[116th Congress Public Law 22]
[From the U.S. Government Publishing Office]



[[Page 133 STAT. 905]]

Public Law 116-22
116th Congress

                                 An Act


 
To reauthorize certain programs under the Public Health Service Act and 
 the Federal Food, Drug, and Cosmetic Act with respect to public health 
   security and all-hazards preparedness and response, and for other 
             purposes. <<NOTE: June 24, 2019 -  [S. 1379]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Pandemic and 
All-Hazards Preparedness and Advancing Innovation Act of 2019. 42 USC 
201 note.>> 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

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

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

Sec. 101. National Health Security Strategy.

              TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

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

                   TITLE III--REACHING ALL COMMUNITIES

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

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, 
           and other significant threats.

[[Page 133 STAT. 906]]

Sec. 405. Reporting on the Federal Select Agent Program.

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

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

      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

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

                   TITLE VII--MISCELLANEOUS PROVISIONS

Sec. 701. Reauthorizations and extensions.
Sec. 702. Location of materials in the stockpile.
Sec. 703. Cybersecurity.
Sec. 704. Strategy and report.
Sec. 705. Technical amendments.

SEC. 2. REFERENCES IN ACT.

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

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

    Section 2802 (42 U.S.C. 300hh-1) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                          (i) by striking ``2014'' and inserting 
                      ``2018''; and
                          (ii) by striking the second sentence and 
                      inserting the following: ``Such National Health 
                      Security Strategy shall describe potential 
                      emergency health security threats and identify the 
                      process for achieving the preparedness goals 
                      described in subsection (b) to be prepared to 
                      identify and respond to such threats and shall be 
                      consistent with the national preparedness goal (as 
                      described in section 504(a)(19) of the Homeland 
                      Security Act of 2002), the National Incident 
                      Management System (as defined in section 501(7) of 
                      such Act), and the National Response Plan 
                      developed pursuant to section 504 of such Act, or 
                      any successor plan.'';
                    (B) in paragraph (2), by inserting before the period 
                at the end of the second sentence the following: ``, and 
                an analysis of any changes to the evidence-based 
                benchmarks and objective standards under sections 319C-1 
                and 319C-2''; and

[[Page 133 STAT. 907]]

                    (C) in paragraph (3)--
                          (i) by striking ``2009'' and inserting 
                      ``2022'';
                          (ii) by inserting ``(including gaps in the 
                      environmental health and animal health workforces, 
                      as applicable), describing the status of such 
                      workforce'' after ``gaps in such workforce'';
                          (iii) by striking ``and identifying 
                      strategies'' and inserting ``identifying 
                      strategies''; and
                          (iv) by inserting before the period at the end 
                      ``, and identifying current capabilities to meet 
                      the requirements of section 2803''; and
            (2) in subsection (b)--
                    (A) in paragraph (2)--
                          (i) in subparagraph (A), by striking ``and 
                      investigation'' and inserting ``investigation, and 
                      related information technology activities'';
                          (ii) in subparagraph (B), by striking ``and 
                      decontamination'' and inserting ``decontamination, 
                      relevant health care services and supplies, and 
                      transportation and disposal of medical waste''; 
                      and
                          (iii) by adding at the end the following:
                    ``(E) Response to environmental hazards.'';
                    (B) in paragraph (3)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``including mental health'' and 
                      inserting ``including pharmacies, mental health 
                      facilities,''; and
                          (ii) in subparagraph (F), by inserting ``or 
                      exposures to agents that could cause a public 
                      health emergency'' before the period;
                    (C) in paragraph (5), by inserting ``and other 
                applicable compacts'' after ``Compact''; and
                    (D) by adding at the end the following:
            ``(9) Zoonotic disease, food, and agriculture.--Improving 
        coordination <<NOTE: Coordination. Consultation.>>  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) <<NOTE: Assessment.>>  Global health security.--
        Assessing current or potential health security threats from 
        abroad to inform domestic public health preparedness and 
        response capabilities.''.

              TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

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

    (a) Evaluating Measurable Evidence-Based Benchmarks and Objective 
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting 
after subsection (j) the following:

[[Page 133 STAT. 908]]

    ``(k) Evaluation.--
            ``(1) <<NOTE: Deadlines.>>  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) <<NOTE: Review.>>  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) <<NOTE: Recommenda- tions.>>  recommendations, 
                as applicable and appropriate, to improve evidence-based 
                benchmarks and objective standards to more accurately 
                assess the ability of entities receiving awards under 
                this section to better achieve the goals under this 
                section and section 2802.''.

    (b) Evaluating the Partnership for State and Regional Hospital 
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended 
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section 
319C-1(g), (i), (j), and (k)''.
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.

    (a) Cooperative Agreement Applications for Improving State and Local 
Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is amended--
            (1) in subsection (a), by inserting ``, acting through the 
        Director of the Centers for Disease Control and Prevention,'' 
        after ``the Secretary''; and
            (2) in subsection (b)(2)(A)--
                    (A) in clause (vi), by inserting ``, including 
                public health agencies with specific expertise that may 
                be relevant to public health security, such as 
                environmental health agencies,'' after ``stakeholders'';
                    (B) by redesignating clauses (vii) through (ix) as 
                clauses (viii) through (x);
                    (C) by inserting after clause (vi) the following:
                          ``(vii) a description of how, as applicable, 
                      such entity may integrate information to account 
                      for individuals with behavioral health needs 
                      following a public health emergency;'';
                    (D) in clause (ix), as so redesignated, by striking 
                ``; and'' and inserting a semicolon; and

[[Page 133 STAT. 909]]

                    (E) by adding at the end the following:
                          ``(xi) a description of how the entity will 
                      partner with health care facilities, including 
                      hospitals and nursing homes and other long-term 
                      care facilities, to promote and improve public 
                      health preparedness and response; and
                          ``(xii) a description of how, as appropriate 
                      and practicable, the entity will include critical 
                      infrastructure partners, such as utility companies 
                      within the entity's jurisdiction, in planning 
                      pursuant to this subparagraph to help ensure that 
                      critical infrastructure will remain functioning 
                      during, or return to function as soon as 
                      practicable after, a public health emergency;''.

    (b) Exception Relating to Application of Certain Requirements.--
            (1) In general.--Section 319C-1(g) (42 U.S.C. 247d-3a(g)) is 
        amended--
                    (A) in paragraph (5)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``Beginning with fiscal year 2009'' 
                      and inserting ``Beginning with fiscal year 2019''; 
                      and
                          (ii) in subparagraph (A)--
                                    (I) by striking ``for the 
                                immediately preceding fiscal year'' and 
                                inserting ``for either of the 2 
                                immediately preceding fiscal years''; 
                                and
                                    (II) by striking ``2008'' and 
                                inserting ``2018''; and
                    (B) in paragraph (6), by amending subparagraph (A) 
                to read as follows:
                    ``(A) <<NOTE: Time periods.>>  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) <<NOTE: 42 USC 247d-3a note.>>  Effective date.--The 
        amendments made by paragraph (1) shall apply with respect to 
        cooperative agreements awarded on or after the date of enactment 
        of this Act.

    (c) Partnership for State and Regional Hospital Preparedness To 
Improve Surge Capacity.--Section 319C-2 (42 U.S.C. 247d-3b) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``, acting through the Assistant 
                Secretary for Preparedness and Response,'' after ``The 
                Secretary''; and
                    (B) by striking ``preparedness for public health 
                emergencies'' and inserting ``preparedness for, and 
                response to,

[[Page 133 STAT. 910]]

                public health emergencies in accordance with subsection 
                (c)'';
            (2) in subsection (b)(1)(A)--
                    (A) by striking ``partnership consisting of'' and 
                inserting ``coalition that includes'';
                    (B) in clause (ii), by striking ``; and'' and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
                    ``(iv) one or more emergency medical service 
                organizations or emergency management organizations; 
                and'';
            (3) in subsection (d)--
                    (A) in paragraph (1)(B), by striking ``partnership'' 
                each place it appears and inserting ``coalition''; and
                    (B) in paragraph (2)(C), by striking ``medical 
                preparedness'' and inserting ``preparedness and 
                response'';
            (4) in subsection (f), by striking ``partnership'' and 
        inserting ``coalition'';
            (5) in subsection (g)(2)--
                    (A) by striking ``Partnerships'' and inserting 
                ``Coalitions'';
                    (B) by striking ``partnerships'' and inserting 
                ``coalitions''; and
                    (C) by inserting ``and response'' after 
                ``preparedness''; and
            (6) in subsection (i)(1)--
                    (A) by striking ``An entity'' and inserting ``A 
                coalition''; and
                    (B) by striking ``such partnership'' and inserting 
                ``such coalition''.

    (d) Public Health Security Grants Authorization of Appropriations.--
Section 319C-1(h)(1)(A) (42 U.S.C. 247d-3a(h)(1)(A)) is amended by 
striking ``$641,900,000 for fiscal year 2014'' and all that follows 
through the period at the end and inserting ``$685,000,000 for each of 
fiscal years 2019 through 2023 for awards pursuant to paragraph (3) 
(subject to the authority of the Secretary to make awards pursuant to 
paragraphs (4) and (5)).''.
    (e) Partnership for State and Regional Hospital Preparedness 
Authorization of Appropriations.--Section 319C-2(j) (42 U.S.C. 247d-
3b(j)) is amended--
            (1) by amending paragraph (1) to read as follows:
            ``(1) In general.--
                    ``(A) Authorization of appropriations.--For purposes 
                of carrying out this section and section 319C-3, in 
                accordance with subparagraph (B), there is authorized to 
                be appropriated $385,000,000 for each of fiscal years 
                2019 through 2023.
                    ``(B) Reservation of amounts for regional systems.--
                          ``(i) In general.--Subject to clause (ii), of 
                      the amount appropriated under subparagraph (A) for 
                      a fiscal year, the Secretary may reserve up to 5 
                      percent for the purpose of carrying out section 
                      319C-3.
                          ``(ii) Reservation contingent on continued 
                      appropriations for this section.--If for fiscal 
                      year 2019 or a subsequent fiscal year, the amount 
                      appropriated under subparagraph (A) is such that, 
                      after

[[Page 133 STAT. 911]]

                      application of clause (i), the amount remaining 
                      for the purpose of carrying out this section would 
                      be less than the amount available for such purpose 
                      for the previous fiscal year, the amount that may 
                      be reserved under clause (i) shall be reduced such 
                      that the amount remaining for the purpose of 
                      carrying out this section is not less than the 
                      amount available for such purpose for the previous 
                      fiscal year.
                          ``(iii) Sunset.--The authority to reserve 
                      amounts under clause (i) shall expire on September 
                      30, 2023.'';
            (2) in paragraph (2), by striking ``paragraph (1) for a 
        fiscal year'' and inserting ``paragraph (1)(A) for a fiscal year 
        and not reserved for the purpose described in paragraph 
        (1)(B)(i)''; and
            (3) in paragraph (3)(A), by striking ``paragraph (1) and not 
        reserved under paragraph (2)'' and inserting ``paragraph (1)(A) 
        and not reserved under paragraph (1)(B)(i) or (2)''.
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE 
                        SYSTEMS.

    (a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is 
amended by inserting after section 319C-2 the following:
``SEC. 319C-3. <<NOTE: 42 USC 247d-3c.>>  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) <<NOTE: Consultation. Deadline.>>  Guidelines.--The Assistant 
Secretary for Preparedness and Response, in consultation with the 
Director of the Centers for Disease Control and Prevention, the 
Administrator of the Centers for Medicare & Medicaid Services, the 
Administrator of the Health Resources and Services Administration, the 
Commissioner of Food and Drugs, the Assistant Secretary for Mental 
Health and Substance Use, the Assistant Secretary of Labor for 
Occupational Safety and Health, the Secretary of Veterans Affairs, the 
heads of such other Federal agencies as the Secretary determines to be 
appropriate, and State, local, Tribal, and territorial public health 
officials, shall, not later than 2 years after the date of enactment of 
this section--
            ``(1) identify and develop a set of guidelines relating to 
        practices and protocols for all-hazards public health emergency 
        preparedness and response for hospitals and health care 
        facilities to provide appropriate patient care during, in 
        advance of, or immediately following, a public health emergency, 
        resulting from one or more chemical, biological, radiological, 
        or nuclear agents, including emerging infectious diseases (which 
        may include existing practices, such as trauma care and medical 
        surge capacity and capabilities), with respect to--
                    ``(A) a regional approach to identifying hospitals 
                and health care facilities based on varying capabilities 
                and capacity to treat patients affected by such 
                emergency, including--

[[Page 133 STAT. 912]]

                          ``(i) <<NOTE: Coordination.>>  the manner in 
                      which the system will coordinate with and 
                      integrate the partnerships and health care 
                      coalitions established under section 319C-2(b); 
                      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) <<NOTE: Web posting.>>  make such guidelines available 
        on the internet website of the Department of Health and Human 
        Services in a manner that does not compromise national security; 
        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) <<NOTE: Consultation.>>  consult and engage with 
        appropriate health care providers and professionals, including 
        physicians, nurses, first responders, health care facilities 
        (including hospitals, primary care clinics, community health 
        centers, mental health facilities, ambulatory care facilities, 
        and dental health facilities), pharmacies, emergency medical 
        providers, trauma care providers, environmental health agencies, 
        public health laboratories, poison control centers, blood banks, 
        tissue banks, and other experts

[[Page 133 STAT. 913]]

        that the Assistant Secretary determines appropriate, to meet the 
        goals under section 2802(b)(3);
            ``(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) <<NOTE: Consultation.>>  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) <<NOTE: Grants. Coordination.>>  In general.--The 
        Assistant Secretary for Preparedness and Response may establish 
        a demonstration project pursuant to the development and 
        implementation of guidelines under subsection (b) to award 
        grants to improve medical surge capacity for all hazards, build 
        and integrate regional medical response capabilities, improve 
        specialty care expertise for all-hazards response, and 
        coordinate medical preparedness and response across State, 
        local, Tribal, territorial, and regional jurisdictions.
            ``(2) Sunset.--The authority under this subsection shall 
        expire on September 30, 2023.''.

