Title IV — Prioritizing a Threat-Based Approach

116th Congress · Approved Jun 24, 2019 · 133 Stat. 905

TITLE IV Prioritizing a Threat-Based Approach

SEC. 401. Assistant Secretary for Preparedness and Response.

Section 2811(b) (42 U.S.C. 300hh–10(b)) is amended—

(1)

in the matter preceding paragraph (1), by inserting “ utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to” after “ shall”; and

(2)

in paragraph (4), by adding at the end the following:

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

SEC. 402. Public Health Emergency Medical Countermeasures Enterprise.

(a)

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

“SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

“(a) In General.—The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the ‘PHEMCE’). The Assistant Secretary for Preparedness and Response shall serve as chair of the PHEMCE.

“(b) Members.—The PHEMCE shall include each of the following members, or the designee of such members:

“(1) The Assistant Secretary for Preparedness and Response.

“(2) The Director of the Centers for Disease Control and Prevention.

“(3) The Director of the National Institutes of Health.

“(4) The Commissioner of Food and Drugs.

“(5) The Secretary of Defense.

“(6) The Secretary of Homeland Security.

“(7) The Secretary of Agriculture.

“(8) The Secretary of Veterans Affairs.

“(9) The Director of National Intelligence.

“(10) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the Secretary determines appropriate.

“(c) Functions.—

“(1) In general.—The functions of the PHEMCE shall include the following:

“(A) Utilize a process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 319F–2(c), including prioritization based on the health security needs of the United States. Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy pursuant to section 2802, the Strategic National Stockpile needs pursuant to section 319F–2, and assessments of current national security threats, including chemical, biological, radiological, and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.

“(B) Identify national health security needs, including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needs under subparagraph (A).

“(C) Assist the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 319F–2(a).

“(D) Provide consultation for the development of the strategy and implementation plan under section 2811(d).

“(2) Input.—In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and consider input from State, local, Tribal, and territorial public health departments or officials, as appropriate.”

(b)

Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan.— Section 2811(d) (42 U.S.C. 300hh–10(d)) is amended—

(1)

in paragraph (1)—

(A)

by striking “ Not later than 180 days after the date of enactment of this subsection, and every year thereafter” and inserting “ Not later than March 15, 2020, and biennially thereafter”; and

(B)

by striking “ Director of the Biomedical” and all that follows through “ Food and Drugs” and inserting “ Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1”; and

(2)

in paragraph (2)(J)(v), by striking “ one-year period” and inserting “ 2-year period”.

SEC. 403. Strategic National Stockpile.

(a)

In General.— Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is amended—

(1)

by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and

(2)

in paragraph (1)—

(A)

by inserting “ the Assistant Secretary for Preparedness and Response and” after “ collaboration with”;

(B)

by inserting “ and optimize” after “ provide for”;

(C)

by inserting “ and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2)” before the period of the first sentence; and

(D)

by striking the second sentence;

(3)

by inserting after paragraph (1) the following:

“(2) Threat-based review.—

“(A) In general.—The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1, review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 2811–1(c)(1)(A). Such review shall be submitted on June 15, 2019, and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, in a manner that does not compromise national security.

“(B) Additions, modifications, and replenishments.—Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—

“(i) information regarding—

“(I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;

“(II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;

“(III) the presence or lack of a commercial market for the countermeasure at the time of procurement;

“(IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;

“(V) an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;

“(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;

“(VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 2811(b)(7), including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and

“(VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and

“(ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.”

(4)

in paragraph (3), as so redesignated—

(A)

in subparagraph (A), by inserting “ and the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1” before the semicolon;

(B)

in subparagraph (C), by inserting “ , and the availability, deployment, dispensing, and administration of countermeasures” before the semicolon;

(C)

by amending subparagraph (E) to read as follows:

“(E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;”

(D)

in subparagraph (G), by striking “ ; and” and inserting a semicolon;

(E)

in subparagraph (H), by striking the period and inserting a semicolon; and

(F)

by adding at the end the following:

“(I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 319L, including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States; and

“(J) provide assistance, including technical assistance, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate.”

; and

(5)

by adding at the end the following:

“(5) GAO report.—

“(A) In general.—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015. Such review shall include—

“(i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;

“(ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;

“(iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;

“(iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;

“(v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);

“(vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;

“(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;

“(viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities; and

“(ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 319L, including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States.

“(B) Submission.—Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.”

(b)

Additional Reporting.— In the first threat-based review submitted after the date of enactment of this Act pursuant to paragraph (2) of section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended by subsection (a), the Secretary shall include a description of the processes and procedures through which the Director of the Strategic National Stockpile and the Director of the Biomedical Advanced Research and Development Authority coordinate with respect to countermeasures and products procured under such section 319F–2(a), including such processes and procedures in place to ensure countermeasures and products under consideration for procurement pursuant to such section 319F–2(a) receive the same consideration regardless of whether such countermeasures or products receive or had received funding under section 319L of the Public Health Service Act (42 U.S.C. 247d–7e), and whether such countermeasures and products are the most appropriate to meet the emergency health security needs of the United States.

(c)

Authorization of Appropriations, Strategic National Stockpile.— Section 319F–2(f)(1) (42 U.S.C. 247d–6b(f)(1)) is amended by striking “ $533,800,000 for each of fiscal years 2014 through 2018” and inserting “ $610,000,000 for each of fiscal years 2019 through 2023, to remain available until expended”.

SEC. 404. Preparing for Pandemic Influenza, Antimicrobial Resistance, and Other Significant Threats.

(a)

Strategic Initiatives.— Section 319L(c)(4) (247d–7e(c)(4)) is amended by adding at the end the following:

“(F) Strategic initiatives.—The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including—

“(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;

“(ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and

“(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.”

(b)

Protection of National Security From Threats.— Section 2811 (42 U.S.C. 300hh–10) is amended by adding at the end the following:

“(f) Protection of National Security From Threats.—

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

“(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F);

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

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

“(2) Authorization of appropriations.—

“(A) In general.—To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.

“(B) Supplement, not supplant.—Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 319L(d) and 319F–2(g).

“(C) Documentation required.—The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading ‘Public Health and Social Services Emergency Fund’ under the heading ‘Office of the Secretary’ under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and allocated to carrying out section 319L(c)(4)(F).”

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

Section 351A(k) (42 U.S.C. 262a(k)) is amended—

(1)

by striking “ The Secretary” and inserting the following:

“(1) In general.—The Secretary”

; and

(2)

by adding at the end the following:

“(2) Implementation of recommendations of the federal experts security advisory panel and the fast track action committee on select agent regulations.—

“(A) In general.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary shall report to the congressional committees of jurisdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel concerning the select agent program.

“(B) Continued updates.—The Secretary shall report to the congressional committees of jurisdiction annually following the submission of the report under subparagraph (A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided for the delay in, or lack of, implementation.”

Title IV — Prioritizing a Threat-Based Approach