Congressional Record, Volume 164 Issue 158 (Tuesday, September 25, 2018)

[Congressional Record Volume 164, Number 158 (Tuesday, September 25, 2018)]
[House]
[Pages H8759-H8789]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND ADVANCING INNOVATION ACT OF
2018

Mrs. BROOKS of Indiana. Mr. Speaker, I move to suspend the rules and
pass the bill (H.R. 6378) 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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows

H.R. 6378

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.

TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

Sec. 101. National Health Security Strategy.

TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

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

TITLE III--REACHING ALL COMMUNITIES

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

TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance,
and other significant threats.
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. Technical amendments.
Sec. 705. Formal strategy relating to children separated from parents
and guardians as a result of zero tolerance policy.
Sec. 706. Reporting relating to children separated from parents and
guardians as a result of zero tolerance policy.
Sec. 707. Technical correction.
Sec. 708. Savings clause.

TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

Section 2802 of the Public Health Service Act (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 of the Public Health
Service Act (42 U.S.C. 247d-3a) is amended by inserting after
subsection (j) the following:
``(k) Evaluation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018 and every 2 years
thereafter, the Secretary shall conduct an evaluation of the
evidence-based benchmarks and objective standards required
under subsection (g). Such evaluation shall be submitted to
the congressional committees of jurisdiction together with
the National Health Security Strategy under section 2802, at
such time as such strategy is submitted.
``(2) Content.--The evaluation under this paragraph shall
include--

[[Page H8760]]

``(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) of the Public
Health Service Act (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 of the
Public Health Service Act (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;
(E) in clause (x), as so redesignated, by inserting ``and''
after the semicolon; and
(F) by adding at the end the following:
``(xi) a description of how the entity will partner with
health care facilities, including hospitals and nursing homes
and other long-term care facilities, to promote and improve
public health preparedness and response; and
``(xii) a description of how, as appropriate and
practicable, the entity will include critical infrastructure
partners, such as utility companies within the entity's
jurisdiction, in planning pursuant to this subparagraph to
help ensure that critical infrastructure will remain
functioning during, or return to function as soon as
practicable after, a public health emergency.''.
(b) Exception Relating to Application of Certain
Requirements.--
(1) In general.--Section 319C-1(g) of the Public Health
Service Act (42 U.S.C. 247d-3a(g)) is amended--
(A) in paragraph (5)--
(i) by striking ``Beginning with fiscal year 2009'' and
inserting ``Beginning with fiscal year 2019'';
(ii) by striking ``for the immediately preceding fiscal
year'' and inserting ``for either of the two immediately
preceding fiscal years''; and
(iii) by striking ``2008'' and inserting ``2018''; and
(B) by amending subparagraph (A) of paragraph (6) 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 section 319C-1 or 319C-2:
``(i) For one (but not both) of the first two fiscal years
immediately following a fiscal year in which an entity
experienced a failure described in subparagraph (A) or (B) of
paragraph (5) by the entity, an amount equal to 10 percent of
the amount the entity was eligible to receive for the
respective fiscal year.
``(ii) For one (but not both) of the first two 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 of
the Public Health Service Act (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) of the Public Health
Service Act (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) of the Public Health Service Act (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 of the Public Health
Service Act (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,

[[Page H8761]]

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 2018 (including any amendments made by such
Act), to address new and emerging public health threats.
``(c) Considerations.--In identifying, developing, and
updating guidelines under subsection (b), the Assistant
Secretary for Preparedness and Response shall--
``(1) include input from hospitals and health care
facilities (including health care coalitions under section
319C-2), State, local, tribal, and territorial public health
departments, and health care or subject matter experts
(including experts with relevant expertise in chemical,
biological, radiological, or nuclear threats, including
emerging infectious diseases), as the Assistant Secretary
determines appropriate, to meet the goals under section
2802(b)(3);
``(2) 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) of the Public
Health Service Act (42 U.S.C. 247d-3b(i)(1)) is amended by
inserting after the first sentence the following ``In
submitting reports under this paragraph an entity shall
include information on the progress that the entity 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) of the Public Health
Service Act (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) of the
Public Health Service Act (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) of the Public
Health Service Act (42 U.S.C. 247d-3b(d)(1)(A)) is amended--
(A) in clause (i), by striking ``; and'' and inserting
``;'';
(B) by redesignating clause (ii) as clause (iii); and
(C) inserting after clause (i), the following:
``(ii) among one or more facilities in a regional health
care emergency system under section 319C-3; and''.

SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA
READINESS.

Title XII of the Public Health Service Act (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.

[[Page H8762]]

``(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 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 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.
``(2) 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.
``(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 are authorized to be appropriated $15,000,000
for each of fiscal years 2019 through 2023, of which--
``(1) \2/3\ of the amount made available each fiscal year
shall be made available for grants under subsection (a); and
``(2) \1/3\ of the amount made available each fiscal year
shall be made available for grants under subsection (b).''.

SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL
AWARENESS AND BIOSURVEILLANCE CAPABILITIES.

(a) Facilities, Capacities, and Biosurveillance
Capabilities.--Section 319D of the Public Health Service Act
(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,''; and
(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.--

[[Page H8763]]

``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2018, the Secretary, in
cooperation with health care providers, State, local, tribal,
and territorial public health officials, and relevant Federal
agencies (including the Office of the National Coordinator
for Health Information Technology and the National Institute
of Standards and Technology), shall, as necessary, adopt
technical and reporting standards, including standards for
interoperability as defined by section 3000, for networks
under paragraph (1) and update such standards as necessary.
Such standards shall be made available on the internet
website of the Department of Health and Human Services, in a
manner that does not compromise national security.
``(B) Deference to standards development organizations.--In
adopting and implementing standards under this subsection and
subsection (c), the Secretary shall give deference to
standards published by standards development organizations
and voluntary consensus-based standards entities.'';
(4) in subsection (c)--
(A) in paragraph (1)--
(i) by striking ``Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, the Secretary'' and inserting
``The Secretary'';
(ii) by inserting ``, and improve as applicable and
appropriate,'' after ``shall establish'';
(iii) by striking ``of rapid'' and inserting ``of, rapid'';
and
(iv) by striking ``such connectivity'' and inserting ``such
interoperability'';
(B) by amending paragraph (2) to read as follows:
``(2) Coordination and consultation.--In establishing and
improving the network under paragraph (1) the Secretary
shall--
``(A) facilitate coordination among agencies within the
Department of Health and Human Services that provide, or have
the potential to provide, information and data to, and
analyses for, the situational awareness and biosurveillance
network under paragraph (1), including coordination among
relevant agencies related to health care services, the
facilitation of health information exchange (including the
Office of the National Coordinator for Health Information
Technology), and public health emergency preparedness and
response; and
``(B) consult with the Secretary of Agriculture, the
Secretary of Commerce (and the Director of the National
Institute of Standards and Technology), the Secretary of
Defense, the Secretary of Homeland Security, 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 2018 and every 6 years
thereafter, the Secretary shall conduct a review of the
elements described in subparagraph (A). Such review shall
include a discussion of the addition of any elements pursuant
to clause (v), including elements added to advancing new
technologies, and identify any challenges in the
incorporation of elements under subparagraph (A). The
Secretary shall provide such review to the congressional
committees of jurisdiction.'';
(D) in paragraph (5)--
(i) by redesignating subparagraphs (A) through (D) as
clauses (i) through (iv), respectively, and adjusting the
margins accordingly;
(ii) by striking ``In establishing'' and inserting the
following:
``(A) In general.--In establishing'';
(iii) by adding at the end the following:
``(B) Public meeting.--
``(i) In general.--Not later than 180 days after the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Secretary shall convene
a public meeting for purposes of discussing and providing
input on the potential goals, functions, and uses of the
network described in paragraph (1) and incorporating the
elements described in paragraph (3)(A).
``(ii) Experts.--The public meeting shall include
representatives of relevant Federal agencies (including
representatives from the Office of the National Coordinator
for Health Information Technology and the National Institute
of Standards and Technology); State, local, tribal, and
territorial public health officials; stakeholders with
expertise in biosurveillance and situational awareness;
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 2018, 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 2018 and on an
annual basis thereafter, in accordance with the strategy and
implementation plan under this paragraph, the Secretary
shall, taking into account recommendations provided by the
National Biodefense Science Board, develop a budget plan
based on the strategy and implementation plan under this
section. Such budget plan shall include--
``(i) a summary of resources previously expended to
establish, improve, and utilize the nationwide public health
situational awareness and biosurveillance network under
paragraph (1);
``(ii) estimates of costs and resources needed to establish
and improve the network under paragraph (1) according to the
strategy and implementation plan under subparagraph (A);
``(iii) the identification of gaps and inefficiencies in
nationwide public health situational awareness and
biosurveillance capabilities, resources, and authorities
needed to address such gaps; and
``(iv) a strategy to minimize and address such gaps and
improve inefficiencies.'';
(G) in paragraph (7), as so redesignated--
(i) in subparagraph (A), by inserting ``(taking into
account zoonotic disease, including gaps in scientific
understanding of the interactions between human, animal, and
environmental health)'' after ``human health'';

[[Page H8764]]

(ii) in subparagraph (B)--

(I) by inserting ``and gaps in surveillance programs''
after ``surveillance programs''; and
(II) by striking ``; and'' and inserting a semicolon;

(iii) in subparagraph (C)--

(I) by inserting ``, animal health organizations related to
zoonotic disease,'' after ``health care entities''; and
(II) by striking the period and inserting ``; and''; and

(iv) by adding at the end the following:
``(D) provide recommendations to the Secretary on policies
and procedures to complete the steps described in this
paragraph in a manner that is consistent with section
2802.''; and
(H) by adding at the end the following:
``(8) Situational awareness and biosurveillance as a
national security priority.--The Secretary, on a periodic
basis as applicable and appropriate, shall meet with the
Director of National Intelligence to inform the development
and capabilities of the nationwide public health situational
awareness and biosurveillance network.'';
(5) in subsection (d)--
(A) in paragraph (1)--
(i) by inserting ``environmental health agencies,'' after
``public health agencies,''; and
(ii) by inserting ``immunization programs,'' after ``poison
control centers,''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking ``and'' at the end;
(ii) in subparagraph (C), by striking the period and
inserting ``; and''; and
(iii) by adding after subparagraph (C) the following:
``(D) an implementation plan that may include measurable
steps to achieve the purposes described in paragraph (1).'';
and
(C) by striking paragraph (5) and inserting the following:
``(5) Technical assistance.--The Secretary may provide
technical assistance to States, localities, tribes, and
territories or a consortium of States, localities, tribes,
and territories receiving an award under this subsection
regarding interoperability and the technical standards set
forth by the Secretary.'';
(6) by redesignating subsections (f) and (g) as subsections
(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 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 2018, 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 of the Public Health Service Act (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; and
(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 of the Public Health Service Act (42 U.S.C.
247d) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the first sentence, by inserting ``or if the
Secretary determines there is the significant potential for a
public health emergency, to allow the Secretary to rapidly
respond to the immediate needs resulting from such public
health emergency or potential public health emergency''
before the period; and
(ii) by inserting ``The Secretary shall plan for the
expedited distribution of funds to appropriate agencies and
entities.'' after the first sentence;
(B) by redesignating paragraph (2) as paragraph (3);
(C) by inserting after paragraph (1) the following:
``(2) Uses.--The Secretary may use amounts in the Fund
established under paragraph (1), to--
``(A) facilitate coordination between and among Federal,
State, local, tribal, and territorial entities and public and
private health care entities that the Secretary determines
may be affected by a public health emergency or potential
public health emergency 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

[[Page H8765]]

All-Hazards Preparedness and Advancing Innovation Act of
2018, the Secretary, in coordination with the Assistant
Secretary for Preparedness and Response, shall conduct a
review of the Fund under this section, and provide
recommendations to the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the
Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives
on policies to improve such Fund for the uses described in
paragraph (2).
``(5) GAO report.--Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Comptroller General of
the United States shall--
``(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 of the Public Health Service
Act (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 ``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) of the Public
Health Service Act (42 U.S.C. 247d-3a(b)(2)(A)(iv)) is
amended to read as follows:
``(iv) a description of the mechanism the entity will
implement to utilize the Emergency Management Assistance
Compact, or other mutual aid agreement, for medical and
public health mutual aid, and, as appropriate, the activities
such entity will implement pursuant to section 319I to
improve enrollment and coordination of volunteer health care
professionals seeking to provide medical services during a
public health emergency, which may include--
``(I) providing a public method of communication for
purposes of volunteer coordination (such as a phone number);
``(II) providing for optional registration to participate
in volunteer services during processes related to State
medical licensing, registration, or certification or renewal
of such licensing, registration or certification; or
``(III) other mechanisms as the State determines
appropriate;''.

SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUNTEER HEALTH
CARE PROFESSIONALS.