    (b) GAO Report to Congress.--
            (1) <<NOTE: Analysis. Evaluation.>>  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) <<NOTE: Recommenda- tions.>>  recommendations to 
                reduce gaps in incentives for regional health partners, 
                including hospitals and health care facilities, to 
                improve capacity and medical surge capabilities to 
                prepare for, and respond to, public health

[[Page 133 STAT. 914]]

                emergencies, consistent with subsection (a), which may 
                include consideration of facilities participating in 
                programs under section 319C-2 of the Public Health 
                Service Act (42 U.S.C. 247d-3b) or in programs under the 
                Centers for Medicare & Medicaid Services (including 
                innovative health care delivery and payment models), and 
                input from private sector financial institutions.
            (3) Consultation.--In carrying out paragraphs (1) and (2), 
        the Comptroller General shall consult with the heads of 
        appropriate Federal agencies, including--
                    (A) the Assistant Secretary for Preparedness and 
                Response;
                    (B) the Director of the Centers for Disease Control 
                and Prevention;
                    (C) the Administrator of the Centers for Medicare & 
                Medicaid Services;
                    (D) the Assistant Secretary for Mental Health and 
                Substance Use;
                    (E) the Assistant Secretary of Labor for 
                Occupational Safety and Health; and
                    (F) the Secretary of Veterans Affairs.

    (c) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-3b(i)(1)) 
is amended by inserting after the first sentence the following: ``In 
submitting reports under this paragraph, a coalition shall include 
information on the progress that the coalition has made toward the 
implementation of section 319C-3 (or barriers to progress, if any).''.
    (d) National Health Security Strategy Incorporation of Regionalized 
Emergency Preparedness and Response.--Subparagraph (G) of section 
2802(b)(3) (42 U.S.C. 300hh-1(b)(3)) is amended to read as follows:
                    ``(G) Optimizing a coordinated and flexible approach 
                to the emergency response and medical surge capacity of 
                hospitals, other health care facilities, critical care, 
                trauma care (which may include trauma centers), and 
                emergency medical systems.''.

    (e) Improving State and Local Public Health Security.--
            (1) State and local security.--Section 319C-1(e) (42 U.S.C. 
        247d-3a(e)) is amended by striking ``, and local emergency 
        plans.'' and inserting ``, local emergency plans, and any 
        regional health care emergency preparedness and response system 
        established pursuant to the applicable guidelines under section 
        319C-3.''.
            (2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
        3b(d)(1)(A)) is amended--
                    (A) in clause (i), by striking ``; and'' and 
                inserting ``;'';
                    (B) by redesignating clause (ii) as clause (iii); 
                and
                    (C) by inserting after clause (i) the following:
                          ``(ii) among one or more facilities in a 
                      regional health care emergency system under 
                      section 319C-3; and''.
SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.

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

[[Page 133 STAT. 915]]

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

``SEC. 1291. <<NOTE: 42 USC 300d-91.>>  MILITARY AND CIVILIAN 
                          PARTNERSHIP FOR TRAUMA READINESS GRANT 
                          PROGRAM.

    ``(a) <<NOTE: Time periods.>>  Military Trauma Team Placement 
Program.--
            ``(1) <<NOTE: Consultation.>>  In general.--The Secretary, 
        acting through the Assistant Secretary for Preparedness and 
        Response and in consultation with the Secretary of Defense, 
        shall award grants to not more than 20 eligible high-acuity 
        trauma centers to enable military trauma teams to provide, on a 
        full-time basis, trauma care and related acute care at such 
        trauma centers.
            ``(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) <<NOTE: Consultation.>>  In general.--The Secretary, 
        acting through the Assistant Secretary for Preparedness and 
        Response and in consultation with the Secretary of Defense, 
        shall award grants to 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) <<NOTE: Time period.>>  shall be for a period 
                of at least 1 year and not more than 3 years (and may be 
                renewed at the end of such period); and
                    ``(B) 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) <<NOTE: Consultation.>>  be deployed by the 
                Secretary of Defense, in consultation with the Secretary 
                of Health and Human Services,

[[Page 133 STAT. 916]]

                for response to a public health emergency pursuant to 
                section 319.
            ``(2) 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) <<NOTE: Consultation.>>  Report to congress.--Not less 
        than once every 2 years, the Secretary, in consultation with the 
        Secretary of Defense, shall submit a report to the congressional 
        committees of jurisdiction that includes information on the 
        effect of placing military trauma care providers in trauma 
        centers awarded grants under this section on--
                    ``(A) maintaining military trauma care providers' 
                readiness and ability to respond to and treat 
                battlefield injuries;
                    ``(B) providing health care to civilian trauma 
                patients in urban and rural settings;
                    ``(C) the capability of trauma centers and military 
                trauma care providers to increase medical surge 
                capacity, including as a result of a large-scale event;
                    ``(D) the ability of grant recipients to maintain 
                the integration of the military trauma providers or 
                teams of providers as part of the trauma center;
                    ``(E) efforts to incorporate military trauma care 
                providers into operational exercises and training and 
                drills for public health emergencies; and
                    ``(F) the capability of military trauma care 
                providers to participate as part of a medical response 
                during or

[[Page 133 STAT. 917]]

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

    ``(f) Definitions.--For purposes of this part:
            ``(1) Eligible high-acuity trauma center.--The term 
        `eligible high-acuity trauma center' means a Level I trauma 
        center that satisfies each of the following:
                    ``(A) Such trauma center has an agreement with the 
                Secretary of Defense to enable military trauma teams to 
                provide trauma care and related acute care at such 
                trauma center.
                    ``(B) At least 20 percent of patients treated at 
                such trauma center in the most recent 3-month period for 
                which data are available are treated for a major trauma 
                at such trauma center.
                    ``(C) Such trauma center utilizes a risk-adjusted 
                benchmarking system and metrics to measure performance, 
                quality, and patient outcomes.
                    ``(D) Such trauma center is an academic training 
                center--
                          ``(i) affiliated with a medical school;
                          ``(ii) that maintains residency programs and 
                      fellowships in critical trauma specialties and 
                      subspecialties, and provides education and 
                      supervision of military trauma team members 
                      according to those specialties and subspecialties; 
                      and
                          ``(iii) that undertakes research in the 
                      prevention and treatment of traumatic injury.
                    ``(E) Such trauma center serves as a medical and 
                public health preparedness and response leader for its 
                community, such as by participating in a partnership for 
                State and regional hospital preparedness established 
                under section 319C-2 or 319C-3.
            ``(2) Eligible trauma center.--The term `eligible trauma 
        center' means a Level I, II, or III trauma center that satisfies 
        each of the following:
                    ``(A) Such trauma center has an agreement with the 
                Secretary of Defense to enable military trauma care 
                providers to provide trauma care and related acute care 
                at such trauma center.
                    ``(B) Such trauma center utilizes a risk-adjusted 
                benchmarking system and metrics to measure performance, 
                quality, and patient outcomes.
                    ``(C) Such trauma center demonstrates a need for 
                integrated military trauma care providers to maintain or 
                improve the trauma clinical capability of such trauma 
                center.
            ``(3) Major trauma.--The term `major trauma' means an injury 
        that is greater than or equal to 15 on the injury severity 
        score.
            ``(4) Military trauma team.--The term `military trauma team' 
        means a complete military trauma team consisting of military 
        trauma care providers.
            ``(5) Military trauma care provider.--The term `military 
        trauma care provider' means a member of the Armed Forces who 
        furnishes emergency, critical care, and other trauma acute

[[Page 133 STAT. 918]]

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

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

    (a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
            (1) in the section heading, by striking ``revitalizing'' and 
        inserting ``facilities and capacities of'';
            (2) in subsection (a)--
                    (A) in the subsection heading, by striking 
                ``Facilities; Capacities'' and inserting ``In General'';
                    (B) in paragraph (1), by striking ``and improved'' 
                and inserting ``, improved, and appropriately 
                maintained'';
                    (C) in paragraph (3), in the matter preceding 
                subparagraph (A), by striking ``expand, enhance, and 
                improve'' and inserting ``expand, improve, enhance, and 
                appropriately maintain''; and
                    (D) by adding at the end the following:
            ``(4) <<NOTE: Deadline. Time period.>>  Study of resources 
        for facilities and capacities.--Not later than June 1, 2022, the 
        Comptroller General of the United States shall conduct a study 
        on Federal spending in fiscal years 2013 through 2018 for 
        activities authorized under this 
        subsection. <<NOTE: Review. Assessment.>>  Such study shall 
        include a review and assessment of obligations and expenditures 
        directly related to each activity under paragraphs (2) and (3), 
        including a specific accounting of, and delineation between, 
        obligations and expenditures incurred for the construction, 
        renovation, equipping, and security upgrades of facilities and 
        associated contracts under this subsection, and the obligations 
        and expenditures incurred to establish and improve the 
        situational awareness and biosurveillance network under 
        subsection (b), and shall identify the agency or agencies 
        incurring such obligations and expenditures.'';
            (3) 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) <<NOTE: Deadline.>>  In general.--Not later 
                than 1 year after the date of the enactment of the 
                Pandemic and All-Hazards Preparedness and Advancing 
                Innovation Act of 2019, the

[[Page 133 STAT. 919]]

                Secretary, in cooperation with health care providers, 
                State, local, Tribal, and territorial public health 
                officials, and relevant Federal agencies (including the 
                Office of the National Coordinator for Health 
                Information Technology and the National Institute of 
                Standards and Technology), shall, as necessary, adopt 
                technical and reporting standards, including standards 
                for interoperability as defined by section 3000, for 
                networks under paragraph (1) and update such standards 
                as necessary. <<NOTE: Web posting.>>  Such standards 
                shall be made available on the internet website of the 
                Department of Health and Human Services, in a manner 
                that does not compromise national security.
                    ``(B) Deference to standards development 
                organizations.--In adopting and implementing standards 
                under this subsection and subsection (c), the Secretary 
                shall give deference to standards published by standards 
                development organizations and voluntary consensus-based 
                standards entities.'';
            (4) in subsection (c)--
                    (A) in paragraph (1)--
                          (i) by striking ``Not later than 2 years after 
                      the date of enactment of the Pandemic and All-
                      Hazards Preparedness Reauthorization Act of 2013, 
                      the Secretary'' and inserting ``The Secretary'';
                          (ii) by inserting ``, and improve as 
                      applicable and appropriate,'' after ``shall 
                      establish'';
                          (iii) by striking ``of rapid'' and inserting 
                      ``of, rapid''; and
                          (iv) by striking ``such connectivity'' and 
                      inserting ``such interoperability'';
                    (B) by amending paragraph (2) to read as follows:
            ``(2) Coordination and consultation.--In establishing and 
        improving the network under paragraph (1), the Secretary shall--
                    ``(A) facilitate coordination among agencies within 
                the Department of Health and Human Services that 
                provide, or have the potential to provide, information 
                and data to, and analyses for, the situational awareness 
                and biosurveillance network under paragraph (1), 
                including coordination among relevant agencies related 
                to health care services, the facilitation of health 
                information exchange (including the Office of the 
                National Coordinator for Health Information Technology), 
                and public health emergency preparedness and response; 
                and
                    ``(B) consult with the Secretary of Agriculture, the 
                Secretary of Commerce (and the Director of the National 
                Institute of Standards and Technology), the Secretary of 
                Defense, the Secretary of Homeland Security, the 
                Secretary of Veterans Affairs, and the heads of other 
                Federal agencies, as the Secretary determines 
                appropriate.'';
                    (C) in paragraph (3)--
                          (i) by redesignating subparagraphs (A) through 
                      (E) as clauses (i) through (v), respectively, and 
                      adjusting the margins accordingly;
                          (ii) in clause (iv), as so redesignated--
                                    (I) by inserting ``immunization 
                                information systems,'' after ``poison 
                                control,''; and

[[Page 133 STAT. 920]]

