj for the period of fiscal years #bjad through #bjah and inserting #g1ajj1jjj1jjj for the period of fiscal years #bjai through #bjbh1 to remain available until expended2 and 7#b7 by striking the second sentence4 7b7 ,the ,biomedical ,advanced ,research and ,development ,authority ,section #cai,l7d77#b7 7#db ,u4,s4,c4 #bdg;d-#g;e7d77#b77 is amended by striking #dae1jjj1jjj for each of fiscal years #bjad through #bjah and inserting #faa1gjj1jjj for each of fiscal years #bjai through #bjbc4 #eje4 ,additional strategies for combating antibiotic resistance 7a7 ,advisory council ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 may continue the ,presidential ,advisory ,council on ,combating ,antibiotic-,resistant ,bacteria1 referred to in this section as the ,advisory ,council4 7b7 ,duties ,the ,advisory ,council shall advise and provide information and recommendations to the ,secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent1 diagnose1 mitigate1 or treat such resistance4 ,such advice1 information1 and recommendations may be related to improving-- 7#a7 the effectiveness of antibiotics2 7#b7 research and advanced research on1 and the development of1 improved and innovative methods for combating or reducing antibiotic resistance1 including new treatments1 rapid point-of-care diagnostics1 alternatives to antibiotics1 including alternatives to animal antibiotics1 and antimicrobial stewardship activities2 7#c7 surveillance of antibiotic-resistant bacterial infections1 including publicly available and up-to-date information on resistance to antibiotics2 7#d7 education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals2 7#e7 methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections1 including stewardship programs2 and 7#f7 coordination with respect to international efforts in order to inform and advance ,united ,states capabilities to combat antibiotic resistance4 7c7 ,meetings and coordination 7#a7 ,meetings ,the ,advisory ,council shall meet not less than biannually and1 to the extent practicable1 in coordination with meetings of the ,antimicrobial ,resistance ,task ,force established in section #cai;,e7a7 of the ,public ,health ,service ,act4 7#b7 ,coordination ,the ,advisory ,council shall1 to the greatest extent practicable1 coordinate activities carried out by the ,council with the ,antimicrobial ,resistance ,task ,force established under section #cai;,e7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7;a774 7d7 ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the activities and duties of the ,advisory ,council4 7e7 ,extension of ,advisory ,council ,not later than ,october #a1 #bjbb1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a recommendation on whether the ,advisory ,council should be extended1 and in addition1 identify whether there are other committees1 councils1 or task forces that have overlapping or similar duties to that of the ,advisory ,council1 and whether such committees1 councils1 or task forces should be combined1 including with respect to section #cai;,e7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#e7;a774 ,,vi ,advancing technologies for medical countermeasures #fja4 ,administration of countermeasures ,section #cai,l7c77#d77;,d77iii7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,d77iii77 is amended by striking and platform technologies and inserting platform technologies1 technologies to administer countermeasures1 and technologies to improve storage and transportation of countermeasures4 #fjb4 ,updating definitions of other transactions ,section #cai,l 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended-- 7#a7 in subsection 7a77#c71 by striking 1 such as and all that follows through ,code2 and 7#b7 in subsection 7c77#e77;,a7-- 7,a7 in clause 7i71 by striking under this subsection and all that follows through ,code and inserting 7as defined in subsection 7a77#c77 under this subsection2 and 7,b7 in clause 7ii7-- 7i7 by amending subclause 7,i7 to read as follows3 7,i7 ,in general ,to the maximum extent practicable1 competitive procedures shall be used when entering into transactions to carry out projects under this subsection4 2 and 7ii7 in subclause 7,,ii7-- 7,i7 by striking #bj1jjj1jjj and inserting #ajj1jjj1jjj2 7,,ii7 by striking senior procurement executive for the ,department 7as designated for purpose of section #af7;c7 of the ,office of ,federal ,procurement ,policy ,act 7#da ,u4,s4,c4 #dad7;c777 and inserting ,assistant ,secretary for ,financial ,resources2 and 7,,iii7 by striking senior procurement executive under and inserting ,assistant ,secretary for ,financial ,resources under4 #fjc4 ,medical countermeasure master files 7a7 ,in general ,the purpose of this section 7including section #efe;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b77 is to support and advance the development or manufacture of security countermeasures1 qualified countermeasures1 and qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products1 and through clarifying the authority to cross-reference to data and information previously submitted to the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 including data and information submitted to medical countermeasure master files or other master files4 7b7 ,medical countermeasure master files ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #efe;,a the following3 #efe;,b4 ,medical countermeasure master files 7a7 ,applicability of reference 7#a7 ,in general ,a person may submit data and information in a master file to the ,secretary with the intent to reference1 or to authorize1 in writing1 another person to reference1 such data or information to support a medical countermeasure submission 7including a supplement or amendment to any such submission71 without requiring the master file holder to disclose the data and information to any such persons authorized to reference the master file4 ,such data and information shall be available for reference by the master file holder or by a person authorized by the master file holder1 in accordance with applicable privacy and confidentiality protocols and regulations4 7#b7 ,reference of certain master files ,in the case that data or information within a medical countermeasure master file is used only to support the conditional approval of an application filed under section #ega1 such master file may be relied upon to support the effectiveness of a product that is the subject of a subsequent medical countermeasure submission only if such application is supplemented by additional data or information to support review and approval in a manner consistent with the standards applicable to such review and approval for such countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product4 7b7 ,medical countermeasure master file content 7#a7 ,in general ,a master file under this section may include data or information to support-- 7,a7 the development of medical countermeasure submissions to support the approval1 licensure1 classification1 clearance1 conditional approval1 or authorization of one or more security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products2 and 7,b7 the manufacture of security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products4 7#b7 ,required updates ,the ,secretary may require1 as appropriate1 that the master file holder ensure that the contents of such master file are updated during the time such master file is referenced for a medical countermeasure submission4 7c7 ,sponsor reference 7#a7 ,in general ,each incorporation of data or information within a medical countermeasure master file shall describe the incorporated material in a manner in which the ,secretary determines appropriate and that permits the review of such information within such master file without necessitating resubmission of such data or information4 ,master files shall be submitted in an electronic format in accordance with sections #eab7;b77#d71 #ega7;a77#d71 and #gde;,a1 as applicable1 and as specified in applicable guidance4 7#b7 ,reference by a master file holder ,a master file holder that is the sponsor of a medical countermeasure submission shall notify the ,secretary in writing of the intent to reference the medical countermeasure master file as a part of the submission4 7#c7 ,reference by an authorized person ,a person submitting an application for review may1 where the ,secretary determines appropriate1 incorporate by reference all or part of the contents of a medical countermeasure master file1 if the master file holder authorizes the incorporation in writing4 7d7 ,acknowledgment of and reliance upon a master file by the ,secretary 7#a7 ,in general ,the ,secretary shall provide the master file holder with a written notification indicating that the ,secretary has reviewed and relied upon specified data or information within a master file and the purposes for which such data or information was incorporated by reference if the ,secretary has reviewed and relied upon such specified data or information to support the approval1 classification1 conditional approval1 clearance1 licensure1 or authorization of a security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product4 ,the ,secretary may rely upon the data and information within the medical countermeasure master file for which such written notification was provided in additional applications1 as applicable and appropriate and upon the request of the master file holder so notified in writing or by an authorized person of such holder4 7#b7 ,certain applications ,if the ,secretary has reviewed and relied upon specified data or information within a medical countermeasure master file to support the conditional approval of an application under section #ega to subsequently support the approval1 clearance1 licensure1 or authorization of a security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product1 the ,secretary shall provide a brief written description to the master file holder regarding the elements of the application fulfilled by the data or information within the master file and how such data or information contained in such application meets the standards of evidence under subsection 7c7 or 7d7 of section #eje1 subsection 7d7 of section #eab1 or section #cea of the ,public ,health ,service ,act 7as applicable71 which shall not include any trade secret or confidential commercial information4 7e7 ,rules of construction ,nothing in this section shall be construed to-- 7#a7 limit the authority of the ,secretary to approve1 license1 clear1 conditionally approve1 or authorize drugs1 biological products1 or devices pursuant to1 as applicable1 this ,act or section #cea of the ,public ,health ,service ,act 7as such applicable ,act is in effect on the day before the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai71 including the standards of evidence1 and applicable conditions1 for approval under the applicable ,act2 7#b7 alter the standards of evidence with respect to approval1 licensure1 or clearance1 as applicable1 of drugs1 biological products1 or devices under this ,act or section #cea of the ,public ,health ,service ,act1 including1 as applicable1 the substantial evidence standards under sections #eje7;d7 and #eab7;d7 or this ,act and section #cea7;a7 of the ,public ,health ,service ,act2 or 7#c7 alter the authority of the ,secretary under this ,act or the ,public ,health ,service ,act to determine the types of data or information previously submitted by a sponsor or any other person that may be incorporated by reference in an application1 request1 or notification for a drug1 biological product1 or device submitted under sections #eje7;i71 #eje7;b71 #eje7;j71 #eab7;b77#a71 #eab7;b77#b71 #eab7;j71 #efd1 #ega1 #ebj7;g71 #eae7;c71 #eac7;f77#b71 or #eaj7k7 of this ,act1 or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 including a supplement or amendment to any such submission1 and the requirements associated with such reference4 7f7 ,definitions ,in this section3 7#a7 ,the term master file holder means a person who submits data and information to the ,secretary with the intent to reference or authorize another person to reference such data or information to support a medical countermeasure submission1 as described in subsection 7a74 7#b7 ,the term medical countermeasure submission means an investigational new drug application under section #eje7;i71 a new drug application under section #eje7;b71 or an abbreviated new drug application under section #eje7;j7 of this ,act1 a biological product license application under section #cea7;a7 of the ,public ,health ,service ,act or a biosimilar biological product license application under section #cea7k7 of the ,public ,health ,service ,act1 a new animal drug application under section #eab7;b77#a7 or abbreviated new animal drug application under section #eab7;b77#b71 an application for conditional approval of a new animal drug under section #ega1 an investigational device application under section #ebj7;g71 an application with respect to a device under section #eae7;c71 a request for classification of a device under section #eac7;f77#b71 a notification with respect to a device under section #eaj7k71 or a request for an emergency use authorization under section #efd to support-- 7,a7 the approval1 licensure1 classification1 clearance1 conditional approval1 or authorization of a