PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF 2018; Congressional Record Vol. 164, No. 158
(House of Representatives - September 25, 2018)

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[Pages H8759-H8789]
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 PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF 
                                  2018

  Mrs. BROOKS of Indiana. Mr. Speaker, I move to suspend the rules and 
pass the bill (H.R. 6378) to reauthorize certain programs under the 
Public Health Service Act and the Federal Food, Drug, and Cosmetic Act 
with respect to public health security and all-hazards preparedness and 
response, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows

                               H.R. 6378

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Pandemic 
     and All-Hazards Preparedness and Advancing Innovation Act of 
     2018''.
       (b) Table of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

Sec. 101. National Health Security Strategy.

             TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

Sec. 201. Improving benchmarks and standards for preparedness and 
              response.
Sec. 202. Amendments to preparedness and response programs.
Sec. 203. Regional health care emergency preparedness and response 
              systems.
Sec. 204. Military and civilian partnership for trauma readiness.
Sec. 205. Public health and health care system situational awareness 
              and biosurveillance capabilities.
Sec. 206. Strengthening and supporting the public health emergency 
              rapid response fund.
Sec. 207. Improving all-hazards preparedness and response by public 
              health emergency volunteers.
Sec. 208. Clarifying State liability law for volunteer health care 
              professionals.
Sec. 209. Report on adequate national blood supply.
Sec. 210. Report on the public health preparedness and response 
              capabilities and capacities of hospitals, long-term care 
              facilities, and other health care facilities.

                  TITLE III--REACHING ALL COMMUNITIES

Sec. 301. Strengthening and assessing the emergency response workforce.
Sec. 302. Health system infrastructure to improve preparedness and 
              response.
Sec. 303. Considerations for at-risk individuals.
Sec. 304. Improving emergency preparedness and response considerations 
              for children.
Sec. 305. National advisory committees on disasters.
Sec. 306. Guidance for participation in exercises and drills.

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, 
              and other significant threats.
Sec. 405. Reporting on the Federal Select Agent Program.

 TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority 
              and the BioShield Special Reserve Fund.
Sec. 505. Additional strategies for combating antibiotic resistance.

      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

Sec. 601. Administration of countermeasures.
Sec. 602. Updating definitions of other transactions.
Sec. 603. Medical countermeasure master files.
Sec. 604. Animal rule report.
Sec. 605. Review of the benefits of genomic engineering technologies 
              and their potential role in national security.
Sec. 606. Report on vaccines development.
Sec. 607. Strengthening mosquito abatement for safety and health.

                  TITLE VII--MISCELLANEOUS PROVISIONS

Sec. 701. Reauthorizations and extensions.
Sec. 702. Location of materials in the stockpile.
Sec. 703. Cybersecurity.
Sec. 704. Technical amendments.
Sec. 705. Formal strategy relating to children separated from parents 
              and guardians as a result of zero tolerance policy.
Sec. 706. Reporting relating to children separated from parents and 
              guardians as a result of zero tolerance policy.
Sec. 707. Technical correction.
Sec. 708. Savings clause.

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

     SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

       Section 2802 of the Public Health Service Act (42 U.S.C. 
     300hh-1) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) by striking ``2014'' and inserting ``2018''; and
       (ii) by striking the second sentence and inserting the 
     following: ``Such National Health Security Strategy shall 
     describe potential emergency health security threats and 
     identify the process for achieving the preparedness goals 
     described in subsection (b) to be prepared to identify and 
     respond to such threats and shall be consistent with the 
     national preparedness goal (as described in section 
     504(a)(19) of the Homeland Security Act of 2002), the 
     National Incident Management System (as defined in section 
     501(7) of such Act), and the National Response Plan developed 
     pursuant to section 504 of such Act, or any successor 
     plan.'';
       (B) in paragraph (2), by inserting before the period at the 
     end of the second sentence the following: ``, and an analysis 
     of any changes to the evidence-based benchmarks and objective 
     standards under sections 319C-1 and 319C-2''; and
       (C) in paragraph (3)--
       (i) by striking ``2009'' and inserting ``2022'';
       (ii) by inserting ``(including gaps in the environmental 
     health and animal health workforces, as applicable), 
     describing the status of such workforce'' after ``gaps in 
     such workforce'';
       (iii) by striking ``and identifying strategies'' and 
     inserting ``identifying strategies''; and
       (iv) by inserting before the period at the end ``, and 
     identifying current capabilities to meet the requirements of 
     section 2803''; and
       (2) in subsection (b)--
       (A) in paragraph (2)--
       (i) in subparagraph (A), by striking ``and investigation'' 
     and inserting ``investigation, and related information 
     technology activities'';
       (ii) in subparagraph (B), by striking ``and 
     decontamination'' and inserting ``decontamination, relevant 
     health care services and supplies, and transportation and 
     disposal of medical waste''; and
       (iii) by adding at the end the following:
       ``(E) Response to environmental hazards.'';
       (B) in paragraph (3)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``including mental health'' and inserting ``including 
     pharmacies, mental health facilities,''; and
       (ii) in subparagraph (F), by inserting ``or exposures to 
     agents that could cause a public health emergency'' before 
     the period;
       (C) in paragraph (5), by inserting ``and other applicable 
     compacts'' after ``Compact''; and
       (D) by adding at the end the following:
       ``(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.
       ``(10) Global health security.--Assessing current or 
     potential health security threats from abroad to inform 
     domestic public health preparedness and response 
     capabilities.''.

             TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

     SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS 
                   AND RESPONSE.

       (a) Evaluating Measurable Evidence-based Benchmarks and 
     Objective Standards.--Section 319C-1 of the Public Health 
     Service Act (42 U.S.C. 247d-3a) is amended by inserting after 
     subsection (j) the following:
       ``(k) Evaluation.--
       ``(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.
       ``(2) Content.--The evaluation under this paragraph shall 
     include--

[[Page H8760]]

       ``(A) a review of evidence-based benchmarks and objective 
     standards, and associated metrics and targets;
       ``(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;
       ``(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
       ``(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.''.
       (b) Evaluating the Partnership for State and Regional 
     Hospital Preparedness.--Section 319C-2(i)(1) of the Public 
     Health Service Act (42 U.S.C. 247-3b(i)(1)) is amended by 
     striking ``section 319C-1(g), (i), and (j)'' and inserting 
     ``section 319C-1(g), (i), (j), and (k)''.

     SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.

       (a) Cooperative Agreement Applications for Improving State 
     and Local Public Health Security.--Section 319C-1 of the 
     Public Health Service Act (42 U.S.C. 247d-3a) is amended--
       (1) in subsection (a), by inserting ``, acting through the 
     Director of the Centers for Disease Control and Prevention,'' 
     after ``the Secretary''; and
       (2) in subsection (b)(2)(A)--
       (A) in clause (vi), by inserting ``, including public 
     health agencies with specific expertise that may be relevant 
     to public health security, such as environmental health 
     agencies,'' after ``stakeholders'';
       (B) by redesignating clauses (vii) through (ix) as clauses 
     (viii) through (x);
       (C) by inserting after clause (vi) the following:
       ``(vii) a description of how, as applicable, such entity 
     may integrate information to account for individuals with 
     behavioral health needs following a public health 
     emergency;'';
       (D) in clause (ix), as so redesignated, by striking ``; 
     and'' and inserting a semicolon;
       (E) in clause (x), as so redesignated, by inserting ``and'' 
     after the semicolon; and
       (F) by adding at the end the following:
       ``(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
       ``(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.''.
       (b) Exception Relating to Application of Certain 
     Requirements.--
       (1) In general.--Section 319C-1(g) of the Public Health 
     Service Act (42 U.S.C. 247d-3a(g)) is amended--
       (A) in paragraph (5)--
       (i) by striking ``Beginning with fiscal year 2009'' and 
     inserting ``Beginning with fiscal year 2019'';
       (ii) by striking ``for the immediately preceding fiscal 
     year'' and inserting ``for either of the two immediately 
     preceding fiscal years''; and
       (iii) by striking ``2008'' and inserting ``2018''; and
       (B) by amending subparagraph (A) of paragraph (6) to read 
     as follows:
       ``(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:
       ``(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.
       ``(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.''.
       (2) Effective date.--The amendments made by paragraph (1) 
     shall apply with respect to cooperative agreements awarded on 
     or after the date of enactment of this Act.
       (c) Partnership for State and Regional Hospital 
     Preparedness to Improve Surge Capacity.--Section 319C-2 of 
     the Public Health Service Act (42 U.S.C. 247d-3b) is 
     amended--
       (1) in subsection (a)--
       (A) by inserting ``, acting through the Assistant Secretary 
     for Preparedness and Response,'' after ``The Secretary''; and
       (B) by striking ``preparedness for public health 
     emergencies'' and inserting ``preparedness for, and response 
     to, public health emergencies in accordance with subsection 
     (c)'';
       (2) in subsection (b)(1)(A)--
       (A) by striking ``partnership consisting of'' and inserting 
     ``coalition that includes'';
       (B) in clause (ii), by striking ``; and'' and inserting a 
     semicolon; and
       (C) by adding at the end the following:
       ``(iv) one or more emergency medical service organizations 
     or emergency management organizations; and'';
       (3) in subsection (d)--
       (A) in paragraph (1)(B), by striking ``partnership'' each 
     place it appears and inserting ``coalition''; and
       (B) in paragraph (2)(C), by striking ``medical 
     preparedness'' and inserting ``preparedness and response'';
       (4) in subsection (f), by striking ``partnership'' and 
     inserting ``coalition'';
       (5) in subsection (g)(2)--
       (A) by striking ``Partnerships'' and inserting 
     ``Coalitions'';
       (B) by striking ``partnerships'' and inserting 
     ``coalitions''; and
       (C) by inserting ``and response'' after ``preparedness''; 
     and
       (6) in subsection (i)(1)--
       (A) by striking ``An entity'' and inserting ``A 
     coalition''; and
       (B) by striking ``such partnership'' and inserting ``such 
     coalition''.
       (d) Public Health Security Grants Authorization of 
     Appropriations.--Section 319C-1(h)(1)(A) of the Public Health 
     Service Act (42 U.S.C. 247d-3a(h)(1)(A)) is amended by 
     striking ``$641,900,000 for fiscal year 2014'' and all that 
     follows through the period at the end and inserting 
     ``$685,000,000 for each of fiscal years 2019 through 2023 for 
     awards pursuant to paragraph (3) (subject to the authority of 
     the Secretary to make awards pursuant to paragraphs (4) and 
     (5)).''.
       (e) Partnership for State and Regional Hospital 
     Preparedness Authorization of Appropriations.--Section 319C-
     2(j) of the Public Health Service Act (42 U.S.C. 247d-3b(j)) 
     is amended--
       (1) by amending paragraph (1) to read as follows:
       ``(1) In general.--
       ``(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.
       ``(B) Reservation of amounts for regional systems.--
       ``(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.
       ``(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.
       ``(iii) Sunset.--The authority to reserve amounts under 
     clause (i) shall expire on September 30, 2023.'';
       (2) in paragraph (2), by striking ``paragraph (1) for a 
     fiscal year'' and inserting ``paragraph (1)(A) for a fiscal 
     year and not reserved for the purpose described in paragraph 
     (1)(B)(i)''; and
       (3) in paragraph (3)(A), by striking ``paragraph (1) and 
     not reserved under paragraph (2)'' and inserting ``paragraph 
     (1)(A) and not reserved under paragraph (1)(B)(i) or (2)''.

     SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND 
                   RESPONSE SYSTEMS.

       (a) In General.--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:

     ``SEC. 319C-3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY 
                   PREPAREDNESS AND RESPONSE SYSTEMS.

       ``(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.
       ``(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--
       ``(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,

[[Page H8761]]

     radiological, or nuclear agents, including emerging 
     infectious diseases (which may include existing practices, 
     such as trauma care and medical surge capacity and 
     capabilities), with respect to--
       ``(A) a regional approach to identifying hospitals and 
     health care facilities based on varying capabilities and 
     capacity to treat patients affected by such emergency, 
     including--
       ``(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
       ``(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;
       ``(B) physical and technological infrastructure, laboratory 
     capacity, staffing, blood supply, and other supply chain 
     needs, taking into account resiliency, geographic 
     considerations, and rural considerations;
       ``(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;
       ``(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
       ``(E) the needs of children and other at-risk individuals;
       ``(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
       ``(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.
       ``(c) Considerations.--In identifying, developing, and 
     updating guidelines under subsection (b), the Assistant 
     Secretary for Preparedness and Response shall--
       ``(1) include input from hospitals and health care 
     facilities (including health care coalitions under section 
     319C-2), State, local, tribal, and territorial public health 
     departments, and health care or subject matter experts 
     (including experts with relevant expertise in chemical, 
     biological, radiological, or nuclear threats, including 
     emerging infectious diseases), as the Assistant Secretary 
     determines appropriate, to meet the goals under section 
     2802(b)(3);
       ``(2) consult 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);
       ``(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
       ``(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.
       ``(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).
       ``(e) Demonstration Project for Regional Health Care 
     Preparedness and Response Systems.--
       ``(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.
       ``(2) Sunset.--The authority under this subsection shall 
     expire on September 30, 2023.''.
       (b) GAO Report to Congress.--
       (1) Report.--Not later than 3 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States (referred to in this subsection as the ``Comptroller 
     General'') shall submit to the Committee on Health, 
     Education, Labor, and Pensions and the Committee on Finance 
     of the Senate and the Committee on Energy and Commerce and 
     the Committee on Ways and Means of the House of 
     Representatives, a report on the extent to which hospitals 
     and health care facilities have implemented the recommended 
     guidelines under section 319C-3(b) of the Public Health 
     Service Act (as added by subsection (a)), including an 
     analysis and evaluation of any challenges hospitals or health 
     care facilities experienced in implementing such guidelines.
       (2) Content.--The Comptroller General shall include in the 
     report under paragraph (1)--
       (A) data on the preparedness and response capabilities that 
     have been informed by the guidelines under section 319C-3(b) 
     of the Public Health Service Act 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
       (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 of the Public Health Service Act (42 
     U.S.C. 247d-3b) or in programs under the Centers for Medicare 
     & Medicaid Services (including innovative health care 
     delivery and payment models), and input from private sector 
     financial institutions.
       (3) Consultation.--In carrying out paragraphs (1) and (2), 
     the Comptroller General shall consult with the heads of 
     appropriate Federal agencies, including--
       (A) the Assistant Secretary for Preparedness and Response;
       (B) the Director of the Centers for Disease Control and 
     Prevention;
       (C) the Administrator of the Centers for Medicare & 
     Medicaid Services;
       (D) the Assistant Secretary for Mental Health and Substance 
     Use;
       (E) the Assistant Secretary of Labor for Occupational 
     Safety and Health; and
       (F) the Secretary of Veterans Affairs.
       (c) Annual Reports.--Section 319C-2(i)(1) of the Public 
     Health Service Act (42 U.S.C. 247d-3b(i)(1)) is amended by 
     inserting after the first sentence the following ``In 
     submitting reports under this paragraph an entity shall 
     include information on the progress that the entity has made 
     toward the implementation of section 319C-3 (or barriers to 
     progress, if any).''.
       (d) National Health Security Strategy Incorporation of 
     Regionalized Emergency Preparedness and Response.--
     Subparagraph (G) of section 2802(b)(3) of the Public Health 
     Service Act (42 U.S.C. 300hh-1(b)(3)) is amended to read as 
     follows:
       ``(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.''.
       (e) Improving State and Local Public Health Security.--
       (1) State and local security.--Section 319C-1(e) of the 
     Public Health Service Act (42 U.S.C. 247d-3a(e)) is amended 
     by striking ``, and local emergency plans.'' and inserting 
     ``, local emergency plans, and any regional health care 
     emergency preparedness and response system established 
     pursuant to the applicable guidelines under section 319C-
     3.''.
       (2) Partnerships.--Section 319C-2(d)(1)(A) of the Public 
     Health Service Act (42 U.S.C. 247d-3b(d)(1)(A)) is amended--
       (A) in clause (i), by striking ``; and'' and inserting 
     ``;'';
       (B) by redesignating clause (ii) as clause (iii); and
       (C) inserting after clause (i), the following:
       ``(ii) among one or more facilities in a regional health 
     care emergency system under section 319C-3; and''.

     SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA 
                   READINESS.

       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:

``PART I--MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT 
                                PROGRAM

     ``SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA 
                   READINESS GRANT PROGRAM.

       ``(a) Military Trauma Team Placement Program.--
       ``(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.
       ``(2) Limitations.--In the case of a grant awarded under 
     paragraph (1) to an eligible high acuity trauma center, such 
     grant--
       ``(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
       ``(B) shall be in an amount that does not exceed $1,000,000 
     per year.

[[Page H8762]]

       ``(3) Availability of funds.--Notwithstanding section 1552 
     of title 31, United States Code, or any other provision of 
     law, funds available to the Secretary for obligation for a 
     grant under this subsection shall remain available for 
     expenditure for 100 days after the last day of the 
     performance period of such grant.
       ``(b) Military Trauma Care Provider Placement Program.--
       ``(1) In general.--The Secretary, acting through the 
     Assistant Secretary for Preparedness and Response and in 
     consultation with the Secretary of Defense, shall award 
     grants to eligible trauma centers to enable military trauma 
     care providers to provide trauma care and related acute care 
     at such trauma centers.
       ``(2) Limitations.--In the case of a grant awarded under 
     paragraph (1) to an eligible trauma center, such grant--
       ``(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
       ``(B) shall be in an amount that does not exceed, in a 
     year--
       ``(i) $100,000 for each military trauma care provider that 
     is a physician at such eligible trauma center; and
       ``(ii) $50,000 for each other military trauma care provider 
     at such eligible trauma center.
       ``(c) Grant Requirements.--
       ``(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--
       ``(A) be deployed by the Secretary of Defense for military 
     operations, for training, or for response to a mass casualty 
     incident; and
       ``(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.
       ``(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.
       ``(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.
       ``(e) Reporting Requirements.--
       ``(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--
       ``(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;
       ``(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;
       ``(C) the educational effect on resident trainees in 
     centers where military trauma teams are assigned;
       ``(D) any research conducted during such year supported by 
     such grant; and
       ``(E) any other information required by the Secretaries for 
     the purpose of evaluating the effect of such grant.
       ``(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--
       ``(A) maintaining military trauma care providers' readiness 
     and ability to respond to and treat battlefield injuries;
       ``(B) providing health care to civilian trauma patients in 
     urban and rural settings;
       ``(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;
       ``(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;
       ``(E) efforts to incorporate military trauma care providers 
     into operational exercises and training and drills for public 
     health emergencies; and
       ``(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.
       ``(f) Definitions.--For purposes of this part:
       ``(1) Eligible trauma center.--The term `eligible trauma 
     center' means a Level I, II, or III trauma center that 
     satisfies each of the following:
       ``(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.
       ``(B) Such trauma center utilizes a risk-adjusted 
     benchmarking system and metrics to measure performance, 
     quality, and patient outcomes.
       ``(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.
       ``(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:
       ``(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.
       ``(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.
       ``(C) Such trauma center utilizes a risk-adjusted 
     benchmarking system and metrics to measure performance, 
     quality, and patient outcomes.
       ``(D) Such trauma center is an academic training center--
       ``(i) affiliated with a medical school;
       ``(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
       ``(iii) that undertakes research in the prevention and 
     treatment of traumatic injury.
       ``(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.
       ``(3) Major trauma.--The term `major trauma' means an 
     injury that is greater than or equal to 15 on the injury 
     severity score.
       ``(4) Military trauma team.--The term `military trauma 
     team' means a complete military trauma team consisting of 
     military trauma care providers.
       ``(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.
       ``(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--
       ``(1) \2/3\ of the amount made available each fiscal year 
     shall be made available for grants under subsection (a); and
       ``(2) \1/3\ of the amount made available each fiscal year 
     shall be made available for grants under subsection (b).''.

     SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL 
                   AWARENESS AND BIOSURVEILLANCE CAPABILITIES.

       (a) Facilities, Capacities, and Biosurveillance 
     Capabilities.--Section 319D of the Public Health Service Act 
     (42 U.S.C. 247d-4) is amended--
       (1) in the section heading, by striking ``revitalizing'' 
     and inserting ``facilities and capacities of'';
       (2) in subsection (a)--
       (A) in the subsection heading, by striking ``Facilities; 
     Capacities'' and inserting ``In General'';
       (B) in paragraph (1), by striking ``and improved'' and 
     inserting ``, improved, and appropriately maintained'';
       (C) in paragraph (3), in the matter preceding subparagraph 
     (A), by striking ``expand, enhance, and improve'' and 
     inserting ``expand, improve, enhance, and appropriately 
     maintain''; and
       (D) by adding at the end the following:
       ``(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.'';
       (3) in subsection (b)--
       (A) in the subsection heading, by striking ``National'' and 
     inserting ``Establishment of Systems of Public Health'';
       (B) in paragraph (1)(B), by inserting ``immunization 
     information systems,'' after ``centers,''; and
       (C) in paragraph (2)--
       (i) by inserting ``develop a plan to, and'' after ``The 
     Secretary shall''; and
       (ii) by inserting ``and in a form readily usable for 
     analytical approaches'' after ``in a secure manner''; and
       (D) by amending paragraph (3) to read as follows:
       ``(3) Standards.--

[[Page H8763]]

       ``(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.
       ``(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.'';
       (4) in subsection (c)--
       (A) in paragraph (1)--
       (i) by striking ``Not later than 2 years after the date of 
     enactment of the Pandemic and All-Hazards Preparedness 
     Reauthorization Act of 2013, the Secretary'' and inserting 
     ``The Secretary'';
       (ii) by inserting ``, and improve as applicable and 
     appropriate,'' after ``shall establish'';
       (iii) by striking ``of rapid'' and inserting ``of, rapid''; 
     and
       (iv) by striking ``such connectivity'' and inserting ``such 
     interoperability'';
       (B) by amending paragraph (2) to read as follows:
       ``(2) Coordination and consultation.--In establishing and 
     improving the network under paragraph (1) the Secretary 
     shall--
       ``(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
       ``(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.'';
       (C) in paragraph (3)--
       (i) by redesignating subparagraphs (A) through (E) as 
     clauses (i) through (v), respectively, and adjusting the 
     margins accordingly;
       (ii) in clause (iv), as so redesignated--

       (I) by inserting ``immunization information systems,'' 
     after ``poison control,''; and
       (II) by striking ``and clinical laboratories'' and 
     inserting ``, clinical laboratories, and public environmental 
     health agencies'';

       (iii) by striking ``The network'' and inserting the 
     following:
       ``(A) In general.--The network''; and
       (iv) by adding at the end the following:
       ``(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.'';
       (D) in paragraph (5)--
       (i) by redesignating subparagraphs (A) through (D) as 
     clauses (i) through (iv), respectively, and adjusting the 
     margins accordingly;
       (ii) by striking ``In establishing'' and inserting the 
     following:
       ``(A) In general.--In establishing'';
       (iii) by adding at the end the following:
       ``(B) Public meeting.--
       ``(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).
       ``(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.
       ``(iii) Topics.--Such public meeting shall include a 
     discussion of--

       ``(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;
       ``(II) standards and implementation specifications that may 
     improve the collection, analysis, and interpretation of data 
     during a public health emergency;
       ``(III) strategies to encourage the access, exchange, and 
     use of information;
       ``(IV) considerations for State, local, tribal, and 
     territorial capabilities and infrastructure related to data 
     exchange and interoperability;
       ``(V) privacy and security protections provided at the 
     Federal, State, local, tribal, and territorial levels, and by 
     nongovernmental stakeholders; and
       ``(VI) opportunities for the incorporation of innovative 
     technologies to improve the network.''; and

       (iv) in subparagraph (A), as so designated by clause (ii)--

       (I) in clause (i), as so redesignated--

       (aa) by striking ``as determined'' and inserting ``as 
     adopted''; and
       (bb) by inserting ``and the National Institute of Standards 
     and Technology'' after ``Office of the National Coordinator 
     for Health Information Technology'';

       (II) in clause (iii), as so redesignated, by striking ``; 
     and'' and inserting a semicolon;
       (III) in clause (iv), as so redesignated, by striking the 
     period and inserting ``; and''; and
       (IV) by adding at the end the following:

       ``(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.'';
       (E) by redesignating paragraph (6) as paragraph (7);
       (F) by inserting after paragraph (5) the following:
       ``(6) Strategy and implementation plan.--
       ``(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--
       ``(i) is informed by the public meeting under paragraph 
     (5)(B);
       ``(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);
       ``(iii) identifies and demonstrates the measurable steps 
     the Secretary will carry out to--

       ``(I) develop, implement, and evaluate the network 
     described in paragraph (1), utilizing elements described in 
     paragraph (3)(A);
       ``(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;
       ``(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
       ``(IV) test and evaluate capabilities of the interoperable 
     network of systems to improve situational awareness and 
     biosurveillance capabilities;

       ``(iv) includes performance measures and the metrics by 
     which performance measures will be assessed with respect to 
     the measurable steps under clause (iii); and
       ``(v) establishes dates by which each measurable step under 
     clause (iii) will be implemented.
       ``(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--
       ``(i) a summary of resources previously expended to 
     establish, improve, and utilize the nationwide public health 
     situational awareness and biosurveillance network under 
     paragraph (1);
       ``(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);
       ``(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
       ``(iv) a strategy to minimize and address such gaps and 
     improve inefficiencies.'';
       (G) in paragraph (7), as so redesignated--
       (i) in subparagraph (A), by inserting ``(taking into 
     account zoonotic disease, including gaps in scientific 
     understanding of the interactions between human, animal, and 
     environmental health)'' after ``human health'';

[[Page H8764]]

       (ii) in subparagraph (B)--

       (I) by inserting ``and gaps in surveillance programs'' 
     after ``surveillance programs''; and
       (II) by striking ``; and'' and inserting a semicolon;

       (iii) in subparagraph (C)--

       (I) by inserting ``, animal health organizations related to 
     zoonotic disease,'' after ``health care entities''; and
       (II) by striking the period and inserting ``; and''; and

       (iv) by adding at the end the following:
       ``(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.''; and
       (H) by adding at the end the following:
       ``(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.'';
       (5) in subsection (d)--
       (A) in paragraph (1)--
       (i) by inserting ``environmental health agencies,'' after 
     ``public health agencies,''; and
       (ii) by inserting ``immunization programs,'' after ``poison 
     control centers,''; and
       (B) in paragraph (2)--
       (i) in subparagraph (B), by striking ``and'' at the end;
       (ii) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (iii) by adding after subparagraph (C) the following:
       ``(D) an implementation plan that may include measurable 
     steps to achieve the purposes described in paragraph (1).''; 
     and
       (C) by striking paragraph (5) and inserting the following:
       ``(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.'';
       (6) by redesignating subsections (f) and (g) as subsections 
     (i) and (j), respectively; and
       (7) by inserting after subsection (e) the following:
       ``(f) Personnel Authorities.--
       ``(1) Specially qualified personnel.--In addition to any 
     other personnel authorities, to carry out subsections (b) and 
     (c), the Secretary may--
       ``(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
       ``(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.
       ``(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).
       ``(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).
       ``(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.''.
       (b) Authorization of Appropriations.--Subsection (i) of 
     section 319D of the Public Health Service Act (42 U.S.C. 
     247d-4), as redesignated by subsection (a)(6), is amended by 
     striking ``$138,300,000 for each of fiscal years 2014 through 
     2018'' and inserting ``$161,800,000 for each of fiscal years 
     2019 through 2023''.
       (c) Biological Threat Detection Report.--The Secretary of 
     Health and Human Services shall, in coordination with the 
     Secretary of Defense and the Secretary of Homeland Security, 
     not later than 180 days after the date of enactment of this 
     Act, report to the Committee on Energy and Commerce, the 
     Committee on Armed Services, and the Committee on Homeland 
     Security of the House of Representatives and the Committee on 
     Health, Education, Labor, and Pensions, the Committee on 
     Armed Services, and the Committee on Homeland Security and 
     Governmental Affairs of the Senate on the state of Federal 
     biological threat detection efforts, including the 
     following--
       (1) an identification of technological, operational, and 
     programmatic successes and failures of domestic detection 
     programs supported by Federal departments and agencies for 
     intentionally-introduced or accidentally-released biological 
     threat agents and naturally occurring infectious diseases;
       (2) a description of Federal efforts to facilitate the 
     exchange of information related to the information described 
     in paragraph (1) among Federal departments and agencies that 
     utilize biological threat detection technology;
       (3) a description of the capabilities of detection systems 
     in use by Federal departments and agencies including the 
     capability to--
       (A) rapidly detect, identify, characterize, and confirm the 
     presence of biological threat agents;
       (B) recover live biological agents from collection devices;
       (C) determine the geographical distribution of biological 
     agents;
       (D) determine the extent of environmental contamination and 
     persistence of biological agents; and
       (E) provide advanced molecular diagnostics to State, local, 
     tribal, and territorial public health and other laboratories 
     that support biological threat detection activities;
       (4) a description of Federal interagency coordination 
     related to biological threat detection;
       (5) a description of efforts by Federal departments and 
     agencies that utilize biological threat detection technology 
     to collaborate with State, local, tribal, and territorial 
     public health laboratories and other users of biological 
     threat detection systems, including collaboration regarding 
     the development of--
       (A) biological threat detection requirements or standards;
       (B) a standardized integration strategy;
       (C) training requirements or guidelines;
       (D) guidelines for a coordinated public health response, 
     including preparedness capabilities, and, as applicable, for 
     coordination with public health surveillance systems; and
       (E) a coordinated environmental remediation plan, as 
     applicable; and
       (6) recommendations related to research, advanced research, 
     development, and procurement for Federal departments and 
     agencies to improve and enhance biological threat detection 
     systems, including recommendations on the transfer of 
     biological threat detection technology among Federal 
     departments and agencies, as necessary and appropriate.

     SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH 
                   EMERGENCY RAPID RESPONSE FUND.

       Section 319 of the Public Health Service Act (42 U.S.C. 
     247d) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1)--
       (i) in the first sentence, by inserting ``or if the 
     Secretary determines there is the significant potential for a 
     public health emergency, to allow the Secretary to rapidly 
     respond to the immediate needs resulting from such public 
     health emergency or potential public health emergency'' 
     before the period; and
       (ii) by inserting ``The Secretary shall plan for the 
     expedited distribution of funds to appropriate agencies and 
     entities.'' after the first sentence;
       (B) by redesignating paragraph (2) as paragraph (3);
       (C) by inserting after paragraph (1) the following:
       ``(2) Uses.--The Secretary may use amounts in the Fund 
     established under paragraph (1), to--
       ``(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);
       ``(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;
       ``(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);
       ``(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;
       ``(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
       ``(F) carry out other activities, as the Secretary 
     determines applicable and appropriate.''; and
       (D) by inserting after paragraph (3), as so redesignated, 
     the following:
       ``(4) Review.--Not later than 2 years after the date of 
     enactment of the Pandemic and

[[Page H8765]]

     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).
       ``(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--
       ``(A) conduct a review of the Fund under this section, 
     including its uses and the resources available in the Fund; 
     and
       ``(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.''; and
       (2) in subsection (c)--
       (A) by inserting ``rapidly respond to public health 
     emergencies or potential public health emergencies and'' 
     after ``used to''; and
       (B) by striking ``section.'' and inserting ``Act or funds 
     otherwise provided for emergency response.''.

     SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE BY 
                   PUBLIC HEALTH EMERGENCY VOLUNTEERS.

       (a) In General.--Section 319I of the Public Health Service 
     Act (42 U.S.C. 247d-7b) is amended--
       (1) in the section heading, by striking ``health 
     professions volunteers'' and inserting ``volunteer health 
     professional'';
       (2) in subsection (a), by adding at the end the following: 
     ``Such health care professionals may include members of the 
     National Disaster Medical System, members of the Medical 
     Reserve Corps, and individual health care professionals.'';
       (3) in subsection (i) by adding at the end ``In order to 
     inform the development of such mechanisms by States, the 
     Secretary shall make available information and material 
     provided by States that have developed mechanisms to waive 
     the application of licensing requirements to applicable 
     health professionals seeking to provide medical services 
     during a public health emergency. Such information shall be 
     made publicly available in a manner that does not compromise 
     national security.''; and
       (4) in subsection (k) by striking ``2014 through 2018'' and 
     inserting ``2019 through 2023''.
       (b) All-Hazards Public Health Emergency Preparedness and 
     Response Plan.--Section 319C-1(b)(2)(A)(iv) of the Public 
     Health Service Act (42 U.S.C. 247d-3a(b)(2)(A)(iv)) is 
     amended to read as follows:
       ``(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--
       ``(I) providing a public method of communication for 
     purposes of volunteer coordination (such as a phone number);
       ``(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
       ``(III) other mechanisms as the State determines 
     appropriate;''.

     SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUNTEER HEALTH 
                   CARE PROFESSIONALS.

       (a) In General.--Title II of the Public Health Service Act 
     (42 U.S.C. 202 et seq.) is amended by inserting after section 
     224 the following:

     ``SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DURING A 
                   PUBLIC HEALTH EMERGENCY.

       ``(a) Limitation on Liability.--Notwithstanding any other 
     provision of law, a health care professional who is a member 
     of the Medical Reserve Corps under section 2813 or who is 
     included in the Emergency System for Advance Registration of 
     Volunteer Health Professionals under section 319I and who--
       ``(1) is responding--
       ``(A) 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
       ``(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
       ``(2) is alleged to be liable for an act or omission--
       ``(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;
       ``(B) in the State or States for which such determination 
     or declaration is made;
       ``(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
       ``(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
       ``(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,
     shall be subject only to the State liability laws of the 
     State in which such act or omission occurred, in the same 
     manner and to the same extent as a similar health care 
     professional who is a resident of such State would be subject 
     to such State laws, except with respect to the licensure, 
     registration, and certification of such individual.
       ``(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.
       ``(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.
       ``(d) Definitions.--In this section:
       ``(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.
       ``(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--
       ``(A) the diagnosis, prevention, or treatment of any human 
     disease or impairment; or
       ``(B) the assessment or care of the health of human beings.
       ``(e) Effective Date.--
       ``(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.
       ``(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).''.
       (b) GAO Study.--Not later than one year after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall conduct a review of--
       (1) the number of health care providers who register under 
     the Emergency System for Advance Registration of Volunteer 
     Health Professionals under section 319I of the Public Health 
     Service Act (42 U.S.C. 247d-7b) in advance to provide 
     services during a public health emergency;
       (2) the number of health care providers who are 
     credentialed to provide services during the period of a 
     public health emergency declaration, including those who are 
     credentialed though programs established in the Emergency 
     System for Advance Registration of Volunteer Health 
     Professionals under such section 319I and those credentialed 
     by authorities within the State in which the emergency 
     occurred;
       (3) the average time to verify the credentials of a health 
     care provider during the period of a public health emergency 
     declaration, including the average time pursuant to the 
     Emergency System for Advance Registration of Volunteer Health 
     Professionals under such section 319I and for an individual's 
     credentials to be verified by an authority within the State; 
     and
       (4) the Emergency System for Advance Registration of 
     Volunteer Health Professionals program in States, including 
     whether physician or medical groups, associations, or other 
     relevant provider organizations utilize such program for 
     purposes of volunteering during public health emergencies.

     SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY.

       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--
       (1) challenges associated with the continuous recruitment 
     of blood donors (including those newly eligible to donate);
       (2) ensuring the adequacy of the blood supply in the case 
     of public health emergencies;
       (3) implementation of the transfusion transmission 
     monitoring system; and
       (4) other measures to promote safety and innovation, such 
     as the development, use, or implementation of new 
     technologies, processes, and procedures to improve the safety 
     and reliability of the blood supply.

     SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND 
                   RESPONSE CAPABILITIES AND CAPACITIES OF 
                   HOSPITALS, LONG-TERM CARE FACILITIES, AND OTHER 
                   HEALTH CARE FACILITIES.

       (a) Study.--
       (1) In general.--Not later than one year after the date of 
     enactment of this Act, the

[[Page H8766]]

     Secretary of Health and Human Services shall enter into an 
     agreement with an appropriate entity to conduct a study 
     regarding the public health preparedness and response 
     capabilities and medical surge capacities of hospitals, long-
     term care facilities, and other health care facilities to 
     prepare for, and respond to, public health emergencies, 
     including natural disasters.
       (2) Consultation.--In conducting the study under paragraph 
     (1), the entity shall consult with Federal, State, local, 
     tribal, and territorial public health officials (as 
     appropriate), and health care providers and facilities with 
     experience in public health preparedness and response 
     activities.
       (3) Evaluation.--The study under paragraph (1) shall 
     include--
       (A) an evaluation of the current benchmarks and objective 
     standards, as applicable, related to programs that support 
     hospitals, long-term care facilities, and other health care 
     facilities, and their effect on improving public health 
     preparedness and response capabilities and medical surge 
     capacities, including the Hospital Preparedness Program, the 
     Public Health Emergency Preparedness cooperative agreements, 
     and the Regional Health Care Emergency Preparedness and 
     Response Systems under section 319C-3 of the Public Health 
     Service Act (as added by section 203);
       (B) the identification of gaps in preparedness, including 
     with respect to such benchmarks and objective standards, such 
     as those identified during recent public health emergencies, 
     for hospitals, long-term care facilities, and other health 
     care facilities to address future potential public health 
     threats;
       (C) an evaluation of coordination efforts between the 
     recipients of Federal funding for programs described in 
     subparagraph (A) and entities with expertise in emergency 
     power systems and other critical infrastructure partners 
     during a public health emergency, to ensure a functioning 
     critical infrastructure, to the greatest extent practicable, 
     during a public health emergency;
       (D) an evaluation of coordination efforts between the 
     recipients of Federal funding for programs described in 
     subparagraph (A) and environmental health agencies with 
     expertise in emergency preparedness and response planning for 
     hospitals, long-term care facilities and other health care 
     facilities; and
       (E) an evaluation of current public health preparedness and 
     response capabilities and medical surge capacities related to 
     at-risk individuals during public health emergencies, 
     including an identification of gaps in such preparedness as 
     they relate to such individuals.
       (b) Report.--
       (1) In general.--The agreement under subsection (a) shall 
     require the entity to submit to the Secretary of Health and 
     Human Services and the congressional committees of 
     jurisdiction, not later than 3 years after the date of 
     enactment of this Act, a report on the results of the study 
     conducted pursuant to this section.
       (2) Contents.--The report under paragraph (1) shall--
       (A) describe the findings and conclusions of the evaluation 
     conducted pursuant to subsection (a); and
       (B) provide recommendations for improving public health 
     preparedness and response capability and medical surge 
     capacity for hospitals, long-term care facilities, and other 
     health care facilities, including--
       (i) improving the existing benchmarks and objective 
     standards for the Federal grant programs described in 
     subsection (a)(3)(A) or developing new benchmarks and 
     standards for such programs; and
       (ii) identifying best practices for improving public health 
     preparedness and response programs and medical surge capacity 
     at hospitals, long-term care facilities, and other health 
     care facilities, including recommendations for the evaluation 
     under subparagraphs (C) and (D) of subsection (a)(3).

                  TITLE III--REACHING ALL COMMUNITIES

     SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE 
                   WORKFORCE.

       (a) National Disaster Medical System.--
       (1) Strengthening the national disaster medical system.--
     Clause (ii) of section 2812(a)(3)(A) of the Public Health 
     Service Act (42 U.S.C. 300hh-11(a)(3)(A)) is amended to read 
     as follows:
       ``(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.''.
       (2) Review of the national disaster medical system.--
     Section 2812(b)(2) of the Public Health Service Act (42 
     U.S.C. 300hh-11(b)(2)) is amended to read as follows:
       ``(2) Joint review and medical surge capacity strategic 
     plan.--
       ``(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--
       ``(i) an evaluation of medical surge capacity, as described 
     in section 2803(a);
       ``(ii) an assessment of the available workforce of the 
     intermittent disaster response personnel described in 
     subsection (c);
       ``(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;
       ``(iv) the effectiveness of efforts to recruit, retain, and 
     train such workforce; and
       ``(v) gaps that may exist in such workforce and 
     recommendations for addressing such gaps.
       ``(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.''.
       (3) Notification of shortage.--Section 2812(c) of the 
     Public Health Service Act (42 U.S.C. 300hh-11(c)) is amended 
     by adding at the end the following:
       ``(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--
       ``(A) the impact such shortage could have on meeting public 
     health needs and emergency medical personnel needs during a 
     public health emergency; and
       ``(B) any identified measures to address such shortage.
       ``(4) Certain appointments.--
       ``(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.
       ``(B) Sunset.--The authority under this paragraph shall 
     expire on September 30, 2021.''.
       (4) Authorization of appropriations.--Section 2812(g) of 
     the Public Health Service Act (42 U.S.C. 300hh-11(g)) is 
     amended by striking ``$52,700,000 for each of fiscal years 
     2014 through 2018'' and inserting ``$57,400,000 for each of 
     fiscal years 2019 through 2023''.
       (b) Volunteer Medical Reserve Corps.--
       (1) In general.--Section 2813(a) of the Public Health 
     Service Act (42 U.S.C. 42 U.S.C. 300hh-15(a)) is amended by 
     striking the second sentence and inserting ``The Secretary 
     may appoint a Director to head the Corps and oversee the 
     activities of the Corps chapters that exist at the State, 
     local, tribal, and territorial levels.''.
       (2) Authorization of appropriations.--Section 2813(i) of 
     the Public Health Service Act (42 U.S.C. 300hh-15(i)) is 
     amended by striking ``2014 through 2018'' and inserting 
     ``2019 through 2023''.
       (c) Strengthening the Epidemic Intelligence Service.--
     Section 317F of the Public Health Service Act (42 U.S.C. Sec. 
     247b-7) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) by inserting ``or preparedness and response activities, 
     including rapid response to public health emergencies and 
     significant public health threats'' after ``conduct 
     prevention activities''; and
       (ii) by striking ``$35,000'' and inserting ``$50,000''; and
       (B) in paragraph (2)(B), by striking ``3 years'' and 
     inserting ``2 years''; and
       (2) in subsection (c)--
       (A) by striking ``For the purpose of carrying out this 
     section'' and inserting the following:
       ``(1) In general.--For the purpose of carrying out this 
     section, except as described in paragraph (2)''; and
       (B) by adding at the end the following:
       ``(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.''.
       (d) Service Benefit for National Disaster Medical System 
     Volunteers.--
       (1) In general.--Section 2812(c) of the Public Health 
     Service Act (42 U.S.C. 300hh-11(c)), as amended by subsection 
     (a)(3), is further amended by adding at the end the 
     following:
       ``(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.''.
       (2) Public safety officer benefits.--Section 1204(9) of 
     title I of the Omnibus Crime Control and Safe Streets Act of 
     1968 (34 U.S.C. 10284(9)) is amended--
       (A) in subparagraph (C)(ii), by striking ``or'' at the end;
       (B) in subparagraph (D), by striking the period and 
     inserting ``; or''; and
       (C) by inserting after subparagraph (D) the following:

[[Page H8767]]

       ``(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--
       ``(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
       ``(ii) determined by the Secretary of Health and Human 
     Services to be hazardous.''.
       (3) Sunset.--The amendments made by paragraphs (1) and (2) 
     shall cease to have force or effect on October 1, 2021.
       (e) Mission Readiness Report to Congress.--
       (1) Report.--Not later than one year after the date of 
     enactment of this section, the Comptroller General of the 
     United States (referred to in this subsection as the 
     ``Comptroller General'') shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report on the medical surge capacity of 
     the United States in the event of a public health emergency, 
     including the capacity and capability of the current health 
     care workforce to prepare for, and respond to the full range 
     of public health emergencies or potential public health 
     emergencies, and recommendations to address any gaps 
     identified in such workforce.
       (2) Contents.--The Comptroller General shall include in the 
     report under paragraph (1)--
       (A) the number of health care providers who have 
     volunteered to provide health care services during a public 
     health emergency, including members of the National Disaster 
     Medical System, the Disaster Medical Assistant Teams, the 
     Medical Reserve Corps, and other volunteer health care 
     professionals in the verification network pursuant to section 
     319I of the Public Health Service Act (42 U.S.C. 247d-7b);
       (B) the capacity of the workforce described in subparagraph 
     (A) to respond to a public health emergency or potential 
     public health emergency, including the capacity to respond to 
     multiple concurrent public health emergencies and the 
     capacity to respond to a nationwide public health emergency;
       (C) the preparedness and response capabilities and mission 
     readiness of the workforce described in subparagraph (A) 
     taking into account areas of health care expertise and 
     considerations for at-risk individuals (as defined in section 
     2802(b)(4)(B) of the Public Health Service Act (42 U.S.C. 
     300hh-1(b)(4)(B));
       (D) an assessment of the effectiveness of efforts to 
     recruit, retain, and train such workforce; and
       (E) identification of gaps that may exist in such workforce 
     and recommendations for addressing such gaps, the extent to 
     which the Assistant Secretary for Preparedness and Response 
     plans to address such gaps, and any recommendations from the 
     Comptroller General to address such gaps.

     SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 
                   PREPAREDNESS AND RESPONSE.

       (a) Coordination of Preparedness.--Section 2811(b)(5) of 
     the Public Health Service Act (42 U.S.C. 300hh-10(b)(5)) is 
     amended by adding at the end the following: ``Such logistical 
     support shall include working with other relevant Federal, 
     State, local, tribal, and territorial public health officials 
     and private sector entities to identify the critical 
     infrastructure assets, systems, and networks needed for the 
     proper functioning of the health care and public health 
     sectors that need to be maintained through any emergency or 
     disaster, including entities capable of assisting with, 
     responding to, and mitigating the effect of a public health 
     emergency, including a public health emergency determined by 
     the Secretary pursuant to section 319(a), an emergency or 
     major disaster declared by the President under the Robert T. 
     Stafford Disaster Relief and Emergency Assistance Act, or the 
     National Emergencies Act, including by establishing methods 
     to exchange critical information and deliver products 
     consumed or used to preserve, protect, or sustain life, 
     health, or safety, and sharing of specialized expertise.''.
       (b) Manufacturing Capacity.--Section 2811(d)(2)(C) of the 
     Public Health Service Act (42 U.S.C. 300hh-10(d)(2)(C)) is 
     amended by inserting ``, and ancillary medical supplies to 
     assist with the utilization of such countermeasures or 
     products,'' after ``products''.
       (c) Evaluation of Barriers to Rapid Delivery of Medical 
     Countermeasures.--
       (1) Rapid delivery study.--The Assistant Secretary for 
     Preparedness and Response may conduct a study on issues that 
     have the potential to adversely affect the handling and rapid 
     delivery of medical countermeasures to individuals during 
     public health emergencies occurring in the United States.
       (2) Notice to congress.--Not later than 9 months after the 
     date of the enactment of this Act, the Assistant Secretary 
     for Preparedness and Response shall notify the Committee on 
     Energy and Commerce of the House of Representatives and the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate if the Assistant Secretary for Preparedness and 
     Response does not plan to conduct the study under paragraph 
     (1) and shall provide such committees a summary explanation 
     for such decision.
       (3) Report to congress.--Not later than 1 year after the 
     Assistant Secretary for Preparedness and Response conducts 
     the study under paragraph (1), such Assistant Secretary shall 
     submit a report to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate containing the 
     findings of such study.

     SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.

       (a) At-risk Individuals in the National Health Security 
     Strategy.--Section 2802(b)(4)(B) of the Public Health Service 
     Act (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
       (1) by striking ``this section and sections 319C-1, 319F, 
     and 319L,'' and inserting ``this Act,''; and
       (2) by striking ``special'' and inserting ``access or 
     functional''.
       (b) Countermeasure Considerations.--Section 319L(c)(6) of 
     the Public Health Service Act (42 U.S.C. 247d-7e(c)(6)) is 
     amended--
       (1) by striking ``elderly'' and inserting ``senior 
     citizens''; and
       (2) by inserting ``with relevant characteristics that 
     warrant consideration during the process of researching and 
     developing such countermeasures and products'' before the 
     period.
       (c) Biosurveillance of Emerging Public Health Threats.--
     Section 2814 is amended--
       (1) in paragraph (7), by striking ``; and'' and inserting a 
     semicolon;
       (2) in paragraph (8), by striking the period and inserting 
     ``; and''; and
       (3) by adding at the end the following:
       ``(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.''.

     SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE 
                   CONSIDERATIONS FOR CHILDREN.

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

     ``SEC. 319D-1. CHILDREN'S PREPAREDNESS UNIT.

       ``(a) Enhancing Emergency Preparedness for Children.--The 
     Secretary, acting through the Director of the Centers for 
     Disease Control and Prevention (referred to in this 
     subsection as the `Director'), shall maintain an internal 
     team of experts, to be known as the Children's Preparedness 
     Unit (referred to in this subsection as the `Unit'), to work 
     collaboratively to provide guidance on the considerations 
     for, and the specific needs of, children before, during, and 
     after public health emergencies. The Unit shall inform the 
     Director regarding emergency preparedness and response 
     efforts pertaining to children at the Centers for Disease 
     Control and Prevention.
       ``(b) Expertise.--The team described in subsection (a) 
     shall include one or more pediatricians, which may be a 
     developmental-behavioral pediatrician, and may also include 
     behavioral scientists, child psychologists, epidemiologists, 
     biostatisticians, health communications staff, and 
     individuals with other areas of expertise, as the Secretary 
     determines appropriate.
       ``(c) Duties.--The team described in subsection (a) may--
       ``(1) assist State, local, tribal, and territorial 
     emergency planning and response activities related to 
     children, which may include developing, identifying, and 
     sharing best practices;
       ``(2) provide technical assistance, training, and 
     consultation to Federal, State, local, tribal, and 
     territorial public health officials to improve preparedness 
     and response capabilities with respect to the needs of 
     children, including providing such technical assistance, 
     training, and consultation to eligible entities in order to 
     support the achievement of measurable evidence-based 
     benchmarks and objective standards applicable to sections 
     319C-1 and 319C-2;
       ``(3) improve the utilization of methods to incorporate the 
     needs of children in planning for and responding to a public 
     health emergency, including public awareness of such methods;
       ``(4) coordinate with, and improve, public-private 
     partnerships, such as health care coalitions pursuant to 
     sections 319C-2 and 319C-3, to address gaps and 
     inefficiencies in emergency preparedness and response efforts 
     for children;
       ``(5) provide expertise and input during the development of 
     guidance and clinical recommendations to address the needs of 
     children when preparing for, and responding to, public health 
     emergencies, including pursuant to section 319C-3; and
       ``(6) carry out other duties related to preparedness and 
     response activities for children, as the Secretary determines 
     appropriate.''.

     SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.

       (a) Reauthorizing the National Advisory Committee on 
     Children and Disasters.--Section 2811A of the Public Health 
     Service Act (42 U.S.C. 300hh-10a) is amended--
       (1) in subsection (b)(2), by inserting ``, mental and 
     behavioral,'' after ``medical'';
       (2) in subsection (d)--
       (A) in paragraph (1), by striking ``15'' and inserting 
     ``25''; and
       (B) by striking paragraph (2) and inserting the following:

[[Page H8768]]

       ``(2) Required non-federal members.--The Secretary, in 
     consultation with such other heads of Federal agencies as may 
     be appropriate, shall appoint to the Advisory Committee under 
     paragraph (1) at least 13 individuals, including--
       ``(A) at least 2 non-Federal professionals with expertise 
     in pediatric medical disaster planning, preparedness, 
     response, or recovery;
       ``(B) at least 2 representatives from State, local, tribal, 
     or territorial agencies with expertise in pediatric disaster 
     planning, preparedness, response, or recovery;
       ``(C) at least 4 members representing health care 
     professionals, which may include members with expertise in 
     pediatric emergency medicine; pediatric trauma, critical 
     care, or surgery; the treatment of pediatric patients 
     affected by chemical, biological, radiological, or nuclear 
     agents, including emerging infectious diseases; pediatric 
     mental or behavioral health related to children affected by a 
     public health emergency; or pediatric primary care; and
       ``(D) other members as the Secretary determines 
     appropriate, of whom--
       ``(i) at least one such member shall represent a children's 
     hospital;
       ``(ii) at least one such member shall be an individual with 
     expertise in schools or child care settings;
       ``(iii) at least one such member shall be an individual 
     with expertise in children and youth with special health care 
     needs; and
       ``(iv) at least one such member shall be an individual with 
     expertise in the needs of parents or family caregivers, 
     including the parents or caregivers of children with 
     disabilities.''.
       ``(3) Federal members.--The Advisory Committee under 
     paragraph (1) shall include the following Federal members or 
     their designees (who may be non-voting members, as determined 
     by the Secretary):
       ``(A) The Assistant Secretary for Preparedness and 
     Response.
       ``(B) The Director of the Biomedical Advanced Research and 
     Development Authority.
       ``(C) The Director of the Centers for Disease Control and 
     Prevention.
       ``(D) The Commissioner of Food and Drugs.
       ``(E) The Director of the National Institutes of Health.
       ``(F) The Assistant Secretary of the Administration for 
     Children and Families.
       ``(G) The Administrator of the Health Resources and 
     Services Administration.
       ``(H) The Administrator of the Federal Emergency Management 
     Agency.
       ``(I) The Administrator of the Administration for Community 
     Living.
       ``(J) The Secretary of Education.
       ``(K) Representatives from such Federal agencies (such as 
     the Substance Abuse and Mental Health Services Administration 
     and the Department of Homeland Security) as the Secretary 
     determines appropriate to fulfill the duties of the Advisory 
     Committee under subsections (b) and (c).''.
       ``(4) Term of appointment.--Each member of the Advisory 
     Committee appointed under paragraph (2) shall serve for a 
     term of 3 years, except that the Secretary may adjust the 
     terms of the Advisory Committee appointees serving on the 
     date of enactment of the Pandemic and All-Hazards 
     Preparedness and Advancing Innovation Act of 2018, or 
     appointees who are initially appointed after such date of 
     enactment, in order to provide for a staggered term of 
     appointment for all members.
       ``(5) Consecutive appointments; maximum terms.--A member 
     appointed under paragraph (2) may serve not more than 3 terms 
     on the Advisory Committee, and not more than 2 of such terms 
     may be served consecutively.'';
       (3) in subsection (e), by adding at the end ``At least one 
     meeting per year shall be an in-person meeting.'';
       (4) by redesignating subsection (f) as subsection (g);
       (5) by inserting after subsection (e) the following:
       ``(f) Coordination.--The Secretary shall coordinate duties 
     and activities authorized under this section in accordance 
     with section 2811D.''; and
       (6) in subsection (g), as so redesignated, by striking 
     ``2018'' and inserting ``2023''.
       (b) Authorizing the National Advisory Committee on Seniors 
     and Disasters.--Subtitle B of title XXVIII of the Public 
     Health Service Act (42 U.S.C. 300hh et seq.) is amended by 
     inserting after section 2811A the following:

     ``SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS AND 
                   DISASTERS.

