    [United States Statutes at Large, Volume 133, 116th Congress, 1st Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    Public Law 116-22
    116th Congress

    An Act

    To reauthorize certain programs under the Public Health Service Act and
    the Federal Food, Drug, and Cosmetic Act with respect to public health
    security and all-hazards preparedness and response, and for other
    purposes. <>

    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 2019''.
    (b) Table of Contents.--The table of contents for this Act is as
    follows:

    Sec. 1. Short title; table of contents.
    Sec. 2. References in Act.

    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.

    [[Page 906]]

    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. Strategy and report.
    Sec. 705. Technical amendments.

    SEC. 2. REFERENCES IN ACT.

    Except as otherwise specified, amendments made by this Act to a
    section or other provision of law are amendments to such section or
    other provision of the Public Health Service Act (42 U.S.C. 201 et
    seq.).

    TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

    SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

    Section 2802 (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

    [[Page 907]]

    (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 (42 U.S.C. 247d-3a) is amended by inserting
    after subsection (j) the following:

    [[Page 908]]

    ``(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 2019 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--
    ``(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) (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 (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; and

    [[Page 909]]

    (E) 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) (42 U.S.C. 247d-3a(g)) is
    amended--
    (A) in paragraph (5)--
    (i) in the matter preceding subparagraph (A),
    by striking ``Beginning with fiscal year 2009''
    and inserting ``Beginning with fiscal year 2019'';
    and
    (ii) in subparagraph (A)--
    (I) by striking ``for the
    immediately preceding fiscal year'' and
    inserting ``for either of the 2
    immediately preceding fiscal years'';
    and
    (II) by striking ``2008'' and
    inserting ``2018''; and
    (B) in paragraph (6), by amending subparagraph (A)
    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 this section or section 319C-2:
    ``(i) For no more than one of each of the
    first 2 fiscal years immediately following a
    fiscal year in which an entity experienced a
    failure described in subparagraph (A) or (B) of
    paragraph (5), an amount equal to 10 percent of
    the amount the entity was eligible to receive for
    the respective fiscal year.
    ``(ii) For no more than one of the first 2
    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 (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,

    [[Page 910]]

    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) (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) (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

    [[Page 911]]

    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 (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, radiological,
    or nuclear agents, including emerging infectious diseases (which
    may include existing practices, such as trauma care and medical
    surge capacity and capabilities), with respect to--
    ``(A) a regional approach to identifying hospitals
    and health care facilities based on varying capabilities
    and capacity to treat patients affected by such
    emergency, including--

    [[Page 912]]

    ``(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 2019 (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

    [[Page 913]]

    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

    [[Page 914]]

    emergencies, consistent with subsection (a), which may
    include consideration of facilities participating in
    programs under section 319C-2 of the Public Health
    Service Act (42 U.S.C. 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) (42 U.S.C. 247d-3b(i)(1))
    is amended by inserting after the first sentence the following: ``In
    submitting reports under this paragraph, a coalition shall include
    information on the progress that the coalition 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) (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) (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) (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) by 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 (42 U.S.C. 300d et seq.) is amended by adding at the end
    the following new part:

    [[Page 915]]

    ``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.
    ``(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,

    [[Page 916]]

    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

    [[Page 917]]

    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 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.
    ``(2) 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.
    ``(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

    [[Page 918]]

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

    ``(g) Authorization of Appropriations.--To carry out this section,
    there is authorized to be appropriated $11,500,000 for each of fiscal
    years 2019 through 2023.''.
    SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL
    AWARENESS AND BIOSURVEILLANCE
    CAPABILITIES.

    (a) Facilities, Capacities, and Biosurveillance Capabilities.--
    Section 319D (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,'';
    (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.--
    ``(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 2019, the

    [[Page 919]]

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

    [[Page 920]]

    (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 2019 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 2019, the Secretary
    shall convene a public meeting for purposes of
    discussing and providing input on the potential
    goals, functions, and uses of the network
    described in paragraph (1) and incorporating the
    elements described in paragraph (3)(A).
    ``(ii) 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,

    [[Page 921]]

    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 2019, the Secretary shall submit to
    the congressional committees of jurisdiction a
    coordinated strategy and an accompanying implementation
    plan that--
    ``(i) is informed by the public meeting under
    paragraph (5)(B);
    ``(ii) <>  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;

    [[Page 922]]

    ``(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 2019 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'';
    (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

    [[Page 923]]

    (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,'';
    (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

    [[Page 924]]

    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
    2019, the Comptroller General of the United States shall conduct an
    independent evaluation and submit to the Secretary and the congressional
    committees of jurisdiction a report concerning the activities conducted
    under subsections (b) and (c), and provide recommendations, as
    applicable and appropriate, on necessary improvements to the
    biosurveillance and situational awareness network.''.

