Title: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Policy area: Emergency Management

Summary:
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
This bill reauthorizes through FY2023 various programs relating to pandemic and all-hazards preparedness, including:
The bill requires the National Health Security Strategy developed by the Department of Health and Human Services (HHS) to describe potential emergency health security threats and identify the process for achieving the preparedness goals.
The bill also requires HHS to develop guidelines to inform regional systems of hospitals and health care facilities of capabilities to treat patients affected by chemical, biological, radiological, or nuclear threats.
The bill reauthorizes through FY2023 funding for medical facilities of the Veterans Administration and for influenza vaccine tracking and distribution.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2852 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  2d Session
                                S. 2852

  To reauthorize certain programs under the Pandemic and All-Hazards 
                   Preparedness Reauthorization Act.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 15, 2018

   Mr. Burr (for himself, Mr. Casey, Mr. Alexander, and Mrs. Murray) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To reauthorize certain programs under the Pandemic and All-Hazards 
                   Preparedness Reauthorization Act.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
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. Public health and health care system situational awareness 
                            and biosurveillance capabilities.
Sec. 205. Strengthening and supporting the public health emergency 
                            rapid response fund.
Sec. 206. Improving preparedness for and response to all-hazards by 
                            public health emergency volunteers.
                  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. Reauthorizing the National Advisory Committee on Children and 
                            Disasters.
Sec. 306. Guidance for participation in exercises and drills.
             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, 
                            and other significant threats.
Sec. 405. Reporting on the Federal Select Agent Program.
 TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority 
                            and the BioShield Special Reserve Fund.
      TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

Sec. 601. Administration of countermeasures.
Sec. 602. Medical countermeasure master files.
Sec. 603. Animal rule report.
                  TITLE VII--MISCELLANEOUS PROVISIONS

Sec. 701. Reauthorizations and extensions.
Sec. 702. Technical amendments.

SEC. 2. REFERENCES IN ACT.

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

      TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

    Section 2802 (42 U.S.C. 300hh-1) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) by striking ``2014'' and inserting 
                        ``2018''; and
                            (ii) by striking the second sentence and 
                        inserting the following: ``Such National Health 
                        Security Strategy shall describe potential 
                        emergency health security threats and identify 
                        the process for achieving the preparedness 
                        goals described in subsection (b) to be 
                        prepared to identify and respond to such 
                        threats and shall be consistent with the 
                        national preparedness goal (as described in 
                        section 504(a)(19) of the Homeland Security Act 
                        of 2002), the National Incident Management 
                        System (as defined in section 501(7) of such 
                        Act), and the National Response Plan developed 
                        pursuant to section 504 of such Act, or any 
                        successor plan.'';
                    (B) in paragraph (2), by inserting before the 
                period at the end of the second sentence the following: 
                ``, and an analysis of any changes to the evidence-
                based benchmarks and objective standards under sections 
                319C-1 and 319C-2''; and
                    (C) in paragraph (3)--
                            (i) by striking ``2009'' and inserting 
                        ``2022'';
                            (ii) by inserting ``(including gaps in the 
                        environmental health workforce), 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)(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.--In 
        consultation with the Secretary of Agriculture, improving 
        coordination among Federal, State, local, tribal, and 
        territorial entities to prevent, detect, and respond to 
        outbreaks of plant or animal disease (including zoonotic 
        disease) that could compromise national security resulting from 
        a deliberate attack, a naturally occurring threat, the 
        intentional adulteration of food, or other public health 
        threats, taking into account interactions between animal 
        health, human health, and animals' and humans' shared 
        environment as directly related to public health emergency 
        preparedness and response capabilities, as applicable.
            ``(10) Global health security.--Assessing current or 
        potential health security threats from abroad to inform 
        domestic public health preparedness and response 
        capabilities.''.

             TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

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

    (a) Evaluating Measurable Evidence-Based Benchmarks and Objective 
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting 
after subsection (j) the following:
    ``(k) Evaluation.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018 and every 2 years thereafter, 
        the Secretary shall conduct an evaluation of the evidence-based 
        benchmarks and objective standards required under subsection 
        (g). Such evaluation shall be submitted to the congressional 
        committees of jurisdiction together with the National Health 
        Security Strategy under section 2802, at such time as such 
        strategy is submitted.
            ``(2) Content.--The evaluation under this paragraph shall 
        include--
                    ``(A) a review of evidence-based benchmarks and 
                objective standards, and associated metrics and 
                targets;
                    ``(B) a discussion of changes to any evidence-based 
                benchmarks and objective standards, and the effect of 
                such changes on the ability to track whether entities 
                are meeting or making progress toward the goals under 
                this section and, to the extent practicable, the 
                applicable goals of the National Health Security 
                Strategy under section 2802;
                    ``(C) a description of amounts received by eligible 
                entities, as described in subsection (b) and section 
                319C-2(b), and amounts received by sub-recipients and 
                the effect of such funding on meeting evidence-based 
                benchmarks and objective standards; and
                    ``(D) recommendations, as applicable and 
                appropriate, to improve evidence-based benchmarks and 
                objective standards to more accurately assess the 
                ability of entities receiving awards under this section 
                to better achieve the goals under this section and 
                section 2802.''.
    (b) Evaluating the Partnership for State and Regional Hospital 
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended 
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section 
319C-1(g), (i), (j), and (k)''.

SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.

    (a) Cooperative Agreement Applications for Improving State and 
Local Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is 
amended--
            (1) in subsection (a), by inserting ``, acting through the 
        Director of the Centers for Disease Control and Prevention,'' 
        after ``the Secretary''; and
            (2) in subsection (b)(2)(A)--
                    (A) in clause (vi), by inserting ``, including 
                public health agencies with specific expertise that may 
                be relevant to public health security, such as 
                environmental health agencies,'' after 
                ``stakeholders'';
                    (B) by redesignating clauses (vii) through (ix) as 
                clauses (viii) through (x); and
                    (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;''.
    (b) Partnership for State and Regional Hospital Preparedness To 
Improve Surge Capacity.--Section 319C-2 (42 U.S.C. 247d-3b) is 
amended--
            (1) in subsection (a)--
                    (A) by inserting ``, acting through the Assistant 
                Secretary for Preparedness and Response,'' after ``The 
                Secretary''; and
                    (B) by striking ``preparedness for public health 
                emergencies'' and inserting ``preparedness for, and 
                response to, public health emergencies in accordance 
                with subsection (c)''; and
            (2) in subsection (b)(1)(A)--
                    (A) in clause (iii), by redesignating subclauses 
                (I) through (III) as items (aa) through (cc), 
                respectively, and adjusting the margins accordingly;
                    (B) by redesignating clauses (i) through (iii) as 
                subclauses (I) through (III) respectively, and 
                adjusting the margins accordingly;
                    (C) by striking ``partnership consisting of--'' and 
                inserting ``partnership--
                            ``(i) consisting of--''; and
                    (D) by adding at the end the following:
                            ``(ii) that may include one or more 
                        emergency medical service organizations or 
                        emergency management organizations; and''.
    (c) 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)).''.
    (d) 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) Reservations 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) Reservations contingent on continued 
                        appropriations.--If the amount appropriated 
                        under subparagraph (A) for fiscal year 2019 or 
                        a subsequent fiscal year is less than or equal 
                        the amount so appropriated 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.'';
            (2) in paragraph (2), by striking ``paragraph (1) for a 
        fiscal year'' and inserting ``paragraph (1)(A) for a fiscal 
        year and not reserved for the purpose described in paragraph 
        (1)(B)(i)''; and
            (3) in paragraph (3)(A), by striking ``paragraph (1) and 
        not reserved under paragraph (2)'' and inserting ``paragraph 
        (1)(A) and not reserved under paragraph (1)(B)(i) or (2)''.

