H.R. 6378 — what changed

removed This Act may be cited as the “Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018”.

added Section 2802 of the Public Health Service Act (42 U.S.C. 300hh–1) is amended—

added “(E) Response to environmental hazards.”

added “(9) Zoonotic disease, food, and agriculture—Improving coordination among Federal, State, local, tribal, and territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.

added “(10) Global health security—Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.”

removed “(I) 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.”

removed “(8) Reporting—The Assistant Secretary for Preparedness and Response shall, beginning on the date of the enactment of this paragraph, submit to the Committee on Energy and Commerce of the House of Representatives weekly reports on the status and welfare of the children who, as a result of the “zero tolerance” policy, were separated from their parent or guardian and are awaiting reunification with their parent or guardian, as well as the number of such children in facilities funded by the Department of Health and Human Services.”

removed “(A) include consideration of the entire medical countermeasures enterprise, including—

removed “(i) basic research and advanced research and development;

removed “(ii) approval, clearance, licensure, and authorized uses of products;

removed “(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile; and

removed “(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development;”

removed “(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;”

added “(k) Evaluation

added “(1) In general—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under section 2802, at such time as such strategy is submitted.

added “(2) Content—The evaluation under this paragraph shall include—

added “(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;

added “(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802;

added “(C) a description of amounts received by eligible entities described in subsection (b) and section 319C–2(b), and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and

added “(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 2802.”

removed “(2) Uses—The Secretary may use amounts in the Fund established under paragraph (1)—

removed “(A) to facilitate coordination between and among Federal, State, local, tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);

removed “(B) to make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to such a public health emergency or potential public health emergency, including further supporting programs under sections 319C–1 and 319C–2;

removed “(C) to 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 such a public health emergency or potential public health emergency;

removed “(D) to strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such a public health emergency or potential public health emergency, including the systems under section 319D;

removed “(E) to support initial emergency operations and assets related to preparation and deployment of intermittent disaster-response personnel under section 2812, and the Medical Reserve Corps under section 2813; and

removed “(F) to carry out other activities, as the Secretary determines applicable and appropriate.”

removed “(4) Review—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2018, the Secretary, in coordination with the Assistant Secretary for Preparedness and Response, shall conduct a review of the Fund under this subsection, 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).

removed “(5) GAO review and report—The Comptroller General of the United States shall conduct a review of the Fund under this subsection, including the uses and the resources available in the Fund. Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2018, the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on such review, including recommendations related to such review.”

changed “(x) “(vii) a description of—of how, as applicable, such entity may integrate information to account for individuals with behavioral health needs following a public health emergency;”

added “(xi) a description of how the entity will partner with health care facilities, including hospitals and nursing homes and other long-term care facilities, to promote and improve public health preparedness and response; and

added “(xii) a description of how, as appropriate and practicable, the entity will include critical infrastructure partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subparagraph to help ensure that critical infrastructure will remain functioning during, or return to function as soon as practicable after, a public health emergency.”

added “(A) In general—The amounts described in this paragraph are the following amounts that are payable to an entity for activities described in section 319C–1 or 319C–2:

added “(i) For one (but not both) of the first two fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5) by the entity, an amount equal to 10 percent of the amount the entity was eligible to receive for the respective fiscal year.

added “(ii) For one (but not both) of the first two fiscal years immediately following the third consecutive fiscal year in which an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of the amount the entity was eligible to receive for the respective fiscal year.”

added “(iv) one or more emergency medical service organizations or emergency management organizations; and”

added “(1) In general

added “(A) Authorization of appropriations—For purposes of carrying out this section and section 319C–3, in accordance with subparagraph (B), there is authorized to be appropriated $385,000,000 for each of fiscal years 2019 through 2023.

added “(B) Reservation of amounts for regional systems

added “(i) In general—Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 319C–3.

added “(ii) Reservation contingent on continued appropriations for this section—If for fiscal year 2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after application of clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i) shall be reduced such that the amount remaining for the purpose of carrying out this section is not less than the amount available for such purpose for the previous fiscal year.

added “(iii) Sunset—The authority to reserve amounts under clause (i) shall expire on September 30, 2023.”

removed “(I) the measures the entity will have in place to prioritize nursing facilities and skilled nursing facilities with respect to public health emergency preparedness in the same manner as such plan will prioritize hospitals, while ensuring that, in prioritizing nursing facilities, skilled nursing facilities, and hospitals, the entity will retain the discretion to prioritize among such facilities; and

removed “(II) the plans that each electric utility company within the entity’s jurisdiction has in place to ensure that each such company will remain functioning or return to functioning as soon as practicable during power outages caused by natural or manmade disasters;”

added “319C–3. Guidelines for regional health care emergency preparedness and response systems

added “(a) Purpose—It is the purpose of this section to identify and provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public health emergency, including threats posed by one or more chemical, biological, radiological, or nuclear agents, including emerging infectious diseases.

added “(b) 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—

added “(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—

added “(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—

added “(i) the manner in which the system will coordinate with and integrate the partnerships and health care coalitions established under section 319C–2(b); and

added “(ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;

added “(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;

added “(C) protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;

added “(D) in a manner that allows for disease containment (within the meaning of section 2802(b)(2)(B)), coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as applicable and appropriate, between systems in different States or regions; and

added “(E) the needs of children and other at-risk individuals;

added “(2) 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; and

added “(3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and information resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (including any amendments made by such Act), to address new and emerging public health threats.

