[Congressional Record Volume 165, Number 93 (Tuesday, June 4, 2019)]
[House]
[Pages H4245-H4265]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF
2019
Ms. ESHOO. Madam Speaker, I move to suspend the rules and pass the
bill (S. 1379) to reauthorize certain programs under the Public Health
Service Act and the Federal Food, Drug, and Cosmetic Act with respect
to public health security and all-hazards preparedness and response,
and for other purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
S. 1379
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic
and All-Hazards Preparedness and Advancing Innovation Act of
2019''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. References in Act.
TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY
Sec. 101. National Health Security Strategy.
TITLE II--IMPROVING PREPAREDNESS AND RESPONSE
Sec. 201. Improving benchmarks and standards for preparedness and
response.
Sec. 202. Amendments to preparedness and response programs.
Sec. 203. Regional health care emergency preparedness and response
systems.
Sec. 204. Military and civilian partnership for trauma readiness.
Sec. 205. Public health and health care system situational awareness
and biosurveillance capabilities.
Sec. 206. Strengthening and supporting the public health emergency
rapid response fund.
Sec. 207. Improving all-hazards preparedness and response by public
health emergency volunteers.
Sec. 208. Clarifying State liability law for volunteer health care
professionals.
Sec. 209. Report on adequate national blood supply.
Sec. 210. Report on the public health preparedness and response
capabilities and capacities of hospitals, long-term care
facilities, and other health care facilities.
[[Page H4246]]
TITLE III--REACHING ALL COMMUNITIES
Sec. 301. Strengthening and assessing the emergency response workforce.
Sec. 302. Health system infrastructure to improve preparedness and
response.
Sec. 303. Considerations for at-risk individuals.
Sec. 304. Improving emergency preparedness and response considerations
for children.
Sec. 305. National advisory committees on disasters.
Sec. 306. Guidance for participation in exercises and drills.
TITLE IV--PRIORITIZING A THREAT-BASED APPROACH
Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance,
and other significant threats.
Sec. 405. Reporting on the Federal Select Agent Program.
TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT
Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority
and the BioShield Special Reserve Fund.
Sec. 505. Additional strategies for combating antibiotic resistance.
TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES
Sec. 601. Administration of countermeasures.
Sec. 602. Updating definitions of other transactions.
Sec. 603. Medical countermeasure master files.
Sec. 604. Animal rule report.
Sec. 605. Review of the benefits of genomic engineering technologies
and their potential role in national security.
Sec. 606. Report on vaccines development.
Sec. 607. Strengthening mosquito abatement for safety and health.
TITLE VII--MISCELLANEOUS PROVISIONS
Sec. 701. Reauthorizations and extensions.
Sec. 702. Location of materials in the stockpile.
Sec. 703. Cybersecurity.
Sec. 704. Strategy and report.
Sec. 705. Technical amendments.
SEC. 2. REFERENCES IN ACT.
Except as otherwise specified, amendments made by this Act
to a section or other provision of law are amendments to such
section or other provision of the Public Health Service Act
(42 U.S.C. 201 et seq.).
TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.
Section 2802 (42 U.S.C. 300hh-1) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``2014'' and inserting ``2018''; and
(ii) by striking the second sentence and inserting the
following: ``Such National Health Security Strategy shall
describe potential emergency health security threats and
identify the process for achieving the preparedness goals
described in subsection (b) to be prepared to identify and
respond to such threats and shall be consistent with the
national preparedness goal (as described in section
504(a)(19) of the Homeland Security Act of 2002), the
National Incident Management System (as defined in section
501(7) of such Act), and the National Response Plan developed
pursuant to section 504 of such Act, or any successor
plan.'';
(B) in paragraph (2), by inserting before the period at the
end of the second sentence the following: ``, and an analysis
of any changes to the evidence-based benchmarks and objective
standards under sections 319C-1 and 319C-2''; and
(C) in paragraph (3)--
(i) by striking ``2009'' and inserting ``2022'';
(ii) by inserting ``(including gaps in the environmental
health and animal health workforces, as applicable),
describing the status of such workforce'' after ``gaps in
such workforce'';
(iii) by striking ``and identifying strategies'' and
inserting ``identifying strategies''; and
(iv) by inserting before the period at the end ``, and
identifying current capabilities to meet the requirements of
section 2803''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``and investigation''
and inserting ``investigation, and related information
technology activities'';
(ii) in subparagraph (B), by striking ``and
decontamination'' and inserting ``decontamination, relevant
health care services and supplies, and transportation and
disposal of medical waste''; and
(iii) by adding at the end the following:
``(E) Response to environmental hazards.'';
(B) in paragraph (3)--
(i) in the matter preceding subparagraph (A), by striking
``including mental health'' and inserting ``including
pharmacies, mental health facilities,''; and
(ii) in subparagraph (F), by inserting ``or exposures to
agents that could cause a public health emergency'' before
the period;
(C) in paragraph (5), by inserting ``and other applicable
compacts'' after ``Compact''; and
(D) by adding at the end the following:
``(9) Zoonotic disease, food, and agriculture.--Improving
coordination among Federal, State, local, Tribal, and
territorial entities (including through consultation with the
Secretary of Agriculture) to prevent, detect, and respond to
outbreaks of plant or animal disease (including zoonotic
disease) that could compromise national security resulting
from a deliberate attack, a naturally occurring threat, the
intentional adulteration of food, or other public health
threats, taking into account interactions between animal
health, human health, and animals' and humans' shared
environment as directly related to public health emergency
preparedness and response capabilities, as applicable.
``(10) Global health security.--Assessing current or
potential health security threats from abroad to inform
domestic public health preparedness and response
capabilities.''.
TITLE II--IMPROVING PREPAREDNESS AND RESPONSE
SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS
AND RESPONSE.
(a) Evaluating Measurable Evidence-Based Benchmarks and
Objective Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is
amended by inserting after subsection (j) the following:
``(k) Evaluation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 and every 2 years
thereafter, the Secretary shall conduct an evaluation of the
evidence-based benchmarks and objective standards required
under subsection (g). Such evaluation shall be submitted to
the congressional committees of jurisdiction together with
the National Health Security Strategy under section 2802, at
such time as such strategy is submitted.
``(2) Content.--The evaluation under this paragraph shall
include--
``(A) a review of evidence-based benchmarks and objective
standards, and associated metrics and targets;
``(B) a discussion of changes to any evidence-based
benchmarks and objective standards, and the effect of such
changes on the ability to track whether entities are meeting
or making progress toward the goals under this section and,
to the extent practicable, the applicable goals of the
National Health Security Strategy under section 2802;
``(C) a description of amounts received by eligible
entities described in subsection (b) and section 319C-2(b),
and amounts received by subrecipients and the effect of such
funding on meeting evidence-based benchmarks and objective
standards; and
``(D) recommendations, as applicable and appropriate, to
improve evidence-based benchmarks and objective standards to
more accurately assess the ability of entities receiving
awards under this section to better achieve the goals under
this section and section 2802.''.
(b) Evaluating the Partnership for State and Regional
Hospital Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-
3b(i)(1)) is amended by striking ``section 319C-1(g), (i),
and (j)'' and inserting ``section 319C-1(g), (i), (j), and
(k)''.
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.
(a) Cooperative Agreement Applications for Improving State
and Local Public Health Security.--Section 319C-1 (42 U.S.C.
247d-3a) is amended--
(1) in subsection (a), by inserting ``, acting through the
Director of the Centers for Disease Control and Prevention,''
after ``the Secretary''; and
(2) in subsection (b)(2)(A)--
(A) in clause (vi), by inserting ``, including public
health agencies with specific expertise that may be relevant
to public health security, such as environmental health
agencies,'' after ``stakeholders'';
(B) by redesignating clauses (vii) through (ix) as clauses
(viii) through (x);
(C) by inserting after clause (vi) the following:
``(vii) a description of how, as applicable, such entity
may integrate information to account for individuals with
behavioral health needs following a public health
emergency;'';
(D) in clause (ix), as so redesignated, by striking ``;
and'' and inserting a semicolon; and
(E) by adding at the end the following:
``(xi) a description of how the entity will partner with
health care facilities, including hospitals and nursing homes
and other long-term care facilities, to promote and improve
public health preparedness and response; and
``(xii) a description of how, as appropriate and
practicable, the entity will include critical infrastructure
partners, such as utility companies within the entity's
jurisdiction, in planning pursuant to this subparagraph to
help ensure that critical infrastructure will
[[Page H4247]]
remain functioning during, or return to function as soon as
practicable after, a public health emergency;''.
(b) Exception Relating to Application of Certain
Requirements.--
(1) In general.--Section 319C-1(g) (42 U.S.C. 247d-3a(g))
is amended--
(A) in paragraph (5)--
(i) in the matter preceding subparagraph (A), by striking
``Beginning with fiscal year 2009'' and inserting ``Beginning
with fiscal year 2019''; and
(ii) in subparagraph (A)--
(I) by striking ``for the immediately preceding fiscal
year'' and inserting ``for either of the 2 immediately
preceding fiscal years''; and
(II) by striking ``2008'' and inserting ``2018''; and
(B) in paragraph (6), by amending subparagraph (A) to read
as follows:
``(A) In general.--The amounts described in this paragraph
are the following amounts that are payable to an entity for
activities described in this section or section 319C-2:
``(i) For no more than one of each of the first 2 fiscal
years immediately following a fiscal year in which an entity
experienced a failure described in subparagraph (A) or (B) of
paragraph (5), an amount equal to 10 percent of the amount
the entity was eligible to receive for the respective fiscal
year.
``(ii) For no more than one of the first 2 fiscal years
immediately following the third consecutive fiscal year in
which an entity experienced such a failure, in lieu of
applying clause (i), an amount equal to 15 percent of the
amount the entity was eligible to receive for the respective
fiscal year.''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply with respect to cooperative agreements awarded on
or after the date of enactment of this Act.
(c) Partnership for State and Regional Hospital
Preparedness To Improve Surge Capacity.--Section 319C-2 (42
U.S.C. 247d-3b) is amended--
(1) in subsection (a)--
(A) by inserting ``, acting through the Assistant Secretary
for Preparedness and Response,'' after ``The Secretary''; and
(B) by striking ``preparedness for public health
emergencies'' and inserting ``preparedness for, and response
to, public health emergencies in accordance with subsection
(c)'';
(2) in subsection (b)(1)(A)--
(A) by striking ``partnership consisting of'' and inserting
``coalition that includes'';
(B) in clause (ii), by striking ``; and'' and inserting a
semicolon; and
(C) by adding at the end the following:
``(iv) one or more emergency medical service organizations
or emergency management organizations; and'';
(3) in subsection (d)--
(A) in paragraph (1)(B), by striking ``partnership'' each
place it appears and inserting ``coalition''; and
(B) in paragraph (2)(C), by striking ``medical
preparedness'' and inserting ``preparedness and response'';
(4) in subsection (f), by striking ``partnership'' and
inserting ``coalition'';
(5) in subsection (g)(2)--
(A) by striking ``Partnerships'' and inserting
``Coalitions'';
(B) by striking ``partnerships'' and inserting
``coalitions''; and
(C) by inserting ``and response'' after ``preparedness'';
and
(6) in subsection (i)(1)--
(A) by striking ``An entity'' and inserting ``A
coalition''; and
(B) by striking ``such partnership'' and inserting ``such
coalition''.
(d) Public Health Security Grants Authorization of
Appropriations.--Section 319C-1(h)(1)(A) (42 U.S.C. 247d-
3a(h)(1)(A)) is amended by striking ``$641,900,000 for fiscal
year 2014'' and all that follows through the period at the
end and inserting ``$685,000,000 for each of fiscal years
2019 through 2023 for awards pursuant to paragraph (3)
(subject to the authority of the Secretary to make awards
pursuant to paragraphs (4) and (5)).''.
(e) Partnership for State and Regional Hospital
Preparedness Authorization of Appropriations.--Section 319C-
2(j) (42 U.S.C. 247d-3b(j)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) In general.--
``(A) Authorization of appropriations.--For purposes of
carrying out this section and section 319C-3, in accordance
with subparagraph (B), there is authorized to be appropriated
$385,000,000 for each of fiscal years 2019 through 2023.
``(B) Reservation of amounts for regional systems.--
``(i) In general.--Subject to clause (ii), of the amount
appropriated under subparagraph (A) for a fiscal year, the
Secretary may reserve up to 5 percent for the purpose of
carrying out section 319C-3.
``(ii) Reservation contingent on continued appropriations
for this section.--If for fiscal year 2019 or a subsequent
fiscal year, the amount appropriated under subparagraph (A)
is such that, after application of clause (i), the amount
remaining for the purpose of carrying out this section would
be less than the amount available for such purpose for the
previous fiscal year, the amount that may be reserved under
clause (i) shall be reduced such that the amount remaining
for the purpose of carrying out this section is not less than
the amount available for such purpose for the previous fiscal
year.
``(iii) Sunset.--The authority to reserve amounts under
clause (i) shall expire on September 30, 2023.'';
(2) in paragraph (2), by striking ``paragraph (1) for a
fiscal year'' and inserting ``paragraph (1)(A) for a fiscal
year and not reserved for the purpose described in paragraph
(1)(B)(i)''; and
(3) in paragraph (3)(A), by striking ``paragraph (1) and
not reserved under paragraph (2)'' and inserting ``paragraph
(1)(A) and not reserved under paragraph (1)(B)(i) or (2)''.
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND
RESPONSE SYSTEMS.
(a) In General.--Part B of title III (42 U.S.C. 243 et
seq.) is amended by inserting after section 319C-2 the
following:
``SEC. 319C-3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY
PREPAREDNESS AND RESPONSE SYSTEMS.
``(a) Purpose.--It is the purpose of this section to
identify and provide guidelines for regional systems of
hospitals, health care facilities, and other public and
private sector entities, with varying levels of capability to
treat patients and increase medical surge capacity during, in
advance of, and immediately following a public health
emergency, including threats posed by one or more chemical,
biological, radiological, or nuclear agents, including
emerging infectious diseases.
``(b) Guidelines.--The Assistant Secretary for Preparedness
and Response, in consultation with the Director of the
Centers for Disease Control and Prevention, the Administrator
of the Centers for Medicare & Medicaid Services, the
Administrator of the Health Resources and Services
Administration, the Commissioner of Food and Drugs, the
Assistant Secretary for Mental Health and Substance Use, the
Assistant Secretary of Labor for Occupational Safety and
Health, the Secretary of Veterans Affairs, the heads of such
other Federal agencies as the Secretary determines to be
appropriate, and State, local, Tribal, and territorial public
health officials, shall, not later than 2 years after the
date of enactment of this section--
``(1) identify and develop a set of guidelines relating to
practices and protocols for all-hazards public health
emergency preparedness and response for hospitals and health
care facilities to provide appropriate patient care during,
in advance of, or immediately following, a public health
emergency, resulting from one or more chemical, biological,
radiological, or nuclear agents, including emerging
infectious diseases (which may include existing practices,
such as trauma care and medical surge capacity and
capabilities), with respect to--
``(A) a regional approach to identifying hospitals and
health care facilities based on varying capabilities and
capacity to treat patients affected by such emergency,
including--
``(i) the manner in which the system will coordinate with
and integrate the partnerships and health care coalitions
established under section 319C-2(b); and
``(ii) informing and educating appropriate first responders
and health care supply chain partners of the regional
emergency preparedness and response capabilities and medical
surge capacity of such hospitals and health care facilities
in the community;
``(B) physical and technological infrastructure, laboratory
capacity, staffing, blood supply, and other supply chain
needs, taking into account resiliency, geographic
considerations, and rural considerations;
``(C) protocols or best practices for the safety and
personal protection of workers who handle human remains and
health care workers (including with respect to protective
equipment and supplies, waste management processes, and
decontamination), sharing of specialized experience among the
health care workforce, behavioral health, psychological
resilience, and training of the workforce, as applicable;
``(D) in a manner that allows for disease containment
(within the meaning of section 2802(b)(2)(B)), coordinated
medical triage, treatment, and transportation of patients,
based on patient medical need (including patients in rural
areas), to the appropriate hospitals or health care
facilities within the regional system or, as applicable and
appropriate, between systems in different States or regions;
and
``(E) the needs of children and other at-risk individuals;
``(2) make such guidelines available on the internet
website of the Department of Health and Human Services in a
manner that does not compromise national security; and
``(3) update such guidelines as appropriate, including
based on input received pursuant to subsections (c) and (e)
and information resulting from applicable reports required
under the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019 (including any amendments made by such
Act), to address new and emerging public health threats.
``(c) Considerations.--In identifying, developing, and
updating guidelines under subsection (b), the Assistant
Secretary for Preparedness and Response shall--
``(1) include input from hospitals and health care
facilities (including health care coalitions under section
319C-2), State, local, Tribal, and territorial public health
departments, and health care or subject matter experts
(including experts with relevant expertise in chemical,
biological, radiological, or nuclear threats, including
emerging infectious diseases), as the Assistant Secretary
determines appropriate, to meet the goals under section
2802(b)(3);
[[Page H4248]]
``(2) consult and engage with appropriate health care
providers and professionals, including physicians, nurses,
first responders, health care facilities (including
hospitals, primary care clinics, community health centers,
mental health facilities, ambulatory care facilities, and
dental health facilities), pharmacies, emergency medical
providers, trauma care providers, environmental health
agencies, public health laboratories, poison control centers,
blood banks, tissue banks, and other experts that the
Assistant Secretary determines appropriate, to meet the goals
under section 2802(b)(3);
``(3) consider feedback related to financial implications
for hospitals, health care facilities, public health
agencies, laboratories, blood banks, tissue banks, and other
entities engaged in regional preparedness planning to
implement and follow such guidelines, as applicable; and
``(4) consider financial requirements and potential
incentives for entities to prepare for, and respond to,
public health emergencies as part of the regional health care
emergency preparedness and response system.