       ``(a) Establishment.--The Secretary, in consultation with 
     the Secretary of Homeland Security and the Secretary of 
     Veterans Affairs, shall establish an advisory committee to be 
     known as the National Advisory Committee on Seniors and 
     Disasters (referred to in this section as the `Advisory 
     Committee').
       ``(b) Duties.--The Advisory Committee shall--
       ``(1) provide advice and consultation with respect to the 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;
       ``(2) evaluate and provide input with respect to the 
     medical and public health needs of seniors related to 
     preparation for, response to, and recovery from all-hazards 
     emergencies; and
       ``(3) provide advice and consultation with respect to State 
     emergency preparedness and response activities relating to 
     seniors, including related drills and exercises pursuant to 
     the preparedness goals under section 2802(b).
       ``(c) Additional Duties.--The Advisory Committee may 
     provide advice and recommendations to the Secretary with 
     respect to seniors and the medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities under this title and title III.
       ``(d) Membership.--
       ``(1) In general.--The Secretary, in consultation with such 
     other heads of agencies as appropriate, shall appoint not 
     more than 17 members to the Advisory Committee. In appointing 
     such members, the Secretary shall ensure that the total 
     membership of the Advisory Committee is an odd number.
       ``(2) Required members.--The Advisory Committee shall 
     include Federal members or their designees (who may be non-
     voting members, as determined by the Secretary) and non-
     Federal members, as follows:
       ``(A) The Assistant Secretary for Preparedness and 
     Response.
       ``(B) The Director of the Biomedical Advanced Research and 
     Development Authority.
       ``(C) The Director of the Centers for Disease Control and 
     Prevention.
       ``(D) The Commissioner of Food and Drugs.
       ``(E) The Director of the National Institutes of Health.
       ``(F) The Administrator of the Centers for Medicare & 
     Medicaid Services.
       ``(G) The Administrator of the Administration for Community 
     Living.
       ``(H) The Administrator of the Federal Emergency Management 
     Agency.
       ``(I) The Under Secretary for Health of the Department of 
     Veterans Affairs.
       ``(J) At least 2 non-Federal health care professionals with 
     expertise in geriatric medical disaster planning, 
     preparedness, response, or recovery.
       ``(K) At least 2 representatives of State, local, 
     territorial, or tribal agencies with expertise in geriatric 
     disaster planning, preparedness, response, or recovery.
       ``(L) Representatives of such other Federal agencies (such 
     as the Department of Energy and the Department of Homeland 
     Security) as the Secretary determines necessary to fulfill 
     the duties of the Advisory Committee.
       ``(e) Meetings.--The Advisory Committee shall meet not less 
     frequently than biannually. At least one meeting per year 
     shall be an in-person meeting.
       ``(f) Coordination.--The Secretary shall coordinate duties 
     and activities authorized under this section in accordance 
     with section 2811D.
       ``(g) Sunset.--
       ``(1) In general.--The Advisory Committee shall terminate 
     on September 30, 2023.
       ``(2) Extension of committee.--Not later than October 1, 
     2022, the Secretary shall submit to Congress a recommendation 
     on whether the Advisory Committee should be extended.''.
       (c) National Advisory Committee on Individuals With 
     Disabilities and Disasters.--Subtitle B of title XXVIII of 
     the Public Health Service Act (42 U.S.C. 300hh et seq.), as 
     amended by subsection (b), is further amended by inserting 
     after section 2811B the following:

     ``SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH 
                   DISABILITIES AND DISASTERS.

       ``(a) Establishment.--The Secretary, in consultation with 
     the Secretary of Homeland Security, shall establish a 
     national advisory committee to be known as the National 
     Advisory Committee on Individuals with Disabilities and 
     Disasters (referred to in this section as the `Advisory 
     Committee').
       ``(b) Duties.--The Advisory Committee shall--
       ``(1) provide advice and consultation with respect to 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;
       ``(2) evaluate and provide input with respect to the 
     medical, public health, and accessibility needs of 
     individuals with disabilities related to preparation for, 
     response to, and recovery from all-hazards emergencies; and
       ``(3) provide advice and consultation with respect to State 
     emergency preparedness and response activities, including 
     related drills and exercises pursuant to the preparedness 
     goals under section 2802(b).
       ``(c) Membership.--
       ``(1) In general.--The Secretary, in consultation with such 
     other heads of agencies and departments as appropriate, shall 
     appoint not more than 17 members to the Advisory Committee. 
     In appointing such members, the Secretary shall ensure that 
     the total membership of the Advisory Committee is an odd 
     number.
       ``(2) Required members.--The Advisory Committee shall 
     include Federal members or their designees (who may be non-
     voting members, as determined by the Secretary) and non-
     Federal members, as follows:
       ``(A) The Assistant Secretary for Preparedness and 
     Response.
       ``(B) The Administrator of the Administration for Community 
     Living.
       ``(C) The Director of the Biomedical Advanced Research and 
     Development Authority.
       ``(D) The Director of the Centers for Disease Control and 
     Prevention.
       ``(E) The Commissioner of Food and Drugs.
       ``(F) The Director of the National Institutes of Health.
       ``(G) The Administrator of the Federal Emergency Management 
     Agency.
       ``(H) The Chair of the National Council on Disability.

[[Page H8769]]

       ``(I) The Chair of the United States Access Board.
       ``(J) The Under Secretary for Health of the Department of 
     Veterans Affairs.
       ``(K) At least 2 non-Federal health care professionals with 
     expertise in disability accessibility before, during, and 
     after disasters, medical and mass care disaster planning, 
     preparedness, response, or recovery.
       ``(L) At least 2 representatives from State, local, 
     territorial, or tribal agencies with expertise in disaster 
     planning, preparedness, response, or recovery for individuals 
     with disabilities.
       ``(M) At least 2 individuals with a disability with 
     expertise in disaster planning, preparedness, response, or 
     recovery for individuals with disabilities.
       ``(d) Meetings.--The Advisory Committee shall meet not less 
     frequently than biannually. At least one meeting per year 
     shall be an in-person meeting.
       ``(e) Disability Defined.--For purposes of this section, 
     the term `disability' has the meaning given such term in 
     section 3 of the Americans with Disabilities Act of 1990.
       ``(f) Coordination.--The Secretary shall coordinate duties 
     and activities authorized under this section in accordance 
     with section 2811D.
       ``(g) Sunset.--
       ``(1) In general.--The Advisory Committee shall terminate 
     on September 30, 2023.
       ``(2) Recommendation.--Not later than October 1, 2022, the 
     Secretary shall submit to Congress a recommendation on 
     whether the Advisory Committee should be extended.''.
       (d) Advisory Committee Coordination.--Subtitle B of title 
     XXVIII of the Public Health Service Act (42 U.S.C. 300hh et 
     seq.), as amended by subsection (c), is further amended by 
     inserting after section 2811C the following:

     ``SEC. 2811D. ADVISORY COMMITTEE COORDINATION.

       ``(a) In General.--The Secretary shall coordinate duties 
     and activities authorized under sections 2811A, 2811B, and 
     2811C, and make efforts to reduce unnecessary or duplicative 
     reporting, or unnecessary duplicative meetings and 
     recommendations under such sections, as practicable. Members 
     of the advisory committees authorized under such sections, or 
     their designees, shall annually meet to coordinate any 
     recommendations, as appropriate, that may be similar, 
     duplicative, or overlapping with respect to addressing the 
     needs of children, seniors, and individuals with disabilities 
     during public health emergencies. If such coordination occurs 
     through an in-person meeting, it shall not be considered the 
     required in-person meetings under any of sections 2811A(e), 
     2811B(e), or 2811C(d).
       ``(b) Coordination and Alignment.--The Secretary, acting 
     through the employee designated pursuant to section 2814, 
     shall align preparedness and response programs or activities 
     to address similar, dual, or overlapping needs of children, 
     seniors, and individuals with disabilities, and any 
     challenges in preparing for and responding to such needs.
       ``(c) Notification.--The Secretary shall annually notify 
     the congressional committees of jurisdiction regarding the 
     steps taken to coordinate, as appropriate, the 
     recommendations under this section, and provide a summary 
     description of such coordination.''.

     SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS.

       Not later than 2 years after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall issue 
     final guidance regarding the ability of personnel funded by 
     programs authorized under this Act (including the amendments 
     made by this Act) to participate in drills and operational 
     exercises related to all-hazards medical and public health 
     preparedness and response. Such drills and operational 
     exercises may include activities that incorporate medical 
     surge capacity planning, medical countermeasure distribution 
     and administration, and preparing for and responding to 
     identified threats for that region. Such personnel may 
     include State, local, tribal, and territorial public health 
     department or agency personnel funded under this Act 
     (including the amendments made by this Act). The Secretary 
     shall consult with the Department of Homeland Security, the 
     Department of Defense, the Department of Veterans Affairs, 
     and other applicable Federal departments and agencies as 
     necessary and appropriate in the development of such 
     guidance. The Secretary shall make the guidance available on 
     the internet website of the Department of Health and Human 
     Services.

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

     SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

       Section 2811 of the Public Health Service Act (42 U.S.C. 
     300hh-10) is amended--
       (1) in subsection (b)--
       (A) in the matter preceding paragraph (1) by inserting 
     ``utilize experience related to public health emergency 
     preparedness and response, biodefense, medical 
     countermeasures, and other relevant topics to'' after 
     ``shall''; and
       (B) in paragraph (4) by adding at the end the following:
       ``(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.''; and
       (2) by adding at the end the following:
       ``(f) Protection of National Security From Threats.--
       ``(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.
       ``(2) Authorization of appropriations.--
       ``(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.
       ``(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).
       ``(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).''.

     SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES 
                   ENTERPRISE.

       (a) In General.--Title XXVIII is amended by inserting after 
     section 2811 of the Public Health Service Act (42 U.S.C. 
     300hh-10) the following:

     ``SEC. 2811-1. PUBLIC HEALTH EMERGENCY MEDICAL 
                   COUNTERMEASURES ENTERPRISE.

       ``(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.
       ``(b) Members.--The PHEMCE shall include each of the 
     following members, or the designee of such members:
       ``(1) The Assistant Secretary for Preparedness and 
     Response.
       ``(2) The Director of the Centers for Disease Control and 
     Prevention.
       ``(3) The Director of the National Institutes of Health.
       ``(4) The Commissioner of Food and Drugs.
       ``(5) The Secretary of Defense.
       ``(6) The Secretary of Homeland Security.
       ``(7) The Secretary of Agriculture.
       ``(8) The Secretary of Veterans Affairs.
       ``(9) The Director of National Intelligence.
       ``(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.
       ``(c) Functions.--
       ``(1) In general.--The functions of the PHEMCE shall 
     include the following:
       ``(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.
       ``(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).
       ``(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).

[[Page H8770]]

       ``(D) Provide consultation for the development of the 
     strategy and implementation plan under section 2811(d).
       ``(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.''.
       (b) Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan.--Section 2811(d) 
     of the Public Health Service Act (42 U.S.C. 300hh-10(d)) is 
     amended--
       (1) in paragraph (1)--
       (A) by striking ``Not later than 180 days after the date of 
     enactment of this subsection, and every year thereafter'' and 
     inserting ``Not later than March 15, 2020, and biennially 
     thereafter''; and
       (B) by striking ``Director of Biomedical'' and all that 
     follows through ``Food and Drugs'' and inserting ``Public 
     Health Emergency Medical Countermeasures Enterprise 
     established under section 2811-1''; and
       (2) in paragraph (2)(J)(v), by striking ``one-year period'' 
     and inserting ``2-year period''.

     SEC. 403. STRATEGIC NATIONAL STOCKPILE.

       (a) In General.--Section 319F-2(a) of the Public Health 
     Service Act (42 U.S.C. 247d-6b(a)) is amended--
       (1) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively; and
       (2) in paragraph (1)--
       (A) by inserting ``the Assistant Secretary for Preparedness 
     and Response and'' after ``collaboration with'';
       (B) by inserting ``and optimize'' after ``provide for'';
       (C) by inserting ``and, as informed by existing 
     recommendations of, or consultations with, the Public Health 
     Emergency Medical Countermeasure Enterprise established under 
     section 2811-1, make necessary additions or modifications to 
     the contents of such stockpile or stockpiles based on the 
     review conducted under paragraph (2)'' before the period of 
     the first sentence; and
       (D) by striking the second sentence;
       (3) by inserting after paragraph (1) the following:
       ``(2) Threat-based review.--
       ``(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.
       ``(B) Additions, modifications, and replenishments.--Each 
     annual threat-based review under subparagraph (A) shall, for 
     each new or modified countermeasure procurement or 
     replenishment, provide--
       ``(i) information regarding--

       ``(I) the quantities of the additional or modified 
     countermeasure procured for, or contracted to be procured 
     for, the stockpile;
       ``(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;
       ``(III) the presence or lack of a commercial market for the 
     countermeasure at the time of procurement;
       ``(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;
       ``(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;
       ``(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;
       ``(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
       ``(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

       ``(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.'';
       (4) in paragraph (3), as so redesignated--
       (A) in subparagraph (A), by inserting ``and the Public 
     Health Emergency Medical Countermeasures Enterprise 
     established under section 2811-1'' before the semicolon;
       (B) in subparagraph (C), by inserting ``, and the 
     availability, deployment, dispensing, and administration of 
     countermeasures'' before the semicolon;
       (C) by amending subparagraph (E) to read as follows:
       ``(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;'';
       (D) in subparagraph (G), by striking ``; and'' and 
     inserting a semicolon;
       (E) in subparagraph (H), by striking the period and 
     inserting a semicolon; and
       (F) by adding at the end the following:
       ``(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
       ``(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.''; and
       (5) by adding at the end the following:
       ``(5) GAO report.--
       ``(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--
       ``(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;
       ``(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;
       ``(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;
       ``(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;
       ``(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);
       ``(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;
       ``(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;
       ``(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

[[Page H8771]]

       ``(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.
       ``(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.''.
       (b) Additional Reporting.--In the first threat-based review 
     submitted after the date of enactment of this Act pursuant to 
     paragraph (2) of section 319F-2(a) of the Public Health 
     Service Act (42 U.S.C. 247d-6b(a)), as amended by subsection 
     (a), the Secretary shall include a description of the 
     processes and procedures through which the Director of 
     Strategic National Stockpile and the Director of the 
     Biomedical Advanced Research and Development Authority 
     coordinate with respect to countermeasures and products 
     procured under such section 319F-2(a), including such 
     processes and procedures in place to ensure countermeasures 
     and products under consideration for procurement pursuant to 
     such section 319F-2(a) receive the same consideration 
     regardless of whether such countermeasures and products 
     receive or had received funding under section 319L of the 
     Public Health Service Act (42 U.S.C. 247d-7e), and whether 
     such countermeasures and products are the most appropriate to 
     meet the emergency health security needs of the United 
     States.
       (c) Authorization of Appropriations, Strategic National 
     Stockpile.--Section 319F-2(f)(1) of the Public Health Service 
     Act (42 U.S.C. 247d-6b(f)(1)) is amended by striking 
     ``$533,800,000 for each of fiscal years 2014 through 2018'' 
     and inserting ``$610,000,000 for each of fiscal years 2019 
     through 2023, to remain available until expended''.

     SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL 
                   RESISTANCE, AND OTHER SIGNIFICANT THREATS.

       (a) Strategic Initiatives.--Section 319L(c)(4) (247d-
     7e(c)(4)) is amended by adding at the end the following:
       ``(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--
       ``(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;
       ``(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
       ``(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.''.
       (b) Emerging Infectious Disease Program.--Section 319L of 
     the Public Health Service Act (42 U.S.C. 247d-7e) is 
     amended--
       (1) by redesignating subsections (d), (e), and (f) as 
     subsections (e), (f), and (g), respectively; and
       (2) by inserting after subsection (c) the following new 
     subsections:
       ``(d) Emerging Infectious Disease Program.--
       ``(1) In general.--The Secretary, acting through the 
     Director of BARDA, shall establish and implement a program 
     that supports--
       ``(A) advanced research and development activities for 
     qualified pandemic or epidemic products; and
       ``(B) manufacturing infrastructure activities with respect 
     to an emerging infectious disease.
       ``(2) Funding.--
       ``(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.
       ``(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).''.

     SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.

       Section 351A(k) of the Public Health Service Act (42 U.S.C. 
     262a(k)) is amended--
       (1) by striking ``The Secretary'' and inserting the 
     following:
       ``(1) In general.--The Secretary''; and
       (2) by adding at the end the following:
       ``(2) Implementation of recommendations of the federal 
     experts security advisory panel and the fast track action 
     committee on select agent regulations.--
       ``(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.
       ``(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.''.

 TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

     SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

       Section 2811(b)(7) of the Public Health Service Act (42 
     U.S.C. 300hh-10(b)(7)) is amended--
       (1) in the matter preceding subparagraph (A), by striking 
     ``March 1'' and inserting ``March 15'';
       (2) in subparagraph (A)--
       (A) in clause (ii), by striking ``; and'' and inserting 
     ``;''; and
       (B) by striking clause (iii) and inserting the following:
       ``(iii) procurement, stockpiling, maintenance, and 
     potential replenishment (including manufacturing 
     capabilities) of all products in the Strategic National 
     Stockpile;
       ``(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; and
       ``(v) potential deployment, distribution, and utilization 
     of medical countermeasures; development of clinical guidance 
     and emergency use instructions for the use of medical 
     countermeasures; and, as applicable, potential post-
     deployment activities related to medical countermeasures;'';
       (3) by redesignating subparagraphs (D) and (E) as 
     subparagraphs (E) and (F), respectively; and
       (4) by inserting after subparagraph (C), the following:
       ``(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;''.

     SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE 
                   NOTIFICATIONS.

       (a) Congressional Notification of Material Threat 
     Determination.--Section 319F-2(c)(2)(C) of the Public Health 
     Service Act (42 U.S.C. 247d-6b(c)(2)(C)) is amended by 
     striking ``The Secretary and the Homeland Security Secretary 
     shall promptly notify the appropriate committees of 
     Congress'' and inserting ``The Secretary and the Secretary of 
     Homeland Security shall send to Congress, on an annual basis, 
     all current material threat determinations and shall promptly 
     notify the Committee on Health, Education, Labor, and 
     Pensions and the Committee on Homeland Security and 
     Governmental Affairs of the Senate and the Committee on 
     Energy and Commerce and the Committee on Homeland Security of 
     the House of Representatives''.
       (b) Contracting Communication.--Section 319F-
     2(c)(7)(B)(ii)(III) of the Public Health Service Act (42 
     U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is amended by adding at the 
     end the following: ``The Secretary shall notify the vendor 
     within 90 days of a determination by the Secretary to renew, 
     extend, or terminate such contract.''.

     SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

       Section 565(f) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bbb-4(f)) is amended--
       (1) by redesignating paragraphs (3) through (6) as 
     paragraphs (4) through (7), respectively;
       (2) by inserting after paragraph (2) the following:
       ``(3) Publication.--The Secretary shall make available on 
     the internet website of

[[Page H8772]]

     the Food and Drug Administration information regarding 
     regulatory management plans, including--
       ``(A) the process by which an applicant may submit a 
     request for a regulatory management plan;
       ``(B) the timeframe by which the Secretary is required to 
     respond to such request;
       ``(C) the information required for the submission of such 
     request;
       ``(D) a description of the types of development milestones 
     and performance targets that could be discussed and included 
     in such plans; and
       ``(E) contact information for beginning the regulatory 
     management plan process.'';
       (3) in paragraph (6), as so redesignated, in the matter 
     preceding subparagraph (A)--
       (A) by striking ``paragraph (4)(A)'' and inserting 
     ``paragraph (5)(A)''; and
       (B) by striking ``paragraph (4)(B)'' and inserting 
     ``paragraph (5)(B)''; and
       (4) in paragraph (7)(A), as so redesignated, by striking 
     ``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.

     SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
                   AUTHORITY AND THE BIOSHIELD SPECIAL RESERVE 
                   FUND.

       (a) BioShield Special Reserve Fund.--Section 319F-2(g)(1) 
     of the Public Health Service Act (42 U.S.C. 247d-6b(g)(1)) is 
     amended--
       (1) by striking ``$2,800,000,000 for the period of fiscal 
     years 2014 through 2018'' and inserting ``$7,100,000,000 for 
     the period of fiscal years 2019 through 2028, to remain 
     available until expended''; and
       (2) by striking the second sentence.
       (b) The Biomedical Advanced Research and Development 
     Authority.--Subsection (e)(2) of section 319L of the Public 
     Health Service Act (42 U.S.C. 247d-7e), as redesignated by 
     section 404(b), is amended by striking ``$415,000,000 for 
     each of fiscal years 2014 through 2018'' and inserting 
     ``$611,700,000 for each of fiscal years 2019 through 2023''.

     SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC 
                   RESISTANCE.

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

     ``SEC. 319E-1. ADVISORY COUNCIL ON COMBATING ANTIBIOTIC-
                   RESISTANT BACTERIA.

       ``(a) Definitions.--In this section:
       ``(1) Action plan.--The term `Action Plan' means the Action 
     Plan described in section 319E(a)(1).
       ``(2) Advisory council.--The term `Advisory Council' means 
     the Presidential Advisory Council on Combating Antibiotic-
     Resistant Bacteria established by Executive Order 13676 of 
     September 18, 2014 (79 Fed. Reg. 56931; relating to combating 
     antibiotic-resistant bacteria).
       ``(3) National strategy.--The term `National Strategy' 
     means the National Strategy for Combating Antibiotic-
     Resistant Bacteria issued by the White House in September 
     2014, and any subsequent update to such strategy or a 
     successor strategy.
       ``(b) Advisory Council.--The Advisory Council shall provide 
     advice, information, and recommendations to the Secretary 
     regarding programs and policies intended to support and 
     evaluate the implementation of Executive Order 13676 of 
     September 18, 2014 (79 Fed. Reg. 56931; relating to combating 
     antibiotic-resistant bacteria), including the National 
     Strategy, and the Action Plan.
       ``(c) Meetings and Duties.--
       ``(1) Meetings.--The Advisory Council shall meet as the 
     Chair determines appropriate but not less than twice per 
     year, and, to the extent practicable, in conjunction with 
     meetings of the task force described in section 319E.
       ``(2) Recommendations.--The Advisory Council shall make 
     recommendations to the Secretary, in consultation with the 
     Secretary of Agriculture and the Secretary of Defense, 
     regarding programs and policies intended to--
       ``(A) preserve the effectiveness of antibiotics by 
     optimizing their use;
       ``(B) advance research to develop improved methods for 
     combating antibiotic resistance and conducting antimicrobial 
     stewardship, as defined in section 319E(h)(3);
       ``(C) strengthen surveillance of antibiotic-resistant 
     bacterial infections;
       ``(D) prevent the transmission of antibiotic-resistant 
     bacterial infections;
       ``(E) advance the development of rapid point-of-care and 
     agricultural diagnostics;
       ``(F) further research on new treatments for bacterial 
     infections;
       ``(G) develop alternatives to antibiotics for animal health 
     purposes;
       ``(H) maximize the dissemination of up-to-date information 
     on the appropriate and proper use of antibiotics to the 
     general public and human and animal health care providers; 
     and
       ``(I) improve international coordination of efforts to 
     combat antibiotic resistance.
       ``(3) Coordination.--The Advisory Council shall, to the 
     greatest extent practicable, coordinate activities carried 
     out by the Council with the Antimicrobial Resistance Task 
     Force established under section 319E(a) (commonly referred to 
     as the `Combating Antibiotic-Resistant Bacteria Task 
     Force').''.

      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

     SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

       Section 319L(c)(4)(D)(iii) of the Public Health Service Act 
     (42 U.S.C. 247d-7e(c)(4)(D)(iii)) is amended by striking 
     ``and platform technologies'' and inserting ``platform 
     technologies, technologies to administer countermeasures, and 
     technologies to improve storage and transportation of 
     countermeasures''.

     SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.

       Section 319L of the Public Health Service Act (42 U.S.C. 
     247d-7e) is amended--
       (1) in subsection (a)(3), by striking ``, such as'' and all 
     that follows through ``Code'';
       (2) in subsection (c)(5)(A)--
       (A) in clause (i), by striking ``under this subsection'' 
     and all that follows through ``Code'' and inserting ``(as 
     defined in subsection (a)(3)) under this subsection''; and
       (B) in clause (ii)--
       (i) by amending subclause (I) to read as follows:

       ``(I) In general.--To the maximum extent practicable, 
     competitive procedures shall be used when entering into 
     transactions to carry out projects under this subsection.''; 
     and

       (ii) in subclause (II)--

       (I) by striking ``$20,000,000'' and inserting 
     ``$100,000,000'';
       (II) by striking ``senior procurement executive for the 
     Department (as designated for the purpose of section 16(c) of 
     the Office of Federal Procurement Policy Act (41 U.S.C. 
     414(c)))'' and inserting ``Assistant Secretary for Financial 
     Resources''; and
       (III) by striking ``senior procurement executive under'' 
     and inserting ``Assistant Secretary for Financial Resources 
     under''.

     SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES.

       (a) In General.--The purpose of this section (including 
     section 565B of the Federal Food, Drug, and Cosmetic Act, as 
     added by subsection (b)) is to support and advance the 
     development or manufacture of security countermeasures, 
     qualified countermeasures, and qualified pandemic or epidemic 
     products by facilitating and encouraging submission of data 
     and information to support such products to medical 
     countermeasure master files, and through clarifying the 
     authority to cross-reference to data and information 
     previously submitted to the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'').
       (b) Medical Countermeasure Master Files.--Chapter V of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
     is amended by inserting after section 565A the following:

     ``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.