                                    (II) by striking ``and clinical 
                                laboratories'' and inserting ``, 
                                clinical laboratories, and public 
                                environmental health agencies'';
                          (iii) by striking ``The network'' and 
                      inserting the following:
                    ``(A) In general.--The network''; and
                          (iv) by adding at the end the following:
                    ``(B) <<NOTE: Deadline. Time periods.>>  Review.--
                Not later than 2 years after the date of the enactment 
                of the Pandemic and All-Hazards Preparedness and 
                Advancing Innovation Act of 2019 and every 6 years 
                thereafter, the Secretary shall conduct a review of the 
                elements described in subparagraph (A). 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) <<NOTE: Deadline.>>  In general.--Not 
                      later than 180 days after the date of enactment of 
                      the Pandemic and All-Hazards Preparedness and 
                      Advancing Innovation Act of 2019, the Secretary 
                      shall convene a public meeting for purposes of 
                      discussing and providing input on the potential 
                      goals, functions, and uses of the network 
                      described in paragraph (1) and incorporating the 
                      elements described in paragraph (3)(A).
                          ``(ii) Experts.--The public meeting shall 
                      include representatives of relevant Federal 
                      agencies (including representatives from the 
                      Office of the National Coordinator for Health 
                      Information Technology and the National Institute 
                      of Standards and Technology); State, local, 
                      Tribal, and territorial public health officials; 
                      stakeholders with expertise in biosurveillance and 
                      situational awareness; stakeholders with expertise 
                      in capabilities relevant to biosurveillance and 
                      situational awareness, such as experts in 
                      informatics and data analytics (including experts 
                      in prediction, modeling, or forecasting); and 
                      other representatives as the Secretary determines 
                      appropriate.
                          ``(iii) Topics.--Such public meeting shall 
                      include a discussion of--
                                    ``(I) data elements, including 
                                minimal or essential data elements, that 
                                are voluntarily provided for such 
                                network, which may include elements from 
                                public health and public and private 
                                health care entities, to the extent 
                                practicable;
                                    ``(II) standards and implementation 
                                specifications that may improve the 
                                collection, analysis,

[[Page 133 STAT. 921]]

                                and interpretation of data during a 
                                public health emergency;
                                    ``(III) strategies to encourage the 
                                access, exchange, and use of 
                                information;
                                    ``(IV) considerations for State, 
                                local, Tribal, and territorial 
                                capabilities and infrastructure related 
                                to data exchange and interoperability;
                                    ``(V) privacy and security 
                                protections provided at the Federal, 
                                State, local, Tribal, and territorial 
                                levels, and by nongovernmental 
                                stakeholders; and
                                    ``(VI) opportunities for the 
                                incorporation of innovative technologies 
                                to improve the network.''; and
                          (iv) in subparagraph (A), as so designated by 
                      clause (ii)--
                                    (I) in clause (i), as so 
                                redesignated--
                                            (aa) by striking ``as 
                                        determined'' and inserting ``as 
                                        adopted''; and
                                            (bb) by inserting ``and the 
                                        National Institute of Standards 
                                        and Technology'' after ``Office 
                                        of the National Coordinator for 
                                        Health Information Technology'';
                                    (II) in clause (iii), as so 
                                redesignated, by striking ``; and'' and 
                                inserting a semicolon;
                                    (III) in clause (iv), as so 
                                redesignated, by striking the period and 
                                inserting ``; and''; and
                                    (IV) by adding at the end the 
                                following:
                          ``(v) pilot test standards and implementation 
                      specifications, consistent with the process 
                      described in section 3002(b)(3)(C), which State, 
                      local, Tribal, and territorial public health 
                      entities may utilize, on a voluntary basis, as a 
                      part of the network.'';
                    (E) by redesignating paragraph (6) as paragraph (7);
                    (F) by inserting after paragraph (5) the following:
            ``(6) Strategy and implementation plan.--
                    ``(A) <<NOTE: Deadline.>>  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) <<NOTE: Review. Assessment.>>  includes 
                      a review and assessment of existing capabilities 
                      of the network and related infrastructure, 
                      including input provided by the public meeting 
                      under paragraph (5)(B);
                          ``(iii) identifies and demonstrates the 
                      measurable steps the Secretary will carry out to--
                                    ``(I) develop, implement, and 
                                evaluate the network described in 
                                paragraph (1), utilizing elements 
                                described in paragraph (3)(A);
                                    ``(II) modernize and enhance 
                                biosurveillance activities, including 
                                strategies to include innovative 
                                technologies and analytical approaches 
                                (including prediction and forecasting 
                                for pandemics and all-hazards) from 
                                public and private entities;

[[Page 133 STAT. 922]]

                                    ``(III) improve information sharing, 
                                coordination, and communication among 
                                disparate biosurveillance systems 
                                supported by the Department of Health 
                                and Human Services, including the 
                                identification of methods to improve 
                                accountability, better utilize resources 
                                and workforce capabilities, and 
                                incorporate innovative technologies 
                                within and across agencies; and
                                    ``(IV) <<NOTE: Evaluation.>>  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) <<NOTE: Deadline.>>  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) <<NOTE: Summary.>>  a summary of 
                      resources previously expended to establish, 
                      improve, and utilize the nationwide public health 
                      situational awareness and biosurveillance network 
                      under paragraph (1);
                          ``(ii) <<NOTE: Cost estimates.>>  estimates of 
                      costs and resources needed to establish and 
                      improve the network under paragraph (1) according 
                      to the strategy and implementation plan under 
                      subparagraph (A);
                          ``(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) <<NOTE: Strategy.>>  a strategy to 
                      minimize and address such gaps and improve 
                      inefficiencies.'';
                    (G) in paragraph (7), as so redesignated--
                          (i) in subparagraph (A), by inserting 
                      ``(taking into account zoonotic disease, including 
                      gaps in scientific understanding of the 
                      interactions between human, animal, and 
                      environmental health)'' after ``human health'';
                          (ii) in subparagraph (B)--
                                    (I) by inserting ``and gaps in 
                                surveillance programs'' after 
                                ``surveillance programs''; and
                                    (II) by striking ``; and'' and 
                                inserting a semicolon;
                          (iii) in subparagraph (C)--
                                    (I) by inserting ``, animal health 
                                organizations related to zoonotic 
                                disease,'' after ``health care 
                                entities''; and

[[Page 133 STAT. 923]]

                                    (II) by striking the period and 
                                inserting ``; and''; and
                          (iv) by adding at the end the following:
                    ``(D) <<NOTE: Recommenda- tions.>>  provide 
                recommendations to the Secretary on policies and 
                procedures to complete the steps described in this 
                paragraph in a manner that is consistent with section 
                2802.''; and
                    (H) by adding at the end the following:
            ``(8) Situational awareness and biosurveillance as a 
        national security priority.--The Secretary, on a periodic basis 
        as applicable and appropriate, shall meet with the Director of 
        National Intelligence to inform the development and capabilities 
        of the nationwide public health situational awareness and 
        biosurveillance network.'';
            (5) in subsection (d)--
                    (A) in paragraph (1)--
                          (i) by inserting ``environmental health 
                      agencies,'' after ``public health agencies,''; and
                          (ii) by inserting ``immunization programs,'' 
                      after ``poison control centers,'';
                    (B) in paragraph (2)--
                          (i) in subparagraph (B), by striking ``and'' 
                      at the end;
                          (ii) in subparagraph (C), by striking the 
                      period and inserting ``; and''; and
                          (iii) by adding after subparagraph (C) the 
                      following:
                    ``(D) an implementation plan that may include 
                measurable steps to achieve the purposes described in 
                paragraph (1).''; and
                    (C) by striking paragraph (5) and inserting the 
                following:
            ``(5) Technical assistance.--The Secretary may provide 
        technical assistance to States, localities, Tribes, and 
        territories or a consortium of States, localities, Tribes, and 
        territories receiving an award under this subsection regarding 
        interoperability and the technical standards set forth by the 
        Secretary.'';
            (6) by redesignating subsections (f) and (g) as subsections 
        (i) and (j), respectively; and
            (7) by inserting after subsection (e) the following:

    ``(f) Personnel Authorities.--
            ``(1) Specially qualified personnel.--In addition to any 
        other personnel authorities, to carry out subsections (b) and 
        (c), the Secretary may--
                    ``(A) appoint highly qualified individuals to 
                scientific or professional positions at the Centers for 
                Disease Control and Prevention, not to exceed 30 such 
                employees at any time (specific to positions authorized 
                by this subsection), with expertise in capabilities 
                relevant to biosurveillance and situational awareness, 
                such as experts in informatics and data analytics 
                (including experts in prediction, modeling, or 
                forecasting), and other related scientific or technical 
                fields; and
                    ``(B) compensate individuals appointed under 
                subparagraph (A) in the same manner and subject to the 
                same terms and conditions in which individuals appointed 
                under

[[Page 133 STAT. 924]]

                9903 of title 5, United States Code, are compensated, 
                without regard to the provisions of chapter 51 and 
                subchapter III of chapter 53 of such title relating to 
                classification and General Schedule pay rates.
            ``(2) Limitations.--The Secretary shall exercise the 
        authority under paragraph (1) in a manner that is consistent 
        with the limitations described in section 319F-1(e)(2).

    ``(g) <<NOTE: Deadline.>>  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) <<NOTE: Deadline. Reports. Recommenda- tions.>>  Independent 
Evaluation.--Not later than 3 years after the date of enactment of the 
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 
2019, the Comptroller General of the United States shall conduct an 
independent evaluation and submit to the Secretary and the congressional 
committees of jurisdiction a report concerning the activities conducted 
under subsections (b) and (c), and provide recommendations, as 
applicable and appropriate, on necessary improvements to the 
biosurveillance and situational awareness network.''.

    (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) <<NOTE: Coordination.>>  Biological Threat Detection Report.--
The Secretary of Health and Human Services shall, in coordination with 
the Secretary of Defense and the Secretary of Homeland Security, not 
later than 180 days after the date of enactment of this Act, report to 
the Committee on Energy and Commerce, the Committee on Armed Services, 
and the Committee on Homeland Security of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions, the 
Committee on Armed Services, and the Committee on Homeland Security and 
Governmental Affairs of the Senate on the state of Federal biological 
threat detection efforts, including the following:
            (1) An identification of technological, operational, and 
        programmatic successes and failures of domestic detection 
        programs supported by Federal departments and agencies for 
        intentionally introduced or accidentally released biological 
        threat agents and naturally occurring infectious diseases.
            (2) A description of Federal efforts to facilitate the 
        exchange of information related to the information described in 
        paragraph (1) among Federal departments and agencies that 
        utilize biological threat detection technology.
            (3) A description of the capabilities of detection systems 
        in use by Federal departments and agencies including the 
        capability to--
                    (A) rapidly detect, identify, characterize, and 
                confirm the presence of biological threat agents;
                    (B) recover live biological agents from collection 
                devices;
                    (C) determine the geographical distribution of 
                biological agents;
                    (D) determine the extent of environmental 
                contamination and persistence of biological agents; and

[[Page 133 STAT. 925]]

                    (E) provide advanced molecular diagnostics to State, 
                local, Tribal, and territorial public health and other 
                laboratories that support biological threat detection 
                activities.
            (4) A description of Federal interagency coordination 
        related to biological threat detection.
            (5) A description of efforts by Federal departments and 
        agencies that utilize biological threat detection technology to 
        collaborate with State, local, Tribal, and territorial public 
        health laboratories and other users of biological threat 
        detection systems, including collaboration regarding the 
        development of--
                    (A) biological threat detection requirements or 
                standards;
                    (B) a standardized integration strategy;
                    (C) training requirements or guidelines;
                    (D) guidelines for a coordinated public health 
                response, including preparedness capabilities, and, as 
                applicable, for coordination with public health 
                surveillance systems; and
                    (E) a coordinated environmental remediation plan, as 
                applicable.
            (6) <<NOTE: Recommenda- tions.>>  Recommendations related to 
        research, advanced research, development, and procurement for 
        Federal departments and agencies to improve and enhance 
        biological threat detection systems, including recommendations 
        on the transfer of biological threat detection technology among 
        Federal departments and agencies, as necessary and appropriate.
SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH EMERGENCY 
                        RAPID RESPONSE FUND.