``(d) Technical Assistance.--The Assistant Secretary for
Preparedness and Response, in consultation with the Director
of the Centers for Disease Control and Prevention and the
Assistant Secretary of Labor for Occupational Safety and
Health, may provide technical assistance and consultation
toward meeting the guidelines described in subsection (b).
``(e) Demonstration Project for Regional Health Care
Preparedness and Response Systems.--
``(1) In general.--The Assistant Secretary for Preparedness
and Response may establish a demonstration project pursuant
to the development and implementation of guidelines under
subsection (b) to award grants to improve medical surge
capacity for all hazards, build and integrate regional
medical response capabilities, improve specialty care
expertise for all-hazards response, and coordinate medical
preparedness and response across State, local, Tribal,
territorial, and regional jurisdictions.
``(2) Sunset.--The authority under this subsection shall
expire on September 30, 2023.''.
(b) GAO Report to Congress.--
(1) Report.--Not later than 3 years after the date of
enactment of this Act, the Comptroller General of the United
States (referred to in this subsection as the ``Comptroller
General'') shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on Finance
of the Senate and the Committee on Energy and Commerce and
the Committee on Ways and Means of the House of
Representatives, a report on the extent to which hospitals
and health care facilities have implemented the recommended
guidelines under section 319C-3(b) of the Public Health
Service Act (as added by subsection (a)), including an
analysis and evaluation of any challenges hospitals or health
care facilities experienced in implementing such guidelines.
(2) Content.--The Comptroller General shall include in the
report under paragraph (1)--
(A) data on the preparedness and response capabilities that
have been informed by the guidelines under section 319C-3(b)
of the Public Health Service Act to improve regional
emergency health care preparedness and response capability,
including hospital and health care facility capacity and
medical surge capabilities to prepare for, and respond to,
public health emergencies; and
(B) recommendations to reduce gaps in incentives for
regional health partners, including hospitals and health care
facilities, to improve capacity and medical surge
capabilities to prepare for, and respond to, public health
emergencies, consistent with subsection (a), which may
include consideration of facilities participating in programs
under section 319C-2 of the Public Health Service Act (42
U.S.C. 247d-3b) or in programs under the Centers for Medicare
& Medicaid Services (including innovative health care
delivery and payment models), and input from private sector
financial institutions.
(3) Consultation.--In carrying out paragraphs (1) and (2),
the Comptroller General shall consult with the heads of
appropriate Federal agencies, including--
(A) the Assistant Secretary for Preparedness and Response;
(B) the Director of the Centers for Disease Control and
Prevention;
(C) the Administrator of the Centers for Medicare &
Medicaid Services;
(D) the Assistant Secretary for Mental Health and Substance
Use;
(E) the Assistant Secretary of Labor for Occupational
Safety and Health; and
(F) the Secretary of Veterans Affairs.
(c) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-
3b(i)(1)) is amended by inserting after the first sentence
the following: ``In submitting reports under this paragraph,
a coalition shall include information on the progress that
the coalition has made toward the implementation of section
319C-3 (or barriers to progress, if any).''.
(d) National Health Security Strategy Incorporation of
Regionalized Emergency Preparedness and Response.--
Subparagraph (G) of section 2802(b)(3) (42 U.S.C. 300hh-
1(b)(3)) is amended to read as follows:
``(G) Optimizing a coordinated and flexible approach to the
emergency response and medical surge capacity of hospitals,
other health care facilities, critical care, trauma care
(which may include trauma centers), and emergency medical
systems.''.
(e) Improving State and Local Public Health Security.--
(1) State and local security.--Section 319C-1(e) (42 U.S.C.
247d-3a(e)) is amended by striking ``, and local emergency
plans.'' and inserting ``, local emergency plans, and any
regional health care emergency preparedness and response
system established pursuant to the applicable guidelines
under section 319C-3.''.
(2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
3b(d)(1)(A)) is amended--
(A) in clause (i), by striking ``; and'' and inserting
``;'';
(B) by redesignating clause (ii) as clause (iii); and
(C) by inserting after clause (i) the following:
``(ii) among one or more facilities in a regional health
care emergency system under section 319C-3; and''.
SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA
READINESS.
Title XII (42 U.S.C. 300d et seq.) is amended by adding at
the end the following new part:
``PART I--MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT
PROGRAM
``SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA
READINESS GRANT PROGRAM.
``(a) Military Trauma Team Placement Program.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response and in
consultation with the Secretary of Defense, shall award
grants to not more than 20 eligible high-acuity trauma
centers to enable military trauma teams to provide, on a
full-time basis, trauma care and related acute care at such
trauma centers.
``(2) Limitations.--In the case of a grant awarded under
paragraph (1) to an eligible high-acuity trauma center, such
grant--
``(A) shall be for a period of at least 3 years and not
more than 5 years (and may be renewed at the end of such
period); and
``(B) shall be in an amount that does not exceed $1,000,000
per year.
``(3) Availability of funds.--Notwithstanding section 1552
of title 31, United States Code, or any other provision of
law, funds available to the Secretary for obligation for a
grant under this subsection shall remain available for
expenditure for 100 days after the last day of the
performance period of such grant.
``(b) Military Trauma Care Provider Placement Program.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response and in
consultation with the Secretary of Defense, shall award
grants to eligible trauma centers to enable military trauma
care providers to provide trauma care and related acute care
at such trauma centers.
``(2) Limitations.--In the case of a grant awarded under
paragraph (1) to an eligible trauma center, such grant--
``(A) shall be for a period of at least 1 year and not more
than 3 years (and may be renewed at the end of such period);
and
``(B) shall be in an amount that does not exceed, in a
year--
``(i) $100,000 for each military trauma care provider that
is a physician at such eligible trauma center; and
``(ii) $50,000 for each other military trauma care provider
at such eligible trauma center.
``(c) Grant Requirements.--
``(1) Deployment and public health emergencies.--As a
condition of receipt of a grant under this section, a grant
recipient shall agree to allow military trauma care providers
providing care pursuant to such grant to--
``(A) be deployed by the Secretary of Defense for military
operations, for training, or for response to a mass casualty
incident; and
``(B) be deployed by the Secretary of Defense, in
consultation with the Secretary of Health and Human Services,
for response to a public health emergency pursuant to section
319.
``(2) Use of funds.--Grants awarded under this section to
an eligible trauma center may be used to train and
incorporate military trauma care providers into such trauma
center, including incorporation into operational exercises
and training drills related to public health emergencies,
expenditures for malpractice insurance, office space,
information technology, specialty education and supervision,
trauma programs, research, and applicable license fees for
such military trauma care providers.
``(d) Rule of Construction.--Nothing in this section shall
be construed to affect any other provision of law that
preempts State licensing requirements for health care
professionals, including with respect to military trauma care
providers.
``(e) Reporting Requirements.--
``(1) Report to the secretary and the secretary of
defense.--Each eligible trauma center or eligible high-acuity
trauma center awarded a grant under subsection (a) or (b) for
a year shall submit to the Secretary and the Secretary of
Defense a report for such year that includes information on--
``(A) the number and types of trauma cases managed by
military trauma teams or military trauma care providers
pursuant to such grant during such year;
``(B) the ability to maintain the integration of the
military trauma providers or
[[Page H4249]]
teams of providers as part of the trauma center, including
the financial effect of such grant on the trauma center;
``(C) the educational effect on resident trainees in
centers where military trauma teams are assigned;
``(D) any research conducted during such year supported by
such grant; and
``(E) any other information required by the Secretaries for
the purpose of evaluating the effect of such grant.
``(2) Report to congress.--Not less than once every 2
years, the Secretary, in consultation with the Secretary of
Defense, shall submit a report to the congressional
committees of jurisdiction that includes information on the
effect of placing military trauma care providers in trauma
centers awarded grants under this section on--
``(A) maintaining military trauma care providers' readiness
and ability to respond to and treat battlefield injuries;
``(B) providing health care to civilian trauma patients in
urban and rural settings;
``(C) the capability of trauma centers and military trauma
care providers to increase medical surge capacity, including
as a result of a large-scale event;
``(D) the ability of grant recipients to maintain the
integration of the military trauma providers or teams of
providers as part of the trauma center;
``(E) efforts to incorporate military trauma care providers
into operational exercises and training and drills for public
health emergencies; and
``(F) the capability of military trauma care providers to
participate as part of a medical response during or in
advance of a public health emergency, as determined by the
Secretary, or a mass casualty incident.
``(f) Definitions.--For purposes of this part:
``(1) Eligible high-acuity trauma center.--The term
`eligible high-acuity trauma center' means a Level I trauma
center that satisfies each of the following:
``(A) Such trauma center has an agreement with the
Secretary of Defense to enable military trauma teams to
provide trauma care and related acute care at such trauma
center.
``(B) At least 20 percent of patients treated at such
trauma center in the most recent 3-month period for which
data are available are treated for a major trauma at such
trauma center.
``(C) Such trauma center utilizes a risk-adjusted
benchmarking system and metrics to measure performance,
quality, and patient outcomes.
``(D) Such trauma center is an academic training center--
``(i) affiliated with a medical school;
``(ii) that maintains residency programs and fellowships in
critical trauma specialties and subspecialties, and provides
education and supervision of military trauma team members
according to those specialties and subspecialties; and
``(iii) that undertakes research in the prevention and
treatment of traumatic injury.
``(E) Such trauma center serves as a medical and public
health preparedness and response leader for its community,
such as by participating in a partnership for State and
regional hospital preparedness established under section
319C-2 or 319C-3.
``(2) Eligible trauma center.--The term `eligible trauma
center' means a Level I, II, or III trauma center that
satisfies each of the following:
``(A) Such trauma center has an agreement with the
Secretary of Defense to enable military trauma care providers
to provide trauma care and related acute care at such trauma
center.
``(B) Such trauma center utilizes a risk-adjusted
benchmarking system and metrics to measure performance,
quality, and patient outcomes.
``(C) Such trauma center demonstrates a need for integrated
military trauma care providers to maintain or improve the
trauma clinical capability of such trauma center.
``(3) Major trauma.--The term `major trauma' means an
injury that is greater than or equal to 15 on the injury
severity score.
``(4) Military trauma team.--The term `military trauma
team' means a complete military trauma team consisting of
military trauma care providers.
``(5) Military trauma care provider.--The term `military
trauma care provider' means a member of the Armed Forces who
furnishes emergency, critical care, and other trauma acute
care services (including a physician, surgeon, physician
assistant, nurse, nurse practitioner, respiratory therapist,
flight paramedic, combat medic, or enlisted medical
technician) or other military trauma care provider as the
Secretary determines appropriate.
``(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $11,500,000
for each of fiscal years 2019 through 2023.''.
SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL
AWARENESS AND BIOSURVEILLANCE CAPABILITIES.
(a) Facilities, Capacities, and Biosurveillance
Capabilities.--Section 319D (42 U.S.C. 247d-4) is amended--
(1) in the section heading, by striking ``revitalizing''
and inserting ``facilities and capacities of'';
(2) in subsection (a)--
(A) in the subsection heading, by striking ``Facilities;
Capacities'' and inserting ``In General'';
(B) in paragraph (1), by striking ``and improved'' and
inserting ``, improved, and appropriately maintained'';
(C) in paragraph (3), in the matter preceding subparagraph
(A), by striking ``expand, enhance, and improve'' and
inserting ``expand, improve, enhance, and appropriately
maintain''; and
(D) by adding at the end the following:
``(4) Study of resources for facilities and capacities.--
Not later than June 1, 2022, the Comptroller General of the
United States shall conduct a study on Federal spending in
fiscal years 2013 through 2018 for activities authorized
under this subsection. Such study shall include a review and
assessment of obligations and expenditures directly related
to each activity under paragraphs (2) and (3), including a
specific accounting of, and delineation between, obligations
and expenditures incurred for the construction, renovation,
equipping, and security upgrades of facilities and associated
contracts under this subsection, and the obligations and
expenditures incurred to establish and improve the
situational awareness and biosurveillance network under
subsection (b), and shall identify the agency or agencies
incurring such obligations and expenditures.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking ``National'' and
inserting ``Establishment of Systems of Public Health'';
(B) in paragraph (1)(B), by inserting ``immunization
information systems,'' after ``centers,'';
(C) in paragraph (2)--
(i) by inserting ``develop a plan to, and'' after ``The
Secretary shall''; and
(ii) by inserting ``and in a form readily usable for
analytical approaches'' after ``in a secure manner''; and
(D) by amending paragraph (3) to read as follows:
``(3) Standards.--
``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019, the Secretary, in
cooperation with health care providers, State, local, Tribal,
and territorial public health officials, and relevant Federal
agencies (including the Office of the National Coordinator
for Health Information Technology and the National Institute
of Standards and Technology), shall, as necessary, adopt
technical and reporting standards, including standards for
interoperability as defined by section 3000, for networks
under paragraph (1) and update such standards as necessary.
Such standards shall be made available on the internet
website of the Department of Health and Human Services, in a
manner that does not compromise national security.
``(B) Deference to standards development organizations.--In
adopting and implementing standards under this subsection and
subsection (c), the Secretary shall give deference to
standards published by standards development organizations
and voluntary consensus-based standards entities.'';
(4) in subsection (c)--
(A) in paragraph (1)--
(i) by striking ``Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, the Secretary'' and inserting
``The Secretary'';
(ii) by inserting ``, and improve as applicable and
appropriate,'' after ``shall establish'';
(iii) by striking ``of rapid'' and inserting ``of, rapid'';
and
(iv) by striking ``such connectivity'' and inserting ``such
interoperability'';
(B) by amending paragraph (2) to read as follows:
``(2) Coordination and consultation.--In establishing and
improving the network under paragraph (1), the Secretary
shall--
``(A) facilitate coordination among agencies within the
Department of Health and Human Services that provide, or have
the potential to provide, information and data to, and
analyses for, the situational awareness and biosurveillance
network under paragraph (1), including coordination among
relevant agencies related to health care services, the
facilitation of health information exchange (including the
Office of the National Coordinator for Health Information
Technology), and public health emergency preparedness and
response; and
``(B) consult with the Secretary of Agriculture, the
Secretary of Commerce (and the Director of the National
Institute of Standards and Technology), the Secretary of
Defense, the Secretary of Homeland Security, the Secretary of
Veterans Affairs, and the heads of other Federal agencies, as
the Secretary determines appropriate.'';
(C) in paragraph (3)--
(i) by redesignating subparagraphs (A) through (E) as
clauses (i) through (v), respectively, and adjusting the
margins accordingly;
(ii) in clause (iv), as so redesignated--
(I) by inserting ``immunization information systems,''
after ``poison control,''; and
(II) by striking ``and clinical laboratories'' and
inserting ``, clinical laboratories, and public environmental
health agencies'';
(iii) by striking ``The network'' and inserting the
following:
``(A) In general.--The network''; and
(iv) by adding at the end the following:
``(B) Review.--Not later than 2 years after the date of the
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 and every 6 years
[[Page H4250]]
thereafter, the Secretary shall conduct a review of the
elements described in subparagraph (A). Such review shall
include a discussion of the addition of any elements pursuant
to clause (v), including elements added to advancing new
technologies, and identify any challenges in the
incorporation of elements under subparagraph (A). The
Secretary shall provide such review to the congressional
committees of jurisdiction.'';
(D) in paragraph (5)--
(i) by redesignating subparagraphs (A) through (D) as
clauses (i) through (iv), respectively, and adjusting the
margins accordingly;
(ii) by striking ``In establishing'' and inserting the
following:
``(A) In general.--In establishing'';
(iii) by adding at the end the following:
``(B) Public meeting.--
``(i) In general.--Not later than 180 days after the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary shall convene
a public meeting for purposes of discussing and providing
input on the potential goals, functions, and uses of the
network described in paragraph (1) and incorporating the
elements described in paragraph (3)(A).
``(ii) Experts.--The public meeting shall include
representatives of relevant Federal agencies (including
representatives from the Office of the National Coordinator
for Health Information Technology and the National Institute
of Standards and Technology); State, local, Tribal, and
territorial public health officials; stakeholders with
expertise in biosurveillance and situational awareness;
stakeholders with expertise in capabilities relevant to
biosurveillance and situational awareness, such as experts in
informatics and data analytics (including experts in
prediction, modeling, or forecasting); and other
representatives as the Secretary determines appropriate.