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

    (a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is 
amended by inserting after section 319C-2 the following:

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

    ``(a) Purpose.--It is the purpose of this section to identify and 
provide guidelines for regional systems of hospitals, health care 
facilities, and other public and private sector entities, with varying 
levels of capability to treat patients and increase medical surge 
capacity during, and in advance of, a public health emergency, 
including threats posed by one or more chemical, biological, 
radiological, and nuclear agents, including emerging infectious 
diseases.
    ``(b) Guidelines.--The Assistant Secretary for Preparedness and 
Response, in consultation with the Director of the Centers for Disease 
Control and Prevention, the Administrator of the Centers for Medicare & 
Medicaid Services, the Administrator of the Health Resources and 
Services Administration, the Commissioner of Food and Drugs, the 
Assistant Secretary for Mental Health and Substance Use, the Assistant 
Secretary of Labor for Occupational Safety and Health, the Secretary of 
Veterans Affairs, heads of such other Federal agencies as the Secretary 
determines to be appropriate, and State, local, tribal, and territorial 
public health officials, shall, not later than 2 years after the date 
of enactment of this section--
            ``(1) identify and develop a set of guidelines relating to 
        practices and protocols for all-hazards public health emergency 
        preparedness and response for hospitals and health care 
        facilities to provide appropriate patient care during, in 
        advance of, or immediately following, a public health 
        emergency, resulting from one or more chemical, biological, 
        radiological, or nuclear agents, including emerging infectious 
        diseases (which may include existing practices, such as trauma 
        care and medical surge capacity and capabilities), with respect 
        to--
                    ``(A) a regional approach to identifying hospitals 
                and health care facilities based on varying 
                capabilities and capacity to treat patients affected by 
                such emergency, including--
                            ``(i) the manner in which the system will 
                        coordinate with and integrate the partnerships 
                        established under section 319C-2(b); and
                            ``(ii) informing and educating appropriate 
                        first responders and health care supply chain 
                        partners of the regional emergency preparedness 
                        and response capabilities and medical surge 
                        capacity of such hospitals and health care 
                        facilities in the community;
                    ``(B) physical and technological infrastructure, 
                laboratory capacity, staffing, blood supply, and other 
                supply chain needs, taking into account resiliency, 
                geographic considerations, and rural considerations;
                    ``(C) protocols or best practices for the safety 
                and personal protection of workers who handle human 
                remains and health care workers (including with respect 
                to protective equipment and supplies, waste management 
                processes, and decontamination), sharing of specialized 
                experience among the health care workforce, behavioral 
                health, psychological resilience, and training of the 
                workforce, as applicable;
                    ``(D) in a manner that allows for disease 
                containment (within the meaning of section 
                2802(b)(2)(B)), coordinated medical triage, treatment, 
                and transportation of patients, based on patient 
                medical need (including patients in rural areas), to 
                the appropriate hospitals or health care facilities 
                within the regional system or, as applicable and 
                appropriate, between systems in different States or 
                regions; and
                    ``(E) the needs of children and other at-risk 
                individuals;
            ``(2) make such guidelines available on the internet 
        website of the Department of Health and Human Services in a 
        manner that does not compromise national security; and
            ``(3) update such guidelines as appropriate, including 
        based on input received pursuant to subsections (c), (e), and 
        (f), 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, and emerging 
        infectious disease as the Assistant Secretary determines 
        appropriate, to meet the goals under section 2802(b)(3);
            ``(2) consult and engage with appropriate health care 
        providers and professionals, including physicians, nurses, 
        first responders, health care facilities (including hospitals, 
        primary care clinics, community health centers, mental health 
        facilities, ambulatory care facilities, and dental health 
        facilities), pharmacies, emergency medical providers, trauma 
        care providers, environmental health agencies, public health 
        laboratories, poison control centers, blood banks, and other 
        experts that the Assistant Secretary determines appropriate, to 
        meet the goals under section 2802(b)(3);
            ``(3) consider feedback related to financial implications 
        for hospitals, health care facilities, public health agencies, 
        laboratories, and other entities engaged in regional 
        preparedness planning to implement and follow such guidelines, 
        as applicable; and
            ``(4) consider financial requirements and potential 
        incentives for entities to prepare for, and respond to, public 
        health emergencies as part of the regional health care 
        emergency preparedness and response system.
    ``(d) Technical Assistance.--The Assistant Secretary for 
Preparedness and Response, in consultation with the Director of the 
Centers for Disease Control and Prevention and the Assistant Secretary 
of Labor for Occupational Safety and Health, may provide technical 
assistance and consultation towards meeting the guidelines described in 
subsection (b).
    ``(e) Demonstration Project for Regional Health Care Preparedness 
and Response Systems.--
            ``(1) In general.--The Assistant Secretary for Preparedness 
        and Response may establish a demonstration project pursuant to 
        the development and implementation of guidelines under 
        subsection (b) to 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.
    ``(f) GAO Report to Congress.--
            ``(1) Report.--Not later than 3 years after the date of 
        enactment of this section, the Comptroller General of the 
        United States (referred to in this subsection as the 
        `Comptroller General') shall submit to the Committee on Health, 
        Education, Labor, and Pensions and the Committee on Finance of 
        the Senate and the Committee on Energy and Commerce and the 
        Committee on Ways and Means of the House of Representatives, a 
        report on the extent to which hospitals and health care 
        facilities have implemented the recommended guidelines under 
        subsection (b), including an analysis and evaluation of any 
        challenges hospitals or health care facilities experienced in 
        implementing such guidelines.
            ``(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 subsection (b) to improve regional emergency 
                health care preparedness and response capability, 
                including hospital and health care facility capacity 
                and medical surge capabilities to prepare for, and 
                respond to, public health emergencies; and
                    ``(B) recommendations to reduce gaps in incentives 
                for regional health partners, including hospitals and 
                health care facilities to improve capacity and medical 
                surge capabilities to prepare for, and respond to, 
                public health emergencies, consistent with subsection 
                (a), which may include consideration of facilities 
                participating in programs under section 319C-2, 
                programs under the Centers for Medicare & Medicaid 
                Services (including innovative health care delivery and 
                payment models), and input from private sector 
                financial institutions.
            ``(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;
                    ``(F) the Secretary of Veterans Affairs; and
                    ``(G) the heads of such other Federal agencies as 
                the Secretary determines appropriate.''.
    (b) 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 ``The 
reports submitted under this paragraph shall also include progress 
towards the implementation of section 319C-3.''.
    (c) National Health Security Strategy Incorporation of Regionalized 
Emergency Preparedness and Response.--Section 2802(b)(3) (42 U.S.C. 
300hh-1(b)(3)) is amended--
            (1) in the matter preceding subparagraph (A), by striking 
        ``including mental health'' and inserting ``including 
        pharmacies, mental health facilities,''; and
            (2) by amending subparagraph (G) 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, which may 
                include the implementation of guidelines for regional 
                health care emergency preparedness and response systems 
                under section 319C-3.''.
    (d) 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) 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. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS 
              AND BIOSURVEILLANCE CAPABILITIES.

