S 1379 — Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

Consultation.

Deadline.>> Guidelines.--The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and Drugs, the Assistant Secretary for Mental Health and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as the Secretary determines to be appropriate, and State, local, Tribal, and territorial public health officials, shall, not later than 2 years after the date of enactment of this section-- ``(1) 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 during, in advance of, or immediately following, a public health emergency, resulting from one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may include existing practices, such as trauma care and medical surge capacity and capabilities), with respect to-- ``(A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and capacity to treat patients affected by such emergency, including-- [[Page 133 STAT.

912]] ``(i) <<NOTE:

Coordination.>> the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under section 319C-2(b);

``(2) make<<NOTE: such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security;

Web posting.>> make such guidelines available on the internet website of the Department of Health and Human Services in a manner that does not compromise national security;

``(c) Considerations.--In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall-- ``(1) include input from hospitals and health care facilities (including health care coalitions under section 319C-2),319C- 2), State, local, Tribal, and territorial public health departments, and health care or subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or nuclear threats, including emerging infectious diseases), as the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

``(2) consult<<NOTE: and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts that the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

Consultation.>> consult and engage with appropriate health care providers and professionals, including physicians, nurses, first responders, health care facilities (including hospitals, primary care clinics, community health centers, mental health facilities, ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts [[Page 133 STAT.

913]] that the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

``(d) Technical<<NOTE: Assistance.--The Assistant Secretary for Preparedness and Response, in consultation with the Director of the Centers for Disease Control and Prevention and the Assistant Secretary of Labor for Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guidelines described in subsection (b).

``(e)Consultation.>> DemonstrationTechnical ProjectAssistance.--The for Regional Health Care Preparedness and Response Systems.-- ``(1) In general.--The Assistant Secretary for Preparedness and ResponseResponse, mayin establishconsultation awith demonstration project pursuant to the developmentDirector and implementation of guidelinesthe underCenters subsection (b) to award grants to improve medical surge capacity for allDisease hazards,Control build and integratePrevention regionaland medicalthe responseAssistant capabilities,Secretary improveof specialtyLabor care expertise for all-hazardsOccupational response,Safety and coordinateHealth, medicalmay preparednessprovide technical assistance and responseconsultation acrosstoward State,meeting local,the Tribal,guidelines territorial,described andin regionalsubsection jurisdictions.(b).

``(e) Demonstration Project for Regional Health Care Preparedness and Response Systems.-- ``(1) <<NOTE:

Grants.

Coordination.>> In general.--The Assistant Secretary for Preparedness and Response may establish a demonstration project pursuant to the development and implementation of guidelines under subsection (b) to award grants to improve medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve specialty care expertise for all-hazards response, and coordinate medical preparedness and response across State, local, Tribal, territorial, and regional jurisdictions.

(b) GAO Report to Congress.-- (1) Report.--Not<<NOTE: later than 3 years after the date of enactment of this Act, the Comptroller General of the United States (referred to in this subsection as the ``Comptroller General'') shall submit to the Committee on Health, Education, Labor, 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 Representatives, a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under section 319C-3(b) of the Public Health Service Act (as added by subsection (a)), including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines.

Analysis.

Evaluation.>> Report.--Not later than years after the date of enactment of this Act, the Comptroller General of the United States (referred to in this subsection as the ``Comptroller General'') shall submit to the Committee on Health, Education, Labor, 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 Representatives, a report on the extent to which hospitals and health care facilities have implemented the recommended guidelines under section 319C-3(b) of the Public Health Service Act (as added by subsection (a)), including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines.

and (B) recommendations<<NOTE: to reduce gaps in incentives for regional health partners, including hospitals and health care facilities, to improve capacity and medical surge capabilities to prepare for, and respond to, public health emergencies, consistent with subsection (a), which may include consideration of facilities participating in programs under section 319C-2 of the Public Health Service Act (42 U.S.C.

Recommenda- tions.>> recommendations to reduce gaps in incentives for regional health partners, including hospitals and health care facilities, to improve capacity and medical surge capabilities to prepare for, and respond to, public health [[Page 133 STAT.

914]] emergencies, consistent with subsection (a), which may include consideration of facilities participating in programs under section 319C-2 of the Public Health Service Act (42 U.S.C.

``PART[[Page I--MILITARY133 ANDSTAT. CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM ``SEC.

915]] ``PART I--MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM ``SEC.

MILITARY<<NOTE: AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM.

``(a)42 MilitaryUSC Trauma300d-91.>> TeamMILITARY PlacementAND Program.--CIVILIAN ``(1)PARTNERSHIP InFOR general.--TheTRAUMA Secretary,READINESS actingGRANT throughPROGRAM. the Assistant Secretary for Preparedness and Response and in consultation with the Secretary of Defense, shall award grants to not more than 20 eligible high-acuity trauma centers to enable military trauma teams to provide, on a full-time basis, trauma care and related acute care at such trauma centers.

``(a) <<NOTE:

Time periods.>> Military Trauma Team Placement Program.-- ``(1) <<NOTE:

Consultation.>> In general.--The Secretary, acting through the Assistant Secretary for Preparedness and Response and in consultation with the Secretary of Defense, shall award grants to not more than 20 eligible high-acuity trauma centers to enable military trauma teams to provide, on a full-time basis, trauma care and related acute care at such trauma centers.

``(3) Availability of funds.--Notwithstanding section 1552 of title 31, United States Code, or any other provision of law, funds available to the Secretary for obligation for a grant under this subsection shall remain available for expenditure for 100 days after the last day of the performance period of such grant.

``(b) Military Trauma Care Provider Placement Program.-- ``(1) In<<NOTE: general.--The Secretary, acting through the Assistant Secretary for Preparedness and Response and in consultation with the Secretary of Defense, shall award grants to eligible trauma centers to enable military trauma care providers to provide trauma care and related acute care at such trauma centers.

``(2)Consultation.>> Limitations.--InIn thegeneral.--The caseSecretary, ofacting athrough grantthe awardedAssistant underSecretary paragraphfor (1)Preparedness toand anResponse eligibleand traumain center,consultation suchwith grant--the ``(A)Secretary shallof beDefense, forshall aaward periodgrants ofto ateligible leasttrauma 1centers yearto andenable notmilitary moretrauma thancare 3providers yearsto (andprovide maytrauma becare renewedand atrelated theacute endcare ofat such period);trauma centers.

``(2) Limitations.--In the case of a grant awarded under paragraph (1) to an eligible trauma center, such grant-- ``(A) <<NOTE:

Time period.>> shall be for a period of at least 1 year and not more than 3 years (and may be renewed at the end of such period);

and ``(B) be<<NOTE: deployed by the Secretary of Defense, in consultation with the Secretary of Health and Human Services, for response to a public health emergency pursuant to section 319.