    (b) Authorization of Appropriations.--Subsection (i) of section 319D
    (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

    [[Page 925]]

    (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.
    (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 (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;

    [[Page 926]]

    ``(C) facilitate and accelerate, as applicable,
    advanced research and development of security
    countermeasures (as defined in section 319F-2),
    qualified countermeasures (as defined in section 319F-
    1), or qualified pandemic or epidemic products (as
    defined in section 319F-3), that are applicable to the
    public health emergency or potential public health
    emergency under paragraph (1);
    ``(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 All-Hazards Preparedness and Advancing
    Innovation Act of 2019, the Secretary, in coordination with the
    Assistant Secretary for Preparedness and Response, shall conduct
    a review of the Fund under this section and provide
    recommendations to the Committee on Health, Education, Labor,
    and Pensions and the Committee on Appropriations of the Senate
    and the Committee on Energy and Commerce and the Committee on
    Appropriations of the House of Representatives on policies to
    improve such Fund for the uses described in paragraph (2).
    ``(5) GAO report.--Not later than 4 years after the date of
    enactment of the Pandemic and All-Hazards Preparedness and
    Advancing Innovation Act of 2019, the Comptroller General of the
    United States shall--
    ``(A) <>  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 (42 U.S.C. 247d-7b) is amended--
    (1) in the section heading, by striking ``health professions
    volunteers'' and inserting ``volunteer health professional'';

    [[Page 927]]

    (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 the following:
    ``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) (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 (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.

    [[Page 928]]

    5170) or under section 201 of the National Emergencies
    Act (50 U.S.C. 1621) during the initial period of such
    declaration;
    ``(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 supersede 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 2019.

    [[Page 929]]

    ``(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 Secretary of
    Health and Human Services shall enter into an agreement with an
    appropriate entity to conduct a study regarding the public
    health preparedness and response capabilities and medical surge
    capacities of hospitals, long-term care facilities, and other
    health care

    [[Page 930]]

    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

    [[Page 931]]

    surge capacity for hospitals, long-term care facilities,
    and other health care facilities, including--
    (i) improving the existing benchmarks and
    objective standards for the Federal grant programs
    described in subsection (a)(3)(A) or developing
    new benchmarks and standards for such programs;
    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) (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) (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 2019, the Secretary, in coordination
    with the Secretary of Homeland Security, the Secretary
    of Defense, and the Secretary of Veterans Affairs, shall
    conduct a joint review of the National Disaster Medical
    System. Such review shall include--
    ``(i) <>  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

    [[Page 932]]

    the findings from the review under subparagraph (A) and
    provide recommendations to modify the policies of the
    National Disaster Medical System as necessary.''.
    (3) Notification of shortage.--Section 2812(c) (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) (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) (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) (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
    (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)--

    [[Page 933]]

    (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 is 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) (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 any eligible individual of any effect
    such designation may have on other benefits for which such
    individual is 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:
    ``(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

    [[Page 934]]

    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) (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)
    or 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) (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''.

    [[Page 935]]

    (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) (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) (42 U.S.C.
    247d-7e(c)(6)) is amended--
    (1) by striking ``elderly'' and inserting ``older adults'';
    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 (42 U.S.C. 243 et seq.) is amended by inserting
    after section 319D the following:

    [[Page 936]]

    ``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 (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 937]]

    ``(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 nonvoting 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).