    (a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
            (1) in the section heading, by striking ``revitalizing'' 
        and inserting ``facilities and capacities of'';
            (2) in subsection (a)--
                    (A) in the subsection heading, by striking 
                ``Facilities; Capacities'' and inserting ``In 
                General'';
                    (B) in paragraph (1), by striking ``and improved'' 
                and inserting ``, improved, and appropriately 
                maintained'';
                    (C) in paragraph (3), in the matter preceding 
                subparagraph (A), by striking ``expand, enhance, and 
                improve'' and inserting ``expand, improve, enhance, and 
                appropriately maintain''; and
                    (D) by adding at the end the following:
            ``(4) Study of resources for facilities and capacities.--
        Not later than June 1, 2022, the Comptroller General of the 
        United States shall conduct a study on Federal spending in 
        fiscal years 2013 through 2018 for activities authorized under 
        this subsection. Such study shall include a review and 
        assessment of obligations and expenditures directly related to 
        each activity under paragraphs (2) and (3), including a 
        specific accounting of, and delineation between, obligations 
        and expenditures incurred for the construction, renovation, 
        equipping, and security upgrades of facilities and associated 
        contracts under this subsection, and the obligations and 
        expenditures incurred to establish and improve the situational 
        awareness and biosurveillance network under subsection (b), and 
        shall identify the agency or agencies incurring such 
        obligations and expenditures.'';
            (3) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``National'' and inserting ``Establishment of Systems 
                of Public Health '';
                    (B) in paragraph (1)(B), by inserting 
                ``immunization information systems,'' after 
                ``centers,'';
                    (C) in paragraph (2)--
                            (i) by inserting ``develop a plan to, and'' 
                        after ``The Secretary shall''; and
                            (ii) by inserting ``and in a form readily 
                        usable for analytical approaches'' after ``in a 
                        secure manner''; and
                    (D) by amending paragraph (3) to read as follows:
            ``(3) Standards.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary, in cooperation with health care providers, 
                State, local, tribal, and territorial public health 
                officials, and relevant Federal agencies (including the 
                Office of the National Coordinator for Health 
                Information Technology and the National Institute of 
                Standards and Technology), shall, as necessary, adopt 
                technical and reporting standards, including standards 
                for interoperability as defined by section 3000, for 
                networks under paragraph (1) and update such standards 
                as necessary. Such standards shall be made available on 
                the internet website of the Department of Health and 
                Human Services, in a manner that does not compromise 
                national security.
                    ``(B) Deference to standards development 
                organizations.--In adopting and implementing standards 
                under this subsection and subsection (c), the Secretary 
                shall give deference to standards published by 
                standards development organizations and voluntary 
                consensus-based standards entities.'';
            (4) in subsection (c)--
                    (A) in paragraph (1)--
                            (i) by striking ``Not later than 2 years 
                        after the date of enactment of the Pandemic and 
                        All-Hazards Preparedness Reauthorization Act of 
                        2013, the Secretary'' and inserting ``The 
                        Secretary'';
                            (ii) by inserting ``, and improve as 
                        applicable and appropriate,'' after ``shall 
                        establish'';
                            (iii) by striking ``of rapid'' and 
                        inserting ``of, rapid''; and
                            (iv) by striking ``such connectivity'' and 
                        inserting ``such interoperability'';
                    (B) by amending paragraph (2) to read as follows:
            ``(2) Coordination and consultation.--In establishing and 
        improving the network under paragraph (1) the Secretary shall--
                    ``(A) facilitate coordination among agencies within 
                the Department of Health and Human Services that 
                provide or have the potential to provide information 
                and data to, and analyses for, the situational 
                awareness and biosurveillance network under paragraph 
                (1), including coordination among relevant agencies 
                related to health care services, the facilitation of 
                health information exchange (including the Office of 
                the National Coordinator for Health Information 
                Technology), and public health emergency preparedness 
                and response; and
                    ``(B) consult with the Secretary of Agriculture, 
                the Secretary of Commerce (and the Director of the 
                National Institute of Standards and Technology), the 
                Secretary of Defense, the Secretary of Homeland 
                Security, and 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 programs,'' after ``poison 
                                control,''; and
                                    (II) by striking ``and clinical 
                                laboratories'' and inserting ``, 
                                clinical laboratories, and public 
                                environmental health agencies'';
                            (iii) by striking ``The network'' and 
                        inserting the following:
                    ``(A) In general.--The network''; and
                            (iv) by adding at the end the following:
                    ``(B) Review.--Not later than 2 years after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018 and 
                every 6 years thereafter, the Secretary shall conduct a 
                review of the elements described in subparagraph (A). 
                Such review shall include a discussion of the addition 
                of any elements pursuant to clause (v), including 
                elements added to advancing new technologies, and 
                identify any challenges in the incorporation of 
                elements under subparagraph (A). The Secretary shall 
                provide such review to the congressional committees of 
                jurisdiction.'';
                    (D) in paragraph (5)--
                            (i) by redesignating subparagraphs (A) 
                        through (D) as clauses (i) through (iv), 
                        respectively, and adjusting the margins 
                        accordingly;
                            (ii) by striking ``In establishing'' and 
                        inserting the following:
                    ``(A) In general.--In establishing'';
                            (iii) by adding at the end the following:
                    ``(B) Public meeting.--
                            ``(i) In general.--Not later than 180 days 
                        after the date of enactment of the Pandemic and 
                        All-Hazards Preparedness and Advancing 
                        Innovation Act of 2018, the Secretary shall 
                        convene a public meeting for purposes of 
                        discussing and providing input on the potential 
                        goals, functions, and uses of the network 
                        described in paragraph (1) and incorporating 
                        the elements described in paragraph (3)(A).
                            ``(ii) Experts.--The public meeting shall 
                        include representatives of relevant Federal 
                        agencies (including representatives from the 
                        Office of the National Coordinator for Health 
                        Information Technology and the National 
                        Institute of Standards and Technology), State, 
                        local, tribal, and territorial public health 
                        officials, stakeholders with expertise in 
                        biosurveillance and situational awareness, and 
                        stakeholders with expertise in capabilities 
                        relevant to biosurveillance and situational 
                        awareness, such as experts in informatics and 
                        data analytics (including experts in prediction 
                        and forecasting), and other representatives as 
                        the Secretary determines appropriate.
                            ``(iii) Topics.--Such public meeting shall 
                        include a discussion of--
                                    ``(I) data elements, including 
                                minimal or essential data elements, 
                                that are voluntarily provided for such 
                                network, which may include elements 
                                from public health and public and 
                                private health care entities, to the 
                                extent practicable;
                                    ``(II) standards and implementation 
                                specifications that may improve the 
                                collection, analysis, and 
                                interpretation of data during a public 
                                health emergency;
                                    ``(III) strategies to encourage the 
                                access, exchange, and use of 
                                information;
                                    ``(IV) considerations for State, 
                                local, tribal, and territorial 
                                capabilities and infrastructure related 
                                to data exchange and interoperability;
                                    ``(V) privacy and security 
                                protections provided at the Federal, 
                                State, local, tribal, and territorial 
                                levels, and by nongovernmental 
                                stakeholders; and
                                    ``(VI) opportunities for the 
                                incorporation of innovative 
                                technologies to improve the network.''; 
                                and
                            (iv) in subparagraph (A), as so designated 
                        by clause (ii)--
                                    (I) in clause (i), as so 
                                redesignated--
                                            (aa) by striking ``as 
                                        determined'' and inserting ``as 
                                        adopted''; and
                                            (bb) by inserting ``and the 
                                        National Institute of Standards 
                                        and Technology'' after ``Office 
                                        of the National Coordinator for 
                                        Health Information 
                                        Technology'';
                                    (II) in clause (iii), as so 
                                redesignated, by striking ``; and'' and 
                                inserting a semicolon;
                                    (III) in clause (iv), as so 
                                redesignated, by striking the period 
                                and inserting ``; and''; and
                                    (IV) by adding at the end the 
                                following:
                            ``(v) pilot test standards and 
                        implementation specifications, consistent with 
                        the process described in section 3002(b)(3)(C), 
                        which State, local, tribal, and territorial 
                        public health entities may utilize, on a 
                        voluntary basis, as a part of the network.'';
                    (E) by redesignating paragraph (6) as paragraph 
                (7);
                    (F) by inserting after paragraph (5) the following:
            ``(6) Strategy and implementation plan.--
                    ``(A) In general.--Not later than 18 months after 
                the date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary shall submit to the appropriate committees of 
                Congress a coordinated strategy and an accompanying 
                implementation plan that--
                            ``(i) is informed by the public meeting 
                        under paragraph (5)(B);
                            ``(ii) includes a review and assessment of 
                        existing capabilities of the network and 
                        related infrastructure, including input 
                        provided by the public meeting under paragraph 
                        (5)(B);
                            ``(iii) identifies and demonstrates the 
                        measurable steps the Secretary will carry out 
                        to--
                                    ``(I) develop, implement, and 
                                evaluate the network described in 
                                paragraph (1), utilizing elements 
                                described in paragraph (3)(A);
                                    ``(II) modernize and enhance 
                                biosurveillance activities, including 
                                strategies to include innovative 
                                technologies and analytical approaches 
                                (including prediction and forecasting 
                                for pandemics and all-hazards) from 
                                public and private entities;
                                    ``(III) improve information 
                                sharing, coordination, and 
                                communication among disparate 
                                biosurveillance systems supported by 
                                the Department of Health and Human 
                                Services, including the identification 
                                of methods to improve accountability, 
                                better utilize resources and workforce 
                                capabilities, and incorporate 
                                innovative technologies within and 
                                across agencies; and
                                    ``(IV) test and evaluate 
                                capabilities of the interoperable 
                                network of systems to improve 
                                situational awareness and 
                                biosurveillance capabilities;
                            ``(iv) includes performance measures and 
                        the metrics by which performance measures will 
                        be assessed with respect to the measurable 
                        steps under clause (iii); and
                            ``(v) establishes dates by which each 
                        measurable step under clause (iii) will be 
                        implemented.''.
                    ``(B) Annual budget plan.--Not later than 2 years 
                after the date of enactment of the Pandemic and All-
                Hazards Preparedness and Advancing Innovation Act of 
                2018 and on an annual basis thereafter, in accordance 
                with the strategy and implementation plan under this 
                paragraph, the Secretary shall, taking into account 
                recommendations provided by the National Biodefense 
                Science Board, develop a budget plan based on the 
                strategy and implementation plan under this section. 
                Such budget plan shall include--
                            ``(i) a summary of resources previously 
                        expended to establish, improve, and utilize the 
                        nationwide public health situational awareness 
                        and biosurveillance network under paragraph 
                        (1);
                            ``(ii) estimates of costs and resources 
                        needed to establish and improve the network 
                        under paragraph (1) according to the strategy 
                        and implementation plan under subparagraph (A);
                            ``(iii) the identification of gaps and 
                        inefficiencies in nationwide public health 
                        situational awareness and biosurveillance 
                        capabilities, resources, and authorities needed 
                        to address such gaps; and
                            ``(iv) a strategy to minimize and address 
                        such gaps and improve inefficiencies.'';
                    (G) in paragraph (7), as so redesignated--
                            (i) in subparagraph (A), by inserting 
                        ``(taking into account zoonotic disease, 
                        including gaps in scientific understanding of 
                        the interactions between human, animal, and 
                        environmental health)'' after ``human health'';
                            (ii) in subparagraph (B)--
                                    (I) by inserting ``and gaps in 
                                surveillance programs'' after 
                                ``surveillance programs''; and
                                    (II) by striking ``; and'' and 
                                inserting a semicolon;
                            (iii) in subparagraph (C)--
                                    (I) by inserting ``, animal health 
                                organizations related to zoonotic 
                                disease,'' after ``health care 
                                entities''; and
                                    (II) by striking the period and 
                                inserting ``; and''; and
                            (iv) by adding at the end the following:
                    ``(D) provide recommendations to the Secretary on 
                policies and procedures to complete the steps described 
                in this paragraph in a manner that is consistent with 
                section 2802.''; and
                    (H) by adding at the end the following:
            ``(8) Situational awareness and biosurveillance as a 
        national security priority.--The Secretary, on a periodic basis 
        as applicable and appropriate, shall meet with the Director of 
        National Intelligence to inform the development and 
        capabilities of the nationwide public health situational 
        awareness and biosurveillance network.'';
            (5) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) by inserting ``environmental health 
                        agencies,'' after ``public health agencies,''; 
                        and
                            (ii) by inserting ``immunization 
                        programs,'' after ``poison control centers,''; 
                        and
                    (B) in paragraph (2)--
                            (i) in subparagraph (B), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (C), by striking the 
                        period and inserting ``; and''; and
                            (iii) by adding after subparagraph (C) the 
                        following:
                    ``(D) an implementation plan that may include 
                measurable steps to achieve the purposes described in 
                paragraph (1).''; and
                    (C) by striking paragraph (5) and inserting the 
                following:
            ``(5) Technical assistance.--The Secretary may provide 
        technical assistance to States, localities, tribes, and 
        territories or a consortium of States, localities, tribes, and 
        territories receiving an award under this subsection regarding 
        interoperability and the technical standards set forth by the 
        Secretary.'';
            (6) by redesignating subsections (f) and (g) as subsections 
        (h) and (i), respectively; and
            (7) by inserting after subsection (e) the following:
    ``(f) Timeline.--The Secretary shall accomplish the purposes under 
subsections (b) and (c) no later than September 30, 2023, and shall 
provide a justification to Congress for any missed or delayed 
implementation of measurable steps identified under subsection 
(c)(6)(A)(iii).
    ``(g) Independent Evaluation.--Not later than 3 years after the 
date of enactment of the Pandemic and All-Hazards Preparedness and 
Advancing Innovation Act of 2018, the Comptroller General of the United 
States shall conduct an independent evaluation, and submit to the 
Secretary and the appropriate committees of Congress 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 (h) 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''.