Consultation.>> be deployed by the Secretary of Defense, in consultation with the Secretary of Health and Human Services, [[Page 133 STAT.

916]] for response to a public health emergency pursuant to section 319.

``(2) Report<<NOTE: to congress.--Not less than once every 2 years, the Secretary, in consultation with the Secretary of Defense, 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-- ``(A) maintaining military trauma care providers' readiness and ability to respond to and treat battlefield injuries;

Consultation.>> Report to congress.--Not less than once every 2 years, the Secretary, in consultation with the Secretary of Defense, 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-- ``(A) maintaining military trauma care providers' readiness and ability to respond to and treat battlefield injuries;

and ``(F) the capability of military trauma care providers to participate as part of a medical response during or in[[Page advance133 ofSTAT. a public health emergency, as determined by the Secretary, or a mass casualty incident.

917]] in advance of a public health emergency, as determined by the Secretary, or a mass casualty incident.

``(5) Military trauma care provider.--The term `military trauma care provider' means a member of the Armed Forces who furnishes emergency, critical care, and other trauma acute care[[Page services133 (includingSTAT. a physician, surgeon, physician assistant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic, or enlisted medical technician) or other military trauma care provider as the Secretary determines appropriate.

918]] care services (including a physician, surgeon, physician assistant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic, or enlisted medical technician) or other military trauma care provider as the Secretary determines appropriate.

``(4) Study<<NOTE: of resources for facilities and capacities.-- Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection.

SuchDeadline. study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.'';

Time period.>> Study of resources for facilities and capacities.--Not later than June 1, 2022, the Comptroller General of the United States shall conduct a study on Federal spending in fiscal years 2013 through 2018 for activities authorized under this subsection.

<<NOTE:

Review.

Assessment.>> Such study shall include a review and assessment of obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a specific accounting of, and delineation between, obligations and expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and the obligations and expenditures incurred to establish and improve the situational awareness and biosurveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations and expenditures.'';

``(3) Standards.-- ``(A) In<<NOTE: general.--Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in cooperation with health care providers, State, local, Tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as necessary.

SuchDeadline.>> standardsIn shallgeneral.--Not belater madethan available1 onyear after the internetdate website of the Departmentenactment of Healththe Pandemic and HumanAll-Hazards Services,Preparedness inand aAdvancing mannerInnovation thatAct doesof not2019, compromisethe national[[Page security.133 STAT.

919]] Secretary, in cooperation with health care providers, State, local, Tribal, and territorial public health officials, and relevant Federal agencies (including the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology), shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as necessary.

<<NOTE:

Web posting.>> Such standards shall be made available on the internet website of the Department of Health and Human Services, in a manner that does not compromise national security.

(4) in subsection (c)-- (A) in paragraph (1)-- (i) by striking ``Not later than 2 years after the date of enactment of the Pandemic and All-HazardsAll- Hazards Preparedness Reauthorization Act of 2013, the Secretary'' and inserting ``The Secretary'';

and (II)[[Page by133 strikingSTAT. ``and clinical laboratories'' and inserting ``, clinical laboratories, and public environmental health agencies'';

920]] (II) by striking ``and clinical laboratories'' and inserting ``, clinical laboratories, and public environmental health agencies'';

``(B) Review.--Not<<NOTE: later than 2 years after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A).

Deadline.

Time periods.>> Review.-- Not later than 2 years after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A).

``(B) Public meeting.-- ``(i) In<<NOTE: general.--Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).

Deadline.>> In general.--Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential goals, functions, and uses of the network described in paragraph (1) and incorporating the elements described in paragraph (3)(A).

``(II) standards and implementation specifications that may improve the collection, analysis, and[[Page interpretation133 ofSTAT. data during a public health emergency;

921]] and interpretation of data during a public health emergency;

``(6) Strategy and implementation plan.-- ``(A) In<<NOTE: general.--Not later than 18 months after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that-- ``(i) is informed by the public meeting under paragraph (5)(B);

``(ii)Deadline.>> includesIn ageneral.--Not reviewlater andthan assessment18 months after the date of existingenactment capabilitiesof the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the networkSecretary shall submit to the congressional committees of jurisdiction a coordinated strategy and relatedan infrastructure,accompanying includingimplementation inputplan providedthat-- ``(i) is informed by the public meeting under paragraph (5)(B);

``(ii) <<NOTE:

Review.

Assessment.>> includes a review and assessment of existing capabilities of the network and related infrastructure, including input provided by the public meeting under paragraph (5)(B);

``(III)[[Page improve133 informationSTAT. sharing, coordination, and communication among disparate biosurveillance systems supported by the Department of Health and Human Services, including the identification of methods to improve accountability, better utilize resources and workforce capabilities, and incorporate innovative technologies within and across agencies;

and922]] ``(IV)``(III) testimprove information sharing, coordination, and evaluatecommunication capabilitiesamong ofdisparate biosurveillance systems supported by the interoperableDepartment networkof Health and Human Services, including the identification of systemsmethods to improve situationalaccountability, awarenessbetter utilize resources and biosurveillanceworkforce capabilities;capabilities, and incorporate innovative technologies within and across agencies;

and ``(IV) <<NOTE:

Evaluation.>> test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;

``(B) Annual<<NOTE: budget plan.--Not later than 2 years after the date of enactment of the Pandemic and All- Hazards Preparedness and Advancing Innovation Act of and on an annual basis thereafter, in accordance with the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan under this section.

SuchDeadline.>> Annual budget planplan.--Not shalllater include--than ``(i)2 ayears summaryafter the date of resourcesenactment previouslyof expendedthe toPandemic establish,and improve,All-Hazards Preparedness and utilizeAdvancing Innovation Act of 2019 and on an annual basis thereafter, in accordance with the nationwidestrategy publicand healthimplementation situationalplan awarenessunder this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and biosurveillanceimplementation networkplan under paragraphthis (1);section.

``(ii)Such estimatesbudget of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan undershall subparagraphinclude-- (A);``(i) <<NOTE:

Summary.>> a summary of resources previously expended to establish, improve, and utilize the nationwide public health situational awareness and biosurveillance network under paragraph (1);

``(ii) <<NOTE:

Cost estimates.>> estimates of costs and resources needed to establish and improve the network under paragraph (1) according to the strategy and implementation plan under subparagraph (A);

and ``(iv) a<<NOTE: strategy to minimize and address such gaps and improve inefficiencies.'';

Strategy.>> a strategy to minimize and address such gaps and improve inefficiencies.'';

and (II)[[Page by133 strikingSTAT. the period and inserting ``;

923]] (II) by striking the period and inserting ``;

``(D) provide<<NOTE: recommendations to the Secretary on policies and procedures to complete the steps described in this paragraph in a manner that is consistent with section 2802.'';

Recommenda- tions.>> 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 2802.'';

and ``(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same terms and conditions in which individuals appointed under 9903[[Page of133 titleSTAT. 5, United States Code, are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.

