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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1379 Enrolled Bill (ENR)]

        S.1379

                     One Hundred Sixteenth Congress

                                 of the

                        United States of America

                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Thursday,
           the third day of January, two thousand and nineteen

                                 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.
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
            (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:
    ``(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
            (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, 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 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--
                ``(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 that the Assistant Secretary 
    determines appropriate, to meet the goals under section 2802(b)(3);
        ``(3) consider feedback related to financial implications for 
    hospitals, health care facilities, public health agencies, 
    laboratories, blood banks, tissue banks, and other entities engaged 
    in regional preparedness planning to implement and follow such 
    guidelines, as applicable; and
        ``(4) consider financial requirements and potential incentives 
    for entities to prepare for, and respond to, public health 
    emergencies as part of the regional health care emergency 
    preparedness and response system.
    ``(d) Technical Assistance.--The Assistant Secretary for 
Preparedness and Response, in consultation with the Director of the 
Centers for Disease Control and Prevention and the Assistant Secretary 
of Labor for Occupational Safety and Health, may provide technical 
assistance and consultation toward meeting the guidelines described in 
subsection (b).
    ``(e) Demonstration Project for Regional Health Care Preparedness 
and Response Systems.--
        ``(1) In general.--The Assistant Secretary for Preparedness and 
    Response may establish a demonstration project pursuant to the 
    development and implementation of guidelines under subsection (b) 
    to award grants to improve medical surge capacity for all hazards, 
    build and integrate regional medical response capabilities, improve 
    specialty care expertise for all-hazards response, and coordinate 
    medical preparedness and response across State, local, Tribal, 
    territorial, and regional jurisdictions.
        ``(2) Sunset.--The authority under this subsection shall expire 
    on September 30, 2023.''.
    (b) GAO Report to Congress.--
        (1) Report.--Not later than 3 years after the date of enactment 
    of this Act, the Comptroller General of the United States (referred 
    to in this subsection as the ``Comptroller General'') shall submit 
    to the Committee on Health, Education, Labor, and Pensions and the 
    Committee on Finance of the Senate and the Committee on Energy and 
    Commerce and the Committee on Ways and Means of the House of 
    Representatives, a report on the extent to which hospitals and 
    health care facilities have implemented the recommended guidelines 
    under section 319C-3(b) of the Public Health Service Act (as added 
    by subsection (a)), including an analysis and evaluation of any 
    challenges hospitals or health care facilities experienced in 
    implementing such guidelines.
        (2) Content.--The Comptroller General shall include in the 
    report under paragraph (1)--
            (A) data on the preparedness and response capabilities that 
        have been informed by the guidelines under section 319C-3(b) of 
        the Public Health Service Act to improve regional emergency 
        health care preparedness and response capability, including 
        hospital and health care facility capacity and medical surge 
        capabilities to prepare for, and respond to, public health 
        emergencies; and
            (B) recommendations to reduce gaps in incentives for 
        regional health partners, including hospitals and health care 
        facilities, to improve capacity and medical surge capabilities 
        to prepare for, and respond to, public health emergencies, 
        consistent with subsection (a), which may include consideration 
        of facilities participating in programs under section 319C-2 of 
        the Public Health Service Act (42 U.S.C. 247d-3b) or in 
        programs under the Centers for Medicare & Medicaid Services 
        (including innovative health care delivery and payment models), 
        and input from private sector financial institutions.
        (3) Consultation.--In carrying out paragraphs (1) and (2), the 
    Comptroller General shall consult with the heads of appropriate 
    Federal agencies, including--
            (A) the Assistant Secretary for Preparedness and Response;
            (B) the Director of the Centers for Disease Control and 
        Prevention;
            (C) the Administrator of the Centers for Medicare & 
        Medicaid Services;
            (D) the Assistant Secretary for Mental Health and Substance 
        Use;
            (E) the Assistant Secretary of Labor for Occupational 
        Safety and Health; and
            (F) the Secretary of Veterans Affairs.
    (c) Annual Reports.--Section 319C-2(i)(1) (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:

``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, 
        for response to a public health emergency pursuant to section 
        319.
        ``(2) Use of funds.--Grants awarded under this section to an 
    eligible trauma center may be used to train and incorporate 
    military trauma care providers into such trauma center, including 
    incorporation into operational exercises and training drills 
    related to public health emergencies, expenditures for malpractice 
    insurance, office space, information technology, specialty 
    education and supervision, trauma programs, research, and 
    applicable license fees for such military trauma care providers.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to affect any other provision of law that preempts State 
licensing requirements for health care professionals, including with 
respect to military trauma care providers.
    ``(e) Reporting Requirements.--
        ``(1) Report to the secretary and the secretary of defense.--
    Each eligible trauma center or eligible high-acuity trauma center 
    awarded a grant under subsection (a) or (b) for a year shall submit 
    to the Secretary and the Secretary of Defense a report for such 
    year that includes information on--
            ``(A) the number and types of trauma cases managed by 
        military trauma teams or military trauma care providers 
        pursuant to such grant during such year;
            ``(B) the ability to maintain the integration of the 
        military trauma providers or teams of providers as part of the 
        trauma center, including the financial effect of such grant on 
        the trauma center;
            ``(C) the educational effect on resident trainees in 
        centers where military trauma teams are assigned;
            ``(D) any research conducted during such year supported by 
        such grant; and
            ``(E) any other information required by the Secretaries for 
        the purpose of evaluating the effect of such grant.
        ``(2) Report to congress.--Not less than once every 2 years, 
    the Secretary, in consultation with the Secretary of Defense, shall 
    submit a report to the congressional committees of jurisdiction 
    that includes information on the effect of placing military trauma 
    care providers in trauma centers awarded grants under this section 
    on--
            ``(A) maintaining military trauma care providers' readiness 
        and ability to respond to and treat battlefield injuries;
            ``(B) providing health care to civilian trauma patients in 
        urban and rural settings;
            ``(C) the capability of trauma centers and military trauma 
        care providers to increase medical surge capacity, including as 
        a result of a large-scale event;
            ``(D) the ability of grant recipients to maintain the 
        integration of the military trauma providers or teams of 
        providers as part of the trauma center;
            ``(E) efforts to incorporate military trauma care providers 
        into operational exercises and training and drills for public 
        health emergencies; and
            ``(F) the capability of military trauma care providers to 
        participate as part of a medical response during or in advance 
        of a public health emergency, as determined by the Secretary, 
        or a mass casualty incident.
    ``(f) Definitions.--For purposes of this part:
        ``(1) Eligible 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 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 Secretary, in cooperation 
        with health care providers, State, local, Tribal, and 
        territorial public health officials, and relevant Federal 
        agencies (including the Office of the National Coordinator for 
        Health Information Technology and the National Institute of 
        Standards and Technology), shall, as necessary, adopt technical 
        and reporting standards, including standards for 
        interoperability as defined by section 3000, for networks under 
        paragraph (1) and update such standards as necessary. Such 
        standards shall be made available on the internet website of 
        the Department of Health and Human Services, in a manner that 
        does not compromise national security.
            ``(B) Deference to standards development organizations.--In 
        adopting and implementing standards under this subsection and 
        subsection (c), the Secretary shall give deference to standards 
        published by standards development organizations and voluntary 
        consensus-based standards entities.'';
        (4) in subsection (c)--
            (A) in paragraph (1)--
                (i) by striking ``Not later than 2 years after the date 
            of enactment of the Pandemic and All-Hazards Preparedness 
            Reauthorization Act of 2013, the Secretary'' and inserting 
            ``The Secretary'';
                (ii) by inserting ``, and improve as applicable and 
            appropriate,'' after ``shall establish'';
                (iii) by striking ``of rapid'' and inserting ``of, 
            rapid''; and
                (iv) by striking ``such connectivity'' and inserting 
            ``such interoperability'';
            (B) by amending paragraph (2) to read as follows:
        ``(2) Coordination and consultation.--In establishing and 
    improving the network under paragraph (1), the Secretary shall--
            ``(A) facilitate coordination among agencies within the 
        Department of Health and Human Services that provide, or have 
        the potential to provide, information and data to, and analyses 
        for, the situational awareness and biosurveillance network 
        under paragraph (1), including coordination among relevant 
        agencies related to health care services, the facilitation of 
        health information exchange (including the Office of the 
        National Coordinator for Health Information Technology), and 
        public health emergency preparedness and response; and
            ``(B) consult with the Secretary of Agriculture, the 
        Secretary of Commerce (and the Director of the National 
        Institute of Standards and Technology), the Secretary of 
        Defense, the Secretary of Homeland Security, the Secretary of 
        Veterans Affairs, and the heads of other Federal agencies, as 
        the Secretary determines appropriate.'';
            (C) in paragraph (3)--
                (i) by redesignating subparagraphs (A) through (E) as 
            clauses (i) through (v), respectively, and adjusting the 
            margins accordingly;
                (ii) in clause (iv), as so redesignated--