added “(c) Considerations—In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—

added “(1) include input from hospitals and health care facilities (including health care coalitions under section 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);

added “(2) 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 that the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

added “(3) consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and

added “(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.

added “(d) Technical 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).

added “(e) Demonstration project for regional health care preparedness and response systems

added “(1) 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.

added “(2) Sunset—The authority under this subsection shall expire on September 30, 2023.”

removed Section 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3b) is amended—

added “(G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.”

removed “(iv) an emergency medical service organization; and

removed “(v) an emergency management organization; and”

“(ii) among one or more facilities in a regional health care emergency system under section 319C–3; and”

removed “(2) Exception relating to application of certain requirements—Beginning with fiscal year 2019, and in each succeeding fiscal year, with respect to entities receiving awards under this section—

removed “(A) paragraph (5)(A) of section 319C–1(g) shall be applied—

removed “(i) by substituting “for the immediately preceding fiscal year” with the following: “for either of the two immediately preceding fiscal years”; and

removed “(ii) by substituting “2019” for “2008”; and

removed “(B) paragraph (6)(A) of section 319C–1(g) shall be applied by substituting—

removed “(i) clause (i) of such paragraph with the following: “For each of the first two fiscal years immediately following a fiscal year in which an entity experienced a failure described in subparagraph (A) or (B) of paragraph (5) by the entity, an amount equal to 10 percent of the amount the entity was eligible to receive for each such fiscal year.”;

removed “(ii) clause (ii) of such paragraph with the following: “For each of the first two fiscal years immediately following two consecutive fiscal years in which an entity experienced such a failure, an amount equal to 15 percent of the amount the entity was eligible to receive for each of such first two fiscal years, disregarding any withholding of funds that would have been made in each such year by virtue of clause (i). The amount determined pursuant to the previous sentence shall be in lieu of any amount that would have been withheld for each such year by virtue of clause (i).”;

removed “(iii) clause (iii) of such paragraph with the following: “For each of the first two fiscal years immediately following three consecutive fiscal years in which an entity experienced such a failure, an amount equal to 20 percent of the amount the entity was eligible to receive for each of such first two fiscal years, disregarding any withholding of funds that would have been made in each such year by virtue of clauses (i) and (ii). The amount determined pursuant to the previous sentence shall be in lieu of any amount that would have been withheld for each such year by virtue of clauses (i) and (ii).”; and

removed “(iv) clause (iv) of such paragraph with the following: “For each of the first two fiscal years immediately following four consecutive fiscal years in which an entity experienced such a failure, an amount equal to 25 percent of the amount the entity was eligible to receive for each of such first two fiscal years, disregarding any withholding of funds that would have been made in each such year by virtue of clauses (i), (ii), and (iii). The amount determined pursuant to the previous sentence shall be in lieu of any amount that would have been withheld for each such year by virtue of clauses (i), (ii), and (iii).”.”

added Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.) is amended by adding at the end the following new part:

added “I Military and Civilian Partnership for Trauma Readiness Grant Program

added “1291. Military and Civilian Partnership for Trauma Readiness Grant Program

added “(a) Military trauma team placement program

added “(1) 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.

added “(2) Limitations—In the case of a grant awarded under paragraph (1) to an eligible high acuity trauma center, such grant—

added “(A) shall be for a period of at least 3 years and not more than 5 years (and may be renewed at the end of such period); and

added “(B) shall be in an amount that does not exceed $1,000,000 per year.

added “(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.

added “(b) Military trauma care provider placement program

added “(1) 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 eligible trauma centers to enable military trauma care providers to provide trauma care and related acute care at such trauma centers.

added “(2) Limitations—In the case of a grant awarded under paragraph (1) to an eligible trauma center, such grant—

added “(A) 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

added “(B) shall be in an amount that does not exceed, in a year—

added “(i) $100,000 for each military trauma care provider that is a physician at such eligible trauma center; and

added “(ii) $50,000 for each other military trauma care provider at such eligible trauma center.

added “(c) Grant requirements

added “(1) Deployment and public health emergencies—As a condition of receipt of a grant under this section, a grant recipient shall agree to allow military trauma care providers providing care pursuant to such grant to—

added “(A) be deployed by the Secretary of Defense for military operations, for training, or for response to a mass casualty incident; and

added “(B) be 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.

added “(2) Use of funds—Grants awarded under this section to an eligible trauma center may be used to train and incorporate military trauma care providers into such trauma center, including incorporation into operational exercises and training drills related to public health emergencies, expenditures for malpractice insurance, office space, information technology, specialty education and supervision, trauma programs, research, and applicable license fees for such military trauma care providers.

added “(d) Rule of construction—Nothing in this section shall be construed to affect any other provision of law that preempts State licensing requirements for health care professionals, including with respect to military trauma care providers.

added “(e) Reporting requirements

added “(1) Report to the secretary and the secretary of defense—Each eligible trauma center or eligible high acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary and the Secretary of Defense a report for such year that includes information on—

added “(A) the number and types of trauma cases managed by military trauma teams or military trauma care providers pursuant to such grant during such year;

added “(B) the ability to maintain the integration of the military trauma providers or teams of providers as part of the trauma center, including the financial effect of such grant on the trauma center;

added “(C) the educational effect on resident trainees in centers where military trauma teams are assigned;

added “(D) any research conducted during such year supported by such grant; and

added “(E) any other information required by the Secretaries for the purpose of evaluating the effect of such grant.