security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product2 or 7,b7 a new indication to an approved security countermeasure1 qualified countermeasure1 or qualified pandemic or epidemic product4 7#c7 ,the terms qualified countermeasure1 security countermeasure1 and qualified pandemic or epidemic product have the meanings given such terms in sections #cai;,f-#a1 #cai;,f-#b1 and #cai;,f-#c1 respectively1 of the ,public ,health ,service ,act4 4 7c7 ,stakeholder ,input ,not later than #ah months after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in consultation with the ,assistant ,secretary for ,preparedness and ,response1 shall solicit input from stakeholders1 including stakeholders developing security countermeasures1 qualified countermeasures1 or qualified pandemic or epidemic products1 and stakeholders developing technologies to assist in the development of such countermeasures with respect to how the ,food and ,drug ,administration can advance the use of tools and technologies to support and advance the development or manufacture of security countermeasures1 qualified countermeasures1 and qualified pandemic or epidemic products1 including through reliance on cross-referenced data and information contained within master files and submissions previously submitted to the ,secretary as set forth in section #efe;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b74 7d7 ,guidance ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section #efe;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b7 or submissions otherwise submitted to the ,secretary may be used for specific tools or technologies 7including platform technologies7 that have the potential to support and advance the development or manufacture of security countermeasures1 qualified countermeasures1 and qualified pandemic or epidemic products4 ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall publish the final guidance not later than #c years after the enactment of this ,act4 #fjd4 ,animal rule report 7a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the application of the requirements under subsections 7c7 and 7d7 of section #efe of the of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 7referred to in this section as the animal rule7 as a component of medical countermeasure advanced development under the ,biomedical ,advanced ,research and ,development ,authority and regulatory review by the ,food and ,drug ,administration4 ,in conducting such study1 the ,comptroller ,general shall examine the following3 7#a7 ,the extent to which advanced development and review of a medical countermeasure are coordinated between the ,biomedical ,advanced ,research and ,development ,authority and the ,food and ,drug ,administration1 including activities that facilitate appropriate and efficient design of studies to support approval1 licensure1 and authorization under the animal rule1 consistent with the recommendations in the animal rule guidance1 issued pursuant to section #efe7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c77 and entitled ,product ,development ,under the ,animal ,rule3 ,guidance for ,industry 7issued in ,october #bjae71 to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved1 licensed1 or authorized under the animal rule4 7#b7 ,the consistency of the application of the animal rule among and between review divisions within the ,food and ,drug ,administration4 7#c7 ,the flexibility pursuant to the animal rule to address variations in countermeasure development and review processes1 including the extent to which qualified animal models are adopted and used within the ,food and ,drug ,administration in regulatory decisionmaking with respect to medical countermeasures4 7#d7 ,the extent to which the guidance issued under section #efe7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7;c771 entitled1 ,product ,development ,under the ,animal ,rule3 ,guidance for ,industry 7issued in ,october #bjae71 has assisted in achieving the purposes described in paragraphs 7#a71 7#b71 and 7#c74 7b7 ,consultations ,in conducting the study under subsection 7a71 the ,comptroller ,general of the ,united ,states shall consult with-- 7#a7 the ,federal agencies responsible for advancing1 reviewing1 and procuring medical countermeasures1 including the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,food and ,drug ,administration1 and the ,department of ,defense2 7#b7 manufacturers involved in the research and development of medical countermeasures to address biological1 chemical1 radiological1 or nuclear threats2 and 7#c7 other biodefense stakeholders1 as applicable4 7c7 ,report ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study conducted under subsection 7a7 and recommendations to improve the application and consistency of the requirements under subsections 7c7 and 7d7 of section #efe of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#d7 to support and expedite the research and development of medical countermeasures1 as applicable4 7d7 ,protection of national security ,the ,comptroller ,general of the ,united ,states shall conduct the study and issue the assessment and report under this section in a manner that does not compromise national security4 #fje4 ,review of the benefits of genomic engineering technologies and their potential role in national security 7a7 ,meeting 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall convene a meeting to discuss the potential role advancements in genomic engineering technologies 7including genome editing technologies7 may have in advancing national health security4 ,such meeting shall be held in a manner that does not compromise national security4 7#b7 ,attendees ,the attendees of the meeting under paragraph 7#a7-- 7,a7 shall include-- 7i7 representatives from the ,office of the ,assistant ,secretary for ,preparedness and ,response1 the ,national ,institutes of ,health1 the ,centers for ,disease ,control and ,prevention1 and the ,food and ,drug ,administration2 and 7ii7 representatives from academic1 private1 and nonprofit entities with expertise in genome engineering technologies1 biopharmaceuticals1 medicine1 or biodefense1 and other relevant stakeholders2 and 7,b7 may include-- 7i7 other representatives from the ,department of ,health and ,human ,services1 as the ,secretary determines appropriate2 and 7ii7 representatives from the ,department of ,homeland ,security1 the ,department of ,defense1 the ,department of ,agriculture1 and other departments1 as the ,secretary may request for the meeting4 7#c7 ,topics ,the meeting under paragraph 7#a7 shall include a discussion of-- 7,a7 the current state of the science of genomic engineering technologies related to national health security1 including-- 7i7 medical countermeasure development1 including potential efficiencies in the development pathway and detection technologies2 and 7ii7 the international and domestic regulation of products utilizing genome editing technologies2 and 7,b7 national security implications1 including-- 7i7 capabilities of the ,united ,states to leverage genomic engineering technologies as a part of the medical countermeasure enterprise1 including current applicable research1 development1 and application efforts underway within the ,department of ,defense2 7ii7 the potential for state and non-state actors to utilize genomic engineering technologies as a national health security threat2 and 7iii7 security measures to monitor and assess the potential threat that may result from utilization of genomic engineering technologies and related technologies for the purpose of compromising national health security4 7b7 ,report ,not later than #bgj days after the meeting described in subsection 7a7 is held1 the ,assistant ,secretary for ,preparedness and ,response shall issue a report to the congressional committees of jurisdiction on the topics discussed at such meeting1 and provide recommendations1 as applicable1 to utilize innovations in genomic engineering 7including genome editing7 and related technologies as a part of preparedness and response activities to advance national health security4 ,such report shall be issued in a manner that does not compromise national security4 #fjf4 ,report on vaccines development ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report describing efforts and activities to coordinate with other countries and international partners during recent public health emergencies with respect to the research and advanced research on1 and development of1 qualified pandemic or epidemic products 7as defined in section #cai;,f-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d774 ,such report may include information regarding relevant work carried out under section #cai,l7c77#e77;,e7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#e77;,e771 through public-private partnerships1 and through collaborations with other countries to assist with or expedite the research and development of qualified pandemic or epidemic products4 ,such report shall not include information that may compromise national security4 #fjg4 ,strengthening mosquito abatement for safety and health 7a7 ,reauthorization of mosquito abatement for safety and health program ,section #cag,s 7#db ,u4,s4,c4 #bdg;b-#ba7 is amended-- 7#a7 in subsection 7a77#a77;,b7-- 7,a7 by inserting including programs to address emerging infectious mosquito-borne diseases1 after subdivisions for control programs12 and 7,b7 by inserting or improving existing control programs before the period at the end2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#a71 by inserting 1 including improvement1 after operation2 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a7-- 7,i7 in clause 7ii71 by striking or at the end2 7,,ii7 in clause 7iii71 by striking the semicolon at the end and inserting 1 including an emerging infectious mosquito-borne disease that presents a serious public health threat2 or2 and 7,,iii7 by adding at the end the following3 7iv7 a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat2 2 and 7ii7 by amending subparagraph 7,d7 to read as follows3 7,d7 7i7 is located in a ,state that has received a grant under subsection 7a72 or 7ii7 that demonstrates to the ,secretary that the control program is consistent with existing ,state mosquito control plans or policies1 or other applicable ,state preparedness plans4 2 7,c7 in paragraph 7#d77;,c71 by striking that extraordinary and all that follows through the period at the end and inserting the following3 8that-- 7i7 extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver2 or 7ii7 the geographical area covered by a political subdivision or consortium for a grant under paragraph 7#a7 has an extreme mosquito control need due to-- 7,i7 the size or density of the potentially impacted human population2 7,,ii7 the size or density of a mosquito population that requires heightened control2 or 7,,iii7 the severity of the mosquito-borne disease1 such that expected serious adverse health outcomes for the human population justify the waiver4 2 and 7,d7 by amending paragraph 7#f7 to read as follows3 7#f7 ,number of grants ,a political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph 7#a74 2 and 7#c7 in subsection 7f7-- 7,a7 in paragraph 7#a7 by striking for fiscal year #bjjc1 and such sums as may be necessary for each of fiscal years #bjjd through #bjjg and inserting for each of fiscal years #bjai through #bjbc2 7,b7 in paragraph 7#b71 by striking the ,public ,health ,security and ,bioterrorism ,preparedness and ,response ,act of #bjjb and inserting this ,act and other medical and public health preparedness and response laws2 and 7,c7 in paragraph 7#c7-- 7i7 in the paragraph heading1 by striking #bjjd and inserting #bjai2 and 7ii7 by striking #bjjd1 and inserting #bjai14 7b7 ,epidemiology-,laboratory capacity grants ,section #bhba 7#db ,u4,s4,c4 #cjj;hh-#ca7 is amended-- 7#a7 in subsection 7a77#a71 by inserting 1 including mosquito and other vector-borne diseases1 after infectious diseases2 and 7#b7 in subsection 7b71 by striking #bjaj through #bjac and inserting #bjai through #bjbc4 ,,vii ,miscellaneous provisions #gja4 ,reauthorizations and extensions 7a7 ,veterans ,affairs ,section #haag7;g7 of title #ch1 ,united ,states ,code1 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 7b7 ,vaccine tracking and distribution ,section #cai;,a7e7 7#db ,u4,s4,c4 #bdg;d-#a7;e77 is amended by striking #bjad through #bjah and inserting #bjai through #bjbc4 7c7 ,temporary reassignment ,section #cai7;e77#h7 7#db ,u4,s4,c4 #bdg;d7e77#h77 is amended by striking #bjah and inserting #bjbc4 7d7 ,strategic ,innovation ,partner ,section #cai,l7c77#d77;,e77ix7 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,e77ix77 is amended by striking #bjbb and inserting #bjbc4 7e7 ,limited antitrust exemption 7#a7 ,in general ,section #dje of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag2 #db ,u4,s4,c4 #bdg;d-#f;a note7 is amended-- 7,a7 in subsection 7a77#a77;,a7-- 7i7 by striking ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 and inserting ,secretary2 7ii7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b77 7as amended by this ,act2 7iii7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a77 7as amended by this ,act2 and 7iv7 by striking of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;d72 7,b7 in subsection 7b71 by striking #ab-year and inserting #ag-year2 7,c7 by