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

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

                  TITLE III--REACHING ALL COMMUNITIES

    SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE 
      WORKFORCE.
    (a) National Disaster Medical System.--
        (1) Strengthening the national disaster medical system.--Clause 
    (ii) of section 2812(a)(3)(A) (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 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)--
            (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 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''.
    (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:
``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:
        ``(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).
        ``(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.
        ``(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--
        ``(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.
    ``(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.

             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:
            ``(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'';
            (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 of emergency 
                preparedness to address such threats;
                    ``(VI) whether such countermeasure is replenishing 
                an expiring or expired countermeasure, is a different 
                countermeasure with the same indication that is 
                replacing an expiring or expired countermeasure, or is 
                a new addition to the stockpile;
                    ``(VII) a description of how such additions or 
                modifications align with projected investments under 
                previous countermeasures budget plans under section 
                2811(b)(7), including expected life-cycle costs, 
                expenditures related to countermeasure procurement to 
                address the threat or threats described in subclause 
                (IV), replenishment dates (including the ability to 
                extend the maximum shelf life of a countermeasure), and 
                the manufacturing capacity required to replenish such 
                countermeasure; and
                    ``(VIII) appropriate protocols and processes for 
                the deployment, distribution, or dispensing of the 
                countermeasure at the State and local level, including 
                plans for relevant capabilities of State and local 
                entities to dispense, distribute, and administer the 
                countermeasure; and

                ``(ii) an assurance, which need not be provided in 
            advance of procurement, that for each countermeasure 
            procured or replenished under this subsection, the 
            Secretary completed a review addressing each item listed 
            under this subsection in advance of such procurement or 
            replenishment.'';
        (4) in paragraph (3), as so redesignated--
            (A) in subparagraph (A), by inserting ``and the Public 
        Health Emergency Medical Countermeasures Enterprise established 
        under section 2811-1'' before the semicolon;
            (B) in subparagraph (C), by inserting ``, and the 
        availability, deployment, dispensing, and administration of 
        countermeasures'' before the semicolon;
            (C) by amending subparagraph (E) to read as follows:
            ``(E) devise plans for effective and timely supply-chain 
        management of the stockpile, in consultation with the Director 
        of the Centers for Disease Control and Prevention, the 
        Assistant Secretary for Preparedness and Response, the 
        Secretary of Transportation, the Secretary of Homeland 
        Security, the Secretary of Veterans Affairs, and the heads of 
        other appropriate Federal agencies; State, local, Tribal, and 
        territorial agencies; and the public and private health care 
        infrastructure, as applicable, taking into account the 
        manufacturing capacity and other available sources of products 
        and appropriate alternatives to supplies in the stockpile;'';
            (D) in subparagraph (G), by striking ``; and'' and 
        inserting a semicolon;
            (E) in subparagraph (H), by striking the period and 
        inserting a semicolon; and
            (F) by adding at the end the following:
            ``(I) ensure that each countermeasure or product under 
        consideration for procurement pursuant to this subsection 
        receives the same consideration regardless of whether such 
        countermeasure or product receives or had received funding 
        under section 319L, including with respect to whether the 
        countermeasure or product is most appropriate to meet the 
        emergency health security needs of the United States; and
            ``(J) provide assistance, including technical assistance, 
        to maintain and improve State and local public health 
        preparedness capabilities to distribute and dispense medical 
        countermeasures and products from the stockpile, as 
        appropriate.''; and
        (5) by adding at the end the following:
        ``(5) GAO report.--
            ``(A) In general.--Not later than 3 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 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 (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''.
    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 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.''.