(a) In General.--Title II of the Public Health Service Act
(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;
and
``(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 supercede 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 2018.
``(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

[[Page H8766]]

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 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) of the Public Health
Service Act (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) of the Public Health Service Act (42
U.S.C. 300hh-11(b)(2)) is amended to read as follows:
``(2) Joint review and medical surge capacity strategic
plan.--
``(A) Review.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Secretary, in
coordination with the Secretary of Homeland Security, the
Secretary of Defense, and the Secretary of Veterans Affairs,
shall conduct a joint review of the National Disaster Medical
System. Such review shall include--
``(i) an evaluation of medical surge capacity, as described
in section 2803(a);
``(ii) an assessment of the available workforce of the
intermittent disaster response personnel described in
subsection (c);
``(iii) the capacity of the workforce described in clause
(ii) to respond to all hazards, including capacity to
simultaneously respond to multiple public health emergencies
and the capacity to respond to a nationwide public health
emergency;
``(iv) the effectiveness of efforts to recruit, retain, and
train such workforce; and
``(v) gaps that may exist in such workforce and
recommendations for addressing such gaps.
``(B) Updates.--As part of the National Health Security
Strategy under section 2802, the Secretary shall update the
findings from the review under subparagraph (A) and provide
recommendations to modify the policies of the National
Disaster Medical System as necessary.''.
(3) Notification of shortage.--Section 2812(c) of the
Public Health Service Act (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) of
the Public Health Service Act (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) of the Public Health
Service Act (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) of
the Public Health Service Act (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 of the Public Health Service Act (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 are 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) of the Public Health
Service Act (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 eligible individuals of any effect such
designation may have on other benefits for which such
individual are 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:

[[Page H8767]]

``(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) of
the Public Health Service Act (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), an emergency or
major disaster declared by the President under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, or the
National Emergencies Act, including by establishing methods
to exchange critical information and deliver products
consumed or used to preserve, protect, or sustain life,
health, or safety, and sharing of specialized expertise.''.
(b) Manufacturing Capacity.--Section 2811(d)(2)(C) of the
Public Health Service Act (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) of the Public Health Service
Act (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) of
the Public Health Service Act (42 U.S.C. 247d-7e(c)(6)) is
amended--
(1) by striking ``elderly'' and inserting ``senior
citizens''; and
(2) by inserting ``with relevant characteristics that
warrant consideration during the process of researching and
developing such countermeasures and products'' before the
period.
(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 of the Public Health Service Act (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 of the Public Health
Service Act (42 U.S.C. 300hh-10a) is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and inserting
``25''; and
(B) by striking paragraph (2) and inserting the following:

[[Page H8768]]

``(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 non-voting 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 2018, or
appointees who are initially appointed after such date of
enactment, in order to provide for a staggered term of
appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than 2 of such terms
may be served consecutively.'';
(3) in subsection (e), by adding at the end ``At least one
meeting per year shall be an in-person meeting.'';
(4) by redesignating subsection (f) as subsection (g);
(5) by inserting after subsection (e) the following:
``(f) Coordination.--The Secretary shall coordinate duties
and activities authorized under this section in accordance
with section 2811D.''; and
(6) in subsection (g), as so redesignated, by striking
``2018'' and inserting ``2023''.
(b) Authorizing the National Advisory Committee on Seniors
and Disasters.--Subtitle B of title XXVIII of the Public
Health Service Act (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 non-
voting 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,
territorial, or tribal 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 of
the Public Health Service Act (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 non-
voting 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.

[[Page H8769]]

``(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,
territorial, or tribal 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 of the Public Health Service Act (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 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 of the Public Health Service Act (42 U.S.C.
300hh-10) is amended--
(1) in subsection (b)--
(A) 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
(B) 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.''; and
(2) by adding at the end the following:
``(f) Protection of National Security From Threats.--
``(1) In general.--In carrying out the duties under
subsection (b)(3), the Assistant Secretary for Preparedness
and Response shall implement strategic initiatives or
activities to address threats, including pandemic influenza,
that pose a significant level of risk to public health and
national security based on the characteristics of such
threat, which may also include a chemical, biological,
radiological, or nuclear agent, including threats with a
significant potential to become a pandemic. Such initiatives
shall include activities to accelerate and support the
advanced research, development, manufacturing capacity,
procurement, and stockpiling of countermeasures, including
initiatives under section 319L(c)(4)(F). Such activities may
also include those related to readiness to respond to
pandemic influenza threats by supporting the development and
manufacturing of influenza virus seeds, clinical trial lots,
and stockpiles of novel influenza strains.
``(2) Authorization of appropriations.--
``(A) In general.--For purposes of carrying out this
subsection, there is authorized to be appropriated
$250,000,000 for each of fiscal years 2019 through 2023.
``(B) Supplement, not supplant.--Funds appropriated under
this subsection shall be used to supplement and not supplant
funds provided under section 319L(e) and section 319F-2(g).
``(C) Documentation required.--The Assistant Secretary for
Preparedness and Response shall, as required under subsection
(b)(7), document amounts expended for purposes of carrying
out this subsection, including amounts appropriated to the
Public Health and Social Services Emergency Fund under title
II of Division H of the Consolidated Appropriations Act, 2018
(Public Law 115-141), as applicable to section
319L(c)(4)(F).''.

SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.

(a) In General.--Title XXVIII is amended by inserting after
section 2811 of the Public Health Service Act (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).

[[Page H8770]]

``(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)
of the Public Health Service Act (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 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) of the Public Health
Service Act (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 annually,
beginning on March 15, 2019, to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, in a manner that does not compromise
national security.
``(B) Additions, modifications, and replenishments.--Each
annual threat-based review under subparagraph (A) shall, for
each new or modified countermeasure procurement or
replenishment, provide--
``(i) information regarding--

``(I) the quantities of the additional or modified
countermeasure procured for, or contracted to be procured
for, the stockpile;
``(II) planning considerations for appropriate
manufacturing capacity and capability to meet the goals of
such additions or modifications (without disclosing
proprietary information), including consideration of the
effect such additions or modifications may have on the
availability of such products and ancillary medical supplies
in the health care system;
``(III) the presence or lack of a commercial market for the
countermeasure at the time of procurement;
``(IV) the emergency health security threat or threats such
countermeasure procurement is intended to address, including
whether such procurement is consistent with meeting emergency
health security needs associated with such threat or threats;
``(V) an assessment of whether the emergency health
security threat or threats described in subclause (IV) could
be addressed in a manner that better utilizes the resources
of the stockpile and permits the greatest possible increase
in the level of emergency preparedness to address such
threats;
``(VI) whether such countermeasure is replenishing an
expiring or expired countermeasure, is a different
countermeasure with the same indication that is replacing an
expiring or expired countermeasure, or is a new addition to
the stockpile;
``(VII) a description of how such additions or
modifications align with projected investments under previous
countermeasures budget plans under section 2811(b)(7),
including expected life-cycle costs, expenditures related to
countermeasure procurement to address the threat or threats
described in subclause (IV), replenishment dates (including
the ability to extend the maximum shelf life of a
countermeasure), and the manufacturing capacity required to
replenish such countermeasure; and
``(VIII) appropriate protocols and processes for the
deployment, distribution, or dispensing of the countermeasure
at the State and local level, including plans for relevant
capabilities of State and local entities to dispense,
distribute, and administer the countermeasure; and

``(ii) an assurance, which need not be provided in advance
of procurement, that for each countermeasure procured or
replenished under this subsection, the Secretary completed a
review addressing each item listed under this subsection in
advance of such procurement or replenishment.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A), by inserting ``and the Public
Health Emergency Medical Countermeasures Enterprise
established under section 2811-1'' before the semicolon;
(B) in subparagraph (C), by inserting ``, and the
availability, deployment, dispensing, and administration of
countermeasures'' before the semicolon;
(C) by amending subparagraph (E) to read as follows:
``(E) devise plans for effective and timely supply-chain
management of the stockpile, in consultation with the
Director of the Centers for Disease Control and Prevention,
the Assistant Secretary for Preparedness and Response, the
Secretary of Transportation, the Secretary of Homeland
Security, the Secretary of Veterans Affairs, and the heads of
other appropriate Federal agencies; State, local, tribal, and
territorial agencies; and the public and private health care
infrastructure, as applicable, taking into account the
manufacturing capacity and other available sources of
products and appropriate alternatives to supplies in the
stockpile;'';
(D) in subparagraph (G), by striking ``; and'' and
inserting a semicolon;
(E) in subparagraph (H), by striking the period and
inserting a semicolon; and
(F) by adding at the end the following:
``(I) ensure that each countermeasure or product under
consideration for procurement pursuant to this subsection
receives the same consideration regardless of whether such
countermeasure or product receives or had received funding
under section 319L, including with respect to whether the
countermeasure or product is most appropriate to meet the
emergency health security needs of the United States; and
``(J) provide assistance, including technical assistance,
to maintain and improve State and local public health
preparedness capabilities to distribute and dispense medical
countermeasures and products from the stockpile, as
appropriate.''; and
(5) by adding at the end the following:
``(5) GAO report.--
``(A) In general.--Not later than 3 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, and every 5 years
thereafter, the Comptroller General of the United States
shall conduct a review of any changes to the contents or
management of the stockpile since January 1, 2015. Such
review shall include--
``(i) an assessment of the comprehensiveness and
completeness of each 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

[[Page H8771]]

``(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 2018 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
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 and 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) of the Public Health Service
Act (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 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) Emerging Infectious Disease Program.--Section 319L of
the Public Health Service Act (42 U.S.C. 247d-7e) is
amended--
(1) by redesignating subsections (d), (e), and (f) as
subsections (e), (f), and (g), respectively; and
(2) by inserting after subsection (c) the following new
subsections:
``(d) Emerging Infectious Disease Program.--
``(1) In general.--The Secretary, acting through the
Director of BARDA, shall establish and implement a program
that supports--
``(A) advanced research and development activities for
qualified pandemic or epidemic products; and
``(B) manufacturing infrastructure activities with respect
to an emerging infectious disease.
``(2) Funding.--
``(A) In general.--To carry out paragraph (1), there is
authorized to be appropriated $250,000,000 for each of fiscal
years 2019 through 2023, to remain available until expended.
``(B) Supplement not supplant.--Any funds provided to the
Secretary under this paragraph shall be used to supplement
and not supplant any other Federal funds provided to carry
out paragraph (1).''.

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

Section 351A(k) of the Public Health Service Act (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 2018, 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) of the Public Health Service Act (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 post-
deployment 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) of the Public Health
Service Act (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) of the Public Health Service Act (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

[[Page H8772]]

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)
of the Public Health Service Act (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.--Subsection (e)(2) of section 319L of the Public
Health Service Act (42 U.S.C. 247d-7e), as redesignated by
section 404(b), 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.

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

``SEC. 319E-1. ADVISORY COUNCIL ON COMBATING ANTIBIOTIC-
RESISTANT BACTERIA.

``(a) Definitions.--In this section:
``(1) Action plan.--The term `Action Plan' means the Action
Plan described in section 319E(a)(1).
``(2) Advisory council.--The term `Advisory Council' means
the Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria established by Executive Order 13676 of
September 18, 2014 (79 Fed. Reg. 56931; relating to combating
antibiotic-resistant bacteria).
``(3) National strategy.--The term `National Strategy'
means the National Strategy for Combating Antibiotic-
Resistant Bacteria issued by the White House in September
2014, and any subsequent update to such strategy or a
successor strategy.
``(b) Advisory Council.--The Advisory Council shall provide
advice, information, and recommendations to the Secretary
regarding programs and policies intended to support and
evaluate the implementation of Executive Order 13676 of
September 18, 2014 (79 Fed. Reg. 56931; relating to combating
antibiotic-resistant bacteria), including the National
Strategy, and the Action Plan.
``(c) Meetings and Duties.--
``(1) Meetings.--The Advisory Council shall meet as the
Chair determines appropriate but not less than twice per
year, and, to the extent practicable, in conjunction with
meetings of the task force described in section 319E.
``(2) Recommendations.--The Advisory Council shall make
recommendations to the Secretary, in consultation with the
Secretary of Agriculture and the Secretary of Defense,
regarding programs and policies intended to--
``(A) preserve the effectiveness of antibiotics by
optimizing their use;
``(B) advance research to develop improved methods for
combating antibiotic resistance and conducting antimicrobial
stewardship, as defined in section 319E(h)(3);
``(C) strengthen surveillance of antibiotic-resistant
bacterial infections;
``(D) prevent the transmission of antibiotic-resistant
bacterial infections;
``(E) advance the development of rapid point-of-care and
agricultural diagnostics;
``(F) further research on new treatments for bacterial
infections;
``(G) develop alternatives to antibiotics for animal health
purposes;
``(H) maximize the dissemination of up-to-date information
on the appropriate and proper use of antibiotics to the
general public and human and animal health care providers;
and
``(I) improve international coordination of efforts to
combat antibiotic resistance.
``(3) 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) (commonly referred to
as the `Combating Antibiotic-Resistant Bacteria Task
Force').''.

TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

Section 319L(c)(4)(D)(iii) of the Public Health Service Act
(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 of the Public Health Service Act (42 U.S.C.
247d-7e) is amended--
(1) in subsection (a)(3), by striking ``, such as'' and all
that follows through ``Code'';
(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 the 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 such products to medical
countermeasure master files, 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'').
(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 help 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 re-submission 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

[[Page H8773]]

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) Acknowledgement of the 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) unless such
disclosure includes 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 2018), 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 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

[[Page H8774]]

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

(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 heading, by striking ``2004'' and inserting
``2019''; and
(ii) by striking ``2004'' and inserting ``2019''.
(b) Epidemiology-Laboratory Capacity Grants.--Section 2821
of the Public Health Service Act (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) by amending subsection (b) to read as follows:
``(b) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$40,000,000 for each of fiscal years 2019 through 2023.''.

TITLE VII--MISCELLANEOUS PROVISIONS

SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

(a) Vaccine Tracking and Distribution.--Section 319A(e) of
the Public Health Service Act (42 U.S.C. 247d-1(e)) is
amended by striking ``2014 through 2018'' and inserting
``2019 through 2023''.
(b) Temporary Reassignment.--Section 319(e)(8) of the
Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended
by striking ``2018'' and inserting ``2023''.
(c) Strategic Innovation Partner.--Section
319L(c)(4)(E)(ix) of the Public Health Service Act (42 U.S.C.
247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and
inserting ``2023''.
(d) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-
Hazards Preparedness Act (42 U.S.C. 247d-6a note) is
amended--
(A) by redesignating such section as section 319L-1;
(B) by transferring such section to the Public Health
Service Act (42 U.S.C. 201 et seq.), to appear after section
319L of such Act (42 U.S.C. 247d-7e);
(C) in subsection (a)(1)(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)''; and
(D) in subsection (b), by striking ``12-year'' and
inserting ``17-year''.
(2) Conforming amendment.--The table of contents in section
1(b) of the Pandemic and All-Hazards Preparedness Act (Public
Law 109-417) is amended by striking the item related to
section 405.

[[Page H8775]]

(e) Inapplicability of Certain Provisions.--Subsection
(e)(1) of section 319L of the Public Health Service Act (42
U.S.C. 247d-7e) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) Non-disclosure 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 2018, 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 of the Public Health
Service Act (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) of the Public Health Service Act (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. TECHNICAL AMENDMENTS.

(a) Public Health Service Act.--Title III of the Public
Health Service Act (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) of
the Public Health Service Act (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 striking ``disclose any'' and inserting ``disclose
or direct--
``(i) any'';
(3) by striking the period and inserting ``; or''; and
(4) 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), does not make
information publicly available, the Secretary shall provide
on the internet website of the Food and Drug Administration
an acknowledgement of the information that has not been
disclosed, pursuant to subparagraph (A).''.

SEC. 705. FORMAL STRATEGY RELATING TO CHILDREN SEPARATED FROM
PARENTS AND GUARDIANS AS A RESULT OF ZERO
TOLERANCE POLICY.

Not later than 14 days after the date of enactment of this
Act, the Assistant Secretary for Preparedness and Response
and the Assistant Secretary for the Administration on
Children and Families shall submit to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a formal strategy to reunify with their parent or
guardian, if the parent or guardian chooses such
reunification, each child who--
(1) as a result of the initiative announced on April 6,
2018, and due to prosecution under section 1325(a) of title
8, United States Code;
(2) was separated from their parent or guardian and placed
into a facility funded by the Department of Health and Human
Services; and
(3) can be safely reunited with such parent or guardian.

SEC. 706. REPORTING RELATING TO CHILDREN SEPARATED FROM
PARENTS AND GUARDIANS AS A RESULT OF ZERO
TOLERANCE POLICY.

Beginning on the date of enactment of this Act, the
Assistant Secretary for Preparedness and Response and the
Assistant Secretary for the Administration on Children and
Families shall submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate weekly reports
on the status and welfare of the children who, as a result of
the ``zero tolerance'' policy, were separated from their
parent or guardian and are awaiting reunification with their
parent or guardian, as well as the number of such children in
facilities funded by the Department of Health and Human
Services.

SEC. 707. TECHNICAL CORRECTION.

Section 801(e)(4)(E)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by
striking ``subparagraph'' both places it appears in subclause
(I) and subclause (II) and inserting ``paragraph''.

SEC. 708. SAVINGS CLAUSE.

Nothing in this Act shall be construed as reducing or
limiting the authorities vested in any other Federal agency
by any other Federal law.

The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from
Indiana (Mrs. Brooks) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentlewoman from Indiana.

[[Page H8776]]

General Leave

Mrs. BROOKS of Indiana. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days in which to revise and extend their
remarks and insert extraneous materials in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Indiana?
There was no objection.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise today to speak in support of the Pandemic and
All-Hazards Preparedness and Advancing Innovation Act of 2018, known as
PAHPA. I am proud to have introduced this important bill with Energy
and Commerce Chairman Greg Walden, Ranking Member Frank Pallone, and
my good friend Representative Eshoo, who is one of the original authors
of the 2006 PAHPA bill and lead author of the last reauthorization in
2013.
This bipartisan public health and national security effort will
ensure our Nation is better prepared to respond to natural disasters
like hurricanes; emerging infectious diseases like Zika and Ebola; and
chemical, biological, radiological, or nuclear attacks, whether from
terrorist groups or from nation-states.
Seventeen years ago, Congress was the target of a biological attack
when letters laced with anthrax arrived in Member offices just days or
soon after the 9/11 terrorist attacks. In the aftermath of 9/11, the
Blue Ribbon Study Panel on Biodefense was formed. It was led by
bipartisan leaders: former Senator Joe Lieberman, former Governor Tom
Ridge, and many others.
In October 2015, after extensive discussions around the country where
they learned from experts, they created their ``National Blueprint for
Biodefense,'' which provided us with a roadmap in drafting this
important legislation.
I was the United States Attorney for the Southern District of Indiana
during those 2001 anthrax attacks, and my own office dealt with an
anthrax hoax when we received a letter with white powder inside. Of
course, at the time, we didn't know it was a hoax. It was incredibly
stressful for that staff member, who had to worry about their very own
health. But that personal experience illustrated to me the importance
of preparedness and sparked my interest in biodefense.
In the years since then, we know that the threat of a chemical,
biological, radiological, or nuclear incident continues to grow. Every
day, our adversaries are looking for more effective and faster ways to
reduce the threat. It is not really a question of if we face the
threat. It is a question of when.
Thanks to PAHPA and the 21st Century Cures Act, we are more prepared
than ever for biological threats and attacks.
In July of just this last year, the FDA approved the first drug to
treat smallpox. It is called TPOXX. But TPOXX isn't the only recent
approval at the FDA. In July, the FDA also approved an autoinjector
that provides a one-time dose of an antidote to block effects of a
nerve agent. This new antidote and TPOXX will help protect Americans
from biological attacks.
But PAHPA is much more than just a biodefense bill. It also ensures a
coordinated healthcare response, whether to hurricanes or other natural
disasters.
Florence has just hit the East Coast and residents in both North and
South Carolina are still recovering and dealing with ongoing flooding.
During the 2017 hurricane season, whether it was Hurricane Harvey,
Irma, Jose, or Maria, far too many Americans were killed. It showed us
that we need to do better to prioritize the needs of every person in
our communities.
The PAHPA bill we are considering today does just that. It
prioritizes our Nation's most vulnerable populations: our children,
senior citizens, and those with disabilities. It reauthorizes the
advisory committee focused on the specific needs of children and
creates new advisory committees to ensure the needs of the elderly and
those with disabilities are considered.
The bill provides liability protections for healthcare professionals
who volunteer after medical disasters. In addition to these types of
Good Samaritan provisions, the bill ensures more healthcare
professionals like nurses, doctors, and others can be hired and trained
when facing a public health crisis by strengthening our National
Disaster Medical System, which provides grants to our regional
healthcare network.
It also ensures we have a robust supply of vaccines and basic
equipment like gloves, hazmat suits, masks, personal protective gear,
and more in our strategic national stockpiles located all across the
country, so that our healthcare professionals and first responders have
what they need.
PAHPA ensures our preparedness and response capabilities will include
a robust pipeline of medical countermeasures by reauthorizing and
increasing funding for the BioShield Special Reserve Fund and BARDA,
the Biomedical Advanced Research and Development Authority.
BARDA's work over the last decade has resulted in FDA approvals for
more than 42 different medical countermeasures. The development of
medical countermeasures is a lengthy and often risky endeavor, which 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 very important.
Last week, we saw even another example of a success of research
funded by BARDA when FDA approved a product called ReCell, the first
spray-on skin product ever approved for use in the United States. This
new treatment will help treat burn victims so they can heal faster and
with less risk of infection from painful skin grafts. By using a piece
of a patient's skin about the size of a credit card, a doctor can turn
it into a single cell-based solution that can be sprayed over the
patient's burns so that new skin can grow and replace the damaged skin.
These types of investments BARDA is making into innovative research
are critical, but it is also important that we continue to address
threats that have been around for years.
It has been 100 years since the 1918 pandemic influenza killed
millions of people around the globe, including 675,000 Americans. Some
experts predict that we are actually due for the potential of another
global pandemic influenza.
To address that threat, the bill we are considering today authorizes
$250 million for the Assistant Secretary for Preparedness and Response,
the ASPR, to address threats like pandemic influenza. Specifically, the
bill directs the ASPR to work to increase manufacturing capacity and
stockpile medical countermeasures.
While the PAHPA bill we are considering today authorizes funding for
research into known threats like pandemic influenza, it also maintains
the flexibility that is the foundation of our medical countermeasure
enterprise to deal with unknown threats for which we may have no
defense today.
Even today, the Democratic Republic of the Congo continues to deal
with an ongoing Ebola outbreak. In order to ensure we are better
prepared when we face an outbreak like Ebola or Zika, the bill we are
considering today does three important things.
First, it improves the existing emergency response fund so that the
Secretary of Health and Human Services does not have to wait on
approval from Congress to immediately fund response measures needed to
contain an outbreak and save lives. This emergency response fund will
create a bridge so that immediate funding is available, so we can then
supplement with an emergency appropriations bill later.
Secondly, the bill requires GAO to conduct a review of the emergency
response fund to help appropriators decide what funding levels and
resources are needed.
The third thing the bill does to help address threats like Ebola and
Zika is to authorize $250 million in funding for an emerging infectious
disease program so that BARDA can invest in new research.
The PAHPA bill reauthorization we are considering is the process of
months of committee work in both the House and the Senate, and I want
to thank all the staff members and all of the organizations, everyone
who has been involved, and all the Members who have participated,
whether it is subcommittee or committee hearings on this bill,
examining our response to threats. I thank everyone involved for their
dedication and commitment to

[[Page H8777]]

making sure we have the procedures, resources, and support in place to
protect our fellow citizens from public health and national security
threats.
I can't emphasize enough how critically important it is to
reauthorize PAHPA. We have a duty as Members of Congress to keep
Americans safe and secure. This bill is an essential component of
accomplishing that goal. I urge all Members to support this critical
bipartisan piece of legislation.
Mr. Speaker, I include in the Record letters from many organizations
that support the bill.

Adult Vaccine Access Coalition,

July 23, 2018.
Hon. Susan W. Brooks,
Member of Congress,
Washington, DC.
Hon. Anna Eshoo,
Member of Congress,
Washington, DC.
Dear Representatives Brooks and Eshoo: On behalf of the
Adult Vaccine Access Coalition (AVAC), we are pleased to
express our support for bipartisan legislation that recently
passed the House Energy and Commerce Committee, ``Pandemic
and All-Hazards Preparedness Reauthorization Act (PAHPA) of
2018''.
AVAC includes more than fifty organizational leaders in
health and public health who are committed to raising
awareness of and engaging in advocacy on the importance of
adult immunization. AVAC priorities and objectives are driven
by a consensus process with the goal of enabling stakeholders
to have a voice in the effort to improve access to and
utilization of adult immunizations.
The bipartisan reauthorization of the PAHPA provides
improvements to key preparedness and response programs,
enhances personnel and hiring authorities, as well as
prioritizes cybersecurity in health care and provides
necessary resources for the development of medical
countermeasures for pandemic influenza and emerging
infectious diseases. We are delighted the Managers' Amendment
included references to immunization programs and immunization
information systems under Section 319D. These additions will
help to strengthen and enhance coordination and integrate
immunization programs and immunization information systems
(IIS) capabilities into public health emergency preparedness,
planning, and response activities.
Immunization Information Systems (IIS), or registries,
confidential, population-based, computerized systems can
record immunization doses administered by participating
providers to persons residing within a given jurisdiction.
They provide state and local public health agencies aggregate
data on immunization coverage rates for disease surveillance
and program operations. IIS' can serve as a vital component
for emergency preparedness and response activities and are an
optimal tool for use during a pandemic or other emerging
infectious disease event by enabling communication with
providers, identifying variations in access and utilization
of immunization, and enabling implementation of targeted
strategies during emergency preparedness and response
activities.
Congratulations on putting together a strong, bipartisan
reauthorization package that reflects many of the important
priorities shared by stakeholders. We look forward to working
with you throughout the process to enact the 2018 Pandemic
and All-Hazards Preparedness Reauthorization Act.
Sincerely,
Lisa Foster,
AVAC Manager.
Abby Bownas,
AVAC Manager.
____