added “(2) 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—

added “(A) maintaining military trauma care providers’ readiness and ability to respond to and treat battlefield injuries;

added “(B) providing health care to civilian trauma patients in urban and rural settings;

added “(C) the capability of trauma centers and military trauma care providers to increase medical surge capacity, including as a result of a large scale event;

added “(D) the ability of grant recipients to maintain the integration of the military trauma providers or teams of providers as part of the trauma center;

added “(E) efforts to incorporate military trauma care providers into operational exercises and training and drills for public health emergencies; and

added “(F) the capability of military trauma care providers to participate as part of a medical response during or in advance of a public health emergency, as determined by the Secretary, or a mass casualty incident.

added “(f) Definitions—For purposes of this part:

added “(1) Eligible trauma center—The term eligible trauma center means a Level I, II, or III trauma center that satisfies each of the following:

added “(A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma care providers to provide trauma care and related acute care at such trauma center.

added “(B) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure performance, quality, and patient outcomes.

added “(C) Such trauma center demonstrates a need for integrated military trauma care providers to maintain or improve the trauma clinical capability of such trauma center.

added “(2) Eligible high acuity trauma center—The term eligible high acuity trauma center means a Level I trauma center that satisfies each of the following:

added “(A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams to provide trauma care and related acute care at such trauma center.

added “(B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which data are available are treated for a major trauma at such trauma center.

added “(C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure performance, quality, and patient outcomes.

added “(D) Such trauma center is an academic training center—

added “(i) affiliated with a medical school;

added “(ii) that maintains residency programs and fellowships in critical trauma specialties and subspecialties, and provides education and supervision of military trauma team members according to those specialties and subspecialties; and

added “(iii) that undertakes research in the prevention and treatment of traumatic injury.

added “(E) Such trauma center serves as a medical and public health preparedness and response leader for its community, such as by participating in a partnership for State and regional hospital preparedness established under section 319C–2 or 319C–3.

added “(3) Major trauma—The term major trauma means an injury that is greater than or equal to 15 on the injury severity score.

added “(4) Military trauma team—The term military trauma team means a complete military trauma team consisting of military trauma care providers.

added “(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 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.

added “(g) Authorization of appropriations—To carry out this section, there are authorized to be appropriated $15,000,000 for each of fiscal years 2019 through 2023, of which—

added “(1) 2/3 of the amount made available each fiscal year shall be made available for grants under subsection (a); and

added “(2) 1/3 of the amount made available each fiscal year shall be made available for grants under subsection (b).”

removed “(k) Evaluation

removed “(1) In general—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy under section 2802, at such time as such strategy is submitted.

removed “(2) Content—The evaluation under this paragraph shall include—

removed “(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets;

removed “(B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of such changes on the ability to track whether entities are meeting or making progress toward the goals under this section and, to the extent practicable, the applicable goals of the National Health Security Strategy under section 2802;

removed “(C) a description of amounts received by eligible entities, as described in subsection (b) and section 319C–2(b), and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and objective standards; and

removed “(D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities receiving awards under this section to better achieve the goals under this section and section 2802.”

added “(4) 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. 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.”

added “(3) Standards

added “(A) In general—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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. 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.

added “(B) Deference to standards development organizations—In adopting and implementing standards under this subsection and subsection (c), the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards entities.”

added “(2) Coordination and consultation—In establishing and improving the network under paragraph (1) the Secretary shall—

added “(A) facilitate coordination among agencies within the Department of Health and Human Services that provide, or have the potential to provide, information and data to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including coordination among relevant agencies related to health care services, the facilitation of health information exchange (including the Office of the National Coordinator for Health Information Technology), and public health emergency preparedness and response; and

added “(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National Institute of Standards and Technology), the Secretary of Defense, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.”

added “(A) In general—The network”

added “(B) Review—Not later than 2 years after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 and every 6 years thereafter, the Secretary shall conduct a review of the elements described in subparagraph (A). Such review shall include a discussion of the addition of any elements pursuant to clause (v), including elements added to advancing new technologies, and identify any challenges in the incorporation of elements under subparagraph (A). The Secretary shall provide such review to the congressional committees of jurisdiction.”

added “(A) In general—In establishing”

added “(B) Public meeting

added “(i) In general—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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).

added “(ii) Experts—The public meeting shall include representatives of relevant Federal agencies (including representatives from the Office of the National Coordinator for Health Information Technology and the National Institute of Standards and Technology); State, local, tribal, and territorial public health officials; stakeholders with expertise in biosurveillance and situational awareness; stakeholders with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting); and other representatives as the Secretary determines appropriate.

added “(iii) Topics—Such public meeting shall include a discussion of—

added “(I) data elements, including minimal or essential data elements, that are voluntarily provided for such network, which may include elements from public health and public and private health care entities, to the extent practicable;

added “(II) standards and implementation specifications that may improve the collection, analysis, and interpretation of data during a public health emergency;

added “(III) strategies to encourage the access, exchange, and use of information;

added “(IV) considerations for State, local, tribal, and territorial capabilities and infrastructure related to data exchange and interoperability;

added “(V) privacy and security protections provided at the Federal, State, local, tribal, and territorial levels, and by nongovernmental stakeholders; and

added “(VI) opportunities for the incorporation of innovative technologies to improve the network.”

added “(v) pilot test standards and implementation specifications, consistent with the process described in section 3002(b)(3)(C), which State, local, tribal, and territorial public health entities may utilize, on a voluntary basis, as a part of the network.”