``(iii) Topics.--Such public meeting shall include a
discussion of--
``(I) data elements, including minimal or essential data
elements, that are voluntarily provided for such network,
which may include elements from public health and public and
private health care entities, to the extent practicable;
``(II) standards and implementation specifications that may
improve the collection, analysis, and interpretation of data
during a public health emergency;
``(III) strategies to encourage the access, exchange, and
use of information;
``(IV) considerations for State, local, Tribal, and
territorial capabilities and infrastructure related to data
exchange and interoperability;
``(V) privacy and security protections provided at the
Federal, State, local, Tribal, and territorial levels, and by
nongovernmental stakeholders; and
``(VI) opportunities for the incorporation of innovative
technologies to improve the network.''; and
(iv) in subparagraph (A), as so designated by clause (ii)--
(I) in clause (i), as so redesignated--
(aa) by striking ``as determined'' and inserting ``as
adopted''; and
(bb) by inserting ``and the National Institute of Standards
and Technology'' after ``Office of the National Coordinator
for Health Information Technology'';
(II) in clause (iii), as so redesignated, by striking ``;
and'' and inserting a semicolon;
(III) in clause (iv), as so redesignated, by striking the
period and inserting ``; and''; and
(IV) by adding at the end the following:
``(v) pilot test standards and implementation
specifications, consistent with the process described in
section 3002(b)(3)(C), which State, local, Tribal, and
territorial public health entities may utilize, on a
voluntary basis, as a part of the network.'';
(E) by redesignating paragraph (6) as paragraph (7);
(F) by inserting after paragraph (5) the following:
``(6) Strategy and implementation plan.--
``(A) In general.--Not later than 18 months after the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary shall submit
to the congressional committees of jurisdiction a coordinated
strategy and an accompanying implementation plan that--
``(i) is informed by the public meeting under paragraph
(5)(B);
``(ii) includes a review and assessment of existing
capabilities of the network and related infrastructure,
including input provided by the public meeting under
paragraph (5)(B);
``(iii) identifies and demonstrates the measurable steps
the Secretary will carry out to--
``(I) develop, implement, and evaluate the network
described in paragraph (1), utilizing elements described in
paragraph (3)(A);
``(II) modernize and enhance biosurveillance activities,
including strategies to include innovative technologies and
analytical approaches (including prediction and forecasting
for pandemics and all-hazards) from public and private
entities;
``(III) improve information sharing, coordination, and
communication among disparate biosurveillance systems
supported by the Department of Health and Human Services,
including the identification of methods to improve
accountability, better utilize resources and workforce
capabilities, and incorporate innovative technologies within
and across agencies; and
``(IV) test and evaluate capabilities of the interoperable
network of systems to improve situational awareness and
biosurveillance capabilities;
``(iv) includes performance measures and the metrics by
which performance measures will be assessed with respect to
the measurable steps under clause (iii); and
``(v) establishes dates by which each measurable step under
clause (iii) will be implemented.
``(B) Annual budget plan.--Not later than 2 years after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019 and on an
annual basis thereafter, in accordance with the strategy and
implementation plan under this paragraph, the Secretary
shall, taking into account recommendations provided by the
National Biodefense Science Board, develop a budget plan
based on the strategy and implementation plan under this
section. Such budget plan shall include--
``(i) a summary of resources previously expended to
establish, improve, and utilize the nationwide public health
situational awareness and biosurveillance network under
paragraph (1);
``(ii) estimates of costs and resources needed to establish
and improve the network under paragraph (1) according to the
strategy and implementation plan under subparagraph (A);
``(iii) the identification of gaps and inefficiencies in
nationwide public health situational awareness and
biosurveillance capabilities, resources, and authorities
needed to address such gaps; and
``(iv) a strategy to minimize and address such gaps and
improve inefficiencies.'';
(G) in paragraph (7), as so redesignated--
(i) in subparagraph (A), by inserting ``(taking into
account zoonotic disease, including gaps in scientific
understanding of the interactions between human, animal, and
environmental health)'' after ``human health'';
(ii) in subparagraph (B)--
(I) by inserting ``and gaps in surveillance programs''
after ``surveillance programs''; and
(II) by striking ``; and'' and inserting a semicolon;
(iii) in subparagraph (C)--
(I) by inserting ``, animal health organizations related to
zoonotic disease,'' after ``health care entities''; and
(II) by striking the period and inserting ``; and''; and
(iv) by adding at the end the following:
``(D) provide recommendations to the Secretary on policies
and procedures to complete the steps described in this
paragraph in a manner that is consistent with section
2802.''; and
(H) by adding at the end the following:
``(8) Situational awareness and biosurveillance as a
national security priority.--The Secretary, on a periodic
basis as applicable and appropriate, shall meet with the
Director of National Intelligence to inform the development
and capabilities of the nationwide public health situational
awareness and biosurveillance network.'';
(5) in subsection (d)--
(A) in paragraph (1)--
(i) by inserting ``environmental health agencies,'' after
``public health agencies,''; and
(ii) by inserting ``immunization programs,'' after ``poison
control centers,'';
(B) in paragraph (2)--
(i) in subparagraph (B), by striking ``and'' at the end;
(ii) in subparagraph (C), by striking the period and
inserting ``; and''; and
(iii) by adding after subparagraph (C) the following:
``(D) an implementation plan that may include measurable
steps to achieve the purposes described in paragraph (1).'';
and
(C) by striking paragraph (5) and inserting the following:
``(5) Technical assistance.--The Secretary may provide
technical assistance to States, localities, Tribes, and
territories or a consortium of States, localities, Tribes,
and territories receiving an award under this subsection
regarding interoperability and the technical standards set
forth by the Secretary.'';
(6) by redesignating subsections (f) and (g) as subsections
(i) and (j), respectively; and
(7) by inserting after subsection (e) the following:
``(f) Personnel Authorities.--
``(1) Specially qualified personnel.--In addition to any
other personnel authorities, to carry out subsections (b) and
(c), the Secretary may--
``(A) appoint highly qualified individuals to scientific or
professional positions at the Centers for Disease Control and
Prevention, not to exceed 30 such employees at any time
(specific to positions authorized by this subsection), with
expertise in capabilities relevant to biosurveillance and
situational awareness, such as experts in informatics and
data analytics (including experts in prediction, modeling, or
forecasting), and other related scientific or technical
fields; and
``(B) compensate individuals appointed under subparagraph
(A) in the same manner and subject to the same terms and
conditions in which individuals appointed under 9903 of title
5, United States Code, are compensated, without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of
such title relating to classification and General Schedule
pay rates.
``(2) Limitations.--The Secretary shall exercise the
authority under paragraph (1) in a
[[Page H4251]]
manner that is consistent with the limitations described in
section 319F-1(e)(2).
``(g) Timeline.--The Secretary shall accomplish the
purposes under subsections (b) and (c) no later than
September 30, 2023, and shall provide a justification to the
congressional committees of jurisdiction for any missed or
delayed implementation of measurable steps identified under
subsection (c)(6)(A)(iii).
``(h) Independent Evaluation.--Not later than 3 years after
the date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019, the
Comptroller General of the United States shall conduct an
independent evaluation and submit to the Secretary and the
congressional committees of jurisdiction a report concerning
the activities conducted under subsections (b) and (c), and
provide recommendations, as applicable and appropriate, on
necessary improvements to the biosurveillance and situational
awareness network.''.
(b) Authorization of Appropriations.--Subsection (i) of
section 319D (42 U.S.C. 247d-4), as redesignated by
subsection (a)(6), is amended by striking ``$138,300,000 for
each of fiscal years 2014 through 2018'' and inserting
``$161,800,000 for each of fiscal years 2019 through 2023''.
(c) Biological Threat Detection Report.--The Secretary of
Health and Human Services shall, in coordination with the
Secretary of Defense and the Secretary of Homeland Security,
not later than 180 days after the date of enactment of this
Act, report to the Committee on Energy and Commerce, the
Committee on Armed Services, and the Committee on Homeland
Security of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions, the Committee on
Armed Services, and the Committee on Homeland Security and
Governmental Affairs of the Senate on the state of Federal
biological threat detection efforts, including the following:
(1) An identification of technological, operational, and
programmatic successes and failures of domestic detection
programs supported by Federal departments and agencies for
intentionally introduced or accidentally released biological
threat agents and naturally occurring infectious diseases.
(2) A description of Federal efforts to facilitate the
exchange of information related to the information described
in paragraph (1) among Federal departments and agencies that
utilize biological threat detection technology.
(3) A description of the capabilities of detection systems
in use by Federal departments and agencies including the
capability to--
(A) rapidly detect, identify, characterize, and confirm the
presence of biological threat agents;
(B) recover live biological agents from collection devices;
(C) determine the geographical distribution of biological
agents;
(D) determine the extent of environmental contamination and
persistence of biological agents; and
(E) provide advanced molecular diagnostics to State, local,
Tribal, and territorial public health and other laboratories
that support biological threat detection activities.
(4) A description of Federal interagency coordination
related to biological threat detection.
(5) A description of efforts by Federal departments and
agencies that utilize biological threat detection technology
to collaborate with State, local, Tribal, and territorial
public health laboratories and other users of biological
threat detection systems, including collaboration regarding
the development of--
(A) biological threat detection requirements or standards;
(B) a standardized integration strategy;
(C) training requirements or guidelines;
(D) guidelines for a coordinated public health response,
including preparedness capabilities, and, as applicable, for
coordination with public health surveillance systems; and
(E) a coordinated environmental remediation plan, as
applicable.
(6) Recommendations related to research, advanced research,
development, and procurement for Federal departments and
agencies to improve and enhance biological threat detection
systems, including recommendations on the transfer of
biological threat detection technology among Federal
departments and agencies, as necessary and appropriate.
SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH
EMERGENCY RAPID RESPONSE FUND.
Section 319 (42 U.S.C. 247d) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the first sentence, by inserting ``or if the
Secretary determines there is the significant potential for a
public health emergency, to allow the Secretary to rapidly
respond to the immediate needs resulting from such public
health emergency or potential public health emergency''
before the period; and
(ii) by inserting ``The Secretary shall plan for the
expedited distribution of funds to appropriate agencies and
entities.'' after the first sentence;
(B) by redesignating paragraph (2) as paragraph (3);
(C) by inserting after paragraph (1) the following:
``(2) Uses.--The Secretary may use amounts in the Fund
established under paragraph (1), to--
``(A) facilitate coordination between and among Federal,
State, local, Tribal, and territorial entities and public and
private health care entities that the Secretary determines
may be affected by a public health emergency or potential
public health emergency referred to in paragraph (1)
(including communication of such entities with relevant
international entities, as applicable);
``(B) make grants, provide for awards, enter into
contracts, and conduct supportive investigations pertaining
to a public health emergency or potential public health
emergency, including further supporting programs under
section 319C-1, 319C-2, or 319C-3;
``(C) facilitate and accelerate, as applicable, advanced
research and development of security countermeasures (as
defined in section 319F-2), qualified countermeasures (as
defined in section 319F-1), or qualified pandemic or epidemic
products (as defined in section 319F-3), that are applicable
to the public health emergency or potential public health
emergency under paragraph (1);
``(D) strengthen biosurveillance capabilities and
laboratory capacity to identify, collect, and analyze
information regarding such public health emergency or
potential public health emergency, including the systems
under section 319D;
``(E) support initial emergency operations and assets
related to preparation and deployment of intermittent
disaster response personnel under section 2812 and the
Medical Reserve Corps under section 2813; and
``(F) carry out other activities, as the Secretary
determines applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so redesignated,
the following:
``(4) Review.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in
coordination with the Assistant Secretary for Preparedness
and Response, shall conduct a review of the Fund under this
section and provide recommendations to the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives on policies to improve such Fund for the uses
described in paragraph (2).
``(5) GAO report.--Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Comptroller General of
the United States shall--
``(A) conduct a review of the Fund under this section,
including its uses and the resources available in the Fund;
and
``(B) submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report on such
review, including recommendations related to such review, as
applicable.''; and
(2) in subsection (c)--
(A) by inserting ``rapidly respond to public health
emergencies or potential public health emergencies and''
after ``used to''; and
(B) by striking ``section.'' and inserting ``Act or funds
otherwise provided for emergency response.''.
SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE BY
PUBLIC HEALTH EMERGENCY VOLUNTEERS.
(a) In General.--Section 319I (42 U.S.C. 247d-7b) is
amended--
(1) in the section heading, by striking ``health
professions volunteers'' and inserting ``volunteer health
professional'';
(2) in subsection (a), by adding at the end the following:
``Such health care professionals may include members of the
National Disaster Medical System, members of the Medical
Reserve Corps, and individual health care professionals.'';
(3) in subsection (i), by adding at the end the following:
``In order to inform the development of such mechanisms by
States, the Secretary shall make available information and
material provided by States that have developed mechanisms to
waive the application of licensing requirements to applicable
health professionals seeking to provide medical services
during a public health emergency. Such information shall be
made publicly available in a manner that does not compromise
national security.''; and
(4) in subsection (k), by striking ``2014 through 2018''
and inserting ``2019 through 2023''.
(b) All-Hazards Public Health Emergency Preparedness and
Response Plan.--Section 319C-1(b)(2)(A)(iv) (42 U.S.C. 247d-
3a(b)(2)(A)(iv)) is amended to read as follows:
``(iv) a description of the mechanism the entity will
implement to utilize the Emergency Management Assistance
Compact, or other mutual aid agreement, for medical and
public health mutual aid, and, as appropriate, the activities
such entity will implement pursuant to section 319I to
improve enrollment and coordination of volunteer health care
professionals seeking to provide medical services during a
public health emergency, which may include--
``(I) providing a public method of communication for
purposes of volunteer coordination (such as a phone number);
``(II) providing for optional registration to participate
in volunteer services during processes related to State
medical licensing, registration, or certification or renewal
of such licensing, registration, or certification; or
[[Page H4252]]
``(III) other mechanisms as the State determines
appropriate;''.
SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUNTEER HEALTH
CARE PROFESSIONALS.
(a) In General.--Title II (42 U.S.C. 202 et seq.) is
amended by inserting after section 224 the following:
``SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DURING A
PUBLIC HEALTH EMERGENCY.
``(a) Limitation on Liability.--Notwithstanding any other
provision of law, a health care professional who is a member
of the Medical Reserve Corps under section 2813 or who is
included in the Emergency System for Advance Registration of
Volunteer Health Professionals under section 319I and who--
``(1) is responding--
``(A) to a public health emergency determined under section
319(a), during the initial period of not more than 90 days
(as determined by the Secretary) of the public health
emergency determination (excluding any period covered by a
renewal of such determination); or
``(B) to a major disaster or an emergency as declared by
the President under section 401 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170)
or under section 201 of the National Emergencies Act (50
U.S.C. 1621) during the initial period of such declaration;
``(2) is alleged to be liable for an act or omission--
``(A) during the initial period of a determination or
declaration described in paragraph (1) and related to the
treatment of individuals in need of health care services due
to such public health emergency, major disaster, or
emergency;
``(B) in the State or States for which such determination
or declaration is made;
``(C) in the health care professional's capacity as a
member of the Medical Reserve Corps or a professional
included in the Emergency System for Advance Registration of
Volunteer Health Professionals under section 319I; and
``(D) in the course of providing services that are within
the scope of the license, registration, or certification of
the professional, as defined by the State of licensure,
registration, or certification; and
``(3) prior to the rendering of such act or omission, was
authorized by the State's authorization of deploying such
State's Emergency System for Advance Registration of
Volunteer Health Professionals described in section 319I or
the Medical Reserve Corps established under section 2813, to
provide health care services,
shall be subject only to the State liability laws of the
State in which such act or omission occurred, in the same
manner and to the same extent as a similar health care
professional who is a resident of such State would be subject
to such State laws, except with respect to the licensure,
registration, and certification of such individual.
``(b) Volunteer Protection Act.--Nothing in this section
shall be construed to affect an individual's right to
protections under the Volunteer Protection Act of 1997.
``(c) Preemption.--This section shall supersede the laws of
any State that would subject a health care professional
described in subsection (a) to the liability laws of any
State other than the State liability laws to which such
individual is subject pursuant to such subsection.
``(d) Definitions.--In this section:
``(1) The term `health care professional' means an
individual licensed, registered, or certified under Federal
or State laws or regulations to provide health care services.
``(2) The term `health care services' means any services
provided by a health care professional, or by any individual
working under the supervision of a health care professional,
that relate to--
``(A) the diagnosis, prevention, or treatment of any human
disease or impairment; or
``(B) the assessment or care of the health of human beings.
``(e) Effective Date.--
``(1) In general.--This section shall take effect 90 days
after the date of the enactment of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019.
``(2) Application.--This section shall apply to a claim for
harm only if the act or omission that caused such harm
occurred on or after the effective date described in
paragraph (1).''.
(b) GAO Study.--Not later than one year after the date of
enactment of this Act, the Comptroller General of the United
States shall conduct a review of--
(1) the number of health care providers who register under
the Emergency System for Advance Registration of Volunteer
Health Professionals under section 319I of the Public Health
Service Act (42 U.S.C. 247d-7b) in advance to provide
services during a public health emergency;
(2) the number of health care providers who are
credentialed to provide services during the period of a
public health emergency declaration, including those who are
credentialed though programs established in the Emergency
System for Advance Registration of Volunteer Health
Professionals under such section 319I and those credentialed
by authorities within the State in which the emergency
occurred;
(3) the average time to verify the credentials of a health
care provider during the period of a public health emergency
declaration, including the average time pursuant to the
Emergency System for Advance Registration of Volunteer Health
Professionals under such section 319I and for an individual's
credentials to be verified by an authority within the State;
and
(4) the Emergency System for Advance Registration of
Volunteer Health Professionals program in States, including
whether physician or medical groups, associations, or other
relevant provider organizations utilize such program for
purposes of volunteering during public health emergencies.
SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY.