Alliance for Biosecurity,

U.S. Chamber of Commerce,

July 27, 2018.
To the Members of the U.S. House of Representatives: On
behalf of the Alliance for Biosecurity and the U.S. Chamber
of Commerce, we support H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018,
and urge the House to pass this bipartisan legislation before
the Pandemic and All-Hazards Preparedness Act (PAHPA) expires
at the end of September 2018. H.R. 6378 is central to
protecting American citizens, organizations, and communities
against natural and man-made biosecurity hazards.
H.R. 6378 would authorize crucial funding for the Project
BioShield Special Reserve Fund and Biomedical Advanced
Research and Development Authority (BARDA). However, we urge
policymakers to account for inflation to ensure that future
spending levels adequately support the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE)
Strategy and implementation Plan, the BARDA Strategic Plan,
and related efforts.
H.R. 6378 would establish several important programs within
BARDA, especially a Pandemic Influenza Program to support
research and development activities to enhance responses to
pandemic influenza and an Emerging Infectious Disease Program
to monitor and address infectious diseases that could cause a
deadly pandemic. Both programs would be funded at $250
million per year through FY 2023.
The bill would also create new and sustainable market-based
incentives to advance cutting-edge biomedical research. Our
groups support developing strategic partnerships between
BARDA and the business community to mitigate threats that
could pose a significant risk to U.S. health and safety.
Reauthorizing PAHPA would also help ensure the
sustainability of the medical countermeasures enterprise by
transferring the authority that governs the procurement of
medical countermeasures from the Centers for Disease Control
and Prevention (CDC) to the Office of the Assistant Secretary
for Preparedness and Response (ASPR).
The legislation would codify ASPR's role in coordinating
Strategic National Stockpile operations with CDC. We also
believe that such teamwork would make the U.S. better
equipped to tackle public health emergencies and natural
disasters.
We urge the full House to swiftly consider and pass H.R.
6378.
Sincerely,
The Honorable Jack Kingston,
Secretariat, Alliance for Biosecurity.
Neil L. Bradley,
Executive Vice President and Chief Policy Officer, U.S.
Chamber of Commerce.
____

Allied BioScience,

Plano, TX, July 23, 2018.
Hon. Susan Brooks,
Member of Congress,
Washington, DC.
Dear Representative Brooks: I write to thank you for a
provision in your recently introduced legislation, H.R. 6378,
the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018. This provision updates the
authorization for the Biomedical Advanced Research and
Development Authority (BARDA) to include the mitigation of
infectious disease. This provision will make our nation
safer.
Allied BioScience (ABS) has engaged BARDA with ideas for
collaboration that have the potential to enhance the
biological safety of our nation by combating antimicrobial
resistance through environmental intervention. Under the
existing authorization, BARDA is limited to developing
pharmacological interventions. This limitation precludes
collaboration at this time. Your legislation amends the
definition of ``qualified pandemic or epidemic products'' to
include ``a product manufactured, used, designed, developed,
modified, licensed, or procured to diagnose, mitigate,
prevent, treat, or cure an infectious disease (as defined in
section 319F-1(a)(2))''. This change would create a path
forward to collaborate to develop novel solutions to
antimicrobial resistance that will provide a safer nation.
ABS has developed a semi-permanent antimicrobial coating
that creates a long-lasting barrier to microbial growth. In
clinical trials, ABS's coating, when applied in an ICU
setting has shown to reduce the presence of Multi-Drug
Resistant Organisms (MDROs) by up to 70% with an efficacy of
at least four months per application. Comparable reductions
in Hospital Acquired Infections have seen a corresponding
reduction. Reduction in rates of infection decreased the need
to treats MDRO's and breaks the cycle of mutation that
creates increasingly potent ``superbugs''. Our research
demonstrates that environmental mitigation is a key component
to addressing antimicrobial resistance.
Thank you again for your efforts to modernize BARDA to
provide the flexibility needed to combat ever-evolving
threats. We enthusiastically support H.R. 6379, and look
forward to its swift passage and enactment into law. If you
have any questions about ABS I would be happy to talk further
with you at your convenience.
Sincerely,
Mike Ruley,
CEO.
____

American Association of Blood Banks, America's Blood
Centers, American Red Cross,
July 25, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, Washington,
DC.
Hon. Susan Brooks,
House of Representatives,
Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy and Commerce Committee,
Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, and
Representatives Brooks and Eshoo: AABB (formerly known as the
American Association of Blood Banks), America's Blood Centers
and the American Red Cross commend the House Energy and
Commerce Committee's commitment to improving the nation's
preparedness and response capabilities through the
reauthorization of the Pandemic and All-Hazards Preparedness
Advancing Innovation Act (PAHPAIA) of 2018 (H.R. 6378).
Collectively, our organizations represent the nation's blood
collection establishments, transfusion services, and
transfusion medicine professionals.
We would like to especially highlight two sections of the
bill important to us and our collective members:
Section 116 is a significant step in examining the unique,
and often overlooked, role of the nation's blood supply in
emergency

[[Page H8778]]

preparedness and response systems and the specific challenges
associated with donor recruitment, implementation of safety
mandates and innovation, and adequacy in the face of public
health emergencies. We believe that policies that support the
availability of a safe and adequate blood supply are needed.
The report required by this section is critical to evaluating
possible solutions.
We strongly support the Committee's specific recognition of
the blood supply in Section 207, which requires the Assistant
Secretary for Preparedness and Response (ASPR) to develop
guidelines for regional health care emergency and response
systems. We support the provision that requires the ASPR to
consult with blood banks and other key stakeholders when
developing and updating guidelines. Including blood centers
in this process is paramount and consistent with the
Department of Health and Human Services' (HHS) recognition of
blood as one of the core functional areas in Emergency
Support Function #8 of the National Response Framework. We
also commend the Committee for recognizing potential
financial implications for blood centers to implement and
follow the guidelines. Given that blood is an essential part
of the nation's trauma system, emergency preparedness and
response system and healthcare system generally, it is
essential that financial barriers not impede the availability
of safe blood ahead of and during response activities.
AABB, America's Blood Centers and the American Red Cross
welcome the opportunity to work with the Committee to ensure
that these important provisions promoting the safety and
availability of the U.S. blood supply remain during
conference negotiations with the Senate.
Mary Beth Bassett,
President, AABB.
Kate Fry,
Chief Executive Officer, America's Blood Centers.
James C. Hrouda,
President, Biomedical Services, American Red Cross.
____

American College of

Emergency Physicians,

July 18, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Greg Walden,
Washington, DC.
Hon. Anna Eshoo,
Washington, DC.
Hon. Frank Pallone,
Washington, DC.
Dear Representatives Brooks, Eshoo, Walden, and Pallone: On
behalf of the American College of Emergency Physicians
(ACEP), our 38,000 members, and the more than 140 million
patients we treat each year, I am writing to express ACEP's
support for H.R. 6378, the ``Pandemic and All-Hazards
Preparedness and Advancing Innovation (PAHPAI) Act of 2018.''
In particular, ACEP appreciates your legislation's focus on
improving regionalized emergency preparedness and response
systems, inclusion of the MISSION ZERO Act's provisions to
facilitate the use of military trauma teams in civilian
trauma centers, and the addition of Good Samaritan liability
protections for health care professionals who volunteer
during federally-declared disasters.
Regionalized systems for emergency care response are vital
to ensuring patients are transported and treated in the most
appropriate setting. While it is important to maximize our
resources and capabilities on a daily basis, it becomes
imperative when health care providers respond to a natural or
man-made disaster. We would like to thank you for emphasizing
the establishment and enhancement of these systems,
especially the demonstration program designed to improve
medical surge capacity, build and integrate regional medical
response capabilities, improve specialty care expertise for
all-hazards response, and coordinate medical preparedness and
response across states, territories, and regional
jurisdictions.
ACEP is very supportive of the trauma system improvements
included in H.R. 6378, specifically the grants for military-
civilian partnerships in trauma care as established in the
MISSION ZERO Act (H.R. 880). ACEP believes this policy serves
three purposes. First, it makes additional trauma care
personnel available to treat severely injured civilian
patients. Second, it allows military trauma teams to maintain
their skills in between rotations to conflict areas. Third,
it allows trauma team members to train together so that when
they are deployed, everyone performs his/her duties in a
coordinated manner with the other members, thereby improving
care to injured military personnel.
The Good Samaritan liability protections established in
this legislation will help encourage availability of health
care professionals during times of disaster, which can be
crucial to supplementing the efforts of emergency physicians
and the Disaster Medical Assistance Teams (DMATs) on-site.
ACEP believes volunteers responding to a disaster, whether
declared by the President of the United States or the
Secretary of the U.S. Department of Health and Human Services
(HHS), should be protected from liability while they are
providing care within the scope of their expertise and are
acting in good faith. We appreciate your efforts to include
this essential provision in H.R. 6378.
Other aspects of the legislation that are important to
emergency physicians and will help ensure the nation is
prepared to contend with all disasters and unexpected
emergencies include your provisions to improve the National
Disaster Medical System (NDMS); expand public health
surveillance; study DMAT readiness capabilities; improve the
Public Health Emergency Fund (PHEF); strengthen the
Healthcare Preparedness and Response Program (HPRP), formerly
the Hospital Preparedness Program (HPP); extend authorization
for the Emergency System for Advanced Registration of
Volunteer Health Professionals (ESAR-VHP); and study hospital
preparedness capabilities. ACEP would also like to commend
you on your oversight of the Assistant Secretary for
Preparedness and Response's (ASPR) efforts to reunify
children who were separated from their parent or guardian
(due to the ``zero tolerance'' policy) and placed into the
custody of HHS.
Finally, we would once again urge the Committee and the
Congress to ensure sufficient funding is provided for the
PHEF, HPRP, NDMS, and Medical Reserve Corps (MRC) to ensure
their effectiveness and we encourage you to seek a
sufficient, guaranteed federal funding stream. Without a
dedicated and appropriate amount of federal resources for
these critical programs, we are greatly concerned that the
nation as a whole, and emergency medical providers
specifically, will not have the infrastructure, personnel, or
tools necessary to provide optimal care during a natural or
man-made disaster or infectious disease outbreak.
Sincerely,
Paul D. Kivela, MD, MBA, FACEP,
ACEP President.
____

American College of Surgeons,

July 20, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce, Washington, DC.
Hon. Frank Pallone,
Ranking Member, Committee on Energy and Commerce, Washington,
DC.
Dear Chairman Walden and Ranking Member Pallone: On behalf
of the more than 80,000 members of the American College of
Surgeons (ACS), we would like to express our support for the
Pandemic and All Hazards Preparedness and Advancing
Innovation Act of 2018 (PAHPAI), H.R. 6378. We appreciate the
work the Energy and Commerce Committee has accomplished to
incorporate important improvements to trauma care and begin
the process for establishing the framework for a trauma
system that can fully meet the needs of any disaster and
provide the highest-quality health care.
ACS is particularly appreciative of the inclusion of the
Mission Zero Act, H.R. 880 in the PAHPAI. Establishing and
maintaining high-quality and adequately-funded trauma systems
throughout the United States, including within the Armed
Forces, is a priority of the ACS and our Committee on Trauma
(COT). The Mission Zero Act authorizes $15 million in grant
funding to assist civilian trauma centers in partnering with
military trauma professionals and creates a pathway to
provide patients with excellent trauma care in times of peace
and conflict. In addition, this legislation requires
utilization of trauma data reporting as a requirement for the
grant program. The measuring and recording of data is a
cornerstone of advancing not only trauma care, but health
care as a whole. Overall, the Mission Zero Act is a critical
step toward achieving the goal of zero preventable injury
deaths after injury.
Inclusion of the Good Samaritan Health Professionals Act,
H.R. 1876, which is legislation that would reduce barriers
for health care providers looking to volunteer during a
federally-declared disaster, is a welcome addition to PAHPAI.
This section in PAHPAI will help to greatly decrease loss of
life as well as improve outcomes during federally declared
public health emergencies.
We also applaud the Committee for highlighting the critical
issue of improving our trauma care system by including
language creating a demonstration project promoting a
regionalized approach to disaster response. Trauma systems
have been organized across the country to manage the time-
sensitive crises of acutely injured patients in an efficient
manner on a daily basis. Trauma systems span the continuum of
care including prior to the point of injury and through
rehabilitation. As a result, these systems engage in numerous
activities aimed at improving care and outcomes, including
bystander training, emergency medical services (EMS) training
and coordination, hospital preparedness, injury prevention
efforts, and continuous quality improvement. All of these
activities will assist with responding to public health
emergencies such as biological, radiological, nuclear events,
and other mass casualty incidents.
The ACS believes the PAHPAI represents significant progress
in the process of ensuring that trauma systems, centers, and
health care providers are able to meet the needs of all
Americans. We thank you for your leadership on this
significant legislation and stand ready to work with you
toward final passage in the House.
Sincerely,

David B. Hoyt, MD, FACS,

Executive Director, American College
of Surgeons.

Mrs. BROOKS of Indiana. Mr. Speaker, I reserve the balance of my
time.