added “(6) Strategy and implementation plan

added “(A) In general—Not later than 18 months after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary shall submit to the congressional committees of jurisdiction a coordinated strategy and an accompanying implementation plan that—

added “(i) is informed by the public meeting under paragraph (5)(B);

added “(ii) 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);

added “(iii) identifies and demonstrates the measurable steps the Secretary will carry out to—

added “(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements described in paragraph (3)(A);

added “(II) modernize and enhance biosurveillance activities, including strategies to include innovative technologies and analytical approaches (including prediction and forecasting for pandemics and all-hazards) from public and private entities;

added “(III) improve information 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; and

added “(IV) test and evaluate capabilities of the interoperable network of systems to improve situational awareness and biosurveillance capabilities;

added “(iv) includes performance measures and the metrics by which performance measures will be assessed with respect to the measurable steps under clause (iii); and

added “(v) establishes dates by which each measurable step under clause (iii) will be implemented.

added “(B) Annual budget plan—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 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. Such budget plan shall include—

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

added “(ii) 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);

added “(iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and biosurveillance capabilities, resources, and authorities needed to address such gaps; and

added “(iv) a strategy to minimize and address such gaps and improve inefficiencies.”

added “(D) 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.”

added “(8) Situational awareness and biosurveillance as a national security priority—The Secretary, on a periodic basis as applicable and appropriate, shall meet with the Director of National Intelligence to inform the development and capabilities of the nationwide public health situational awareness and biosurveillance network.”

added “(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph (1).”

added “(5) Technical assistance—The Secretary may provide technical assistance to States, localities, tribes, and territories or a consortium of States, localities, tribes, and territories receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.”

added “(f) Personnel authorities

added “(1) Specially qualified personnel—In addition to any other personnel authorities, to carry out subsections (b) and (c), the Secretary may—

added “(A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such as experts in informatics and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and

added “(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 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.

added “(2) Limitations—The Secretary shall exercise the authority under paragraph (1) in a manner that is consistent with the limitations described in section 319F–1(e)(2).

added “(g) Timeline—The 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).

added “(h) Independent evaluation—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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.”

removed Section 319D(f) of the Public Health Service Act (42 U.S.C. 247d–4(f)) 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”.

changed Section 319I(k) 319 of the Public Health Service Act (42 U.S.C. 247d–7b(k)) 247d) is amended by striking “fiscal years 2014 through 2018” and inserting “fiscal years 2019 through 2023”.amended—

added “(2) Uses—The Secretary may use amounts in the Fund established under paragraph (1), to—

added “(A) facilitate coordination between and among Federal, State, local, tribal, and territorial entities and public and private health care entities that the Secretary determines may be affected by a public health emergency or potential public health emergency referred to in paragraph (1) (including communication of such entities with relevant international entities, as applicable);

added “(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining to a public health emergency or potential public health emergency, including further supporting programs under section 319C–1, 319C–2, or 319C–3;

added “(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);

added “(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information regarding such public health emergency or potential public health emergency, including the systems under section 319D;

added “(E) support initial emergency operations and assets related to preparation and deployment of intermittent disaster response personnel under section 2812, and the Medical Reserve Corps under section 2813; and

added “(F) carry out other activities, as the Secretary determines applicable and appropriate.”

added “(4) Review—Not later than 2 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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).

added “(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 2018, the Comptroller General of the United States shall—

added “(A) conduct a review of the Fund under this section, including its uses and the resources available in the Fund; and

added “(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.”

added “(iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical and public health mutual aid, and, as appropriate, the activities such entity will implement pursuant to section 319I to improve enrollment and coordination of volunteer health care professionals seeking to provide medical services during a public health emergency, which may include—

added “(I) providing a public method of communication for purposes of volunteer coordination (such as a phone number);

added “(II) providing for optional registration to participate in volunteer services during processes related to State medical licensing, registration, or certification or renewal of such licensing, registration or certification; or

added “(III) other mechanisms as the State determines appropriate;”

removed Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319C–2 the following new section:

removed “319C–3. Guidelines for regional health care emergency preparedness and response systems

removed “(a) Purpose—It is the purpose of this section to identify and provide guidelines for regional systems of hospitals, health care facilities, and other public and private sector entities, with varying levels of capability to treat patients and increase medical surge capacity during, in advance of, and immediately following a public health emergency, including threats posed by one or more chemical, biological, radiological, and nuclear agents, including emerging infectious diseases.

removed “(b) 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—

removed “(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—

removed “(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—

removed “(i) the manner in which the system will coordinate with and integrate the health care coalitions and entities described in section 319C–2(b); and

removed “(ii) informing and educating appropriate first responders and health care supply chain partners of the regional emergency preparedness and response capabilities and medical surge capacity of such hospitals and health care facilities in the community;

removed “(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain needs, taking into account resiliency, geographic considerations, and rural considerations;

removed “(C) protocols or best practices for the safety and personal protection of workers who handle human remains and health care workers (including with respect to protective equipment and supplies, waste management processes, and decontamination), sharing of specialized experience among the health care workforce, behavioral health, psychological resilience, and training of the workforce, as applicable;

removed “(D) in a manner that allows for disease containment (within the meaning of section 2802(b)(2)(B)), coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as applicable and appropriate, between systems in different States or regions; and

removed “(E) the needs of children and other at-risk individuals;

removed “(2) make such guidelines available on the public website of the Department of Health and Human Services in a manner that does not compromise national security; and

removed “(3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (f), to address new and emerging public health threats.