SEC. 205. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH EMERGENCY 
              RAPID RESPONSE FUND.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended--
            (1) in subsection (b)--
                    (A) in paragraph (1)--
                            (i) in the first sentence, by inserting 
                        ``or if the Secretary determines there is the 
                        significant potential for a public health 
                        emergency, to allow the Secretary to rapidly 
                        respond to the immediate needs resulting from 
                        such public health emergency or potential 
                        public health emergency'' before the period; 
                        and
                            (ii) by inserting ``The Secretary shall 
                        plan for the expedited distribution of funds to 
                        appropriate agencies and entities.'' after the 
                        first sentence;
                    (B) by redesignating paragraph (2) as paragraph 
                (3);
                    (C) by inserting after paragraph (1) the following:
            ``(2) Uses.--The Secretary may use amounts in the Fund 
        established under paragraph (1), to--
                    ``(A) facilitate coordination between and among 
                Federal, State, local, tribal, and territorial entities 
                and public and private health care entities that the 
                Secretary determines may be affected by a public health 
                emergency or potential public health emergency 
                (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 or 319C-2;
                    ``(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 on 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 expenses under 
                section 2812, and the Medical Reserve Corps under 
                section 2813; and
                    ``(F) other activities, as the Secretary determines 
                applicable and appropriate.''; and
                    (D) by inserting after paragraph (3), as so 
                redesignated, the following:
            ``(4) Review.--Not later than 2 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, the Secretary, in 
        coordination with the Assistant Secretary for Preparedness and 
        Response, shall conduct a review of the Fund under this 
        section, and provide recommendations to the Committee on 
        Health, Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate and the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives on policies to improve such Fund for the uses 
        described in paragraph (2).
            ``(5) GAO report.--Not later than 4 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, the Comptroller General of 
        the United States shall conduct a review of the Fund under this 
        section, including the uses and the resources available in the 
        Fund.''; 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. 206. IMPROVING PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS BY 
              PUBLIC HEALTH EMERGENCY VOLUNTEERS.