[[Page H8779]]

House of Representatives,

Committee on Homeland Security,

Washington, DC, September 24, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy & Commerce,
Washington, DC.
Dear Chairman Walden: I write concerning H.R. 6378, the
``Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018''. This legislation includes matters
that fall within the Rule X jurisdiction of the Committee on
Homeland Security.
In order to expedite floor consideration of H.R. 6378, the
Committee on Homeland Security will forgo action on this
bill. However, this is conditional on our mutual
understanding that forgoing consideration of the bill would
not prejudice the Committee with respect to the appointment
of conferees or to any future jurisdictional claim over the
subject matters contained in the bill or similar legislation
that fall within the Committee's Rule X jurisdiction. I
request you urge the Speaker to name members of the Committee
to any conference committee names to consider such
provisions.
Please place a copy of this letter and your response
acknowledging our jurisdictional interest in the
Congressional Record during House Floor consideration of the
bill. I look forward to working with the Committee on Energy
and Commerce as the bill moves through the legislative
process.
Sincerely,
Michael T. McCaul,
Chairman.
____

House of Representatives,

Committee on Energy and Commerce,

Washington, DC, September 24, 2018.
Hon. Michael T. McCaul,
Chairman, Committee on Homeland Security,
Washington, DC.
Dear Chairman McCaul: Thank you for your letter concerning
H.R. 6378, Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, and I appreciate your
willingness to forgo action on the bill.
I agree that forgoing consideration of the bill should not
prejudice the Committee on Homeland Security with respect to
the appointment of conferees or to any future jurisdictional
claim over the subject matters contained in the bill or
similar legislation that fall within the Committee's Rule X
jurisdiction. I will request that the Speaker name members of
the Committee to any conference committee to consider such
provisions.
Finally, I will place a copy of your letter and this
response into the Congressional Record during consideration
of the measure on the House floor.
Sincerely,
Greg Walden,
Chairman.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 6378, the Pandemic All-Hazards
Preparedness and Advancing Innovation Act of 2018. I want to thank
Chairman Walden and Representatives Eshoo and Brooks, as well as all
the staff, for their hard work on this bill. Together, we have ensured
a robust product that reflects priorities for Members on both sides of
the aisle and the agencies responsible for ensuring our emergency
preparedness.
This is a vitally important public health bill that ensures that we
can prepare for and respond to health security events like
bioterrorism, emerging infectious diseases, and natural disasters. It
will support the development of new treatments and the stockpiling of
medications and supplies that will be deployed to communities
nationwide in the case of an emergency.
As we all know, effectively preparing for and responding to these
events requires extensive coordination between Federal, State, local,
and Tribal governments, as well as private sector organizations across
the country.
This bill reauthorizes or establishes critical programs that will
help us better prepare and respond to any major health emergency.
Let me discuss some of the specifics of how this bill will help us do
that.
It reauthorizes a loan repayment program that would help to
strengthen and grow our public health workforce. This is critically
important, as we are still trying to dig out of a public health funding
hole that began during the Great Recession.
This bill also makes a technical update to the Hospital Preparedness
Program to reflect the use of the term ``coalition'' instead of
``partnership'' by grantees and other stakeholders. This language
change is not intended to make changes related to the current
cooperative agreement structure, nor does it intend to alter the role
and responsibilities of States, territories, and directly funded
cities, which are awardees of funding under the Hospital Preparedness
Program.
Therefore, it continues to require that the Centers for Disease
Control and Prevention, the CDC, provide funding through cooperative
agreements to States, territories, and cities to support healthcare
coalitions in their communities through the Hospital Preparedness
Program.

{time} 1515

The bill also amends the Public Health Emergency Preparedness Program
to require public health departments to partner with nursing homes and
hospitals to promote and improve public health preparedness and
response.
It also requires public health departments to work with utility
companies and other critical infrastructure partners to help ensure
that electricity and other critical infrastructure will remain
functioning or return to function as soon as practicable after a public
health emergency.
Both of these requirements are intended to help prevent another
tragedy like the tragic deaths that occurred at a Florida nursing home
last year in the aftermath of Hurricane Irma.
Mr. Speaker, this bill also updates the authorization for the public
health emergency rapid response fund so we can prevent any delay in
HHS' rapid response to public health emergencies in the future.
It also maintains the administration's flexibility to determine the
best placement for the Strategic National Stockpile, or SNS. I have
concerns with moving the SNS from the direction of the Centers for
Disease Control and Prevention to the Assistant Secretary for
Preparedness and Response. To date, I have yet to hear a strong
argument in support of this move.
I also believe CDC has the relationships and expertise that make the
most sense for managing and operationalizing the stockpile. The CDC
also has a record of successful stewardship of the SNS. That is why I
supported the increased transparency and reporting included in this
bill.
Wherever the Strategic National Stockpile is placed, it is critical
that we ensure that our current preparedness and response capabilities
are not weakened by its placement.
I also want to highlight two provisions that were included that will
ensure Congress receives the information it needs to respond to the
Trump administration's family separation crisis. The Assistant
Secretary for Preparedness and Response will be required to submit to
the Energy and Commerce Committee a formal strategy on their family
reunification efforts as well as keep the committee informed on the
status of the children still awaiting reunification.
The Trump administration's cruel zero-tolerance policy resulted in a
manmade crisis that has impacted the lives of thousands of parents and
children. While we can't undo the damage done by this policy, these
provisions ensure that Congress has the information it needs to help
reunite each child with their family and make sure this never happens
again.
Furthermore, while these provisions are important, they should not
take the place of an actual oversight hearing on this cruel policy.
This is something committee Democrats have repeatedly requested, and we
will continue to do so.
Finally, Mr. Speaker, overall, I want to say this is a good bill. Our
national preparedness and response capabilities will be better prepared
to respond to public health threats thanks to the passage of the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
Mr. Speaker, I urge my colleagues to support H.R. 6378, and I reserve
the balance of my time.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield 5 minutes to the
gentleman from Oregon (Mr. Walden), the chairman of the Energy and
Commerce Committee.
Mr. WALDEN. Mr. Speaker, I rise today, obviously, in support of the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
I want to thank my friend and colleague from New Jersey (Mr.
Pallone), our ranking Democrat on the committee, for working with me on
this effort, but especially I want to thank Representative Brooks from
Indiana for her tireless effort and the partnership of my friend,
Representative Anna Eshoo of California. She and Mrs.

[[Page H8780]]

Brooks really did the heavy lift here for the committee on this effort.
They were able to shepherd this critical reauthorization to the floor
today with unanimous support both in the subcommittee and in the full
committee.
So, for those out there who are watching our proceedings, know that
actually we do work together and we do get some really important public
policy done.
These programs, commonly known as PAHPA, enable critical partnerships
between the Federal Government, State and local authorities, and the
private sector to ensure our Nation is responsibly prepared for and
able to respond to public health emergencies. It is time that we get it
right; it is critical that we get it right; and we are.
It is not really a matter of if, but when, the next pandemic strikes.
The projections simply are horrifying. A full-blown pandemic flu
outbreak could literally kill millions of people within months--within
months. We must have the tools, backed by stable and predictable
funding, to respond to these threats and especially to the threat of
pandemic flu.
With this vote, the House will take an important step toward keeping
our families safe in the worst-case scenarios of dangerous disease
outbreak or in the case of chemical or biological attack. We are moving
this reauthorization on time and in a bipartisan fashion.
Like my colleague from Indiana, I remember when anthrax was sent to
our offices and to the postal facility, and loss of life and illness
and concern, and we all wondered what is next. That was part of what
prompted us to get to this point and pass this legislation, not only
today but back then.
This is really important work, Mr. Speaker, and I commend my
colleagues and the staff, who really do the incredible work to help us
get it right. This is legislation now that will head over to the
Senate, where I hope they will give it the same due consideration that
we are about to here today, and then get this down to President Trump's
desk, where he will sign it into law.
Mr. Speaker, I want to again thank my colleagues and staff on both
sides of the aisle.
Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I
reserve the balance of my time.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield 5 minutes to the
gentleman from Texas (Mr. Burgess), the subcommittee chair for the
Subcommittee on Health.
Mr. BURGESS. Mr. Speaker, I thank the gentlewoman for yielding.
Mr. Speaker, one century ago, our country was in the midst of the
worst pandemic in history. It claimed the lives of almost 700,000
Americans and killed more than 50 million people worldwide.
Mr. Speaker, we listened to testimony; we discussed aspects of this
legislation before us today; and it is critical that we remember the
significance of the centennial anniversary of the 1918 influenza
pandemic as we consider this legislation today.
The creation of the Assistant Secretary for Preparedness and Response
under the original legislation of 2006 has helped us to make monumental
strides in preparedness, coordination, and response. Close
collaboration between the Centers for Disease Control and the Food and
Drug Administration and our State, local, and territorial public health
partners has been vital in making this progress.
Much like politics, much of public health is local and executed on
the ground by our hospitals, our health departments, and our emergency
responders, who are our front lines in addressing infectious diseases,
disasters, and threats.
We must evaluate the domestic biological surveillance systems, such
as BioWatch. This bill will help bring those programs up to date so
they are operating with the most efficient capabilities and
technologies. We must also look for innovative ways to continue to
advance our medical countermeasures and ensure that Americans can
access the medications that will provide critical protection in the
future.
As we consider the problem of antimicrobial resistance in this
country, we must discuss new methods to curb this growing problem.
It is important to note that this reauthorization bill is being heard
on the floor of the House prior to the expiration of the fiscal year,
at which time the current authorization expires. The House, once again,
has done its work in this regard, and we do urge our counterparts in
the Senate to do their work as well.
This reauthorization includes an important provision: The MISSION
ZERO Act. The MISSION ZERO Act seeks to connect American patients with
battle-tested trauma care through the craft of military trauma care
providers. The bill provides grants to allow military trauma care
providers and teams to offer care in our Nation's leading trauma
centers and systems.
The need for top-notch trauma care extends across our Nation, far
away from the battlefield. I first introduced this bipartisan bill with
my fellow Texan, Representative Gene Green, following a police shooting
in Dallas 2 years ago.
Over 2 years ago, five police officers were killed and nine more were
injured in a shooting in downtown Dallas. In the immediate aftermath of
the attack, area hospitals sprung into action and activated their
disaster plans. The staff at Parkland Hospital, Baylor University
Hospital, and other medical professionals provided excellent emergency
care to victims of the attack.
Frontline facilities and responders in Dallas experienced this
firsthand in 2014 when a patient presented with Ebola to a Dallas-Ft.
Worth emergency department.
We must remember that infectious diseases are a mere plane ride away,
and we must continue to ensure that we are prepared and ready to
respond to emerging infectious diseases worldwide.
This Pandemic and All-Hazards Preparedness Reauthorization Act is
critical to protecting the lives of Americans and providing the
necessary tools and infrastructure when disaster strikes.
I want to thank Representative Susan Brooks and Anna Eshoo for their
work on this legislation before us today. Mr. Speaker, I strongly
support this legislation, and I urge my colleagues to do the same.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield 1 minute to the
gentleman from Florida (Mr. Bilirakis), who also serves on the
Subcommittee on Health.
Mr. BILIRAKIS. Mr. Speaker, I want to thank Congresswoman Brooks, who
is doing an outstanding job. We both served on the House Committee on
Homeland Security, and we chaired a subcommittee prior to Energy and
Commerce. She is doing an outstanding job.
Mr. Speaker, I rise today in strong support of H.R. 6378, the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
From storm-related injuries and illnesses to delivery and logistics
issues, last year's historically costly hurricane season tested the
mettle of our health delivery system, and I am pleased to see children,
seniors, and other at-risk patient communities being addressed in this
reauthorization.
This bill also encourages innovative partnerships and coalitions,
like the Nicklaus Children's Hospital and the Florida International
University, to continue to develop novel approaches to healthcare
delivery and, ultimately, save lives.
Mr. Speaker, I urge my colleagues to support this critical piece of
legislation.
Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I want to again thank all my colleagues on both sides of
the aisle for moving and working on this legislation.
Mr. Speaker, I urge my colleagues to support H.R. 6378, and I yield
back the balance of my time.
Mrs. BROOKS of Indiana. Mr. Speaker, I yield myself the balance of my
time.
Mr. Speaker, I would like to particularly thank Dr. Burgess and the
ranking member of the Subcommittee on Health, Gene Green, for their
leadership in working with so many of us who have brought this
legislation to the floor at this time.
It is really so very critical that all relevant Federal agencies,
particularly the leadership of CDC and the ASPR, work together with our
local and State partners that are truly on the ground; and I certainly
urge my colleagues to