removed “(c) Considerations—In identifying, developing, and updating guidelines under subsection (b), the Assistant Secretary for Preparedness and Response shall—

removed “(1) include input from hospitals and health care facilities (including health care coalitions under section 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, and emerging infectious disease), as the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

removed “(2) 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, and other experts that the Assistant Secretary determines appropriate, to meet the goals under section 2802(b)(3);

removed “(3) consider feedback related to financial implications for hospitals, health care facilities, public health agencies, laboratories, blood banks, and other entities engaged in regional preparedness planning to implement and follow such guidelines, as applicable; and

removed “(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health emergencies as part of the regional health care emergency preparedness and response system.

removed “(d) Technical 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 towards meeting the guidelines described in subsection (b).

removed “(e) Demonstration project for regional health care preparedness and response systems

removed “(1) 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.

removed “(2) Sunset—The authority under this subsection shall expire on September 30, 2023.

removed “(f) GAO report to Congress

removed “(1) Report—Not later than 3 years 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 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 subsection (b), including an analysis and evaluation of any challenges hospitals or health care facilities experienced in implementing such guidelines.

removed “(2) Content—The Comptroller General shall include in the report under paragraph (1)—

removed “(A) data on the preparedness and response capabilities that have been informed by the guidelines under subsection (b) to improve regional emergency health care preparedness and response capability, including hospital and health care facility capacity and medical surge capabilities to prepare for, and respond to, public health emergencies; and

removed “(B) 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 emergencies, consistent with subsection (a), which may include consideration of facilities participating in programs under section 319C–2, programs under the Centers for Medicare & Medicaid Services (including innovative health care delivery and payment models), and input from private sector financial institutions.

removed “(3) Consultation—In carrying out paragraphs (1) and (2), the Comptroller General shall consult with the heads of appropriate Federal agencies, including—

removed “(A) the Assistant Secretary for Preparedness and Response;

removed “(B) the Director of the Centers for Disease Control and Prevention;

removed “(C) the Administrator of the Centers for Medicare & Medicaid Services;

removed “(D) the Assistant Secretary for Mental Health and Substance Use;

removed “(E) the Assistant Secretary of Labor for Occupational Safety and Health;

removed “(F) the Secretary of Veterans Affairs; and

removed “(G) the heads of such other Federal agencies as the Secretary determines appropriate.”

added “225. Health care professionals assisting during a public health emergency

added “(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—

added “(1) is responding—

added “(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); or

added “(B) to a major disaster or an emergency as declared by the President under section 401 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170) or under section 201 of the National Emergencies Act (50 U.S.C.1621) during the initial period of such declaration; and

added “(2) is alleged to be liable for an act or omission—

added “(A) during the initial period of a determination or declaration described in paragraph (1) and related to the treatment of individuals in need of health care services due to such public health emergency, major disaster, or emergency;

added “(B) in the State or States for which such determination or declaration is made;

added “(C) in the health care professional’s capacity as a member of the Medical Reserve Corps or a professional included in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I; and

added “(D) in the course of providing services that are within the scope of the license, registration, or certification of the professional, as defined by the State of licensure, registration, or certification; and

added “(3) prior to the rendering of such act or omission, was authorized by the State’s authorization of deploying such State’s Emergency System for Advance Registration of Volunteer Health Professionals described in section 319I or the Medical Reserve Corps established under section 2813, to provide health care services,

added “(b) Volunteer protection act—Nothing in this section shall be construed to affect an individual's right to protections under the Volunteer Protection Act of 1997.

added “(c) Preemption—This section shall supercede the laws of any State that would subject a health care professional described in subsection (a) to the liability laws of any State other than the State liability laws to which such individual is subject pursuant to such subsection.

added “(d) Definitions—In this section:

added “(1) The term health care professional means an individual licensed, registered, or certified under Federal or State laws or regulations to provide health care services.

added “(2) The term health care services means any services provided by a health care professional, or by any individual working under the supervision of a health care professional, that relate to—

added “(A) the diagnosis, prevention, or treatment of any human disease or impairment; or

added “(B) the assessment or care of the health of human beings.

added “(e) Effective date

added “(1) In general—This section shall take effect 90 days after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018.

added “(2) Application—This section shall apply to a claim for harm only if the act or omission that caused such harm occurred on or after the effective date described in paragraph (1).”

added Not 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—

removed “224A. Limitation on liability for volunteer health care professionals

removed “(a) Limitation on liability—Except as provided in subsection (b), a health care professional serving, for purposes of responding to a disaster, as a volunteer shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services if the act or omission occurs—

removed “(1) during the period of the disaster;

removed “(2) in the State or States for which the disaster is declared;

removed “(3) while the health care professional is acting in the professional’s capacity as a volunteer;

removed “(4) in the course of providing health care services that are within the scope of the license, registration, or certification of the volunteer, as defined by the State of licensure, registration, or certification; and

removed “(5) while the health care professional is acting in a good faith belief that the individual being provided such health care services is in need of such health care services.

removed “(b) Exceptions—Subsection (a) does not apply with respect to harm caused by an act or omission of a health care professional in the provision of health care services as described in such subsection if—

removed “(1) the harm was caused by an act or omission constituting willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional; or

removed “(2) the health care professional provided such health care services under the influence (as determined pursuant to applicable State law) of alcohol or an intoxicating drug.

removed “(c) Preemption—No State or political subdivision of a State may establish or continue in effect any laws relating to the liability for acts or omissions relating to the provision of health care services by health care professionals serving, for purposes of responding to a disaster, as volunteers that are inconsistent with this section, unless such laws provide greater protection from such liability.