       ``(a) Applicability of Reference.--
       ``(1) In general.--A person may submit data and information 
     in a master file to the Secretary with the intent to 
     reference, or to authorize, in writing, another person to 
     reference, such data or information to support a medical 
     countermeasure submission (including a supplement or 
     amendment to any such submission), without requiring the 
     master file holder to disclose the data and information to 
     any such persons authorized to reference the master file. 
     Such data and information shall be available for reference by 
     the master file holder or by a person authorized by the 
     master file holder, in accordance with applicable privacy and 
     confidentiality protocols and regulations.
       ``(2) Reference of certain master files.--In the case that 
     data or information within a medical countermeasure master 
     file is used only to support the conditional approval of an 
     application filed under section 571, such master file may be 
     relied upon to help support the effectiveness of a product 
     that is the subject of a subsequent medical countermeasure 
     submission only if such application is supplemented by 
     additional data or information to support review and approval 
     in a manner consistent with the standards applicable to such 
     review and approval for such countermeasure, qualified 
     countermeasure, or qualified pandemic or epidemic product.
       ``(b) Medical Countermeasure Master File Content.--
       ``(1) In general.--A master file under this section may 
     include data or information to support--
       ``(A) the development of medical countermeasure submissions 
     to support the approval, licensure, classification, 
     clearance, conditional approval, or authorization of one or 
     more security countermeasures, qualified countermeasures, or 
     qualified pandemic or epidemic products; and
       ``(B) the manufacture of security countermeasures, 
     qualified countermeasures, or qualified pandemic or epidemic 
     products.
       ``(2) Required updates.--The Secretary may require, as 
     appropriate, that the master file holder ensure that the 
     contents of such master file are updated during the time such 
     master file is referenced for a medical countermeasure 
     submission.
       ``(c) Sponsor Reference.--
       ``(1) In general.--Each incorporation of data or 
     information within a medical countermeasure master file shall 
     describe the incorporated material in a manner in which the 
     Secretary determines appropriate and that permits the review 
     of such information within such master file without 
     necessitating re-submission of such data or information. 
     Master files shall be submitted in an electronic format in 
     accordance with sections 512(b)(4), 571(a)(4), and 745A, as 
     applicable, and as specified in applicable guidance.
       ``(2) Reference by a master file holder.--A master file 
     holder that is the sponsor of a medical countermeasure 
     submission shall notify the Secretary in writing of the

[[Page H8773]]

     intent to reference the medical countermeasure master file as 
     a part of the submission.
       ``(3) Reference by an authorized person.--A person 
     submitting an application for review may, where the Secretary 
     determines appropriate, incorporate by reference all or part 
     of the contents of a medical countermeasure master file, if 
     the master file holder authorizes the incorporation in 
     writing.
       ``(d) Acknowledgement of the Reliance Upon a Master File by 
     the Secretary.--
       ``(1) In general.--The Secretary shall provide the master 
     file holder with a written notification indicating that the 
     Secretary has reviewed and relied upon specified data or 
     information within a master file and the purposes for which 
     such data or information was incorporated by reference if the 
     Secretary has reviewed and relied upon such specified data or 
     information to support the approval, classification, 
     conditional approval, clearance, licensure, or authorization 
     of a security countermeasure, qualified countermeasure, or 
     qualified pandemic or epidemic product. The Secretary may 
     rely upon the data and information within the medical 
     countermeasure master file for which such written 
     notification was provided in additional applications, as 
     applicable and appropriate and upon the request of the master 
     file holder so notified in writing or by an authorized person 
     of such holder.
       ``(2) Certain applications.--If the Secretary has reviewed 
     and relied upon specified data or information within a 
     medical countermeasure master file to support the conditional 
     approval of an application under section 571 to subsequently 
     support the approval, clearance, licensure, or authorization 
     of a security countermeasure, qualified countermeasure, or 
     qualified pandemic or epidemic product, the Secretary shall 
     provide a brief written description to the master file holder 
     regarding the elements of the application fulfilled by the 
     data or information within the master file and how such data 
     or information contained in such application meets the 
     standards of evidence under subsection (c) or (d) of section 
     505, subsection (d) of section 512, or section 351 of the 
     Public Health Service Act (as applicable) unless such 
     disclosure includes any trade secret or confidential 
     commercial information.
       ``(e) Rules of Construction.--Nothing in this section shall 
     be construed to--
       ``(1) limit the authority of the Secretary to approve, 
     license, clear, conditionally approve, or authorize drugs, 
     biological products, or devices pursuant to, as applicable, 
     this Act or section 351 of the Public Health Service Act (as 
     such applicable Act is in effect on the day before the date 
     of enactment of the Pandemic and All-Hazards Preparedness and 
     Advancing Innovation Act of 2018), including the standards of 
     evidence, and applicable conditions, for approval under the 
     applicable Act;
       ``(2) alter the standards of evidence with respect to 
     approval, licensure, or clearance, as applicable, of drugs, 
     biological products, or devices under this Act or section 351 
     of the Public Health Service Act, including, as applicable, 
     the substantial evidence standards under sections 505(d) and 
     512(d) or this Act and section 351(a) of the Public Health 
     Service Act; or
       ``(3) alter the authority of the Secretary under this Act 
     or the Public Health Service Act to determine the types of 
     data or information previously submitted by a sponsor or any 
     other person that may be incorporated by reference in an 
     application, request, or notification for a drug, biological 
     product, or device submitted under sections 505(i), 505(b), 
     505(j), 512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 
     515(c), 513(f)(2), or 510(k) of this Act, or subsection (a) 
     or (k) of section 351 of the Public Health Service Act, 
     including a supplement or amendment to any such submission, 
     and the requirements associated with such reference.
       ``(f) Definitions.--In this section:
       ``(1) The term `master file holder' means a person who 
     submits data and information to the Secretary with the intent 
     to reference or authorize another person to reference such 
     data or information to support a medical countermeasure 
     submission, as described in subsection (a).
       ``(2) The term `medical countermeasure submission' means an 
     investigational new drug application under section 505(i), a 
     new drug application under section 505(b), or an abbreviated 
     new drug application under section 505(j) of this Act, a 
     biological product license application under section 351(a) 
     of the Public Health Service Act or a biosimilar biological 
     product license application under section 351(k) of the 
     Public Health Service Act, a new animal drug application 
     under section 512(b)(1) or abbreviated new animal drug 
     application under section 512(b)(2), an application for 
     conditional approval of a new animal drug under section 571, 
     an investigational device application under section 520(g), 
     an application with respect to a device under section 515(c), 
     a request for classification of a device under section 
     513(f)(2), a notification with respect to a device under 
     section 510(k), or a request for an emergency use 
     authorization under section 564 to support--
       ``(A) the approval, licensure, classification, clearance, 
     conditional approval, or authorization of a security 
     countermeasure, qualified countermeasure, or qualified 
     pandemic or epidemic product; or
       ``(B) a new indication to an approved security 
     countermeasure, qualified countermeasure, or qualified 
     pandemic or epidemic product.
       ``(3) The terms `qualified countermeasure', `security 
     countermeasure', and `qualified pandemic or epidemic product' 
     have the meanings given such terms in sections 319F-1, 319F-
     2, and 319F-3, respectively, of the Public Health Service 
     Act.''.
       (c) Stakeholder Input.--Not later than 18 months after the 
     date of enactment of this Act, the Secretary, acting through 
     the Commissioner of Food and Drugs and in consultation with 
     the Assistant Secretary for Preparedness and Response, shall 
     solicit input from stakeholders, including stakeholders 
     developing security countermeasures, qualified 
     countermeasures, or qualified pandemic or epidemic products, 
     and stakeholders developing technologies to assist in the 
     development of such countermeasures with respect to how the 
     Food and Drug Administration can advance the use of tools and 
     technologies to support and advance the development or 
     manufacture of security countermeasures, qualified 
     countermeasures, and qualified pandemic or epidemic products, 
     including through reliance on cross-referenced data and 
     information contained within master files and submissions 
     previously submitted to the Secretary as set forth in section 
     565B of the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (b).
       (d) Guidance.--Not later than 2 years after the date of 
     enactment of this Act, the Secretary, acting through the 
     Commissioner of Food and Drugs, shall publish draft guidance 
     about how reliance on cross-referenced data and information 
     contained within master files under section 565B of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (b) or submissions otherwise submitted to the Secretary may 
     be used for specific tools or technologies (including 
     platform technologies) that have the potential to support and 
     advance the development or manufacture of security 
     countermeasures, qualified countermeasures, and qualified 
     pandemic or epidemic products. The Secretary, acting through 
     the Commissioner of Food and Drugs, shall publish the final 
     guidance not later than 3 years after the enactment of this 
     Act.

     SEC. 604. ANIMAL RULE REPORT.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study on the application of the requirements 
     under subsections (c) and (d) of section 565 of the of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) 
     (referred to in this section as the ``animal rule'') as a 
     component of medical countermeasure advanced development 
     under the Biomedical Advanced Research and Development 
     Authority and regulatory review by the Food and Drug 
     Administration. In conducting such study, the Comptroller 
     General shall examine the following:
       (1) The extent to which advanced development and review of 
     a medical countermeasure are coordinated between the 
     Biomedical Advanced Research and Development Authority and 
     the Food and Drug Administration, including activities that 
     facilitate appropriate and efficient design of studies to 
     support approval, licensure, and authorization under the 
     animal rule, consistent with the recommendations in the 
     animal rule guidance, issued pursuant to section 565(c) of 
     the Federal Food Drug and Cosmetic Act (21 U.S.C. 360bbb-
     4(c)) and entitled ``Product Development Under the Animal 
     Rule: Guidance for Industry'' (issued in October 2015), to 
     resolve discrepancies in the design of adequate and well-
     controlled efficacy studies conducted in animal models 
     related to the provision of substantial evidence of 
     effectiveness for the product approved, licensed, or 
     authorized under the animal rule.
       (2) The consistency of the application of the animal rule 
     among and between review divisions within the Food and Drug 
     Administration.
       (3) The flexibility pursuant to the animal rule to address 
     variations in countermeasure development and review 
     processes, including the extent to which qualified animal 
     models are adopted and used within the Food and Drug 
     Administration in regulatory decisionmaking with respect to 
     medical countermeasures.
       (4) The extent to which the guidance issued under section 
     565(c) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 
     360bbb-4(c)), entitled, ``Product Development Under the 
     Animal Rule: Guidance for Industry'' (issued in October 
     2015), has assisted in achieving the purposes described in 
     paragraphs (1), (2), and (3).
       (b) Consultations.--In conducting the study under 
     subsection (a), the Comptroller General of the United States 
     shall consult with--
       (1) the Federal agencies responsible for advancing, 
     reviewing, and procuring medical countermeasures, including 
     the Office of the Assistant Secretary for Preparedness and 
     Response, the Biomedical Advanced Research and Development 
     Authority, the Food and Drug Administration, and the 
     Department of Defense;
       (2) manufacturers involved in the research and development 
     of medical countermeasures to address biological, chemical, 
     radiological, or nuclear threats; and
       (3) other biodefense stakeholders, as applicable.
       (c) Report.--Not later than 3 years after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall submit to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives a report 
     containing the results of the study conducted

[[Page H8774]]

     under subsection (a) and recommendations to improve the 
     application and consistency of the requirements under 
     subsections (c) and (d) of section 565 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) to support and 
     expedite the research and development of medical 
     countermeasures, as applicable.
       (d) Protection of National Security.--The Comptroller 
     General of the United States shall conduct the study and 
     issue the assessment and report under this section in a 
     manner that does not compromise national security.

     SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING 
                   TECHNOLOGIES AND THEIR POTENTIAL ROLE IN 
                   NATIONAL SECURITY.

       (a) Meeting.--
       (1) In general.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall convene a meeting to discuss the potential role 
     advancements in genomic engineering technologies (including 
     genome editing technologies) may have in advancing national 
     health security. Such meeting shall be held in a manner that 
     does not compromise national security.
       (2) Attendees.--The attendees of the meeting under 
     paragraph (1)--
       (A) shall include--
       (i) representatives from the Office of the Assistant 
     Secretary for Preparedness and Response, the National 
     Institutes of Health, the Centers for Disease Control and 
     Prevention, and the Food and Drug Administration; and
       (ii) representatives from academic, private, and nonprofit 
     entities with expertise in genome engineering technologies, 
     biopharmaceuticals, medicine, or biodefense, and other 
     relevant stakeholders; and
       (B) may include--
       (i) other representatives from the Department of Health and 
     Human Services, as the Secretary determines appropriate; and
       (ii) representatives from the Department of Homeland 
     Security, the Department of Defense, the Department of 
     Agriculture, and other departments, as the Secretary may 
     request for the meeting.
       (3) Topics.--The meeting under paragraph (1) shall include 
     a discussion of--
       (A) the current state of the science of genomic engineering 
     technologies related to national health security, including--
       (i) medical countermeasure development, including potential 
     efficiencies in the development pathway and detection 
     technologies; and
       (ii) the international and domestic regulation of products 
     utilizing genome editing technologies; and
       (B) national security implications, including--
       (i) capabilities of the United States to leverage genomic 
     engineering technologies as a part of the medical 
     countermeasure enterprise, including current applicable 
     research, development, and application efforts underway 
     within the Department of Defense;
       (ii) the potential for state and non-state actors to 
     utilize genomic engineering technologies as a national health 
     security threat; and
       (iii) security measures to monitor and assess the potential 
     threat that may result from utilization of genomic 
     engineering technologies and related technologies for the 
     purpose of compromising national health security.
       (b) Report.--Not later than 270 days after the meeting 
     described in subsection (a) is held, the Assistant Secretary 
     for Preparedness and Response shall issue a report to the 
     congressional committees of jurisdiction on the topics 
     discussed at such meeting, and provide recommendations, as 
     applicable, to utilize innovations in genomic engineering 
     (including genome editing) and related technologies as a part 
     of preparedness and response activities to advance national 
     health security. Such report shall be issued in a manner that 
     does not compromise national security.

     SEC. 606. REPORT ON VACCINES DEVELOPMENT.

       Not later than one year after the date of the enactment of 
     this Act, the Secretary of Health and Human Services shall 
     submit to the Committee on Health, Education, Labor, and 
     Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives a report describing 
     efforts and activities to coordinate with other countries and 
     international partners during recent public health 
     emergencies with respect to the research and advanced 
     research on, and development of, qualified pandemic or 
     epidemic products (as defined in section 319F-3 of the Public 
     Health Service Act (42 U.S.C. 247d-6d)). Such report may 
     include information regarding relevant work carried out under 
     section 319L(c)(5)(E) of the Public Health Service Act (42 
     U.S.C. 247d-7e(c)(5)(E)), through public-private 
     partnerships, and through collaborations with other countries 
     to assist with or expedite the research and development of 
     qualified pandemic or epidemic products. Such report shall 
     not include information that may compromise national 
     security.

     SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND 
                   HEALTH.

       (a) Reauthorization of Mosquito Abatement for Safety and 
     Health Program.--Section 317S of the Public Health Service 
     Act (42 U.S.C. 247b-21) is amended--
       (1) in subsection (a)(1)(B)--
       (A) by inserting ``including programs to address emerging 
     infectious mosquito-borne diseases,'' after ``subdivisions 
     for control programs,''; and
       (B) by inserting ``or improving existing control programs'' 
     before the period at the end;
       (2) in subsection (b)--
       (A) in paragraph (1), by inserting ``, including 
     improvement,'' after ``operation'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) in clause (ii), by striking ``or'' at the end;
       (II) in clause (iii), by striking the semicolon at the end 
     and inserting ``, including an emerging infectious mosquito-
     borne disease that presents a serious public health threat; 
     or''; and
       (III) by adding at the end the following:

       ``(iv) a public health emergency due to the incidence or 
     prevalence of a mosquito-borne disease that presents a 
     serious public health threat;''; and
       (ii) by amending subparagraph (D) to read as follows:
       ``(D)(i) is located in a State that has received a grant 
     under subsection (a); or
       ``(ii) that demonstrates to the Secretary that the control 
     program is consistent with existing State mosquito control 
     plans or policies, or other applicable State preparedness 
     plans.'';
       (C) in paragraph (4)(C), by striking ``that extraordinary'' 
     and all that follows through the period at the end and 
     inserting the following: ``that--
       ``(i) extraordinary economic conditions in the political 
     subdivision or consortium of political subdivisions involved 
     justify the waiver; or
       ``(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--

       ``(I) the size or density of the potentially impacted human 
     population;
       ``(II) the size or density of a mosquito population that 
     requires heightened control; or
       ``(III) the severity of the mosquito-borne disease, such 
     that expected serious adverse health outcomes for the human 
     population justify the waiver.''; and

       (D) by amending paragraph (6) to read as follows:
       ``(6) Number of grants.--A political subdivision or a 
     consortium of political subdivisions may not receive more 
     than one grant under paragraph (1).''; and
       (3) in subsection (f)--
       (A) in paragraph (1) by striking ``for fiscal year 2003, 
     and such sums as may be necessary for each of fiscal years 
     2004 through 2007'' and inserting ``for each of fiscal years 
     2019 through 2023'';
       (B) in paragraph (2), by striking ``the Public Health 
     Security and Bioterrorism Preparedness and Response Act of 
     2002'' and inserting ``this Act and other medical and public 
     health preparedness and response laws''; and
       (C) in paragraph (3)--
       (i) in the heading, by striking ``2004'' and inserting 
     ``2019''; and
       (ii) by striking ``2004'' and inserting ``2019''.
       (b) Epidemiology-Laboratory Capacity Grants.--Section 2821 
     of the Public Health Service Act (42 U.S.C. 300hh-31) is 
     amended--
       (1) in subsection (a)(1), by inserting ``, including 
     mosquito and other vector-borne diseases,'' after 
     ``infectious diseases''; and
       (2) by amending subsection (b) to read as follows:
       ``(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.''.

                  TITLE VII--MISCELLANEOUS PROVISIONS

     SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

       (a) Vaccine Tracking and Distribution.--Section 319A(e) of 
     the Public Health Service Act (42 U.S.C. 247d-1(e)) is 
     amended by striking ``2014 through 2018'' and inserting 
     ``2019 through 2023''.
       (b) Temporary Reassignment.--Section 319(e)(8) of the 
     Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended 
     by striking ``2018'' and inserting ``2023''.
       (c) Strategic Innovation Partner.--Section 
     319L(c)(4)(E)(ix) of the Public Health Service Act (42 U.S.C. 
     247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and 
     inserting ``2023''.
       (d) Limited Antitrust Exemption.--
       (1) In general.--Section 405 of the Pandemic and All-
     Hazards Preparedness Act (42 U.S.C. 247d-6a note) is 
     amended--
       (A) by redesignating such section as section 319L-1;
       (B) by transferring such section to the Public Health 
     Service Act (42 U.S.C. 201 et seq.), to appear after section 
     319L of such Act (42 U.S.C. 247d-7e);
       (C) in subsection (a)(1)(A)--
       (i) by striking ``Secretary of Health and Human Services 
     (referred to in this subsection as the `Secretary')'' and 
     inserting ``Secretary'';
       (ii) by striking ``of the Public Health Service Act (42 
     U.S.C. 247d-6b)) (as amended by this Act'';
       (iii) by striking ``of the Public Health Service Act (42 
     U.S.C. 247d- 6a)) (as amended by this Act''; and
       (iv) by striking ``of the Public Health Service Act (42 
     U.S.C. 247d-6d)''; and
       (D) in subsection (b), by striking ``12-year'' and 
     inserting ``17-year''.
       (2) Conforming amendment.--The table of contents in section 
     1(b) of the Pandemic and All-Hazards Preparedness Act (Public 
     Law 109-417) is amended by striking the item related to 
     section 405.

[[Page H8775]]

       (e) Inapplicability of Certain Provisions.--Subsection 
     (e)(1) of section 319L of the Public Health Service Act (42 
     U.S.C. 247d-7e) is amended--
       (1) by amending subparagraph (A) to read as follows:
       ``(A) Non-disclosure of information.--
       ``(i) In general.--Information described in clause (ii) 
     shall be deemed to be information described in section 
     552(b)(3) of title 5, United States Code.
       ``(ii) Information described.--The information described in 
     this clause is information relevant to programs of the 
     Department of Health and Human Services that could compromise 
     national security and reveal significant and not otherwise 
     publicly known vulnerabilities of existing medical or public 
     health defenses against chemical, biological, radiological, 
     or nuclear threats, and is comprised of--

       ``(I) specific technical data or scientific information 
     that is created or obtained during the countermeasure and 
     product advanced research and development carried out under 
     subsection (c);
       ``(II) information pertaining to the location security, 
     personnel, and research materials and methods of high-
     containment laboratories conducting research with select 
     agents, toxins, or other agents with a material threat 
     determination under section 319F-2(c)(2); or
       ``(III) security and vulnerability assessments.'';

       (2) by redesignating subparagraph (C) as subparagraph (D);
       (3) by inserting after subparagraph (B) the following:
       ``(C) Reporting.--One year after the date of enactment of 
     the Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018, and annually thereafter, the 
     Secretary shall report to the Committee on Health, Education, 
     Labor, and Pensions of the Senate and the Committee on Energy 
     and Commerce of the House of Representatives on the number of 
     instances in which the Secretary has used the authority under 
     this subsection to withhold information from disclosure, as 
     well as the nature of any request under section 552 of title 
     5, United States Code that was denied using such 
     authority.''; and
       (4) in subparagraph (D), as so redesignated, by striking 
     ``12'' and inserting ``17''.

     SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.

       Subsection (d) of section 319F-2 of the Public Health 
     Service Act (42 U.S.C. 247d-6b) is amended to read as 
     follows:
       ``(d) Disclosures.--No Federal agency may disclose under 
     section 552 of title 5, United States Code any information 
     identifying the location at which materials in the stockpile 
     described in subsection (a) are stored, or other information 
     regarding the contents or deployment capability of the 
     stockpile that could compromise national security.''.

     SEC. 703. CYBERSECURITY.

       (a) Strategy for Public Health Preparedness and Response to 
     Cybersecurity Threats.--
       (1) Strategy.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall prepare and submit to the relevant committees of 
     Congress a strategy for public health preparedness and 
     response to address cybersecurity threats (as defined in 
     section 102 of Cybersecurity Information Sharing Act of 2015 
     (6 U.S.C. 1501)) that present a threat to national health 
     security. Such strategy shall include--
       (A) identifying the duties, functions, and preparedness 
     goals for which the Secretary is responsible in order to 
     prepare for and respond to such cybersecurity threats, 
     including metrics by which to measure success in meeting 
     preparedness goals;
       (B) identifying gaps in public health capabilities to 
     achieve such preparedness goals; and
       (C) strategies to address identified gaps and strengthen 
     public health emergency preparedness and response 
     capabilities to address such cybersecurity threats.
       (2) Protection of national security.--The Secretary shall 
     make such strategy available to the Committee on Health, 
     Education, Labor, and Pensions of the Senate, the Committee 
     on Energy and Commerce of the House of Representatives, and 
     other congressional committees of jurisdiction, in a manner 
     that does not compromise national security.
       (b) Coordination of Preparedness for and Response to All-
     hazards Public Health Emergencies.--Subparagraph (D) of 
     section 2811(b)(4) of the Public Health Service Act (42 
     U.S.C. 300hh-10(b)(4)) is amended to read as follows:
       ``(D) Policy coordination and strategic direction.--Provide 
     integrated policy coordination and strategic direction, 
     before, during, and following public health emergencies, with 
     respect to all matters related to Federal public health and 
     medical preparedness and execution and deployment of the 
     Federal response for public health emergencies and incidents 
     covered by the National Response Plan described in section 
     504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C. 
     314(a)(6)), or any successor plan; and such Federal responses 
     covered by the National Cybersecurity Incident Response Plan 
     developed under section 228(c) of the Homeland Security Act 
     of 2002 (6 U.S.C. 149(c)), including public health 
     emergencies or incidents related to cybersecurity threats 
     that present a threat to national health security.''.

     SEC. 704. TECHNICAL AMENDMENTS.

       (a) Public Health Service Act.--Title III of the Public 
     Health Service Act (42 U.S.C. 241 et seq.) is amended--
       (1) in paragraphs (1) and (5) of section 319F-1(a) (42 
     U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each 
     place such term appears and inserting ``section 319F(e)''; 
     and
       (2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking 
     ``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.
       (b) Public Health Security Grants.--Section 319C-1(b)(2) of 
     the Public Health Service Act (42 U.S.C. 247d-3a(b)(2)) is 
     amended--
       (1) in subparagraph (C), by striking ``individuals,,'' and 
     inserting ``individuals,''; and
       (2) in subparagraph (F), by striking ``make satisfactory 
     annual improvement and describe'' and inserting ``makes 
     satisfactory annual improvement and describes''.
       (c) Emergency Use Instructions.--Subparagraph (A) of 
     section 564A(e)(2) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360bbb-3a(e)(2)) is amended by striking 
     ``subsection (a)(1)(C)(i)'' and inserting ``subsection 
     (a)(1)(C)''.
       (d) Products Held for Emergency Use.--Section 564B(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
     3b) is amended--
       (1) in subparagraph (B), by inserting a comma after 
     ``505''; and
       (2) in subparagraph (C), by inserting ``or section 564A'' 
     before the period at the end.
       (e) Transparency.--Section 507(c)(3) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
       (1) by striking ``Nothing in'' and inserting the following:
       ``(A) In general.--Nothing in'';
       (2) by striking ``disclose any'' and inserting ``disclose 
     or direct--
       ``(i) any'';
       (3) by striking the period and inserting ``; or''; and
       (4) by adding at the end the following:
       ``(ii) in the case of a drug development tool that may be 
     used to support the development of a qualified 
     countermeasure, security countermeasure, or qualified 
     pandemic or epidemic product, as defined in sections 319F-1, 
     319F-2, and 319F-3, respectively, of the Public Health 
     Service Act, any information that the Secretary determines 
     has a significant potential to affect national security.
       ``(B) Public acknowledgment.--In the case that the 
     Secretary, pursuant to subparagraph (A), does not make 
     information publicly available, the Secretary shall provide 
     on the internet website of the Food and Drug Administration 
     an acknowledgement of the information that has not been 
     disclosed, pursuant to subparagraph (A).''.

     SEC. 705. FORMAL STRATEGY RELATING TO CHILDREN SEPARATED FROM 
                   PARENTS AND GUARDIANS AS A RESULT OF ZERO 
                   TOLERANCE POLICY.