redesignating such section #dje as section #cai,l-#a2 and 7,d7 by transferring such section #cai,l-#a1 as redesignated1 to the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq471 to appear after section #cai,l of such ,act 7#db ,u4,s4,c4 #bdg;d-#g;e74 7#b7 ,conforming amendment ,the table of contents in section #a7;b7 of the ,pandemic and ,all-,hazards ,preparedness ,act 7,public ,law #aji-dag7 is amended by striking the item related to section #dje4 7f7 ,inapplicability of certain provisions ,subsection 7e77#a7 of section #cai,l 7#db ,u4,s4,c4 #bdg;d-#g;e7e77#a77 is amended-- 7#a7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,nondisclosure of information 7i7 ,in general ,information described in clause 7ii7 shall be deemed to be information described in section #eeb7;b77#c7 of title #e1 ,united ,states ,code4 7ii7 ,information described ,the information described in this clause is information relevant to programs of the ,department of ,health and ,human ,services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical1 biological1 radiological1 or nuclear threats1 and is comprised of-- 7,i7 specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection 7c72 7,,ii7 information pertaining to the location security1 personnel1 and research materials and methods of high-containment laboratories conducting research with select agents1 toxins1 or other agents with a material threat determination under section #cai;,f-#b7;c77#b72 or 7,,iii7 security and vulnerability assessments4 2 7#b7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 7#c7 by inserting after subparagraph 7,b7 the following3 7,c7 ,reporting ,one year after the date of enactment of the ,pandemic and ,all-,hazards ,preparedness and ,advancing ,innovation ,act of #bjai1 and annually thereafter1 the ,secretary shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the number of instances in which the ,secretary has used the authority under this subsection to withhold information from disclosure1 as well as the nature of any request under section #eeb of title #e1 ,united ,states ,code that was denied using such authority4 2 and 7#d7 in subparagraph 7,d71 as so redesignated1 by striking #ab and inserting #ag4 #gjb4 ,location of materials in the stockpile ,subsection 7d7 of section #cai;,f-#b 7#db ,u4,s4,c4 #bdg;d-#f;b7 is amended to read as follows3 7d7 ,disclosures ,no ,federal agency may disclose under section #eeb of title #e1 ,united ,states ,code any information identifying the location at which materials in the stockpile described in subsection 7a7 are stored1 or other information regarding the contents or deployment capability of the stockpile that could compromise national security4 4 #gjc4 ,cybersecurity 7a7 ,strategy for public health preparedness and response to cybersecurity threats 7#a7 ,strategy ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall prepare and submit to the relevant committees of ,congress a strategy for public health preparedness and response to address cybersecurity threats 7as defined in section #ajb of ,cybersecurity ,information ,sharing ,act of #bjae 7#f ,u4,s4,c4 #aeja77 that present a threat to national health security4 ,such strategy shall include-- 7,a7 identifying the duties1 functions1 and preparedness goals for which the ,secretary is responsible in order to prepare for and respond to such cybersecurity threats1 including metrics by which to measure success in meeting preparedness goals2 7,b7 identifying gaps in public health capabilities to achieve such preparedness goals2 and 7,c7 strategies to address identified gaps and strengthen public health emergency preparedness and response capabilities to address such cybersecurity threats4 7#b7 ,protection of national security ,the ,secretary shall make such strategy available to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and other congressional committees of jurisdiction1 in a manner that does not compromise national security4 7b7 ,coordination of preparedness for and response to all-,hazards public health emergencies ,subparagraph 7,d7 of section #bhaa7;b77#d7 7#db ,u4,s4,c4 #cjj;hh-#aj7;b77#d77 is amended to read as follows3 7,d7 ,policy coordination and strategic direction ,provide integrated policy coordination and strategic direction1 before1 during1 and following public health emergencies1 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 described in section #ejd7;a77#f7 of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #cad7;a77#f771 or any successor plan2 and such ,federal responses covered by the ,national ,cybersecurity ,incident ,response ,plan developed under section #bbh7;c7 of the ,homeland ,security ,act of #bjjb 7#f ,u4,s4,c4 #adi7;c771 including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security4 4 #gjd4 ,strategy and report ,not later than #ad days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in coordination with the ,assistant ,secretary for ,preparedness and ,response and the ,assistant ,secretary for the ,administration on ,children and ,families or other appropriate office1 and in collaboration with other departments1 as appropriate1 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and other relevant congressional committees-- 7#a7 a formal strategy1 including interdepartmental actions and efforts to reunify children with their parents or guardians1 in all cases in which such children have been separated from their parents or guardians as a result of the initiative announced on ,april #f1 #bjah1 and due to prosecution under section #bge7;a7 of the ,immigration and ,nationality ,act 7#h ,u4,s4,c4 #acbe7;a771 if the parent or guardian chooses such reunification and the child-- 7,a7 was separated from a parent or guardian and placed into a facility funded by the ,department of ,health and ,human ,services2 7,b7 as of the date of the enactment of this ,act1 remains in the care of the ,department of ,health and ,human ,services2 and 7,c7 can be safely reunited with such parent or guardian2 and 7#b7 a report on challenges and deficiencies related to the oversight of1 and care for1 unaccompanied alien children and appropriately reuniting such children with their parents or guardians1 and the actions taken to address any challenges and deficiencies related to unaccompanied alien children in the custody of the ,department of ,health and ,human ,services1 including deficiencies identified and publicly reported by ,congress1 the ,government ,accountability ,office1 or the inspectors general of the ,department of ,health and ,human ,services or other ,federal departments4 #gje4 ,technical amendments 7a7 ,public ,health ,service ,act ,title ,,iii 7#db ,u4,s4,c4 #bda et seq47 is amended-- 7#a7 in paragraphs 7#a7 and 7#e7 of section #cai;,f-#a7;a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a771 by striking section #cai;,f7h7 each place such term appears and inserting section #cai;,f7e72 and 7#b7 in section #cai,k7a7 7#db ,u4,s4,c4 #bdg;d-#g;d7a771 by striking section #cai;,f7h77#d7 and inserting section #cai;,f7e77#d74 7b7 ,public health security grants ,section #cai;,c-#a7;b77#b7 7#db ,u4,s4,c4 #bdg;d-#c;a7b77#b77 is amended-- 7#a7 in subparagraph 7,c71 by striking individuals11 and inserting individuals12 and 7#b7 in subparagraph 7,f71 by striking make satisfactory annual improvement and describe and inserting makes satisfactory annual improvement and describes4 7c7 ,emergency use instructions ,subparagraph 7,a7 of section #efd;,a7e77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7e77#b77 is amended by striking subsection 7a77#a77;,c77i7 and inserting subsection 7a77#a77;,c74 7d7 ,products held for emergency use ,section #efd;,b7#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7 is amended-- 7#a7 in subparagraph 7,b71 by inserting a comma after #eje2 and 7#b7 in subparagraph 7,c71 by inserting or section #efd;,a before the period at the end4 7e7 ,transparency ,section #ejg7;c77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceg7;c77#c77 is amended-- 7#a7 by striking ,nothing in and inserting the following3 7,a7 ,in general ,nothing in 2 7#b7 by inserting or directing after authorizing2 7#c7 by striking disclose any and inserting 8disclose-- 7i7 any 2 7#d7 by striking the period and inserting 2 or2 and 7#e7 by adding at the end the following3 7ii7 in the case of a drug development tool that may be used to support the development of a qualified countermeasure1 security countermeasure1 or qualified pandemic or epidemic product1 as defined in sections #cai;,f-#a1 #cai;,f-#b1 and #cai;,f-#c1 respectively1 of the ,public ,health ,service ,act1 any information that the ,secretary determines has a significant potential to affect national security4 7,b7 ,public acknowledgment ,in the case that the ,secretary1 pursuant to subparagraph 7,a77ii71 does not make information publicly available1 the ,secretary shall provide on the internet website of the ,food and ,drug ,administration an acknowledgment of the information that has not been disclosed1 pursuant to subparagraph 7,a77ii74 4 ,b ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform #ajjj4 ,short title2 references in division 7a7 ,short title ,this division may be cited as the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai4 7b7 ,references ,except as otherwise specified1 any reference to this ,act contained in this division shall be treated as referring only to the provisions of this division4 ,i ,,otc ,drug ,review #ajja4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,f of such ,act 7#ba ,u4,s4,c4 #cee;g7 the following3 #eje;,g4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,nonprescription drugs marketed without an approved application ,nonprescription drugs marketed without an approved drug application under section #eje1 as of the date of the enactment of this section1 shall be treated in accordance with this subsection4 7#a7 ,drugs subject to a final monograph2 category ,i drugs subject to a tentative final monograph ,a drug is deemed to be generally recognized as safe and effective under section #bja7p77#a71 not a new drug under section #bja7p71 and not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 in conformity with the requirements for nonprescription use of a final monograph issued under part #ccj of title #ba1 ,code of ,federal ,regulations 7except as provided in paragraph 7#b771 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7ii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the proposed requirements for nonprescription use of such tentative final monograph1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7iii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#b7 ,treatment of sunscreen drugs ,with respect to sunscreen drugs subject to this section1 the applicable requirements in terms of conformity with a final monograph1 for purposes of paragraph 7#a77;,a77i71 shall be the requirements specified in part #ceb of title #ba1 ,code of ,federal ,regulations1 as published on ,may #ba1 #aiii1 beginning on page #bgfhg of volume #fd of the ,federal ,register1 except that the applicable requirements governing effectiveness and labeling shall be those specified in section #bja4cbg of title #ba1 ,code of ,federal ,regulations4 7#c7 ,category ,,iii drugs subject to a tentative final monograph2 category ,i drugs subject to proposed monograph or advance notice of proposed rulemaking ,a drug that is not described in paragraph 7#a71 7#b71 or 7#d7 is not required to be the subject of an application approved under section #eje1 and is not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 classified in category ,,iii for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with-- 7,i7 the conditions of use1 including indication and dosage strength1 if any1 described for such category ,,iii drug in such preamble or in an applicable subsequent proposed rule2 7,,ii7 the proposed requirements for drugs classified in such tentative final monograph in category ,i in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug2 and 7,,iii7 the general requirements for nonprescription drugs and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 had been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#d7 ,category ,,ii drugs deemed new drugs ,a drug that is classified in category ,,ii for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje beginning on the day that is #ahj calendar days after the date of the enactment of this section1 unless1 before such day1 the ,secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application4 7#e7 ,drugs not ,,grase deemed new drugs ,a drug that the ,secretary has determined not to be generally recognized as safe and effective under section #bja7p77#a7 under a final determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje4 7#f7 ,other drugs deemed new drugs ,except as provided in subsection 7m71 a drug is deemed to be a new drug under section #bja7p7 and misbranded under section #ejb7;ee7 if the drug-- 7,a7 is not subject to section #ejc7;b77#a72 and 7,b7 is not described in paragraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,administrative orders 7#a7 ,in general 7,a7 ,determination ,the ,secretary may1 on the initiative of the ,secretary or at the request of one or more requestors1 issue an administrative order determining whether there are conditions under which a specific drug1 a class of drugs1 or a combination