    Section 319 (42 U.S.C. 247d) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)--
                          (i) in the first sentence, by inserting ``or 
                      if the Secretary determines there is the 
                      significant potential for a public health 
                      emergency, to allow the Secretary to rapidly 
                      respond to the immediate needs resulting from such 
                      public health emergency or potential public health 
                      emergency'' before the period; and
                          (ii) by inserting ``The Secretary shall plan 
                      for the expedited distribution of funds to 
                      appropriate agencies and entities.'' after the 
                      first sentence;
                    (B) by redesignating paragraph (2) as paragraph (3);
                    (C) by inserting after paragraph (1) the following:
            ``(2) Uses.--The Secretary may use amounts in the Fund 
        established under paragraph (1), to--
                    ``(A) facilitate coordination between and among 
                Federal, State, local, Tribal, and territorial entities 
                and public and private health care entities that the 
                Secretary determines may be affected by a public health 
                emergency or potential public health emergency referred 
                to in paragraph (1) (including communication of such 
                entities with relevant international entities, as 
                applicable);
                    ``(B) make grants, provide for awards, enter into 
                contracts, and conduct supportive investigations 
                pertaining to a public health emergency or potential 
                public health emergency, including further supporting 
                programs under section 319C-1, 319C-2, or 319C-3;

[[Page 133 STAT. 926]]

                    ``(C) facilitate and accelerate, as applicable, 
                advanced research and development of security 
                countermeasures (as defined in section 319F-2), 
                qualified countermeasures (as defined in section 319F-
                1), or qualified pandemic or epidemic products (as 
                defined in section 319F-3), that are applicable to the 
                public health emergency or potential public health 
                emergency under paragraph (1);
                    ``(D) strengthen biosurveillance capabilities and 
                laboratory capacity to identify, collect, and analyze 
                information regarding such public health emergency or 
                potential public health emergency, including the systems 
                under section 319D;
                    ``(E) support initial emergency operations and 
                assets related to preparation and deployment of 
                intermittent disaster response personnel under section 
                2812 and the Medical Reserve Corps under section 2813; 
                and
                    ``(F) carry out other activities, as the Secretary 
                determines applicable and appropriate.''; and
                    (D) by inserting after paragraph (3), as so 
                redesignated, the following:
            ``(4) <<NOTE: Deadline. Coordination. Recommenda- tions.>>  
        Review.--Not later than 2 years after the date of enactment of 
        the Pandemic and All-Hazards Preparedness and Advancing 
        Innovation Act of 2019, the Secretary, in coordination with the 
        Assistant Secretary for Preparedness and Response, shall conduct 
        a review of the Fund under this section and provide 
        recommendations to the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate 
        and the Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives on policies to 
        improve such Fund for the uses described in paragraph (2).
            ``(5) GAO report.--Not later than 4 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2019, the Comptroller General of the 
        United States shall--
                    ``(A) <<NOTE: Review.>>  conduct a review of the 
                Fund under this section, including its uses and the 
                resources available in the Fund; and
                    ``(B) <<NOTE: Recommenda- tions.>>  submit to the 
                Committee on Health, Education, Labor, and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives a report on such review, 
                including recommendations related to such review, as 
                applicable.''; and
            (2) in subsection (c)--
                    (A) by inserting ``rapidly respond to public health 
                emergencies or potential public health emergencies and'' 
                after ``used to''; and
                    (B) by striking ``section.'' and inserting ``Act or 
                funds otherwise provided for emergency response.''.
SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE BY 
                        PUBLIC HEALTH EMERGENCY VOLUNTEERS.

    (a) In General.--Section 319I (42 U.S.C. 247d-7b) is amended--
            (1) in the section heading, by striking ``health professions 
        volunteers'' and inserting ``volunteer health professional'';

[[Page 133 STAT. 927]]

            (2) in subsection (a), by adding at the end the following: 
        ``Such health care professionals may include members of the 
        National Disaster Medical System, members of the Medical Reserve 
        Corps, and individual health care professionals.'';
            (3) in subsection (i), by adding at the end the following: 
        ``In order to inform the development of such mechanisms by 
        States, the Secretary shall make available information and 
        material provided by States that have developed mechanisms to 
        waive the application of licensing requirements to applicable 
        health professionals seeking to provide medical services during 
        a public health emergency. <<NOTE: Public information.>>  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. <<NOTE: 42 USC 234.>>  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) <<NOTE: Time period. Determination.>>  to a 
                public health emergency determined under section 319(a), 
                during the initial period of not more than 90 days (as 
                determined by the Secretary) of the public health 
                emergency determination (excluding any period covered by 
                a renewal of such determination); or
                    ``(B) to a major disaster or an emergency as 
                declared by the President under section 401 of the 
                Robert T. Stafford Disaster Relief and Emergency 
                Assistance Act (42 U.S.C.

[[Page 133 STAT. 928]]

                5170) or under section 201 of the National Emergencies 
                Act (50 U.S.C. 1621) during the initial period of such 
                declaration;
            ``(2) is alleged to be liable for an act or omission--
                    ``(A) during the initial period of a determination 
                or declaration described in paragraph (1) and related to 
                the treatment of individuals in need of health care 
                services due to such public health emergency, major 
                disaster, or emergency;
                    ``(B) in the State or States for which such 
                determination or declaration is made;
                    ``(C) in the health care professional's capacity as 
                a member of the Medical Reserve Corps or a professional 
                included in the Emergency System for Advance 
                Registration of Volunteer Health Professionals under 
                section 319I; and
                    ``(D) in the course of providing services that are 
                within the scope of the license, registration, or 
                certification of the professional, as defined by the 
                State of licensure, registration, or certification; and
            ``(3) prior to the rendering of such act or omission, was 
        authorized by the State's authorization of deploying such 
        State's Emergency System for Advance Registration of Volunteer 
        Health Professionals described in section 319I or the Medical 
        Reserve Corps established under section 2813, to provide health 
        care services,

shall be subject only to the State liability laws of the State in which 
such act or omission occurred, in the same manner and to the same extent 
as a similar health care professional who is a resident of such State 
would be subject to such State laws, except with respect to the 
licensure, registration, and certification of such individual.
    ``(b) Volunteer Protection Act.--Nothing in this section shall be 
construed to affect an individual's right to protections under the 
Volunteer Protection Act of 1997.
    ``(c) Preemption.--This section shall supersede the laws of any 
State that would subject a health care professional described in 
subsection (a) to the liability laws of any State other than the State 
liability laws to which such individual is subject pursuant to such 
subsection.
    ``(d) Definitions.--In this section:
            ``(1) The term `health care professional' means an 
        individual licensed, registered, or certified under Federal or 
        State laws or regulations to provide health care services.
            ``(2) The term `health care services' means any services 
        provided by a health care professional, or by any individual 
        working under the supervision of a health care professional, 
        that relate to--
                    ``(A) the diagnosis, prevention, or treatment of any 
                human disease or impairment; or
                    ``(B) the assessment or care of the health of human 
                beings.

    ``(e) Effective Date.--
            ``(1) In general.--This section shall take effect 90 days 
        after the date of the enactment of the Pandemic and All-Hazards 
        Preparedness and Advancing Innovation Act of 2019.

[[Page 133 STAT. 929]]

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

    (b) <<NOTE: Deadline. Review.>>  GAO Study.--Not later than one year 
after the date of enactment of this Act, the Comptroller General of the 
United States shall conduct a review of--
            (1) the number of health care providers who register under 
        the Emergency System for Advance Registration of Volunteer 
        Health Professionals under section 319I of the Public Health 
        Service Act (42 U.S.C. 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 <<NOTE: Recommenda- tions.>>  later than 1 year after the date 
of the enactment of this Act, the Secretary of Health and Human Services 
shall submit to Congress a report containing recommendations related to 
maintaining an adequate national blood supply, including--
            (1) challenges associated with the continuous recruitment of 
        blood donors (including those newly eligible to donate);
            (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) <<NOTE: Contracts.>>  In general.--Not later than one 
        year after the date of enactment of this Act, the Secretary of 
        Health and Human Services shall enter into an agreement with an 
        appropriate entity to conduct a study regarding the public 
        health preparedness and response capabilities and medical surge 
        capacities of hospitals, long-term care facilities, and other 
        health care

[[Page 133 STAT. 930]]

        facilities to prepare for, and respond to, public health 
        emergencies, including natural disasters.
            (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) <<NOTE: Recommenda- tions.>>  provide 
                recommendations for improving public health preparedness 
                and response capability and medical

[[Page 133 STAT. 931]]

                surge capacity for hospitals, long-term care facilities, 
                and other health care facilities, including--
                          (i) improving the existing benchmarks and 
                      objective standards for the Federal grant programs 
                      described in subsection (a)(3)(A) or developing 
                      new benchmarks and standards for such programs; 
                      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) <<NOTE: Deadline. Coordination.>>  Review.--
                Not later than 180 days after the date of enactment of 
                the Pandemic and All-Hazards Preparedness and Advancing 
                Innovation Act of 2019, the Secretary, in coordination 
                with the Secretary of Homeland Security, the Secretary 
                of Defense, and the Secretary of Veterans Affairs, shall 
                conduct a joint review of the National Disaster Medical 
                System. Such review shall include--
                          ``(i) <<NOTE: Evaluation.>>  an evaluation of 
                      medical surge capacity, as described in section 
                      2803(a);
                          ``(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) <<NOTE: Recommenda- tions.>>  gaps that 
                      may exist in such workforce and recommendations 
                      for addressing such gaps.
                    ``(B) <<NOTE: Recommenda- tions.>>  Updates.--As 
                part of the National Health Security Strategy under 
                section 2802, the Secretary shall update

[[Page 133 STAT. 932]]

                the findings from the review under subparagraph (A) and 
                provide recommendations to modify the policies of the 
                National Disaster Medical System as necessary.''.
            (3) Notification of shortage.--Section 2812(c) (42 U.S.C. 
        300hh-11(c)) is amended by adding at the end the following:
            ``(3) <<NOTE: Deadline.>>  Notification.--Not later than 30 
        days after the date on which the Secretary determines the number 
        of intermittent disaster-response personnel of the National 
        Disaster Medical System is insufficient to address a public 
        health emergency or potential public health emergency, the 
        Secretary shall submit to the congressional committees of 
        jurisdiction a notification detailing--
                    ``(A) the impact such shortage could have on meeting 
                public health needs and emergency medical personnel 
                needs during a public health emergency; and
                    ``(B) any identified measures to address such 
                shortage.
            ``(4) Certain appointments.--
                    ``(A) <<NOTE: Determination.>>  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. <<NOTE: Time 
                period.>>  The Secretary shall provide updates on the 
                number of vacant or unfilled positions within such 
                system to the congressional committees of jurisdiction 
                each quarter for which this authority is in effect.
                    ``(B) Sunset.--The authority under this paragraph 
                shall expire on September 30, 2021.''.
            (4) Authorization of appropriations.--Section 2812(g) (42 
        U.S.C. 300hh-11(g)) is amended by striking ``$52,700,000 for 
        each of fiscal years 2014 through 2018'' and inserting 
        ``$57,400,000 for each of fiscal years 2019 through 2023''.

    (b) Volunteer Medical Reserve Corps.--
            (1) In general.--Section 2813(a) (42 U.S.C. 42 U.S.C. 300hh-
        15(a)) is amended by striking the second sentence and inserting 
        ``The Secretary may appoint a Director to head the Corps and 
        oversee the activities of the Corps chapters that exist at the 
        State, local, Tribal, and territorial levels.''.
            (2) Authorization of appropriations.--Section 2813(i) (42 
        U.S.C. 300hh-15(i)) is amended by striking ``2014 through 2018'' 
        and inserting ``2019 through 2023''.

    (c) Strengthening the Epidemic Intelligence Service.--Section 317F 
(42 U.S.C. Sec. 247b-7) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                          (i) by inserting ``or preparedness and 
                      response activities, including rapid response to 
                      public health emergencies and significant public 
                      health threats'' after ``conduct prevention 
                      activities''; and
                          (ii) by striking ``$35,000'' and inserting 
                      ``$50,000''; and
                    (B) in paragraph (2)(B), by striking ``3 years'' and 
                inserting ``2 years''; and
            (2) in subsection (c)--

[[Page 133 STAT. 933]]

                    (A) by striking ``For the purpose of carrying out 
                this section'' and inserting the following:
            ``(1) In general.--For the purpose of carrying out this 
        section, except as described in paragraph (2)''; and
                    (B) by adding at the end the following:
            ``(2) <<NOTE: Time periods. Appropriation authorization.>>  
        Epidemic intelligence service program.--For purposes of carrying 
        out this section with respect to qualified health professionals 
        serving in the Epidemic Intelligence Service, as authorized 
        under section 317G, there is authorized to be appropriated 
        $1,000,000 for each of fiscal years 2019 through 2023.''.

    (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. <<NOTE: Notification.>>  The Secretary shall 
        provide notification to any eligible individual of any effect 
        such designation may have on other benefits for which such 
        individual is eligible, including benefits from private 
        entities.''.
            (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) <<NOTE: Determination.>>  determined by 
                      the Secretary of Health and Human Services to be 
                      hazardous.''.
            (3) <<NOTE: 34 USC 10284 note.>>  Sunset.--The amendments 
        made by paragraphs (1) and (2) shall cease to have force or 
        effect on October 1, 2021.

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

[[Page 133 STAT. 934]]

        or potential public health emergencies, and recommendations to 
        address any gaps identified in such workforce.
            (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) <<NOTE: Recommenda- tions.>>  identification of 
                gaps that may exist in such workforce and 
                recommendations for addressing such gaps, the extent to 
                which the Assistant Secretary for Preparedness and 
                Response plans to address such gaps, and any 
                recommendations from the Comptroller General to address 
                such gaps.
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 <<NOTE: Determination.>>  logistical support shall include 
working with other relevant Federal, State, local, Tribal, and 
territorial public health officials and private sector entities to 
identify the critical infrastructure assets, systems, and networks 
needed for the proper functioning of the health care and public health 
sectors that need to be maintained through any emergency or disaster, 
including entities capable of assisting with, responding to, and 
mitigating the effect of a public health emergency, including a public 
health emergency determined by the Secretary pursuant to section 319(a) 
or an emergency or major disaster declared by the President under the 
Robert T. Stafford Disaster Relief and Emergency Assistance Act or the 
National Emergencies Act, including by establishing methods to exchange 
critical information and deliver products consumed or used to preserve, 
protect, or sustain life, health, or safety, and sharing of specialized 
expertise.''.