Not later than 1 year after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
submit to Congress a report containing recommendations
related to maintaining an adequate national blood supply,
including--
(1) challenges associated with the continuous recruitment
of blood donors (including those newly eligible to donate);
(2) ensuring the adequacy of the blood supply in the case
of public health emergencies;
(3) implementation of the transfusion transmission
monitoring system; and
(4) other measures to promote safety and innovation, such
as the development, use, or implementation of new
technologies, processes, and procedures to improve the safety
and reliability of the blood supply.
SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND
RESPONSE CAPABILITIES AND CAPACITIES OF
HOSPITALS, LONG-TERM CARE FACILITIES, AND OTHER
HEALTH CARE FACILITIES.
(a) Study.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall enter into an agreement with an appropriate
entity to conduct a study regarding the public health
preparedness and response capabilities and medical surge
capacities of hospitals, long-term care facilities, and other
health care facilities to prepare for, and respond to, public
health emergencies, including natural disasters.
(2) Consultation.--In conducting the study under paragraph
(1), the entity shall consult with Federal, State, local,
Tribal, and territorial public health officials (as
appropriate), and health care providers and facilities with
experience in public health preparedness and response
activities.
(3) Evaluation.--The study under paragraph (1) shall
include--
(A) an evaluation of the current benchmarks and objective
standards, as applicable, related to programs that support
hospitals, long-term care facilities, and other health care
facilities, and their effect on improving public health
preparedness and response capabilities and medical surge
capacities, including the Hospital Preparedness Program, the
Public Health Emergency Preparedness cooperative agreements,
and the Regional Health Care Emergency Preparedness and
Response Systems under section 319C-3 of the Public Health
Service Act (as added by section 203);
(B) the identification of gaps in preparedness, including
with respect to such benchmarks and objective standards, such
as those identified during recent public health emergencies,
for hospitals, long-term care facilities, and other health
care facilities to address future potential public health
threats;
(C) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and entities with expertise in emergency
power systems and other critical infrastructure partners
during a public health emergency, to ensure a functioning
critical infrastructure, to the greatest extent practicable,
during a public health emergency;
(D) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and environmental health agencies with
expertise in emergency preparedness and response planning for
hospitals, long-term care facilities, and other health care
facilities; and
(E) an evaluation of current public health preparedness and
response capabilities and medical surge capacities related to
at-risk individuals during public health emergencies,
including an identification of gaps in such preparedness as
they relate to such individuals.
(b) Report.--
(1) In general.--The agreement under subsection (a) shall
require the entity to submit to the Secretary of Health and
Human Services and the congressional committees of
jurisdiction, not later than 3 years after the date of
enactment of this Act, a report on the results of the study
conducted pursuant to this section.
(2) Contents.--The report under paragraph (1) shall--
(A) describe the findings and conclusions of the evaluation
conducted pursuant to subsection (a); and
(B) provide recommendations for improving public health
preparedness and response capability and medical surge
capacity for hospitals, long-term care facilities, and other
health care facilities, including--
(i) improving the existing benchmarks and objective
standards for the Federal grant programs described in
subsection (a)(3)(A) or developing new benchmarks and
standards for such programs; and
(ii) identifying best practices for improving public health
preparedness and response programs and medical surge capacity
at hospitals, long-term care facilities, and other
[[Page H4253]]
health care facilities, including recommendations for the
evaluation under subparagraphs (C) and (D) of subsection
(a)(3).
TITLE III--REACHING ALL COMMUNITIES
SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE
WORKFORCE.
(a) National Disaster Medical System.--
(1) Strengthening the national disaster medical system.--
Clause (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh-
11(a)(3)(A)) is amended to read as follows:
``(ii) be present at locations, and for limited periods of
time, specified by the Secretary on the basis that the
Secretary has determined that a location is at risk of a
public health emergency during the time specified, or there
is a significant potential for a public health emergency.''.
(2) Review of the national disaster medical system.--
Section 2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to
read as follows:
``(2) Joint review and medical surge capacity strategic
plan.--
``(A) Review.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in
coordination with the Secretary of Homeland Security, the
Secretary of Defense, and the Secretary of Veterans Affairs,
shall conduct a joint review of the National Disaster Medical
System. Such review shall include--
``(i) an evaluation of medical surge capacity, as described
in section 2803(a);
``(ii) an assessment of the available workforce of the
intermittent disaster response personnel described in
subsection (c);
``(iii) the capacity of the workforce described in clause
(ii) to respond to all hazards, including capacity to
simultaneously respond to multiple public health emergencies
and the capacity to respond to a nationwide public health
emergency;
``(iv) the effectiveness of efforts to recruit, retain, and
train such workforce; and
``(v) gaps that may exist in such workforce and
recommendations for addressing such gaps.
``(B) Updates.--As part of the National Health Security
Strategy under section 2802, the Secretary shall update the
findings from the review under subparagraph (A) and provide
recommendations to modify the policies of the National
Disaster Medical System as necessary.''.
(3) Notification of shortage.--Section 2812(c) (42 U.S.C.
300hh-11(c)) is amended by adding at the end the following:
``(3) Notification.--Not later than 30 days after the date
on which the Secretary determines the number of intermittent
disaster-response personnel of the National Disaster Medical
System is insufficient to address a public health emergency
or potential public health emergency, the Secretary shall
submit to the congressional committees of jurisdiction a
notification detailing--
``(A) the impact such shortage could have on meeting public
health needs and emergency medical personnel needs during a
public health emergency; and
``(B) any identified measures to address such shortage.
``(4) Certain appointments.--
``(A) In general.--If the Secretary determines that the
number of intermittent disaster response personnel within the
National Disaster Medical System under this section is
insufficient to address a public health emergency or
potential public health emergency, the Secretary may appoint
candidates directly to personnel positions for intermittent
disaster response within such system. The Secretary shall
provide updates on the number of vacant or unfilled positions
within such system to the congressional committees of
jurisdiction each quarter for which this authority is in
effect.
``(B) Sunset.--The authority under this paragraph shall
expire on September 30, 2021.''.
(4) Authorization of appropriations.--Section 2812(g) (42
U.S.C. 300hh-11(g)) is amended by striking ``$52,700,000 for
each of fiscal years 2014 through 2018'' and inserting
``$57,400,000 for each of fiscal years 2019 through 2023''.
(b) Volunteer Medical Reserve Corps.--
(1) In general.--Section 2813(a) (42 U.S.C. 42 U.S.C.
300hh-15(a)) is amended by striking the second sentence and
inserting ``The Secretary may appoint a Director to head the
Corps and oversee the activities of the Corps chapters that
exist at the State, local, Tribal, and territorial levels.''.
(2) Authorization of appropriations.--Section 2813(i) (42
U.S.C. 300hh-15(i)) is amended by striking ``2014 through
2018'' and inserting ``2019 through 2023''.
(c) Strengthening the Epidemic Intelligence Service.--
Section 317F (42 U.S.C. Sec. 247b-7) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by inserting ``or preparedness and response activities,
including rapid response to public health emergencies and
significant public health threats'' after ``conduct
prevention activities''; and
(ii) by striking ``$35,000'' and inserting ``$50,000''; and
(B) in paragraph (2)(B), by striking ``3 years'' and
inserting ``2 years''; and
(2) in subsection (c)--
(A) by striking ``For the purpose of carrying out this
section'' and inserting the following:
``(1) In general.--For the purpose of carrying out this
section, except as described in paragraph (2)''; and
(B) by adding at the end the following:
``(2) Epidemic intelligence service program.--For purposes
of carrying out this section with respect to qualified health
professionals serving in the Epidemic Intelligence Service,
as authorized under section 317G, there is authorized to be
appropriated $1,000,000 for each of fiscal years 2019 through
2023.''.
(d) Service Benefit for National Disaster Medical System
Volunteers.--
(1) In general.--Section 2812(c) (42 U.S.C. 300hh-11(c)),
as amended by subsection (a)(3), is further amended by adding
at the end the following:
``(5) Service benefit.--Individuals appointed to serve
under this subsection shall be considered eligible for
benefits under part L of title I of the Omnibus Crime Control
and Safe Streets Act of 1968. The Secretary shall provide
notification to any eligible individual of any effect such
designation may have on other benefits for which such
individual is eligible, including benefits from private
entities.''.
(2) Public safety officer benefits.--Section 1204(9) of
title I of the Omnibus Crime Control and Safe Streets Act of
1968 (34 U.S.C. 10284(9)) is amended--
(A) in subparagraph (C)(ii), by striking ``or'' at the end;
(B) in subparagraph (D), by striking the period and
inserting ``; or''; and
(C) by inserting after subparagraph (D) the following:
``(E) an individual appointed to the National Disaster
Medical System under section 2812 of the Public Health
Service Act (42 U.S.C. 300hh-11) who is performing official
duties of the Department of Health and Human Services, if
those official duties are--
``(i) related to responding to a public health emergency or
potential public health emergency, or other activities for
which the Secretary of Health and Human Services has
activated such National Disaster Medical System; and
``(ii) determined by the Secretary of Health and Human
Services to be hazardous.''.
(3) Sunset.--The amendments made by paragraphs (1) and (2)
shall cease to have force or effect on October 1, 2021.
(e) Mission Readiness Report to Congress.--
(1) Report.--Not later than one year after the date of
enactment of this section, the Comptroller General of the
United States (referred to in this subsection as the
``Comptroller General'') shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, a report on the medical surge capacity of
the United States in the event of a public health emergency,
including the capacity and capability of the current health
care workforce to prepare for, and respond to, the full range
of public health emergencies or potential public health
emergencies, and recommendations to address any gaps
identified in such workforce.
(2) Contents.--The Comptroller General shall include in the
report under paragraph (1)--
(A) the number of health care providers who have
volunteered to provide health care services during a public
health emergency, including members of the National Disaster
Medical System, the Disaster Medical Assistant Teams, the
Medical Reserve Corps, and other volunteer health care
professionals in the verification network pursuant to section
319I of the Public Health Service Act (42 U.S.C. 247d-7b);
(B) the capacity of the workforce described in subparagraph
(A) to respond to a public health emergency or potential
public health emergency, including the capacity to respond to
multiple concurrent public health emergencies and the
capacity to respond to a nationwide public health emergency;
(C) the preparedness and response capabilities and mission
readiness of the workforce described in subparagraph (A)
taking into account areas of health care expertise and
considerations for at-risk individuals (as defined in section
2802(b)(4)(B) of the Public Health Service Act (42 U.S.C.
300hh-1(b)(4)(B)));
(D) an assessment of the effectiveness of efforts to
recruit, retain, and train such workforce; and
(E) identification of gaps that may exist in such workforce
and recommendations for addressing such gaps, the extent to
which the Assistant Secretary for Preparedness and Response
plans to address such gaps, and any recommendations from the
Comptroller General to address such gaps.
SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE
PREPAREDNESS AND RESPONSE.
(a) Coordination of Preparedness.--Section 2811(b)(5) (42
U.S.C. 300hh-10(b)(5)) is amended by adding at the end the
following: ``Such logistical support shall include working
with other relevant Federal, State, local, Tribal, and
territorial public health officials and private sector
entities to identify the critical infrastructure assets,
systems, and networks needed for the proper functioning of
the health care and public health sectors that need to be
maintained through any emergency or disaster, including
entities capable of assisting with, responding to, and
mitigating the effect of a public health emergency, including
a public health emergency determined by the Secretary
pursuant to section 319(a) or an emergency or major disaster
declared by the President under the
[[Page H4254]]
Robert T. Stafford Disaster Relief and Emergency Assistance
Act or the National Emergencies Act, including by
establishing methods to exchange critical information and
deliver products consumed or used to preserve, protect, or
sustain life, health, or safety, and sharing of specialized
expertise.''.
(b) Manufacturing Capacity.--Section 2811(d)(2)(C) (42
U.S.C. 300hh-10(d)(2)(C)) is amended by inserting ``, and
ancillary medical supplies to assist with the utilization of
such countermeasures or products,'' after ``products''.
(c) Evaluation of Barriers to Rapid Delivery of Medical
Countermeasures.--
(1) Rapid delivery study.--The Assistant Secretary for
Preparedness and Response may conduct a study on issues that
have the potential to adversely affect the handling and rapid
delivery of medical countermeasures to individuals during
public health emergencies occurring in the United States.
(2) Notice to congress.--Not later than 9 months after the
date of the enactment of this Act, the Assistant Secretary
for Preparedness and Response shall notify the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate if the Assistant Secretary for Preparedness and
Response does not plan to conduct the study under paragraph
(1) and shall provide such committees a summary explanation
for such decision.
(3) Report to congress.--Not later than 1 year after the
Assistant Secretary for Preparedness and Response conducts
the study under paragraph (1), such Assistant Secretary shall
submit a report to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate containing the
findings of such study.
SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.
(a) At-Risk Individuals in the National Health Security
Strategy.--Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B))
is amended--
(1) by striking ``this section and sections 319C-1, 319F,
and 319L,'' and inserting ``this Act,''; and
(2) by striking ``special'' and inserting ``access or
functional''.
(b) Countermeasure Considerations.--Section 319L(c)(6) (42
U.S.C. 247d-7e(c)(6)) is amended--
(1) by striking ``elderly'' and inserting ``older adults'';
and
(2) by inserting ``with relevant characteristics that
warrant consideration during the process of researching and
developing such countermeasures and products'' before the
period.
(c) Biosurveillance of Emerging Public Health Threats.--
Section 2814 is amended--
(1) in paragraph (7), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (8), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(9) facilitate coordination to ensure that, in
implementing the situational awareness and biosurveillance
network under section 319D, the Secretary considers
incorporating data and information from Federal, State,
local, Tribal, and territorial public health officials and
entities relevant to detecting emerging public health threats
that may affect at-risk individuals, such as pregnant and
postpartum women and infants, including adverse health
outcomes of such populations related to such emerging public
health threats.''.
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE
CONSIDERATIONS FOR CHILDREN.
Part B of title III (42 U.S.C. 243 et seq.) is amended by
inserting after section 319D the following:
``SEC. 319D-1. CHILDREN'S PREPAREDNESS UNIT.
``(a) Enhancing Emergency Preparedness for Children.--The
Secretary, acting through the Director of the Centers for
Disease Control and Prevention (referred to in this
subsection as the `Director'), shall maintain an internal
team of experts, to be known as the Children's Preparedness
Unit (referred to in this subsection as the `Unit'), to work
collaboratively to provide guidance on the considerations
for, and the specific needs of, children before, during, and
after public health emergencies. The Unit shall inform the
Director regarding emergency preparedness and response
efforts pertaining to children at the Centers for Disease
Control and Prevention.
``(b) Expertise.--The team described in subsection (a)
shall include one or more pediatricians, which may be a
developmental-behavioral pediatrician, and may also include
behavioral scientists, child psychologists, epidemiologists,
biostatisticians, health communications staff, and
individuals with other areas of expertise, as the Secretary
determines appropriate.
``(c) Duties.--The team described in subsection (a) may--
``(1) assist State, local, Tribal, and territorial
emergency planning and response activities related to
children, which may include developing, identifying, and
sharing best practices;
``(2) provide technical assistance, training, and
consultation to Federal, State, local, Tribal, and
territorial public health officials to improve preparedness
and response capabilities with respect to the needs of
children, including providing such technical assistance,
training, and consultation to eligible entities in order to
support the achievement of measurable evidence-based
benchmarks and objective standards applicable to sections
319C-1 and 319C-2;
``(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public
health emergency, including public awareness of such methods;
``(4) coordinate with, and improve, public-private
partnerships, such as health care coalitions pursuant to
sections 319C-2 and 319C-3, to address gaps and
inefficiencies in emergency preparedness and response efforts
for children;
``(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies, including pursuant to section 319C-3; and
``(6) carry out other duties related to preparedness and
response activities for children, as the Secretary determines
appropriate.''.
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.
(a) Reauthorizing the National Advisory Committee on
Children and Disasters.--Section 2811A (42 U.S.C. 300hh-10a)
is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and inserting
``25''; and
(B) by striking paragraph (2) and inserting the following:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals, including--
``(A) at least 2 non-Federal professionals with expertise
in pediatric medical disaster planning, preparedness,
response, or recovery;
``(B) at least 2 representatives from State, local, Tribal,
or territorial agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery;
``(C) at least 4 members representing health care
professionals, which may include members with expertise in
pediatric emergency medicine; pediatric trauma, critical
care, or surgery; the treatment of pediatric patients
affected by chemical, biological, radiological, or nuclear
agents, including emerging infectious diseases; pediatric
mental or behavioral health related to children affected by a
public health emergency; or pediatric primary care; and
``(D) other members as the Secretary determines
appropriate, of whom--
``(i) at least one such member shall represent a children's
hospital;
``(ii) at least one such member shall be an individual with
expertise in schools or child care settings;
``(iii) at least one such member shall be an individual
with expertise in children and youth with special health care
needs; and
``(iv) at least one such member shall be an individual with
expertise in the needs of parents or family caregivers,
including the parents or caregivers of children with
disabilities.
``(3) Federal members.--The Advisory Committee under
paragraph (1) shall include the following Federal members or
their designees (who may be nonvoting members, as determined
by the Secretary):
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced Research and
Development Authority.
``(C) The Director of the Centers for Disease Control and
Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of Health.
``(F) The Assistant Secretary of the Administration for
Children and Families.
``(G) The Administrator of the Health Resources and
Services Administration.
``(H) The Administrator of the Federal Emergency Management
Agency.