of drugs1 is determined to be-- 7i7 not subject to section #ejc7;b77#a72 and 7ii7 generally recognized as safe and effective under section #bja7p77#a74 7,b7 ,effect ,a drug or combination of drugs shall be deemed to not require approval under section #eje if such drug or combination of drugs-- 7i7 is determined by the ,secretary to meet the conditions specified in clauses 7i7 and 7ii7 of subparagraph 7,a72 7ii7 is marketed in conformity with an administrative order under this subsection2 7iii7 meets the general requirements for nonprescription drugs2 and 7iv7 meets the requirements under subsections 7c7 and 7k74 7,c7 ,standard ,the ,secretary shall find that a drug is not generally recognized as safe and effective under section #bja7p77#a7 if-- 7i7 the evidence shows that the drug is not generally recognized as safe and effective under section #bja7p77#a72 or 7ii7 the evidence is inadequate to show that the drug is generally recognized as safe and effective under section #bja7p77#a74 7#b7 ,administrative orders initiated by the secretary 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 upon the ,secretary's initiative1 the ,secretary shall-- 7i7 make reasonable efforts to notify informally1 not later than #b business days before the issuance of the proposed order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for the drugs or combination of drugs that will be subject to the administrative order2 7ii7 after any such reasonable efforts of notification-- 7,i7 issue a proposed administrative order by publishing it on the website of the ,food and ,drug ,administration and include in such order the reasons for the issuance of such order2 and 7,,ii7 publish a notice of availability of such proposed order in the ,federal ,register2 7iii7 except as provided in subparagraph 7,b71 provide for a public comment period with respect to such proposed order of not less than #de calendar days2 and 7iv7 if1 after completion of the proceedings specified in clauses 7i7 through 7iii71 the ,secretary determines that it is appropriate to issue a final administrative order-- 7,i7 issue the final administrative order1 together with a detailed statement of reasons1 which order shall not take effect until the time for requesting judicial review under paragraph 7#c77;,d77ii7 has expired2 7,,ii7 publish a notice of such final administrative order in the ,federal ,register2 7,,iii7 afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which initially must be requested within #de calendar days of the issuance of the order1 and1 for subsequent levels of appeal1 within #cj calendar days of the prior decision2 and 7,,iv7 except with respect to drugs described in paragraph 7#c77;,b71 upon completion of the formal dispute resolution procedure1 inform the persons which sought such dispute resolution of their right to request a hearing4 7,b7 ,exceptions ,when issuing an administrative order under paragraph 7#a7 on the ,secretary's initiative proposing to determine that a drug described in subsection 7a77#c7 is not generally recognized as safe and effective under section #bja7p77#a71 the ,secretary shall follow the procedures in subparagraph 7,a71 except that-- 7i7 the proposed order shall include notice of-- 7,i7 the general categories of data the ,secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section #bja7p77#a72 and 7,,ii7 the format for submissions by interested persons2 7ii7 the ,secretary shall provide for a public comment period of no less than #ahj calendar days with respect to such proposed order1 except when the ,secretary determines1 for good cause1 that a shorter period is in the interest of public health2 and 7iii7 any person who submits data in such comment period shall include a certification that the person has submitted all evidence created1 obtained1 or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section #bja7p77#a74 7#c7 ,hearings2 judicial review 7,a7 ,in general ,only a person who participated in each stage of formal dispute resolution under subclause 7,,iii7 of paragraph 7#b77;,a77iv7 of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug4 ,if a hearing is sought1 such person must submit a request for a hearing1 which shall be based solely on information in the administrative record1 to the ,secretary not later than #cj calendar days after receiving notice of the final decision of the formal dispute resolution procedure4 7,b7 ,no hearing required with respect to orders relating to certain drugs 7i7 ,in general ,the ,secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph 7#b77;,a77iv7 if the final administrative order involved relates to a drug-- 7,i7 that is described in subsection 7a77#c77;,a72 and 7,,ii7 with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug4 7ii7 ,human data studies and non-human data defined ,in this subparagraph3 7,i7 ,the term human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies4 7,,ii7 ,the term non-human data means data from testing other than with human subjects which provides information concerning safety or effectiveness4 7,c7 ,hearing procedures 7i7 ,denial of request for hearing ,if the ,secretary determines that information submitted in a request for a hearing under subparagraph 7,a7 with respect to a final administrative order issued under paragraph 7#b77;,a77iv7 does not identify the existence of a genuine and substantial question of material fact1 the ,secretary may deny such request4 ,in making such a determination1 the ,secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies4 7ii7 ,single hearing for multiple related requests ,if more than one request for a hearing is submitted with respect to the same administrative order under subparagraph 7,a71 the ,secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate4 7iii7 ,presiding officer ,the presiding officer of a hearing requested under subparagraph 7,a7 shall-- 7,i7 be designated by the ,secretary2 7,,ii7 not be an employee of the ,center for ,drug ,evaluation and ,research2 and 7,,iii7 not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order4 7iv7 ,rights of parties to hearing ,the parties to a hearing requested under subparagraph 7,a7 shall have the right to present testimony1 including testimony of expert witnesses1 and to cross-examine witnesses presented by other parties4 ,where appropriate1 the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication4 7v7 ,final decision 7,i7 ,at the conclusion of a hearing requested under subparagraph 7,a71 the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law4 ,the decision of the presiding officer shall be final4 7,,ii7 ,the final decision may not take effect until the period under subparagraph 7,d77ii7 for submitting a request for judicial review of such decision expires4 7,d7 ,judicial review of final administrative order 7i7 ,in general ,the procedures described in section #eje7;h7 shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the ,united ,states in lieu of the appellate courts specified in such section4 7ii7 ,period to submit a request for judicial review ,a person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than #fj calendar days after the latest of-- 7,i7 the date on which notice of such order is published2 7,,ii7 the date on which a hearing with respect to such order is denied under subparagraph 7,b7 or 7,c77i72 7,,iii7 the date on which a final decision is made following a hearing under subparagraph 7,c77v72 or 7,,iv7 if no hearing is requested1 the date on which the time for requesting a hearing expires4 7#d7 ,expedited procedure with respect to administrative orders initiated by the ,secretary 7,a7 ,imminent hazard to the public health 7i7 ,in general ,in the case of a determination by the ,secretary that a drug1 class of drugs1 or combination of drugs subject to this section poses an imminent hazard to the public health1 the ,secretary1 after first making reasonable efforts to notify1 not later than #dh hours before issuance of such order under this subparagraph1 sponsors who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs-- 7,i7 may issue an interim final administrative order for such drug1 class of drugs1 or combination of drugs under paragraph 7#a71 together with a detailed statement of the reasons for such order2 7,,ii7 shall publish in the ,federal ,register a notice of availability of any such order2 and 7,,iii7 shall provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,nondelegation ,the ,secretary may not delegate the authority to issue an interim final administrative order under this subparagraph4 7,b7 ,safety labeling changes 7i7 ,in general ,in the case of a determination by the ,secretary that a change in the labeling of a drug1 class of drugs1 or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug1 the ,secretary may-- 7,i7 make reasonable efforts to notify informally1 not later than #dh hours before the issuance of the interim final order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs2 7,,ii7 after reasonable efforts of notification1 issue an interim final administrative order in accordance with paragraph 7#a7 to require such change1 together with a detailed statement of the reasons for such order2 7,,iii7 publish in the ,federal ,register a notice of availability of such order2 and 7,,iv7 provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,content of order ,an interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug4 7,c7 ,effective date ,an order under subparagraph 7,a7 or 7,b7 shall take effect on a date specified by the ,secretary4 7,d7 ,final order ,after the completion of the proceedings in subparagraph 7,a7 or 7,b71 the ,secretary shall-- 7i7 issue a final order in accordance with paragraph 7#a72 7ii7 publish a notice of availability of such final administrative order in the ,federal ,register2 and 7iii7 afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which must initially be within #de calendar days of the issuance of the order1 and for subsequent levels of appeal1 within #cj calendar days of the prior decision4 7,e7 ,hearings ,a sponsor of a drug subject to a final order issued under subparagraph 7,d7 and that participated in each stage of formal dispute resolution under clause 7iii7 of such subparagraph may request a hearing on such order4 ,the provisions of subparagraphs 7,a71 7,b71 and 7,c7 of paragraph 7#c71 other than paragraph 7#c77;,c77v77,,ii71 shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph 7#b77;,a77iv74 7,f7 ,timing 7i7 ,final order and hearing ,the ,secretary shall-- 7,i7 not later than #f months after the date on which the comment period closes under subparagraph 7,a7 or 7,b71 issue a final order in accordance with paragraph 7#a72 and 7,,ii7 not later than #ab months after the date on which such final order is issued1 complete any hearing under subparagraph 7,e74 7ii7 ,dispute resolution request ,the ,secretary shall specify in an interim final order issued under subparagraph 7,a7 or 7,b7 such shorter periods for requesting dispute resolution under subparagraph 7,d77iii7 as are necessary to meet the requirements of this subparagraph4 7,g7 ,judicial review ,a final order issued pursuant to subparagraph 7,f7 shall be subject to judicial review in accordance with paragraph 7#c77;,d74 7#e7 ,administrative order initiated at the request of a requestor 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 at the request of a requestor with respect to certain drugs1 classes of drugs1 or combinations of drugs-- 7i7 the ,secretary shall1 after receiving a request under this subparagraph1 determine whether the request is sufficiently complete and formatted to permit a substantive review2 7ii7 if the ,secretary determines that the request is sufficiently complete and formatted to permit a substantive review1 the ,secretary shall-- 7,i7 file the request2 and 7,,ii7 initiate proceedings with respect to issuing an administrative order in accordance with paragraphs 7#b7 and 7#c72 and 7iii7 except as provided in paragraph 7#f71 if the ,secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review1 the requestor may demand that the request be filed over protest1 and the ,secretary shall initiate proceedings to review the request in accordance with paragraph 7#b77;,a74 7,b7 ,request to initiate proceedings 7i7 ,in general ,a requestor seeking an administrative order under paragraph 7#a7 with respect to certain drugs1 classes of drugs1 or combinations of drugs1 shall submit to the ,secretary a request to initiate proceedings for such order in the form and manner as specified by the ,secretary4 ,such requestor may submit a request under this subparagraph for the issuance of an administrative order-- 7,i7 determining whether a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje2 or 7,,ii7 determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje1 if1 absent such a changed condition of use1 such drug is-- 7aa7 generally recognized as safe and effective under section #bja7p77#a7 in accordance with subsection 7a77#a71 7a77#b71 or an order under this subsection2 or 7bb7 subject to subsection 7a77#c71 but only if such requestor initiates such request in conjunction with a request for the ,secretary to determine whether such drug is generally recognized as safe and effective under section #bja7p77#a71 which is filed by the ,secretary under subparagraph 7,a77ii74 7ii7 ,exception ,the ,secretary is not required to