       Not later than 14 days after the date of enactment of this 
     Act, the Assistant Secretary for Preparedness and Response 
     and the Assistant Secretary for the Administration on 
     Children and Families 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 formal strategy to reunify with their parent or 
     guardian, if the parent or guardian chooses such 
     reunification, each child who--
       (1) as a result of the initiative announced on April 6, 
     2018, and due to prosecution under section 1325(a) of title 
     8, United States Code;
       (2) was separated from their parent or guardian and placed 
     into a facility funded by the Department of Health and Human 
     Services; and
       (3) can be safely reunited with such parent or guardian.

     SEC. 706. REPORTING RELATING TO CHILDREN SEPARATED FROM 
                   PARENTS AND GUARDIANS AS A RESULT OF ZERO 
                   TOLERANCE POLICY.

       Beginning on the date of enactment of this Act, the 
     Assistant Secretary for Preparedness and Response and the 
     Assistant Secretary for the Administration on Children and 
     Families 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 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.

     SEC. 707. TECHNICAL CORRECTION.

       Section 801(e)(4)(E)(iii) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by 
     striking ``subparagraph'' both places it appears in subclause 
     (I) and subclause (II) and inserting ``paragraph''.

     SEC. 708. SAVINGS CLAUSE.

       Nothing in this Act shall be construed as reducing or 
     limiting the authorities vested in any other Federal agency 
     by any other Federal law.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
Indiana (Mrs. Brooks) and the gentleman from New Jersey (Mr. Pallone) 
each will control 20 minutes.
  The Chair recognizes the gentlewoman from Indiana.

[[Page H8776]]

  



                             General Leave

  Mrs. BROOKS of Indiana. Mr. Speaker, I ask unanimous consent that all 
Members may have 5 legislative days in which to revise and extend their 
remarks and insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from Indiana?
  There was no objection.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker, I rise today to speak in support of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation Act of 2018, known as 
PAHPA. I am proud to have introduced this important bill with Energy 
and Commerce Chairman  Greg Walden, Ranking Member Frank Pallone, and 
my good friend Representative Eshoo, who is one of the original authors 
of the 2006 PAHPA bill and lead author of the last reauthorization in 
2013.
  This bipartisan public health and national security effort will 
ensure our Nation is better prepared to respond to natural disasters 
like hurricanes; emerging infectious diseases like Zika and Ebola; and 
chemical, biological, radiological, or nuclear attacks, whether from 
terrorist groups or from nation-states.
  Seventeen years ago, Congress was the target of a biological attack 
when letters laced with anthrax arrived in Member offices just days or 
soon after the 9/11 terrorist attacks. In the aftermath of 9/11, the 
Blue Ribbon Study Panel on Biodefense was formed. It was led by 
bipartisan leaders: former Senator Joe Lieberman, former Governor Tom 
Ridge, and many others.
  In October 2015, after extensive discussions around the country where 
they learned from experts, they created their ``National Blueprint for 
Biodefense,'' which provided us with a roadmap in drafting this 
important legislation.
  I was the United States Attorney for the Southern District of Indiana 
during those 2001 anthrax attacks, and my own office dealt with an 
anthrax hoax when we received a letter with white powder inside. Of 
course, at the time, we didn't know it was a hoax. It was incredibly 
stressful for that staff member, who had to worry about their very own 
health. But that personal experience illustrated to me the importance 
of preparedness and sparked my interest in biodefense.
  In the years since then, we know that the threat of a chemical, 
biological, radiological, or nuclear incident continues to grow. Every 
day, our adversaries are looking for more effective and faster ways to 
reduce the threat. It is not really a question of if we face the 
threat. It is a question of when.
  Thanks to PAHPA and the 21st Century Cures Act, we are more prepared 
than ever for biological threats and attacks.
  In July of just this last year, the FDA approved the first drug to 
treat smallpox. It is called TPOXX. But TPOXX isn't the only recent 
approval at the FDA. In July, the FDA also approved an autoinjector 
that provides a one-time dose of an antidote to block effects of a 
nerve agent. This new antidote and TPOXX will help protect Americans 
from biological attacks.
  But PAHPA is much more than just a biodefense bill. It also ensures a 
coordinated healthcare response, whether to hurricanes or other natural 
disasters.
  Florence has just hit the East Coast and residents in both North and 
South Carolina are still recovering and dealing with ongoing flooding. 
During the 2017 hurricane season, whether it was Hurricane Harvey, 
Irma, Jose, or Maria, far too many Americans were killed. It showed us 
that we need to do better to prioritize the needs of every person in 
our communities.
  The PAHPA bill we are considering today does just that. It 
prioritizes our Nation's most vulnerable populations: our children, 
senior citizens, and those with disabilities. It reauthorizes the 
advisory committee focused on the specific needs of children and 
creates new advisory committees to ensure the needs of the elderly and 
those with disabilities are considered.
  The bill provides liability protections for healthcare professionals 
who volunteer after medical disasters. In addition to these types of 
Good Samaritan provisions, the bill ensures more healthcare 
professionals like nurses, doctors, and others can be hired and trained 
when facing a public health crisis by strengthening our National 
Disaster Medical System, which provides grants to our regional 
healthcare network.
  It also ensures we have a robust supply of vaccines and basic 
equipment like gloves, hazmat suits, masks, personal protective gear, 
and more in our strategic national stockpiles located all across the 
country, so that our healthcare professionals and first responders have 
what they need.
  PAHPA ensures our preparedness and response capabilities will include 
a robust pipeline of medical countermeasures by reauthorizing and 
increasing funding for the BioShield Special Reserve Fund and BARDA, 
the Biomedical Advanced Research and Development Authority.
  BARDA's work over the last decade has resulted in FDA approvals for 
more than 42 different medical countermeasures. The development of 
medical countermeasures is a lengthy and often risky endeavor, which is 
why sending a clear signal that BARDA remains a strong and committed 
partner with academic institutions and the private sector in these 
efforts is so very important.
  Last week, we saw even another example of a success of research 
funded by BARDA when FDA approved a product called ReCell, the first 
spray-on skin product ever approved for use in the United States. This 
new treatment will help treat burn victims so they can heal faster and 
with less risk of infection from painful skin grafts. By using a piece 
of a patient's skin about the size of a credit card, a doctor can turn 
it into a single cell-based solution that can be sprayed over the 
patient's burns so that new skin can grow and replace the damaged skin.
  These types of investments BARDA is making into innovative research 
are critical, but it is also important that we continue to address 
threats that have been around for years.
  It has been 100 years since the 1918 pandemic influenza killed 
millions of people around the globe, including 675,000 Americans. Some 
experts predict that we are actually due for the potential of another 
global pandemic influenza.
  To address that threat, the bill we are considering today authorizes 
$250 million for the Assistant Secretary for Preparedness and Response, 
the ASPR, to address threats like pandemic influenza. Specifically, the 
bill directs the ASPR to work to increase manufacturing capacity and 
stockpile medical countermeasures.
  While the PAHPA bill we are considering today authorizes funding for 
research into known threats like pandemic influenza, it also maintains 
the flexibility that is the foundation of our medical countermeasure 
enterprise to deal with unknown threats for which we may have no 
defense today.
  Even today, the Democratic Republic of the Congo continues to deal 
with an ongoing Ebola outbreak. In order to ensure we are better 
prepared when we face an outbreak like Ebola or Zika, the bill we are 
considering today does three important things.
  First, it improves the existing emergency response fund so that the 
Secretary of Health and Human Services does not have to wait on 
approval from Congress to immediately fund response measures needed to 
contain an outbreak and save lives. This emergency response fund will 
create a bridge so that immediate funding is available, so we can then 
supplement with an emergency appropriations bill later.
  Secondly, the bill requires GAO to conduct a review of the emergency 
response fund to help appropriators decide what funding levels and 
resources are needed.
  The third thing the bill does to help address threats like Ebola and 
Zika is to authorize $250 million in funding for an emerging infectious 
disease program so that BARDA can invest in new research.
  The PAHPA bill reauthorization we are considering is the process of 
months of committee work in both the House and the Senate, and I want 
to thank all the staff members and all of the organizations, everyone 
who has been involved, and all the Members who have participated, 
whether it is subcommittee or committee hearings on this bill, 
examining our response to threats. I thank everyone involved for their 
dedication and commitment to

[[Page H8777]]

making sure we have the procedures, resources, and support in place to 
protect our fellow citizens from public health and national security 
threats.
  I can't emphasize enough how critically important it is to 
reauthorize PAHPA. We have a duty as Members of Congress to keep 
Americans safe and secure. This bill is an essential component of 
accomplishing that goal. I urge all Members to support this critical 
bipartisan piece of legislation.
  Mr. Speaker, I include in the Record letters from many organizations 
that support the bill.

                               Adult Vaccine Access Coalition,

                                                    July 23, 2018.
     Hon. Susan W. Brooks,
     Member of Congress,
     Washington, DC.
     Hon. Anna Eshoo,
     Member of Congress,
     Washington, DC.
       Dear Representatives Brooks and Eshoo: On behalf of the 
     Adult Vaccine Access Coalition (AVAC), we are pleased to 
     express our support for bipartisan legislation that recently 
     passed the House Energy and Commerce Committee, ``Pandemic 
     and All-Hazards Preparedness Reauthorization Act (PAHPA) of 
     2018''.
       AVAC includes more than fifty organizational leaders in 
     health and public health who are committed to raising 
     awareness of and engaging in advocacy on the importance of 
     adult immunization. AVAC priorities and objectives are driven 
     by a consensus process with the goal of enabling stakeholders 
     to have a voice in the effort to improve access to and 
     utilization of adult immunizations.
       The bipartisan reauthorization of the PAHPA provides 
     improvements to key preparedness and response programs, 
     enhances personnel and hiring authorities, as well as 
     prioritizes cybersecurity in health care and provides 
     necessary resources for the development of medical 
     countermeasures for pandemic influenza and emerging 
     infectious diseases. We are delighted the Managers' Amendment 
     included references to immunization programs and immunization 
     information systems under Section 319D. These additions will 
     help to strengthen and enhance coordination and integrate 
     immunization programs and immunization information systems 
     (IIS) capabilities into public health emergency preparedness, 
     planning, and response activities.
       Immunization Information Systems (IIS), or registries, 
     confidential, population-based, computerized systems can 
     record immunization doses administered by participating 
     providers to persons residing within a given jurisdiction. 
     They provide state and local public health agencies aggregate 
     data on immunization coverage rates for disease surveillance 
     and program operations. IIS' can serve as a vital component 
     for emergency preparedness and response activities and are an 
     optimal tool for use during a pandemic or other emerging 
     infectious disease event by enabling communication with 
     providers, identifying variations in access and utilization 
     of immunization, and enabling implementation of targeted 
     strategies during emergency preparedness and response 
     activities.
       Congratulations on putting together a strong, bipartisan 
     reauthorization package that reflects many of the important 
     priorities shared by stakeholders. We look forward to working 
     with you throughout the process to enact the 2018 Pandemic 
     and All-Hazards Preparedness Reauthorization Act.
           Sincerely,
     Lisa Foster,
       AVAC Manager.
     Abby Bownas,
       AVAC Manager.
                                  ____

                                         Alliance for Biosecurity,


                                     U.S. Chamber of Commerce,

                                                    July 27, 2018.
       To the Members of the U.S. House of Representatives: On 
     behalf of the Alliance for Biosecurity and the U.S. Chamber 
     of Commerce, we support H.R. 6378, the Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018, 
     and urge the House to pass this bipartisan legislation before 
     the Pandemic and All-Hazards Preparedness Act (PAHPA) expires 
     at the end of September 2018. H.R. 6378 is central to 
     protecting American citizens, organizations, and communities 
     against natural and man-made biosecurity hazards.
       H.R. 6378 would authorize crucial funding for the Project 
     BioShield Special Reserve Fund and Biomedical Advanced 
     Research and Development Authority (BARDA). However, we urge 
     policymakers to account for inflation to ensure that future 
     spending levels adequately support the Public Health 
     Emergency Medical Countermeasures Enterprise (PHEMCE) 
     Strategy and implementation Plan, the BARDA Strategic Plan, 
     and related efforts.
       H.R. 6378 would establish several important programs within 
     BARDA, especially a Pandemic Influenza Program to support 
     research and development activities to enhance responses to 
     pandemic influenza and an Emerging Infectious Disease Program 
     to monitor and address infectious diseases that could cause a 
     deadly pandemic. Both programs would be funded at $250 
     million per year through FY 2023.
       The bill would also create new and sustainable market-based 
     incentives to advance cutting-edge biomedical research. Our 
     groups support developing strategic partnerships between 
     BARDA and the business community to mitigate threats that 
     could pose a significant risk to U.S. health and safety.
       Reauthorizing PAHPA would also help ensure the 
     sustainability of the medical countermeasures enterprise by 
     transferring the authority that governs the procurement of 
     medical countermeasures from the Centers for Disease Control 
     and Prevention (CDC) to the Office of the Assistant Secretary 
     for Preparedness and Response (ASPR).
       The legislation would codify ASPR's role in coordinating 
     Strategic National Stockpile operations with CDC. We also 
     believe that such teamwork would make the U.S. better 
     equipped to tackle public health emergencies and natural 
     disasters.
       We urge the full House to swiftly consider and pass H.R. 
     6378.
           Sincerely,
     The Honorable Jack Kingston,
       Secretariat, Alliance for Biosecurity.
     Neil L. Bradley,
       Executive Vice President and Chief Policy Officer, U.S. 
     Chamber of Commerce.
                                  ____



                                            Allied BioScience,

                                         Plano, TX, July 23, 2018.
     Hon. Susan Brooks,
     Member of Congress,
     Washington, DC.
       Dear Representative Brooks: I write to thank you for a 
     provision in your recently introduced legislation, H.R. 6378, 
     the Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018. This provision updates the 
     authorization for the Biomedical Advanced Research and 
     Development Authority (BARDA) to include the mitigation of 
     infectious disease. This provision will make our nation 
     safer.
       Allied BioScience (ABS) has engaged BARDA with ideas for 
     collaboration that have the potential to enhance the 
     biological safety of our nation by combating antimicrobial 
     resistance through environmental intervention. Under the 
     existing authorization, BARDA is limited to developing 
     pharmacological interventions. This limitation precludes 
     collaboration at this time. Your legislation amends the 
     definition of ``qualified pandemic or epidemic products'' to 
     include ``a product manufactured, used, designed, developed, 
     modified, licensed, or procured to diagnose, mitigate, 
     prevent, treat, or cure an infectious disease (as defined in 
     section 319F-1(a)(2))''. This change would create a path 
     forward to collaborate to develop novel solutions to 
     antimicrobial resistance that will provide a safer nation.
       ABS has developed a semi-permanent antimicrobial coating 
     that creates a long-lasting barrier to microbial growth. In 
     clinical trials, ABS's coating, when applied in an ICU 
     setting has shown to reduce the presence of Multi-Drug 
     Resistant Organisms (MDROs) by up to 70% with an efficacy of 
     at least four months per application. Comparable reductions 
     in Hospital Acquired Infections have seen a corresponding 
     reduction. Reduction in rates of infection decreased the need 
     to treats MDRO's and breaks the cycle of mutation that 
     creates increasingly potent ``superbugs''. Our research 
     demonstrates that environmental mitigation is a key component 
     to addressing antimicrobial resistance.
       Thank you again for your efforts to modernize BARDA to 
     provide the flexibility needed to combat ever-evolving 
     threats. We enthusiastically support H.R. 6379, and look 
     forward to its swift passage and enactment into law. If you 
     have any questions about ABS I would be happy to talk further 
     with you at your convenience.
           Sincerely,
                                                       Mike Ruley,
     CEO.
                                  ____

         American Association of Blood Banks, America's Blood 
           Centers, American Red Cross,
                                                    July 25, 2018.
     Hon. Greg Walden,
     Chairman, House Energy and Commerce Committee, Washington, 
         DC.
     Hon. Susan Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy and Commerce Committee, 
         Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, and 
     Representatives Brooks and Eshoo: AABB (formerly known as the 
     American Association of Blood Banks), America's Blood Centers 
     and the American Red Cross commend the House Energy and 
     Commerce Committee's commitment to improving the nation's 
     preparedness and response capabilities through the 
     reauthorization of the Pandemic and All-Hazards Preparedness 
     Advancing Innovation Act (PAHPAIA) of 2018 (H.R. 6378). 
     Collectively, our organizations represent the nation's blood 
     collection establishments, transfusion services, and 
     transfusion medicine professionals.
       We would like to especially highlight two sections of the 
     bill important to us and our collective members:
       Section 116 is a significant step in examining the unique, 
     and often overlooked, role of the nation's blood supply in 
     emergency

[[Page H8778]]

     preparedness and response systems and the specific challenges 
     associated with donor recruitment, implementation of safety 
     mandates and innovation, and adequacy in the face of public 
     health emergencies. We believe that policies that support the 
     availability of a safe and adequate blood supply are needed. 
     The report required by this section is critical to evaluating 
     possible solutions.
       We strongly support the Committee's specific recognition of 
     the blood supply in Section 207, which requires the Assistant 
     Secretary for Preparedness and Response (ASPR) to develop 
     guidelines for regional health care emergency and response 
     systems. We support the provision that requires the ASPR to 
     consult with blood banks and other key stakeholders when 
     developing and updating guidelines. Including blood centers 
     in this process is paramount and consistent with the 
     Department of Health and Human Services' (HHS) recognition of 
     blood as one of the core functional areas in Emergency 
     Support Function #8 of the National Response Framework. We 
     also commend the Committee for recognizing potential 
     financial implications for blood centers to implement and 
     follow the guidelines. Given that blood is an essential part 
     of the nation's trauma system, emergency preparedness and 
     response system and healthcare system generally, it is 
     essential that financial barriers not impede the availability 
     of safe blood ahead of and during response activities.
       AABB, America's Blood Centers and the American Red Cross 
     welcome the opportunity to work with the Committee to ensure 
     that these important provisions promoting the safety and 
     availability of the U.S. blood supply remain during 
     conference negotiations with the Senate.
     Mary Beth Bassett,
       President, AABB.
     Kate Fry,
       Chief Executive Officer, America's Blood Centers.
     James C. Hrouda,
       President, Biomedical Services, American Red Cross.
                                  ____

                                               American College of


                                         Emergency Physicians,

                                                    July 18, 2018.
     Hon. Susan Brooks,
     Washington, DC.
     Hon. Greg Walden,
     Washington, DC.
     Hon. Anna Eshoo,
     Washington, DC.
     Hon. Frank Pallone,
     Washington, DC.
       Dear Representatives Brooks, Eshoo, Walden, and Pallone: On 
     behalf of the American College of Emergency Physicians 
     (ACEP), our 38,000 members, and the more than 140 million 
     patients we treat each year, I am writing to express ACEP's 
     support for H.R. 6378, the ``Pandemic and All-Hazards 
     Preparedness and Advancing Innovation (PAHPAI) Act of 2018.''
       In particular, ACEP appreciates your legislation's focus on 
     improving regionalized emergency preparedness and response 
     systems, inclusion of the MISSION ZERO Act's provisions to 
     facilitate the use of military trauma teams in civilian 
     trauma centers, and the addition of Good Samaritan liability 
     protections for health care professionals who volunteer 
     during federally-declared disasters.
       Regionalized systems for emergency care response are vital 
     to ensuring patients are transported and treated in the most 
     appropriate setting. While it is important to maximize our 
     resources and capabilities on a daily basis, it becomes 
     imperative when health care providers respond to a natural or 
     man-made disaster. We would like to thank you for emphasizing 
     the establishment and enhancement of these systems, 
     especially the demonstration program designed to improve 
     medical surge capacity, build and integrate regional medical 
     response capabilities, improve specialty care expertise for 
     all-hazards response, and coordinate medical preparedness and 
     response across states, territories, and regional 
     jurisdictions.
       ACEP is very supportive of the trauma system improvements 
     included in H.R. 6378, specifically the grants for military-
     civilian partnerships in trauma care as established in the 
     MISSION ZERO Act (H.R. 880). ACEP believes this policy serves 
     three purposes. First, it makes additional trauma care 
     personnel available to treat severely injured civilian 
     patients. Second, it allows military trauma teams to maintain 
     their skills in between rotations to conflict areas. Third, 
     it allows trauma team members to train together so that when 
     they are deployed, everyone performs his/her duties in a 
     coordinated manner with the other members, thereby improving 
     care to injured military personnel.
       The Good Samaritan liability protections established in 
     this legislation will help encourage availability of health 
     care professionals during times of disaster, which can be 
     crucial to supplementing the efforts of emergency physicians 
     and the Disaster Medical Assistance Teams (DMATs) on-site. 
     ACEP believes volunteers responding to a disaster, whether 
     declared by the President of the United States or the 
     Secretary of the U.S. Department of Health and Human Services 
     (HHS), should be protected from liability while they are 
     providing care within the scope of their expertise and are 
     acting in good faith. We appreciate your efforts to include 
     this essential provision in H.R. 6378.
       Other aspects of the legislation that are important to 
     emergency physicians and will help ensure the nation is 
     prepared to contend with all disasters and unexpected 
     emergencies include your provisions to improve the National 
     Disaster Medical System (NDMS); expand public health 
     surveillance; study DMAT readiness capabilities; improve the 
     Public Health Emergency Fund (PHEF); strengthen the 
     Healthcare Preparedness and Response Program (HPRP), formerly 
     the Hospital Preparedness Program (HPP); extend authorization 
     for the Emergency System for Advanced Registration of 
     Volunteer Health Professionals (ESAR-VHP); and study hospital 
     preparedness capabilities. ACEP would also like to commend 
     you on your oversight of the Assistant Secretary for 
     Preparedness and Response's (ASPR) efforts to reunify 
     children who were separated from their parent or guardian 
     (due to the ``zero tolerance'' policy) and placed into the 
     custody of HHS.
       Finally, we would once again urge the Committee and the 
     Congress to ensure sufficient funding is provided for the 
     PHEF, HPRP, NDMS, and Medical Reserve Corps (MRC) to ensure 
     their effectiveness and we encourage you to seek a 
     sufficient, guaranteed federal funding stream. Without a 
     dedicated and appropriate amount of federal resources for 
     these critical programs, we are greatly concerned that the 
     nation as a whole, and emergency medical providers 
     specifically, will not have the infrastructure, personnel, or 
     tools necessary to provide optimal care during a natural or 
     man-made disaster or infectious disease outbreak.
           Sincerely,
                                   Paul D. Kivela, MD, MBA, FACEP,
     ACEP President.
                                  ____



                                 American College of Surgeons,

                                                    July 20, 2018.
     Hon. Greg Walden,
     Chairman, Committee on Energy and Commerce, Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, Committee on Energy and Commerce, Washington, 
         DC.
       Dear Chairman Walden and Ranking Member Pallone: On behalf 
     of the more than 80,000 members of the American College of 
     Surgeons (ACS), we would like to express our support for the 
     Pandemic and All Hazards Preparedness and Advancing 
     Innovation Act of 2018 (PAHPAI), H.R. 6378. We appreciate the 
     work the Energy and Commerce Committee has accomplished to 
     incorporate important improvements to trauma care and begin 
     the process for establishing the framework for a trauma 
     system that can fully meet the needs of any disaster and 
     provide the highest-quality health care.
       ACS is particularly appreciative of the inclusion of the 
     Mission Zero Act, H.R. 880 in the PAHPAI. Establishing and 
     maintaining high-quality and adequately-funded trauma systems 
     throughout the United States, including within the Armed 
     Forces, is a priority of the ACS and our Committee on Trauma 
     (COT). The Mission Zero Act authorizes $15 million in grant 
     funding to assist civilian trauma centers in partnering with 
     military trauma professionals and creates a pathway to 
     provide patients with excellent trauma care in times of peace 
     and conflict. In addition, this legislation requires 
     utilization of trauma data reporting as a requirement for the 
     grant program. The measuring and recording of data is a 
     cornerstone of advancing not only trauma care, but health 
     care as a whole. Overall, the Mission Zero Act is a critical 
     step toward achieving the goal of zero preventable injury 
     deaths after injury.
       Inclusion of the Good Samaritan Health Professionals Act, 
     H.R. 1876, which is legislation that would reduce barriers 
     for health care providers looking to volunteer during a 
     federally-declared disaster, is a welcome addition to PAHPAI. 
     This section in PAHPAI will help to greatly decrease loss of 
     life as well as improve outcomes during federally declared 
     public health emergencies.
       We also applaud the Committee for highlighting the critical 
     issue of improving our trauma care system by including 
     language creating a demonstration project promoting a 
     regionalized approach to disaster response. Trauma systems 
     have been organized across the country to manage the time-
     sensitive crises of acutely injured patients in an efficient 
     manner on a daily basis. Trauma systems span the continuum of 
     care including prior to the point of injury and through 
     rehabilitation. As a result, these systems engage in numerous 
     activities aimed at improving care and outcomes, including 
     bystander training, emergency medical services (EMS) training 
     and coordination, hospital preparedness, injury prevention 
     efforts, and continuous quality improvement. All of these 
     activities will assist with responding to public health 
     emergencies such as biological, radiological, nuclear events, 
     and other mass casualty incidents.
       The ACS believes the PAHPAI represents significant progress 
     in the process of ensuring that trauma systems, centers, and 
     health care providers are able to meet the needs of all 
     Americans. We thank you for your leadership on this 
     significant legislation and stand ready to work with you 
     toward final passage in the House.
           Sincerely,

                                      David B. Hoyt, MD, FACS,

                              Executive Director, American College
                                                      of Surgeons.

  Mrs. BROOKS of Indiana. Mr. Speaker, I reserve the balance of my 
time.


[[Page H8779]]


                                         House of Representatives,


                               Committee on Homeland Security,

                               Washington, DC, September 24, 2018.
     Hon. Greg Walden,
     Chairman, Committee on Energy & Commerce,
     Washington, DC.
       Dear Chairman Walden: I write concerning H.R. 6378, the 
     ``Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018''. This legislation includes matters 
     that fall within the Rule X jurisdiction of the Committee on 
     Homeland Security.
       In order to expedite floor consideration of H.R. 6378, the 
     Committee on Homeland Security will forgo action on this 
     bill. However, this is conditional on our mutual 
     understanding that forgoing consideration of the bill would 
     not prejudice the Committee with respect to the appointment 
     of conferees or to any future jurisdictional claim over the 
     subject matters contained in the bill or similar legislation 
     that fall within the Committee's Rule X jurisdiction. I 
     request you urge the Speaker to name members of the Committee 
     to any conference committee names to consider such 
     provisions.
       Please place a copy of this letter and your response 
     acknowledging our jurisdictional interest in the 
     Congressional Record during House Floor consideration of the 
     bill. I look forward to working with the Committee on Energy 
     and Commerce as the bill moves through the legislative 
     process.
           Sincerely,
                                                Michael T. McCaul,
     Chairman.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                               Washington, DC, September 24, 2018.
     Hon. Michael T. McCaul,
     Chairman, Committee on Homeland Security,
     Washington, DC.
       Dear Chairman McCaul: Thank you for your letter concerning 
     H.R. 6378, Pandemic and All-Hazards Preparedness and 
     Advancing Innovation Act of 2018, and I appreciate your 
     willingness to forgo action on the bill.
       I agree that forgoing consideration of the bill should not 
     prejudice the Committee on Homeland Security with respect to 
     the appointment of conferees or to any future jurisdictional 
     claim over the subject matters contained in the bill or 
     similar legislation that fall within the Committee's Rule X 
     jurisdiction. I will request that the Speaker name members of 
     the Committee to any conference committee to consider such 
     provisions.
       Finally, I will place a copy of your letter and this 
     response into the Congressional Record during consideration 
     of the measure on the House floor.
           Sincerely,
                                                      Greg Walden,
                                                         Chairman.