    (b) Manufacturing Capacity.--Section 2811(d)(2)(C) (42 U.S.C. 300hh-
10(d)(2)(C)) is amended by inserting ``, and ancillary medical supplies 
to assist with the utilization of such countermeasures or products,'' 
after ``products''.

[[Page 133 STAT. 935]]

    (c) Evaluation of Barriers to Rapid Delivery of Medical 
Countermeasures.--
            (1) Rapid delivery study.--The Assistant Secretary for 
        Preparedness and Response may conduct a study on issues that 
        have the potential to adversely affect the handling and rapid 
        delivery of medical countermeasures to individuals during public 
        health emergencies occurring in the United States.
            (2) <<NOTE: Deadline. Summary.>>  Notice to congress.--Not 
        later than 9 months after the date of the enactment of this Act, 
        the Assistant Secretary for Preparedness and Response shall 
        notify the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate if the Assistant Secretary for 
        Preparedness and Response does not plan to conduct the study 
        under paragraph (1) and shall provide such committees a summary 
        explanation for such decision.
            (3) Report to congress.--Not later than 1 year after the 
        Assistant Secretary for Preparedness and Response conducts the 
        study under paragraph (1), such Assistant Secretary shall submit 
        a report to the Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate containing the findings of such 
        study.
SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.

    (a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
            (1) by striking ``this section and sections 319C-1, 319F, 
        and 319L,'' and inserting ``this Act,''; and
            (2) by striking ``special'' and inserting ``access or 
        functional''.

    (b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C. 
247d-7e(c)(6)) is amended--
            (1) by striking ``elderly'' and inserting ``older adults''; 
        and
            (2) by inserting ``with relevant characteristics that 
        warrant consideration during the process of researching and 
        developing such countermeasures and products'' before the 
        period.

    (c) Biosurveillance of Emerging Public Health Threats.--Section 2814 
is amended--
            (1) in paragraph (7), by striking ``; and'' and inserting a 
        semicolon;
            (2) in paragraph (8), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
            ``(9) facilitate coordination to ensure that, in 
        implementing the situational awareness and biosurveillance 
        network under section 319D, the Secretary considers 
        incorporating data and information from Federal, State, local, 
        Tribal, and territorial public health officials and entities 
        relevant to detecting emerging public health threats that may 
        affect at-risk individuals, such as pregnant and postpartum 
        women and infants, including adverse health outcomes of such 
        populations related to such emerging public health threats.''.
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE 
                        CONSIDERATIONS FOR CHILDREN.

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

[[Page 133 STAT. 936]]

``SEC. 319D-1. <<NOTE: 42 USC 247d-4b.>>  CHILDREN'S PREPAREDNESS 
                              UNIT.

    ``(a) Enhancing Emergency Preparedness for Children.--The Secretary, 
acting through the Director of the Centers for Disease Control and 
Prevention (referred to in this subsection as the `Director'), shall 
maintain an internal team of experts, to be known as the Children's 
Preparedness Unit (referred to in this subsection as the `Unit'), to 
work collaboratively to provide guidance on the considerations for, and 
the specific needs of, children before, during, and after public health 
emergencies. The Unit shall inform the Director regarding emergency 
preparedness and response efforts pertaining to children at the Centers 
for Disease Control and Prevention.
    ``(b) Expertise.--The team described in subsection (a) shall include 
one or more pediatricians, which may be a developmental-behavioral 
pediatrician, and may also include behavioral scientists, child 
psychologists, epidemiologists, biostatisticians, health communications 
staff, and individuals with other areas of expertise, as the Secretary 
determines appropriate.
    ``(c) Duties.--The team described in subsection (a) may--
            ``(1) assist State, local, Tribal, and territorial emergency 
        planning and response activities related to children, which may 
        include developing, identifying, and sharing best practices;
            ``(2) provide technical assistance, training, and 
        consultation to Federal, State, local, Tribal, and territorial 
        public health officials to improve preparedness and response 
        capabilities with respect to the needs of children, including 
        providing such technical assistance, training, and consultation 
        to eligible entities in order to support the achievement of 
        measurable evidence-based benchmarks and objective standards 
        applicable to sections 319C-1 and 319C-2;
            ``(3) improve the utilization of methods to incorporate the 
        needs of children in planning for and responding to a public 
        health emergency, including public awareness of such methods;
            ``(4) coordinate with, and improve, public-private 
        partnerships, such as health care coalitions pursuant to 
        sections 319C-2 and 319C-3, to address gaps and inefficiencies 
        in emergency preparedness and response efforts for children;
            ``(5) provide expertise and input during the development of 
        guidance and clinical recommendations to address the needs of 
        children when preparing for, and responding to, public health 
        emergencies, including pursuant to section 319C-3; and
            ``(6) carry out other duties related to preparedness and 
        response activities for children, as the Secretary determines 
        appropriate.''.
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.

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

[[Page 133 STAT. 937]]

            ``(2) <<NOTE: Consultation. Appointments.>>  Required non-
        federal members.--The Secretary, in consultation with such other 
        heads of Federal agencies as may be appropriate, shall appoint 
        to the Advisory Committee under paragraph (1) at least 13 
        individuals, including--
                    ``(A) at least 2 non-Federal professionals with 
                expertise in pediatric medical disaster planning, 
                preparedness, response, or recovery;
                    ``(B) at least 2 representatives from State, local, 
                Tribal, or territorial agencies with expertise in 
                pediatric disaster planning, preparedness, response, or 
                recovery;
                    ``(C) at least 4 members representing health care 
                professionals, which may include members with expertise 
                in pediatric emergency medicine; pediatric trauma, 
                critical care, or surgery; the treatment of pediatric 
                patients affected by chemical, biological, radiological, 
                or nuclear agents, including emerging infectious 
                diseases; pediatric mental or behavioral health related 
                to children affected by a public health emergency; or 
                pediatric primary care; and
                    ``(D) other members as the Secretary determines 
                appropriate, of whom--
                          ``(i) at least one such member shall represent 
                      a children's hospital;
                          ``(ii) at least one such member shall be an 
                      individual with expertise in schools or child care 
                      settings;
                          ``(iii) at least one such member shall be an 
                      individual with expertise in children and youth 
                      with special health care needs; and
                          ``(iv) at least one such member shall be an 
                      individual with expertise in the needs of parents 
                      or family caregivers, including the parents or 
                      caregivers of children with disabilities.
            ``(3) Federal members.--The Advisory Committee under 
        paragraph (1) shall include the following Federal members or 
        their designees (who may be nonvoting members, as determined by 
        the Secretary):
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(C) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the National Institutes of 
                Health.
                    ``(F) The Assistant Secretary of the Administration 
                for Children and Families.
                    ``(G) The Administrator of the Health Resources and 
                Services Administration.
                    ``(H) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(I) The Administrator of the Administration for 
                Community Living.
                    ``(J) The Secretary of Education.
                    ``(K) Representatives from such Federal agencies 
                (such as the Substance Abuse and Mental Health Services 
                Administration and the Department of Homeland Security) 
                as the Secretary determines appropriate to fulfill the 
                duties of the Advisory Committee under subsections (b) 
                and (c).

[[Page 133 STAT. 938]]

            ``(4) Term of appointment.--Each member of the Advisory 
        Committee appointed under paragraph (2) shall serve for a term 
        of 3 years, except that the Secretary may adjust the terms of 
        the Advisory Committee appointees serving on the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2019, or appointees who are 
        initially appointed after such date of enactment, in order to 
        provide for a staggered term of appointment for all members.
            ``(5) Consecutive appointments; maximum terms.--A member 
        appointed under paragraph (2) may serve not more than 3 terms on 
        the Advisory Committee, and not more than two of such terms may 
        be served consecutively.'';
            (3) in subsection (e), by adding at the end ``At least one 
        meeting per year shall be an in-person meeting.'';
            (4) by redesignating subsection (f) as subsection (g);
            (5) by inserting after subsection (e) the following:

    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.''; and
            (6) in subsection (g), as so redesignated, by striking 
        ``2018'' and inserting ``2023''.

    (b) Authorizing the National Advisory Committee on Seniors and 
Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.) is 
amended by inserting after section 2811A the following:
``SEC. 2811B. <<NOTE: 42 USC 300hh-10c.>>  NATIONAL ADVISORY 
                            COMMITTEE ON SENIORS AND DISASTERS.

    ``(a) <<NOTE: Consultation.>>  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) <<NOTE: Consultations.>>  Duties.--The Advisory Committee 
shall--
            ``(1) provide advice and consultation with respect to the 
        activities carried out pursuant to section 2814, as applicable 
        and appropriate;
            ``(2) <<NOTE: Evaluation.>>  evaluate and provide input with 
        respect to the medical and public health needs of seniors 
        related to preparation for, response to, and recovery from all-
        hazards emergencies; 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) <<NOTE: Recommenda- tions.>>  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) <<NOTE: Consultation. Appointments.>>  In general.--
        The Secretary, in consultation with such other heads of agencies 
        as appropriate, shall appoint not more than 17 members to the 
        Advisory Committee. In appointing such members, the Secretary 
        shall ensure that the total membership of the Advisory Committee 
        is an odd number.

[[Page 133 STAT. 939]]

            ``(2) Required members.--The Advisory Committee shall 
        include Federal members or their designees (who may be nonvoting 
        members, as determined by the Secretary) and non-Federal 
        members, as follows:
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(C) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the National Institutes of 
                Health.
                    ``(F) The Administrator of the Centers for Medicare 
                & Medicaid Services.
                    ``(G) The Administrator of the Administration for 
                Community Living.
                    ``(H) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(I) The Under Secretary for Health of the 
                Department of Veterans Affairs.
                    ``(J) At least 2 non-Federal health care 
                professionals with expertise in geriatric medical 
                disaster planning, preparedness, response, or recovery.
                    ``(K) At least 2 representatives of State, local, 
                Tribal, or territorial agencies with expertise in 
                geriatric disaster planning, preparedness, response, or 
                recovery.
                    ``(L) Representatives of such other Federal agencies 
                (such as the Department of Energy and the Department of 
                Homeland Security) as the Secretary determines necessary 
                to fulfill the duties of the Advisory Committee.

    ``(e) Meetings.--The Advisory Committee shall meet not less 
frequently than biannually. At least one meeting per year shall be an 
in-person meeting.
    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.
    ``(g) Sunset.--
            ``(1) In general.--The Advisory Committee shall terminate on 
        September 30, 2023.
            ``(2) <<NOTE: Deadline. Recommenda- tion.>>  Extension of 
        committee.--Not later than October 1, 2022, the Secretary shall 
        submit to Congress a recommendation on whether the Advisory 
        Committee should be extended.''.

    (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. <<NOTE: 42 USC 300hh-10d.>>  NATIONAL ADVISORY 
                            COMMITTEE ON INDIVIDUALS WITH 
                            DISABILITIES AND DISASTERS.

    ``(a) <<NOTE: Consultation.>>  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) <<NOTE: Consultations.>>  Duties.--The Advisory Committee 
shall--

[[Page 133 STAT. 940]]

            ``(1) provide advice and consultation with respect to 
        activities carried out pursuant to section 2814, as applicable 
        and appropriate;
            ``(2) <<NOTE: Evaluation.>>  evaluate and provide input with 
        respect to the medical, public health, and accessibility needs 
        of individuals with disabilities related to preparation for, 
        response to, and recovery from all-hazards emergencies; 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) <<NOTE: Consultation. Appointments.>>  In general.--
        The Secretary, in consultation with such other heads of agencies 
        and departments as appropriate, shall appoint not more than 17 
        members to the Advisory Committee. In appointing such members, 
        the Secretary shall ensure that the total membership of the 
        Advisory Committee is an odd number.
            ``(2) <<NOTE: Determination.>>  Required members.--The 
        Advisory Committee shall include Federal members or their 
        designees (who may be nonvoting members, as determined by the 
        Secretary) and non-Federal members, as follows:
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Administrator of the Administration for 
                Community Living.
                    ``(C) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(D) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(E) The Commissioner of Food and Drugs.
                    ``(F) The Director of the National Institutes of 
                Health.
                    ``(G) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(H) The Chair of the National Council on 
                Disability.
                    ``(I) The Chair of the United States Access Board.
                    ``(J) The Under Secretary for Health of the 
                Department of Veterans Affairs.
                    ``(K) At least 2 non-Federal health care 
                professionals with expertise in disability accessibility 
                before, during, and after disasters, medical and mass 
                care disaster planning, preparedness, response, or 
                recovery.
                    ``(L) At least 2 representatives from State, local, 
                Tribal, or territorial agencies with expertise in 
                disaster planning, preparedness, response, or recovery 
                for individuals with disabilities.
                    ``(M) At least 2 individuals with a disability with 
                expertise in disaster planning, preparedness, response, 
                or recovery for individuals with disabilities.

    ``(d) Meetings.--The Advisory Committee shall meet not less 
frequently than biannually. At least one meeting per year shall be an 
in-person meeting.
    ``(e) Disability Defined.--For purposes of this section, the term 
`disability' has the meaning given such term in section 3 of the 
Americans with Disabilities Act of 1990.