924]] of title 5, United States Code, are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.

``(g) Timeline.--The<<NOTE: Secretary shall accomplish the purposes under subsections (b) and (c) no later than September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii).

``(h)Deadline.>> IndependentTimeline.--The Evaluation.--NotSecretary latershall thanaccomplish 3 years after the datepurposes ofunder enactmentsubsections of(b) the Pandemic and All-Hazards(c) Preparednessno andlater Advancingthan InnovationSeptember Act30, of2023, 2019,and the Comptroller General of the United States shall conductprovide ana independentjustification evaluation and submit to the Secretary and the congressional committees of jurisdiction afor reportany concerningmissed theor activitiesdelayed conductedimplementation underof subsectionsmeasurable (b)steps andidentified (c),under andsubsection provide(c)(6)(A)(iii). recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.''.

``(h) <<NOTE:

Deadline.

Reports.

Recommenda- tions.>> Independent Evaluation.--Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, 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 (b) and (c), and provide recommendations, as applicable and appropriate, on necessary improvements to the biosurveillance and situational awareness network.''.

247d-4), as redesignated by subsection (a)(6), is amended by striking ``$138,300,000 for each of fiscal years 2014 through 2018'' and inserting ``$161,800,000 for each of fiscal years 2019 through 2023''.

(c) Biological<<NOTE: Threat Detection Report.--The Secretary of Health and Human Services shall, in coordination with the Secretary of Defense and the Secretary of Homeland Security, not later than 180 days after the date of enactment of this Act, report to the Committee on Energy and Commerce, the Committee on Armed Services, and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions, the Committee on Armed Services, and the Committee on Homeland Security and Governmental Affairs of the Senate on the state of Federal biological threat detection efforts, including the following:

Coordination.>> Biological Threat Detection Report.-- The Secretary of Health and Human Services shall, in coordination with the Secretary of Defense and the Secretary of Homeland Security, not later than 180 days after the date of enactment of this Act, report to the Committee on Energy and Commerce, the Committee on Armed Services, and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions, the Committee on Armed Services, and the Committee on Homeland Security and Governmental Affairs of the Senate on the state of Federal biological threat detection efforts, including the following:

and (E)[[Page provide133 advancedSTAT. molecular diagnostics to State, local, Tribal, and territorial public health and other laboratories that support biological threat detection activities.

925]] (E) provide advanced molecular diagnostics to State, local, Tribal, and territorial public health and other laboratories that support biological threat detection activities.

(6) Recommendations<<NOTE: related to research, advanced research, development, and procurement for Federal departments and agencies to improve and enhance biological threat detection systems, including recommendations on the transfer of biological threat detection technology among Federal departments and agencies, as necessary and appropriate.

Recommenda- tions.>> Recommendations related to research, advanced research, development, and procurement for Federal departments and agencies to improve and enhance biological threat detection systems, including recommendations on the transfer of biological threat detection technology among Federal departments and agencies, as necessary and appropriate.

``(C)[[Page facilitate133 andSTAT. accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 319F-2), qualified countermeasures (as defined in section 319F- 1), or qualified pandemic or epidemic products (as defined in section 319F-3), that are applicable to the public health emergency or potential public health emergency under paragraph (1);

926]] ``(C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as defined in section 319F-2), qualified countermeasures (as defined in section 319F- 1), or qualified pandemic or epidemic products (as defined in section 319F-3), that are applicable to the public health emergency or potential public health emergency under paragraph (1);

``(4) Review.--Not<<NOTE: later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, 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 (2).

``(5)Deadline. GAO report.--Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Comptroller General of the United States shall-- ``(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund;

andCoordination. ``(B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.'';

Recommenda- tions.>> Review.--Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this section and provide recommendations to the Committee on Health, Education, Labor, 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 (2).

``(5) GAO report.--Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Comptroller General of the United States shall-- ``(A) <<NOTE:

Review.>> conduct a review of the Fund under this section, including its uses and the resources available in the Fund;

and ``(B) <<NOTE:

Recommenda- tions.>> submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on such review, including recommendations related to such review, as applicable.'';

(2)[[Page in133 subsectionSTAT. (a), by adding at the end the following:

927]] (2) in subsection (a), by adding at the end the following:

Such<<NOTE: information shall be made publicly available in a manner that does not compromise national security.'';

Public information.>> Such information shall be made publicly available in a manner that does not compromise national security.'';

HEALTH<<NOTE: CARE PROFESSIONALS ASSISTING DURING A PUBLIC HEALTH EMERGENCY.

``(a)42 LimitationUSC on234.>> Liability.--NotwithstandingHEALTH anyCARE otherPROFESSIONALS provisionASSISTING ofDURING law,A aPUBLIC healthHEALTH careEMERGENCY. professional who is a member of the Medical Reserve Corps under section 2813 or who is included in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I and who-- ``(1) is responding-- ``(A) to a public health emergency determined under section 319(a), during the initial period of not more than 90 days (as determined by the Secretary) of the public health emergency determination (excluding any period covered by a renewal of such determination);

``(a) Limitation on Liability.--Notwithstanding any other provision of law, a health care professional who is a member of the Medical Reserve Corps under section 2813 or who is included in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I and who-- ``(1) is responding-- ``(A) <<NOTE:

Time period.

Determination.>> to a public health emergency determined under section 319(a), during the initial period of not more than 90 days (as determined by the Secretary) of the public health emergency determination (excluding any period covered by a renewal of such determination);

5170)[[Page or133 underSTAT. section 201 of the National Emergencies Act (50 U.S.C.

928]] 5170) or under section 201 of the National Emergencies Act (50 U.S.C.

``(2)[[Page Application.--This133 sectionSTAT. 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 (1).''.

(b)929]] GAO``(2) Study.--NotApplication.--This latersection than one year after the date of enactment of this Act, the Comptroller General of the United States shall conductapply to a reviewclaim of--for (1)harm theonly numberif of health care providers who register under the Emergencyact Systemor foromission Advancethat Registrationcaused ofsuch Volunteerharm Healthoccurred Professionalson underor sectionafter 319I of the Publiceffective Healthdate Servicedescribed Actin (42paragraph U.S.C.(1).''.