complete review of a request for a change described in clause 7i77,,ii7 if the ,secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section #bja7p77#a7 under paragraph 7#a7 and issues a final order announcing that determination4 7iii7 ,withdrawal ,the requestor may withdraw a request under this paragraph1 according to the procedures set forth pursuant to subsection 7d77#b77;,b74 ,notwithstanding any other provision of this section1 if such request is withdrawn1 the ,secretary may cease proceedings under this subparagraph4 7,c7 ,exclusivity 7i7 ,in general ,a final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such order71 for a period of #ah months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order1 to market drugs-- 7,i7 incorporating changes described in clause 7ii72 and 7,,ii7 subject to the limitations under clause 7iv74 7ii7 ,changes described ,a change described in this clause is a change subject to an order specified in clause 7i71 which-- 7,i7 provides for a drug to contain an active ingredient 7including any ester or salt of the active ingredient7 not previously incorporated in a drug described in clause 7iii72 or 7,,ii7 provides for a change in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor 7or for which the requestor has an exclusive right of reference7 were essential to the issuance of such order4 7iii7 ,drugs described ,the drugs described in this clause are drugs-- 7,i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a final order issued under this section2 7,,iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a772 or 7,,iv7 described in subsection 7m77#a71 other than drugs subject to an active enforcement action under chapter ,,iii of this ,act4 7iv7 ,limitations on exclusivity 7,i7 ,in general ,only one #ah-month period under this subparagraph shall be granted1 under each order described in clause 7i71 with respect to changes 7to the drug subject to such order7 which are either-- 7aa7 changes described in clause 7ii77,i71 relating to active ingredients2 or 7bb7 changes described in clause 7ii77,,ii71 relating to conditions of use4 7,,ii7 ,no exclusivity allowed ,no exclusivity shall apply to changes to a drug which are-- 7aa7 the subject of a ,tier #b ,,otc monograph order request 7as defined in section #gdd,l72 7bb7 safety-related changes1 as defined by the ,secretary1 or any other changes the ,secretary considers necessary to assure safe use2 or 7cc7 changes related to methods of testing safety or efficacy4 7v7 ,new human data studies defined ,in this subparagraph1 the term new human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies1 the results of which-- 7,i7 have not been relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje2 and 7,,ii7 do not duplicate the results of another study that was relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje4 7#f7 ,information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request 7,a7 ,in general ,in response to a request under this section that a drug described in subparagraph 7,b7 be generally recognized as safe and effective1 the ,secretary-- 7i7 may file such request1 if the request includes information specified under subparagraph 7,c7 with respect to safe nonprescription marketing and use of such drug2 or 7ii7 if the request fails to include information specified under subparagraph 7,c71 shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph 7,d74 7,b7 ,drug described ,a drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug-- 7i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a final order under this section2 or 7iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a774 7,c7 ,information demonstrating prima facie safe nonprescription marketing and use ,information specified in this subparagraph1 with respect to a request described in subparagraph 7,a77i71 is-- 7i7 information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the ,united ,states as a nonprescription drug under comparable conditions of use2 7ii7 if the drug has not been previously marketed in the ,united ,states as a nonprescription drug1 information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section #hjb7;b77#a77;,a7 or designated by the ,secretary in accordance with section #hjb7;b77#a77;,b7-- 7,i7 for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug2 and 7,,ii7 during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the ,secretary for such monitoring purposes1 including for adverse events associated with nonprescription use of the drug2 or 7iii7 if the ,secretary determines that information described in clause 7i7 or 7ii7 is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug1 such other information the ,secretary determines is sufficient for such purposes4 7,d7 ,marketing pursuant to new drug application ,in the case of a request described in subparagraph 7,a77ii71 the drug subject to such request may be resubmitted for filing only if-- 7i7 the drug is marketed as a nonprescription drug1 under conditions of use comparable to the conditions specified in the request1 for such period as the ,secretary determines appropriate 7not to exceed #e consecutive years7 pursuant to an application approved under section #eje2 and 7ii7 during such period1 #a1jjj1jjj retail packages of the drug1 or an equivalent quantity as determined by the ,secretary1 were distributed for retail sale1 as determined in such manner as the ,secretary finds appropriate4 7,e7 ,rule of application ,except in the case of a request involving a drug described in section #ehf7i71 as in effect on ,january #a1 #bjag1 if the ,secretary refuses to file a request under this paragraph1 the requestor may not file such request over protest under paragraph 7#e77;,a77iii74 7#g7 ,packaging ,an administrative order issued under paragraph 7#b71 7#d77;,a71 or 7#e7 may include requirements for the packaging of a drug to encourage use in accordance with labeling4 ,such requirements may include unit dose packaging1 requirements for products intended for use by pediatric populations1 requirements to reduce risk of harm from unsupervised ingestion1 and other appropriate requirements4 ,this paragraph does not authorize the ,food and ,drug ,administration to require standards or testing procedures as described in part #agjj of title #af1 ,code of ,federal ,regulations4 7#h7 ,final and tentative final monographs for category ,i drugs deemed final administrative orders 7,a7 ,in general ,a final monograph or tentative final monograph described in subparagraph 7,b7 shall be deemed to be a final administrative order under this subsection and may be amended1 revoked1 or otherwise modified in accordance with the procedures of this subsection4 7,b7 ,monographs described ,for purposes of subparagraph 7,a71 a final monograph or tentative final monograph is described in this subparagraph if it-- 7i7 establishes conditions of use for a drug described in paragraph 7#a7 or 7#b7 of subsection 7a72 and 7ii7 represents the most recently promulgated version of such conditions1 including as modified1 in whole or in part1 by any proposed or final rule4 7,c7 ,deemed orders include harmonizing technical amendments ,the deemed establishment of a final administrative order under subparagraph 7,a7 shall be construed to include any technical amendments to such order as the ,secretary determines necessary to ensure that such order is appropriately harmonized1 in terms of terminology or cross-references1 with the applicable provisions of this ,act 7and regulations thereunder7 and any other orders issued under this section4 7c7 ,procedure for minor changes 7#a7 ,in general ,minor changes in the dosage form of a drug that is described in paragraph 7#a7 or 7#b7 of subsection 7a7 or the subject of an order issued under subsection 7b7 may be made by a requestor without the issuance of an order under subsection 7b7 if-- 7,a7 the requestor maintains such information as is necessary to demonstrate that the change-- 7i7 will not affect the safety or effectiveness of the drug2 and 7ii7 will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product2 and 7,b7 the change is in conformity with the requirements of an applicable administrative order issued by the ,secretary under paragraph 7#c74 7#b7 ,additional information 7,a7 ,access to records ,a sponsor shall submit records requested by the ,secretary relating to such a minor change under section #gjd7;a77#d71 within #ae business days of receiving such a request1 or such longer period as the ,secretary may provide4 7,b7 ,insufficient information ,if the ,secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient1 the ,secretary-- 7i7 may so inform the sponsor of the drug in writing2 and 7ii7 if the ,secretary so informs the sponsor1 shall provide the sponsor of the drug with a reasonable opportunity to provide additional information4 7,c7 ,failure to submit sufficient information ,if the sponsor fails to provide such additional information within a time prescribed by the ,secretary1 or if the ,secretary determines that such additional information does not demonstrate that the change does not-- 7i7 affect the safety or effectiveness of the drug2 or 7ii7 materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product1 the drug as modified is a new drug under section #bja7p7 and shall be deemed to be misbranded under section #ejb7;ee74 7#c7 ,determining whether a change will affect safety or effectiveness 7,a7 ,in general ,the ,secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product1 together with guidance for applying those orders to specific dosage forms4 7,b7 ,standard practices ,the orders and guidance issued by the ,secretary under subparagraph 7,a7 shall take into account relevant public standards and standard practices for evaluating the quality of drugs1 and may take into account the special needs of populations1 including children4 7d7 ,confidentiality of information submitted to the ,secretary 7#a7 ,in general ,subject to paragraph 7#b71 any information1 including reports of testing conducted on the drug or drugs involved1 that is submitted by a requestor in connection with proceedings on an order under this section 7including any minor change under subsection 7c77 and is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code1 shall not be disclosed to the public unless the requestor consents to that disclosure4 7#b7 ,public availability 7,a7 ,in general ,except as provided in subparagraph 7,b71 the ,secretary shall-- 7i7 make any information submitted by a requestor in support of a request under subsection 7b77#e77;,a7 available to the public not later than the date on which the proposed order is issued2 and 7ii7 make any information submitted by any other person with respect to an order requested 7or initiated by the ,secretary7 under subsection 7b71 available to the public upon such submission4 7,b7 ,limitations on public availability ,information described in subparagraph 7,a7 shall not be made public if-- 7i7 the information pertains to pharmaceutical quality information1 unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section #bja7p77#a72 7ii7 the information is submitted in a requestor-initiated request1 but the requestor withdraws such request1 in accordance with withdrawal procedures established by the ,secretary1 before the ,secretary issues the proposed order2 7iii7 the ,secretary requests and obtains the information under subsection 7c7 and such information is not submitted in relation to an order under subsection 7b72 or 7iv7 the information is of the type contained in raw datasets4 7e7 ,updates to drug listing information ,a sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section #eaj7;j7 within #cj calendar days of the date when the drug is first commercially marketed1 except that a sponsor who was the order requestor with respect to an order subject to subsection 7b77#e77;,c7 7or a licensee1 assignee1 or successor in interest of such requestor7 shall submit updated drug listing information on or before the date when the drug is first commercially marketed4 7f7 ,approvals under section #eje ,the provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections #eje7;b77#a71 #eje7;b77#b71 and #eje7;j74 ,a determination under this section that a drug is not subject to section #ejc7;b77#a71 is generally recognized as safe and effective under section #bja7p77#a71 and is not a new drug under section #bja7p7 shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section #eje7;b77#b71 so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section4 7g7 ,public availability of administrative orders ,the ,secretary shall establish1 maintain1 update 7as determined necessary by the ,secretary but no less frequently than annually71 and make publicly available1 with respect to orders issued under this section-- 7#a7 a repository of each final order and interim final order in effect1 including the complete text of the order2 and 7#b7 a listing of all orders proposed and under development under subsection 7b77#b71 including-- 7,a7 a brief description of each such order2 and 7,b7 the ,secretary's expectations1 if resources permit1 for issuance of proposed orders over a #c-year period4 7h7 ,development advice to sponsors or requestors ,the ,secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the ,food and ,drug ,administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section4 