``(I) The Administrator of the Administration for Community
Living.
``(J) The Secretary of Education.
``(K) Representatives from such Federal agencies (such as
the Substance Abuse and Mental Health Services Administration
and the Department of Homeland Security) as the Secretary
determines appropriate to fulfill the duties of the Advisory
Committee under subsections (b) and (c).
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a
term of 3 years, except that the Secretary may adjust the
terms of the Advisory Committee appointees serving on the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019, or
appointees who are initially appointed after such date of
enactment, in order to provide for a staggered term of
appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than two of such
terms may be served consecutively.'';
(3) in subsection (e), by adding at the end ``At least one
meeting per year shall be an in-person meeting.'';
[[Page H4255]]
(4) by redesignating subsection (f) as subsection (g);
(5) by inserting after subsection (e) the following:
``(f) Coordination.--The Secretary shall coordinate duties
and activities authorized under this section in accordance
with section 2811D.''; and
(6) in subsection (g), as so redesignated, by striking
``2018'' and inserting ``2023''.
(b) Authorizing the National Advisory Committee on Seniors
and Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh
et seq.) is amended by inserting after section 2811A the
following:
``SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS AND
DISASTERS.
``(a) Establishment.--The Secretary, in consultation with
the Secretary of Homeland Security and the Secretary of
Veterans Affairs, shall establish an advisory committee to be
known as the National Advisory Committee on Seniors and
Disasters (referred to in this section as the `Advisory
Committee').
``(b) Duties.--The Advisory Committee shall--
``(1) provide advice and consultation with respect to the
activities carried out pursuant to section 2814, as
applicable and appropriate;
``(2) evaluate and provide input with respect to the
medical and public health needs of seniors related to
preparation for, response to, and recovery from all-hazards
emergencies; and
``(3) provide advice and consultation with respect to State
emergency preparedness and response activities relating to
seniors, including related drills and exercises pursuant to
the preparedness goals under section 2802(b).
``(c) Additional Duties.--The Advisory Committee may
provide advice and recommendations to the Secretary with
respect to seniors and the medical and public health grants
and cooperative agreements as applicable to preparedness and
response activities under this title and title III.
``(d) Membership.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies as appropriate, shall appoint not
more than 17 members to the Advisory Committee. In appointing
such members, the Secretary shall ensure that the total
membership of the Advisory Committee is an odd number.
``(2) Required members.--The Advisory Committee shall
include Federal members or their designees (who may be
nonvoting members, as determined by the Secretary) and non-
Federal members, as follows:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced Research and
Development Authority.
``(C) The Director of the Centers for Disease Control and
Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of Health.
``(F) The Administrator of the Centers for Medicare &
Medicaid Services.
``(G) The Administrator of the Administration for Community
Living.
``(H) The Administrator of the Federal Emergency Management
Agency.
``(I) The Under Secretary for Health of the Department of
Veterans Affairs.
``(J) At least 2 non-Federal health care professionals with
expertise in geriatric medical disaster planning,
preparedness, response, or recovery.
``(K) At least 2 representatives of State, local, Tribal,
or territorial agencies with expertise in geriatric disaster
planning, preparedness, response, or recovery.
``(L) Representatives of such other Federal agencies (such
as the Department of Energy and the Department of Homeland
Security) as the Secretary determines necessary to fulfill
the duties of the Advisory Committee.
``(e) Meetings.--The Advisory Committee shall meet not less
frequently than biannually. At least one meeting per year
shall be an in-person meeting.
``(f) Coordination.--The Secretary shall coordinate duties
and activities authorized under this section in accordance
with section 2811D.
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate
on September 30, 2023.
``(2) Extension of committee.--Not later than October 1,
2022, the Secretary shall submit to Congress a recommendation
on whether the Advisory Committee should be extended.''.
(c) National Advisory Committee on Individuals With
Disabilities and Disasters.--Subtitle B of title XXVIII (42
U.S.C. 300hh et seq.), as amended by subsection (b), is
further amended by inserting after section 2811B the
following:
``SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH
DISABILITIES AND DISASTERS.
``(a) Establishment.--The Secretary, in consultation with
the Secretary of Homeland Security, shall establish a
national advisory committee to be known as the National
Advisory Committee on Individuals with Disabilities and
Disasters (referred to in this section as the `Advisory
Committee').
``(b) Duties.--The Advisory Committee shall--
``(1) provide advice and consultation with respect to
activities carried out pursuant to section 2814, as
applicable and appropriate;
``(2) evaluate and provide input with respect to the
medical, public health, and accessibility needs of
individuals with disabilities related to preparation for,
response to, and recovery from all-hazards emergencies; and
``(3) provide advice and consultation with respect to State
emergency preparedness and response activities, including
related drills and exercises pursuant to the preparedness
goals under section 2802(b).
``(c) Membership.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies and departments as appropriate, shall
appoint not more than 17 members to the Advisory Committee.
In appointing such members, the Secretary shall ensure that
the total membership of the Advisory Committee is an odd
number.
``(2) Required members.--The Advisory Committee shall
include Federal members or their designees (who may be
nonvoting members, as determined by the Secretary) and non-
Federal members, as follows:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Administrator of the Administration for Community
Living.
``(C) The Director of the Biomedical Advanced Research and
Development Authority.
``(D) The Director of the Centers for Disease Control and
Prevention.
``(E) The Commissioner of Food and Drugs.
``(F) The Director of the National Institutes of Health.
``(G) The Administrator of the Federal Emergency Management
Agency.
``(H) The Chair of the National Council on Disability.
``(I) The Chair of the United States Access Board.
``(J) The Under Secretary for Health of the Department of
Veterans Affairs.
``(K) At least 2 non-Federal health care professionals with
expertise in disability accessibility before, during, and
after disasters, medical and mass care disaster planning,
preparedness, response, or recovery.
``(L) At least 2 representatives from State, local, Tribal,
or territorial agencies with expertise in disaster planning,
preparedness, response, or recovery for individuals with
disabilities.
``(M) At least 2 individuals with a disability with
expertise in disaster planning, preparedness, response, or
recovery for individuals with disabilities.
``(d) Meetings.--The Advisory Committee shall meet not less
frequently than biannually. At least one meeting per year
shall be an in-person meeting.
``(e) Disability Defined.--For purposes of this section,
the term `disability' has the meaning given such term in
section 3 of the Americans with Disabilities Act of 1990.
``(f) Coordination.--The Secretary shall coordinate duties
and activities authorized under this section in accordance
with section 2811D.
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate
on September 30, 2023.
``(2) Recommendation.--Not later than October 1, 2022, the
Secretary shall submit to Congress a recommendation on
whether the Advisory Committee should be extended.''.
(d) Advisory Committee Coordination.--Subtitle B of title
XXVIII (42 U.S.C. 300hh et seq.), as amended by subsection
(c), is further amended by inserting after section 2811C the
following:
``SEC. 2811D. ADVISORY COMMITTEE COORDINATION.
``(a) In General.--The Secretary shall coordinate duties
and activities authorized under sections 2811A, 2811B, and
2811C, and make efforts to reduce unnecessary or duplicative
reporting, or unnecessary duplicative meetings and
recommendations under such sections, as practicable. Members
of the advisory committees authorized under such sections, or
their designees, shall annually meet to coordinate any
recommendations, as appropriate, that may be similar,
duplicative, or overlapping with respect to addressing the
needs of children, seniors, and individuals with disabilities
during public health emergencies. If such coordination occurs
through an in-person meeting, it shall not be considered the
required in-person meetings under any of sections 2811A(e),
2811B(e), or 2811C(d).
``(b) Coordination and Alignment.--The Secretary, acting
through the employee designated pursuant to section 2814,
shall align preparedness and response programs or activities
to address similar, dual, or overlapping needs of children,
seniors, and individuals with disabilities, and any
challenges in preparing for and responding to such needs.
``(c) Notification.--The Secretary shall annually notify
the congressional committees of jurisdiction regarding the
steps taken to coordinate, as appropriate, the
recommendations under this section, and provide a summary
description of such coordination.''.
SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS.
Not later than 2 years after the date of enactment of this
Act, the Secretary of Health and Human Services shall issue
final guidance regarding the ability of personnel funded by
programs authorized under this Act (including the amendments
made by this Act) to participate in drills and operational
exercises related to all-hazards medical and public health
preparedness and response. Such drills and operational
exercises may include activities that incorporate medical
surge capacity planning, medical countermeasure distribution
and administration, and preparing for and responding to
identified threats for that region. Such personnel
[[Page H4256]]
may include State, local, Tribal, and territorial public
health department or agency personnel funded under this Act
(including the amendments made by this Act). The Secretary
shall consult with the Department of Homeland Security, the
Department of Defense, the Department of Veterans Affairs,
and other applicable Federal departments and agencies as
necessary and appropriate in the development of such
guidance. The Secretary shall make the guidance available on
the internet website of the Department of Health and Human
Services.
TITLE IV--PRIORITIZING A THREAT-BASED APPROACH
SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.
Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``utilize experience related to public health emergency
preparedness and response, biodefense, medical
countermeasures, and other relevant topics to'' after
``shall''; and
(2) in paragraph (4), by adding at the end the following:
``(I) Threat awareness.--Coordinate with the Director of
the Centers for Disease Control and Prevention, the Director
of National Intelligence, the Secretary of Homeland Security,
the Assistant to the President for National Security Affairs,
the Secretary of Defense, and other relevant Federal
officials, such as the Secretary of Agriculture, to maintain
a current assessment of national security threats and inform
preparedness and response capabilities based on the range of
the threats that have the potential to result in a public
health emergency.''.
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.
(a) In General.--Title XXVIII is amended by inserting after
section 2811 (42 U.S.C. 300hh-10) the following:
``SEC. 2811-1. PUBLIC HEALTH EMERGENCY MEDICAL
COUNTERMEASURES ENTERPRISE.
``(a) In General.--The Secretary shall establish the Public
Health Emergency Medical Countermeasures Enterprise (referred
to in this section as the `PHEMCE'). The Assistant Secretary
for Preparedness and Response shall serve as chair of the
PHEMCE.
``(b) Members.--The PHEMCE shall include each of the
following members, or the designee of such members:
``(1) The Assistant Secretary for Preparedness and
Response.
``(2) The Director of the Centers for Disease Control and
Prevention.
``(3) The Director of the National Institutes of Health.
``(4) The Commissioner of Food and Drugs.
``(5) The Secretary of Defense.
``(6) The Secretary of Homeland Security.
``(7) The Secretary of Agriculture.
``(8) The Secretary of Veterans Affairs.
``(9) The Director of National Intelligence.
``(10) Representatives of any other Federal agency, which
may include the Director of the Biomedical Advanced Research
and Development Authority, the Director of the Strategic
National Stockpile, the Director of the National Institute of
Allergy and Infectious Diseases, and the Director of the
Office of Public Health Preparedness and Response, as the
Secretary determines appropriate.
``(c) Functions.--
``(1) In general.--The functions of the PHEMCE shall
include the following:
``(A) Utilize a process to make recommendations to the
Secretary regarding research, advanced research, development,
procurement, stockpiling, deployment, distribution, and
utilization with respect to countermeasures, as defined in
section 319F-2(c), including prioritization based on the
health security needs of the United States. Such
recommendations shall be informed by, when available and
practicable, the National Health Security Strategy pursuant
to section 2802, the Strategic National Stockpile needs
pursuant to section 319F-2, and assessments of current
national security threats, including chemical, biological,
radiological, and nuclear threats, including emerging
infectious diseases. In the event that members of the PHEMCE
do not agree upon a recommendation, the Secretary shall
provide a determination regarding such recommendation.
``(B) Identify national health security needs, including
gaps in public health preparedness and response related to
countermeasures and challenges to addressing such needs
(including any regulatory challenges), and support alignment
of countermeasure procurement with recommendations to address
such needs under subparagraph (A).
``(C) Assist the Secretary in developing strategies related
to logistics, deployment, distribution, dispensing, and use
of countermeasures that may be applicable to the activities
of the strategic national stockpile under section 319F-2(a).
``(D) Provide consultation for the development of the
strategy and implementation plan under section 2811(d).
``(2) Input.--In carrying out subparagraphs (B) and (C) of
paragraph (1), the PHEMCE shall solicit and consider input
from State, local, Tribal, and territorial public health
departments or officials, as appropriate.''.
(b) Public Health Emergency Medical Countermeasures
Enterprise Strategy and Implementation Plan.--Section 2811(d)
(42 U.S.C. 300hh-10(d)) is amended--
(1) in paragraph (1)--
(A) by striking ``Not later than 180 days after the date of
enactment of this subsection, and every year thereafter'' and
inserting ``Not later than March 15, 2020, and biennially
thereafter''; and
(B) by striking ``Director of the Biomedical'' and all that
follows through ``Food and Drugs'' and inserting ``Public
Health Emergency Medical Countermeasures Enterprise
established under section 2811-1''; and
(2) in paragraph (2)(J)(v), by striking ``one-year period''
and inserting ``2-year period''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.
(a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a))
is amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) in paragraph (1)--
(A) by inserting ``the Assistant Secretary for Preparedness
and Response and'' after ``collaboration with'';
(B) by inserting ``and optimize'' after ``provide for'';
(C) by inserting ``and, as informed by existing
recommendations of, or consultations with, the Public Health
Emergency Medical Countermeasure Enterprise established under
section 2811-1, make necessary additions or modifications to
the contents of such stockpile or stockpiles based on the
review conducted under paragraph (2)'' before the period of
the first sentence; and
(D) by striking the second sentence;
(3) by inserting after paragraph (1) the following:
``(2) Threat-based review.--
``(A) In general.--The Secretary shall conduct an annual
threat-based review (taking into account at-risk individuals)
of the contents of the stockpile under paragraph (1),
including non-pharmaceutical supplies, and, in consultation
with the Public Health Emergency Medical Countermeasures
Enterprise established under section 2811-1, review contents
within the stockpile and assess whether such contents are
consistent with the recommendations made pursuant to section
2811-1(c)(1)(A). Such review shall be submitted on June 15,
2019, and on March 15 of each year thereafter, to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives, in a manner that does not
compromise national security.
``(B) Additions, modifications, and replenishments.--Each
annual threat-based review under subparagraph (A) shall, for
each new or modified countermeasure procurement or
replenishment, provide--
``(i) information regarding--
``(I) the quantities of the additional or modified
countermeasure procured for, or contracted to be procured
for, the stockpile;
``(II) planning considerations for appropriate
manufacturing capacity and capability to meet the goals of
such additions or modifications (without disclosing
proprietary information), including consideration of the
effect such additions or modifications may have on the
availability of such products and ancillary medical supplies
in the health care system;
``(III) the presence or lack of a commercial market for the
countermeasure at the time of procurement;
``(IV) the emergency health security threat or threats such
countermeasure procurement is intended to address, including
whether such procurement is consistent with meeting emergency
health security needs associated with such threat or threats;
``(V) an assessment of whether the emergency health
security threat or threats described in subclause (IV) could
be addressed in a manner that better utilizes the resources
of the stockpile and permits the greatest possible increase
in the level of emergency preparedness to address such
threats;
``(VI) whether such countermeasure is replenishing an
expiring or expired countermeasure, is a different
countermeasure with the same indication that is replacing an
expiring or expired countermeasure, or is a new addition to
the stockpile;
``(VII) a description of how such additions or
modifications align with projected investments under previous
countermeasures budget plans under section 2811(b)(7),
including expected life-cycle costs, expenditures related to
countermeasure procurement to address the threat or threats
described in subclause (IV), replenishment dates (including
the ability to extend the maximum shelf life of a
countermeasure), and the manufacturing capacity required to
replenish such countermeasure; and
``(VIII) appropriate protocols and processes for the
deployment, distribution, or dispensing of the countermeasure
at the State and local level, including plans for relevant
capabilities of State and local entities to dispense,
distribute, and administer the countermeasure; and
``(ii) an assurance, which need not be provided in advance
of procurement, that for each countermeasure procured or
replenished under this subsection, the Secretary completed a
review addressing each item listed under this subsection in
advance of such procurement or replenishment.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A), by inserting ``and the Public
Health Emergency Medical Countermeasures Enterprise
established under section 2811-1'' before the semicolon;
(B) in subparagraph (C), by inserting ``, and the
availability, deployment, dispensing, and administration of
countermeasures'' before the semicolon;
[[Page H4257]]
(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
[[Page H4258]]
funds provided under sections 319L(d) and 319F-2(g).
``(C) Documentation required.--The Assistant Secretary for
Preparedness and Response, in accordance with subsection
(b)(7), shall document amounts expended for purposes of
carrying out this subsection, including amounts appropriated
under the heading `Public Health and Social Services
Emergency Fund' under the heading `Office of the Secretary'
under title II of division H of the Consolidated
Appropriations Act, 2018 (Public Law 115-141) and allocated
to carrying out section 319L(c)(4)(F).''.
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.
Section 351A(k) (42 U.S.C. 262a(k)) is amended--
(1) by striking ``The Secretary'' and inserting the
following:
``(1) In general.--The Secretary''; and
(2) by adding at the end the following:
``(2) Implementation of recommendations of the federal
experts security advisory panel and the fast track action
committee on select agent regulations.--
``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019, the Secretary shall
report to the congressional committees of jurisdiction on the
implementation of recommendations of the Federal Experts
Security Advisory Panel concerning the select agent program.