[[Page H8781]]

pass this important piece of legislation not only to ensure that public
health is of paramount importance in this country, but, also, because
this is an incredibly important piece of national security legislation.
Mr. Speaker, I yield back the balance of my time.
Ms. ESHOO. Mr. Speaker, I rise in support of this bipartisan
legislation, the Pandemic and All-Hazards Preparedness and Innovation
Act and I'm very proud to have Representative Susan Brooks as my
partner. This legislation is the product of negotiation and compromise
between the House and the Senate and I'm pleased that my colleagues
were able to reach agreement on a bill that ensures our nation is
prepared to respond to a wide range of public health emergencies,
whether man-made or occurring through a natural disaster or infectious
disease.
In 2001 our nation endured the horrific attacks on September 11th and
the anthrax attacks that followed shortly thereafter. Congress realized
that our country was not prepared to coordinate responses to mass
casualty events or chemical attacks, and in 2006, I wrote legislation
with then-Representative Richard Burr to address these shortfalls. That
important legislation, the original Pandemic and All-Hazards
Preparedness Act, was signed into law the same year.
The Pandemic and All-Hazards Preparedness and Innovation Act we're
considering today is critical to our national security. The legislation
updates the original PAHPA by directing federal agencies to respond to
new and emerging threats, and strengthens our nation's existing
preparedness and response programs. The reauthorization meets the
challenges that we face today and those we anticipate facing in the
future.
Events over the past few years including Zika, the reemergence of
Ebola, and the constant looming threat of a biological attack by
another nation or hostile non-state enemies underscore the real threats
our country continues to face. In 2017, our nation experienced the most
destructive hurricane season in recent memory, followed quickly by the
most deadly flu season in decades. This year, parts of our country have
already faced devastating hurricanes and the season is not over yet.
Our experience with each of these hazards reminds us that our country
is not yet adequately prepared to deal with potentially devastating
widespread public health crises. That's why this legislation is so
critical.
The legislation provides the authorization and federal resources to
invest in programs that allow the Biomedical Advanced Research and
Development Authority to maintain its nimble and flexible framework
while responding to the existing and emerging threats our country may
face. It also directs BARDA to address antimicrobial resistance which
is critical to our nation's biodefense If we have a chemical or
biological attack that leaves individuals with burns or open wounds,
the medical countermeasures BARDA has developed to treat that attack
will be useless if those injured contract secondary antibiotic
resistant infections.
BARDA was created by my original legislation and has been extremely
successful in investing in drugs that are needed to be stockpiled, and
where the federal government is the only customer. There is no other
market for these products and that's why BARDA is so important. BARDA
has worked with over 190 partners and brought 35 medical
countermeasures through research and development to FDA approval No
private company has a track record that compares to what BARDA has
accomplished in just over 10 years.
This bill restores multiyear appropriations for the Project BioShield
Special Reserve Fund. My original legislation provided advanced
appropriations for Project BioShield for the purpose of accelerating
the research, development, purchase, and availability of effective
medical countermeasures against biological, chemical, radiological, and
nuclear (CBRN) threats. Restoring multiyear appropriations offers our
partners with the government the certainty they need to invest in these
important medical countermeasures which are a matter of national
security. I urge the appropriators to fully fund the multiyear
appropriations this legislation authorizes.
I'm proud that our legislation incorporates many provisions that were
important to Members in both the Republican Conference, the Democratic
Caucus, and to our colleagues in the Senate, to meet the needs of
vulnerable communities during natural and manmade disasters.
The legislation also reauthorizes the HHS National Advisory Committee
on Children and Disasters and authorizes the Children's Preparedness
Unit at the CDC. This is critically important to address the persistent
gaps in our nation's preparedness and response for the most vulnerable
in many crises, our nation's children
The bill 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.
It includes a proposal to prioritize bringing nursing homes back onto
the power grid at the same time as hospitals after a disaster.
It includes provisions related to regional health partnerships,
pregnant and postpartum women and environmental health.
I'm proud of this legislation and I urge my colleagues to support the
Pandemic and All-Hazards Preparedness and Innovation Act.
Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters
in the Record.

Health Industry

Distributors Association,

July 17, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Susan Brooks,
House of Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, Congresswoman
Brooks and Congresswoman Eshoo: On behalf of the Health
Industry Distributors Association (HIDA), we appreciate the
opportunity to express our support for H.R. 6378, the
Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018 (PAHPAI). HIDA commends you for your
leadership on this issue and appreciates the active
engagement of your staff with industry to incorporate lessons
learned from recent events such as Ebola and the 2017
hurricane season, in H.R. 6378, to continually improve our
nation's preparedness capabilities.
HIDA is the trade association representing medical products
distributors, all of which deliver medical products and
supplies, manage logistics, and offer customer services to
more than 294,000 points of care. HIDA members primarily
distribute items used in every day medical services and
procedures, ranging from gauze and gloves to diagnostic
laboratory tests. Their customers include over 210,000
physician offices, 6,500 hospitals, and 44,000 nursing home
and extended care facilities throughout the country, as well
as numerous federal agencies and their healthcare facilities.
As you know, the medical supply chain plays a critical role
in preparedness, as it supplies key infection prevention
products and protective equipment such as respirators, face
shields, hoods, impermeable gowns and gloves to first
responders and health care providers. Additionally, the
medical supply chain is the primary source for the diagnostic
and point-of-care rapid tests needed to identify infectious
disease, as well as the ancillary products such as gloves,
needles and syringes needed to deliver medical
countermeasures effectively.
HIDA and its members have collaborated with federal
agencies on identifying opportunities to improve coordination
and develop solutions that create more elasticity in the
supply chain for key products. One of the many lessons
learned during the 2017 hurricane season was a considerable
need to improve coordination during an emergency response,
ensuring appropriate infrastructure partners are included in
a prioritization process for access to affected areas after
an event. We appreciate the Committees' acknowledgement of
the importance of this issue in the legislation, as well as
the recognition of the healthcare supply chain in H.R. 6378.
Specifically, we support the following:
Section 101 provisions important to the healthcare supply
chain including
The value of public and private sector coordination during
an event to ensure critical supplies are delivered and
information is shared.
The requirement that ancillary products needed to deliver a
medical countermeasure are incorporated into the Public
Health Emergency Medical Countermeasure Enterprise planning
process.
Section 319C-3 provisions that create a regional healthcare
system plan and that it be communicated to supply chain
partners so needed product can be redirected during a
response.
HIDA thanks you for your continued commitment to
preparedness and look forward to working with you on H.R.
6378.
Sincerely,

Linda Rouse O'Neill,

Vice President, Government Affairs,
Health Industry Distributors Association.

[[Page H8782]]

____
Infectious Disease Society

of America,

July 17, 2018.
Hon. Greg Walden,
Chairman, Energy & Commerce Committee, House of
Representatives, Washington, DC.
Hon. Frank Pallone, Jr.,
Ranking Member, Energy & Commerce Committee, House of
Representatives, Washington, DC.
Hon. Susan Brooks,
Energy & Commerce Committee,
House of Representatives, Washington, DC.
Hon. Anna Eshoo,
Energy & Commerce Committee,
House of Representatives, Washington, DC.
Dear Chairman Walden, Ranking Member Pallone,
Representative Brooks and Representative Eshoo: Thank you for
your leadership in introducing H.R. 6378, the Pandemic and
All-Hazards Preparedness and Advancing Innovation Act of 2018
(PAHPAI) that both reauthorizes and strengthens the Pandemic
All-Hazards Preparedness Act (PAHPA). IDSA represents over
11,000 infectious diseases physicians and scientists. Many of
our members work on the frontlines of public health
emergencies, including bioterror attacks, outbreaks, and
natural disasters (e.g., hurricanes that carry significant
infectious diseases risks).
The programs and authorities contained within PAHPA provide
essential resources for communities and health care
facilities to prepare for and respond to public health
threats. Further, PAHPA provides critical support for the
research and development (R&D) of life-saving medical
countermeasures (including vaccines, diagnostics, and
antimicrobial drugs). In particular, IDSA is pleased to offer
our strong support for the provision in H.R. 6378 to
reinstate loan repayment authority for the Centers for
Disease Control and Prevention to improve programs that train
public health responders and future leaders, such as the
Epidemic Intelligence Service. We also support the bill's
attention to antimicrobial resistance. We look forward to
working with the Committee on continued efforts to address
this urgent public health threat.
A successful response to a public health emergency depends
upon skilled personnel. Section 115 of H.R. 6378 will
strengthen the ability of the CDC to recruit physicians to
serve in the Epidemic Intelligence Service--a fellowship
program that trains expert responders to infectious disease
outbreaks and other public health emergencies. We greatly
appreciate your inclusion of this important provision.
IDSA remains deeply concerned about antimicrobial
resistance that threatens our national health security. We
appreciate language in Section 302 authorizing the Biomedical
Advanced Research and Development Authority to undertake
strategic initiatives to address antimicrobial resistance, as
well as Section 406 that codifies the Advisory Council on
Combating Antibiotic Resistant Bacteria. These substantive
efforts will continue to strengthen our national response to
antimicrobial resistance, though we believe additional
efforts will be essential to spur the research, development
and appropriate use of urgently needed new antibiotics.
Once again, IDSA thanks you for your dedication to our
nation's health security. We look forward to continuing to
work with you on these crucial issues.
Sincerely,
Paul G. Auwaerter, MD, MBA, FIDSA,
President, IDSA.
____

National Association of County &

City Health Officials,

Washington, DC, July 18, 2018.
Hon. Greg Walden,
Chairman, House Energy & Commerce Committee, House of
Representatives, Washington, DC.
Hon. Susan Brooks,
U.S. House of Representatives,
Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy & Commerce Committee, House of
Representatives, Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, and
Representatives Brooks and Eshoo: On behalf of the National
Association of County and City Health Officials (NACCHO), I
am writing in support of the ``Pandemic and All-Hazards
Preparedness Advancing Innovation Act (PAHPAIA) of 2018''
(H.R. 6378). NACCHO is the voice of the nearly 3,000 local
health departments across the country that prepare
communities for disasters, respond if emergencies occur, and
lend support throughout the recovery process. PAHPAIA will
provide needed stability for the nation's emergency
preparedness and response enterprise. We thank you for your
leadership on this legislation that is essential to
protecting our nation and look forward to working with you to
strengthen the legislation as it moves forward.
Among the many provisions in the bill, NACCHO highlights
the following:

PHEP, HPP, MRC

The programs reauthorized in PAHPAIA are vital to local
health departments. The Public Health Emergency Preparedness
(PHEP) program and Hospital Preparedness Program (HPP),
reauthorized in PAHPAIA, are complementary programs with
different purposes. PHEP supports local health departments'
response to public health threats and helps to build
resilient communities. HPP enables health care systems to
save lives during emergencies that exceed day-to-day capacity
of health and emergency response systems. In addition, the
Medical Reserve Corps (MRC) program provides additional
public health personnel to respond to emergency needs as well
as everyday health threats.
The PHEP, HPP and MRC programs deserve a level of funding
that is consistent with the threats that are experienced on
the ground level in cities and counties across the nation. In
2017, Congress spent a record breaking $80 billion to provide
relief from Hurricanes Harvey, Irma and Maria, and
devastating wildfires in California. Without the support of
PHEP, HPP and MRC, the cost could have been much higher. A
comprehensive, cost saving and proactive public health
approach to disaster preparedness helps communities to
effectively mitigate the damage and costs of disasters and
help recover in the aftermath. Sustained funding to support
local preparedness and response capacity helps local health
departments build and convene diverse partners such as
police, fire, transportation, planning departments, and
community based organizations and develop and implement
evidence-based, community-centered strategies.

Medical Countermeasures

NACCHO supports the codification of the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE). The
PHEMCE Strategy and Implementation should require that state
and local health departments be involved in all phases of the
medical countermeasures (MCM) enterprise including in initial
investment; research and development of vaccines, medicines,
diagnostics and equipment for responding to emerging public
health threats; and distribution and dispensing of
countermeasures. NACCHO urges that state and local public
health departments have a permanent place in the PHEMCE
membership to ensure that all decisions that will affect
state and local health functions are vetted by public health
authorities.
Current funding, support, and expertise provided to state
and local health departments for the Strategic National
Stockpile must be maintained regardless of the infrastructure
or location of the SNS--it is too vital to this country's
ability to respond in the midst of a variety of large-scale
emergencies.

Public Health Emergency Fund

NACCHO appreciates that the bill strengthens existing
authorities for the Public Health Emergency Fund (PHEF). A
standing rapid response fund to provide bridge funding
between base preparedness funding and supplemental
appropriations for acute emergencies and emerging threats is
absolutely necessary.
NACCHO also appreciates the inclusion of provisions to
maintain the pipeline of workers in the Epidemic Intelligence
Service and to improve preparedness for children, seniors and
people with disabilities. NACCHO appreciates the Committee's
acknowledgement that pandemic influenza, antimicrobial
resistance and other emerging infectious diseases are under
the umbrella of the Biomedical Advanced Research and
Development Authority's (BARDA) mission. Recent years have
demonstrated that infectious diseases represent as
significant a threat to our national security as a natural
disaster or terror attack.
Thank you for your work to strengthen and enhance our
nation's preparedness and response system. We look forward to
continuing to work with you as this legislation moves
forward.
Sincerely,
Lori Tremmel Freeman, MBA,
Chief Executive Officer.
____

The Partnership for

Inclusive Disaster Strategies,

Charleston, SC, July 18, 2018.
Letter of Support for H.R. 6378--Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018.