(b) <<NOTE:

Deadline.

Review.>> GAO Study.--Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a review of-- (1) the number of health care providers who register under the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I of the Public Health Service Act (42 U.S.C.

Not later<<NOTE: than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply, including-- (1) challenges associated with the continuous recruitment of blood donors (including those newly eligible to donate);

Recommenda- tions.>> later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply, including-- (1) challenges associated with the continuous recruitment of blood donors (including those newly eligible to donate);

(a) Study.-- (1) In<<NOTE: general.--Not later than one year after the date of enactment of this Act, 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 hospitals, long-term care facilities, and other health care facilities to prepare for, and respond to, public health emergencies, including natural disasters.

Contracts.>> In general.--Not later than one year after the date of enactment of this Act, 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 hospitals, long-term care facilities, and other health care [[Page 133 STAT.

930]] facilities to prepare for, and respond to, public health emergencies, including natural disasters.

and (B) provide<<NOTE: recommendations for improving public health preparedness and response capability and medical surge capacity for hospitals, long-term care facilities, and other health care facilities, including-- (i) improving the existing benchmarks and objective standards for the Federal grant programs described in subsection (a)(3)(A) or developing new benchmarks and standards for such programs;

Recommenda- tions.>> provide recommendations for improving public health preparedness and response capability and medical [[Page 133 STAT.

931]] surge capacity for hospitals, long-term care facilities, and other health care facilities, including-- (i) improving the existing benchmarks and objective standards for the Federal grant programs described in subsection (a)(3)(A) or developing new benchmarks and standards for such programs;

(2) Review of the national disaster medical system.--system.--Section Section 2812(b)(2) (42 U.S.C.

``(2) Joint review and medical surge capacity strategic plan.-- ``(A) Review.--Not<<NOTE: later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the National Disaster Medical System.

SuchDeadline. review shall include-- ``(i) an evaluation of medical surge capacity, as described in section 2803(a);

Coordination.>> Review.-- Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the National Disaster Medical System.

Such review shall include-- ``(i) <<NOTE:

Evaluation.>> an evaluation of medical surge capacity, as described in section 2803(a);

and ``(v) gaps<<NOTE: that may exist in such workforce and recommendations for addressing such gaps.

``(B)Recommenda- Updates.--Astions.>> partgaps ofthat themay Nationalexist Healthin Securitysuch Strategyworkforce under section 2802, the Secretary shall update the findings from the review under subparagraph (A) and provide recommendations tofor modifyaddressing thesuch policiesgaps. of the National Disaster Medical System as necessary.''.

``(B) <<NOTE:

Recommenda- tions.>> Updates.--As part of the National Health Security Strategy under section 2802, the Secretary shall update [[Page 133 STAT.

932]] the findings from the review under subparagraph (A) and provide recommendations to modify the policies of the National Disaster Medical System as necessary.''.

``(3) Notification.--Not<<NOTE: later than 30 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 emergency, the Secretary shall submit to the congressional committees of jurisdiction a notification detailing-- ``(A) the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency;

Deadline.>> Notification.--Not later than 30 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 emergency, the Secretary shall submit to the congressional committees of jurisdiction a notification detailing-- ``(A) the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency;

``(4) Certain appointments.-- ``(A) In<<NOTE: 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 emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system.

TheDetermination.>> SecretaryIn shallgeneral.--If providethe updatesSecretary ondetermines that the number of vacantintermittent ordisaster unfilledresponse positionspersonnel within suchthe systemNational Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the congressionalSecretary committeesmay ofappoint jurisdictioncandidates eachdirectly quarterto personnel positions for whichintermittent thisdisaster authorityresponse iswithin insuch effect.system.

<<NOTE:

Time period.>> 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 effect.

300hh-15(a))300hh- 15(a)) 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 State, local, Tribal, and territorial levels.''.

and (2) in subsection (c)-- (A)[[Page by133 strikingSTAT. ``For the purpose of carrying out this section'' and inserting the following:

933]] (A) by striking ``For the purpose of carrying out this section'' and inserting the following:

``(2) Epidemic<<NOTE: intelligence service program.--For purposes of carrying out this section with respect to qualified health professionals serving in the Epidemic Intelligence Service, as authorized under section 317G, there is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.''.

Time periods.

Appropriation authorization.>> Epidemic intelligence service program.--For purposes of carrying out this section with respect to qualified health professionals serving in the Epidemic Intelligence Service, as authorized under section 317G, there is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.''.

The<<NOTE: Secretary shall provide notification to any eligible individual of any effect such designation may have on other benefits for which such individual is eligible, including benefits from private entities.''.

Notification.>> The Secretary shall provide notification to any eligible individual of any effect such designation may have on other benefits for which such individual is eligible, including benefits from private entities.''.

and ``(ii) determined<<NOTE: by the Secretary of Health and Human Services to be hazardous.''.

(3)Determination.>> Sunset.--Thedetermined amendmentsby madethe bySecretary paragraphsof (1)Health and (2)Human shallServices cease to havebe forcehazardous.''. or effect on October 1, 2021.

(e)(3) Mission<<NOTE: Readiness Report to Congress.-- (1) Report.--Not later than one year after the date of enactment of this section, the Comptroller General of the United States (referred to in this subsection as the ``Comptroller General'') shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the medical surge capacity of the United States in the event of a public health emergency, including the capacity and capability of the current health care workforce to prepare for, and respond to, the full range of public health emergencies or potential public health emergencies, and recommendations to address any gaps identified in such workforce.

34 USC 10284 note.>> Sunset.--The amendments made by paragraphs (1) and (2) shall cease to have force or effect on October 1, 2021.

(e) Mission Readiness Report to Congress.-- (1) <<NOTE:

Recommenda- tions.>> Report.--Not later than one year after the date of enactment of this section, the Comptroller General of the United States (referred to in this subsection as the ``Comptroller General'') shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the medical surge capacity of the United States in the event of a public health emergency, including the capacity and capability of the current health care workforce to prepare for, and respond to, the full range of public health emergencies [[Page 133 STAT.

934]] or potential public health emergencies, and recommendations to address any gaps identified in such workforce.

300hh-300hh-1(b)(4)(B))); 1(b)(4)(B)));

and (E) identification<<NOTE: of gaps that may exist in such workforce and recommendations for addressing such gaps, the extent to which the Assistant Secretary for Preparedness and Response plans to address such gaps, and any recommendations from the Comptroller General to address such gaps.