[[Page 133 STAT. 941]]

    ``(f) Coordination.--The Secretary shall coordinate duties and 
activities authorized under this section in accordance with section 
2811D.
    ``(g) Sunset.--
            ``(1) In general.--The Advisory Committee shall terminate on 
        September 30, 2023.
            ``(2) <<NOTE: Deadline.>>  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. <<NOTE: 42 USC 300hh-10e.>>  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. <<NOTE: Recommenda- tions.>>  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) <<NOTE: Deadline. Summary.>>  Notification.--The Secretary 
shall annually notify the congressional committees of jurisdiction 
regarding the steps taken to coordinate, as appropriate, the 
recommendations under this section, and provide a summary description of 
such coordination.''.
SEC. 306. <<NOTE: 42 USC 300hh note. Deadline.>>  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). <<NOTE: Consultation.>>  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. <<NOTE: Web posting.>>  The Secretary 
shall make the guidance available on the internet website of the 
Department of Health and Human Services.

[[Page 133 STAT. 942]]

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

SEC. 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) <<NOTE: Coordination. Assessment.>>  Threat 
                awareness.--Coordinate with the Director of the Centers 
                for Disease Control and Prevention, the Director of 
                National Intelligence, the Secretary of Homeland 
                Security, the Assistant to the President for National 
                Security Affairs, the Secretary of Defense, and other 
                relevant Federal officials, such as the Secretary of 
                Agriculture, to maintain a current assessment of 
                national security threats and inform preparedness and 
                response capabilities based on the range of the threats 
                that have the potential to result in a public health 
                emergency.''.
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. <<NOTE: 42 USC 300hh-10a.>>  PUBLIC HEALTH 
                              EMERGENCY MEDICAL COUNTERMEASURES 
                              ENTERPRISE.

    ``(a) <<NOTE: Establishment.>>  In General.--The Secretary shall 
establish the Public Health Emergency Medical Countermeasures Enterprise 
(referred to in this section as the `PHEMCE'). The Assistant Secretary 
for Preparedness and Response shall serve as chair of the PHEMCE.

    ``(b) Members.--The PHEMCE shall include each of the following 
members, or the designee of such members:
            ``(1) The Assistant Secretary for Preparedness and Response.
            ``(2) The Director of the Centers for Disease Control and 
        Prevention.
            ``(3) The Director of the National Institutes of Health.
            ``(4) The Commissioner of Food and Drugs.
            ``(5) The Secretary of Defense.
            ``(6) The Secretary of Homeland Security.
            ``(7) The Secretary of Agriculture.
            ``(8) The Secretary of Veterans Affairs.
            ``(9) The Director of National Intelligence.
            ``(10) Representatives of any other Federal agency, which 
        may include the Director of the Biomedical Advanced Research and 
        Development Authority, the Director of the Strategic National 
        Stockpile, the Director of the National Institute of Allergy and 
        Infectious Diseases, and the Director of the Office of Public 
        Health Preparedness and Response, as the Secretary determines 
        appropriate.

    ``(c) Functions.--
            ``(1) In general.--The functions of the PHEMCE shall include 
        the following:

[[Page 133 STAT. 943]]

                    ``(A) <<NOTE: Recommenda- tions. Assessments.>>  
                Utilize a process to make recommendations to the 
                Secretary regarding research, advanced research, 
                development, procurement, stockpiling, deployment, 
                distribution, and utilization with respect to 
                countermeasures, as defined in section 319F-2(c), 
                including prioritization based on the health security 
                needs of the United States. 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. <<NOTE: Determination.>>  In the 
                event that members of the PHEMCE do not agree upon a 
                recommendation, the Secretary shall provide a 
                determination regarding such recommendation.
                    ``(B) <<NOTE: Recommenda- tions.>>  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) <<NOTE: Strategies.>>  Assist the Secretary in 
                developing strategies related to logistics, deployment, 
                distribution, dispensing, and use of countermeasures 
                that may be applicable to the activities of the 
                strategic national stockpile under section 319F-2(a).
                    ``(D) <<NOTE: Consultation.>>  Provide consultation 
                for the development of the strategy and implementation 
                plan under section 2811(d).
            ``(2) Input.--In carrying out subparagraphs (B) and (C) of 
        paragraph (1), the PHEMCE shall solicit and consider input from 
        State, local, Tribal, and territorial public health departments 
        or officials, as appropriate.''.

    (b) Public Health Emergency Medical Countermeasures Enterprise 
Strategy and Implementation Plan.--Section 2811(d) (42 U.S.C. 300hh-
10(d)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``Not later than 180 days after the 
                date of enactment of this subsection, and every year 
                thereafter'' and inserting ``Not later than March 15, 
                2020, and biennially thereafter''; and
                    (B) by striking ``Director of the Biomedical'' and 
                all that follows through ``Food and Drugs'' and 
                inserting ``Public Health Emergency Medical 
                Countermeasures Enterprise established under section 
                2811-1''; and
            (2) in paragraph (2)(J)(v), by striking ``one-year period'' 
        and inserting ``2-year period''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.

    (a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is 
amended--
            (1) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively; and
            (2) in paragraph (1)--
                    (A) by inserting ``the Assistant Secretary for 
                Preparedness and Response and'' after ``collaboration 
                with'';

[[Page 133 STAT. 944]]

                    (B) by inserting ``and optimize'' after ``provide 
                for'';
                    (C) by inserting ``and, as informed by existing 
                recommendations of, or consultations with, the Public 
                Health Emergency Medical Countermeasure Enterprise 
                established under section 2811-1, make necessary 
                additions or modifications to the contents of such 
                stockpile or stockpiles based on the review conducted 
                under paragraph (2)'' before the period of the first 
                sentence; and
                    (D) by striking the second sentence;
            (3) by inserting after paragraph (1) the following:
            ``(2) Threat-based review.--
                    ``(A) <<NOTE: Consultation. Assessment.>>  In 
                general.--The Secretary shall conduct an annual threat-
                based review (taking into account at-risk individuals) 
                of the contents of the stockpile under paragraph (1), 
                including non-pharmaceutical supplies, and, in 
                consultation with the Public Health Emergency Medical 
                Countermeasures Enterprise established under section 
                2811-1, review contents within the stockpile and assess 
                whether such contents are consistent with the 
                recommendations made pursuant to section 2811-
                1(c)(1)(A). <<NOTE: Deadlines.>>  Such review shall be 
                submitted on June 15, 2019, and on March 15 of each year 
                thereafter, to the Committee on Health, Education, 
                Labor, and Pensions and the Committee on Appropriations 
                of the Senate and the Committee on Energy and Commerce 
                and the Committee on Appropriations of the House of 
                Representatives, in a manner that does not compromise 
                national security.
                    ``(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) <<NOTE: Assessment.>>  an 
                                assessment of whether the emergency 
                                health security threat or threats 
                                described in subclause (IV) could be 
                                addressed in a manner that better 
                                utilizes the resources of the stockpile 
                                and permits the greatest possible 
                                increase in the level

[[Page 133 STAT. 945]]

                                of emergency preparedness to address 
                                such threats;
                                    ``(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) <<NOTE: Consultation.>>  devise plans for 
                effective and timely supply-chain management of the 
                stockpile, in consultation with the Director of the 
                Centers for Disease Control and Prevention, the 
                Assistant Secretary for Preparedness and Response, the 
                Secretary of Transportation, the Secretary of Homeland 
                Security, the Secretary of Veterans Affairs, and the 
                heads of other appropriate Federal agencies; State, 
                local, Tribal, and territorial agencies; and the public 
                and private health care infrastructure, as applicable, 
                taking into account the manufacturing capacity and other 
                available sources of products and appropriate 
                alternatives to supplies in the stockpile;'';
                    (D) in subparagraph (G), by striking ``; and'' and 
                inserting a semicolon;
                    (E) in subparagraph (H), by striking the period and 
                inserting a semicolon; and
                    (F) by adding at the end the following:

[[Page 133 STAT. 946]]

                    ``(I) ensure that each countermeasure or product 
                under consideration for procurement pursuant to this 
                subsection receives the same consideration regardless of 
                whether such countermeasure or product receives or had 
                received funding under section 319L, including with 
                respect to whether the countermeasure or product is most 
                appropriate to meet the emergency health security needs 
                of the United States; and
                    ``(J) provide assistance, including technical 
                assistance, to maintain and improve State and local 
                public health preparedness capabilities to distribute 
                and dispense medical countermeasures and products from 
                the stockpile, as appropriate.''; and
            (5) by adding at the end the following:
            ``(5) GAO report.--
                    ``(A) <<NOTE: Deadline. Time 
                period. Review. Assessments.>>  In general.--Not later 
                than 3 years after the date of enactment of the Pandemic 
                and All-Hazards Preparedness and Advancing Innovation 
                Act of 2019, and every 5 years thereafter, the 
                Comptroller General of the United States shall conduct a 
                review of any changes to the contents or management of 
                the stockpile since January 1, 2015. 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) <<NOTE: Analysis.>>  an analysis of how 
                      such procurement decisions made progress toward 
                      meeting emergency health security needs related to 
                      the identified threats for countermeasures added, 
                      modified, or replenished under paragraph (1);
                          ``(vi) a description of the resources expended 
                      related to the procurement of countermeasures

[[Page 133 STAT. 947]]

                      (including additions, modifications, and 
                      replenishments) in the stockpile, and how such 
                      expenditures relate to the ability of the 
                      stockpile to meet emergency health security needs;
                          ``(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) <<NOTE: Deadline.>>  Submission.--Not later 
                than 6 months after completing a classified version of 
                the review under subparagraph (A), the Comptroller 
                General shall submit an unclassified version of the 
                review to the congressional committees of 
                jurisdiction.''.

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

[[Page 133 STAT. 948]]

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

    (a) Strategic Initiatives.--Section 319L(c)(4) (247d-7e(c)(4)) is 
amended by adding at the end the following:
                    ``(F) <<NOTE: Determination.>>  Strategic 
                initiatives.--The Secretary, acting through the Director 
                of BARDA, may implement strategic initiatives, including 
                by building on existing programs and by awarding 
                contracts, grants, and cooperative agreements, or 
                entering into other transactions, to support innovative 
                candidate products in preclinical and clinical 
                development that address priority, naturally occurring 
                and man-made threats that, as determined by the 
                Secretary, pose a significant level of risk to national 
                security based on the characteristics of a chemical, 
                biological, radiological or nuclear threat, or existing 
                capabilities to respond to such a threat (including 
                medical response and treatment capabilities and 
                manufacturing infrastructure). Such initiatives shall 
                accelerate and support the advanced research, 
                development, and procurement of countermeasures and 
                products, as applicable, to address areas including--
                          ``(i) chemical, biological, radiological, or 
                      nuclear threats, including emerging infectious 
                      diseases, for which insufficient approved, 
                      licensed, or authorized countermeasures exist, or 
                      for which such threat, or the result of an 
                      exposure to such threat, may become resistant to 
                      countermeasures or existing countermeasures may be 
                      rendered ineffective;
                          ``(ii) threats that consistently exist or 
                      continually circulate and have a significant 
                      potential to become a pandemic, such as pandemic 
                      influenza, which may include the advanced research 
                      and development, manufacturing, and appropriate 
                      stockpiling of qualified pandemic or epidemic 
                      products, and products, technologies, or processes 
                      to support the advanced research and development 
                      of such countermeasures (including multiuse 
                      platform technologies for diagnostics, vaccines, 
                      and therapeutics; virus seeds; clinical trial 
                      lots; novel virus strains; and antigen and 
                      adjuvant material); and
                          ``(iii) threats that may result primarily or 
                      secondarily from a chemical, biological, 
                      radiological, or nuclear agent, or emerging 
                      infectious diseases, and which may present 
                      increased treatment complications such as the 
                      occurrence of resistance to available 
                      countermeasures or potential countermeasures, 
                      including antimicrobial resistant pathogens.''.

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

[[Page 133 STAT. 949]]

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

    Section 351A(k) (42 U.S.C. 262a(k)) is amended--
            (1) by striking ``The Secretary'' and inserting the 
        following:
            ``(1) In general.--The Secretary''; and
            (2) by adding at the end the following:
            ``(2) Implementation of recommendations of the federal 
        experts security advisory panel and the fast track action 
        committee on select agent regulations.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2019, the 
                Secretary shall report to the congressional committees 
                of jurisdiction on the implementation of recommendations 
                of the Federal Experts Security Advisory Panel 
                concerning the select agent program.
                    ``(B) Continued updates.--The Secretary shall report 
                to the congressional committees of jurisdiction annually 
                following the submission of the report under 
                subparagraph (A) until the recommendations described in 
                such subparagraph are fully implemented, or a 
                justification is provided for the delay in, or lack of, 
                implementation.''.