removed “(d) Relationship to Volunteer Protection Act of 1997—The protections from liability under this section are in addition to the protections from liability under the Volunteer Protection Act of 1997.

removed “(e) Definitions—In this section:

removed “(1) The term disaster means—

removed “(A) a national emergency declared by the President under the National Emergencies Act;

removed “(B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act; or

removed “(C) a public health emergency that is determined by the Secretary under section 319 of this Act with respect to one or more States specified in such determination—

removed “(i) during only the initial period covered by such determination; and

removed “(ii) excluding any period covered by a renewal of such determination.

removed “(2) The term harm includes physical, nonphysical, economic, and noneconomic losses.

removed “(3) The term health care professional means an individual who is licensed, registered, or certified under Federal or State law to provide health care services.

removed “(4) The term health care services means any services provided by a health care professional, or by any individual working under the supervision of a health care professional, that relate to—

removed “(A) the diagnosis, prevention, or treatment of any human disease or impairment; or

removed “(B) the assessment or care of the health of a human being.

removed “(5) The term State includes each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.

removed “(6)

removed “(A) The term volunteer means a health care professional who, in providing health care services in response to a disaster, does not receive—

removed “(i) compensation; or

removed “(ii) any other thing of value in lieu of compensation, in excess of $500 per year.

removed “(B) For purposes of subparagraph (A), the term compensation—

removed “(i) includes payment under any insurance policy or health plan, or under any Federal health care program (as defined in section 1128B(f) of the Social Security Act) or State health benefits program; and

removed “(ii) excludes—

removed “(I) reasonable reimbursement or allowance for expenses actually incurred;

removed “(II) receipt of paid leave; and

removed “(III) receipt of items to be used exclusively for providing the health care services referred to in subparagraph (A).”

added “(ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified, or there is a significant potential for a public health emergency.”

added “(2) Joint review and medical surge capacity strategic plan

added “(A) Review—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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—

added “(i) an evaluation of medical surge capacity, as described in section 2803(a);

added “(ii) an assessment of the available workforce of the intermittent disaster response personnel described in subsection (c);

added “(iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency;

added “(iv) the effectiveness of efforts to recruit, retain, and train such workforce; and

added “(v) gaps that may exist in such workforce and recommendations for addressing such gaps.

added “(B) Updates—As part of the National Health Security Strategy under section 2802, the Secretary shall update the findings from the review under subparagraph (A) and provide recommendations to modify the policies of the National Disaster Medical System as necessary.”

added “(3) 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—

added “(A) the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency; and

added “(B) any identified measures to address such shortage.

added “(4) Certain appointments

added “(A) In general—If the Secretary determines that the number of intermittent disaster response personnel within the National Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system. 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.

added “(B) Sunset—The authority under this paragraph shall expire on September 30, 2021.”

removed “(C) the Strategic National Stockpile pursuant to section 319F–2;”

added “(1) In general—For the purpose of carrying out this section, except as described in paragraph (2)”

added “(2) 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 are authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.”

added “(5) Service benefit—Individuals appointed to serve under this subsection shall be considered eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The Secretary shall provide notification to eligible individuals of any effect such designation may have on other benefits for which such individual are eligible, including benefits from private entities.”

added “(E) an individual appointed to the National Disaster Medical System under section 2812 of the Public Health Service Act (42 U.S.C. 300hh–11) who is performing official duties of the Department of Health and Human Services, if those official duties are—

added “(i) related to responding to a public health emergency or potential public health emergency, or other activities for which the Secretary of Health and Human Services has activated such National Disaster Medical System; and

added “(ii) determined by the Secretary of Health and Human Services to be hazardous.”

removed “(1) Authorization of appropriations—In addition to amounts appropriated to the special reserve fund prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 319L (relating to the Biomedical Advanced Research and Development Authority), $7,100,000,000 for the fiscal years 2019 through 2028. Funds authorized by the preceding sentence for fiscal years 2020 through 2027 may be provided by advance appropriation, to be obligated at a rate of not less than $710,000,000 per year. Amounts appropriated pursuant to this paragraph are authorized to remain available until expended.”

removed “(F) Strategic initiatives—The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding grants supporting innovative candidate products in preclinical and clinical development, to 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). Such initiatives shall accelerate and support the advanced research, development, and procurement of, countermeasures and products, as applicable, to address areas including—

removed “(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;

removed “(ii) threats that consistently exist or continually circulate and have significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and

removed “(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious disease, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.”

removed “(i) In general—The Secretary shall have the authority to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects under this section.”

removed “(I) To the maximum extent practicable, competitive procedures shall be used when entering into agreements to carry out projects under this section.”

removed “(d) Pandemic influenza program—The Secretary, acting through the Director of BARDA, shall establish and implement a program that—

removed “(1) supports research and development activities for qualified pandemic or epidemic products (as defined in section 319F–3(i)), including by developing innovative technologies to enhance rapid response to threats relating to pandemic influenza;

removed “(2) ensures readiness to respond to pandemic influenza threats by supporting the development and manufacturing of influenza virus seeds, clinical trial lots, and stockpiles of novel influenza strains; and

removed “(3) sustains and replenishes pandemic stockpiles of bulk antigen and adjuvant material, including annually testing the potency and shelf-life potential of all existing pandemic stockpiles held by the Department of Health and Human Services.