 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 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 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''.
    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.
        ``(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 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).
        ``(2) The term `medical countermeasure submission' means an 
    investigational new drug application under section 505(i), a new 
    drug application under section 505(b), or an abbreviated new drug 
    application under section 505(j) of this Act, a biological product 
    license application under section 351(a) of the Public Health 
    Service Act or a biosimilar biological product license application 
    under section 351(k) of the Public Health Service Act, a new animal 
    drug application under section 512(b)(1) or abbreviated new animal 
    drug application under section 512(b)(2), an application for 
    conditional approval of a new animal drug under section 571, an 
    investigational device application under section 520(g), an 
    application with respect to a device under section 515(c), a 
    request for classification of a device under section 513(f)(2), a 
    notification with respect to a device under section 510(k), or a 
    request for an emergency use authorization under section 564 to 
    support--
            ``(A) the approval, licensure, classification, clearance, 
        conditional approval, or authorization of a security 
        countermeasure, qualified countermeasure, or qualified pandemic 
        or epidemic product; or
            ``(B) a new indication to an approved security 
        countermeasure, qualified countermeasure, or qualified pandemic 
        or epidemic product.
        ``(3) The terms `qualified countermeasure', `security 
    countermeasure', and `qualified pandemic or epidemic product' have 
    the meanings given such terms in sections 319F-1, 319F-2, and 319F-
    3, respectively, of the Public Health Service Act.''.
    (c) Stakeholder Input.--Not later than 18 months after the date of 
enactment of this Act, the Secretary, acting through the Commissioner 
of Food and Drugs and in consultation with the Assistant Secretary for 
Preparedness and Response, shall solicit input from stakeholders, 
including stakeholders developing security countermeasures, qualified 
countermeasures, or qualified pandemic or epidemic products, and 
stakeholders developing technologies to assist in the development of 
such countermeasures with respect to how the Food and Drug 
Administration can advance the use of tools and technologies to support 
and advance the development or manufacture of security countermeasures, 
qualified countermeasures, and qualified pandemic or epidemic products, 
including through reliance on cross-referenced data and information 
contained within master files and submissions previously submitted to 
the Secretary as set forth in section 565B of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (b).
    (d) Guidance.--Not later than 2 years after the date of enactment 
of this Act, the Secretary, acting through the Commissioner of Food and 
Drugs, shall publish draft guidance about how reliance on cross-
referenced data and information contained within master files under 
section 565B of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (b) or submissions otherwise submitted to the Secretary may 
be used for specific tools or technologies (including platform 
technologies) that have the potential to support and advance the 
development or manufacture of security countermeasures, qualified 
countermeasures, and qualified pandemic or epidemic products. The 
Secretary, acting through the Commissioner of Food and Drugs, shall 
publish the final guidance not later than 3 years after the enactment 
of this Act.
    SEC. 604. ANIMAL RULE REPORT.
    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the application of the requirements under 
subsections (c) and (d) of section 565 of the of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) (referred to in this 
section as the ``animal rule'') as a component of medical 
countermeasure advanced development under the Biomedical Advanced 
Research and Development Authority and regulatory review by the Food 
and Drug Administration. In conducting such study, the Comptroller 
General shall examine the following:
        (1) The extent to which advanced development and review of a 
    medical countermeasure are coordinated between the Biomedical 
    Advanced Research and Development Authority and the Food and Drug 
    Administration, including activities that facilitate appropriate 
    and efficient design of studies to support approval, licensure, and 
    authorization under the animal rule, consistent with the 
    recommendations in the animal rule guidance, issued pursuant to 
    section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 360bbb-4(c)) and entitled ``Product Development Under the 
    Animal Rule: Guidance for Industry'' (issued in October 2015), to 
    resolve discrepancies in the design of adequate and well-controlled 
    efficacy studies conducted in animal models related to the 
    provision of substantial evidence of effectiveness for the product 
    approved, licensed, or authorized under the animal rule.
        (2) The consistency of the application of the animal rule among 
    and between review divisions within the Food and Drug 
    Administration.
        (3) The flexibility pursuant to the animal rule to address 
    variations in countermeasure development and review processes, 
    including the extent to which qualified animal models are adopted 
    and used within the Food and Drug Administration in regulatory 
    decisionmaking with respect to medical countermeasures.
        (4) The extent to which the guidance issued under section 
    565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    360bbb-4(c)), entitled, ``Product Development Under the Animal 
    Rule: Guidance for Industry'' (issued in October 2015), has 
    assisted in achieving the purposes described in paragraphs (1), 
    (2), and (3).
    (b) Consultations.--In conducting the study under subsection (a), 
the Comptroller General of the United States shall consult with--