``(B) Continued updates.--The Secretary shall report to the
congressional committees of jurisdiction annually following
the submission of the report under subparagraph (A) until the
recommendations described in such subparagraph are fully
implemented, or a justification is provided for the delay in,
or lack of, implementation.''.
TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT
SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.
Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
(1) in the matter preceding subparagraph (A), by striking
``March 1'' and inserting ``March 15'';
(2) in subparagraph (A)--
(A) in clause (ii), by striking ``; and'' and inserting
``;''; and
(B) by striking clause (iii) and inserting the following:
``(iii) procurement, stockpiling, maintenance, and
potential replenishment (including manufacturing
capabilities) of all products in the Strategic National
Stockpile;
``(iv) the availability of technologies that may assist in
the advanced research and development of countermeasures and
opportunities to use such technologies to accelerate and
navigate challenges unique to countermeasure research and
development; and
``(v) potential deployment, distribution, and utilization
of medical countermeasures; development of clinical guidance
and emergency use instructions for the use of medical
countermeasures; and, as applicable, potential postdeployment
activities related to medical countermeasures;'';
(3) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively; and
(4) by inserting after subparagraph (C), the following:
``(D) identify the full range of anticipated medical
countermeasure needs related to research and development,
procurement, and stockpiling, including the potential need
for indications, dosing, and administration technologies, and
other countermeasure needs as applicable and appropriate;''.
SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE
NOTIFICATIONS.
(a) Congressional Notification of Material Threat
Determination.--Section 319F-2(c)(2)(C) (42 U.S.C. 247d-
6b(c)(2)(C)) is amended by striking ``The Secretary and the
Homeland Security Secretary shall promptly notify the
appropriate committees of Congress'' and inserting ``The
Secretary and the Secretary of Homeland Security shall send
to Congress, on an annual basis, all current material threat
determinations and shall promptly notify the Committee on
Health, Education, Labor, and Pensions and the Committee on
Homeland Security and Governmental Affairs of the Senate and
the Committee on Energy and Commerce and the Committee on
Homeland Security of the House of Representatives''.
(b) Contracting Communication.--Section 319F-
2(c)(7)(B)(ii)(III) (42 U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is
amended by adding at the end the following: ``The Secretary
shall notify the vendor within 90 days of a determination by
the Secretary to renew, extend, or terminate such
contract.''.
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.
Section 565(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-4(f)) is amended--
(1) by redesignating paragraphs (3) through (6) as
paragraphs (4) through (7), respectively;
(2) by inserting after paragraph (2) the following:
``(3) Publication.--The Secretary shall make available on
the internet website of the Food and Drug Administration
information regarding regulatory management plans,
including--
``(A) the process by which an applicant may submit a
request for a regulatory management plan;
``(B) the timeframe by which the Secretary is required to
respond to such request;
``(C) the information required for the submission of such
request;
``(D) a description of the types of development milestones
and performance targets that could be discussed and included
in such plans; and
``(E) contact information for beginning the regulatory
management plan process.'';
(3) in paragraph (6), as so redesignated, in the matter
preceding subparagraph (A)--
(A) by striking ``paragraph (4)(A)'' and inserting
``paragraph (5)(A)''; and
(B) by striking ``paragraph (4)(B)'' and inserting
``paragraph (5)(B)''; and
(4) in paragraph (7)(A), as so redesignated, by striking
``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY AND THE BIOSHIELD SPECIAL RESERVE
FUND.
(a) BioShield Special Reserve Fund.--Section 319F-2(g)(1)
(42 U.S.C. 247d-6b(g)(1)) is amended--
(1) by striking ``$2,800,000,000 for the period of fiscal
years 2014 through 2018'' and inserting ``$7,100,000,000 for
the period of fiscal years 2019 through 2028, to remain
available until expended''; and
(2) by striking the second sentence.
(b) The Biomedical Advanced Research and Development
Authority.--Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) is
amended by striking ``$415,000,000 for each of fiscal years
2014 through 2018'' and inserting ``$611,700,000 for each of
fiscal years 2019 through 2023''.
SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC
RESISTANCE.
(a) Advisory Council.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
may continue the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, referred to in this section as
the ``Advisory Council''.
(b) Duties.--The Advisory Council shall advise and provide
information and recommendations to the Secretary regarding
programs and policies intended to reduce or combat
antibiotic-resistant bacteria that may present a public
health threat and improve capabilities to prevent, diagnose,
mitigate, or treat such resistance. Such advice, information,
and recommendations may be related to improving--
(1) the effectiveness of antibiotics;
(2) research and advanced research on, and the development
of, improved and innovative methods for combating or reducing
antibiotic resistance, including new treatments, rapid point-
of-care diagnostics, alternatives to antibiotics, including
alternatives to animal antibiotics, and antimicrobial
stewardship activities;
(3) surveillance of antibiotic-resistant bacterial
infections, including publicly available and up-to-date
information on resistance to antibiotics;
(4) education for health care providers and the public with
respect to up-to-date information on antibiotic resistance
and ways to reduce or combat such resistance to antibiotics
related to humans and animals;
(5) methods to prevent or reduce the transmission of
antibiotic-resistant bacterial infections, including
stewardship programs; and
(6) coordination with respect to international efforts in
order to inform and advance United States capabilities to
combat antibiotic resistance.
(c) Meetings and Coordination.--
(1) Meetings.--The Advisory Council shall meet not less
than biannually and, to the extent practicable, in
coordination with meetings of the Antimicrobial Resistance
Task Force established in section 319E(a) of the Public
Health Service Act.
(2) Coordination.--The Advisory Council shall, to the
greatest extent practicable, coordinate activities carried
out by the Council with the Antimicrobial Resistance Task
Force established under section 319E(a) of the Public Health
Service Act (42 U.S.C. 247d-5(a)).
(d) FACA.--The Federal Advisory Committee Act (5 U.S.C.
App.) shall apply to the activities and duties of the
Advisory Council.
(e) Extension of Advisory Council.--Not later than October
1, 2022, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a recommendation on whether the Advisory
Council should be extended, and in addition, identify whether
there are other committees, councils, or task forces that
have overlapping or similar duties to that of the Advisory
Council, and whether such committees, councils, or task
forces should be combined, including with respect to section
319E(a) of the Public Health Service Act (42 U.S.C. 247d-
5(a)).
TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES
SEC. 601. ADMINISTRATION OF COUNTERMEASURES.
Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d-
7e(c)(4)(D)(iii)) is amended by striking ``and platform
technologies'' and inserting ``platform technologies,
technologies to administer countermeasures, and technologies
to improve storage and transportation of countermeasures''.
SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.
Section 319L (42 U.S.C. 247d-7e) is amended--
[[Page H4259]]
(1) in subsection (a)(3), by striking ``, such as'' and all
that follows through ``Code''; and
(2) in subsection (c)(5)(A)--
(A) in clause (i), by striking ``under this subsection''
and all that follows through ``Code'' and inserting ``(as
defined in subsection (a)(3)) under this subsection''; and
(B) in clause (ii)--
(i) by amending subclause (I) to read as follows:
``(I) In general.--To the maximum extent practicable,
competitive procedures shall be used when entering into
transactions to carry out projects under this subsection.'';
and
(ii) in subclause (II)--
(I) by striking ``$20,000,000'' and inserting
``$100,000,000'';
(II) by striking ``senior procurement executive for the
Department (as designated for purpose of section 16(c) of the
Office of Federal Procurement Policy Act (41 U.S.C.
414(c)))'' and inserting ``Assistant Secretary for Financial
Resources''; and
(III) by striking ``senior procurement executive under''
and inserting ``Assistant Secretary for Financial Resources
under''.
SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES.
(a) In General.--The purpose of this section (including
section 565B of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (b)) is to support and advance the
development or manufacture of security countermeasures,
qualified countermeasures, and qualified pandemic or epidemic
products by facilitating and encouraging submission of data
and information to support the development of such products,
and through clarifying the authority to cross-reference to
data and information previously submitted to the Secretary of
Health and Human Services (referred to in this section as the
``Secretary''), including data and information submitted to
medical countermeasure master files or other master files.
(b) Medical Countermeasure Master Files.--Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)
is amended by inserting after section 565A the following:
``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.
``(a) Applicability of Reference.--
``(1) In general.--A person may submit data and information
in a master file to the Secretary with the intent to
reference, or to authorize, in writing, another person to
reference, such data or information to support a medical
countermeasure submission (including a supplement or
amendment to any such submission), without requiring the
master file holder to disclose the data and information to
any such persons authorized to reference the master file.
Such data and information shall be available for reference by
the master file holder or by a person authorized by the
master file holder, in accordance with applicable privacy and
confidentiality protocols and regulations.
``(2) Reference of certain master files.--In the case that
data or information within a medical countermeasure master
file is used only to support the conditional approval of an
application filed under section 571, such master file may be
relied upon to support the effectiveness of a product that is
the subject of a subsequent medical countermeasure submission
only if such application is supplemented by additional data
or information to support review and approval in a manner
consistent with the standards applicable to such review and
approval for such countermeasure, qualified countermeasure,
or qualified pandemic or epidemic product.
``(b) Medical Countermeasure Master File Content.--
``(1) In general.--A master file under this section may
include data or information to support--
``(A) the development of medical countermeasure submissions
to support the approval, licensure, classification,
clearance, conditional approval, or authorization of one or
more security countermeasures, qualified countermeasures, or
qualified pandemic or epidemic products; and
``(B) the manufacture of security countermeasures,
qualified countermeasures, or qualified pandemic or epidemic
products.
``(2) Required updates.--The Secretary may require, as
appropriate, that the master file holder ensure that the
contents of such master file are updated during the time such
master file is referenced for a medical countermeasure
submission.
``(c) Sponsor Reference.--
``(1) In general.--Each incorporation of data or
information within a medical countermeasure master file shall
describe the incorporated material in a manner in which the
Secretary determines appropriate and that permits the review
of such information within such master file without
necessitating resubmission of such data or information.
Master files shall be submitted in an electronic format in
accordance with sections 512(b)(4), 571(a)(4), and 745A, as
applicable, and as specified in applicable guidance.
``(2) Reference by a master file holder.--A master file
holder that is the sponsor of a medical countermeasure
submission shall notify the Secretary in writing of the
intent to reference the medical countermeasure master file as
a part of the submission.
``(3) Reference by an authorized person.--A person
submitting an application for review may, where the Secretary
determines appropriate, incorporate by reference all or part
of the contents of a medical countermeasure master file, if
the master file holder authorizes the incorporation in
writing.
``(d) Acknowledgment of and Reliance Upon a Master File by
the Secretary.--
``(1) In general.--The Secretary shall provide the master
file holder with a written notification indicating that the
Secretary has reviewed and relied upon specified data or
information within a master file and the purposes for which
such data or information was incorporated by reference if the
Secretary has reviewed and relied upon such specified data or
information to support the approval, classification,
conditional approval, clearance, licensure, or authorization
of a security countermeasure, qualified countermeasure, or
qualified pandemic or epidemic product. The Secretary may
rely upon the data and information within the medical
countermeasure master file for which such written
notification was provided in additional applications, as
applicable and appropriate and upon the request of the master
file holder so notified in writing or by an authorized person
of such holder.
``(2) Certain applications.--If the Secretary has reviewed
and relied upon specified data or information within a
medical countermeasure master file to support the conditional
approval of an application under section 571 to subsequently
support the approval, clearance, licensure, or authorization
of a security countermeasure, qualified countermeasure, or
qualified pandemic or epidemic product, the Secretary shall
provide a brief written description to the master file holder
regarding the elements of the application fulfilled by the
data or information within the master file and how such data
or information contained in such application meets the
standards of evidence under subsection (c) or (d) of section
505, subsection (d) of section 512, or section 351 of the
Public Health Service Act (as applicable), which shall not
include any trade secret or confidential commercial
information.
``(e) Rules of Construction.--Nothing in this section shall
be construed to--
``(1) limit the authority of the Secretary to approve,
license, clear, conditionally approve, or authorize drugs,
biological products, or devices pursuant to, as applicable,
this Act or section 351 of the Public Health Service Act (as
such applicable Act is in effect on the day before the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019), including the standards of
evidence, and applicable conditions, for approval under the
applicable Act;
``(2) alter the standards of evidence with respect to
approval, licensure, or clearance, as applicable, of drugs,
biological products, or devices under this Act or section 351
of the Public Health Service Act, including, as applicable,
the substantial evidence standards under sections 505(d) and
512(d) or this Act and section 351(a) of the Public Health
Service Act; or
``(3) alter the authority of the Secretary under this Act
or the Public Health Service Act to determine the types of
data or information previously submitted by a sponsor or any
other person that may be incorporated by reference in an
application, request, or notification for a drug, biological
product, or device submitted under sections 505(i), 505(b),
505(j), 512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g),
515(c), 513(f)(2), or 510(k) of this Act, or subsection (a)
or (k) of section 351 of the Public Health Service Act,
including a supplement or amendment to any such submission,
and the requirements associated with such reference.
``(f) Definitions.--In this section:
``(1) The term `master file holder' means a person who
submits data and information to the Secretary with the intent
to reference or authorize another person to reference such
data or information to support a medical countermeasure
submission, as described in subsection (a).
``(2) The term `medical countermeasure submission' means an
investigational new drug application under section 505(i), a
new drug application under section 505(b), or an abbreviated
new drug application under section 505(j) of this Act, a
biological product license application under section 351(a)
of the Public Health Service Act or a biosimilar biological
product license application under section 351(k) of the
Public Health Service Act, a new animal drug application
under section 512(b)(1) or abbreviated new animal drug
application under section 512(b)(2), an application for
conditional approval of a new animal drug under section 571,
an investigational device application under section 520(g),
an application with respect to a device under section 515(c),
a request for classification of a device under section
513(f)(2), a notification with respect to a device under
section 510(k), or a request for an emergency use
authorization under section 564 to support--
``(A) the approval, licensure, classification, clearance,
conditional approval, or authorization of a security
countermeasure, qualified countermeasure, or qualified
pandemic or epidemic product; or
``(B) a new indication to an approved security
countermeasure, qualified countermeasure, or qualified
pandemic or epidemic product.
``(3) The terms `qualified countermeasure', `security
countermeasure', and `qualified pandemic or epidemic product'
have the meanings given such terms in sections 319F-1, 319F-
2, and 319F-3, respectively, of the Public Health Service
Act.''.
(c) Stakeholder Input.--Not later than 18 months after the
date of enactment of this
[[Page H4260]]
Act, the Secretary, acting through the Commissioner of Food
and Drugs and in consultation with the Assistant Secretary
for Preparedness and Response, shall solicit input from
stakeholders, including stakeholders developing security
countermeasures, qualified countermeasures, or qualified
pandemic or epidemic products, and stakeholders developing
technologies to assist in the development of such
countermeasures with respect to how the Food and Drug
Administration can advance the use of tools and technologies
to support and advance the development or manufacture of
security countermeasures, qualified countermeasures, and
qualified pandemic or epidemic products, including through
reliance on cross-referenced data and information contained
within master files and submissions previously submitted to
the Secretary as set forth in section 565B of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (b).
(d) Guidance.--Not later than 2 years after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall publish draft guidance
about how reliance on cross-referenced data and information
contained within master files under section 565B of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(b) or submissions otherwise submitted to the Secretary may
be used for specific tools or technologies (including
platform technologies) that have the potential to support and
advance the development or manufacture of security
countermeasures, qualified countermeasures, and qualified
pandemic or epidemic products. The Secretary, acting through
the Commissioner of Food and Drugs, shall publish the final
guidance not later than 3 years after the enactment of this
Act.
SEC. 604. ANIMAL RULE REPORT.
(a) Study.--The Comptroller General of the United States
shall conduct a study on the application of the requirements
under subsections (c) and (d) of section 565 of the of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-4)
(referred to in this section as the ``animal rule'') as a
component of medical countermeasure advanced development
under the Biomedical Advanced Research and Development
Authority and regulatory review by the Food and Drug
Administration. In conducting such study, the Comptroller
General shall examine the following:
(1) The extent to which advanced development and review of
a medical countermeasure are coordinated between the
Biomedical Advanced Research and Development Authority and
the Food and Drug Administration, including activities that
facilitate appropriate and efficient design of studies to
support approval, licensure, and authorization under the
animal rule, consistent with the recommendations in the
animal rule guidance, issued pursuant to section 565(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
4(c)) and entitled ``Product Development Under the Animal
Rule: Guidance for Industry'' (issued in October 2015), to
resolve discrepancies in the design of adequate and well-
controlled efficacy studies conducted in animal models
related to the provision of substantial evidence of
effectiveness for the product approved, licensed, or
authorized under the animal rule.
(2) The consistency of the application of the animal rule
among and between review divisions within the Food and Drug
Administration.
(3) The flexibility pursuant to the animal rule to address
variations in countermeasure development and review
processes, including the extent to which qualified animal
models are adopted and used within the Food and Drug
Administration in regulatory decisionmaking with respect to
medical countermeasures.
(4) The extent to which the guidance issued under section
565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4(c)), entitled, ``Product Development Under the
Animal Rule: Guidance for Industry'' (issued in October
2015), has assisted in achieving the purposes described in
paragraphs (1), (2), and (3).