    Section 319I (42 U.S.C. 247d-7b) is amended:
            (1) 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.'';
            (2) in subsection (i) by adding at the end ``In order to 
        inform the development of such mechanisms by States, the 
        Secretary shall make available information and material 
        provided by States that have developed mechanisms to waive the 
        application of licensing requirements to applicable health 
        professionals seeking to provide medical services during a 
        public health emergency. Such information shall be made 
        publicly available in a manner that does not jeopardize 
        national security.''; and
            (3) in subsection (k) by striking ``$2014 through 2018'' 
        and inserting ``2019 through 2023''.

                  TITLE III--REACHING ALL COMMUNITIES

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

    (a) 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.''.
    (b) Volunteer Medical Reserve Corps.--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, and tribal levels.''
    (c) Review of the National Disaster Medical System.--Section 
2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to read as follows:
            ``(2) Joint review and medical surge capacity strategic 
        plan.--
                    ``(A) Review.--Not later than 180 days after the 
                date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary, in coordination with the Secretary of 
                Homeland Security, the Secretary of Defense, and the 
                Secretary of Veterans Affairs, shall conduct a joint 
                review of the National Disaster Medical System. Such 
                review shall include--
                            ``(i) an evaluation of medical surge 
                        capacity, as described in section 2803(a);
                            ``(ii) an assessment of the available 
                        workforce of the intermittent disaster response 
                        personnel described in subsection (c);
                            ``(iii) the capacity of the workforce 
                        described in clause (ii) to respond to all 
                        hazards, including capacity to simultaneously 
                        respond to multiple public health emergencies 
                        and the capacity to respond to a nationwide 
                        public health emergency;
                            ``(iv) the effectiveness of efforts to 
                        recruit, retain, and train such workforce; and
                            ``(v) gaps that may exist in such workforce 
                        and recommendations for addressing such gaps.
                    ``(B) Updates.--As part of the National Health 
                Security Strategy under section 2802, the Secretary 
                shall update the findings from the review under 
                subparagraph (A) and provide recommendations to modify 
                the policies of the National Disaster Medical System as 
                necessary.''.
    (d) Notification of NDMS Shortage.--Section 2812(c) (42 U.S.C. 
300hh-11(c)) is amended by adding at the end the following:
            ``(3) Service benefit.--Individuals appointed to serve 
        under this subsection shall be considered public safety 
        officers under part L of title I of the Omnibus Crime Control 
        and Safe Streets Act of 1968. The Secretary shall provide 
        notification to eligible individuals of any effect such 
        designation may have on other benefits for which such 
        individuals are eligible, including benefits from private 
        entities.
            ``(4) Notification.--Not later than 30 days after the date 
        on which the Secretary determines the number of intermittent 
        disaster response personnel of such 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 the impact 
        such shortage could have on meeting public health needs and 
        emergency medical personnel needs during a public health 
        emergency, and any identified measures to address such 
        shortage.
            ``(5) Certain appointments.--
                    ``(A) In general.--If the Secretary determines that 
                the number of intermittent disaster response personnel 
                within the National Disaster Medical System under this 
                section is insufficient to address a public health 
                emergency or potential public health emergency, the 
                Secretary may appoint candidates directly to personnel 
                positions for intermittent disaster response within 
                such system. The Secretary shall provide updates on the 
                number of vacant or unfilled positions within such 
                system to the congressional committees of jurisdiction 
                each quarter for which this authority is in effect.
                    ``(B) Sunset.--The authority under this paragraph 
                shall expire on September 30, 2021.''.
    (e) 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--
            (1) in subparagraph (C)(ii), by striking ``or'' at the end;
            (2) in subparagraph (D), by striking the period and 
        inserting ``; or''; and
            (3) 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 
                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.''.
    (f) National Disaster Medical System 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''.
    (g) Medical Reserve Corps 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''.

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

    (a) Coordination of Preparedness.--Section 2811(b)(5) (42 U.S.C. 
300hh-10(b)(5)) is amended by adding at the end the following: ``Such 
logistical support shall include working with other relevant Federal, 
State, local, tribal, and territorial public health officials and 
private sector partners 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 an emergency under section 319, an emergency or major 
disaster 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 products,'' after 
``products''.

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 ``senior 
        citizens''; and
            (2) by inserting ``with relevant characteristics that 
        warrant consideration during the process of researching and 
        developing such countermeasures and products'' before the 
        period.

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

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

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

    ``(a) Enhancing Emergency Preparedness for Children.--The 
Secretary, acting through the Director of the Centers for Disease 
Control and Prevention (referred to in this subsection as the 
`Director'), shall maintain an internal team of experts, to be known as 
the Children's Preparedness Unit (referred to in this subsection as the 
`Unit'), to work collaboratively to provide guidance on the 
considerations for, and the specific needs of, children before, during, 
and after public health emergencies. The Unit shall inform the Director 
regarding emergency preparedness and response efforts pertaining to 
children at the Centers for Disease Control and Prevention.
    ``(b) Expertise.--The team described in subsection (a) shall 
include one or more pediatricians, which may be a developmental-
behavior 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; and
            ``(6) carry out other duties related to preparedness and 
        response activities for children, as the Secretary determines 
        appropriate.''.

SEC. 305. REAUTHORIZING THE NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
              DISASTERS.

    Section 2811A (42 U.S.C. 300hh-10a) is amended--
            (1) in subsection (b)(2), by inserting ``, mental and 
        behavioral,'' after ``medical'';
            (2) in subsection (d)--
                    (A) in paragraph (1), by striking ``15'' and 
                inserting ``25''; and
                    (B) by striking paragraph (2) and inserting the 
                following:
            ``(2) Required non-federal members.--The Secretary, in 
        consultation with such other heads of Federal agencies as may 
        be appropriate, shall appoint to the Advisory Committee under 
        paragraph (1) at least 13 individuals to perform the duties 
        described in subsections (b) and (c), 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 and 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:
                    ``(A) The Assistant Secretary for Preparedness and 
                Response.
                    ``(B) The Director of the Biomedical Advanced 
                Research and Development Authority.
                    ``(C) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the National Institutes of 
                Health.
                    ``(F) The Assistant Secretary of the Administration 
                for Children and Families.
                    ``(G) The Administrator of the Health Resources and 
                Services Administration.
                    ``(H) The Administrator of the Federal Emergency 
                Management Agency.
                    ``(I) The Administrator of the Administration for 
                Community Living.
                    ``(J) The Secretary of Education.
                    ``(K) Representatives from such Federal agencies 
                (such as the Substance Abuse and Mental Health Services 
                Administration and the Department of Homeland Security) 
                as the Secretary determines appropriate to fulfill the 
                duties of the Advisory Committee under subsections (b) 
                and (c).''.
            ``(4) Term of appointment.--Each member of the Advisory 
        Committee appointed under paragraph (2) shall serve for a term 
        of 3 years, except that the Secretary may adjust the terms of 
        the Advisory Committee appointees serving on the date of 
        enactment of the Pandemic and All-Hazards Preparedness and 
        Advancing Innovation Act of 2018, or appointees who are 
        initially appointed after such date of enactment, in order to 
        provide for a staggered term of appointment for all members.
            ``(5) Consecutive appointments; maximum terms.--A member 
        appointed under paragraph (2) may serve not more than 3 terms 
        on the Advisory Committee, and not more than 2 of which 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.''; and
            (4) in subsection (f) by striking ``2018'' and inserting 
        ``2023''.

