(a) In general

There is established within the Department of Health and Human Services the position of the Assistant Secretary for Preparedness and Response. The President, with the advice and consent of the Senate, shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary.

(b) Duties

Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to carry out the following functions:

(1) Leadership

Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies and, consistent with the National Response Framework and other applicable provisions of law, assist the Secretary in carrying out the functions under section 300hh of this title.

(2) Personnel

Register, credential, organize, train, equip, and have the authority to deploy Federal public health and medical personnel under the authority of the Secretary, including the National Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.

(3) Countermeasures

Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 247d-6a of this title), security countermeasures (as defined in section 247d-6b of this title), and qualified pandemic or epidemic products (as defined in section 247d-6d of this title).

(4) Coordination

(A) Federal integration

Coordinate with relevant Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.

(B) State, local, and tribal integration

Coordinate with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency.

(C) Emergency medical services

Promote improved emergency medical services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public health emergencies.

(D) Policy coordination and strategic direction

Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan described in section 314(a)(6) of title 6, or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 660(b) of title 6, including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.

(E) Identification of inefficiencies

Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and recommend actions necessary to overcome these obstacles, such as—

(i) improving coordination with relevant Federal officials;

(ii) partnering with other public or private entities to leverage capabilities maintained by such entities, as appropriate and consistent with this subsection; and

(iii) coordinating efforts to support or establish new capabilities, as appropriate.

(F) Coordination of grants and agreements

Align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this chapter, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to—

(i) optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and

(ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.

(G) Drill and operational exercises

Carry out drills and operational exercises each year, including national-level and State-level full-scale exercises not less than once every 4 years, in consultation 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, to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness and response, including exercises—

(i) based on ¹

(I) identified threats for which countermeasures are available and for which no countermeasures are available; and

(II) unknown threats for which no countermeasures are available;

(ii) that assess the ability of the Strategic National Stockpile, as appropriate, to provide medical countermeasures, medical products, and other supplies, including ancillary medical supplies, to support the response to a public health emergency or potential public health emergency, including a threat that requires the large-scale and simultaneous deployment of stockpiles and a long-term public health and medical response; and

(iii) conducted in coordination with State and local health officials.

(H) National security priority

On a periodic basis consult with, as applicable and appropriate, the Assistant to the President for National Security Affairs, to provide an update on, and discuss, medical and public health preparedness and response activities pursuant to this chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], including progress on the development, approval, clearance, and licensure of medical countermeasures.

(I) Threat awareness

Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.

(J) Medical product and supply capacity planning

Coordinate efforts within the Department of Health and Human Services to support—

(i) preparedness for medical product and medical supply needs directly related to responding to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and incidents covered by the National Response Framework, including—

(I) sharing information, including with appropriate stakeholders, related to the anticipated need for, and availability of, such products and supplies during such responses;

(II) supporting activities, which may include public-private partnerships, to maintain capacity of medical products and medical supplies, as applicable and appropriate; and

(III) planning for potential surges in medical supply needs for purposes of a response to such a threat; and

(ii) situational awareness with respect to anticipated need for, and availability of, such medical products and medical supplies within the United States during a response to such a threat.

(5) Logistics

In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies. Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.

(6) Leadership

Provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response.

(7) Countermeasures budget plan

Develop, and update not later than March 15 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d-6a of this title), security countermeasures (as defined in section 247d-6b of this title), and qualified pandemic or epidemic products (as defined in section 247d-6d of this title) for each such threat. Each such plan shall—

(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;

(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and

(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;

(B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;

(C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 247d-6b of this title;

(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;

(E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and

(F) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.

(c) Functions

The Assistant Secretary for Preparedness and Response shall—

(1) have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;

(2) have authority over and responsibility for—

(A) the National Disaster Medical System pursuant to section 300hh-11 of this title;

(B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 247d-3b of this title;

(C) the Biomedical Advanced Research and Development Authority pursuant to section 247d-7e of this title;

(D) the Medical Reserve Corps pursuant to section 300hh-15 of this title;

(E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 247d-7b of this title; and

(F) administering grants and related authorities related to trauma care under parts A through C of subchapter X, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary;

(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—

(A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 247d-3a of this title;

(B) the Strategic National Stockpile pursuant to section 247d-6b of this title; and

(C) the Cities Readiness Initiative; and

(4) assume other duties as determined appropriate by the Secretary.

(d) Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan

(1) In general

Not later than March 15, 2020, and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh-10a of this title. Such strategy and plan shall be known as the “Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan”.