Recommenda- tions.>> identification of gaps that may exist in such workforce and recommendations for addressing such gaps, the extent to which the Assistant Secretary for Preparedness and Response plans to address such gaps, and any recommendations from the Comptroller General to address such gaps.

``Such logistical<<NOTE: support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T.

Determination.>> logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T.

300hh-10(d)(2)(C))300hh- 10(d)(2)(C)) is amended by inserting ``, and ancillary medical supplies to assist with the utilization of such countermeasures or products,'' after ``products''.

(c)[[Page Evaluation133 ofSTAT. Barriers to Rapid Delivery of Medical Countermeasures.-- (1) 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 States.

(2)935]] Notice(c) toEvaluation congress.--Notof laterBarriers thanto 9Rapid monthsDelivery after the date of theMedical enactmentCountermeasures.-- of(1) thisRapid Act,delivery thestudy.--The Assistant Secretary for Preparedness and Response shallmay notifyconduct thea Committeestudy on Energyissues andthat Commercehave of the Housepotential ofto Representativesadversely andaffect the Committeehandling on Health, Education, Labor, and Pensionsrapid delivery of themedical Senatecountermeasures ifto theindividuals Assistantduring Secretarypublic forhealth Preparednessemergencies andoccurring Responsein does not plan to conduct the studyUnited underStates. paragraph (1) and shall provide such committees a summary explanation for such decision.

(2) <<NOTE:

Deadline.

Summary.>> Notice to congress.--Not later than 9 months after the date of the enactment of this Act, the Assistant Secretary for Preparedness and Response shall notify the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate if the Assistant Secretary for Preparedness and Response does not plan to conduct the study under paragraph (1) and shall provide such committees a summary explanation for such decision.

(c) Biosurveillance of Emerging Public Health Threats.--Section 2814 is amended-- (1) in paragraph (7), by striking ``;

``SEC.[[Page 133 STAT.

936]] ``SEC.

CHILDREN'S<<NOTE: PREPAREDNESS UNIT.

42 USC 247d-4b.>> CHILDREN'S PREPAREDNESS UNIT.

``(b) Expertise.--The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-developmental-behavioral behavioral pediatrician, and may also include behavioral scientists, child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the Secretary determines appropriate.

``(2)[[Page Required133 non-federalSTAT. members.--The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including-- ``(A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;

937]] ``(2) <<NOTE:

Consultation.

Appointments.>> Required non- federal members.--The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including-- ``(A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;

``(4)[[Page Term133 ofSTAT. appointment.--Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, 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 2019, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.

938]] ``(4) Term of appointment.--Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, 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 2019, or appointees who are initially appointed after such date of enactment, in order to provide for a staggered term of appointment for all members.

NATIONAL<<NOTE: ADVISORY COMMITTEE ON SENIORS AND DISASTERS.

``(a)42 Establishment.--TheUSC Secretary,300hh-10c.>> inNATIONAL consultationADVISORY withCOMMITTEE theON SecretarySENIORS ofAND HomelandDISASTERS. Security and the Secretary of Veterans Affairs, shall establish an advisory committee to be known as the National Advisory Committee on Seniors and Disasters (referred to in this section as the `Advisory Committee').

``(b)``(a) Duties.--The<<NOTE: Advisory Committee shall-- ``(1) provide advice and consultation with respect to the activities carried out pursuant to section 2814, as applicable and appropriate;

``(2)Consultation.>> evaluateEstablishment.--The andSecretary, providein inputconsultation with respectthe toSecretary theof medicalHomeland Security and publicthe healthSecretary needs of seniorsVeterans relatedAffairs, shall establish an advisory committee to preparationbe for,known responseas to,the National Advisory Committee on Seniors and recoveryDisasters from(referred all-hazardsto emergencies;in this section as the `Advisory Committee').

``(b) <<NOTE:

Consultations.>> Duties.--The Advisory Committee shall-- ``(1) provide advice and consultation with respect to the activities carried out pursuant to section 2814, as applicable and appropriate;

``(2) <<NOTE:

Evaluation.>> evaluate and provide input with respect to the medical and public health needs of seniors related to preparation for, response to, and recovery from all- hazards emergencies;

``(c) Additional<<NOTE: 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 III.

``(d)Recommenda- Membership.--tions.>> ``(1)Additional InDuties.--The general.--TheAdvisory Secretary,Committee inmay consultationprovide advice and recommendations to the Secretary with suchrespect otherto headsseniors ofand agenciesthe asmedical appropriate,and shallpublic appointhealth notgrants moreand thancooperative 17agreements membersas applicable to thepreparedness Advisoryand Committee.response activities under this title and title III.

``(d) Membership.-- ``(1) <<NOTE:

Consultation.

Appointments.>> In general.-- The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more than 17 members to the Advisory Committee.

``(2)[[Page Required133 members.--TheSTAT. Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non- Federal members, as follows:

939]] ``(2) Required members.--The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:

``(2) Extension<<NOTE: of committee.--Not later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.''.

Deadline.

Recommenda- tion.>> Extension of committee.--Not later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.''.

NATIONAL<<NOTE: ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES AND DISASTERS.

``(a)42 Establishment.--TheUSC Secretary,300hh-10d.>> inNATIONAL consultationADVISORY withCOMMITTEE theON SecretaryINDIVIDUALS ofWITH HomelandDISABILITIES Security,AND shallDISASTERS. establish a national advisory committee to be known as the National Advisory Committee on Individuals with Disabilities and Disasters (referred to in this section as the `Advisory Committee').

``(b)``(a) Duties.--The<<NOTE: Advisory Committee shall-- ``(1) provide advice and consultation with respect to activities carried out pursuant to section 2814, as applicable and appropriate;

``(2)Consultation.>> evaluateEstablishment.--The andSecretary, providein inputconsultation with respectthe Secretary of Homeland Security, shall establish a national advisory committee to thebe medical,known publicas health,the andNational accessibilityAdvisory needsCommittee ofon individualsIndividuals with disabilitiesDisabilities relatedand toDisasters preparation(referred for,to responsein to,this andsection recoveryas fromthe all-hazards`Advisory emergencies;Committee').

``(b) <<NOTE:

Consultations.>> Duties.--The Advisory Committee shall-- [[Page 133 STAT.

940]] ``(1) provide advice and consultation with respect to activities carried out pursuant to section 2814, as applicable and appropriate;

``(2) <<NOTE:

Evaluation.>> evaluate and provide input with respect to the medical, public health, and accessibility needs of individuals with disabilities related to preparation for, response to, and recovery from all-hazards emergencies;

``(c) Membership.-- ``(1) In<<NOTE: general.--The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall appoint not more than 17 members to the Advisory Committee.