[[Page 133 STAT. 950]]

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

SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

    Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
            (1) in the matter preceding subparagraph (A), by striking 
        ``March 1'' and inserting ``March 15'';
            (2) in subparagraph (A)--
                    (A) in clause (ii), by striking ``; and'' and 
                inserting ``;''; and
                    (B) by striking clause (iii) and inserting the 
                following:
                          ``(iii) procurement, stockpiling, maintenance, 
                      and potential replenishment (including 
                      manufacturing capabilities) of all products in the 
                      Strategic National Stockpile;
                          ``(iv) the availability of technologies that 
                      may assist in the advanced research and 
                      development of countermeasures and opportunities 
                      to use such technologies to accelerate and 
                      navigate challenges unique to countermeasure 
                      research and development; and
                          ``(v) potential deployment, distribution, and 
                      utilization of medical countermeasures; 
                      development of clinical guidance and emergency use 
                      instructions for the use of medical 
                      countermeasures; and, as applicable, potential 
                      postdeployment activities related to medical 
                      countermeasures;'';
            (3) by redesignating subparagraphs (D) and (E) as 
        subparagraphs (E) and (F), respectively; and
            (4) by inserting after subparagraph (C), the following:
                    ``(D) identify the full range of anticipated medical 
                countermeasure needs related to research and 
                development, procurement, and stockpiling, including the 
                potential need for indications, dosing, and 
                administration technologies, and other countermeasure 
                needs as applicable and appropriate;''.
SEC. 502. <<NOTE: Determinations.>>  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) <<NOTE: Deadline.>>  Contracting Communication.--Section 319F-
2(c)(7)(B)(ii)(III) (42 U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is amended by 
adding at the end the following: ``The Secretary shall notify the

[[Page 133 STAT. 951]]

vendor within 90 days of a determination by the Secretary to renew, 
extend, or terminate such contract.''.
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

    Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-4(f)) is amended--
            (1) by redesignating paragraphs (3) through (6) as 
        paragraphs (4) through (7), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) <<NOTE: Web posting.>>  Publication.--The Secretary 
        shall make available on the internet website of the Food and 
        Drug Administration information regarding regulatory management 
        plans, including--
                    ``(A) the process by which an applicant may submit a 
                request for a regulatory management plan;
                    ``(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. <<NOTE: 42 USC 247d-5 note.>>  ADDITIONAL STRATEGIES FOR 
                        COMBATING ANTIBIOTIC RESISTANCE.

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

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

[[Page 133 STAT. 952]]

bacteria that may present a public health threat and improve 
capabilities to prevent, diagnose, mitigate, or treat such resistance. 
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) <<NOTE: Coordination.>>  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) <<NOTE: Applicability.>>  FACA.--The Federal Advisory Committee 
Act (5 U.S.C. App.) shall apply to the activities and duties of the 
Advisory Council.

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

      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

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

[[Page 133 STAT. 953]]

SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.

    Section 319L (42 U.S.C. 247d-7e) is amended--
            (1) in subsection (a)(3), by striking ``, such as'' and all 
        that follows through ``Code''; and
            (2) in subsection (c)(5)(A)--
                    (A) in clause (i), by striking ``under this 
                subsection'' and all that follows through ``Code'' and 
                inserting ``(as defined in subsection (a)(3)) under this 
                subsection''; and
                    (B) in clause (ii)--
                          (i) by amending subclause (I) to read as 
                      follows:
                                    ``(I) In general.--To the maximum 
                                extent practicable, competitive 
                                procedures shall be used when entering 
                                into transactions to carry out projects 
                                under this subsection.''; and
                          (ii) in subclause (II)--
                                    (I) by striking ``$20,000,000'' and 
                                inserting ``$100,000,000'';
                                    (II) by striking ``senior 
                                procurement executive for the Department 
                                (as designated for purpose of section 
                                16(c) of the Office of Federal 
                                Procurement Policy Act (41 U.S.C. 
                                414(c)))'' and inserting ``Assistant 
                                Secretary for Financial Resources''; and
                                    (III) by striking ``senior 
                                procurement executive under'' and 
                                inserting ``Assistant Secretary for 
                                Financial Resources under''.
SEC. 603. <<NOTE: 21 USC 360bbb-4b note.>>  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. <<NOTE: 21 USC 360bbb-4b.>>  MEDICAL COUNTERMEASURE 
                          MASTER FILES.

    ``(a) Applicability of Reference.--
            ``(1) In general.--A person may submit data and information 
        in a master file to the Secretary with the intent to reference, 
        or to authorize, in writing, another person to reference, such 
        data or information to support a medical countermeasure 
        submission (including a supplement or amendment to any such 
        submission), without requiring the master file holder to 
        disclose the data and information to any such persons authorized 
        to reference the master file. Such data and information shall be 
        available for reference by the master file holder or by a person 
        authorized by the master file holder, in accordance with 
        applicable privacy and confidentiality protocols and 
        regulations.

[[Page 133 STAT. 954]]

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

    ``(b) Medical Countermeasure Master File Content.--
            ``(1) In general.--A master file under this section may 
        include data or information to support--
                    ``(A) the development of medical countermeasure 
                submissions to support the approval, licensure, 
                classification, clearance, conditional approval, or 
                authorization of one or more security countermeasures, 
                qualified countermeasures, or qualified pandemic or 
                epidemic products; and
                    ``(B) the manufacture of security countermeasures, 
                qualified countermeasures, or qualified pandemic or 
                epidemic products.
            ``(2) Required updates.--The Secretary may require, as 
        appropriate, that the master file holder ensure that the 
        contents of such master file are updated during the time such 
        master file is referenced for a medical countermeasure 
        submission.

    ``(c) Sponsor Reference.--
            ``(1) In general.--Each incorporation of data or information 
        within a medical countermeasure master file shall describe the 
        incorporated material in a manner in which the Secretary 
        determines appropriate and that permits the review of such 
        information within such master file without necessitating 
        resubmission of such data or information. Master files shall be 
        submitted in an electronic format in accordance with sections 
        512(b)(4), 571(a)(4), and 745A, as applicable, and as specified 
        in applicable guidance.
            ``(2) <<NOTE: Notification.>>  Reference by a master file 
        holder.--A master file holder that is the sponsor of a medical 
        countermeasure submission shall notify the Secretary in writing 
        of the intent to reference the medical countermeasure master 
        file as a part of the submission.
            ``(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) <<NOTE: Notification.>>  In general.--The Secretary 
        shall provide the master file holder with a written notification 
        indicating that the Secretary has reviewed and relied upon 
        specified data or information within a master file and the 
        purposes for which such data or information was incorporated by 
        reference if the Secretary has reviewed and relied upon such 
        specified data or information to support the approval, 
        classification, conditional approval, clearance, licensure, or 
        authorization of a security

[[Page 133 STAT. 955]]

        countermeasure, qualified countermeasure, or qualified pandemic 
        or epidemic product. The Secretary may rely upon the data and 
        information within the medical countermeasure master file for 
        which such written notification was provided in additional 
        applications, as applicable and appropriate and upon the request 
        of the master file holder so notified in writing or by an 
        authorized person of such holder.
            ``(2) Certain applications.--If the Secretary has reviewed 
        and relied upon specified data or information within a medical 
        countermeasure master file to support the conditional approval 
        of an application under section 571 to subsequently support the 
        approval, clearance, licensure, or authorization of a security 
        countermeasure, qualified countermeasure, or qualified pandemic 
        or epidemic product, the Secretary shall provide a brief written 
        description to the master file holder regarding the elements of 
        the application fulfilled by the data or information within the 
        master file and how such data or information contained in such 
        application meets the standards of evidence under subsection (c) 
        or (d) of section 505, subsection (d) of section 512, or section 
        351 of the Public Health Service Act (as applicable), which 
        shall not include any trade secret or confidential commercial 
        information.

    ``(e) Rules of Construction.--Nothing in this section shall be 
construed to--
            ``(1) limit the authority of the Secretary to approve, 
        license, clear, conditionally approve, or authorize drugs, 
        biological products, or devices pursuant to, as applicable, this 
        Act or section 351 of the Public Health Service Act (as such 
        applicable Act is in effect on the day before the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2019), including the standards of 
        evidence, and applicable conditions, for approval under the 
        applicable Act;
            ``(2) alter the standards of evidence with respect to 
        approval, licensure, or clearance, as applicable, of drugs, 
        biological products, or devices under this Act or section 351 of 
        the Public Health Service Act, including, as applicable, the 
        substantial evidence standards under sections 505(d) and 512(d) 
        or this Act and section 351(a) of the Public Health Service Act; 
        or
            ``(3) alter the authority of the Secretary under this Act or 
        the Public Health Service Act to determine the types of data or 
        information previously submitted by a sponsor or any other 
        person that may be incorporated by reference in an application, 
        request, or notification for a drug, biological product, or 
        device submitted under sections 505(i), 505(b), 505(j), 
        512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 515(c), 
        513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of 
        section 351 of the Public Health Service Act, including a 
        supplement or amendment to any such submission, and the 
        requirements associated with such reference.

    ``(f) Definitions.--In this section:
            ``(1) The term `master file holder' means a person who 
        submits data and information to the Secretary with the intent to 
        reference or authorize another person to reference such data or 
        information to support a medical countermeasure submission, as 
        described in subsection (a).

[[Page 133 STAT. 956]]

            ``(2) The term `medical countermeasure submission' means an 
        investigational new drug application under section 505(i), a new 
        drug application under section 505(b), or an abbreviated new 
        drug application under section 505(j) of this Act, a biological 
        product license application under section 351(a) of the Public 
        Health Service Act or a biosimilar biological product license 
        application under section 351(k) of the Public Health Service 
        Act, a new animal drug application under section 512(b)(1) or 
        abbreviated new animal drug application under section 512(b)(2), 
        an application for conditional approval of a new animal drug 
        under section 571, an investigational device application under 
        section 520(g), an application with respect to a device under 
        section 515(c), a request for classification of a device under 
        section 513(f)(2), a notification with respect to a device under 
        section 510(k), or a request for an emergency use authorization 
        under section 564 to support--
                    ``(A) the approval, licensure, classification, 
                clearance, conditional approval, or authorization of a 
                security countermeasure, qualified countermeasure, or 
                qualified pandemic or epidemic product; or
                    ``(B) a new indication to an approved security 
                countermeasure, qualified countermeasure, or qualified 
                pandemic or epidemic product.
            ``(3) The terms `qualified countermeasure', `security 
        countermeasure', and `qualified pandemic or epidemic product' 
        have the meanings given such terms in sections 319F-1, 319F-2, 
        and 319F-3, respectively, of the Public Health Service Act.''.

    (c) <<NOTE: Deadline. Consultation.>>  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) <<NOTE: Deadlines.>>  Guidance.--Not later than 2 years after 
the date of enactment of this Act, the Secretary, acting through the 
Commissioner of Food and Drugs, shall publish draft guidance about how 
reliance on cross-referenced data and information contained within 
master files under section 565B of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (b) or submissions otherwise submitted to 
the Secretary may be used for specific tools or technologies (including 
platform technologies) that have the potential to support and advance 
the development or manufacture of security countermeasures, qualified 
countermeasures, and qualified pandemic or epidemic 
products. <<NOTE: Publication.>>  The Secretary, acting through the 
Commissioner of Food and Drugs, shall publish the final guidance not 
later than 3 years after the enactment of this Act.

[[Page 133 STAT. 957]]

SEC. 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. <<NOTE: Examination.>>  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) <<NOTE: Recommenda- tions.>>  Report.--Not later than 3 years 
after the date of enactment of this Act, the Comptroller General of the 
United States shall submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy and Commerce of

[[Page 133 STAT. 958]]

the House of Representatives a report containing the results of the 
study conducted under subsection (a) and recommendations to improve the 
application and consistency of the requirements under subsections (c) 
and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 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) <<NOTE: Deadline.>>  In general.--Not later than 1 year 
        after the date of enactment of this Act, the Secretary of Health 
        and Human Services (referred to in this section as the 
        ``Secretary'') shall convene a meeting to discuss the potential 
        role advancements in genomic engineering technologies (including 
        genome editing technologies) may have in advancing national 
        health security. Such meeting shall be held in a manner that 
        does not compromise national security.
            (2) Attendees.--The attendees of the meeting under paragraph 
        (1)--
                    (A) shall include--
                          (i) representatives from the Office of the 
                      Assistant Secretary for Preparedness and Response, 
                      the National Institutes of Health, the Centers for 
                      Disease Control and Prevention, and the Food and 
                      Drug Administration; and
                          (ii) representatives from academic, private, 
                      and nonprofit entities with expertise in genome 
                      engineering technologies, biopharmaceuticals, 
                      medicine, or biodefense, and other relevant 
                      stakeholders; and
                    (B) may include--
                          (i) other representatives from the Department 
                      of Health and Human Services, as the Secretary 
                      determines appropriate; and
                          (ii) representatives from the Department of 
                      Homeland Security, the Department of Defense, the 
                      Department of Agriculture, and other departments, 
                      as the Secretary may request for the meeting.
            (3) Topics.--The meeting under paragraph (1) shall include a 
        discussion of--
                    (A) the current state of the science of genomic 
                engineering technologies related to national health 
                security, including--
                          (i) medical countermeasure development, 
                      including potential efficiencies in the 
                      development pathway and detection technologies; 
                      and
                          (ii) the international and domestic regulation 
                      of products utilizing genome editing technologies; 
                      and
                    (B) national security implications, including--

[[Page 133 STAT. 959]]

                          (i) capabilities of the United States to 
                      leverage genomic engineering technologies as a 
                      part of the medical countermeasure enterprise, 
                      including current applicable research, 
                      development, and application efforts underway 
                      within the Department of Defense;
                          (ii) the potential for state and non-state 
                      actors to utilize genomic engineering technologies 
                      as a national health security threat; and
                          (iii) security measures to monitor and assess 
                      the potential threat that may result from 
                      utilization of genomic engineering technologies 
                      and related technologies for the purpose of 
                      compromising national health security.