  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 6378, the Pandemic All-Hazards 
Preparedness and Advancing Innovation Act of 2018. I want to thank 
Chairman Walden and Representatives Eshoo and Brooks, as well as all 
the staff, for their hard work on this bill. Together, we have ensured 
a robust product that reflects priorities for Members on both sides of 
the aisle and the agencies responsible for ensuring our emergency 
preparedness.
  This is a vitally important public health bill that ensures that we 
can prepare for and respond to health security events like 
bioterrorism, emerging infectious diseases, and natural disasters. It 
will support the development of new treatments and the stockpiling of 
medications and supplies that will be deployed to communities 
nationwide in the case of an emergency.
  As we all know, effectively preparing for and responding to these 
events requires extensive coordination between Federal, State, local, 
and Tribal governments, as well as private sector organizations across 
the country.
  This bill reauthorizes or establishes critical programs that will 
help us better prepare and respond to any major health emergency.
  Let me discuss some of the specifics of how this bill will help us do 
that.
  It reauthorizes a loan repayment program that would help to 
strengthen and grow our public health workforce. This is critically 
important, as we are still trying to dig out of a public health funding 
hole that began during the Great Recession.
  This bill also makes a technical update to the Hospital Preparedness 
Program to reflect the use of the term ``coalition'' instead of 
``partnership'' by grantees and other stakeholders. This language 
change is not intended to make changes related to the current 
cooperative agreement structure, nor does it intend to alter the role 
and responsibilities of States, territories, and directly funded 
cities, which are awardees of funding under the Hospital Preparedness 
Program.
  Therefore, it continues to require that the Centers for Disease 
Control and Prevention, the CDC, provide funding through cooperative 
agreements to States, territories, and cities to support healthcare 
coalitions in their communities through the Hospital Preparedness 
Program.

                              {time}  1515

  The bill also amends the Public Health Emergency Preparedness Program 
to require public health departments to partner with nursing homes and 
hospitals to promote and improve public health preparedness and 
response.
  It also requires public health departments to work with utility 
companies and other critical infrastructure partners to help ensure 
that electricity and other critical infrastructure will remain 
functioning or return to function as soon as practicable after a public 
health emergency.
  Both of these requirements are intended to help prevent another 
tragedy like the tragic deaths that occurred at a Florida nursing home 
last year in the aftermath of Hurricane Irma.
  Mr. Speaker, this bill also updates the authorization for the public 
health emergency rapid response fund so we can prevent any delay in 
HHS' rapid response to public health emergencies in the future.
  It also maintains the administration's flexibility to determine the 
best placement for the Strategic National Stockpile, or SNS. I have 
concerns with moving the SNS from the direction of the Centers for 
Disease Control and Prevention to the Assistant Secretary for 
Preparedness and Response. To date, I have yet to hear a strong 
argument in support of this move.
  I also believe CDC has the relationships and expertise that make the 
most sense for managing and operationalizing the stockpile. The CDC 
also has a record of successful stewardship of the SNS. That is why I 
supported the increased transparency and reporting included in this 
bill.
  Wherever the Strategic National Stockpile is placed, it is critical 
that we ensure that our current preparedness and response capabilities 
are not weakened by its placement.
  I also want to highlight two provisions that were included that will 
ensure Congress receives the information it needs to respond to the 
Trump administration's family separation crisis. The Assistant 
Secretary for Preparedness and Response will be required to submit to 
the Energy and Commerce Committee a formal strategy on their family 
reunification efforts as well as keep the committee informed on the 
status of the children still awaiting reunification.
  The Trump administration's cruel zero-tolerance policy resulted in a 
manmade crisis that has impacted the lives of thousands of parents and 
children. While we can't undo the damage done by this policy, these 
provisions ensure that Congress has the information it needs to help 
reunite each child with their family and make sure this never happens 
again.
  Furthermore, while these provisions are important, they should not 
take the place of an actual oversight hearing on this cruel policy. 
This is something committee Democrats have repeatedly requested, and we 
will continue to do so.
  Finally, Mr. Speaker, overall, I want to say this is a good bill. Our 
national preparedness and response capabilities will be better prepared 
to respond to public health threats thanks to the passage of the 
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
  Mr. Speaker, I urge my colleagues to support H.R. 6378, and I reserve 
the balance of my time.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield 5 minutes to the 
gentleman from Oregon (Mr. Walden), the chairman of the Energy and 
Commerce Committee.
  Mr. WALDEN. Mr. Speaker, I rise today, obviously, in support of the 
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
  I want to thank my friend and colleague from New Jersey (Mr. 
Pallone), our ranking Democrat on the committee, for working with me on 
this effort, but especially I want to thank Representative Brooks from 
Indiana for her tireless effort and the partnership of my friend, 
Representative Anna Eshoo of California. She and Mrs.

[[Page H8780]]

Brooks really did the heavy lift here for the committee on this effort. 
They were able to shepherd this critical reauthorization to the floor 
today with unanimous support both in the subcommittee and in the full 
committee.
  So, for those out there who are watching our proceedings, know that 
actually we do work together and we do get some really important public 
policy done.
  These programs, commonly known as PAHPA, enable critical partnerships 
between the Federal Government, State and local authorities, and the 
private sector to ensure our Nation is responsibly prepared for and 
able to respond to public health emergencies. It is time that we get it 
right; it is critical that we get it right; and we are.
  It is not really a matter of if, but when, the next pandemic strikes. 
The projections simply are horrifying. A full-blown pandemic flu 
outbreak could literally kill millions of people within months--within 
months. We must have the tools, backed by stable and predictable 
funding, to respond to these threats and especially to the threat of 
pandemic flu.
  With this vote, the House will take an important step toward keeping 
our families safe in the worst-case scenarios of dangerous disease 
outbreak or in the case of chemical or biological attack. We are moving 
this reauthorization on time and in a bipartisan fashion.
  Like my colleague from Indiana, I remember when anthrax was sent to 
our offices and to the postal facility, and loss of life and illness 
and concern, and we all wondered what is next. That was part of what 
prompted us to get to this point and pass this legislation, not only 
today but back then.
  This is really important work, Mr. Speaker, and I commend my 
colleagues and the staff, who really do the incredible work to help us 
get it right. This is legislation now that will head over to the 
Senate, where I hope they will give it the same due consideration that 
we are about to here today, and then get this down to President Trump's 
desk, where he will sign it into law.
  Mr. Speaker, I want to again thank my colleagues and staff on both 
sides of the aisle.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I 
reserve the balance of my time.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield 5 minutes to the 
gentleman from Texas (Mr. Burgess), the subcommittee chair for the 
Subcommittee on Health.
  Mr. BURGESS. Mr. Speaker, I thank the gentlewoman for yielding.
  Mr. Speaker, one century ago, our country was in the midst of the 
worst pandemic in history. It claimed the lives of almost 700,000 
Americans and killed more than 50 million people worldwide.
  Mr. Speaker, we listened to testimony; we discussed aspects of this 
legislation before us today; and it is critical that we remember the 
significance of the centennial anniversary of the 1918 influenza 
pandemic as we consider this legislation today.
  The creation of the Assistant Secretary for Preparedness and Response 
under the original legislation of 2006 has helped us to make monumental 
strides in preparedness, coordination, and response. Close 
collaboration between the Centers for Disease Control and the Food and 
Drug Administration and our State, local, and territorial public health 
partners has been vital in making this progress.
  Much like politics, much of public health is local and executed on 
the ground by our hospitals, our health departments, and our emergency 
responders, who are our front lines in addressing infectious diseases, 
disasters, and threats.
  We must evaluate the domestic biological surveillance systems, such 
as BioWatch. This bill will help bring those programs up to date so 
they are operating with the most efficient capabilities and 
technologies. We must also look for innovative ways to continue to 
advance our medical countermeasures and ensure that Americans can 
access the medications that will provide critical protection in the 
future.
  As we consider the problem of antimicrobial resistance in this 
country, we must discuss new methods to curb this growing problem.
  It is important to note that this reauthorization bill is being heard 
on the floor of the House prior to the expiration of the fiscal year, 
at which time the current authorization expires. The House, once again, 
has done its work in this regard, and we do urge our counterparts in 
the Senate to do their work as well.
  This reauthorization includes an important provision: The MISSION 
ZERO Act. The MISSION ZERO Act seeks to connect American patients with 
battle-tested trauma care through the craft of military trauma care 
providers. The bill provides grants to allow military trauma care 
providers and teams to offer care in our Nation's leading trauma 
centers and systems.
  The need for top-notch trauma care extends across our Nation, far 
away from the battlefield. I first introduced this bipartisan bill with 
my fellow Texan, Representative Gene Green, following a police shooting 
in Dallas 2 years ago.
  Over 2 years ago, five police officers were killed and nine more were 
injured in a shooting in downtown Dallas. In the immediate aftermath of 
the attack, area hospitals sprung into action and activated their 
disaster plans. The staff at Parkland Hospital, Baylor University 
Hospital, and other medical professionals provided excellent emergency 
care to victims of the attack.
  Frontline facilities and responders in Dallas experienced this 
firsthand in 2014 when a patient presented with Ebola to a Dallas-Ft. 
Worth emergency department.
  We must remember that infectious diseases are a mere plane ride away, 
and we must continue to ensure that we are prepared and ready to 
respond to emerging infectious diseases worldwide.
  This Pandemic and All-Hazards Preparedness Reauthorization Act is 
critical to protecting the lives of Americans and providing the 
necessary tools and infrastructure when disaster strikes.
  I want to thank Representative Susan Brooks and Anna Eshoo for their 
work on this legislation before us today. Mr. Speaker, I strongly 
support this legislation, and I urge my colleagues to do the same.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield 1 minute to the 
gentleman from Florida (Mr. Bilirakis), who also serves on the 
Subcommittee on Health.
  Mr. BILIRAKIS. Mr. Speaker, I want to thank Congresswoman Brooks, who 
is doing an outstanding job. We both served on the House Committee on 
Homeland Security, and we chaired a subcommittee prior to Energy and 
Commerce. She is doing an outstanding job.
  Mr. Speaker, I rise today in strong support of H.R. 6378, the 
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
  From storm-related injuries and illnesses to delivery and logistics 
issues, last year's historically costly hurricane season tested the 
mettle of our health delivery system, and I am pleased to see children, 
seniors, and other at-risk patient communities being addressed in this 
reauthorization.
  This bill also encourages innovative partnerships and coalitions, 
like the Nicklaus Children's Hospital and the Florida International 
University, to continue to develop novel approaches to healthcare 
delivery and, ultimately, save lives.
  Mr. Speaker, I urge my colleagues to support this critical piece of 
legislation.
  Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time.
  Mr. Speaker, I want to again thank all my colleagues on both sides of 
the aisle for moving and working on this legislation.
  Mr. Speaker, I urge my colleagues to support H.R. 6378, and I yield 
back the balance of my time.
  Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself the balance of my 
time.
  Mr. Speaker, I would like to particularly thank Dr. Burgess and the 
ranking member of the Subcommittee on Health, Gene Green, for their 
leadership in working with so many of us who have brought this 
legislation to the floor at this time.
  It is really so very critical that all relevant Federal agencies, 
particularly the leadership of CDC and the ASPR, work together with our 
local and State partners that are truly on the ground; and I certainly 
urge my colleagues to

[[Page H8781]]

pass this important piece of legislation not only to ensure that public 
health is of paramount importance in this country, but, also, because 
this is an incredibly important piece of national security legislation.
  Mr. Speaker, I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I rise in support of this bipartisan 
legislation, the Pandemic and All-Hazards Preparedness and Innovation 
Act and I'm very proud to have Representative Susan Brooks as my 
partner. This legislation is the product of negotiation and compromise 
between the House and the Senate and I'm pleased that my colleagues 
were able to reach agreement on a bill that ensures our nation is 
prepared to respond to a wide range of public health emergencies, 
whether man-made or occurring through a natural disaster or infectious 
disease.
  In 2001 our nation endured the horrific attacks on September 11th and 
the anthrax attacks that followed shortly thereafter. Congress realized 
that our country was not prepared to coordinate responses to mass 
casualty events or chemical attacks, and in 2006, I wrote legislation 
with then-Representative Richard Burr to address these shortfalls. That 
important legislation, the original Pandemic and All-Hazards 
Preparedness Act, was signed into law the same year.
  The Pandemic and All-Hazards Preparedness and Innovation Act we're 
considering today is critical to our national security. The legislation 
updates the original PAHPA by directing federal agencies to respond to 
new and emerging threats, and strengthens our nation's existing 
preparedness and response programs. The reauthorization meets the 
challenges that we face today and those we anticipate facing in the 
future.
  Events over the past few years including Zika, the reemergence of 
Ebola, and the constant looming threat of a biological attack by 
another nation or hostile non-state enemies underscore the real threats 
our country continues to face. In 2017, our nation experienced the most 
destructive hurricane season in recent memory, followed quickly by the 
most deadly flu season in decades. This year, parts of our country have 
already faced devastating hurricanes and the season is not over yet. 
Our experience with each of these hazards reminds us that our country 
is not yet adequately prepared to deal with potentially devastating 
widespread public health crises. That's why this legislation is so 
critical.
  The legislation provides the authorization and federal resources to 
invest in programs that allow the Biomedical Advanced Research and 
Development Authority to maintain its nimble and flexible framework 
while responding to the existing and emerging threats our country may 
face. It also directs BARDA to address antimicrobial resistance which 
is critical to our nation's biodefense If we have a chemical or 
biological attack that leaves individuals with burns or open wounds, 
the medical countermeasures BARDA has developed to treat that attack 
will be useless if those injured contract secondary antibiotic 
resistant infections.
  BARDA was created by my original legislation and has been extremely 
successful in investing in drugs that are needed to be stockpiled, and 
where the federal government is the only customer. There is no other 
market for these products and that's why BARDA is so important. BARDA 
has worked with over 190 partners and brought 35 medical 
countermeasures through research and development to FDA approval No 
private company has a track record that compares to what BARDA has 
accomplished in just over 10 years.
  This bill restores multiyear appropriations for the Project BioShield 
Special Reserve Fund. My original legislation provided advanced 
appropriations for Project BioShield for the purpose of accelerating 
the research, development, purchase, and availability of effective 
medical countermeasures against biological, chemical, radiological, and 
nuclear (CBRN) threats. Restoring multiyear appropriations offers our 
partners with the government the certainty they need to invest in these 
important medical countermeasures which are a matter of national 
security. I urge the appropriators to fully fund the multiyear 
appropriations this legislation authorizes.
  I'm proud that our legislation incorporates many provisions that were 
important to Members in both the Republican Conference, the Democratic 
Caucus, and to our colleagues in the Senate, to meet the needs of 
vulnerable communities during natural and manmade disasters.
  The legislation also reauthorizes the HHS National Advisory Committee 
on Children and Disasters and authorizes the Children's Preparedness 
Unit at the CDC. This is critically important to address the persistent 
gaps in our nation's preparedness and response for the most vulnerable 
in many crises, our nation's children
  The bill also establishes an Advisory Council for People with 
Disabilities and an Advisory Council on Seniors to focus on the needs 
of these special populations during a public health emergency.
  It includes a proposal to prioritize bringing nursing homes back onto 
the power grid at the same time as hospitals after a disaster.
  It includes provisions related to regional health partnerships, 
pregnant and postpartum women and environmental health.
  I'm proud of this legislation and I urge my colleagues to support the 
Pandemic and All-Hazards Preparedness and Innovation Act.
  Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters 
in the Record.

                                                   Health Industry


                                     Distributors Association,

                                                    July 17, 2018.
     Hon. Greg Walden,
     Chairman, House Energy and Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Susan Brooks,
     House of Representatives, Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy and Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, Congresswoman 
     Brooks and Congresswoman Eshoo: On behalf of the Health 
     Industry Distributors Association (HIDA), we appreciate the 
     opportunity to express our support for H.R. 6378, the 
     Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018 (PAHPAI). HIDA commends you for your 
     leadership on this issue and appreciates the active 
     engagement of your staff with industry to incorporate lessons 
     learned from recent events such as Ebola and the 2017 
     hurricane season, in H.R. 6378, to continually improve our 
     nation's preparedness capabilities.
       HIDA is the trade association representing medical products 
     distributors, all of which deliver medical products and 
     supplies, manage logistics, and offer customer services to 
     more than 294,000 points of care. HIDA members primarily 
     distribute items used in every day medical services and 
     procedures, ranging from gauze and gloves to diagnostic 
     laboratory tests. Their customers include over 210,000 
     physician offices, 6,500 hospitals, and 44,000 nursing home 
     and extended care facilities throughout the country, as well 
     as numerous federal agencies and their healthcare facilities.
       As you know, the medical supply chain plays a critical role 
     in preparedness, as it supplies key infection prevention 
     products and protective equipment such as respirators, face 
     shields, hoods, impermeable gowns and gloves to first 
     responders and health care providers. Additionally, the 
     medical supply chain is the primary source for the diagnostic 
     and point-of-care rapid tests needed to identify infectious 
     disease, as well as the ancillary products such as gloves, 
     needles and syringes needed to deliver medical 
     countermeasures effectively.
       HIDA and its members have collaborated with federal 
     agencies on identifying opportunities to improve coordination 
     and develop solutions that create more elasticity in the 
     supply chain for key products. One of the many lessons 
     learned during the 2017 hurricane season was a considerable 
     need to improve coordination during an emergency response, 
     ensuring appropriate infrastructure partners are included in 
     a prioritization process for access to affected areas after 
     an event. We appreciate the Committees' acknowledgement of 
     the importance of this issue in the legislation, as well as 
     the recognition of the healthcare supply chain in H.R. 6378. 
     Specifically, we support the following:
       Section 101 provisions important to the healthcare supply 
     chain including
       The value of public and private sector coordination during 
     an event to ensure critical supplies are delivered and 
     information is shared.
       The requirement that ancillary products needed to deliver a 
     medical countermeasure are incorporated into the Public 
     Health Emergency Medical Countermeasure Enterprise planning 
     process.
       Section 319C-3 provisions that create a regional healthcare 
     system plan and that it be communicated to supply chain 
     partners so needed product can be redirected during a 
     response.
       HIDA thanks you for your continued commitment to 
     preparedness and look forward to working with you on H.R. 
     6378.
           Sincerely,

                                          Linda Rouse O'Neill,

                               Vice President, Government Affairs,
                         Health Industry Distributors Association.

[[Page H8782]]

     
                                  ____
                                        Infectious Disease Society


                                                   of America,

                                                    July 17, 2018.
     Hon. Greg Walden,
     Chairman, Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Frank Pallone, Jr.,
     Ranking Member, Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Susan Brooks,
     Energy & Commerce Committee,
     House of Representatives, Washington, DC.
     Hon. Anna Eshoo,
     Energy & Commerce Committee,
     House of Representatives, Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, 
     Representative Brooks and Representative Eshoo: Thank you for 
     your leadership in introducing H.R. 6378, the Pandemic and 
     All-Hazards Preparedness and Advancing Innovation Act of 2018 
     (PAHPAI) that both reauthorizes and strengthens the Pandemic 
     All-Hazards Preparedness Act (PAHPA). IDSA represents over 
     11,000 infectious diseases physicians and scientists. Many of 
     our members work on the frontlines of public health 
     emergencies, including bioterror attacks, outbreaks, and 
     natural disasters (e.g., hurricanes that carry significant 
     infectious diseases risks).
       The programs and authorities contained within PAHPA provide 
     essential resources for communities and health care 
     facilities to prepare for and respond to public health 
     threats. Further, PAHPA provides critical support for the 
     research and development (R&D) of life-saving medical 
     countermeasures (including vaccines, diagnostics, and 
     antimicrobial drugs). In particular, IDSA is pleased to offer 
     our strong support for the provision in H.R. 6378 to 
     reinstate loan repayment authority for the Centers for 
     Disease Control and Prevention to improve programs that train 
     public health responders and future leaders, such as the 
     Epidemic Intelligence Service. We also support the bill's 
     attention to antimicrobial resistance. We look forward to 
     working with the Committee on continued efforts to address 
     this urgent public health threat.
       A successful response to a public health emergency depends 
     upon skilled personnel. Section 115 of H.R. 6378 will 
     strengthen the ability of the CDC to recruit physicians to 
     serve in the Epidemic Intelligence Service--a fellowship 
     program that trains expert responders to infectious disease 
     outbreaks and other public health emergencies. We greatly 
     appreciate your inclusion of this important provision.
       IDSA remains deeply concerned about antimicrobial 
     resistance that threatens our national health security. We 
     appreciate language in Section 302 authorizing the Biomedical 
     Advanced Research and Development Authority to undertake 
     strategic initiatives to address antimicrobial resistance, as 
     well as Section 406 that codifies the Advisory Council on 
     Combating Antibiotic Resistant Bacteria. These substantive 
     efforts will continue to strengthen our national response to 
     antimicrobial resistance, though we believe additional 
     efforts will be essential to spur the research, development 
     and appropriate use of urgently needed new antibiotics.
       Once again, IDSA thanks you for your dedication to our 
     nation's health security. We look forward to continuing to 
     work with you on these crucial issues.
           Sincerely,
     Paul G. Auwaerter, MD, MBA, FIDSA,
       President, IDSA.
                                  ____

                                  National Association of County &


                                        City Health Officials,

                                    Washington, DC, July 18, 2018.
     Hon. Greg Walden,
     Chairman, House Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Susan Brooks,
     U.S. House of Representatives,
     Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, and 
     Representatives Brooks and Eshoo: On behalf of the National 
     Association of County and City Health Officials (NACCHO), I 
     am writing in support of the ``Pandemic and All-Hazards 
     Preparedness Advancing Innovation Act (PAHPAIA) of 2018'' 
     (H.R. 6378). NACCHO is the voice of the nearly 3,000 local 
     health departments across the country that prepare 
     communities for disasters, respond if emergencies occur, and 
     lend support throughout the recovery process. PAHPAIA will 
     provide needed stability for the nation's emergency 
     preparedness and response enterprise. We thank you for your 
     leadership on this legislation that is essential to 
     protecting our nation and look forward to working with you to 
     strengthen the legislation as it moves forward.
       Among the many provisions in the bill, NACCHO highlights 
     the following:


                             PHEP, HPP, MRC

       The programs reauthorized in PAHPAIA are vital to local 
     health departments. The Public Health Emergency Preparedness 
     (PHEP) program and Hospital Preparedness Program (HPP), 
     reauthorized in PAHPAIA, are complementary programs with 
     different purposes. PHEP supports local health departments' 
     response to public health threats and helps to build 
     resilient communities. HPP enables health care systems to 
     save lives during emergencies that exceed day-to-day capacity 
     of health and emergency response systems. In addition, the 
     Medical Reserve Corps (MRC) program provides additional 
     public health personnel to respond to emergency needs as well 
     as everyday health threats.
       The PHEP, HPP and MRC programs deserve a level of funding 
     that is consistent with the threats that are experienced on 
     the ground level in cities and counties across the nation. In 
     2017, Congress spent a record breaking $80 billion to provide 
     relief from Hurricanes Harvey, Irma and Maria, and 
     devastating wildfires in California. Without the support of 
     PHEP, HPP and MRC, the cost could have been much higher. A 
     comprehensive, cost saving and proactive public health 
     approach to disaster preparedness helps communities to 
     effectively mitigate the damage and costs of disasters and 
     help recover in the aftermath. Sustained funding to support 
     local preparedness and response capacity helps local health 
     departments build and convene diverse partners such as 
     police, fire, transportation, planning departments, and 
     community based organizations and develop and implement 
     evidence-based, community-centered strategies.


                        Medical Countermeasures

       NACCHO supports the codification of the Public Health 
     Emergency Medical Countermeasures Enterprise (PHEMCE). The 
     PHEMCE Strategy and Implementation should require that state 
     and local health departments be involved in all phases of the 
     medical countermeasures (MCM) enterprise including in initial 
     investment; research and development of vaccines, medicines, 
     diagnostics and equipment for responding to emerging public 
     health threats; and distribution and dispensing of 
     countermeasures. NACCHO urges that state and local public 
     health departments have a permanent place in the PHEMCE 
     membership to ensure that all decisions that will affect 
     state and local health functions are vetted by public health 
     authorities.
       Current funding, support, and expertise provided to state 
     and local health departments for the Strategic National 
     Stockpile must be maintained regardless of the infrastructure 
     or location of the SNS--it is too vital to this country's 
     ability to respond in the midst of a variety of large-scale 
     emergencies.


                      Public Health Emergency Fund

       NACCHO appreciates that the bill strengthens existing 
     authorities for the Public Health Emergency Fund (PHEF). A 
     standing rapid response fund to provide bridge funding 
     between base preparedness funding and supplemental 
     appropriations for acute emergencies and emerging threats is 
     absolutely necessary.
       NACCHO also appreciates the inclusion of provisions to 
     maintain the pipeline of workers in the Epidemic Intelligence 
     Service and to improve preparedness for children, seniors and 
     people with disabilities. NACCHO appreciates the Committee's 
     acknowledgement that pandemic influenza, antimicrobial 
     resistance and other emerging infectious diseases are under 
     the umbrella of the Biomedical Advanced Research and 
     Development Authority's (BARDA) mission. Recent years have 
     demonstrated that infectious diseases represent as 
     significant a threat to our national security as a natural 
     disaster or terror attack.
       Thank you for your work to strengthen and enhance our 
     nation's preparedness and response system. We look forward to 
     continuing to work with you as this legislation moves 
     forward.
           Sincerely,
                                        Lori Tremmel Freeman, MBA,
     Chief Executive Officer.
                                  ____

                                               The Partnership for


                                Inclusive Disaster Strategies,

                                    Charleston, SC, July 18, 2018.
     Letter of Support for H.R. 6378--Pandemic and All-Hazards 
         Preparedness and Advancing Innovation Act of 2018.