Consultation.

Appointments.>> In general.-- The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall appoint not more than 17 members to the Advisory Committee.

``(2) Required<<NOTE: members.--The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non- Federal members, as follows:

Determination.>> Required members.--The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:

``(f)[[Page Coordination.--The133 SecretarySTAT. shall coordinate duties and activities authorized under this section in accordance with section 2811D.

941]] ``(f) Coordination.--The Secretary shall coordinate duties and activities authorized under this section in accordance with section 2811D.

``(2) Recommendation.--Not<<NOTE: later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.''.

Deadline.>> Recommendation.--Not later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.''.

ADVISORY<<NOTE: COMMITTEE COORDINATION.

42 USC 300hh-10e.>> ADVISORY COMMITTEE COORDINATION.

Members<<NOTE: of the advisory committees authorized under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate, that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and individuals with disabilities during public health emergencies.

IfRecommenda- suchtions.>> coordinationMembers occursof throughthe anadvisory in-personcommittees meeting,authorized itunder such sections, or their designees, shall notannually meet to coordinate any recommendations, as appropriate, that may be consideredsimilar, theduplicative, requiredor in-personoverlapping meetingswith underrespect anyto addressing the needs of sectionschildren, 2811A(e),seniors, 2811B(e),and orindividuals 2811C(d).with disabilities during public health emergencies.

If such coordination occurs through an in- person meeting, it shall not be considered the required in-person meetings under any of sections 2811A(e), 2811B(e), or 2811C(d).

``(c) Notification.--The<<NOTE: Secretary shall annually notify the congressional committees of jurisdiction regarding the steps taken to coordinate, as appropriate, the recommendations under this section, and provide a summary description of such coordination.''.

Deadline.

Summary.>> Notification.--The Secretary shall annually notify the congressional committees of jurisdiction regarding the steps taken to coordinate, as appropriate, the recommendations under this section, and provide a summary description of such coordination.''.

GUIDANCE<<NOTE: FOR PARTICIPATION IN EXERCISES AND DRILLS.

42 USC 300hh note.

Deadline.>> GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS.

The<<NOTE: Secretary shall consult with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies as necessary and appropriate in the development of such guidance.

Consultation.>> The Secretary shall makeconsult with the guidanceDepartment availableof onHomeland Security, the internetDepartment website of Defense, the Department of HealthVeterans Affairs, and Humanother Services.applicable Federal departments and agencies as necessary and appropriate in the development of such guidance.

TITLE<<NOTE: IV--PRIORITIZING A THREAT-BASED APPROACH SEC.

Web posting.>> The Secretary shall make the guidance available on the internet website of the Department of Health and Human Services.

[[Page 133 STAT.

942]] TITLE IV--PRIORITIZING A THREAT-BASED APPROACH SEC.

``(I) Threat<<NOTE: awareness.--Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, 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 emergency.''.

Coordination.

Assessment.>> Threat awareness.--Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, 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 emergency.''.

PUBLIC<<NOTE: HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

``(a)42 InUSC General.--The300hh-10a.>> SecretaryPUBLIC shallHEALTH establishEMERGENCY theMEDICAL PublicCOUNTERMEASURES HealthENTERPRISE. Emergency Medical Countermeasures Enterprise (referred to in this section as the `PHEMCE').

``(a) <<NOTE:

Establishment.>> In General.--The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the `PHEMCE').

``(A)[[Page Utilize133 aSTAT. process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 319F-2(c), including prioritization based on the health security needs of the United States.

943]] ``(A) <<NOTE:

Recommenda- tions.

Assessments.>> Utilize a process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 319F-2(c), including prioritization based on the health security needs of the United States.

In<<NOTE: the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.

``(B)Determination.>> IdentifyIn nationalthe healthevent securitythat needs,members includingof gapsthe inPHEMCE publicdo healthnot preparednessagree andupon responsea relatedrecommendation, tothe countermeasuresSecretary andshall challengesprovide toa addressingdetermination suchregarding needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needsrecommendation. under subparagraph (A).

``(C)``(B) Assist<<NOTE: the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 319F-2(a).

``(D)Recommenda- Providetions.>> consultationIdentify fornational thehealth developmentsecurity ofneeds, theincluding strategygaps in public health preparedness and implementationresponse planrelated to countermeasures and challenges to addressing such needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needs under sectionsubparagraph 2811(d).(A).

``(C) <<NOTE:

Strategies.>> Assist the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 319F-2(a).

``(D) <<NOTE:

Consultation.>> Provide consultation for the development of the strategy and implementation plan under section 2811(d).

(B)[[Page by133 insertingSTAT. ``and optimize'' after ``provide for'';

944]] (B) by inserting ``and optimize'' after ``provide for'';

``(2) Threat-based review.-- ``(A) In<<NOTE: general.--The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811-1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811- 1(c)(1)(A).

SuchConsultation. review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, 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, in a manner that does not compromise national security.

Assessment.>> In general.--The Secretary shall conduct an annual threat- based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811-1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811- 1(c)(1)(A).

<<NOTE:

Deadlines.>> Such review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, 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, in a manner that does not compromise national security.

``(V) an<<NOTE: assessment of whether the emergency health security threat or threats described in subclause (IV) 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 threats;

Assessment.>> an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level [[Page 133 STAT.

945]] of emergency preparedness to address such threats;

``(E) devise<<NOTE: plans for effective and timely supply- chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies;

Consultation.>> devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies;

``(I)[[Page ensure133 thatSTAT. 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 319L, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States;

946]] ``(I) 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 319L, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States;

``(5) GAO report.-- ``(A) In<<NOTE: general.--Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015.

Deadline.

Time period.

Review.

Assessments.>> In general.--Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015.

``(v) an<<NOTE: analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);

``(vi)Analysis.>> aan descriptionanalysis of thehow resourcessuch expended related to the procurement ofdecisions countermeasuresmade (includingprogress additions,toward modifications,meeting andemergency replenishments)health insecurity theneeds stockpile,related and how such expenditures relate to the abilityidentified ofthreats thefor stockpilecountermeasures toadded, meetmodified, emergencyor healthreplenished securityunder needs;paragraph (1);

``(vi) a description of the resources expended related to the procurement of countermeasures [[Page 133 STAT.

947]] (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;

``(B) Submission.--Not<<NOTE: later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.''.

Deadline.>> Submission.--Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.''.

(c) Authorization of Appropriations, Strategic National Stockpile.--SectionStockpile.-- Section 319F-2(f)(1) (42 U.S.C.

SEC.[[Page 133 STAT.

948]] SEC.