Dear Representative Eshoo and Representative Brooks: The
Partnership for Inclusive Disaster Strategies (the
Partnership) is the nation's only coalition of national,
state and local stakeholder organizations working together to
advocate for equal access to emergency and disaster services
and programs for children and adults with disabilities
before, during and after disasters. The footprint of our
membership reaches every congressional district in the
country, with a presence in virtually every community.
The Partnership drives disability community leadership,
training, technical assistance, policy and operational
initiatives that improve outcomes for disaster impacted
communities through self-determination, health, safety,
independence, empowerment, integration and inclusion of
children and adults with disabilities in all aspects of
community preparedness, response and disaster resilience.
Our leaders include the nation's leading experts on
disability inclusive emergency management. We have maintained
a daily presence in support of disaster response, recovery
and mitigation initiatives in TX, FL. USVI and PR since
hurricanes Harvey, Irma and Maria made landfall in 2017, and
our current focus includes the impact on individuals

[[Page H8783]]

with disabilities and disaster impacted communities from the
wild fires in CA and the lava flows in Hawaii.
Despite thousands of disaster related deaths and the
disproportionate impact of the disasters on countless people
with ``chronic health conditions'' (also clearly defined as
disabilities under the ADA legal definition) in 2017 & 2018,
the recently released FEMA After Action Report only mentions
disability in a footnote and a list of acronyms defining the
position of Disability Integration Advisors, never in any
other context.
Further, according to FEMA, ``the hurricanes and wildfires
collectively affected more than 47 million people--nearly 15
percent of the Nation's population''. Given these statistics,
it is likely that close to 10 million of these disaster
impacted individuals should have been provided with the civil
rights protections of equal access to emergency services and
programs. It is unfortunate that there is no indication of
any focus in the document on FEMA's obligations, efforts or
recommendations.
Clearly there is an urgent need for advice and consultation
from disability inclusive emergency management experts to
improve outcomes for disaster impacted children and adults
with disabilities and their communities.
We are writing in support of H.R. 6378-Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018,
with specific support for Section 110, the establishment of a
NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES
IN ALL-HAZARDS EMERGENCIES.
The Advisory Committee will:
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 public
health, accessibility, and medical needs of individuals with
disabilities as they relate 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).
We are especially interested in the Committee report which
will include recommendations that offer specific improvements
that could be made across local, State, tribal, territorial,
and Federal efforts to improve outcomes in areas that
include--
``(A) preparedness;
``(B) planning;
``(C) exercises and drills;
``(D) alerts, warning, and notifications;
``(E) evacuation;
``(F) sheltering;
``(G) health maintenance;
``(H) accessing emergency programs and services;
``(I) medical care (including mental health care);
``(J) temporary housing;
``(K) mitigation; and
``(L) community resilience; and
``(2) assess the strength of existing policies to
incorporate such individuals as well as the efficacy of
implementation.
We offer our enthusiastic support for the membership of
this Committee, which will include
at least four representatives who are individuals with
disabilities that have substantive expertise in disability
inclusive emergency management policy and operations;
at least two 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; and
at least two representatives from State, local,
territorial, or tribal agencies with expertise in disability-
inclusive disaster planning, preparedness, response, or
recovery.
The Partnership applauds your leadership and welcomes every
opportunity to work with you, and your colleagues to ensure
that establishment of this vital Advisory Committee is
included in final passage of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018.
Sincerely,
Marcie Roth,
Chief Executive Officer.
____

PEW Charitable Trusts,

Washington, DC, July 17, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, Washington,
DC.
Hon. Frank Pallone,
Ranking Member, House Energy and Commerce Committee,
Washington, DC.
Hon. Susan W. Brooks,
House Energy and Commerce Committee, Washington, DC.
Hon. Anna G. Eshoo,
House Energy and Commerce Committee, Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, Congresswoman
Brooks and Congresswoman Eshoo: The Pew Charitable Trusts
thanks you for your continued efforts to respond to the
ongoing threat of antibiotic resistance through the
introduction of H.R. 6378, the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018 (PAHPA).
This important legislation reauthorizes the essential work of
the HHS Office of the Assistant Secretary for Preparedness
and Response (ASPR)'s Biomedical Advanced Research and
Development Authority (BARDA) to address public health
emergencies and bring desperately-needed antibiotics to
patients. Effective antibacterials are central to the
nation's ability to respond to public health threats,
including chemical, biological, radiological, and nuclear
attacks (CBRN), pandemic influenza, and emerging infectious
disease--antibiotics are an integral part of the nation's
armament to address these threats.
We especially want to thank the Members of the House Energy
and Commerce Committee for including language related to
antibiotic resistance in Section 302 of PAHPA. This language
will ensure that BARDA is explicitly authorized to address
all CBRN threats--both intentional and naturally occurring--
through robust support of innovative approaches in both
preclinical and clinical development. BARDA's unique
experience working with industry to drive innovation is
particularly important to advance novel therapeutics and
preventive interventions and to help bridge the gap between
basic science and successful clinical drug development.
BARDA safeguards our nation's health infrastructure by
revitalizing and encouraging antibacterial innovation to
ensure that we have a healthy pool of candidate products to
address emerging threats. The CARB-X accelerator addresses
critical gaps along the early stages of the antibacterial
pipeline, and BARDA's Broad Spectrum Antimicrobials program
advances therapeutics into late stage clinical development.
The two programs work in tandem to support a robust pipeline
of novel approaches for highly resistant infections and
emerging threat pathogens.
Thank you for continued support of this important work.
Sincerely,
Kathy Talkington,
Antibiotic Resistance Project Director.
____

American Association of

Poison Control Centers,

Alexandria, VA, July 20, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Anna Eshoo,
Washington, DC.
Dear Congresswomen Brooks and Eshoo: The American
Association of Poison Control Centers (AAPCC) would like to
extend our support for H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018.
As you already know, AAPCC supports the nation's 55 poison
control centers in their efforts to prevent and treat poison
exposures. Poison control centers across the U.S. receive
approximately 3 million calls annually that cover a variety
of substances, including prescription and over-the-counter
medications, illegal drugs, household products, pesticides,
cosmetics, environmental toxins, food, plants, and animal
bites and stings. These calls come from a wide variety of
individuals, including the public, health care providers, 911
PSAPs (Public Safety Answering Points), schools, health
departments, law enforcement, and other safety agencies. The
centers operate 24 hours a day, 7 days a week, 365 days a
year and are accessed through a federally funded nationwide
toll free number: 800-222-1222 (Poison Help).
When someone calls 800-222-1222, the calls are answered by
highly trained Specialists in Poison Information (pharmacists
and nurses), who diagnose, triage, and offer treatment
recommendations to callers with 24-hour oversight from Board
Certified Medical and Clinical Toxicologists. We answer calls
from every state and territory in our nation. We know that
you and your staff are already familiar with the wonderful
work of the Indiana Poison Center and the California Poison
Control System.
There are three references, all in Title II, to poison
centers in Public Law 113-5 (the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013). These provisions
allow states and public health departments to work directly
with their regional poison center and have resulted in
improved preparedness preparations in multiple communities
throughout the nation. Thank you for keeping these poison
center references in H.R. 6378.
We also deeply appreciate your inclusion of poison centers
in Section 207, Regional Health Care Emergency Preparedness
and Response Systems. Poison centers have a unique set of
knowledge and are the primary source for poisoning
information. Our employees are trained to handle stressful,
potentially life altering situations on a daily basis and we
already have the infrastructure in place as a 24/7 365 days a
year call center. We are a vital resource on a number of
topics from chemical spills to mass exposure to an unknown
toxin to a public health emergency including the pandemic flu
or Ebola and Zika. The poison control system is a well-
established, nationwide network made up of sophisticated and
specially trained medical professionals who handle calls
related to over 420,000 products and substances and their
related toxicities.
Our poison centers support your efforts and look forward to
our work together on this important topic. Finally, a special
thank you to your staff, Catherine Knowles and Rachel Fybel
for all of their assistance. Thank you, as always, for your
continued support of our 55 poison centers.
Warmest regards,
William Banner, Jr., MD, PhD,
President, AAPCC, Oklahoma Center for Poison & Drug
Information.

[[Page H8784]]

Stephen Kaminski, JD,
CEO and Executive Director, AAPCC.

Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters
in the Record.
American Society

for Microbiology,

Washington, DC, July 23, 2018.
Hon. Paul Ryan,
Speaker of the House, House of Representatives, Washington,
DC.
Hon. Greg Walden,
Chairman, Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Susan Brooks,
House of Representatives, Washington, DC.
Hon. Nancy Pelosi,
Minority Leader, House of Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Speaker Ryan, Minority Leader Pelosi, Chairman Walden,
Ranking Member Pallone, Representative Brooks and
Representative Eshoo: The American Society for Microbiology
(ASM) congratulates the Energy and Commerce Committee on its
passage of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018 (H.R. 6378) and encourages
its swift passage in the House.
ASM is the largest single life science society, composed of
more than 32,000 scientists and health professionals. Our
mission is to promote and advance the microbial sciences,
including programs and initiatives funded by the federal
government departments and agencies, by virtue of the
pervasive role of microorganisms in health and society.
Antimicrobial resistance is among the most consequential
issues facing world today. ASM is therefore pleased that H.R.
6378 includes Section 406, a provision that would guarantee
the continued work of the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria (PACCARB) by
codifying the Advisory Council. A guarantee of PACCARB's
continuance also sustains the One Health partnerships--the
integration of human, animal, and environmental domains--that
have been formed since the establishment of PACCARB.
This year marks the 100th anniversary of the Influenza
Pandemic of 1918, which killed almost 40 million people, and
serves a reminder that the United States must be prepared to
rapidly respond to declared and potential public health
emergencies, including infectious disease epidemics.
ASM strongly supports the legislation's reauthorization of
the Biomedical Advanced Research Development Authority
(BARDA) and is pleased to see inclusion and authorization of
a Pandemic Influenza Program and Emerging Infectious Disease
Program. Authorization of funding for the Strategic National
Stockpile and the Bioshield Special Reserve Fund are all
critically important to our public health security.
Therefore, it is important that reauthorization be met with a
corresponding commitment of federal resources.
Lastly, ASM appreciates that the legislation points to the
need for an adequately funded Public Health Emergency Fund
(PHEF) and strengthens existing authorities for which PHEF
dollars may be used, including in anticipation of a potential
public health emergency. Vigilance will be required to make
sure our country is adequately prepared to make financial
resources available in a timely manner to potential or
immediate public health emergencies, and so we look forward
to your continued leadership in this regard.
ASM believes that H.R. 6378 will further our nation's
preparedness to respond in a timely and coordinated manner to
declared and potential public health threats. Toward this
end, ASM strongly supports swift final passage by the Senate
and House. We appreciate your championship of these issues
and stands ready to work with you towards this goal. Should
you have any questions, please contact Allen Segal, Director,
ASM Public Policy and Advocacy.
Sincerely,
Stefano Bertuzzi, Ph.D., MPH,
CEO, American Society for Microbiology.
Allen D. Segal,
Director, Public Policy and Advocacy, American Society for
Microbiology.
____

ASTHO, September 23, 2018.