    [[Page 938]]

    ``(4) Term of appointment.--Each member of the Advisory
    Committee appointed under paragraph (2) shall serve for a term
    of 3 years, except that the Secretary may adjust the terms of
    the Advisory Committee appointees serving on the date of
    enactment of the Pandemic and All-Hazards Preparedness and
    Advancing Innovation Act of 2019, or appointees who are
    initially appointed after such date of enactment, in order to
    provide for a staggered term of appointment for all members.
    ``(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 two 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 (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.

    [[Page 939]]

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

    [[Page 940]]

    ``(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 nonvoting 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.
    ``(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,
    Tribal, or territorial 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.

    [[Page 941]]

    ``(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 (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.

    [[Page 942]]

    TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

    SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
    (1) 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
    (2) 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.''.
    SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
    ENTERPRISE.

    (a) In General.--Title XXVIII is amended by inserting after section
    2811 (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:

    [[Page 943]]

    ``(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).
    ``(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) (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 the 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) (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'';

    [[Page 944]]

    (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 on June 15, 2019, and on March 15 of each year
    thereafter, to the Committee on Health, Education,
    Labor, and Pensions and the Committee on Appropriations
    of the Senate and the Committee on Energy and Commerce
    and the Committee on Appropriations of the House of
    Representatives, in a manner that does not compromise
    national security.
    ``(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

    [[Page 945]]

    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:

    [[Page 946]]

    ``(I) ensure that each countermeasure or product
    under consideration for procurement pursuant to this
    subsection receives the same consideration regardless of
    whether such countermeasure or product receives or had
    received funding under section 319L, including with
    respect to whether the countermeasure or product is most
    appropriate to meet the emergency health security needs
    of the United States; 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 2019, and every 5 years thereafter, the
    Comptroller General of the United States shall conduct a
    review of any changes to the contents or management of
    the stockpile since January 1, 2015. 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

    [[Page 947]]

    (including additions, modifications, and
    replenishments) in the stockpile, and how such
    expenditures relate to the ability of the
    stockpile to meet emergency health security needs;
    ``(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
    ``(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 2019
    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 the Strategic National Stockpile and the Director of the Biomedical
    Advanced Research and Development Authority coordinate with respect to
    countermeasures and products procured under such section 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 or 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) (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''.

    [[Page 948]]

    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 a 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) Protection of National Security From Threats.--Section 2811 (42
    U.S.C. 300hh-10) is amended by adding at the end the following:
    ``(f) Protection of National Security From Threats.--
    ``(1) In general.--In carrying out subsection (b)(3), the
    Assistant Secretary for Preparedness and Response shall
    implement strategic initiatives or activities to address
    threats, including pandemic influenza and which may include a
    chemical, biological, radiological, or nuclear agent (including
    any such agent with a significant potential to become a
    pandemic), that pose a significant level of risk to public
    health and national

    [[Page 949]]

    security based on the characteristics of such threat. Such
    initiatives shall include activities to--
    ``(A) accelerate and support the advanced research,
    development, manufacturing capacity, procurement, and
    stockpiling of countermeasures, including initiatives
    under section 319L(c)(4)(F);
    ``(B) support the development and manufacturing of
    virus seeds, clinical trial lots, and stockpiles of
    novel virus strains; and
    ``(C) maintain or improve preparedness activities,
    including for pandemic influenza.
    ``(2) Authorization of appropriations.--
    ``(A) In general.--To carry out this subsection,
    there is authorized to be appropriated $250,000,000 for
    each of fiscal years 2019 through 2023.
    ``(B) Supplement, not supplant.--Amounts
    appropriated under this paragraph shall be used to
    supplement and not supplant funds provided under
    sections 319L(d) and 319F-2(g).
    ``(C) Documentation required.--The Assistant
    Secretary for Preparedness and Response, in accordance
    with subsection (b)(7), shall document amounts expended
    for purposes of carrying out this subsection, including
    amounts appropriated under the heading `Public Health
    and Social Services Emergency Fund' under the heading
    `Office of the Secretary' under title II of division H
    of the Consolidated Appropriations Act, 2018 (Public Law
    115-141) and allocated to carrying out section
    319L(c)(4)(F).''.
    SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.

    Section 351A(k) (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 2019, 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.''.

    [[Page 950]]

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

    SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

    Section 2811(b)(7) (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
    postdeployment 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) (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) (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

    [[Page 951]]

    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 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) (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.--
    Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) 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.