``(F) Strategic<<NOTE: initiatives.--The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure).

Determination.>> Strategic initiatives.--The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure).

``(f) Protection of National Security From Threats.-- ``(1) In general.--In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security[[Page based133 onSTAT. the characteristics of such threat.

949]] security based on the characteristics of such threat.

TITLE[[Page V--INCREASING133 COMMUNICATIONSTAT. IN MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT SEC.

950]] TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT SEC.

MATERIAL<<NOTE: THREAT AND MEDICAL COUNTERMEASURE NOTIFICATIONS.

Determinations.>> MATERIAL THREAT AND MEDICAL COUNTERMEASURE NOTIFICATIONS.

(b) Contracting<<NOTE: Communication.--Section 319F-2(c)(7)(B)(ii)(III) (42 U.S.C.

Deadline.>> Contracting Communication.--Section 319F- 2(c)(7)(B)(ii)(III) (42 U.S.C.

``The Secretary shall notify the vendor[[Page within133 90STAT. days of a determination by the Secretary to renew, extend, or terminate such contract.''.

951]] vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.''.

``(3) Publication.--The<<NOTE: Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including-- ``(A) the process by which an applicant may submit a request for a regulatory management plan;

Web posting.>> Publication.--The Secretary shall make available on the internet website of the Food and Drug Administration information regarding regulatory management plans, including-- ``(A) the process by which an applicant may submit a request for a regulatory management plan;

ADDITIONAL<<NOTE: STRATEGIES FOR COMBATING ANTIBIOTIC RESISTANCE.

(a)42 AdvisoryUSC Council.--The247d-5 Secretarynote.>> ofADDITIONAL HealthSTRATEGIES andFOR HumanCOMBATING ServicesANTIBIOTIC (referredRESISTANCE. to in this section as the ``Secretary'') may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the ``Advisory Council''.

(b)(a) Duties.--The<<NOTE: 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 prevent, diagnose, mitigate, or treat such resistance.

Continuation.>> Advisory Council.--The Secretary of Health and Human Services (referred to in this section as the ``Secretary'') may continue the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the ``Advisory Council''.

(b) <<NOTE:

Recommenda- tions.>> 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 [[Page 133 STAT.

952]] bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance.

(2) research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-point-of- of-carecare diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities;

and (6) coordination<<NOTE: with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.

Coordination.>> coordination with respect to international efforts in order to inform and advance United States capabilities to combat antibiotic resistance.

(d) FACA.--The<<NOTE: Federal Advisory Committee Act (5 U.S.C.

Applicability.>> FACA.--The Federal Advisory Committee Act (5 U.S.C.

(e) Extension<<NOTE: of Advisory Council.--Not later than October 1, 2022, the Secretary shall submit to the Committee on Health, Education, Labor, 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 extended, and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, including with respect to section 319E(a) of the Public Health Service Act (42 U.S.C.

Deadline.

Recommenda- tion.>> Extension of Advisory Council.--Not later than October 1, 2022, the Secretary shall submit to the Committee on Health, Education, Labor, 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 extended, and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that of the Advisory Council, and whether such committees, councils, or task forces should be combined, including with respect to section 319E(a) of the Public Health Service Act (42 U.S.C.

SEC.[[Page 133 STAT.

953]] SEC.

MEDICAL<<NOTE: COUNTERMEASURE MASTER FILES.

21 USC 360bbb-4b note.>> MEDICAL COUNTERMEASURE MASTER FILES.

MEDICAL<<NOTE: COUNTERMEASURE MASTER FILES.

21 USC 360bbb-4b.>> MEDICAL COUNTERMEASURE MASTER FILES.

``(2)[[Page Reference133 ofSTAT. 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 571, 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 countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

954]] ``(2) 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 571, 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 countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

``(2) Reference<<NOTE: 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 submission.

Notification.>> 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 submission.

``(d) Acknowledgment of and Reliance Upon a Master File by the Secretary.-- ``(1) In<<NOTE: 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 approval, classification, conditional approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

Notification.>> 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 approval, classification, conditional approval, clearance, licensure, or authorization of a security [[Page 133 STAT.

955]] countermeasure, qualified countermeasure, or qualified pandemic or epidemic product.

``(2) 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 571 to subsequently support the approval, clearance, licensure, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, 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 (c) or (d) of section 505, subsection (d) of section 512, or section 351 of the Public Health Service Act (as applicable), which shall not include any trade secret or confidential commercial information.

``(2)[[Page The133 termSTAT. `medical countermeasure submission' means an investigational new drug application under section 505(i), a new drug application under section 505(b), or an abbreviated new drug application under section 505(j) of this Act, a biological product license application under section 351(a) of the Public Health Service Act or a biosimilar biological product license application under section 351(k) of the Public Health Service Act, a new animal drug application under section 512(b)(1) or abbreviated new animal drug application under section 512(b)(2), an application for conditional approval of a new animal drug under section 571, an investigational device application under section 520(g), an application with respect to a device under section 515(c), a request for classification of a device under section 513(f)(2), a notification with respect to a device under section 510(k), or a request for an emergency use authorization under section 564 to support-- ``(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product;

956]] ``(2) The term `medical countermeasure submission' means an investigational new drug application under section 505(i), a new drug application under section 505(b), or an abbreviated new drug application under section 505(j) of this Act, a biological product license application under section 351(a) of the Public Health Service Act or a biosimilar biological product license application under section 351(k) of the Public Health Service Act, a new animal drug application under section 512(b)(1) or abbreviated new animal drug application under section 512(b)(2), an application for conditional approval of a new animal drug under section 571, an investigational device application under section 520(g), an application with respect to a device under section 515(c), a request for classification of a device under section 513(f)(2), a notification with respect to a device under section 510(k), or a request for an emergency use authorization under section 564 to support-- ``(A) the approval, licensure, classification, clearance, conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product;

(c) Stakeholder<<NOTE: Input.--Not later than 18 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall solicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, 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 countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, 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 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

(d)Deadline. Guidance.--Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross- referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products.

TheConsultation.>> Stakeholder Input.--Not later than 18 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs,Drugs and in consultation with the Assistant Secretary for Preparedness and Response, shall publishsolicit input from stakeholders, including stakeholders developing security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products, and stakeholders developing technologies to assist in the finaldevelopment guidanceof notsuch latercountermeasures thanwith 3respect yearsto afterhow the enactmentFood and Drug Administration can advance the use of thistools Act.and technologies to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, 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 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).

SEC.(d) <<NOTE:

Deadlines.>> Guidance.--Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall publish draft guidance about how reliance on cross-referenced data and information contained within master files under section 565B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b) or submissions otherwise submitted to the Secretary may be used for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products.