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

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

             TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
            (1) in the matter preceding paragraph (1) by inserting 
        ``utilize experience related to public health emergency 
        preparedness and response, biodefense, medical countermeasures, 
        and other relevant topics to'' after ``shall''; and
            (2) in paragraph (4) by adding at the end the following:
                    ``(I) Threat awareness.--Coordinate with the 
                Director of the Centers for Disease Control and 
                Prevention, the Director of National Intelligence, the 
                Secretary of Homeland Security, the Assistant to the 
                President for National Security Affairs, the Secretary 
                of Defense, and other relevant Federal officials, to 
                maintain a current assessment of national security 
                threats and inform preparedness and response 
                capabilities based on the range of the threats that 
                have the potential to result in a public health 
                emergency.''.

SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

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

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

    ``(a) In General.--The Secretary shall establish the Public Health 
Emergency Medical Countermeasures Enterprise (referred to in this 
section as the `PHEMCE'). The Assistant Secretary for Preparedness and 
Response shall serve as chair of the PHEMCE.
    ``(b) Members.--The PHEMCE shall include each of the following 
members, or the designee of such members:
            ``(1) The Assistant Secretary for Preparedness and 
        Response.
            ``(2) The Director of the Centers for Disease Control and 
        Prevention.
            ``(3) The Director of the National Institutes of Health.
            ``(4) The Commissioner of Food and Drugs.
            ``(5) The Secretary of Defense.
            ``(6) The Secretary of Homeland Security.
            ``(7) The Secretary of Agriculture.
            ``(8) The Secretary of Veterans Affairs.
            ``(9) Representatives of any other Federal agency, which 
        may include the Director of the Biomedical Advanced Research 
        and Development Authority, and the Director of the Strategic 
        National Stockpile, as the Secretary determines appropriate.
    ``(c) Functions.--
            ``(1) In general.--The functions of the PHEMCE shall 
        include the following:
                    ``(A) Establish a process pursuant to section 
                2811(d)(2)(B) to make recommendations to the Secretary 
                regarding the prioritization of research, development, 
                and procurement of countermeasures, as defined in 
                section 319F-2(c), based on the health security needs 
                of the United States. Such recommendations shall be 
                informed by the National Health Security Strategy 
                pursuant to section 2802, the Strategic National 
                Stockpile review required under section 319F-2(a)(2), 
                the countermeasures budget plan pursuant to section 
                2811(b)(7), and an assessment of current national 
                security threats, including chemical, biological, 
                radiological and nuclear threats, including emerging 
                infectious diseases. In the event that members of the 
                PHEMCE do not agree upon a recommendation, the 
                Secretary shall provide a determination regarding such 
                recommendation.
                    ``(B) Identify national health security needs, 
                including gaps in public health preparedness and 
                response related to countermeasures and challenges to 
                addressing such needs (including any regulatory 
                challenges), and provide for alignment of 
                countermeasure procurement with recommendations under 
                subparagraph (A).
                    ``(C) Develop strategies related to logistics, 
                deployment, distribution, dispensing, and use of 
                countermeasures that may be applicable to the 
                activities of the strategic national stockpile under 
                section 319F-2(a).
                    ``(D) Provide consultation for the development of 
                the strategy and implementation plan under section 
                2811(d).
            ``(2) Input.--In carrying out subparagraphs (B) and (C) of 
        paragraph (1), the PHEMCE shall solicit and consider input from 
        State, local, tribal, and territorial public health 
        departments, as appropriate.''.
    (b) Public Health Emergency Medical Countermeasures Enterprise 
Strategy and Implementation Plan.--Section 2811(d)(1) (42 U.S.C. 300hh-
10(d)(1)) is amended--
            (1) 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
            (2) by striking ``Director of Biomedical'' and all that 
        follows through ``Food and Drugs'' and inserting ``Public 
        Health Emergency Medical Countermeasures Enterprise established 
        under section 2811-1''.

SEC. 403. STRATEGIC NATIONAL STOCKPILE.