    (b) <<NOTE: Recommenda- tions.>>  Report.--Not later than 270 days 
after the meeting described in subsection (a) is held, the Assistant 
Secretary for Preparedness and Response shall issue a report to the 
congressional committees of jurisdiction on the topics discussed at such 
meeting, and provide recommendations, as applicable, to utilize 
innovations in genomic engineering (including genome editing) and 
related technologies as a part of preparedness and response activities 
to advance national health security. Such report shall be issued in a 
manner that does not compromise national security.
SEC. 606. REPORT ON VACCINES DEVELOPMENT.

    Not later than one year after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall submit to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives a 
report describing efforts and activities to coordinate with other 
countries and international partners during recent public health 
emergencies with respect to the research and advanced research on, and 
development of, qualified pandemic or epidemic products (as defined in 
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)). 
Such report may include information regarding relevant work carried out 
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(5)(E)), through public-private partnerships, and through 
collaborations with other countries to assist with or expedite the 
research and development of qualified pandemic or epidemic products. 
Such report shall not include information that may compromise national 
security.
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND HEALTH.

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

[[Page 133 STAT. 960]]

                                    (I) in clause (ii), by striking 
                                ``or'' at the end;
                                    (II) in clause (iii), by striking 
                                the semicolon at the end and inserting 
                                ``, including an emerging infectious 
                                mosquito-borne disease that presents a 
                                serious public health threat; or''; and
                                    (III) by adding at the end the 
                                following:
                          ``(iv) a public health emergency due to the 
                      incidence or prevalence of a mosquito-borne 
                      disease that presents a serious public health 
                      threat;''; and
                          (ii) by amending subparagraph (D) to read as 
                      follows:
                    ``(D)(i) is located in a State that has received a 
                grant under subsection (a); or
                    ``(ii) that demonstrates to the Secretary that the 
                control program is consistent with existing State 
                mosquito control plans or policies, or other applicable 
                State preparedness plans.'';
                    (C) in paragraph (4)(C), by striking ``that 
                extraordinary'' and all that follows through the period 
                at the end and inserting the following: ``that--
                          ``(i) extraordinary economic conditions in the 
                      political subdivision or consortium of political 
                      subdivisions involved justify the waiver; or
                          ``(ii) the geographical area covered by a 
                      political subdivision or consortium for a grant 
                      under paragraph (1) has an extreme mosquito 
                      control need due to--
                                    ``(I) the size or density of the 
                                potentially impacted human population;
                                    ``(II) the size or density of a 
                                mosquito population that requires 
                                heightened control; or
                                    ``(III) the severity of the 
                                mosquito-borne disease, such that 
                                expected serious adverse health outcomes 
                                for the human population justify the 
                                waiver.''; and
                    (D) by amending paragraph (6) to read as follows:
            ``(6) Number of grants.--A political subdivision or a 
        consortium of political subdivisions may not receive more than 
        one grant under paragraph (1).''; and
            (3) in subsection (f)--
                    (A) in paragraph (1) by striking ``for fiscal year 
                2003, and such sums as may be necessary for each of 
                fiscal years 2004 through 2007'' and inserting ``for 
                each of fiscal years 2019 through 2023'';
                    (B) in paragraph (2), by striking ``the Public 
                Health Security and Bioterrorism Preparedness and 
                Response Act of 2002'' and inserting ``this Act and 
                other medical and public health preparedness and 
                response laws''; and
                    (C) in paragraph (3)--
                          (i) in the paragraph heading, by striking 
                      ``2004'' and inserting ``2019''; and
                          (ii) by striking ``2004,'' and inserting 
                      ``2019,''.

    (b) Epidemiology-Laboratory Capacity Grants.--Section 2821 (42 
U.S.C. 300hh-31) is amended--
            (1) in subsection (a)(1), by inserting ``, including 
        mosquito and other vector-borne diseases,'' after ``infectious 
        diseases''; and

[[Page 133 STAT. 961]]

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

                   TITLE VII--MISCELLANEOUS PROVISIONS

SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

    (a) Veterans Affairs.--Section 8117(g) of title 38, United States 
Code, is amended by striking ``2014 through 2018'' and inserting ``2019 
through 2023''.
    (b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C. 
247d-1(e)) is amended by striking ``2014 through 2018'' and inserting 
``2019 through 2023''.
    (c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C. 
247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
    (d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42 
U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and 
inserting ``2023''.
    (e) Limited Antitrust Exemption.--
            (1) In general.--Section 405 of the Pandemic and All-Hazards 
        Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a note) is 
        amended--
                    (A) in subsection (a)(1)(A)--
                          (i) by striking ``Secretary of Health and 
                      Human Services (referred to in this subsection as 
                      the `Secretary')'' and inserting ``Secretary'';
                          (ii) by striking ``of the Public Health 
                      Service Act (42 U.S.C. 247d-6b)) (as amended by 
                      this Act'';
                          (iii) by striking ``of the Public Health 
                      Service Act (42 U.S.C. 247d-6a)) (as amended by 
                      this Act''; and
                          (iv) by striking ``of the Public Health 
                      Service Act (42 U.S.C. 247d-6d)'';
                    (B) in subsection (b), by striking ``12-year'' and 
                inserting ``17-year'';
                    (C) by redesignating such section 405 as section 
                319L-1; and
                    (D) <<NOTE: 42 USC 247d-7f.>>  by transferring such 
                section 319L-1, as redesignated, to the Public Health 
                Service Act (42 U.S.C. 201 et seq.), to appear after 
                section 319L of such Act (42 U.S.C. 247d-7e).
            (2) Conforming amendments.--
                    (A) Table of contents.--The table of contents in 
                section 1(b) of the Pandemic and All-Hazards 
                Preparedness Act (Public Law 109-417) is amended by 
                striking the item related to section 405.
                    (B) Reference.--Section 319L(c)(4)(A)(iii) (42 
                U.S.C. 247d-7e) is amended by striking ``section 405 of 
                the Pandemic and All-Hazards Preparedness Act'' and 
                inserting ``section 319L-1''.

    (f) Inapplicability of Certain Provisions.--Subsection (e)(1) of 
section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
            (1) by amending subparagraph (A) to read as follows:
                    ``(A) Nondisclosure of information.--
                          ``(i) In general.--Information described in 
                      clause (ii) shall be deemed to be information 
                      described in section 552(b)(3) of title 5, United 
                      States Code.

[[Page 133 STAT. 962]]

                          ``(ii) Information described.--The information 
                      described in this clause is information relevant 
                      to programs of the Department of Health and Human 
                      Services that could compromise national security 
                      and reveal significant and not otherwise publicly 
                      known vulnerabilities of existing medical or 
                      public health defenses against chemical, 
                      biological, radiological, or nuclear threats, and 
                      is comprised of--
                                    ``(I) specific technical data or 
                                scientific information that is created 
                                or obtained during the countermeasure 
                                and product advanced research and 
                                development carried out under subsection 
                                (c);
                                    ``(II) information pertaining to the 
                                location security, personnel, and 
                                research materials and methods of high-
                                containment laboratories conducting 
                                research with select agents, toxins, or 
                                other agents with a material threat 
                                determination under section 319F-
                                2(c)(2); or
                                    ``(III) security and vulnerability 
                                assessments.'';
            (2) by redesignating subparagraph (C) as subparagraph (D);
            (3) by inserting after subparagraph (B) the following:
                    ``(C) Reporting.--One year after the date of 
                enactment of the Pandemic and All-Hazards Preparedness 
                and Advancing Innovation Act of 2019, and annually 
                thereafter, the Secretary shall report to the Committee 
                on Health, Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the House of 
                Representatives on the number of instances in which the 
                Secretary has used the authority under this subsection 
                to withhold information from disclosure, as well as the 
                nature of any request under section 552 of title 5, 
                United States Code that was denied using such 
                authority.''; and
            (4) in subparagraph (D), as so redesignated, by striking 
        ``12'' and inserting ``17''.
SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.

    Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is amended to 
read as follows:
    ``(d) Disclosures.--No Federal agency may disclose under section 552 
of title 5, United States Code any information identifying the location 
at which materials in the stockpile described in subsection (a) are 
stored, or other information regarding the contents or deployment 
capability of the stockpile that could compromise national security.''.
SEC. 703. CYBERSECURITY.

    (a) Strategy for Public Health Preparedness and Response to 
Cybersecurity Threats.--
            (1) <<NOTE: Deadline.>>  Strategy.--Not later than 18 months 
        after the date of enactment of this Act, the Secretary of Health 
        and Human Services (referred to in this section as the 
        ``Secretary'') shall prepare and submit to the relevant 
        committees of Congress a strategy for public health preparedness 
        and response to address cybersecurity threats (as defined in 
        section 102 of Cybersecurity Information Sharing Act of 2015 (6 
        U.S.C. 1501)) that present a threat to national health security. 
        Such strategy shall include--

[[Page 133 STAT. 963]]

                    (A) identifying the duties, functions, and 
                preparedness goals for which the Secretary is 
                responsible in order to prepare for and respond to such 
                cybersecurity threats, including metrics by which to 
                measure success in meeting preparedness goals;
                    (B) identifying gaps in public health capabilities 
                to achieve such preparedness goals; and
                    (C) strategies to address identified gaps and 
                strengthen public health emergency preparedness and 
                response capabilities to address such cybersecurity 
                threats.
            (2) Protection of national security.--The Secretary shall 
        make such strategy available to the Committee on Health, 
        Education, Labor, and Pensions of the Senate, the Committee on 
        Energy and Commerce of the House of Representatives, and other 
        congressional committees of jurisdiction, in a manner that does 
        not compromise national security.

    (b) Coordination of Preparedness for and Response to All-Hazards 
Public Health Emergencies.--Subparagraph (D) of section 2811(b)(4) (42 
U.S.C. 300hh-10(b)(4)) is amended to read as follows:
                    ``(D) Policy coordination and strategic direction.--
                Provide integrated policy coordination and strategic 
                direction, before, during, and following public health 
                emergencies, with respect to all matters related to 
                Federal public health and medical preparedness and 
                execution and deployment of the Federal response for 
                public health emergencies and incidents covered by the 
                National Response Plan described in section 504(a)(6) of 
                the Homeland Security Act of 2002 (6 U.S.C. 314(a)(6)), 
                or any successor plan; and such Federal responses 
                covered by the National Cybersecurity Incident Response 
                Plan developed under section 228(c) of the Homeland 
                Security Act of 2002 (6 U.S.C. 149(c)), including public 
                health emergencies or incidents related to cybersecurity 
                threats that present a threat to national health 
                security.''.
SEC. 704. STRATEGY AND REPORT.

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

[[Page 133 STAT. 964]]

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

    (a) Public Health Service Act.--Title III (42 U.S.C. 241 et seq.) is 
amended--
            (1) in paragraphs (1) and (5) of section 319F-1(a) (42 
        U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each place 
        such term appears and inserting ``section 319F(e)''; and
            (2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking 
        ``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.

    (b) Public Health Security Grants.--Section 319C-1(b)(2) (42 U.S.C. 
247d-3a(b)(2)) is amended--
            (1) in subparagraph (C), by striking ``individuals,,'' and 
        inserting ``individuals,''; and
            (2) in subparagraph (F), by striking ``make satisfactory 
        annual improvement and describe'' and inserting ``makes 
        satisfactory annual improvement and describes''.

    (c) Emergency Use Instructions.--Subparagraph (A) of section 
564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3a(e)(2)) is amended by striking ``subsection (a)(1)(C)(i)'' and 
inserting ``subsection (a)(1)(C)''.
    (d) Products Held for Emergency Use.--Section 564B(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b) is amended--
            (1) in subparagraph (B), by inserting a comma after ``505''; 
        and
            (2) in subparagraph (C), by inserting ``or section 564A'' 
        before the period at the end.

    (e) Transparency.--Section 507(c)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
            (1) by striking ``Nothing in'' and inserting the following:
                    ``(A) In general.--Nothing in'';
            (2) by inserting ``or directing'' after ``authorizing'';
            (3) by striking ``disclose any'' and inserting ``disclose--
                          ``(i) any'';
            (4) by striking the period and inserting ``; or''; and
            (5) by adding at the end the following:
                          ``(ii) in the case of a drug development tool 
                      that may be used to support the development of a 
                      qualified countermeasure, security countermeasure, 
                      or qualified pandemic or epidemic product, as 
                      defined in sections 319F-1, 319F-2, and 319F-3, 
                      respectively, of the Public Health Service Act, 
                      any information that the

[[Page 133 STAT. 965]]

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

    Approved June 24, 2019.

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

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

                                  <all>