removed “(e) Emerging infectious disease program—The Secretary, acting through the Director of BARDA, shall establish and implement a program that supports research and development, and manufacturing infrastructure, activities with respect to an emerging infectious disease.”

removed “(3) Funding for pandemic influenza program

removed “(A) In general—To carry out the purposes of subsection (d), there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023, to remain available until expended.

removed “(B) Supplement not supplant—Any funds provided to the Secretary under this paragraph shall be used to supplement and not supplant any other Federal funds provided to carry out the purposes of subsection (d).

removed “(4) Funding for emerging infectious disease program

removed “(A) In general—To carry out the purposes of subsection (e), there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023, to remain available until expended.

removed “(B) Supplement not supplant—Any funds provided to the Secretary under this paragraph shall be used to supplement and not supplant any other Federal funds provided to carry out the purposes of subsection (e).”

added “(9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance network under section 319D, the Secretary considers incorporating data and information from Federal, State, local, tribal, and territorial public health officials and entities relevant to detecting emerging public health threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, including adverse health outcomes of such populations related to such emerging public health threats.”

removed Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report detailing the activities carried out by the Department of Health and Human Services to support the development of vaccines to prevent future epidemics, including work carried out through domestic and global public-private partnerships and other collaborations intended to spur the development of such vaccines. Such report shall include information related to the provision of any funding or technical assistance to such entities.

added Section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) is amended—

removed “(4) Cybersecurity threats—In the next version of the National Health Security Strategy prepared after the date of the enactment of this paragraph, the National Health Security Strategy shall include a national strategy focused on addressing cybersecurity threats to the public health and health care system, including—

removed “(A) defining the functions, capabilities, and gaps in such system; and

removed “(B) identifying strategies to strengthen the preparedness and response of such system to cybersecurity threats and incidents, including with respect to continuity of care and risk mitigation to prevent harm to human health in case of a cybersecurity incident.”

added “(I) 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.”

added “(f) Protection of national security from threats

added “(1) In general—In carrying out the duties under subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza, that pose a significant level of risk to public health and national security based on the characteristics of such threat, which may also include a chemical, biological, radiological, or nuclear agent, including threats with a significant potential to become a pandemic. Such initiatives shall include activities to accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F). Such activities may also include those related to readiness to respond to pandemic influenza threats by supporting the development and manufacturing of influenza virus seeds, clinical trial lots, and stockpiles of novel influenza strains.

added “(2) Authorization of appropriations

added “(A) In general—For purposes of carrying out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.

added “(B) Supplement, not supplant—Funds appropriated under this subsection shall be used to supplement and not supplant funds provided under section 319L(e) and section 319F–2(g).

added “(C) Documentation required—The Assistant Secretary for Preparedness and Response shall, as required under subsection (b)(7), document amounts expended for purposes of carrying out this subsection, including amounts appropriated to the Public Health and Social Services Emergency Fund under title II of Division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141), as applicable to section 319L(c)(4)(F).”

removed “(4) have lead responsibility within the Department of Health and Human Services for ensuring the ability of the health care sector to provide continuity of care during a cybersecurity incident; and”

added “2811–1. Public health emergency medical countermeasures enterprise

added “(a) In general—The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the “PHEMCE”). The Assistant Secretary for Preparedness and Response shall serve as chair of the PHEMCE.

added “(b) Members—The PHEMCE shall include each of the following members, or the designee of such members:

added “(1) The Assistant Secretary for Preparedness and Response.

added “(2) The Director of the Centers for Disease Control and Prevention.

added “(3) The Director of the National Institutes of Health.

added “(4) The Commissioner of Food and Drugs.

added “(5) The Secretary of Defense.

added “(6) The Secretary of Homeland Security.

added “(7) The Secretary of Agriculture.

added “(8) The Secretary of Veterans Affairs.

added “(9) The Director of National Intelligence.

added “(10) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the Secretary determines appropriate.

added “(c) Functions

added “(1) In general—The functions of the PHEMCE shall include the following:

added “(A) 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. Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy pursuant to section 2802, the Strategic National Stockpile needs pursuant to section 319F–2, and assessments of current national security threats, including chemical, biological, radiological and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.

added “(B) Identify national health security needs, including gaps in public health preparedness and response related 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 subparagraph (A).

added “(C) 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).

added “(D) Provide consultation for the development of the strategy and implementation plan under section 2811(d).

added “(2) Input—In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and consider input from State, local, tribal, and territorial public health departments or officials, as appropriate.”

removed “(3) National security limitation—In making information publicly available pursuant to paragraph (1), the Secretary—

removed “(A) shall not disclose information that would compromise national security; and

removed “(B) may make available summaries in lieu of data and evidence contained in qualification submissions.”

added “(2) Threat-based review

added “(A) 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). Such review shall be submitted annually, beginning on March 15, 2019, 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.

added “(B) Additions, modifications, and replenishments—Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—

added “(i) information regarding—

added “(I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;

added “(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;

added “(III) the presence or lack of a commercial market for the countermeasure at the time of procurement;

added “(IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;

added “(V) 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 of emergency preparedness to address such threats;

added “(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;

added “(VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 2811(b)(7), including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and

added “(VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and

added “(ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.”

added “(E) 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; State, local, tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;”

added “(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; and

added “(J) provide assistance, including technical assistance, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate.”

added “(5) GAO report

added “(A) In general—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, 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. Such review shall include—

added “(i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;

added “(ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;

added “(iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;

added “(iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;

added “(v) an 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);

added “(vi) a description of the resources expended related to the procurement of countermeasures (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;

added “(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;

added “(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities; and

added “(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 319L, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States.