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

    (b) <>  Duties.--The Advisory Council
    shall advise and provide information and recommendations to the
    Secretary regarding programs and policies intended to reduce or combat
    antibiotic-resistant

    [[Page 952]]

    bacteria that may present a public health threat and improve
    capabilities to prevent, diagnose, mitigate, or treat such resistance.
    Such advice, information, and recommendations may be related to
    improving--
    (1) the effectiveness of antibiotics;
    (2) research and advanced research on, and the development
    of, improved and innovative methods for combating or reducing
    antibiotic resistance, including new treatments, rapid point-of-
    care diagnostics, alternatives to antibiotics, including
    alternatives to animal antibiotics, and antimicrobial
    stewardship activities;
    (3) surveillance of antibiotic-resistant bacterial
    infections, including publicly available and up-to-date
    information on resistance to antibiotics;
    (4) education for health care providers and the public with
    respect to up-to-date information on antibiotic resistance and
    ways to reduce or combat such resistance to antibiotics related
    to humans and animals;
    (5) methods to prevent or reduce the transmission of
    antibiotic-resistant bacterial infections, including stewardship
    programs; and
    (6) <>  coordination with respect to
    international efforts in order to inform and advance United
    States capabilities to combat antibiotic resistance.

    (c) Meetings and Coordination.--
    (1) Meetings.--The Advisory Council shall meet not less than
    biannually and, to the extent practicable, in coordination with
    meetings of the Antimicrobial Resistance Task Force established
    in section 319E(a) of the Public Health Service Act.
    (2) 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) of the Public Health Service
    Act (42 U.S.C. 247d-5(a)).

    (d) <>  FACA.--The Federal Advisory Committee
    Act (5 U.S.C. App.) shall apply to the activities and duties of the
    Advisory Council.

    (e) <>  Extension of Advisory
    Council.--Not later than October 1, 2022, the Secretary shall submit to
    the Committee on Health, Education, Labor, and Pensions of the Senate
    and the Committee on Energy and Commerce of the House of Representatives
    a recommendation on whether the Advisory Council should be extended, and
    in addition, identify whether there are other committees, councils, or
    task forces that have overlapping or similar duties to that of the
    Advisory Council, and whether such committees, councils, or task forces
    should be combined, including with respect to section 319E(a) of the
    Public Health Service Act (42 U.S.C. 247d-5(a)).

    TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

    SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

    Section 319L(c)(4)(D)(iii) (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''.

    [[Page 953]]

    SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.

    Section 319L (42 U.S.C. 247d-7e) is amended--
    (1) in subsection (a)(3), by striking ``, such as'' and all
    that follows through ``Code''; and
    (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 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 the development of such products, 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''), including data and
    information submitted to medical countermeasure master files or other
    master files.
    (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.

    [[Page 954]]

    ``(2) Reference of certain master files.--In the case that
    data or information within a medical countermeasure master file
    is used only to support the conditional approval of an
    application filed under section 571, such master file may be
    relied upon to support the effectiveness of a product that is
    the subject of a subsequent medical countermeasure submission
    only if such application is supplemented by additional data or
    information to support review and approval in a manner
    consistent with the standards applicable to such review and
    approval for such countermeasure, qualified countermeasure, or
    qualified pandemic or epidemic product.

    ``(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
    resubmission 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 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) Acknowledgment of and 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

    [[Page 955]]

    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), which
    shall not include 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 2019), 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).

    [[Page 956]]

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

    [[Page 957]]

    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

    [[Page 958]]

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

    [[Page 959]]

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

    [[Page 960]]

    (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 paragraph heading, by striking
    ``2004'' and inserting ``2019''; and
    (ii) by striking ``2004,'' and inserting
    ``2019,''.