       Dear Representative Eshoo and Representative Brooks: The 
     Partnership for Inclusive Disaster Strategies (the 
     Partnership) is the nation's only coalition of national, 
     state and local stakeholder organizations working together to 
     advocate for equal access to emergency and disaster services 
     and programs for children and adults with disabilities 
     before, during and after disasters. The footprint of our 
     membership reaches every congressional district in the 
     country, with a presence in virtually every community.
       The Partnership drives disability community leadership, 
     training, technical assistance, policy and operational 
     initiatives that improve outcomes for disaster impacted 
     communities through self-determination, health, safety, 
     independence, empowerment, integration and inclusion of 
     children and adults with disabilities in all aspects of 
     community preparedness, response and disaster resilience.
       Our leaders include the nation's leading experts on 
     disability inclusive emergency management. We have maintained 
     a daily presence in support of disaster response, recovery 
     and mitigation initiatives in TX, FL. USVI and PR since 
     hurricanes Harvey, Irma and Maria made landfall in 2017, and 
     our current focus includes the impact on individuals

[[Page H8783]]

     with disabilities and disaster impacted communities from the 
     wild fires in CA and the lava flows in Hawaii.
       Despite thousands of disaster related deaths and the 
     disproportionate impact of the disasters on countless people 
     with ``chronic health conditions'' (also clearly defined as 
     disabilities under the ADA legal definition) in 2017 & 2018, 
     the recently released FEMA After Action Report only mentions 
     disability in a footnote and a list of acronyms defining the 
     position of Disability Integration Advisors, never in any 
     other context.
       Further, according to FEMA, ``the hurricanes and wildfires 
     collectively affected more than 47 million people--nearly 15 
     percent of the Nation's population''. Given these statistics, 
     it is likely that close to 10 million of these disaster 
     impacted individuals should have been provided with the civil 
     rights protections of equal access to emergency services and 
     programs. It is unfortunate that there is no indication of 
     any focus in the document on FEMA's obligations, efforts or 
     recommendations.
       Clearly there is an urgent need for advice and consultation 
     from disability inclusive emergency management experts to 
     improve outcomes for disaster impacted children and adults 
     with disabilities and their communities.
       We are writing in support of H.R. 6378-Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018, 
     with specific support for Section 110, the establishment of a 
     NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES 
     IN ALL-HAZARDS EMERGENCIES.
       The Advisory Committee will:
       1. provide advice and consultation with respect to 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;
       2. evaluate and provide input with respect to the public 
     health, accessibility, and medical needs of individuals with 
     disabilities as they relate to preparation for, response to, 
     and recovery from all-hazards emergencies; and
       3. provide advice and consultation with respect to State 
     emergency preparedness and response activities, including 
     related drills and exercises pursuant to the preparedness 
     goals under section 2802(b).
       We are especially interested in the Committee report which 
     will include recommendations that offer specific improvements 
     that could be made across local, State, tribal, territorial, 
     and Federal efforts to improve outcomes in areas that 
     include--
       ``(A) preparedness;
       ``(B) planning;
       ``(C) exercises and drills;
       ``(D) alerts, warning, and notifications;
       ``(E) evacuation;
       ``(F) sheltering;
       ``(G) health maintenance;
       ``(H) accessing emergency programs and services;
       ``(I) medical care (including mental health care);
       ``(J) temporary housing;
       ``(K) mitigation; and
       ``(L) community resilience; and
       ``(2) assess the strength of existing policies to 
     incorporate such individuals as well as the efficacy of 
     implementation.
       We offer our enthusiastic support for the membership of 
     this Committee, which will include
       at least four representatives who are individuals with 
     disabilities that have substantive expertise in disability 
     inclusive emergency management policy and operations;
       at least two non-Federal health care professionals with 
     expertise in disability accessibility before, during, and 
     after disasters, medical and mass care disaster planning, 
     preparedness, response, or recovery; and
       at least two representatives from State, local, 
     territorial, or tribal agencies with expertise in disability-
     inclusive disaster planning, preparedness, response, or 
     recovery.
       The Partnership applauds your leadership and welcomes every 
     opportunity to work with you, and your colleagues to ensure 
     that establishment of this vital Advisory Committee is 
     included in final passage of the Pandemic and All-Hazards 
     Preparedness and Advancing Innovation Act of 2018.
           Sincerely,
                                                      Marcie Roth,
     Chief Executive Officer.
                                  ____



                                        PEW Charitable Trusts,

                                    Washington, DC, July 17, 2018.
     Hon. Greg Walden,
     Chairman, House Energy and Commerce Committee, Washington, 
         DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy and Commerce Committee, 
         Washington, DC.
     Hon. Susan W. Brooks,
     House Energy and Commerce Committee, Washington, DC.
     Hon. Anna G. Eshoo,
     House Energy and Commerce Committee, Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, Congresswoman 
     Brooks and Congresswoman Eshoo: The Pew Charitable Trusts 
     thanks you for your continued efforts to respond to the 
     ongoing threat of antibiotic resistance through the 
     introduction of H.R. 6378, the Pandemic and All-Hazards 
     Preparedness and Advancing Innovation Act of 2018 (PAHPA). 
     This important legislation reauthorizes the essential work of 
     the HHS Office of the Assistant Secretary for Preparedness 
     and Response (ASPR)'s Biomedical Advanced Research and 
     Development Authority (BARDA) to address public health 
     emergencies and bring desperately-needed antibiotics to 
     patients. Effective antibacterials are central to the 
     nation's ability to respond to public health threats, 
     including chemical, biological, radiological, and nuclear 
     attacks (CBRN), pandemic influenza, and emerging infectious 
     disease--antibiotics are an integral part of the nation's 
     armament to address these threats.
       We especially want to thank the Members of the House Energy 
     and Commerce Committee for including language related to 
     antibiotic resistance in Section 302 of PAHPA. This language 
     will ensure that BARDA is explicitly authorized to address 
     all CBRN threats--both intentional and naturally occurring--
     through robust support of innovative approaches in both 
     preclinical and clinical development. BARDA's unique 
     experience working with industry to drive innovation is 
     particularly important to advance novel therapeutics and 
     preventive interventions and to help bridge the gap between 
     basic science and successful clinical drug development.
       BARDA safeguards our nation's health infrastructure by 
     revitalizing and encouraging antibacterial innovation to 
     ensure that we have a healthy pool of candidate products to 
     address emerging threats. The CARB-X accelerator addresses 
     critical gaps along the early stages of the antibacterial 
     pipeline, and BARDA's Broad Spectrum Antimicrobials program 
     advances therapeutics into late stage clinical development. 
     The two programs work in tandem to support a robust pipeline 
     of novel approaches for highly resistant infections and 
     emerging threat pathogens.
       Thank you for continued support of this important work.
           Sincerely,
                                                 Kathy Talkington,
     Antibiotic Resistance Project Director.
                                  ____

                                           American Association of


                                       Poison Control Centers,

                                    Alexandria, VA, July 20, 2018.
     Hon. Susan Brooks,
     Washington, DC.
     Hon. Anna Eshoo,
     Washington, DC.
       Dear Congresswomen Brooks and Eshoo: The American 
     Association of Poison Control Centers (AAPCC) would like to 
     extend our support for H.R. 6378, the Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018.
       As you already know, AAPCC supports the nation's 55 poison 
     control centers in their efforts to prevent and treat poison 
     exposures. Poison control centers across the U.S. receive 
     approximately 3 million calls annually that cover a variety 
     of substances, including prescription and over-the-counter 
     medications, illegal drugs, household products, pesticides, 
     cosmetics, environmental toxins, food, plants, and animal 
     bites and stings. These calls come from a wide variety of 
     individuals, including the public, health care providers, 911 
     PSAPs (Public Safety Answering Points), schools, health 
     departments, law enforcement, and other safety agencies. The 
     centers operate 24 hours a day, 7 days a week, 365 days a 
     year and are accessed through a federally funded nationwide 
     toll free number: 800-222-1222 (Poison Help).
       When someone calls 800-222-1222, the calls are answered by 
     highly trained Specialists in Poison Information (pharmacists 
     and nurses), who diagnose, triage, and offer treatment 
     recommendations to callers with 24-hour oversight from Board 
     Certified Medical and Clinical Toxicologists. We answer calls 
     from every state and territory in our nation. We know that 
     you and your staff are already familiar with the wonderful 
     work of the Indiana Poison Center and the California Poison 
     Control System.
       There are three references, all in Title II, to poison 
     centers in Public Law 113-5 (the Pandemic and All-Hazards 
     Preparedness Reauthorization Act of 2013). These provisions 
     allow states and public health departments to work directly 
     with their regional poison center and have resulted in 
     improved preparedness preparations in multiple communities 
     throughout the nation. Thank you for keeping these poison 
     center references in H.R. 6378.
       We also deeply appreciate your inclusion of poison centers 
     in Section 207, Regional Health Care Emergency Preparedness 
     and Response Systems. Poison centers have a unique set of 
     knowledge and are the primary source for poisoning 
     information. Our employees are trained to handle stressful, 
     potentially life altering situations on a daily basis and we 
     already have the infrastructure in place as a 24/7 365 days a 
     year call center. We are a vital resource on a number of 
     topics from chemical spills to mass exposure to an unknown 
     toxin to a public health emergency including the pandemic flu 
     or Ebola and Zika. The poison control system is a well-
     established, nationwide network made up of sophisticated and 
     specially trained medical professionals who handle calls 
     related to over 420,000 products and substances and their 
     related toxicities.
       Our poison centers support your efforts and look forward to 
     our work together on this important topic. Finally, a special 
     thank you to your staff, Catherine Knowles and Rachel Fybel 
     for all of their assistance. Thank you, as always, for your 
     continued support of our 55 poison centers.
       Warmest regards,
     William Banner, Jr., MD, PhD,
       President, AAPCC, Oklahoma Center for Poison & Drug 
     Information.

[[Page H8784]]

  

     Stephen Kaminski, JD,
       CEO and Executive Director, AAPCC.

  Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters 
in the Record.
                                                  American Society


                                             for Microbiology,

                                    Washington, DC, July 23, 2018.
     Hon. Paul Ryan,
     Speaker of the House, House of Representatives, Washington, 
         DC.
     Hon. Greg Walden,
     Chairman, Energy and Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Susan Brooks,
     House of Representatives, Washington, DC.
     Hon. Nancy Pelosi,
     Minority Leader, House of Representatives, Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, Energy and Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Speaker Ryan, Minority Leader Pelosi, Chairman Walden, 
     Ranking Member Pallone, Representative Brooks and 
     Representative Eshoo: The American Society for Microbiology 
     (ASM) congratulates the Energy and Commerce Committee on its 
     passage of the Pandemic and All-Hazards Preparedness and 
     Advancing Innovation Act of 2018 (H.R. 6378) and encourages 
     its swift passage in the House.
       ASM is the largest single life science society, composed of 
     more than 32,000 scientists and health professionals. Our 
     mission is to promote and advance the microbial sciences, 
     including programs and initiatives funded by the federal 
     government departments and agencies, by virtue of the 
     pervasive role of microorganisms in health and society.
       Antimicrobial resistance is among the most consequential 
     issues facing world today. ASM is therefore pleased that H.R. 
     6378 includes Section 406, a provision that would guarantee 
     the continued work of the Presidential Advisory Council on 
     Combating Antibiotic-Resistant Bacteria (PACCARB) by 
     codifying the Advisory Council. A guarantee of PACCARB's 
     continuance also sustains the One Health partnerships--the 
     integration of human, animal, and environmental domains--that 
     have been formed since the establishment of PACCARB.
       This year marks the 100th anniversary of the Influenza 
     Pandemic of 1918, which killed almost 40 million people, and 
     serves a reminder that the United States must be prepared to 
     rapidly respond to declared and potential public health 
     emergencies, including infectious disease epidemics.
       ASM strongly supports the legislation's reauthorization of 
     the Biomedical Advanced Research Development Authority 
     (BARDA) and is pleased to see inclusion and authorization of 
     a Pandemic Influenza Program and Emerging Infectious Disease 
     Program. Authorization of funding for the Strategic National 
     Stockpile and the Bioshield Special Reserve Fund are all 
     critically important to our public health security. 
     Therefore, it is important that reauthorization be met with a 
     corresponding commitment of federal resources.
       Lastly, ASM appreciates that the legislation points to the 
     need for an adequately funded Public Health Emergency Fund 
     (PHEF) and strengthens existing authorities for which PHEF 
     dollars may be used, including in anticipation of a potential 
     public health emergency. Vigilance will be required to make 
     sure our country is adequately prepared to make financial 
     resources available in a timely manner to potential or 
     immediate public health emergencies, and so we look forward 
     to your continued leadership in this regard.
       ASM believes that H.R. 6378 will further our nation's 
     preparedness to respond in a timely and coordinated manner to 
     declared and potential public health threats. Toward this 
     end, ASM strongly supports swift final passage by the Senate 
     and House. We appreciate your championship of these issues 
     and stands ready to work with you towards this goal. Should 
     you have any questions, please contact Allen Segal, Director, 
     ASM Public Policy and Advocacy.
           Sincerely,
     Stefano Bertuzzi, Ph.D., MPH,
       CEO, American Society for Microbiology.
     Allen D. Segal,
       Director, Public Policy and Advocacy, American Society for 
     Microbiology.
                                  ____



                                    ASTHO, September 23, 2018.

     Hon. Lamar Alexander,
     Chairman, Health, Education, Labor and Pensions Committee, 
         U.S. Senate, Washington, DC.
     Hon. Gregg Walden,
     Chairman, Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Patty Murray,
     Ranking Member, Health, Education, Labor and Pensions 
         Committee, U.S. Senate, Washington, DC.
     Hon. Frank Pallone, Jr,
     Ranking Member, Energy & Commerce Committee, House of 
         Representatives, Washington, DC.
       Dear Chairman Alexander, Ranking Member Murray, Chairman 
     Walden, and Ranking Member Pallone: The Association of State 
     and Territorial Health Officials (ASTHO) submits this letter 
     in support of most of the public health provisions included 
     in the ``Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018'' (H.R. 6378). ASTHO is the national 
     nonprofit organization representing the state and territorial 
     public health agencies of the United States, U.S. 
     territories, and Washington, D.C. ASTHO's members, the chief 
     health officials of these jurisdictions, are dedicated to 
     formulating and influencing sound public health policy and 
     assuring excellence in public health practice.
       ASTHO is pleased that this bill retains elements proven to 
     be necessary, reasonable, and successful, while making 
     further refinements to the underlying statute, as well as 
     responding to and including many of ASTHO's priorities. These 
     priorities, outlined in previously submitted comment letters, 
     include suggestions for clarifications and acknowledgments 
     regarding the importance of state, local, territorial, and 
     tribal public health. These provisions include:
       Reauthorizing the Public Health Emergency Preparedness 
     Program (PHEP) and Hospital Preparedness Program (HPP). PHEP 
     and HPP are key to the foundational capabilities of public 
     health preparedness and healthcare
       Codifying the role of CDC to administer the PHEP program
       Bolstering the Public Health Emergency Rapid Response Fund 
     and mechanisms to quickly distribute funds
       Requiring that the Public Health Emergency Medical 
     Countermeasure Enterprise (PHEMCE) solicit and consider input 
     from state, local, tribal, and territorial public health 
     departments or officials
       Improving the nation's ability to take a ``OneHealth'' 
     approach to preparedness and response capabilities
       Reauthorizing the temporary reassignment of state and local 
     personnel during public health emergencies
       Requiring the HHS secretary, in collaboration with ASPR and 
     CDC, to maintain the strategic national stockpile
       Including a provision to strengthen the Epidemic 
     Intelligence Service by increasing the loan repayment amount 
     from $35,000 to $50,000
       In addition, ASTHO expresses our concern and seeks 
     clarification from the committee on changes to HPP, 
     particularly those that alter eligibility requirements for 
     funding from a ``partnership'' to``coalitions.'' One of the 
     most crucial functions of HPP is to bring together and 
     incentivize ``diverse and often competitive healthcare 
     organizations to work together.'' As neutral conveners, state 
     and territorial public health departments are the most 
     appropriate entities and stewards of taxpayer dollars. They 
     are also responsible for statewide planning and coordination 
     of services and fundamentally serve all residents in their 
     jurisdictions--not just lives covered under a plan or 
     specific catchment area. With the establishment of hundreds 
     of Healthcare Coalitions across the country, ASTHO seeks 
     assurance that the letter, spirit, and intent of this 
     modification does not in any way change the current 
     cooperative agreement structure and stature, nor does it 
     alter the role and responsibilities of states, territories, 
     and directly-funded cities as awardees of funds under HPP.
       ASTHO also remains concerned that authorization levels--
     $685 million for PHEP and $385 million for HPP--are 
     significantly lower than our suggested authorization levels 
     of $824 million for PHEP and $474 million for HPP. ASTHO is 
     concerned that authorizing at these proposed levels will be 
     insufficient. Both PHEP and HPP must be resourced at 
     sufficient levels to ensure that every community is prepared 
     for disasters. An efficient and effective state and local 
     workforce depends heavily on reliable, ongoing funding 
     support for a network of state and local expertise, 
     relationships and trust that is carefully built over time 
     through shared responses, training, and exercises.
       Regarding sections that speak to ``reservations of amounts 
     for regional systems,'' ASTHO would also like to reiterate 
     that HPP is already funded at a vastly insufficient level 
     given the task of preparing the healthcare system for a surge 
     of patients, continuity of operations, and recovery. Any 
     funding reductions to HPP through a tap will have an adverse 
     impact on real-time all-hazards preparedness and response 
     activities carried out by the existing healthcare coalitions. 
     The costs associated with exploring the development of a 
     regional system or network should not be at the expense of 
     current critical medical readiness and patient care services.
       Finally, while we appreciate that the bill strengthens 
     existing authorities for the Public Health Emergency Fund, we 
     continue to urge Congress to create a mechanism to fund and 
     replenish it. Without sufficient and dedicated funding, it 
     will be impossible to quickly access funds when needed.
       ASTHO appreciates the opportunity to provide our comments 
     on this critical legislation and the bipartisan efforts of 
     both the House and Senate committees.
           Sincerely,
     John Wiesman, DrPH, MPH,
       ASTHO President, Secretary of Health, Washington State 
     Department of Health Olympia, WA.

[[Page H8785]]

     
                                  ____
                                          Biotechnology Innovation


                                                 Organization,

                                               September 24, 2018.
     Hon. Susan Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Representatives Brooks and Eshoo: On behalf of the 
     Biotechnology Innovation Organization (BIO), I am writing to 
     express our strong support for final passage of H.R. 6378, 
     the ``Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018''. I wish to commend you for your 
     extraordinary work getting this legislation to the House 
     floor.
       BIO represents more than 1,000 biotechnology companies, 
     academic institutions, state biotechnology centers and 
     related organizations across the United States and in more 
     than 30 other nations. BIO's members are committed to 
     investing in, developing, and delivering innovative vaccines, 
     therapeutics, and diagnostic tools that are transforming how 
     we protect, treat and cure people from devastating infectious 
     diseases. Many of BIO's members are active partners with the 
     U.S. government to strengthen our national health security 
     through the development and stockpile of medical 
     countermeasures (MCM) against the myriad threats facing our 
     nation. The value that these MCMs offer to first responders, 
     patients and their caregivers, and the global community is 
     phenomenal.
       BIO was pleased to see the Act continue to provide support 
     for critical preparedness programs such as the BioShield 
     Special Reserve Fund (SRF), the Biomedical Advanced Research 
     and Development Authority (BARDA), and the Strategic National 
     Stockpile (SNS)--all of which are necessary to ensure that we 
     can maintain a robust medical countermeasures enterprise that 
     can address known and unknown threats. We are also pleased to 
     see that significant threats such pandemic influenza, 
     emerging infectious diseases, and antimicrobial resistance 
     are specifically recognized in the Act and that BARDA has 
     been authorized appropriations to address these dangerous 
     threats. We are very supportive of the overall authorization 
     of $2.4 billion annually to the MCM enterprise, which will 
     allow the Secretary of Health and Human Services to more 
     fully prepare for many of the threats affecting our national 
     health security.
       BIO thanks you for your commitment to our national health 
     security and your important work to ensure that our nation is 
     adequately prepared to respond to the myriad threats we face 
     domestically and abroad. BIO and our member companies look 
     forward to continuing to work with you to further strengthen 
     our preparedness against all potential national security and 
     public health threats as outlined in the National Biodefense 
     Strategy.
           With Sincerest Regards,
                                               James C. Greenwood,
     President and CEO.
                                  ____



                         California Life Sciences Association,

                                                    July 16, 2018.
     Hon. Susan Brooks,
     Washington, DC.
     Hon. Anna G. Eshoo,
     Washington, DC.
       Dear Representatives Brooks and Eshoo: On behalf of 
     California Life Sciences Association (CLSA)--the statewide 
     public policy organization representing California's leading 
     life science innovators, including medical device, 
     diagnostic, biotechnology and pharmaceutical companies, 
     research universities and private, non-profit institutes, and 
     venture capital firms--I am writing to express our support 
     for H.R. 6378, the Pandemic and All Hazards Preparedness and 
     Advancing Innovation (PAHPAI) Act of 2018, your legislation 
     that will strengthen and improve our national preparedness 
     and response for public health emergencies, and accelerate 
     medical countermeasure research and development. Thank you 
     for your leadership on this critically important issue.
       As you know, the recent Ebola and Zika outbreaks and 
     ongoing threats from terrorist organizations like ISIS have 
     repeatedly exposed our nation's continued vulnerability to 
     bioterror and pandemic threats, demonstrating the need for 
     robust biodefense preparedness. Robust, long-term funding, 
     and strong and sustained public-private partnerships remain 
     critical in ensuring a well-funded, well-coordinated, swift 
     and effective response from all stakeholders. This includes, 
     critically, a robust statutory framework for securing our 
     nation from chemical, biological, radiological, and nuclear 
     (CBRN) threats, as well as from pandemic influenza (PI), 
     antimicrobial resistance (AMR), and emerging infectious 
     diseases (EID).
       To that end, H.R. 6378 strengthens our country's national 
     preparedness and response efforts for public health 
     emergencies by codifying the Public Health Emergency Medical 
     Countermeasure Enterprise and the duties of the Assistant 
     Secretary for Preparedness and Response (ASPR), while 
     maintaining the important role of the Centers for Disease 
     Control in emergency and response activities. The legislation 
     also provides the authorization and federal resources to 
     invest in programs related to Pandemic Influenza and Emerging 
     Infectious Diseases.
       We are pleased the bill provides new authorities to the 
     Director of the Biomedical Advanced Research and Development 
     Authority (BARDA) to develop strategic initiatives for 
     threats that pose a significant level of risk to national 
     security, including antimicrobial resistant pathogens. We 
     also encourage you to continue working with you colleagues on 
     the House Committee on Energy & Commerce and congressional 
     leadership to explore the creation of new incentives to 
     encourage investment into the development of products to 
     treat or prevent a disease attributable to a multi-drug 
     resistant bacterial or fungal pathogen.
       According to the Centers for Disease Control and Prevention 
     (CDC), each year at least two million people in the United 
     States are infected with bacteria that cannot be treated with 
     an antibiotic, resulting in roughly 23,000 deaths and health 
     care costs as much as $20 billion annually. These staggering 
     statistics illustrate a dangerous reality: even as the rate 
     of anti-microbial resistance has grown, research and drug 
     development has not kept pace with the dire need for new 
     medicines to treat these increasingly lethal ``superbugs.''
       Given the threat that these deadly pathogens pose to public 
     health in the United States and across the world, the need 
     for effective public-private partnerships between the 
     government, academia and industry has never been greater. The 
     growing epidemic of multidrug-resistant infections knows no 
     borders and the reestablishment of antibiotic development as 
     a viable investment for life sciences innovators is 
     imperative to public health and preparedness.
       Thank you again for your leadership of H.R. 6378, as well 
     as your long-standing support for legislation and policy 
     measures that improve our nation's biodefense preparedness 
     and response capabilities.
       CLSA is pleased to join a broad group of stakeholders in 
     offering our strong support for H.R. 6378, the Pandemic and 
     All Hazards Preparedness and Advancing Innovation Act of 
     2018. Please let me know if CLSA can be of assistance to you.
           Sincerely,

                                         Jennifer Nieto Carey,

                                Vice President--Federal Government
     Relations & Alliance Development.
                                  ____



                                                    Cellphire,

                                     Rockville, MD, July 18, 2018.
     Hon. Greg Walden,
     Chairman, House Energy and Commerce Committee, Washington, 
         DC.
     Hon. Susan Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy and Commerce Committee, 
         Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone and 
     Representatives Brooks and Eshoo: We write in support of HR 
     6378, the Pandemic and All Hazards Preparedness Act (PAHPA) 
     Reauthorization. Cellphire supports the Committee's inclusion 
     of the national blood supply in the Committee mark-up of 
     PAHPA. Numerous inquiries and hearings conducted after 9/11 
     revealed the need for a coordinated response to insure 
     preparedness through maintaining an adequate blood supply and 
     providing a rapid coordinated response system to distribute 
     blood products immediately to the affected area(s) as well as 
     recruit and manage donations required for continual resupply 
     during the crisis. The need for a coordinated response to the 
     nation's blood needs was first recognized in the National 
     Response Plan, Emergency Support Function #8, Public Health 
     and Medical Services Annex:
       Blood, Organs, and Blood Tissues--ESF #8 may task HHS 
     components and request assistance from other ESF #8 partner 
     organizations to monitor and ensure the safety, availability, 
     and logistical requirements of blood, organs, and tissues. 
     This includes the ability of the existing supply chain 
     resources to meet the manufacturing, testing, storage, and 
     distribution of these products.
       We applaud the Committee's recognition of the national 
     blood supply's importance as referenced in Section 116 which 
     requires the Secretary of Health and Human Services to 
     provide a report on recommendations related to maintaining an 
     adequate blood supply Hospitals across the nation as well as 
     blood product companies like Cellphire are dependent on the 
     stability of the blood supply and the ability of the U.S. 
     blood supply ``system'' to respond to disaster. The 
     organizations representing the nation's blood centers, 
     hospital-based blood banks and transfusion services, and 
     transfusion medicine professionals have requested that you 
     consider asking the Office of the Assistant Secretary for 
     Preparedness and Response (ASPR) to make the sustainability 
     of our nation's blood supply a critical element of our 
     emergency preparedness and response systems. In addition, a 
     joint letter to the New England Journal of Medicine authored 
     by Harvey Klein MD, Chief Department of Medicine, the NIH 
     Clinical Center, Chris Hrouda, President ARC Biomedical 
     Services, and Jay Epstein MD, Director, Office of Blood 
     Research and Review, Center for Biologics Evaluation and 
     Research, FDA, warned of an approaching crisis in the 
     sustainability of the U.S. Blood System. The concern 
     regarding the sustainability and responsiveness of the U.S. 
     blood supply was also raised by a RAND Corporation study 
     initiated by the Department of Health and Human Services, 
     ``Toward a Sustainable Blood Supply in the United States, An 
     Analysis of the Current System and Alternatives to the 
     Future''.