(2) Requirements

The plan under paragraph (1) shall—

(A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 247d-6a of this title), security countermeasures (as defined in section 247d-6b of this title), or qualified pandemic or epidemic products (as defined in section 247d-6d of this title) for each threat;

(B) evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;

(C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products, and ancillary medical supplies to assist with the utilization of such countermeasures or products, to address a chemical, biological, radiological, and nuclear threat or threats;

(D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes—

(i) the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication (such as the award, denial of award, or solicitation termination); and

(ii) an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones for each medical countermeasure priority under subparagraph (C), including projected needs with regard to replenishment of the Strategic National Stockpile;

(E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 247d-7g of this title;

(F) evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);

(G) report on the amount of funds available for procurement in the special reserve fund as defined in section 247d-6b(h) of this title and the impact this funding will have on meeting the requirements under section 247d-6b of this title;

(H) incorporate input from Federal, State, local, and tribal stakeholders;

(I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in ² 300hh-1(b)(4)(B) of this title), as applicable under subparagraph (C), including with regard to the projected needs for related stockpiling and replenishment of the Strategic National Stockpile, including by addressing the needs of pediatric populations with respect to such countermeasures and products in the Strategic National Stockpile, including—

(i) a list of such countermeasures and products necessary to address the needs of pediatric populations;

(ii) a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and products for pediatric populations;

(iii) a description of existing gaps in the Strategic National Stockpile and the development of such countermeasures and products to address the needs of pediatric populations; and

(iv) an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);

(J) identify the use of authority and activities undertaken pursuant to sections 247d-6a(b)(1), 247d-6a(b)(2), 247d-6a(b)(3), 247d-6a(c), 247d-6a(d), 247d-6a(e), 247d-6b(c)(7)(C)(iii), 247d-6b(c)(7)(C)(iv), and 247d-6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb-3], by summarizing—

(i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;

(ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;

(iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;

(iv) whether, with respect to each procurement that is approved by the President under section 247d-6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and

(v) with respect to section 247d-6a(d) of this title, for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and

(K) be made publicly available.

(3) GAO report

(A) In general

Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan.

(B) Content

The report described in subparagraph (A) shall review and assess—

(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);

(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 247d-7e of this title; and

(iii) the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection.

(e) Protection of national security

In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.

(f) Protection of national security from threats

(1) In general

In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security based on the characteristics of such threat. Such initiatives shall include activities to—

(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 247d-7e(c)(4)(F) of this title;

(B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and

(C) maintain or improve preparedness activities, including for pandemic influenza.

(2) Authorization of appropriations

(A) In general

To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.

(B) Supplement, not supplant

Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 247d-7e(d) and 247d-6b(g) of this title.

(C) Documentation required

The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading “Public Health and Social Services Emergency Fund” under the heading “Office of the Secretary” under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115-141) and allocated to carrying out section 247d-7e(c)(4)(F) of this title.

(g) Appearances before Congress

(1) In general

Each fiscal year, the Assistant Secretary for Preparedness and Response shall appear before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives at hearings, on topics such as—

(A) coordination of Federal activities to prepare for, and respond to, public health emergencies;

(B) activities and capabilities of the Strategic National Stockpile, including whether, and the degree to which, recommendations made pursuant to section 300hh-10a(c)(1)(A) of this title have been met;

(C) support for State, local, and Tribal public health and medical preparedness;

(D) activities implementing the countermeasures budget plan described under subsection (b)(7), including—

(i) any challenges in meeting the full range of identified medical countermeasure needs; and

(ii) progress in supporting advanced research, development, and procurement of medical countermeasures, pursuant to subsection (b)(3);

(E) the strategic direction of, and activities related to, the sustainment of manufacturing surge capacity and capabilities for medical countermeasures pursuant to section 247d-7e of this title and the distribution and deployment of such countermeasures;

(F) any additional objectives, activities, or initiatives that have been carried out or are planned by the Assistant Secretary for Preparedness and Response and associated challenges, as appropriate;

(G) the specific all-hazards threats that the Assistant Secretary for Preparedness and Response is preparing to address, or that are being addressed, through the activities described in subparagraphs (A) through (F); and

(H) objectives, activities, or initiatives related to the coordination and consultation required under subsections (b)(4)(H) and (b)(4)(I), in a manner consistent with paragraph (3), as appropriate.

(2) Clarifications

(A) Waiver authority

The Chair of the Committee on Health, Education, Labor, and Pensions of the Senate or the Chair of the Committee on Energy and Commerce of the House of Representatives may waive the requirements of paragraph (1) for the applicable fiscal year with respect to the applicable Committee.

(B) Scope of requirements

The requirements of this subsection shall not be construed to impact the appearance of other Federal officials or the Assistant Secretary at hearings of either Committee described in paragraph (1) at other times and for purposes other than the times and purposes described in paragraph (1) ³

(3) Closed hearings

Information that is not appropriate for disclosure during an open hearing under paragraph (1) in order to protect national security may instead be discussed in a closed hearing that immediately follows such open hearing.