    (a) 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 ``and optimize'' after ``provide 
                for'';
                    (B) 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
                    (C) by striking the second sentence;
            (3) by inserting after paragraph (1) the following:
            ``(2) Threat-based review.--
                    ``(A) In general.--The Secretary shall conduct a 
                biennial threat-based review (taking into account at-
                risk individuals) of the contents of the stockpile 
                under paragraph (1), including non-pharmaceutical 
                supplies, and, in consultation with the Public Health 
                Emergency Medical Countermeasures Enterprise 
                established under section 2811-1, review contents 
                within the stockpile and assess whether such contents 
                are consistent with the recommendations made pursuant 
                to section 2811-1(c)(1)(A). Such review shall be 
                submitted biennially, beginning on March 15, 2019, to 
                the Committee on Health, Education, Labor, and Pensions 
                and the Committee on Appropriations of the Senate and 
                the Committee on Energy and Commerce and the Committee 
                on Appropriations of the House of Representatives, in a 
                manner that does not compromise national security.
                    ``(B) Additions, modifications, and 
                replenishments.--Each biennial threat-based review 
                under subparagraph (A) shall, for each new or modified 
                countermeasure procurement or replenishment, provide--
                            ``(i) information regarding--
                                    ``(I) the quantities of the 
                                additional or modified countermeasure 
                                procured for, or contracted to be 
                                procured for, the stockpile;
                                    ``(II) planning considerations for 
                                appropriate manufacturing capacity and 
                                capability to meet the goals of such 
                                additions or modifications (without 
                                disclosing proprietary information), 
                                including consideration of the effect 
                                such additions or modifications may 
                                have on the availability of such 
                                products and ancillary medical supplies 
                                in the health care system;
                                    ``(III) the presence or lack of a 
                                commercial market for the 
                                countermeasure at the time of 
                                procurement;
                                    ``(IV) the emergency health 
                                security threat or threats such 
                                countermeasure procurement is intended 
                                to address, including whether such 
                                procurement is consistent with meeting 
                                emergency health security needs 
                                associated with such threat or threats;
                                    ``(V) an assessment of whether the 
                                emergency health security threat or 
                                threats described in subclause (IV) 
                                could be addressed in a manner that 
                                better utilizes the resources of the 
                                stockpile and permits the greatest 
                                possible increase in the level of 
                                emergency preparedness to address such 
                                threats;
                                    ``(VI) whether such countermeasure 
                                is replenishing an expired 
                                countermeasure, is a different 
                                countermeasure with the same indication 
                                that is replacing an expired 
                                countermeasure, or is a new addition to 
                                the stockpile;
                                    ``(VII) a description of how such 
                                additions or modifications align with 
                                the countermeasures budget plan as 
                                required 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 that for each 
                        countermeasure produced or replenished under 
                        this subsection, the Secretary completed a 
                        review addressing each item listed under this 
                        subsection in advance of such procurement or 
                        replenishment, which need not be provided in 
                        advance of procurement.'';
            (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; and
                    (C) by amending subparagraph (E) to read as 
                follows:
                    ``(E) devise plans for effective and timely supply-
                chain management of the stockpile, in consultation with 
                the Director of the Centers for Disease Control and 
                Prevention, the Assistant Secretary for Preparedness 
                and Response, the Secretary of Transportation, the 
                Secretary of Homeland Security, the Secretary of 
                Veterans Affairs, and the heads of other appropriate 
                Federal agencies, State, local, tribal, and territorial 
                agencies, and the public and private health care 
                infrastructure, as applicable, taking into account the 
                manufacturing capacity and other available sources of 
                products and appropriate alternatives to supplies in 
                the stockpile''; and
            (5) by adding at the end the following:
            ``(5) GAO report.--
                    ``(A) In general.--Not later than 3 years after the 
                date of enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, and 
                every 5 years thereafter, the Comptroller General of 
                the United States shall conduct a review of any changes 
                to the contents or management of the stockpile since 
                January 1, 2015. Such review shall include--
                            ``(i) an assessment of the 
                        comprehensiveness and completeness of each 
                        biennial threat-based review under paragraph 
                        (2), including whether all newly procured or 
                        replenished countermeasures within the 
                        stockpile were described in each annual review, 
                        and whether, consistent with paragraph (2)(B), 
                        the Secretary conducted the necessary internal 
                        review in advance of such procurement or 
                        replenishment;
                            ``(ii) an assessment of whether the 
                        Secretary established health security and 
                        science-based justifications, and a description 
                        of such justifications for procurement 
                        decisions related to health security needs with 
                        respect to the identified threat, for additions 
                        or modifications to the stockpile based on the 
                        information provided in such reviews under 
                        paragraph (2)(B), including whether such review 
                        was conducted prior to procurement, 
                        modification, or replenishment;
                            ``(iii) an assessment of the plans 
                        developed by the Secretary for the deployment, 
                        distribution, and dispensing of countermeasures 
                        procured, modified, or replenished under 
                        paragraph (1), including whether such plans 
                        were developed prior to procurement, 
                        modification, or replenishment;
                            ``(iv) an accounting of countermeasures 
                        procured, modified, or replenished under 
                        paragraph (1) that received advanced research 
                        and development funding from the Biomedical 
                        Advanced Research and Development Authority;
                            ``(v) an analysis of how such procurement 
                        decisions made progress towards meeting 
                        emergency health security needs related to the 
                        identified threats for countermeasures added, 
                        modified, or replenished under paragraph (1);
                            ``(vi) a description of the resources 
                        expended related to the procurement of 
                        countermeasures (including additions, 
                        modifications, and replenishments) in the 
                        stockpile, and how such expenditures relate to 
                        the emergency health security needs of the 
                        stockpile;
                            ``(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; 
                        and
                            ``(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.
                    ``(B) Submission.--Not later than 6 months after 
                completing a classified version of the review under 
                subparagraph (A), the Comptroller General shall submit 
                an unclassified version of the review to the 
                appropriate committees of Congress.''.
    (b) 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''.

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

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

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

    Section 351A(k) (42 U.S.C. 262a) is amended--
            (1) by striking ``The Secretary'' and inserting the 
        following:
            ``(1) In general.--The Secretary''; and
            (2) by adding at the end the following:
            ``(2) Implementation of recommendations of the federal 
        experts security advisory panel and the fast track action 
        committee on select agent regulations.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the enactment of the Pandemic and All-Hazards 
                Preparedness and Advancing Innovation Act of 2018, the 
                Secretary shall provide an update to the appropriate 
                committees of Congress on the implementation of 
                recommendations of the Federal Experts Security 
                Advisory Panel concerning the select agent program.
                    ``(B) Continued updates.--The Secretary shall 
                provide status updates at 6-month intervals following 
                the submission of the update under subparagraph (A) 
                until the recommendations described in such 
                subparagraph are fully implemented, or a justification 
                is provided for the delay in, or lack of, 
                implementation.''.

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

SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

    Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
            (1) in the matter preceding subparagraph (A), by striking 
        ``March 1 of each year'' and inserting ``March 15, 2020 and 
        every 2 years thereafter'';
            (2) by striking subparagraph (A) and inserting the 
        following:
                    ``(A) include consideration of the entire medical 
                countermeasures enterprise, including--
                            ``(i) basic research and advanced research 
                        and development;
                            ``(ii) approval, clearance, licensure, and 
                        authorized uses of products;
                            ``(iii) procurement, stockpiling, 
                        maintenance, and potential replenishment 
                        (including manufacturing capabilities) of all 
                        products in the Strategic National Stockpile; 
                        and
                            ``(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;''.
            (3) by redesignating subparagraphs (D) and (E) as 
        subparagraphs (E) and (F), respectively;
            (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;''; and
            (5) in subparagraph (E), as so redesignated, by striking 
        ``March 15 of each year'' and inserting ``March 15, 2020, and 
        every 2 years thereafter''.

SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE NOTIFICATIONS.

    (a) Congressional Notification of Material Threat Determination.--
Section 319F-2(c)(2)(C) (42 U.S.C. 247d-6b(c)(2)(C)) is amended by 
striking ``The Secretary and the Homeland Security Secretary shall 
promptly notify the appropriate committees of Congress'' and inserting 
``The Secretary and the Secretary of Homeland Security shall send to 
Congress, on an annual basis, all current material threat 
determinations and shall promptly notify the Committee on Health, 
Education, Labor, and Pensions and the Committee on Homeland Security 
and Government Affairs of the Senate and the Committee on Energy and 
Commerce and the Committee on Homeland Security of the House of 
Representatives''.
    (b) Contracting Communications.--
            (1) Contract duration.--Section 319F-2(c)(7)(B)(ii)(III) 
        (42 U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is amended by adding at 
        the end the following: ``The Secretary shall notify the vendor 
        within 90 days of a determination by the Secretary to renew 
        such contract.''.
            (2) Expedited authorities.--Section 319L(c)(5)(B)(i) (42 
        U.S.C. 247d-7e(c)(5)(B)(i)) is amended by adding at the end the 
        following: ``Upon award, extension, or termination of any such 
        contract, grant, cooperative agreement, and other transaction, 
        the Secretary shall provide a written notification to the 
        receiving entity that includes a justification for such award, 
        extension, or termination.''.

SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

    Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-4(f)) is amended--
            (1) by redesignating paragraphs (3) through (6) as 
        paragraphs (4) through (7), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) Publication.--The Secretary shall make available on 
        the internet website of the Food and Drug Administration 
        information regarding regulatory management plans, including--
                    ``(A) the process by which an applicant may submit 
                a request for a regulatory management plan;
                    ``(B) the timeframe by which the Secretary is 
                required to respond to such request;
                    ``(C) the information required for the submission 
                of such request;
                    ``(D) a description of the types of development 
                milestones and performance targets that could be 
                discussed and included in such plans; and
                    ``(E) contact information for beginning the 
                regulatory management plan process.'';
            (3) in paragraph (6), as so redesignated, in the matter 
        preceding subparagraph (A)--
                    (A) by striking ``paragraph (4)(A)'' and inserting 
                ``paragraph (5)(A)''; and
                    (B) by striking ``paragraph (4)(B)'' and inserting 
                ``paragraph (5)(B)''; and
            (4) in paragraph (7)(A), as so redesignated, by striking 
        ``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.