    (b) Epidemiology-Laboratory Capacity Grants.--Section 2821 (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

    [[Page 961]]

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

    TITLE VII--MISCELLANEOUS PROVISIONS

    SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

    (a) Veterans Affairs.--Section 8117(g) of title 38, United States
    Code, is amended by striking ``2014 through 2018'' and inserting ``2019
    through 2023''.
    (b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C.
    247d-1(e)) is amended by striking ``2014 through 2018'' and inserting
    ``2019 through 2023''.
    (c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
    247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
    (d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42
    U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and
    inserting ``2023''.
    (e) Limited Antitrust Exemption.--
    (1) In general.--Section 405 of the Pandemic and All-Hazards
    Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a note) is
    amended--
    (A) 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)'';
    (B) in subsection (b), by striking ``12-year'' and
    inserting ``17-year'';
    (C) by redesignating such section 405 as section
    319L-1; and
    (D) <>  by transferring such
    section 319L-1, as redesignated, 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).
    (2) Conforming amendments.--
    (A) Table of contents.--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.
    (B) Reference.--Section 319L(c)(4)(A)(iii) (42
    U.S.C. 247d-7e) is amended by striking ``section 405 of
    the Pandemic and All-Hazards Preparedness Act'' and
    inserting ``section 319L-1''.

    (f) Inapplicability of Certain Provisions.--Subsection (e)(1) of
    section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
    (1) by amending subparagraph (A) to read as follows:
    ``(A) Nondisclosure 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.

    [[Page 962]]

    ``(ii) Information described.--The information
    described in this clause is information relevant
    to programs of the Department of Health and Human
    Services that could compromise national security
    and reveal significant and not otherwise publicly
    known vulnerabilities of existing medical or
    public health defenses against chemical,
    biological, radiological, or nuclear threats, and
    is comprised of--
    ``(I) specific technical data or
    scientific information that is created
    or obtained during the countermeasure
    and product advanced research and
    development carried out under subsection
    (c);
    ``(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 2019, 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 (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--

    [[Page 963]]

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

    Not <>  later than 14
    days after the date of the enactment of this Act, the Secretary of
    Health and Human Services, in coordination with the Assistant Secretary
    for Preparedness and Response and the Assistant Secretary for the
    Administration on Children and Families or other appropriate office, and
    in collaboration with other departments, as appropriate, shall submit to
    the Committee on Energy and Commerce of the House of Representatives,
    the Committee on Health, Education, Labor, and Pensions of the Senate,
    and other relevant congressional committees--
    (1) a formal strategy, including interdepartmental actions
    and efforts to reunify children with their parents or guardians,
    in all cases in which such children have been separated from
    their parents or guardians as a result of the initiative
    announced on April 6, 2018, and due to prosecution under section
    275(a) of the Immigration and Nationality Act (8 U.S.C.
    1325(a)), if the parent or guardian chooses such reunification
    and the child--
    (A) was separated from a parent or guardian and
    placed into a facility funded by the Department of
    Health and Human Services;

    [[Page 964]]

    (B) <>  as of the date of the
    enactment of this Act, remains in the care of the
    Department of Health and Human Services; and
    (C) can be safely reunited with such parent or
    guardian; and
    (2) a report on challenges and deficiencies related to the
    oversight of, and care for, unaccompanied alien children and
    appropriately reuniting such children with their parents or
    guardians, and the actions taken to address any challenges and
    deficiencies related to unaccompanied alien children in the
    custody of the Department of Health and Human Services,
    including deficiencies identified and publicly reported by
    Congress, the Government Accountability Office, or the
    inspectors general of the Department of Health and Human
    Services or other Federal departments.
    SEC. 705. TECHNICAL AMENDMENTS.

    (a) Public Health Service Act.--Title III (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) (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 inserting ``or directing'' after ``authorizing'';
    (3) by striking ``disclose any'' and inserting ``disclose--
    ``(i) any'';
    (4) by striking the period and inserting ``; or''; and
    (5) 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

    [[Page 965]]

    Secretary determines has a significant potential
    to affect national security.
    ``(B) Public acknowledgment.--In the case that the
    Secretary, pursuant to subparagraph (A)(ii), does not
    make information publicly available, the Secretary shall
    provide on the internet website of the Food and Drug
    Administration an acknowledgment of the information that
    has not been disclosed, pursuant to subparagraph
    (A)(ii).''.

    Approved June 24, 2019.

    LEGISLATIVE HISTORY--S. 1379:
    ---------------------------------------------------------------------------

    CONGRESSIONAL RECORD, Vol. 165 (2019):
    May 16, considered and passed Senate.
    June 4, considered and passed House.