(b) Consultations.--In conducting the study under
subsection (a), the Comptroller General of the United States
shall consult with--
(1) the Federal agencies responsible for advancing,
reviewing, and procuring medical countermeasures, including
the Office of the Assistant Secretary for Preparedness and
Response, the Biomedical Advanced Research and Development
Authority, the Food and Drug Administration, and the
Department of Defense;
(2) manufacturers involved in the research and development
of medical countermeasures to address biological, chemical,
radiological, or nuclear threats; and
(3) other biodefense stakeholders, as applicable.
(c) Report.--Not later than 3 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report
containing the results of the study conducted under
subsection (a) and recommendations to improve the application
and consistency of the requirements under subsections (c) and
(d) of section 565 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-4) to support and expedite the research
and development of medical countermeasures, as applicable.
(d) Protection of National Security.--The Comptroller
General of the United States shall conduct the study and
issue the assessment and report under this section in a
manner that does not compromise national security.
SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING
TECHNOLOGIES AND THEIR POTENTIAL ROLE IN
NATIONAL SECURITY.
(a) Meeting.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall convene a meeting to discuss the potential role
advancements in genomic engineering technologies (including
genome editing technologies) may have in advancing national
health security. Such meeting shall be held in a manner that
does not compromise national security.
(2) Attendees.--The attendees of the meeting under
paragraph (1)--
(A) shall include--
(i) representatives from the Office of the Assistant
Secretary for Preparedness and Response, the National
Institutes of Health, the Centers for Disease Control and
Prevention, and the Food and Drug Administration; and
(ii) representatives from academic, private, and nonprofit
entities with expertise in genome engineering technologies,
biopharmaceuticals, medicine, or biodefense, and other
relevant stakeholders; and
(B) may include--
(i) other representatives from the Department of Health and
Human Services, as the Secretary determines appropriate; and
(ii) representatives from the Department of Homeland
Security, the Department of Defense, the Department of
Agriculture, and other departments, as the Secretary may
request for the meeting.
(3) Topics.--The meeting under paragraph (1) shall include
a discussion of--
(A) the current state of the science of genomic engineering
technologies related to national health security, including--
(i) medical countermeasure development, including potential
efficiencies in the development pathway and detection
technologies; and
(ii) the international and domestic regulation of products
utilizing genome editing technologies; and
(B) national security implications, including--
(i) capabilities of the United States to leverage genomic
engineering technologies as a part of the medical
countermeasure enterprise, including current applicable
research, development, and application efforts underway
within the Department of Defense;
(ii) the potential for state and non-state actors to
utilize genomic engineering technologies as a national health
security threat; and
(iii) security measures to monitor and assess the potential
threat that may result from utilization of genomic
engineering technologies and related technologies for the
purpose of compromising national health security.
(b) Report.--Not later than 270 days after the meeting
described in subsection (a) is held, the Assistant Secretary
for Preparedness and Response shall issue a report to the
congressional committees of jurisdiction on the topics
discussed at such meeting, and provide recommendations, as
applicable, to utilize innovations in genomic engineering
(including genome editing) and related technologies as a part
of preparedness and response activities to advance national
health security. Such report shall be issued in a manner that
does not compromise national security.
SEC. 606. REPORT ON VACCINES DEVELOPMENT.
Not later than one year after the date of the enactment of
this Act, the Secretary of Health and Human Services shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report describing
efforts and activities to coordinate with other countries and
international partners during recent public health
emergencies with respect to the research and advanced
research on, and development of, qualified pandemic or
epidemic products (as defined in section 319F-3 of the Public
Health Service Act (42 U.S.C. 247d-6d)). Such report may
include information regarding relevant work carried out under
section 319L(c)(5)(E) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(5)(E)), through public-private
partnerships, and through collaborations with other countries
to assist with or expedite the research and development of
qualified pandemic or epidemic products. Such report shall
not include information that may compromise national
security.
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND
HEALTH.
(a) Reauthorization of Mosquito Abatement for Safety and
Health Program.--Section 317S (42 U.S.C. 247b-21) is
amended--
(1) in subsection (a)(1)(B)--
(A) by inserting ``including programs to address emerging
infectious mosquito-borne diseases,'' after ``subdivisions
for control programs,''; and
(B) by inserting ``or improving existing control programs''
before the period at the end;
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``, including
improvement,'' after ``operation'';
[[Page H4261]]
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (ii), by striking ``or'' at the end;
(II) in clause (iii), by striking the semicolon at the end
and inserting ``, including an emerging infectious mosquito-
borne disease that presents a serious public health threat;
or''; and
(III) by adding at the end the following:
``(iv) a public health emergency due to the incidence or
prevalence of a mosquito-borne disease that presents a
serious public health threat;''; and
(ii) by amending subparagraph (D) to read as follows:
``(D)(i) is located in a State that has received a grant
under subsection (a); or
``(ii) that demonstrates to the Secretary that the control
program is consistent with existing State mosquito control
plans or policies, or other applicable State preparedness
plans.'';
(C) in paragraph (4)(C), by striking ``that extraordinary''
and all that follows through the period at the end and
inserting the following: ``that--
``(i) extraordinary economic conditions in the political
subdivision or consortium of political subdivisions involved
justify the waiver; or
``(ii) the geographical area covered by a political
subdivision or consortium for a grant under paragraph (1) has
an extreme mosquito control need due to--
``(I) the size or density of the potentially impacted human
population;
``(II) the size or density of a mosquito population that
requires heightened control; or
``(III) the severity of the mosquito-borne disease, such
that expected serious adverse health outcomes for the human
population justify the waiver.''; and
(D) by amending paragraph (6) to read as follows:
``(6) Number of grants.--A political subdivision or a
consortium of political subdivisions may not receive more
than one grant under paragraph (1).''; and
(3) in subsection (f)--
(A) in paragraph (1) by striking ``for fiscal year 2003,
and such sums as may be necessary for each of fiscal years
2004 through 2007'' and inserting ``for each of fiscal years
2019 through 2023'';
(B) in paragraph (2), by striking ``the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002'' and inserting ``this Act and other medical and public
health preparedness and response laws''; and
(C) in paragraph (3)--
(i) in the paragraph heading, by striking ``2004'' and
inserting ``2019''; and
(ii) by striking ``2004,'' and inserting ``2019,''.
(b) Epidemiology-Laboratory Capacity Grants.--Section 2821
(42 U.S.C. 300hh-31) is amended--
(1) in subsection (a)(1), by inserting ``, including
mosquito and other vector-borne diseases,'' after
``infectious diseases''; and
(2) in subsection (b), by striking ``2010 through 2013''
and inserting ``2019 through 2023''.
TITLE VII--MISCELLANEOUS PROVISIONS
SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.
(a) Veterans Affairs.--Section 8117(g) of title 38, United
States Code, is amended by striking ``2014 through 2018'' and
inserting ``2019 through 2023''.
(b) Vaccine Tracking and Distribution.--Section 319A(e) (42
U.S.C. 247d-1(e)) is amended by striking ``2014 through
2018'' and inserting ``2019 through 2023''.
(c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
247d(e)(8)) is amended by striking ``2018'' and inserting
``2023''.
(d) Strategic Innovation Partner.--Section
319L(c)(4)(E)(ix) (42 U.S.C. 247d-7e(c)(4)(E)(ix)) is amended
by striking ``2022'' and inserting ``2023''.
(e) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-
Hazards Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-
6a note) is amended--
(A) in subsection (a)(1)(A)--
(i) by striking ``Secretary of Health and Human Services
(referred to in this subsection as the `Secretary')'' and
inserting ``Secretary'';
(ii) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6b)) (as amended by this Act'';
(iii) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6a)) (as amended by this Act''; and
(iv) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6d)'';
(B) in subsection (b), by striking ``12-year'' and
inserting ``17-year'';
(C) by redesignating such section 405 as section 319L-1;
and
(D) by transferring such section 319L-1, as redesignated,
to the Public Health Service Act (42 U.S.C. 201 et seq.), to
appear after section 319L of such Act (42 U.S.C. 247d-7e).
(2) Conforming amendments.--
(A) Table of contents.--The table of contents in section
1(b) of the Pandemic and All-Hazards Preparedness Act (Public
Law 109-417) is amended by striking the item related to
section 405.
(B) Reference.--Section 319L(c)(4)(A)(iii) (42 U.S.C. 247d-
7e) is amended by striking ``section 405 of the Pandemic and
All-Hazards Preparedness Act'' and inserting ``section 319L-
1''.
(f) Inapplicability of Certain Provisions.--Subsection
(e)(1) of section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) Nondisclosure of information.--
``(i) In general.--Information described in clause (ii)
shall be deemed to be information described in section
552(b)(3) of title 5, United States Code.
``(ii) Information described.--The information described in
this clause is information relevant to programs of the
Department of Health and Human Services that could compromise
national security and reveal significant and not otherwise
publicly known vulnerabilities of existing medical or public
health defenses against chemical, biological, radiological,
or nuclear threats, and is comprised of--
``(I) specific technical data or scientific information
that is created or obtained during the countermeasure and
product advanced research and development carried out under
subsection (c);
``(II) information pertaining to the location security,
personnel, and research materials and methods of high-
containment laboratories conducting research with select
agents, toxins, or other agents with a material threat
determination under section 319F-2(c)(2); or
``(III) security and vulnerability assessments.'';
(2) by redesignating subparagraph (C) as subparagraph (D);
(3) by inserting after subparagraph (B) the following:
``(C) Reporting.--One year after the date of enactment of
the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, and annually thereafter, the
Secretary shall report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives on the number of
instances in which the Secretary has used the authority under
this subsection to withhold information from disclosure, as
well as the nature of any request under section 552 of title
5, United States Code that was denied using such
authority.''; and
(4) in subparagraph (D), as so redesignated, by striking
``12'' and inserting ``17''.
SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.
Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is
amended to read as follows:
``(d) Disclosures.--No Federal agency may disclose under
section 552 of title 5, United States Code any information
identifying the location at which materials in the stockpile
described in subsection (a) are stored, or other information
regarding the contents or deployment capability of the
stockpile that could compromise national security.''.
SEC. 703. CYBERSECURITY.
(a) Strategy for Public Health Preparedness and Response to
Cybersecurity Threats.--
(1) Strategy.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall prepare and submit to the relevant committees of
Congress a strategy for public health preparedness and
response to address cybersecurity threats (as defined in
section 102 of Cybersecurity Information Sharing Act of 2015
(6 U.S.C. 1501)) that present a threat to national health
security. Such strategy shall include--
(A) identifying the duties, functions, and preparedness
goals for which the Secretary is responsible in order to
prepare for and respond to such cybersecurity threats,
including metrics by which to measure success in meeting
preparedness goals;
(B) identifying gaps in public health capabilities to
achieve such preparedness goals; and
(C) strategies to address identified gaps and strengthen
public health emergency preparedness and response
capabilities to address such cybersecurity threats.
(2) Protection of national security.--The Secretary shall
make such strategy available to the Committee on Health,
Education, Labor, and Pensions of the Senate, the Committee
on Energy and Commerce of the House of Representatives, and
other congressional committees of jurisdiction, in a manner
that does not compromise national security.
(b) Coordination of Preparedness for and Response to All-
Hazards Public Health Emergencies.--Subparagraph (D) of
section 2811(b)(4) (42 U.S.C. 300hh-10(b)(4)) is amended to
read as follows:
``(D) Policy coordination and strategic direction.--Provide
integrated policy coordination and strategic direction,
before, during, and following public health emergencies, with
respect to all matters related to Federal public health and
medical preparedness and execution and deployment of the
Federal response for public health emergencies and incidents
covered by the National Response Plan described in section
504(a)(6) of the Homeland Security Act of 2002 (6 U.S.C.
314(a)(6)), or any successor plan; and such Federal responses
covered by the National Cybersecurity Incident Response Plan
developed under section 228(c) of the Homeland Security Act
of 2002 (6 U.S.C. 149(c)), including public health
emergencies or incidents related to cybersecurity threats
that present a threat to national health security.''.
SEC. 704. STRATEGY AND REPORT.
Not later than 14 days after the date of the enactment of
this Act, the Secretary of Health and Human Services, in
coordination
[[Page H4262]]
with the Assistant Secretary for Preparedness and Response
and the Assistant Secretary for the Administration on
Children and Families or other appropriate office, and in
collaboration with other departments, as appropriate, shall
submit to the Committee on Energy and Commerce of the House
of Representatives, the Committee on Health, Education,
Labor, and Pensions of the Senate, and other relevant
congressional committees--
(1) a formal strategy, including interdepartmental actions
and efforts to reunify children with their parents or
guardians, in all cases in which such children have been
separated from their parents or guardians as a result of the
initiative announced on April 6, 2018, and due to prosecution
under section 275(a) of the Immigration and Nationality Act
(8 U.S.C. 1325(a)), if the parent or guardian chooses such
reunification and the child--
(A) was separated from a parent or guardian and placed into
a facility funded by the Department of Health and Human
Services;
(B) as of the date of the enactment of this Act, remains in
the care of the Department of Health and Human Services; and
(C) can be safely reunited with such parent or guardian;
and
(2) a report on challenges and deficiencies related to the
oversight of, and care for, unaccompanied alien children and
appropriately reuniting such children with their parents or
guardians, and the actions taken to address any challenges
and deficiencies related to unaccompanied alien children in
the custody of the Department of Health and Human Services,
including deficiencies identified and publicly reported by
Congress, the Government Accountability Office, or the
inspectors general of the Department of Health and Human
Services or other Federal departments.
SEC. 705. TECHNICAL AMENDMENTS.
(a) Public Health Service Act.--Title III (42 U.S.C. 241 et
seq.) is amended--
(1) in paragraphs (1) and (5) of section 319F-1(a) (42
U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each
place such term appears and inserting ``section 319F(e)'';
and
(2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking
``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.
(b) Public Health Security Grants.--Section 319C-1(b)(2)
(42 U.S.C. 247d-3a(b)(2)) is amended--
(1) in subparagraph (C), by striking ``individuals,,'' and
inserting ``individuals,''; and
(2) in subparagraph (F), by striking ``make satisfactory
annual improvement and describe'' and inserting ``makes
satisfactory annual improvement and describes''.
(c) Emergency Use Instructions.--Subparagraph (A) of
section 564A(e)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb-3a(e)(2)) is amended by striking
``subsection (a)(1)(C)(i)'' and inserting ``subsection
(a)(1)(C)''.
(d) Products Held for Emergency Use.--Section 564B(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-
3b) is amended--
(1) in subparagraph (B), by inserting a comma after
``505''; and
(2) in subparagraph (C), by inserting ``or section 564A''
before the period at the end.
(e) Transparency.--Section 507(c)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(A) In general.--Nothing in'';
(2) by inserting ``or directing'' after ``authorizing'';
(3) by striking ``disclose any'' and inserting ``disclose--
``(i) any'';
(4) by striking the period and inserting ``; or''; and
(5) by adding at the end the following:
``(ii) in the case of a drug development tool that may be
used to support the development of a qualified
countermeasure, security countermeasure, or qualified
pandemic or epidemic product, as defined in sections 319F-1,
319F-2, and 319F-3, respectively, of the Public Health
Service Act, any information that the Secretary determines
has a significant potential to affect national security.
``(B) Public acknowledgment.--In the case that the
Secretary, pursuant to subparagraph (A)(ii), does not make
information publicly available, the Secretary shall provide
on the internet website of the Food and Drug Administration
an acknowledgment of the information that has not been
disclosed, pursuant to subparagraph (A)(ii).''.
The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from
California (Ms. Eshoo) and the gentlewoman from Indiana (Mrs. Brooks)
each will control 20 minutes.
The Chair recognizes the gentlewoman from California.
General Leave
Ms. ESHOO. Madam Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on S. 1379.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from California?
There was no objection.
Ms. ESHOO. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in support of this bipartisan legislation, the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act,
fondly called PAHPA, so that is the way I am going to refer to it.
In January of this year, the House passed a version of this
legislation by a vote of 401-17. It was the first suspension that was
considered in this new Congress, and so I am really very, very pleased
that the Senate finally took up this critical legislation and sent it
back to the House for us to consider once again.
The bill strips out an unrelated issue that the Senate had to
struggle with, and it simply includes the public health emergency and
response legislation that my wonderful partner, Representative Susan
Brooks, and I have worked on for over a year. Imagine how relieved we
are and thrilled we are to be on the floor today with this. Our
legislation reflects months of negotiations and compromise reached by
the House and Senate.
We know the importance of the bill we are considering today, and it
actually is critical to our national security.
In 2001, our country endured the horrific attacks on September 11 and
the anthrax attacks that followed shortly thereafter. Congress realized
at that time that our country was not prepared to coordinate responses
to mass casualty events or chemical attacks, and it is why I wrote the
legislation with then-Representative Richard Burr to address these
shortfalls. This bill updates that original legislation by directing
Federal agencies to respond to new and emerging threats and also
strengthen our Nation's existing preparedness and response programs.
This bill reauthorizes critical programs that ensure our Nation is
prepared to respond to naturally occurring and manmade disasters.
Events over the past few years--the ongoing measles outbreak,
destructive wildfires and hurricanes, and the reemergence of Ebola--as
well as the constant looming threat of a biological attack by another
nation or a hostile state enemy underscore the importance of this
legislation.
These threats are real, and our country must be prepared to
adequately respond to them. Our experience with each one of those
hazards reminds us that our country is not yet adequately prepared to
deal with potentially devastating, widespread public health crises.
That is why this legislation is so critical, and this reauthorization
meets the challenges that we face today and those we anticipate facing
in the future.