7i7 ,participation of multiple sponsors or requestors ,the ,secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section1 including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding4 7j7 ,electronic format ,all submissions under this section shall be in electronic format4 7k7 ,effect on existing regulations governing nonprescription drugs 7#a7 ,regulations of general applicability to nonprescription drugs ,except as provided in this subsection1 nothing in this section supersedes regulations establishing general requirements for nonprescription drugs1 including regulations of general applicability contained in parts #bja1 #bej1 and #ccj of title #ba1 ,code of ,federal ,regulations1 or any successor regulations4 ,the ,secretary shall establish or modify such regulations by means of rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7#b7 ,regulations establishing requirements for specific nonprescription drugs 7,a7 ,the provisions of section #caj4ede of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section1 shall be deemed to be a final order under subsection 7b74 7,b7 ,regulations in effect on the day before the date of the enactment of this section1 establishing requirements for specific nonprescription drugs marketed pursuant to this section 7including such requirements in parts #bja and #bej of title #ba1 ,code of ,federal ,regulations71 shall be deemed to be final orders under subsection 7b71 only as they apply to drugs-- 7i7 subject to paragraph 7#a71 7#b71 7#c71 or 7#d7 of subsection 7a72 or 7ii7 otherwise subject to an order under this section4 7#c7 ,withdrawal of regulations ,the ,secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part #ccj and other relevant parts of title #ba1 ,code of ,federal ,regulations 7as in effect on the day before the date of the enactment of this section71 or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references4 ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the ,federal ,register 7or upon such date as specified in such notice74 7l7 ,guidance ,the ,secretary shall issue guidance that specifies-- 7#a7 the procedures and principles for formal meetings between the ,secretary and sponsors or requestors for drugs subject to this section2 7#b7 the format and content of data submissions to the ,secretary under this section2 7#c7 the format of electronic submissions to the ,secretary under this section2 7#d7 consolidated proceedings for appeal and the procedures for such proceedings where appropriate2 and 7#e7 for minor changes in drugs1 recommendations on how to comply with the requirements in orders issued under subsection 7c77#c74 7m7 ,rule of construction 7#a7 ,in general ,this section shall not affect the treatment or status of a nonprescription drug-- 7,a7 that is marketed without an application approved under section #eje as of the date of the enactment of this section2 7,b7 that is not subject to an order issued under this section2 and 7,c7 to which paragraphs 7#a71 7#b71 7#c71 7#d71 or 7#e7 of subsection 7a7 do not apply4 7#b7 ,treatment of products previously found to be subject to time and extent requirements 7,a7 ,notwithstanding subsection 7a71 a drug described in subparagraph 7,b7 may only be lawfully marketed1 without an application approved under section #eje1 pursuant to an order issued under this section4 7,b7 ,a drug described in this subparagraph is a drug which1 prior to the date of the enactment of this section1 the ,secretary determined in a proposed or final rule to be ineligible for review under the ,,otc drug review 7as such phrase ,,otc drug review was used in section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section74 7#c7 ,preservation of authority 7,a7 ,nothing in paragraph 7#a7 shall be construed to preclude or limit the applicability of any provision of this ,act other than this section4 7,b7 ,nothing in subsection 7a7 shall be construed to prohibit the ,secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section #bja7p77#a71 as the ,secretary determines appropriate4 7n7 ,investigational new drugs ,a drug is not subject to this section if an exemption for investigational use under section #eje7;i7 is in effect for such drug4 7o7 ,inapplicability of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to collections of information made under this section4 7p7 ,inapplicability of notice and comment rulemaking and other requirements ,the requirements of subsection 7b7 shall apply with respect to orders issued under this section instead of the requirements of subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7q7 ,definitions ,in this section3 7#a7 ,the term nonprescription drug refers to a drug not subject to the requirements of section #ejc7;b77#a74 7#b7 ,the term sponsor refers to any person marketing1 manufacturing1 or processing a drug that-- 7,a7 is listed pursuant to section #eaj7;j72 and 7,b7 is or will be subject to an administrative order under this section of the ,food and ,drug ,administration4 7#c7 ,the term requestor refers to any person or group of persons marketing1 manufacturing1 processing1 or developing a drug4 4 7b7 ,,gao study ,not later than #d years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a study to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate addressing the effectiveness and overall impact of exclusivity under section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 and section #ehf;,c of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 including the impact of such exclusivity on consumer access4 ,such study shall include-- 7#a7 an analysis of the impact of exclusivity under such section #eje;,g for nonprescription drug products1 including-- 7,a7 the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective2 7,b7 whether the exclusivity for such drug products was granted for-- 7i7 a new active ingredient 7including any ester or salt of the active ingredient72 or 7ii7 changes in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor were essential2 7,c7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the drug product2 7,d7 an analysis of the implementation of the exclusivity provision in such section #eje;,g1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the nonprescription drug market2 7iii7 the impact of such provision on competition in the nonprescription drug market2 7iv7 the impact of such provision on consumer access to nonprescription drug products2 7v7 the impact of such provision on the prices of nonprescription drug products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient to encourage the development of nonprescription drug products that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient incentive to encourage innovation in the nonprescription drug market2 and 7#b7 an analysis of the impact of exclusivity under such section #ehf;,c for sunscreen ingredients1 including-- 7,a7 the number of sunscreen ingredients that were granted exclusivity and the specific ingredient that was determined to be generally recognized as safe and effective2 7,b7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the sunscreen ingredient2 7,c7 whether1 and to what extent1 the sunscreen ingredient granted exclusivity had previously been available outside of the ,united ,states2 7,d7 an analysis of the implementation of the exclusivity provision in such section #ehf;,c1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the sunscreen market2 7iii7 the impact of such provision on competition in the sunscreen market2 7iv7 the impact of such provision on consumer access to sunscreen products2 7v7 the impact of such provision on the prices of sunscreen products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been utilized by sunscreen ingredient sponsors and whether such process has been sufficient to encourage the development of sunscreen ingredients that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #ehf;,c have been sufficient incentive to encourage innovation in the sunscreen market4 7c7 ,conforming amendment ,section #gea7;d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is amended-- 7#a7 in the matter preceding subparagraph 7,a7-- 7,a7 by striking final regulation promulgated and inserting final order under section #eje;,g2 and 7,b7 by striking and not misbranded2 and 7#b7 in subparagraph 7,a71 by striking regulation in effect and inserting regulation or order in effect4 #ajjb4 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7ee7 ,if it is a nonprescription drug that is subject to section #eje;,g1 is not the subject of an application approved under section #eje1 and does not comply with the requirements under section #eje;,g4 7ff7 ,if it is a drug and it was manufactured1 prepared1 propagated1 compounded1 or processed in a facility for which fees have not been paid as required by section #gdd,m4 4 #ajjc4 ,drugs excluded from the over-the-counter drug review 7a7 ,in general ,nothing in this ,act 7or the amendments made by this ,act7 shall apply to any nonprescription drug 7as defined in section #eje;,g7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act7 which was excluded by the ,food and ,drug ,administration from the ,over-the-,counter ,drug ,review in accordance with the paragraph numbered #be on page #idff of volume #cg of the ,federal ,register1 published on ,may #aa1 #aigb4 7b7 ,rule of construction ,nothing in this section shall be construed to preclude or limit the applicability of any other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #ajjd4 ,treatment of ,sunscreen ,innovation ,act 7a7 ,review of nonprescription sunscreen active ingredients 7#a7 ,applicability of section #eje;,g for pending submissions 7,a7 ,in general ,a sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that1 as of the date of enactment of this ,act1 is subject to a proposed sunscreen order under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means of giving written notification to the ,secretary of ,health and ,human ,services within #ahj calendar days of the enactment of this ,act1 to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7,b7 ,election exercised ,upon receipt by the ,secretary of ,health and ,human ,services of a timely notification under subparagraph 7,a7-- 7i7 the proposed sunscreen order involved is deemed to be a request for an order under subsection 7b7 of section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act2 and 7ii7 such order is deemed to have been accepted for filing under subsection 7b77#f77;,a77i7 of such section #eje;,g4 7,c7 ,election not exercised ,if a notification under subparagraph 7,a7 is not received by the ,secretary of ,health and ,human ,services within #ahj calendar days of the date of enactment of this ,act1 the review of the proposed sunscreen order described in subparagraph 7,a7-- 7i7 shall continue under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 and 7ii7 shall not be eligible for review under section #eje;,g1 added by section #ajja of this ,act4 7#b7 ,definitions ,in this subsection1 the terms sponsor1 nonprescription1 sunscreen active ingredient1 and proposed sunscreen order have the meanings given to those terms in section #ehf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,amendments to sunscreen provisions 7#a7 ,final sunscreen orders ,paragraph 7#c7 of section #ehf;,c7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is amended to read as follows3 7#c7 ,relationship to orders under section #eje;,g ,a final sunscreen order shall be deemed to be a final order under section #eje;,g4 4 7#b7 ,meetings ,paragraph 7#g7 of section #ehf;,c7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is amended-- 7,a7 by striking ,a sponsor may request and inserting the following3 7,a7 ,in general ,a sponsor may request 2 and 7,b7 by adding at the end the following3 7,b7 ,confidential meetings ,a sponsor may request one or more confidential meetings with respect to a proposed sunscreen order1 including a letter deemed to be a proposed sunscreen order under paragraph 7#c71 to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order1 as appropriate4 ,the ,secretary shall convene a confidential meeting with such sponsor in a reasonable time period4 ,if a sponsor requests more than one confidential meeting for the same proposed sunscreen order1 the ,secretary may refuse to grant an additional confidential meeting request if the ,secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order1 or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion4 ,the ,secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets4 ,this subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7#c7 ,exclusivity ,section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is amended by adding at the end the following3 7f7 ,exclusivity 7#a7 ,in general ,a final sunscreen order shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 for a period of #ah months1 to market a sunscreen ingredient under this section incorporating changes described in paragraph 7#b7 subject to the limitations under paragraph 7#d71 beginning on the date the requestor 7or any licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 may lawfully market such sunscreen ingredient pursuant to the order4 7#b7 ,changes described ,a change described in this paragraph is a change subject to an order specified in paragraph 7#a7 that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph 7#c74 7#c7 ,marketed sunscreen ,the marketed sunscreen ingredients described in this paragraph are sunscreen ingredients-- 7,a7 marketed in accordance with a final monograph for sunscreen drug products set forth at part #ceb of title #ba1 ,code of ,federal ,regulations 7as published at #fd ,fed4 ,reg4 #bgfhg72 or 7,b7 marketed in accordance with a final order issued under this section4 7#d7 ,limitations on exclusivity ,only one #ah-month period may be granted per ingredient under paragraph 7#a74 7#e7 ,listing of licensees1 assignees1 or successors in interest ,requestors shall submit to the ,secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce1 a list of licensees1 assignees1 or successors in interest under paragraph 7#a74 4 7#d7 ,sunset provision ,subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is amended by adding at the end the following3 #ehf;,h4 ,sunset ,this subchapter shall cease to be effective at the end of fiscal year #bjbb4 4 7#e7 ,treatment of final sunscreen order ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by striking section #ehf;,e of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatment of ,authority ,regarding ,finalization of ,sunscreen ,monograph 7#a7 ,in general 7,a7 ,revision of final sunscreen order ,not later than ,november #bf1 #bjai1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall amend and revise the final administrative order concerning nonprescription sunscreen 7referred to in this subsection as the sunscreen order7 for which the content1 prior to the date of enactment of this ,act1 was represented by the final monograph for sunscreen drug products set forth in part #ceb of title #ba1 ,code of ,federal ,regulations 7as in effect on ,may #ba1 #aiii74 7,b7 ,issuance of revised sunscreen order2 effective date ,a revised sunscreen order described in subparagraph 7,a7 shall be-- 7i7 issued in accordance with the procedures described in section #eje;,g7c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 issued in proposed form not later than ,may #bh1 #bjai2 7iii7 effective not later than ,november #bf1 #bjbj2 and 7iv7 issued by the ,secretary at least #a year prior to the effective date of the revised order4 7#b7 ,reports ,if a revised sunscreen order issued under paragraph 7#a7 does not include provisions related to the effectiveness of various sun protection factor levels1 and does not address all dosage forms known to the ,secretary to be used in sunscreens marketed in the ,united ,states without a new drug application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 the ,secretary shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on the rationale for omission of such provisions from such order1 and a plan and timeline to compile any information necessary to address such provisions through such order4 7d7 ,treatment of non-sunscreen time and extent applications 7#a7 ,in general ,any application described in section #ehf;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 that was submitted to the ,secretary pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as such provisions were in effect immediately prior to the date of enactment date of this ,act1 shall be extinguished as of such date of enactment1 subject to paragraph 7#b74 7#b7 ,order request ,nothing in paragraph 7#a7 precludes the submission of an order request under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act1 with respect to a drug that was the subject of an application extinguished under paragraph 7#a74 #ajje4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs 7a7 ,in general ,subject to subsection 7c71 the ,secretary of ,health and ,human ,services shall1 beginning not later than #a year after the date of enactment of this ,act1 annually submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a letter describing the progress of the ,food and ,drug ,administration-- 7#a7 in evaluating the cough and cold monograph described in subsection 7b7 with respect to children under age #f2 and 7#b7 as appropriate1 revising such cough and cold monograph to address such children through the order process under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7b7 ,cough and cold monograph described ,the cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive1 expectorant1 nasal decongestant1 or antihistamine active ingredients 7or combinations thereof7 are generally recognized as safe and effective1 as specified in part #cda of title #ba1 ,code of ,federal ,regulations 7as in effect immediately prior to the date of enactment of this ,act71 and included in an order deemed to be established under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7c7 ,duration of authority ,the requirement under subsection 7a7 shall terminate as of the date of a letter submitted by the ,secretary of ,health and ,human ,services pursuant to such subsection in which the ,secretary indicates that the ,food and ,drug ,administration has completed its evaluation and revised1 in a final order1 as applicable1 the cough and cold monograph as described in subsection 7a77#b74 #ajjf4 ,technical corrections 7a7 ,imports and exports ,section #hja7;e77#d77;,e77iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is amended by striking subparagraph each place such term appears and inserting paragraph4 7b7 ,,fda ,reauthorization ,act of #bjag 7#a7 ,in general ,section #ije7;b77#d7 of the ,,fda ,reauthorization ,act of #bjag 7,public ,law#aae-eb7 is amended by striking ,section #gdd;,h7e77#b77;,b7 and inserting ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as of the enactment of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 ,,ii ,user ,fees #bjja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,over-the-,counter ,monograph ,user ,fee ,act of #bjai4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to ,,otc monograph drug activities1 as set forth in the goals identified for purposes of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjjb4 ,fees relating to over-the-counter drugs ,subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by inserting after part #i the following3 #aj ,fees ,relating to ,over-the-,counter ,drugs #gdd,l4 ,definitions ,in this part3 7#a7 ,the term affiliate means a business entity that has a relationship with a second business entity if1 directly or indirectly-- 7,a7 one business entity controls1 or has the power to control1 the other business entity2 or 7,b7 a third party controls1 or has power to control1 both of the business entities4 7#b7 ,the term contract manufacturing organization facility means an ,,otc monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the ,,otc monograph drug produced at such facility directly to wholesalers1 retailers1 or consumers in the ,united ,states4 7#c7 ,the term costs of resources allocated for ,,otc monograph drug activities means the expenses in connection with ,,otc monograph drug activities for-- 7,a7 officers and employees of the ,food and ,drug ,administration1 contractors of the ,food and ,drug ,administration1 advisory committees1 and costs related to such officers1 employees1 and committees and costs related to contracts with such contractors2 7,b7 management of information1 and the acquisition1 maintenance1 and repair of computer resources2 7,c7 leasing1 maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies2 and 7,d7 collecting fees under section #gdd,m and accounting for resources allocated for ,,otc monograph drug activities4 7#d7 ,the term ,,fda establishment identifier is the unique number automatically generated by ,food and ,drug ,administration's ,field ,accomplishments and ,compliance ,tracking ,system 7,,facts7 7or any successor system74 7#e7 ,the term ,,otc monograph drug means a nonprescription drug without an approved new drug application which is governed by the provisions of section #eje;,g4 7#f7 ,the term ,,otc monograph drug activities means activities of the ,secretary associated with ,,otc monograph drugs and inspection of facilities associated with such products1 including the following activities3 7,a7 ,the activities necessary for review and evaluation of ,,otc monographs and ,,otc monograph order requests1 including-- 7i7 orders proposing or finalizing applicable conditions of use for ,,otc monograph drugs2 7ii7 orders affecting status regarding general recognition of safety and effectiveness of an ,,otc monograph ingredient or combination of ingredients under specified conditions of use2 7iii7 all ,,otc monograph drug development and review activities1 including intra-agency collaboration2 7iv7 regulation and policy development activities related to ,,otc monograph drugs2 7v7 development of product standards for products subject to review and evaluation2 7vi7 meetings referred to in section #eje;,g7i72 7vii7 review of labeling prior to issuance of orders related to ,,otc monograph drugs or conditions of use2 and 7viii7 regulatory science activities related to ,,otc monograph drugs4 7,b7 ,inspections related to ,,otc monograph drugs4 7,c7 ,monitoring of clinical and other research conducted in connection with ,,otc monograph drugs4 7,d7 ,safety activities with respect to ,,otc monograph drugs1 including-- 7i7 collecting1 developing1 and reviewing safety information on ,,otc monograph drugs1 including adverse event reports2 7ii7 developing and using improved adverse event data-collection systems1 including information technology systems2 and 7iii7 developing and using improved analytical tools to assess potential safety risks1 including access to external databases4 7,e7 ,other activities necessary for implementation of section #eje;,g4 7#g7 ,the term ,,otc monograph order request means a request for an order submitted under section #eje;,g7b77#e74 7#h7 ,the term ,tier #a ,,otc monograph order request means any ,,otc monograph order request not determined to be a ,tier #b ,,otc monograph order request4 7#i7 7,a7 ,the term ,tier #b ,,otc monograph order request means1 subject to subparagraph 7,b71 an ,,otc monograph order request for-- 7i7 the reordering of existing information in the drug facts label of an ,,otc monograph drug2 7ii7 the addition of information to the other information section of the drug facts label of an ,,otc monograph drug1 as limited by section #bja4ff7;c77#g7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7iii7 modification to the directions for use section of the drug facts label of an ,,otc monograph drug1 if such changes conform to changes made pursuant to section #eje;,g7c77#c77;,a72 7iv7 the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph2 7v7 a change to ingredient nomenclature to align with nomenclature of a standards-setting organization2 or 7vi7 addition of an interchangeable term in accordance with section #ccj4a of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,the ,secretary may1 based on program implementation experience or other factors found appropriate by the ,secretary1 characterize any ,,otc monograph order request as a ,tier #b ,,otc monograph order request 7including recharacterizing a request from ,tier #a to ,tier #b7 and publish such determination in a proposed order issued pursuant to section #eje;,g4 7#aj7 7,a7 ,the term ,,otc monograph drug facility means a foreign or domestic business or other entity that-- 7i7 is-- 7,i7 under one management1 either direct or indirect2 and 7,,ii7 at one geographic location or address engaged in manufacturing or processing the finished dosage form of an ,,otc monograph drug2 7ii7 includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more ,,otc monograph drugs to manufacture or process such drugs2 and 7iii7 does not include a business or other entity whose only manufacturing or processing activities are one or more of the following3 production of clinical research supplies1 testing1 or placement of outer packaging on packages containing multiple products1 for such purposes as creating multipacks1 when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging4 7,b7 ,for purposes of subparagraph 7,a77i77,,ii71 separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are-- 7i7 closely related to the same business enterprise2 7ii7 under the supervision of the same local management2 and 7iii7 under a single ,,fda establishment identifier and capable of being inspected by the ,food and ,drug ,administration during a single inspection4 7,c7 ,if a business or other entity would meet criteria specified in subparagraph 7,a71 but for being under multiple management1 the business or other entity is deemed to constitute multiple facilities1 one per management entity1 for purposes of this paragraph4 7#aa7 ,the term ,,otc monograph drug meeting means any meeting regarding the content of a proposed ,,otc monograph order request4 7#ab7 ,the term person includes an affiliate of a person4 7#ac7 ,the terms requestor and sponsor have the meanings given such terms in section #eje;,g4 #gdd,m4 ,authority to assess and use ,,otc monograph fees 7a7 ,types of fees ,beginning with fiscal year #bjai1 the ,secretary shall assess and collect fees in accordance with this section as follows3 7#a7 ,facility fee 7,a7 ,in general ,each person that owns a facility identified as an ,,otc monograph drug facility on ,december #ca of the fiscal year or at any time during the preceding #ab-month period shall be assessed an annual fee for each such facility as determined under