        (1) the Federal agencies responsible for advancing, reviewing, 
    and procuring medical countermeasures, including the Office of the 
    Assistant Secretary for Preparedness and Response, the Biomedical 
    Advanced Research and Development Authority, the Food and Drug 
    Administration, and the Department of Defense;
        (2) manufacturers involved in the research and development of 
    medical countermeasures to address biological, chemical, 
    radiological, or nuclear threats; and
        (3) other biodefense stakeholders, as applicable.
    (c) Report.--Not later than 3 years after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report containing the results of the study conducted 
under subsection (a) and recommendations to improve the application and 
consistency of the requirements under subsections (c) and (d) of 
section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4) to support and expedite the research and development of 
medical countermeasures, as applicable.
    (d) Protection of National Security.--The Comptroller General of 
the United States shall conduct the study and issue the assessment and 
report under this section in a manner that does not compromise national 
security.
    SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING 
      TECHNOLOGIES AND THEIR POTENTIAL ROLE IN NATIONAL SECURITY.
    (a) Meeting.--
        (1) In general.--Not later than 1 year after the date of 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary'') shall convene a 
    meeting to discuss the potential role advancements in genomic 
    engineering technologies (including genome editing technologies) 
    may have in advancing national health security. Such meeting shall 
    be held in a manner that does not compromise national security.
        (2) Attendees.--The attendees of the meeting under paragraph 
    (1)--
            (A) shall include--
                (i) representatives from the Office of the Assistant 
            Secretary for Preparedness and Response, the National 
            Institutes of Health, the Centers for Disease Control and 
            Prevention, and the Food and Drug Administration; and
                (ii) representatives from academic, private, and 
            nonprofit entities with expertise in genome engineering 
            technologies, biopharmaceuticals, medicine, or biodefense, 
            and other relevant stakeholders; and
            (B) may include--
                (i) other representatives from the Department of Health 
            and Human Services, as the Secretary determines 
            appropriate; and
                (ii) representatives from the Department of Homeland 
            Security, the Department of Defense, the Department of 
            Agriculture, and other departments, as the Secretary may 
            request for the meeting.
        (3) Topics.--The meeting under paragraph (1) shall include a 
    discussion of--
            (A) the current state of the science of genomic engineering 
        technologies related to national health security, including--
                (i) medical countermeasure development, including 
            potential efficiencies in the development pathway and 
            detection technologies; and
                (ii) the international and domestic regulation of 
            products utilizing genome editing technologies; and
            (B) national security implications, including--
                (i) capabilities of the United States to leverage 
            genomic engineering technologies as a part of the medical 
            countermeasure enterprise, including current applicable 
            research, development, and application efforts underway 
            within the Department of Defense;
                (ii) the potential for state and non-state actors to 
            utilize genomic engineering technologies as a national 
            health security threat; and
                (iii) security measures to monitor and assess the 
            potential threat that may result from utilization of 
            genomic engineering technologies and related technologies 
            for the purpose of compromising national health security.
    (b) Report.--Not later than 270 days after the meeting described in 
subsection (a) is held, the Assistant Secretary for Preparedness and 
Response shall issue a report to the congressional committees of 
jurisdiction on the topics discussed at such meeting, and provide 
recommendations, as applicable, to utilize innovations in genomic 
engineering (including genome editing) and related technologies as a 
part of preparedness and response activities to advance national health 
security. Such report shall be issued in a manner that does not 
compromise national security.
    SEC. 606. REPORT ON VACCINES DEVELOPMENT.
    Not later than one year after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report describing efforts and activities to coordinate with other 
countries and international partners during recent public health 
emergencies with respect to the research and advanced research on, and 
development of, qualified pandemic or epidemic products (as defined in 
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)). 
Such report may include information regarding relevant work carried out 
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(5)(E)), through public-private partnerships, and through 
collaborations with other countries to assist with or expedite the 
research and development of qualified pandemic or epidemic products. 
Such report shall not include information that may compromise national 
security.
    SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND HEALTH.
    (a) Reauthorization of Mosquito Abatement for Safety and Health 
Program.--Section 317S (42 U.S.C. 247b-21) is amended--
        (1) in subsection (a)(1)(B)--
            (A) by inserting ``including programs to address emerging 
        infectious mosquito-borne diseases,'' after ``subdivisions for 
        control programs,''; and
            (B) by inserting ``or improving existing control programs'' 
        before the period at the end;
        (2) in subsection (b)--
            (A) in paragraph (1), by inserting ``, including 
        improvement,'' after ``operation'';
            (B) in paragraph (2)--
                (i) in subparagraph (A)--