<<NOTE:

Publication.>> The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act.

[[Page 133 STAT.

957]] SEC.

In<<NOTE: conducting such study, the Comptroller General shall examine the following:

Examination.>> In conducting such study, the Comptroller General shall examine the following:

(c) Report.--Not<<NOTE: later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, 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 (a) and recommendations to improve the application and consistency of the requirements under subsections (c) and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

Recommenda- tions.>> Report.--Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of [[Page 133 STAT.

958]] the House of Representatives a report containing the results of the study conducted under subsection (a) and recommendations to improve the application and consistency of the requirements under subsections (c) and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

(a) Meeting.-- (1) In<<NOTE: general.--Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall convene a meeting to discuss the potential role advancements in genomic engineering technologies (including genome editing technologies) may have in advancing national health security.

Deadline.>> In general.--Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall convene a meeting to discuss the potential role advancements in genomic engineering technologies (including genome editing technologies) may have in advancing national health security.

and (B) national security implications, including-- (i)[[Page capabilities133 ofSTAT. the United States to leverage genomic engineering technologies as a part of the medical countermeasure enterprise, including current applicable research, development, and application efforts underway within the Department of Defense;

959]] (i) capabilities of the United States to leverage genomic engineering technologies as a part of the medical countermeasure enterprise, including current applicable research, development, and application efforts underway within the Department of Defense;

(b) Report.--Not<<NOTE: later than 270 days after the meeting described in subsection (a) is held, the Assistant Secretary for Preparedness and Response shall issue a report to the congressional committees of jurisdiction on the topics discussed at such meeting, and provide recommendations, as applicable, to utilize innovations in genomic engineering (including genome editing) and related technologies as a part of preparedness and response activities to advance national health security.

Recommenda- tions.>> Report.--Not later than 270 days after the meeting described in subsection (a) is held, the Assistant Secretary for Preparedness and Response shall issue a report to the congressional committees of jurisdiction on the topics discussed at such meeting, and provide recommendations, as applicable, to utilize innovations in genomic engineering (including genome editing) and related technologies as a part of preparedness and response activities to advance national health security.

(B) in paragraph (2)-- (i) in subparagraph (A)-- (I)[[Page in133 clauseSTAT. (ii), by striking ``or'' at the end;

960]] (I) in clause (ii), by striking ``or'' at the end;

and (2)[[Page in133 subsectionSTAT. (b), by striking ``2010 through 2013'' and inserting ``2019 through 2023''.

961]] (2) in subsection (b), by striking ``2010 through 2013'' and inserting ``2019 through 2023''.

(e) Limited Antitrust Exemption.-- (1) In general.--Section 405 of the Pandemic and All-All-Hazards Hazards Preparedness Act (Public Law 109-417;

and (D) by<<NOTE: transferring such section 319L-1, as redesignated, to the Public Health Service Act (42 U.S.C.

42 USC 247d-7f.>> by transferring such section 319L-1, as redesignated, to the Public Health Service Act (42 U.S.C.

``(ii)[[Page Information133 described.--TheSTAT. 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 chemical, biological, radiological, or nuclear threats, and is comprised of-- ``(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);

962]] ``(ii) 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 chemical, biological, radiological, or nuclear threats, and is comprised of-- ``(I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);

``(d) Disclosures.--No Federal agency may disclose under section 552 of title 5, United States Code any information identifying the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents or deployment capability of the stockpile that could compromise national security.''.

(a) Strategy for Public Health Preparedness and Response to Cybersecurity Threats.-- (1) Strategy.--Not<<NOTE: later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall prepare and submit to the relevant committees of Congress a strategy for public health preparedness and response to address cybersecurity threats (as defined in section 102 of Cybersecurity Information Sharing Act of 2015 (6 U.S.C.

Deadline.>> Strategy.--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall prepare and submit to the relevant committees of Congress a strategy for public health preparedness and response to address cybersecurity threats (as defined in section 102 of Cybersecurity Information Sharing Act of 2015 (6 U.S.C.

Such strategy shall include-- (A)[[Page identifying133 theSTAT. duties, functions, and preparedness goals for which the Secretary is responsible in order to prepare for and respond to such cybersecurity threats, including metrics by which to measure success in meeting preparedness goals;

963]] (A) identifying the duties, functions, and preparedness goals for which the Secretary is responsible in order to prepare for and respond to such cybersecurity threats, including metrics by which to measure success in meeting preparedness goals;

``(D) Policy coordination and strategic direction.--Providedirection.-- Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, 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 504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C.

and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the Homeland Security Act of 2002 (6 U.S.C.

Not later<<NOTE: than 14 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response and the Assistant Secretary for the Administration on Children and Families or other appropriate office, and in collaboration with other departments, as appropriate, shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and other relevant congressional committees-- (1) a formal strategy, including interdepartmental actions and efforts to reunify children with their parents or guardians, in all cases in which such children have been separated from their parents or guardians as a result of the initiative announced on April 6, 2018, and due to prosecution under section 275(a) of the Immigration and Nationality Act (8 U.S.C.

Deadline.

Coordination.

Collaboration.>> later than 14 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response and the Assistant Secretary for the Administration on Children and Families or other appropriate office, and in collaboration with other departments, as appropriate, shall submit to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and other relevant congressional committees-- (1) a formal strategy, including interdepartmental actions and efforts to reunify children with their parents or guardians, in all cases in which such children have been separated from their parents or guardians as a result of the initiative announced on April 6, 2018, and due to prosecution under section 275(a) of the Immigration and Nationality Act (8 U.S.C.

(B)[[Page as133 ofSTAT. the date of the enactment of this Act, remains in the care of the Department of Health and Human Services;

964]] (B) <<NOTE:

Effective date.>> as of the date of the enactment of this Act, remains in the care of the Department of Health and Human Services;

``(ii) in the case of a drug development tool that may be used to support the development of a qualified countermeasure, security countermeasure, or qualified pandemic or epidemic product, as defined in sections 319F-1, 319F-2, and 319F-3, respectively, of the Public Health Service Act, any information that the Secretary[[Page determines133 hasSTAT. a significant potential to affect national security.

965]] Secretary determines has a significant potential to affect national security.

PassedApproved theJune Senate24, May 16, 2019.

Attest:LEGISLATIVE HISTORY--S.

Secretary.1379:

116th--------------------------------------------------------------------------- CONGRESSCONGRESSIONAL 1stRECORD, SessionVol. S.

1379165 _______________________________________________________________________(2019): AN ACT To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes.

May 16, considered and passed Senate.

June 4, considered and passed House.

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