added “(B) 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.”

removed Not later than 14 days after the date of the enactment of this Act, the Assistant Secretary for Preparedness and Response shall submit to the Committee on Energy and Commerce of the House of Representatives a formal strategy—

added “(F) 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). Such initiatives shall accelerate and support the advanced research, development, and procurement of, countermeasures and products, as applicable, to address areas including—

added “(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;

added “(ii) threats that consistently exist or continually circulate and have significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and

added “(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.”

added “(d) Emerging infectious disease program

added “(1) In general—The Secretary, acting through the Director of BARDA, shall establish and implement a program that supports—

added “(A) advanced research and development activities for qualified pandemic or epidemic products; and

added “(B) manufacturing infrastructure activities with respect to an emerging infectious disease.

added “(2) Funding

added “(A) In general—To carry out paragraph (1), there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023, to remain available until expended.

added “(B) Supplement not supplant—Any funds provided to the Secretary under this paragraph shall be used to supplement and not supplant any other Federal funds provided to carry out paragraph (1).”

removed Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.), as amended by section 104, is further amended by inserting after section 319D–1 of such Act, the following new section:

removed “319D–2. Biological threat detection

removed “(a) Exchange of information

removed “(1) In general—The Secretary of Health and Human Services, in coordination with the Secretary of Defense and the Secretary of Homeland Security, shall—

removed “(A) facilitate the identification by Federal departments and agencies of technological, operational, and programmatic successes and failures of domestic detection programs for intentionally introduced, accidentally released, and naturally occurring infectious diseases;

removed “(B) facilitate the exchange of information described in subparagraph (A) among Federal departments and agencies that utilize biological threat detection technology; and

removed “(C) make recommendations on research, development, and procurement to Federal departments and agencies to replace and enhance biological threat detection systems in use, including recommendation for the transfer of biological threat detection technology among Federal departments and agencies.

removed “(2) Considerations—In carrying out paragraph (1), the Secretary of Health and Human Services shall take into consideration the capabilities of the system with respect to each of the following:

removed “(A) Rapidly detecting, identifying, characterizing, and confirming the presence of biological threat agents.

removed “(B) Recovering live biological agents from collection devices.

removed “(C) Determining the geographical distribution of biological agents.

removed “(D) Determining the extent of environmental contamination and persistence of biological agents.

removed “(E) Providing advanced molecular diagnostics to State, local, tribal, and territorial public health and other laboratories that support biological threat detection activities.

removed “(b) Collaboration—The Secretary of Health and Human Services, in consultation with Secretary of Defense, the Secretary of Homeland Security, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal departments and agencies that utilize biological threat detection technology, shall collaborate with State, local, tribal, and territorial public health laboratories and other users of current and future biological threat detection systems to develop—

removed “(1) biological threat detection requirements, including—

removed “(A) technical, quality, and biosafety standards, including the review of validation data prior to and throughout deployment of a biological threat detection system; and

removed “(B) requirements for—

removed “(i) the assessment of quality standards and the development and deployment of biological threat detection systems; and

removed “(ii) metrics for, collaborative assessment of, and deployment of biosafety standards;

removed “(2) a standardized integration strategy for—

removed “(A) the level to which biological threat detection processes and systems are defined and executed;

removed “(B) the locations at which such processes and systems are performed; and

removed “(C) the extent to which data is shared among State, local, tribal, and territorial public health laboratories and Federal departments and agencies;

removed “(3) State, local, tribal, and territorial laboratory training requirements for—

removed “(A) supporting and participating in biological threat detection systems; and

removed “(B) addressing flexibility at the jurisdictional level allowing for adoption of technology based on need and assessment of the efficacy and local utility of technology by the jurisdiction;

removed “(4) guidelines for a coordinated public health response addressing all aspect of a response, including clinical and epidemiological guidelines for utilizing information produced by biological threat detection systems and responding to intentionally introduced, accidentally released, and naturally occurring infectious diseases; and

removed “(5) a coordinated remediation plan with Federal departments and agencies and State and local public health agencies to facilitate rapid, safe, and coordinated restoration of facilities and localities after a contaminating biological event.”

added Section 351A(k) of the Public Health Service Act (42 U.S.C. 262a(k)) is amended—

added “(1) In general—The Secretary”

added “(2) Implementation of recommendations of the federal experts security advisory panel and the fast track action committee on select agent regulations

added “(A) In general—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.

added “(B) Continued updates—The Secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.”

removed “(iv) a public health emergency due to the incidence or prevalence of a mosquito-borne disease that presents a serious public health threat;”

removed “(D)

removed “(i) is located in a State that has received a grant under subsection (a); or

removed “(ii) demonstrates to the Secretary that the control program for which a grant is sought is consistent with existing State mosquito control plans or policies, and other applicable State preparedness plans.”

removed “(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions involved justify the waiver; or

removed “(ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph (1) has an extreme mosquito control need due to—

removed “(I) the size or density of the potentially impacted human population;

removed “(II) the size or density of a mosquito population that requires heightened control; or

removed “(III) the severity of the mosquito-borne disease, such that expected serious adverse health outcomes for the human population justify the waiver.”

removed “(6) Number of grants—A political subdivision or a consortium of political subdivisions may not receive more than one grant under paragraph (1).”

removed “(b) Authorization of appropriations—There are authorized to be appropriated to carry out this section $40,000,000 for each of fiscal years 2019 through 2023.”