[[Page H8786]]

       The goal at Cellphire, currently supported by the ASPR 
     through BARDA, is to develop and field a freeze-dried 
     platelet product to stop hemorrhage that can alleviate 
     platelet shortages and lead to a life-saving product that 
     controls bleeding and can be stockpiled. Supplying, 
     distributing and resupplying this and other blood products 
     during a crisis requires a sustainable blood supply.
       The PAHPA Re-authorization bill includes language for the 
     Assistant Secretary of Preparedness Response (ASPR) to 
     include the stability of the blood supply as it considers 
     guidelines for infrastructure. Section 203 further lists the 
     blood banks in the stakeholder groups with whom ASPR should 
     engage to obtain feedback on financial implications as it 
     relates to regional preparedness planning pursuant to the 
     guidelines.
       We believe the reference to the national blood supply and 
     the inclusion of the blood collection centers and hospital 
     blood banks in ASPR guidelines to establish infrastructure 
     and regional preparedness planning will ensure our nation's 
     blood supply is ready and prepared for surge capacity in the 
     event of a disaster or terrorist attack.
       Thank you for your leadership in addressing the blood 
     supply in HR 6378, the PAHPA Reauthorization. We support the 
     Committee's attention to this urgent matter of national 
     security.
           Sincerely,
     Michael Fitzpatrick, Ph.D , COL (Ret.) U.S. Army,
       President and Director of Research, Cellphire, Inc.
                                  ____

                                            Coalition for Epidemic


                                     Preparedness Innovations,

                                                    July 17, 2018.
     Hon. Greg Walden,
     Chairman,
     Washington DC.
     Hon. Frank Pallone,
     Ranking, Energy and Commerce Committee, Washington DC.
       Dear Chairman Walden and Ranking Member Pallone: I write in 
     strong support of HR 6378, the Pandemic and All-Hazards 
     Preparedness and Advancing Innovation Act (PAHPA.) As you 
     know, public health emergencies can result from natural 
     disasters, emerging pathogens, or man-made threats. Just last 
     year we saw health challenges emerge on multiple fronts due 
     to hurricanes, a virulent strain of the flu, and outbreaks of 
     plague, Lassa, Nipah and Ebola overseas. The United States 
     must do everything in its power to prepare for health 
     emergencies, and HR 6378 goes a long way towards helping the 
     Department of Health and Human Services (HHS) achieve that 
     goal.
       As the CEO of CEPI, an international coalition whose 
     mission it is to develop vaccines to prevent future 
     epidemics, I am heartened to see language in the bill asking 
     HHS to report on its work developing vaccines to prevent 
     epidemics, including its collaborations with international 
     organizations (Section 303). As we saw in the recent Ebola 
     outbreak in the Democratic Republic of Congo, vaccines and 
     international coalitions can play a critically important role 
     in outbreak response and HHS should maximize its support for 
     this kind of vaccine research and development.
       I am also pleased that HR 6378 creates an emerging 
     infectious disease program within the Biomedical Advanced 
     Research and Development Authority (BARDA) [Section 302]. 
     CEPI would welcome the opportunity to partner with BARDA on 
     future vaccine candidates for emerging infectious diseases of 
     global significance. In addition, the codification of the 
     Public Health Emergency Medical Countermeasure Enterprise 
     (PHEMCE) is another important feature of this bill [Section 
     101]. The PHEMCE works to ensure that medical countermeasure 
     development is aligned across the government and that 
     bottlenecks can be anticipated and prevented, which is 
     important to prevent costly duplication of work and other 
     inefficiencies.
       In summary, I believe that HR 6378 will strengthen US 
     public health preparedness, particularly when it comes to 
     vaccines and medical countermeasure development and 
     coordination, and I am pleased that it will be considered by 
     your committee.
           Sincerely,
                                            Richard Hatchett, CEO.

  Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters 
in the Record.


                                                        Cerus,

                                       Concord, CA, July 17, 2018.
     Hon. Greg Walden,
     Chairman, House Energy and Commerce Committee, House of 
         Representatives, Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Energy & Commerce Committee, House of 
         Representatives, Washington, DC,
       Dear Chairman Walden and Ranking Member Pallone: As you 
     review and deliberate over H.R. 6378, the Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018, we 
     wanted to provide our support for the efforts in the 
     legislation to preserve and protect the nation's blood 
     supply--especially in a public health emergency.
       As you know, the American public expects the nation's blood 
     supply is safe and available every day, but especially in 
     situations of natural or man-made disasters. Blood 
     transfusions can be lifesaving measures, but this depends on 
     our collective ability to ensure the safety and availability 
     of the blood supply. Though the danger of transfusion-
     transmitted infections has decreased in recent years due to 
     improved blood testing for specific pathogens such as HIV and 
     hepatitis, these tests do not detect the presence of all 
     viruses, bacteria, and parasites known to contaminate blood 
     donations. In 2015 at the height of the Zika epidemic in 
     Puerto Rico, the FDA released guidance calling for the use of 
     blood treatment pathogen reduction technology as an option to 
     reduce the risk of transfusion-transmission of Zika. This 
     pathogen reduction technology helped ensure that very ill 
     patients would have adequate access to safe blood and that 
     they would not contract Zika virus infection from their 
     therapeutic blood transfusions.
       Section 116 is critical to ensuring the blood collection 
     community, in concert with the Department of Health and Human 
     Services, begins to cohesively examine the challenges with 
     preserving capacity in the nation's blood supply for major 
     emergency care, addressing issues like recruiting sufficient 
     donors to ensure the adequacy of the current supply to meet 
     public health emergencies and implementation of innovative 
     and best safety practices.
       The inclusion of blood banks in Section 203 is also 
     critical for ensuring the blood banking community has an 
     opportunity to engage along with hospitals, health care 
     facilities, public agencies and others to provide input into 
     our nation's new ``Healthcare Preparedness and it Response 
     Program.'' The inclusion of blood banks is critical in 
     providing feedback on the financial implications for the 
     program as the industry faces many challenges in ensuring a 
     transfusion-ready blood supply.
       I sincerely appreciate the time and effort that both of 
     you, your fellow Committee members and the staff have placed 
     in drafting, reviewing, and deliberation over H.R. 6378. I 
     look forward to continuing to work with all of you in 
     supporting our nation's ability to respond in public health 
     emergencies.
           Sincerely,
                                           Dr. Laurence Corash, MD
     Chief Scientific Officer, Cerus.
                                  ____

                                                    July 19, 2018.
     Hon. Greg Walden,
     Chairman, Committee on Energy and Commerce, Washington, DC.
     Hon. Susan W. Brooks,
     Washington, DC.
     Hon. Frank Pallone, Jr.,
     Ranking Member, Committee on Energy and Commerce, Washington, 
         DC.
     Hon. Anna Eshoo,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, and 
     Representatives Brooks and Eshoo: Child Care Aware of America 
     cares deeply about the health and well-being of children and 
     their success in child care. We would like to thank you for 
     your bipartisan commitment to reauthorizing the Pandemic and 
     All-Hazards Preparedness Act. As the Pandemic and All-Hazards 
     Preparedness (PAHPA) and Advancing Innovation Act of 2018 
     moves forward, we want to voice our support for extending and 
     expanding the authorization of the National Advisory 
     Committee on Children and Disasters (NACCD) to address the 
     ongoing gaps in our nation's preparedness and response for 
     children. Recent natural disasters such as Hurricanes Harvey, 
     Irma and Maria have demonstrated that our nation still is not 
     fully prepared to respond to the child care needs of 
     children.
       We also appreciate the proposed additional expertise to the 
     NACCD to include non-federal experts in pediatric mental or 
     behavioral health, pediatric infectious disease, children's 
     hospitals, and children and youth with special health care 
     needs, and particularly, professionals with expertise in 
     child care or school settings.
       The NACCD was established to provide advice and 
     consultation to the Department of Health and Human Services 
     (HHS) Secretary and the Assistant Secretary for Preparedness 
     and Response (ASPR) on issues related to the medical and 
     public health needs of children before, during, and after 
     disasters. The NACCD has completed several reports in recent 
     years focused on youth leadership, surge capacity, and the 
     provision of human services. Their expertise has been 
     invaluable in ensuring that children are protected during 
     public health emergencies and disasters.
       Our organization learned that after Hurricane Irma, 22% of 
     the child care facilities in the state of Florida were closed 
     due to the storm. In the Miami-Dade-Monroe area specifically, 
     32% of facilities were closed. Following Hurricane Harvey, 
     18% of child care facilities were closed in the Houston area. 
     This means that thousands of children and their families were 
     left without child care. This carries an incredible burden on 
     families as they struggle to find child care when they are 
     needed at work. Furthermore, the interruption of normalcy can 
     cause stress on children leading to negative consequences for 
     brain development. Including expertise in child care will 
     help in making sure that the needs of the 11 million children 
     in child care will be met before, during, and after a 
     disaster.
       Children are not little adults. They have specialized needs 
     that must be considered when planning for, responding to, and 
     recovering from a disaster. This includes having a strong, 
     well-funded public health and medical system. We thank you 
     considering the many needs of children and including them

[[Page H8787]]

     in the Pandemic and All-Hazards Preparedness (PAHPA) and 
     Advancing Innovation Act of 2018.
           Sincerely,
     Child Care Aware of America.
                                  ____



                                                CHIME & AEHIS,

                                                    July 23, 2018.
     Re Inclusion of Cybersecurity in the Pandemic and All-Hazards 
         Preparedness and Advancing Innovation Act of 2018
     Hon. Greg Walden,
     Chairman, House Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
     Hon. Frank Pallone,
     Ranking Member, House Committee on Energy and Commerce, House 
         of Representatives, Washington, DC.
       Dear Chairman Walden and Ranking Member Pallone: The 
     College of Healthcare Information Management Executives 
     (CHIME) and the Association for Executives in Healthcare 
     Information Security (AEHIS) sincerely appreciate the 
     inclusion of cybersecurity provisions in section 401 of the 
     Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018. This critical section of legislation 
     recognizes the importance of ensuring the nation's health 
     systems are better prepared and better able to respond in the 
     event of a cybersecurity incident.
       CHIME is an executive organization dedicated to serving 
     chief information officers (CIOs), chief medical information 
     officers (CMIOs), chief nursing information officers (CNIOs) 
     and other senior healthcare IT leaders. Consisting of more 
     than 2,600 members in 51 countries, our members are 
     responsible for the selection and implementation of clinical 
     and business technology systems that are facilitating 
     healthcare transformation. CHIME members are among the 
     nation's foremost health IT experts, including on the topic 
     of cybersecurity. Launched by CHIME in 2014, AEHIS represents 
     more than 850 chief information security officers (CISOs) and 
     provides education and networking for senior IT security 
     leaders in healthcare. CHIME and AEHIS members take their 
     responsibility to protect the privacy and security of patient 
     data and devices networked to their system very seriously.
       The widespread attacks experienced by health systems 
     worldwide during the spring of 2017 highlighted the need to 
     consider the cybersecurity readiness of the healthcare sector 
     and demonstrated the importance of increased preparedness and 
     rapid response in the event of an incident. Cybersecurity 
     threats are growing in frequency and sophistication coming 
     from a variety of actors seeking to send our country's 
     healthcare system into disarray. Our members continue to 
     worry about the threats to patient care and safety posed by 
     cybersecurity attacks.
       CHIME and AEHIS appreciate the inclusion of cybersecurity 
     in the Pandemic All Hazards Preparedness Reauthorization Act 
     of 2018. We agree that cybersecurity threats and the 
     recognition of their potential to disrupt healthcare delivery 
     is of the utmost importance to patient safety and therefore, 
     needs to be a part of the National Health Security Strategy. 
     CHIME and AEHIS believe it is imperative that cybersecurity 
     is treated as a threat to our nation in similarity to other 
     hazards. We also appreciate the designation of the Assistant 
     Secretary for Preparedness and Response (ASPR) as the leader 
     within the Department of Health and Human Services (HHS) in 
     the event of a cybersecurity incident. Our members have 
     repeatedly cited confusion, leading to frustration, about 
     which operating division within HHS has responsibility over 
     cybersecurity and serves as a liaison to the industry.
       We appreciate your continued interest and leadership on 
     this important and increasingly urgent subject. We stand 
     ready to work with you and your colleagues to pursue 
     legislative solutions to improve the cybersecurity readiness 
     of the nation's healthcare sector.
           Sincerely,
     Cletis Earle,
       Chair, CHIME Board of Trustees Vice President, CIO 
     Information Technology,
       Kaleida Health.
     Erik Decker,
       Chair, AEHIS Board CISO and Chief Privacy Officer,
       University of Chicago Medicine.
                                  ____



                                        Emergent BioSolutions,

                                                    July 17, 2018.
     Hon. Susan Brooks,
     Washington, DC.
     Hon. Greg Walden,
     Washington, DC.
     Hon. Anna Eshoo,
     Washington, DC.
     Hon. Frank Pallone,
     Washington, DC.
       Dear Reps. Brooks, Eshoo, Walden, and Pallone: Thank you to 
     you and your staff for your hard work in introducing H.R. 
     6378, the Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018. This legislation, like PAHPRA and 
     PAHPA before it, is vital to ensuring our nation is safe from 
     and prepared for both human-deployed and natural chemical, 
     biological, radiological, and nuclear (CBRN) threats. 
     Emergent is pleased to support PAHPAI.
       We are appreciative of your staff for taking the time to 
     meet with us and solicit feedback about the PAHPAI. Thank you 
     for your leadership in ensuring the legislation further 
     strengthens our nation's preparedness for biological threats.
       Funding Levels: Emergent strongly supports the robust 
     funding levels authorized in PAHPAI. This funding is needed 
     to continue to grow the public-private partnership Congress 
     created to ensure the U.S. is adequately prepared for CBRN 
     threats. Sustained and expanded investment in these programs 
     is a vital market pull to ensure private partners produce 
     medical countermeasures for the most serious threats we face 
     as a nation, such as anthrax, smallpox, and chemical threats. 
     If the government fails to adequately support the Special 
     Reserve Fund, BARDA, and the SNS, the nation faces the dual 
     risk of squandering resources already invested into research 
     and preparedness, while also being underprepared or 
     unprepared for material threats to our national security.
       Identified Authorization Funding Levels for Key Programs: 
     Emergent is strongly supportive of the inclusion of specific 
     funding authorization that breaks out the minimum amounts for 
     the critical Pandemic Influenza and Emerging Infectious 
     Disease (EID) activities supported through BARDA. Specific 
     authorizations help ensure that BARDA's priorities receive 
     consistent funding needed to drive the development of 
     countermeasures to respond to material threats, pandemic 
     influenza, emerging infectious diseases, and other public 
     health hazards.
       Other Transaction (OT) Authority: We appreciate your 
     efforts to update the medical countermeasure enterprise's OT 
     authority and harmonize it with the OT authority of other 
     agencies. These changes will provide the enterprise needed 
     flexibility to better prepare for manmade and naturally-
     occurring biological threats.
       The public health threat matrix is real and growing. 
     Reauthorization of PAHPAI is vital to ensuring our nation is 
     prepared for the most severe threats facing the country. As 
     introduced, PAHPAI will greatly enhance our nation's 
     biosecurity preparedness. We believe that Emergent is 
     uniquely positioned to enable the U.S. and allied governments 
     to address many of these threats based on our growing 
     portfolio of medical countermeasures, decades of experience 
     and expertise in government partnering and contracting, and 
     our broad and deep manufacturing capabilities. We hope we can 
     be a resource as the committee continues to work towards 
     passage of PAHPAI.
           Sincerely,
                                                      Chris Frech,
       Senior Vice President, Global Government Affairs, Emergent 
     BioSolutions, Inc.
                                  ____



                                                    Genentech,

                                     Washington, DC, 17 July 2018.
     Hon. Anna G. Eshoo,
     House of Representatives,
     Washington, DC.
     Hon. Greg Walden,
     Chairman, Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
     Hon. Susan W. Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone, Jr.,
     Ranking Member, Committee on Energy and Commerce, House of 
         Representatives, Washington, DC.
       Dear Representatives Eshoo and Brooks, Chairman Walden, and 
     Ranking Member Pallone: Genentech, Inc. (Genentech) would 
     like to express our strong support for H.R. 6378--The 
     Pandemic and All Hazards Preparedness and Advancing 
     Innovation Act of 2018. We applaud your shared leadership and 
     bipartisan efforts to strengthen the nation's public health 
     preparedness and response programs. We are particularly 
     appreciative that H.R. 6378 authorizes a specific Pandemic 
     Influenza program at the Biomedical Advanced Research and 
     Development Authority (BARDA) to support research and 
     development activities to enhance a rapid response to 
     pandemic influenza.
       As you continue your work toward reauthorization, Genentech 
     welcomes the opportunity to share our relevant experience and 
     provide any needed feedback.
           Sincerely,
                                                       David Burt,
     Senior Director, Federal Government Affairs.
                                  ____



                                       Grifols Public Affairs,

                                    Washington, DC, July 24, 2018.
     Hon. Susan Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Congresswoman Brooks and Congresswoman Eshoo: Thank 
     you for your leadership on healthcare issues in the Congress. 
     Grifols is proud to join the public health and infectious 
     disease communities in expressing our strong support for H.R. 
     6378, the ``Pandemic and All-Hazards Preparedness and 
     Advancing Innovation Act of 2018.'' This legislation is 
     critical to maintaining our national preparedness in response 
     to public health emergencies.
       Grifols is a global healthcare company with a 75-year 
     history of producing plasma-derived medicines, diagnostic 
     tools and hospital pharmacy products. Grifols is a leader in 
     transfusion medicine as a supplier of blood and plasma 
     infectious disease screening systems that are critical to 
     safeguarding the U.S. blood supply.

[[Page H8788]]

       The Nation's experience with emerging infectious diseases, 
     such as Zika, demonstrates the need for a coordinated 
     response to public health threats. In a report commissioned 
     by the Department of Health and Human Services Office of the 
     Assistant Secretary of Health, the RAND Corporation found 
     there are 86 emerging or recently emerged pathogens that 
     threaten the safety of the blood supply. The threat posed by 
     these emerging infectious diseases exhibits the need to plan 
     for managing potential outbreaks.
       In particular, Grifols is supportive of the provisions in 
     H.R. 6378 to aid the development and appropriate utilization 
     of multiuse platform technologies for diagnostics, vaccines, 
     and therapeutics; virus seeds; clinical trial lots; novel 
     virus strains; and antigen and adjuvant material; as well as 
     the provisions aimed at strengthening the U.S. blood supply:
       Requiring a report on the adequacy of the national blood 
     supply
       Establish guidelines, in consultation with health care 
     providers--including blood banks, relating to emergency 
     preparedness which consider the needs of the blood supply, 
     taking into account resiliency, geographic and rural 
     considerations, as well as the financial implications of 
     implementing such guidelines
       Seeking input from all blood supply stakeholders in the 
     development of emergency preparedness guidelines will help 
     strengthen the public health infrastructure by ensuring that 
     the unique needs of the blood supply are met.
       In the interests of U.S. public health, we encourage 
     Congress to pass H.R. 6378 to ensure a robust response to 
     public health threats.
           Sincerely,
                                               Christopher Healey,
                                                   Vice President.

  Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters 
in the Record.

                                                    July 18, 2018.
     Hon. Susan Brooks,
     Washington, DC.
     Hon. Anna Eshoo,
     Washington, DC.
       Dear Representatives Brooks and Eshoo: I am writing on 
     behalf of Roche Diagnostics Corporation in support of H.R. 
     6378, Pandemic and All-Hazards Preparedness and Advancing 
     Innovation Act of 2018. Congratulations on advancing this 
     legislation out of the Energy and Commerce Committee.
       We applaud your efforts in improving the nation's overall 
     preparedness and response capabilities. We especially 
     appreciate the Committee's recognition that diagnostics can 
     play a key role in responding to public health and medical 
     emergencies.
       We look forward to continuing to work with you as this 
     legislation advances in Congress.
           Sincerely,

                                              Russell C. Ring,

                               Vice President, Government Affairs,
     Roche Diagnostics Corporation.
                                  ____

                                      Strategic Health Information


                                       Exchange Collaborative,

                                                    July 18, 2018.
       Reps. Brooks and Eshoo and Members of the Energy and 
     Commerce Committee: On behalf of the Strategic Health 
     Information Exchange Collaborative (SHIEC), which represents 
     more than 60 Health Information Exchanges (HIEs) across the 
     nation, thank you for your leadership on the reauthorization 
     of the Pandemic and All Hazards Preparedness Act (PAHPAI). 
     SHIEC HIEs have played an important role across the country 
     and have a strong interest in emergency preparedness and 
     disaster relief. SHIEC HIEs have demonstrated the important 
     role they play in federal, state, and local governments. In 
     2017 SHIEC HIEs in Texas partnered with local providers and 
     patients to access critical medical information in the wake 
     of Hurricane Harvey, and SHIEC HIEs in New York helped to 
     thwart a ransomware attack and safeguard patient information. 
     SHIEC is a recognized leader in medical record 
     interoperability via the Patient Centered Data Home. This 
     initiative allows patients, no matter where they are--whether 
     caught up in emergencies while traveling or displaced by 
     disasters--access to their medical information when and where 
     they need it.
       SHIEC is pleased with the proposed direction for this 
     reauthorization of PAHPAI, particularly the broadened scope 
     of Title II regarding ``Optimizing State and Local All-
     Hazards Preparedness and Response.'' State and local agencies 
     and hospitals are not the only healthcare stakeholders during 
     a crisis. There are many entities that should be consulted in 
     emergency-planning. Addressing the problems and solutions 
     more broadly allows state and local agencies and hospitals to 
     better prepare and handle disasters.
       To this end SHIEC applauds the Committee's inclusion of not 
     just the brick and mortar infrastructure, but also the 
     ``technological infrastructure'' while developing guidelines 
     and protocols. SHIEC is also happy to see the broad reference 
     to ``healthcare or subject matter experts'' which replaces a 
     more restrictive reference to healthcare providers and 
     agencies.
       SHIEC recommends inclusion of HIEs specifically. As the 
     data trustees in a community, SHIEC HIEs offer vital services 
     to support a community in crisis. Awareness and realization 
     of this full benefit has yet to be achieved in some areas. 
     Without inclusion of clarifying language, SHIEC is concerned 
     HIEs may still be left out of planning. SHIEC hopes however, 
     that the broader, more inclusive language that the Committee 
     has proposed will be expansive enough to ensure HIEs a seat 
     at the emergency preparedness and disaster relief table.
       Thank you,
                                            Kelly Hoover Thompson,
     CEO.
                                  ____



                                                       Takeda,

                                     Cambridge, MA, July 20, 2018.
     Hon. Greg Walden,
     Chariman, House Energy and Commerce Committee,
     House of Representatives,
     Washington, DC.
     Hon. Susan W. Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone, Jr.,
     Ranking Member, House and Energy and Commerce Committee,
     House of Representatives,
     Washington, DC.
     Hon. Anna G. Eshoo,
     House of Representatives,
     Washington, DC.
       Chairman Walden, Ranking Member Pallone, and 
     Representatives Brooks and Eshoo: Takeda Vaccines appreciates 
     the opportunity to support H.R. 6378, the Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018. 
     The legislation contains important provisions to improve the 
     nation's ability to respond to public health emergencies and 
     to accelerate research and development of medical 
     countermeasures. Of particular note is the creation of the 
     Emerging Infectious Disease Program within the Biomedical 
     Advanced Research and Development Authority (``BARDA'') that 
     will support research and development and manufacturing 
     infrastructure with respect to emerging infectious diseases.
       Takeda is a global, research and development-driven 
     pharmaceutical company committed to bringing better health 
     and a brighter future to patients by translating science into 
     life-changing medicines. In addition to its efforts in 
     oncology, gastroenterology, and neuroscience, Takeda is 
     actively engaged in the research and development of vaccines 
     including one for the deadly Zika virus. We appreciate the 
     collaboration with BARDA to advance innovation in this 
     disease state.
       Takeda applauds the action of the House Energy and Commerce 
     Committee to pass H.R. 6378 on July 18, 2018, and thanks the 
     Members and staff for their hard work on this critical bill.
           Sincerely,
                                            Rajeev Venkayya, M.D.,
                 President, Global Vaccines Business Unit, Takeda 
     Pharmaceutical Company Limited.
                                  ____



                         Trauma Center Association of America,

                                                    July 24, 2018.
     Hon. Greg Walden,
     Chairman, House Committee on Energy & Commerce,
     Washington, DC.
     Hon. Susan Brooks,
     House of Representatives,
     Washington, DC.
     Hon. Frank Pallone, Jr.,
     Ranking Member, House Committee on Energy & Commerce,
     Washington, DC.
     Hon. Anna Eshoo,
     House of Representatives,
     Washington, DC.
       Dear Chairman Walden, Ranking Member Pallone, Rep. Brooks 
     and Rep. Eshoo: The Trauma Center Association of America 
     (``TCAA'') strongly supports H.R. 6378, the Pandemic and All-
     Hazards Preparedness and Advancing Innovation Act of 2018. We 
     applaud your bipartisan leadership in developing this 
     legislation that will help improve and strengthen the 
     preparedness and response capabilities of our nation's trauma 
     care system.
       We appreciate your willingness to work with TCAA and our 
     members as you crafted this important piece of legislation. 
     Specifically, we are pleased to see that the bill 
     reauthorizes federal grant funding to support the core 
     missions of trauma centers to offset the cost of activities 
     such as patient stabilization and transfer, trauma education 
     and outreach, coordination with local and regional trauma 
     systems, essential personnel, trauma staff recruitment and 
     retention, ensuring surge capacity, and trauma-related 
     emotional and mental health services.
       Additionally, TCAA has long advocated for the MISSION ZERO 
     Act, and we strongly support the inclusion of language to 
     establish a grant program for military-civilian partnerships 
     in trauma care that will allow both sectors to benefit from 
     the others' expertise and experience. This will benefit 
     patients both on and off the battlefield and we look forward 
     to continuing to work with you to implement this program.
       Finally, we were pleased to see that the bill requires the 
     development of guidelines, and the authorization of a 
     demonstration program, to promote coordination and surge 
     capacity among regional systems of hospitals and other public 
     health facilities during a public health emergency. This will 
     help improve our nation's response capabilities and give more 
     patients access to high quality trauma care.
       We look forward to passage of H.R. 6378 and continued work 
     with the Senate to ensure that this legislation becomes law. 
     Again, thank you for your hard work and commitment to 
     preparing and equipping our

[[Page H8789]]

     healthcare system for future disasters and public health 
     emergencies.
                                      Eileen Whalen, MHA, BSN, RN,
          Chair, Board of Directors. Trauma Center Association of 
                                                          America.
                                      Jennifer Ward, MBA, BSN, RN,
                  President, Trauma Center Association of America.

  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from Indiana (Mrs. Brooks) that the House suspend the rules 
and pass the bill, H.R. 6378, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  The title of the bill was amended so as to read: ``A bill to 
reauthorize certain programs under the Pandemic and All-Hazards 
Preparedness Reauthorization Act.''.
  A motion to reconsider was laid on the table.

                          ____________________