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

                ``(iv) a public health emergency due to the incidence 
            or prevalence of a mosquito-borne disease that presents a 
            serious public health threat;''; and
                (ii) by amending subparagraph (D) to read as follows:
            ``(D)(i) is located in a State that has received a grant 
        under subsection (a); or
            ``(ii) that demonstrates to the Secretary that the control 
        program is consistent with existing State mosquito control 
        plans or policies, or other applicable State preparedness 
        plans.'';
            (C) in paragraph (4)(C), by striking ``that extraordinary'' 
        and all that follows through the period at the end and 
        inserting the following: ``that--
                ``(i) extraordinary economic conditions in the 
            political subdivision or consortium of political 
            subdivisions involved justify the waiver; or
                ``(ii) the geographical area covered by a political 
            subdivision or consortium for a grant under paragraph (1) 
            has an extreme mosquito control need due to--

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

            (D) by amending paragraph (6) to read as follows:
        ``(6) Number of grants.--A political subdivision or a 
    consortium of political subdivisions may not receive more than one 
    grant under paragraph (1).''; and
        (3) in subsection (f)--
            (A) in paragraph (1) by striking ``for fiscal year 2003, 
        and such sums as may be necessary for each of fiscal years 2004 
        through 2007'' and inserting ``for each of fiscal years 2019 
        through 2023'';
            (B) in paragraph (2), by striking ``the Public Health 
        Security and Bioterrorism Preparedness and Response Act of 
        2002'' and inserting ``this Act and other medical and public 
        health preparedness and response laws''; and
            (C) in paragraph (3)--
                (i) in the 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
        (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.
                ``(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--
            (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;
            (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 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).''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```