The bill provides the authorization and Federal resources to invest
in programs that allow the Biomedical Advanced Research and Development
Authority, or BARDA, to develop medical countermeasures for use after a
public health emergency and to address antimicrobial resistance. PAHPA-
I reauthorizes the HHS National Advisory Committee on Children and
Disasters and also authorizes the Children's Preparedness Unit at the
CDC.
It also establishes an advisory council for people with disabilities
and an advisory council on seniors to focus on the needs of these
special populations during a public health emergency.
{time} 1445
It also, very importantly, includes a proposal to prioritize bringing
nursing homes back onto the power grid at the same time as hospitals
after a disaster, and it includes provisions related to regional health
partnerships, pregnant and postpartum women, and environmental health.
PAHPA expired last September 30--that is, September 30 of 2018--so
reauthorizing these programs is imperative to our national security.
Madam Speaker, I am proud of the legislation. I urge my colleagues to
once again vote for it.
I have said this many times, but it is worth restating again: I
salute and couldn't have had a better, more dedicated partner in this
effort than Congresswoman Susan Brooks. We look forward to the bill
going directly to the President's desk and being signed into law so we
can get to work on other things.
Madam Speaker, I reserve the balance of my time.
Mrs. BROOKS of Indiana. Madam Speaker, I yield myself such time as I
may consume.
[[Page H4263]]
Madam Speaker, I rise today in support of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019, or PAHPA.
I am proud to have worked with my dear friend and colleague from
California, Representative Eshoo, who was one of the original authors
and a leader in the 2006 PAHPA bill and the lead author of the last
reauthorization in 2013.
Along with Representative Eshoo, this work would not have been done
without Chairman Pallone, Ranking Member Walden, and Representative Dr.
Burgess. We have worked closely with Senators Burr, Alexander, Casey,
and Murray to craft this reauthorization of PAHPA.
PAHPA is a bipartisan public health and national security effort to
ensure our Nation is better prepared to respond to public health
emergencies resulting from chemical, biological, radiological, or
nuclear attacks, whether it be from a terrorist group or nation-state,
a natural disaster or emerging infectious diseases.
I was the United States attorney for the Southern District of Indiana
during the 2001 anthrax attacks. In September of `01, shortly after 9/
11, the anthrax attacks infected more than 17 people and killed 5.
Not only was Congress a target, with letters containing anthrax
spores sent to Senators Daschle and Leahy, but even my own U.S.
attorney's office in Indiana dealt with a hoax when we received a
letter with powder inside.
It was a scary time because those types of letters were sent all
across the country. It was a very scary time for our Nation, the hoaxes
that I and others received, but it helped illustrate the importance of
having accurate diagnostics.
In the 18 years since then, these types of threats--the actual
threats of chemical, biological, radiological, and nuclear--continue to
grow. In fact, every day, our adversaries are looking for more
effective and faster ways to produce a threat. It is not a question of
if we will face a threat; it is a question of when.
People may not realize, but a single gallon of concentrated anthrax
can contain enough spores to kill every individual on the planet.
According to a 2017 report from the Harvard Kennedy School, the
Belfer Center for Science and International Affairs, in 2015, the North
Korean State media released a series of photographs of the Pyongyang
Biotechnical Institute. The photos revealed that North Korea could
produce military-sized batches of biological weapons--specifically,
anthrax--at this facility.
North Korea is believed to have started a biological weapons program
in the sixties and is now assumed to have several pathogens in
possession.
Smallpox is highly contagious, and individuals remain contagious
until that last smallpox scab falls off. Untreated smallpox is twice as
contagious as the flu and more than three times as deadly, potentially
killing every third person infected.
But, thanks to PAHPA and the work of the Energy and Commerce
Committee with the 21st Century Cures Act, we are more prepared for
biological threats and attacks. Last year, the FDA approved the first
drug ever to treat smallpox and approved an autoinjector which provides
that one-time dose of an antidote to block the effects of nerve agents.
The approval of TPOXX and Seizalam will help protect Americans from
biological attacks.
But the threats we are facing are not hypothetical. The ongoing Ebola
outbreak--and it is ongoing--is now the second largest outbreak in
history. Since August of 2018, more than 1,000 people in the DRC,
Democratic Republic of the Congo, have died from Ebola. More than 2,000
cases have been reported, with 14 new, confirmed cases just within the
last week.
We also know that Zika virus continues to be a threat. The majority
of people infected with Zika don't develop symptoms, but the Zika
infection during pregnancy can cause horrible congenital abnormalities.
Eighty-six countries have reported evidence of mosquito-transmitted
Zika.
I share this because of the threats like Ebola and Zika.
Reauthorizing and increasing funding for the BioShield Special Reserve
Fund and BARDA, the Biomedical Advanced Research and Development
Authority, are critically important.
PAHPA increases funding for BARDA from $2.8 billion to $7.1 billion
over 10 years because BARDA's work over the last decade has resulted in
FDA approvals of more than 42 different medical countermeasures.
Development of medical countermeasures is lengthy. It is a risky
endeavor. It is why sending a clear signal that BARDA remains a strong
and committed partner with academic institutions and the private sector
in these efforts is so important.
So, while the investments BARDA is making into innovative research
and new treatments are critical, it is also important that we continue
to address the threats that have been around for years.
In 1918, the pandemic influenza killed about 20 to 50 million people
around the globe, including 675,000 people here in the United States.
Experts predict we are due for another global pandemic influenza.
Research funded by BARDA has already significantly expanded our
domestic vaccine production capability, and the bill we are considering
today will authorize $250 million more for the Assistant Secretary for
Preparedness and Response, or the ASPR, to address threats like
pandemic influenza.
Specifically, PAHPA directs the ASPR to work to increase
manufacturing capacity and stockpile these medical countermeasures.
While the PAHPA bill we are considering today authorizes funding for
research into known threats like pan flu, it maintains the flexibility
that is the foundation of our medical countermeasure enterprise to deal
with the unknown threats for which we may have no defense.
PAHPA also improves State and local public health security by
reauthorizing the National Disaster Medical System so that we have the
needed workforce, the experts in the workforce, when facing a public
health emergency like we currently face right now with 981 measle cases
across 26 States.
The current number of measles cases is the highest number of cases in
the United States in nearly three decades, with just 41 new cases
reported last week. So this allows the ASPR to reassign and move health
professionals during public health emergencies.
PAHPA also ensures a coordinated healthcare response to natural
disasters. The many hurricanes--Florence, Harvey, Irma, Jose, and
Maria--killed hundreds of Americans and showed us we have to do better
to prioritize the needs of every person in our community. PAHPA does
that by prioritizing our most vulnerable populations: children,
seniors, and people with disabilities.
We can't forget about the volunteers who work to save lives in the
wake of natural disasters. In addition to Good Samaritan provisions
within PAHPA that will provide new liability protections for medical
professionals who volunteer after a disaster, this bill also ensures
that more healthcare professionals, like nurses and doctors, can be
hired and trained when facing a public health crisis by strengthening
our National Disaster Medical System.
And, very importantly, it ensures we have a robust supply of
vaccines; basic equipment like gloves, Hazmat suits, and masks; and
more in our strategic national stockpile located all across the country
so that these professionals have the equipment and the tools that they
need.
Finally, PAHPA includes provisions from the Subcommittee on Health
Ranking Member Burgess' MISSION ZERO bill. Today will be the fifth time
the House has passed these provisions that authorize grants to trauma
centers to enable military trauma teams to provide care at our centers.
These important provisions will integrate military trauma providers
into trainings and drills for public health emergencies to not only
allow civilians the chance to learn about the military's best
practices, but give our military trauma care providers the opportunity
to use their cutting-edge expertise without leaving the military.
This public health, national security bill is the result of months of
work, and I want to commend the Energy and Commerce staff on both sides
of the aisle and, particularly, our staffs--Catherine Knowles and
Rachel Fybel--for their tireless work in ensuring that this got through
both the House and the Senate.
[[Page H4264]]
Madam Speaker, I cannot emphasize enough how important it is to
reauthorize PAHPA. I urge all Members to support this piece of critical
legislation, and I reserve the balance of my time.
Ms. ESHOO. Madam Speaker, I reserve the balance of my time.
Mrs. BROOKS of Indiana. Madam Speaker, I yield 3 minutes to the
gentleman from Oregon (Mr. Walden), ranking member of the Committee on
Energy and Commerce. He had been chair at one time, when it passed one
time out of the House, but now is ranking. I want to thank him so much
for his work.
Mr. WALDEN. Madam Speaker, I thank both my friend from California and
my friend from Indiana, who really did amazing work on this
legislation--not once, but twice, and probably a few times in between--
to get it to this point.
I am delighted to stand on this House floor once again and support
PAHPA, the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act.
This is really important. I think my colleagues have spoken of the
specific reasons that we can talk about here on the House floor. In the
classified settings that we have had, we all know how serious this
threat is and how important it is for us to work together to address
it, and we have done that in the last Congress and now in this
Congress.
So, I want to thank my friend Mr. Pallone, who chairs the committee
now, for continuing this effort to advance this bill forward, and
especially thank Representatives Brooks and Eshoo for their tireless
work to really get this across the finish line.
PAHPA does enable critical partnerships between the Federal
Government and State and local authorities and the private sector. This
will help ensure that our country is responsibly prepared for and able
to respond to public health emergencies.
It is not a matter of if, as everyone said already, but when the next
pandemic or emergency will strike. From pandemic flu to cybersecurity
incidents, our government agencies at all levels must have the tools to
respond to these threats, and we must make sure they have them.
In my own State of Oregon, we face a constant threat from wildfires,
floods, air quality issues, and other things. But we also have begun to
prepare for what we are told will be a devastating earthquake at some
point, known as Cascadia, which could take thousands of lives in Oregon
and leave behind tens of billions of dollars worth of damage and
disable our major airport, take down bridges. Basically, everybody on
the west side of the State would have to come over to the east side.
This is predicted. Earthquakes have happened before; recorded history
shows it; and we are overdue.
So this is the kind of legislation that would help. It would make
sure that they can put a pallet load of the right drugs and medicines
on a plane and get it right there, and they will have a system all
ready to distribute that. That is just one of many things that this
legislation accomplishes.
Sending this to the President's desk is long overdue. I am glad we
are going to have this vote today. Our government officials need these
tools at their disposal, and I thank my colleagues for the terrific
work they have done to get us to this point.
Mrs. BROOKS of Indiana. Madam Speaker, I yield 3 minutes to the
gentleman from Georgia (Mr. Carter), a fellow Energy and Commerce
Committee member, the only pharmacist in Congress, who knows more about
these issues than most. I appreciate his partnership and work on this
important piece of legislation.
Mr. CARTER of Georgia. Madam Speaker, I thank the gentlewoman for
yielding.
Madam Speaker, I rise today in support of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act, also known as PAHPA.
It is a good thing we are here to vote on this bill today, but the
work on this issue has been going on for a while.
We held reauthorization hearings in the Energy and Commerce Committee
in June of last year and were able to pass the bill through the
committee and out of the House shortly thereafter.
We again passed PAHPA in January, which has continued to be
championed by my good friend Mrs. Brooks of Indiana.
PAHPA is important legislation that will improve our Nation's public
health, medical preparedness, and response capabilities for
emergencies. Whether it is a natural disaster, an accidental
catastrophe, or a deliberate act of terror, it is the contents of this
bill that will keep Americans safe.
This bill will upgrade our preparedness by boosting our domestic
biological surveillance systems and help upgrade our medical
countermeasures.
This bill also takes a particular look at how we address
antimicrobial resistance so we can help protect future generations from
the threat of widespread pandemic.
{time} 1500
Living on the Georgia coast, my district understands the threat of
natural disasters in the form of hurricanes all too well. This bill
improves our disaster response coordination, so we minimize the human
toll of these deadly storms.
Since funding expired on September 30th of last year, the House has
voted multiple times to reauthorize PAHPA. I look forward to President
Trump signing this vital, lifesaving legislation into law.
I urge my colleagues to support this legislation.
Mrs. BROOKS of Indiana. Madam Speaker, I am prepared to close.
I yield myself such time as I may consume.
Madam Speaker, I appreciate my colleagues for speaking out and their
support of this important legislation.
The provisions in PAHPA we are reauthorizing today do complement the
National Biodefense Strategy the administration released last fall, and
it will ensure that our Nation is better prepared. The administration's
National Biodefense Strategy is designed to improve the coordination
and communication between agencies, so the United States is better
protected against naturally-occurring threats, or whether they might be
deliberate attacks.
Again, I urge my colleagues to support this critical piece of
legislation. It would not have been possible but for the incredible
partnership of Congresswoman Eshoo and the leadership that she and her
office and the Energy and Commerce Committee has demonstrated in this
very important piece of public health and national security
legislation.
Madam Speaker, I yield back the balance of my time.
Ms. ESHOO. Madam Speaker, I yield myself such time as I may consume.
I would just like to make a few comments in closing because I don't
have any more speakers and assert my right to close last.
I think every good word that could be said about this legislation has
already been stated, so I want to urge all of my colleagues to vote
``aye'' on this. It is legislation that has been scrutinized and re-
scrutinized, and even though it has taken time and gone past its
reauthorization date, that makes it all the more important that it be
passed because the agencies really cannot do what we have been
describing, and this has gone on since last October.
I think that the bookends on this are national security and public
health preparedness for manmade disasters and others, and neither one
of these can be addressed by any individual. This has to be done by us
on behalf of our country.
So I want to thank Catherine Knowles for her very fine work in
working with Rachel Fybel from my office. We really pay tribute to you
because they have worked so hard every single day, not just for weeks,
not just for months, but well over a year to get us to this point.
I urge all colleagues to support this legislation. We are proud to
recommend it to them.
Madam Speaker, I yield back the balance of my time,
Ms. JACKSON LEE. Madam Speaker, I rise in strong support of S. 1379,
the ``Pandemic and All-Hazards Preparedness and Advancing Innovation
Act of 2019'' (PAHPAI), which increases our essential efforts to ensure
the United States is prepared to respond to national disasters and
crises.
After the horrific terrorist attacks of September 11, 2001 and the
preceding anthrax attacks, Congress recognized that the United
[[Page H4265]]
States was underprepared to respond to public health emergencies and
national disasters and passed the original Pandemic and All-Hazards
Preparedness Act, Pub. L. 109-417 to address this weakness.
PAHPAI was reauthorized in 2013, but in recent years, the threats to
our country have changed, and PAHPAI must be updated to ensure that we
are prepared to respond to increasing natural disasters, emerging
infectious diseases, and chemical, biological, and nuclear attacks.
S. 1379 has been adapted to meet the mounting challenges that face us
today and those that will face our children tomorrow.
As a biodefense bill, PAHPAI will further protect our country from
internal and external terrorists.
As a health care response bill, PAHPAI creates and ensures
coordinated healthcare efforts in the face of natural disasters such as
hurricanes.
This bill also addresses the nation's need for pandemic preparedness.
Texas has experienced pandemics first hand--with the first diagnosed
case of Ebola in the United States in 2014.
Thomas Eric Duncan after traveling from Africa to visit family
members in Dallas, Texas became ill.
He went to Texas Health Presbyterian Hospital Dallas for care but was
not admitted after presenting with a 103-degree temperature, and Ebola
symptoms.
At the time the CDC had alerted all doctors, hospitals, clinics, and
pharmacies with alerts to screen all patients for Ebola symptoms.
Mr. Duncan's Ebola symptoms worsened over the days following his
visit to Texas Health Presbyterian Hospital Dallas, and he returned by
ambulance to the hospital and only then was he finally admitted for
treatment.
By that time his condition had worsened, and Mr. Duncan died from
Ebola.
His death was a tragedy and the two nurses who were infected while
trying to care for him are heroes.
Two years later, in 2016, the Zika Virus pandemic reached Texas
carried by mosquitoes.
This disease attacked babies while developing in their mother's womb,
which destroyed brain tissue, resulting in severe brain and cranial
deformities.
Houston, Texas, has a tropical climate with many climatic
similarities with other states along the Gulf Coast, parts of Central
and South America as well as the Caribbean. Tropical climates are
hospitable to mosquitoes that carry the Zika Virus.
I have shared concerns among Federal, state, and local agency
officials regarding a need to have a plan to address future pandemics
our nation may face.
This bill will pave the way for much needed work in pandemic
preparedness.
PAHPAI will ensure that more health care professionals can be hired
and trained to prioritize vulnerable populations such as children, the
elderly, and people with disabilities.
To incentivize and protect practitioners, this bill will also provide
health care professionals who volunteer after natural disasters with
liability coverage.
To support disaster workers and devastated communities, PAHPAI will
also ensure the availability of health care supplies by stocking the
Strategic National Stockpiles, located across the United States, with
vaccines, gloves, masks, and more.
PAHPAI also renews and increases funding to the BioShield Special
Reserve Fund and Biomedical Advanced Research and Development Authority
(BARDA), which is invaluable to our response capabilities.
S. 1379 is essential to ensuring that the United States is prepared
to provide quality care to those in need after devastating events.
Madam Speaker, I urge my colleagues to join me in supporting S. 1379
to establish and strengthen the nation's emergency preparedness in the
face of health crises and national disasters.
The SPEAKER pro tempore. The question is on the motion offered by the
gentlewoman from California (Ms. Eshoo) that the House suspend the
rules and pass the bill, S. 1379.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.
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