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

    (a) Bioshield Special Reserve Fund.--Section 319F-2(g)(1) (42 
U.S.C. 247d-6b(g)(1)) is amended--
            (1) by striking ``$2,800,000,000 for the period of fiscal 
        years 2014 through 2018'' and inserting ``$3,500,000,000 for 
        the period of fiscal years 2019 through 2023, 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''.

      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'' inserting ``platform 
technologies, technologies to administer countermeasures, technologies 
to improve storage, and transportation of countermeasures''.

SEC. 602. MEDICAL COUNTERMEASURE MASTER FILES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 565A 
the following:

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

    ``(a) Purpose.--The purpose of this section is to support and 
accelerate the development or manufacture of security countermeasures, 
qualified countermeasures, and qualified pandemic or epidemic products 
by facilitating and encouraging submission of data and information to 
support such products to master files, and through clarifying the 
authority to cross-reference to data and information previously 
submitted to the Secretary.
    ``(b) Applicability of Reference.--
            ``(1) In general.--A person may submit data and information 
        to the Secretary with the intent to reference, or to authorize, 
        in writing, another person to reference, such data or 
        information, in accordance with subsections (d) and (e) of 
        section 314.420 of title 21, Code of Federal Regulations (or 
        any successor regulations), 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.
            ``(2) Master file holder.--In this section, the term 
        `master file holder' means a person who submits data and 
        information to the Secretary with the intent to reference or 
        authorize to reference such data or information to support a 
        medical countermeasure submission, as described in paragraph 
        (1).
    ``(c) Medical Countermeasure Master File Content.--
            ``(1) In general.--A master file under this section may 
        include information to support and accelerate--
                    ``(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.
    ``(d) Sponsor Reference.--
            ``(1) In general.--Each incorporation of information or 
        data contained in a master file by reference shall describe the 
        incorporated material in a manner in which the Secretary 
        determines appropriate and that permits the review of such 
        information without necessitating resubmission of such 
        information or data. Master files shall be submitted in an 
        electronic format in accordance with section 745A and as 
        specified in applicable guidance.
            ``(2) Reference by a master file holder.--A master file 
        holder that is the sponsor of a medical countermeasure 
        submission shall notify the Secretary in writing of the intent 
        to reference the medical countermeasure master file as a part 
        of the submission.
            ``(3) Reference by an authorized person.--A sponsor of a 
        medical countermeasure submission 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.
    ``(e) Acknowledgement of Master File by the Secretary.--The 
Secretary shall provide the master file holder with a written 
notification indicating that the Secretary has reviewed and relied upon 
specified information or data within a master file and the purposes for 
which such information or data was incorporated by reference if the 
Secretary has reviewed and relied upon such specified information or 
data to support the approval, classification, conditional approval, 
clearance, licensure, or authorization of a security countermeasure, 
qualified countermeasure, or qualified pandemic or epidemic product. 
The Secretary may rely upon the data and information within the medical 
countermeasure master file for which such written notification was 
provided in additional applications, as applicable and appropriate and 
upon the request of the master file holder so notified in writing or by 
an authorized person of such holder.
    ``(f) Rules of Construction.--Nothing in this section shall be 
construed to--
            ``(1) alter the authority of the Secretary to approve, 
        license, classify, clear, conditionally approve, or authorize 
        drugs, biological products, or devices pursuant to this Act or 
        section 351 of the Public Health Service Act (as authorized 
        prior to the date of enactment of the Pandemic and All-Hazards 
        Preparedness and Advancing Innovation Act of 2018), including 
        the standards of evidence, and applicable conditions, for 
        approval under the applicable Act; or
            ``(2) alter the authority of the Secretary under this Act 
        or the Public Health Service Act to determine the types of 
        information or data 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), 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.
    ``(g) Definitions.--In this section:
            ``(1) 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 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 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.
            ``(2) 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.''.
    (b) Stakeholder Input.--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''), 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 accelerate the development or manufacture of security 
countermeasures, qualified countermeasures, and qualified pandemic or 
epidemic products, including through the 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 (a).
    (c) Guidance.--Not later than 2 years after the 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 (a) 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 
accelerate the development or manufacture of security countermeasures, 
qualified countermeasures, qualified pandemic or epidemic products. The 
Secretary, acting through the Commissioner of Food and Drugs, shall 
publish the final guidance not later than 3 years after the enactment 
of this Act.

SEC. 603. ANIMAL RULE REPORT.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the application of the requirements under section 
565(d) of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4(d)) (referred to in this section as the ``animal rule'') as a 
component of medical countermeasure advanced development under the 
Biomedical Advanced Research and Development Authority and regulatory 
review by the Food and Drug Administration. In conducting such study, 
the Comptroller General shall examine the following:
            (1) The extent to which advanced development and review of 
        a medical countermeasure are coordinated between the Biomedical 
        Advanced Research and Development Authority and the Food and 
        Drug Administration, including activities 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 flexibilities 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, and nuclear threats; and
            (3) other biodefense stakeholders, as applicable.
    (c) Report.--Not later than 3 years after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report containing the results of the study conducted 
under subsection (a) and recommendations to improve the application and 
consistency of the requirements under subsections (c) and (d) of 
section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4) to support and expedite the research and development of 
medical countermeasures, as applicable.
    (d) Protection of National Security.--The Comptroller General of 
the United States shall conduct the study and issue the assessment and 
report under this section in a manner that does not compromise national 
security.

                  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) Public Disclosure Exemption.--Section 319L(e)(1)(C) (42 U.S.C. 
247d-7e(e)(1)(C)) is amended by striking ``12'' and inserting ``17''.
    (f) Limited Antitrust Exemption.--
            (1) In general.--Section 405 of the Pandemic and All-
        Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended--
                    (A) by redesignating such section as section 319L-
                1;
                    (B) transferring such section to the Public Health 
                Service Act (42 U.S.C. 201 et seq.), to appear after 
                section 319L of such Act (42 U.S.C. 247d-7e);
                    (C) in subsection (a)(1)--
                            (i) by striking ``Secretary of Health and 
                        Human Services (referred to in this subsection 
                        as the `Secretary')'' and inserting 
                        ``Secretary'';
                            (ii) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6b)) (as amended by 
                        this Act'';
                            (iii) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6a)) (as amended by 
                        this Act''; and
                            (iv) by striking ``of the Public Health 
                        Service Act (42 U.S.C. 247d-6d)''; and
                    (D) in subsection (b), by striking ``12-year'' and 
                inserting ``17-year''.
            (2) Effective date.--The amendment made by paragraph (1)(D) 
        shall take effect as if enacted on December 17, 2012.
            (3) Conforming amendment.--The table of contents in section 
        1(b) of the Pandemic and All-Hazards Preparedness Act (Public 
        Law 109-417) is amended by striking the item related to section 
        405.

SEC. 702. 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) Federal Food, Drug, and Cosmetic Act.--The Federal Food, Drug, 
and Cosmetic Act is amended--
            (1) in section 564A(e)(2)(A) (21 U.S.C. 360bbb-
        3a(e)(2)(A)), by striking ``subsection (a)(1)(C)(i)'' and 
        inserting ``subsection (a)(1)(C)''; and
            (2) in section 564B(2)(C) (21 U.S.C. 360bbb-3b(2)(C)), by 
        inserting ``or section 564A''.
                                 <all>