subsection 7c74 7,b7 ,exceptions 7i7 ,a fee shall not be assessed under subparagraph 7,a7 if the identified ,,otc monograph drug facility-- 7,i7 has ceased all activities related to ,,otc monograph drugs prior to ,january #ca1 #bjai1 for the first program year1 and ,december #ca of the fiscal year for subsequent fiscal years2 and 7,,ii7 has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section #eaj4 7ii7 ,the amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an ,,otc monograph drug facility that is not a contract manufacturing organization facility4 7,c7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7c74 7,d7 ,due date 7i7 ,for first program year ,for fiscal year #bjai1 the facility fees required under subparagraph 7,a7 shall be due #de calendar days after publication of the ,federal ,register notice provided for under subsection 7c77#d77;,a74 7ii7 ,subsequent fiscal years ,for each fiscal year after fiscal year #bjai1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day of ,june of such year2 or 7,,ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year4 7#b7 ,,otc monograph order request fee 7,a7 ,in general ,each person that submits an ,,otc monograph order request shall be subject to a fee for an ,,otc monograph order request4 ,the amount of such fee shall be-- 7i7 for a ,tier #a ,,otc monograph order request1 #ejj1jjj1 adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b772 and 7ii7 for a ,tier #b ,,otc monograph order request1 #ajj1jjj adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b774 7,b7 ,due date ,the ,,otc monograph order request fees required under subparagraph 7,a7 shall be due on the date of submission of the ,,otc monograph order request4 7,c7 ,exception for certain safety changes ,a person who is named as the requestor in an ,,otc monograph order shall not be subject to a fee under subparagraph 7,a7 if the ,secretary finds that the ,,otc monograph order request seeks to change the drug facts labeling of an ,,otc monograph drug in a way that would add to or strengthen-- 7i7 a contraindication1 warning1 or precaution2 7ii7 a statement about risk associated with misuse or abuse2 or 7iii7 an instruction about dosage and administration that is intended to increase the safe use of the ,,otc monograph drug4 7,d7 ,refund of fee if order request is recategorized as a ,tier #b ,,otc monograph order request ,if the ,secretary determines that an ,,otc monograph request initially characterized as ,tier #a shall be re-characterized as a ,tier #b ,,otc monograph order request1 and the requestor has paid a ,tier #a fee in accordance with subparagraph 7,a77i71 the ,secretary shall refund the requestor the difference between the ,tier #a and ,tier #b fees determined under subparagraphs 7,a77i7 and 7,a77ii71 respectively4 7,e7 ,refund of fee if order request refused for filing or withdrawn before filing ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,b7 for any order request which is refused for filing or was withdrawn before being accepted or refused for filing4 7,f7 ,fees for order requests previously refused for filing or withdrawn before filing ,an ,,otc monograph order request that was submitted but was refused for filing1 or was withdrawn before being accepted or refused for filing1 shall be subject to the full fee under subparagraph 7,a7 upon being resubmitted or filed over protest4 7,g7 ,refund of fee if order request withdrawn ,if an order request is withdrawn after the order request was filed1 the ,secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed4 ,the ,secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph4 ,a determination by the ,secretary concerning a refund under this subparagraph shall not be reviewable4 7#c7 ,refunds 7,a7 ,in general ,other than refunds provided pursuant to any of subparagraphs 7,d7 through 7,g7 of paragraph 7#b71 the ,secretary shall not refund any fee paid under paragraph 7#a7 except as provided in subparagraph 7,b74 7,b7 ,disputes concerning fees ,to qualify for the return of a fee claimed to have been paid in error under paragraph 7#a7 or 7#b71 a person shall submit to the ,secretary a written request justifying such return within #ahj calendar days after such fee was paid4 7#d7 ,notice ,within the timeframe specified in subsection 7c71 the ,secretary shall publish in the ,federal ,register the amount of the fees under paragraph 7#a7 for such fiscal year4 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjai ,for fiscal year #bjai1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for fiscal year #bjai 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 and 7,c7 additional direct cost adjustments 7as determined under subsection 7c77#c774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjbj through #bjbc1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 7,d7 additional direct cost adjustments 7as determined under subsection 7c77#c772 and 7,e7 additional dollar amounts for each fiscal year as follows3 7i7 #g1jjj1jjj for fiscal year #bjbj4 7ii7 #f1jjj1jjj for fiscal year #bjba4 7iii7 #g1jjj1jjj for fiscal year #bjbb4 7iv7 #c1jjj1jjj for fiscal year #bjbc4 7#c7 ,annual base revenue ,for purposes of paragraphs 7#a77;,a7 and 7#b77;,a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjai1 #h1jjj1jjj2 and 7,b7 for fiscal years #bjbj through #bjbc1 the dollar amount of the total revenue amount established under this subsection for the previous fiscal year1 not including any adjustments made under subsection 7c77#b7 or 7c77#c74 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for fiscal year #bjbj and each subsequent fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,b7 ,,otc monograph order request fees ,for purposes of subsection 7a77#b71 the dollar amount of the inflation adjustment to the fee for ,,otc monograph order requests for fiscal year #bjbj and each subsequent fiscal year shall be equal to the product of-- 7i7 the applicable fee under subsection 7a77#b7 for the preceding fiscal year2 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,c7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to-- 7i7 for each of fiscal years #bjbj and #bjba1 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data2 and 7ii7 for each of fiscal years #bjbb and #bjbc1 the sum of-- 7,i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years2 and 7,,ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years4 7#b7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjai and subsequent fiscal years1 for purposes of subsections 7b77#a77;,b7 and 7b77#b77;,c71 the ,secretary may1 in addition to adjustments under paragraph 7#a71 further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for ,,otc monograph drug activities for not more than the number of weeks specified in subparagraph 7,b74 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #c weeks for fiscal year #bjai2 7ii7 #g weeks for fiscal year #bjbj2 7iii7 #aj weeks for fiscal year #bjba2 7iv7 #aj weeks for fiscal year #bjbb2 and 7v7 #aj weeks for fiscal year #bjbc4 7,c7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #aj weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #aj weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#d7 establishing fee revenue and fees for the fiscal year involved4 7#c7 ,additional direct cost adjustment ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees for purposes of subsection 7b77#b77;,d7 by an amount equal to-- 7,a7 #ad1jjj1jjj for fiscal year #bjai2 7,b7 #g1jjj1jjj for fiscal year #bjbj2 7,c7 #d1jjj1jjj for fiscal year #bjba2 7,d7 #c1jjj1jjj for fiscal year #bjbb2 and 7,e7 #c1jjj1jjj for fiscal year #bjbc4 7#d7 ,annual fee setting 7,a7 ,fiscal year #bjai ,the ,secretary shall1 not later than the second ,monday in ,march of #bjai-- 7i7 establish ,,otc monograph drug facility fees for fiscal year #bjai under subsection 7a71 based on the revenue amount for such year under subsection 7b7 and the adjustments provided under this subsection2 and 7ii7 publish fee revenue1 facility fees1 and ,,otc monograph order requests in the ,federal ,register4 7,b7 ,subsequent fiscal years ,the ,secretary shall1 not later than the second ,monday in ,march of each fiscal year that begins after ,september #cj1 #bjai-- 7i7 establish for each such fiscal year1 based on the revenue amounts under subsection 7b7 and the adjustments provided under this subsection-- 7,i7 ,,otc monograph drug facility fees under subsection 7a77#a72 and 7,,ii7 ,,otc monograph order request fees under subsection 7a77#b72 and 7ii7 publish such fee revenue amounts1 facility fees1 and ,,otc monograph order request fees in the ,federal ,register4 7d7 ,identification of facilities ,each person that owns an ,,otc monograph drug facility shall submit to the ,secretary the information required under this subsection each year4 ,such information shall1 for each fiscal year-- 7#a7 be submitted as part of the requirements for drug establishment registration set forth in section #eaj2 and 7#b7 include for each such facility1 at a minimum1 identification of the facility's business operation as that of an ,,otc monograph drug facility4 7e7 ,effect of failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,in general ,failure to pay the fee under subsection 7a77#a7 within #bj calendar days of the due date as specified in subparagraph 7,d7 of such subsection shall result in the following3 7i7 ,the ,secretary shall place the facility on a publicly available arrears list4 7ii7 ,all ,,otc monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section #ejb7;ff74 7,b7 ,application of penalties ,the penalties under this paragraph shall apply until the fee established by subsection 7a77#a7 is paid4 7#b7 ,order requests ,an ,,otc monograph order request submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for filing by the ,secretary until all fees owed by such person under this section have been paid4 7#c7 ,meetings ,a person subject to fees under this section shall be considered ineligible for ,,otc monograph drug meetings until all such fees owed by such person have been paid4 7f7 ,crediting and availability of fees 7#a7 ,in general ,fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for ,,otc monograph drug activities4 7#b7 ,collections and appropriation ,acts 7,a7 ,in general ,subject to subparagraph 7,c71 the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation1 for such fiscal year4 7,b7 ,use of fees and limitation ,the fees authorized by this section shall be available to defray increases in the costs of the resources allocated for ,,otc monograph drug activities 7including increases in such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such activities71 only if the ,secretary allocates for such purpose an amount for such fiscal year 7excluding amounts from fees collected under this section7 no less than #ab1jjj1jjj1 multiplied by the adjustment factor applicable to the fiscal year involved under subsection 7c77#a74 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs funded by appropriations and allocated for ,,otc monograph drug activities are not more than #ae percent below the level specified in such subparagraph4 7,d7 ,provision for early payments in subsequent years ,payment of fees authorized under this section for a fiscal year 7after fiscal year #bjai71 prior to the due date for such fees1 may be accepted by the ,secretary in accordance with authority provided in advance in a prior year appropriations ,act4 7#c7 ,authorization of appropriations ,for each of the fiscal years #bjai through #bjbc1 there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section4 7g7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under subsection 7a7 within #cj calendar days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7h7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employers1 and advisory committees not engaged in ,,otc monograph drug activities1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 #gdd,n4 ,reauthorization2 reporting requirements 7a7 ,performance report ,beginning with fiscal year #bjai1 and not later than #abj calendar days after the end of each fiscal year thereafter for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the letters described in section #bjja7;b7 of the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting such goals4 7b7 ,fiscal report ,not later than #abj calendar days after the end of fiscal year #bjai and each subsequent fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected for such fiscal year4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the internet website of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to the ,congress with respect to the goals described in subsection 7a71 and plans for meeting the goals1 for ,,otc monograph drug activities for the first #e fiscal years after fiscal year #bjbc1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,c7 scientific and academic experts2 7,d7 health care professionals2 7,e7 representatives of patient and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj calendar days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#c7 ,transmittal of recommendations ,not later than ,january #ae1 #bjbc1 the ,secretary shall transmit to the ,congress the revised recommendations under paragraph 7#b71 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 4 ,passed the ,house of ,representatives ,january #h1 #bjai4;,clerk4