Hon. Lamar Alexander,
Chairman, Health, Education, Labor and Pensions Committee,
U.S. Senate, Washington, DC.
Hon. Gregg Walden,
Chairman, Energy & Commerce Committee, House of
Representatives, Washington, DC.
Hon. Patty Murray,
Ranking Member, Health, Education, Labor and Pensions
Committee, U.S. Senate, Washington, DC.
Hon. Frank Pallone, Jr,
Ranking Member, Energy & Commerce Committee, House of
Representatives, Washington, DC.
Dear Chairman Alexander, Ranking Member Murray, Chairman
Walden, and Ranking Member Pallone: The Association of State
and Territorial Health Officials (ASTHO) submits this letter
in support of most of the public health provisions included
in the ``Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018'' (H.R. 6378). ASTHO is the national
nonprofit organization representing the state and territorial
public health agencies of the United States, U.S.
territories, and Washington, D.C. ASTHO's members, the chief
health officials of these jurisdictions, are dedicated to
formulating and influencing sound public health policy and
assuring excellence in public health practice.
ASTHO is pleased that this bill retains elements proven to
be necessary, reasonable, and successful, while making
further refinements to the underlying statute, as well as
responding to and including many of ASTHO's priorities. These
priorities, outlined in previously submitted comment letters,
include suggestions for clarifications and acknowledgments
regarding the importance of state, local, territorial, and
tribal public health. These provisions include:
Reauthorizing the Public Health Emergency Preparedness
Program (PHEP) and Hospital Preparedness Program (HPP). PHEP
and HPP are key to the foundational capabilities of public
health preparedness and healthcare
Codifying the role of CDC to administer the PHEP program
Bolstering the Public Health Emergency Rapid Response Fund
and mechanisms to quickly distribute funds
Requiring that the Public Health Emergency Medical
Countermeasure Enterprise (PHEMCE) solicit and consider input
from state, local, tribal, and territorial public health
departments or officials
Improving the nation's ability to take a ``OneHealth''
approach to preparedness and response capabilities
Reauthorizing the temporary reassignment of state and local
personnel during public health emergencies
Requiring the HHS secretary, in collaboration with ASPR and
CDC, to maintain the strategic national stockpile
Including a provision to strengthen the Epidemic
Intelligence Service by increasing the loan repayment amount
from $35,000 to $50,000
In addition, ASTHO expresses our concern and seeks
clarification from the committee on changes to HPP,
particularly those that alter eligibility requirements for
funding from a ``partnership'' to``coalitions.'' One of the
most crucial functions of HPP is to bring together and
incentivize ``diverse and often competitive healthcare
organizations to work together.'' As neutral conveners, state
and territorial public health departments are the most
appropriate entities and stewards of taxpayer dollars. They
are also responsible for statewide planning and coordination
of services and fundamentally serve all residents in their
jurisdictions--not just lives covered under a plan or
specific catchment area. With the establishment of hundreds
of Healthcare Coalitions across the country, ASTHO seeks
assurance that the letter, spirit, and intent of this
modification does not in any way change the current
cooperative agreement structure and stature, nor does it
alter the role and responsibilities of states, territories,
and directly-funded cities as awardees of funds under HPP.
ASTHO also remains concerned that authorization levels--
$685 million for PHEP and $385 million for HPP--are
significantly lower than our suggested authorization levels
of $824 million for PHEP and $474 million for HPP. ASTHO is
concerned that authorizing at these proposed levels will be
insufficient. Both PHEP and HPP must be resourced at
sufficient levels to ensure that every community is prepared
for disasters. An efficient and effective state and local
workforce depends heavily on reliable, ongoing funding
support for a network of state and local expertise,
relationships and trust that is carefully built over time
through shared responses, training, and exercises.
Regarding sections that speak to ``reservations of amounts
for regional systems,'' ASTHO would also like to reiterate
that HPP is already funded at a vastly insufficient level
given the task of preparing the healthcare system for a surge
of patients, continuity of operations, and recovery. Any
funding reductions to HPP through a tap will have an adverse
impact on real-time all-hazards preparedness and response
activities carried out by the existing healthcare coalitions.
The costs associated with exploring the development of a
regional system or network should not be at the expense of
current critical medical readiness and patient care services.
Finally, while we appreciate that the bill strengthens
existing authorities for the Public Health Emergency Fund, we
continue to urge Congress to create a mechanism to fund and
replenish it. Without sufficient and dedicated funding, it
will be impossible to quickly access funds when needed.
ASTHO appreciates the opportunity to provide our comments
on this critical legislation and the bipartisan efforts of
both the House and Senate committees.
Sincerely,
John Wiesman, DrPH, MPH,
ASTHO President, Secretary of Health, Washington State
Department of Health Olympia, WA.

[[Page H8785]]

____
Biotechnology Innovation

Organization,

September 24, 2018.
Hon. Susan Brooks,
House of Representatives,
Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Representatives Brooks and Eshoo: On behalf of the
Biotechnology Innovation Organization (BIO), I am writing to
express our strong support for final passage of H.R. 6378,
the ``Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018''. I wish to commend you for your
extraordinary work getting this legislation to the House
floor.
BIO represents more than 1,000 biotechnology companies,
academic institutions, state biotechnology centers and
related organizations across the United States and in more
than 30 other nations. BIO's members are committed to
investing in, developing, and delivering innovative vaccines,
therapeutics, and diagnostic tools that are transforming how
we protect, treat and cure people from devastating infectious
diseases. Many of BIO's members are active partners with the
U.S. government to strengthen our national health security
through the development and stockpile of medical
countermeasures (MCM) against the myriad threats facing our
nation. The value that these MCMs offer to first responders,
patients and their caregivers, and the global community is
phenomenal.
BIO was pleased to see the Act continue to provide support
for critical preparedness programs such as the BioShield
Special Reserve Fund (SRF), the Biomedical Advanced Research
and Development Authority (BARDA), and the Strategic National
Stockpile (SNS)--all of which are necessary to ensure that we
can maintain a robust medical countermeasures enterprise that
can address known and unknown threats. We are also pleased to
see that significant threats such pandemic influenza,
emerging infectious diseases, and antimicrobial resistance
are specifically recognized in the Act and that BARDA has
been authorized appropriations to address these dangerous
threats. We are very supportive of the overall authorization
of $2.4 billion annually to the MCM enterprise, which will
allow the Secretary of Health and Human Services to more
fully prepare for many of the threats affecting our national
health security.
BIO thanks you for your commitment to our national health
security and your important work to ensure that our nation is
adequately prepared to respond to the myriad threats we face
domestically and abroad. BIO and our member companies look
forward to continuing to work with you to further strengthen
our preparedness against all potential national security and
public health threats as outlined in the National Biodefense
Strategy.
With Sincerest Regards,
James C. Greenwood,
President and CEO.
____

California Life Sciences Association,

July 16, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Anna G. Eshoo,
Washington, DC.
Dear Representatives Brooks and Eshoo: On behalf of
California Life Sciences Association (CLSA)--the statewide
public policy organization representing California's leading
life science innovators, including medical device,
diagnostic, biotechnology and pharmaceutical companies,
research universities and private, non-profit institutes, and
venture capital firms--I am writing to express our support
for H.R. 6378, the Pandemic and All Hazards Preparedness and
Advancing Innovation (PAHPAI) Act of 2018, your legislation
that will strengthen and improve our national preparedness
and response for public health emergencies, and accelerate
medical countermeasure research and development. Thank you
for your leadership on this critically important issue.
As you know, the recent Ebola and Zika outbreaks and
ongoing threats from terrorist organizations like ISIS have
repeatedly exposed our nation's continued vulnerability to
bioterror and pandemic threats, demonstrating the need for
robust biodefense preparedness. Robust, long-term funding,
and strong and sustained public-private partnerships remain
critical in ensuring a well-funded, well-coordinated, swift
and effective response from all stakeholders. This includes,
critically, a robust statutory framework for securing our
nation from chemical, biological, radiological, and nuclear
(CBRN) threats, as well as from pandemic influenza (PI),
antimicrobial resistance (AMR), and emerging infectious
diseases (EID).
To that end, H.R. 6378 strengthens our country's national
preparedness and response efforts for public health
emergencies by codifying the Public Health Emergency Medical
Countermeasure Enterprise and the duties of the Assistant
Secretary for Preparedness and Response (ASPR), while
maintaining the important role of the Centers for Disease
Control in emergency and response activities. The legislation
also provides the authorization and federal resources to
invest in programs related to Pandemic Influenza and Emerging
Infectious Diseases.
We are pleased the bill provides new authorities to the
Director of the Biomedical Advanced Research and Development
Authority (BARDA) to develop strategic initiatives for
threats that pose a significant level of risk to national
security, including antimicrobial resistant pathogens. We
also encourage you to continue working with you colleagues on
the House Committee on Energy & Commerce and congressional
leadership to explore the creation of new incentives to
encourage investment into the development of products to
treat or prevent a disease attributable to a multi-drug
resistant bacterial or fungal pathogen.
According to the Centers for Disease Control and Prevention
(CDC), each year at least two million people in the United
States are infected with bacteria that cannot be treated with
an antibiotic, resulting in roughly 23,000 deaths and health
care costs as much as $20 billion annually. These staggering
statistics illustrate a dangerous reality: even as the rate
of anti-microbial resistance has grown, research and drug
development has not kept pace with the dire need for new
medicines to treat these increasingly lethal ``superbugs.''
Given the threat that these deadly pathogens pose to public
health in the United States and across the world, the need
for effective public-private partnerships between the
government, academia and industry has never been greater. The
growing epidemic of multidrug-resistant infections knows no
borders and the reestablishment of antibiotic development as
a viable investment for life sciences innovators is
imperative to public health and preparedness.
Thank you again for your leadership of H.R. 6378, as well
as your long-standing support for legislation and policy
measures that improve our nation's biodefense preparedness
and response capabilities.
CLSA is pleased to join a broad group of stakeholders in
offering our strong support for H.R. 6378, the Pandemic and
All Hazards Preparedness and Advancing Innovation Act of
2018. Please let me know if CLSA can be of assistance to you.
Sincerely,

Jennifer Nieto Carey,

Vice President--Federal Government
Relations & Alliance Development.
____

Cellphire,

Rockville, MD, July 18, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, Washington,
DC.
Hon. Susan Brooks,
House of Representatives,
Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy and Commerce Committee,
Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone and
Representatives Brooks and Eshoo: We write in support of HR
6378, the Pandemic and All Hazards Preparedness Act (PAHPA)
Reauthorization. Cellphire supports the Committee's inclusion
of the national blood supply in the Committee mark-up of
PAHPA. Numerous inquiries and hearings conducted after 9/11
revealed the need for a coordinated response to insure
preparedness through maintaining an adequate blood supply and
providing a rapid coordinated response system to distribute
blood products immediately to the affected area(s) as well as
recruit and manage donations required for continual resupply
during the crisis. The need for a coordinated response to the
nation's blood needs was first recognized in the National
Response Plan, Emergency Support Function #8, Public Health
and Medical Services Annex:
Blood, Organs, and Blood Tissues--ESF #8 may task HHS
components and request assistance from other ESF #8 partner
organizations to monitor and ensure the safety, availability,
and logistical requirements of blood, organs, and tissues.
This includes the ability of the existing supply chain
resources to meet the manufacturing, testing, storage, and
distribution of these products.
We applaud the Committee's recognition of the national
blood supply's importance as referenced in Section 116 which
requires the Secretary of Health and Human Services to
provide a report on recommendations related to maintaining an
adequate blood supply Hospitals across the nation as well as
blood product companies like Cellphire are dependent on the
stability of the blood supply and the ability of the U.S.
blood supply ``system'' to respond to disaster. The
organizations representing the nation's blood centers,
hospital-based blood banks and transfusion services, and
transfusion medicine professionals have requested that you
consider asking the Office of the Assistant Secretary for
Preparedness and Response (ASPR) to make the sustainability
of our nation's blood supply a critical element of our
emergency preparedness and response systems. In addition, a
joint letter to the New England Journal of Medicine authored
by Harvey Klein MD, Chief Department of Medicine, the NIH
Clinical Center, Chris Hrouda, President ARC Biomedical
Services, and Jay Epstein MD, Director, Office of Blood
Research and Review, Center for Biologics Evaluation and
Research, FDA, warned of an approaching crisis in the
sustainability of the U.S. Blood System. The concern
regarding the sustainability and responsiveness of the U.S.
blood supply was also raised by a RAND Corporation study
initiated by the Department of Health and Human Services,
``Toward a Sustainable Blood Supply in the United States, An
Analysis of the Current System and Alternatives to the
Future''.

[[Page H8786]]

The goal at Cellphire, currently supported by the ASPR
through BARDA, is to develop and field a freeze-dried
platelet product to stop hemorrhage that can alleviate
platelet shortages and lead to a life-saving product that
controls bleeding and can be stockpiled. Supplying,
distributing and resupplying this and other blood products
during a crisis requires a sustainable blood supply.
The PAHPA Re-authorization bill includes language for the
Assistant Secretary of Preparedness Response (ASPR) to
include the stability of the blood supply as it considers
guidelines for infrastructure. Section 203 further lists the
blood banks in the stakeholder groups with whom ASPR should
engage to obtain feedback on financial implications as it
relates to regional preparedness planning pursuant to the
guidelines.
We believe the reference to the national blood supply and
the inclusion of the blood collection centers and hospital
blood banks in ASPR guidelines to establish infrastructure
and regional preparedness planning will ensure our nation's
blood supply is ready and prepared for surge capacity in the
event of a disaster or terrorist attack.
Thank you for your leadership in addressing the blood
supply in HR 6378, the PAHPA Reauthorization. We support the
Committee's attention to this urgent matter of national
security.
Sincerely,
Michael Fitzpatrick, Ph.D , COL (Ret.) U.S. Army,
President and Director of Research, Cellphire, Inc.
____

Coalition for Epidemic

Preparedness Innovations,

July 17, 2018.
Hon. Greg Walden,
Chairman,
Washington DC.
Hon. Frank Pallone,
Ranking, Energy and Commerce Committee, Washington DC.
Dear Chairman Walden and Ranking Member Pallone: I write in
strong support of HR 6378, the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act (PAHPA.) As you
know, public health emergencies can result from natural
disasters, emerging pathogens, or man-made threats. Just last
year we saw health challenges emerge on multiple fronts due
to hurricanes, a virulent strain of the flu, and outbreaks of
plague, Lassa, Nipah and Ebola overseas. The United States
must do everything in its power to prepare for health
emergencies, and HR 6378 goes a long way towards helping the
Department of Health and Human Services (HHS) achieve that
goal.
As the CEO of CEPI, an international coalition whose
mission it is to develop vaccines to prevent future
epidemics, I am heartened to see language in the bill asking
HHS to report on its work developing vaccines to prevent
epidemics, including its collaborations with international
organizations (Section 303). As we saw in the recent Ebola
outbreak in the Democratic Republic of Congo, vaccines and
international coalitions can play a critically important role
in outbreak response and HHS should maximize its support for
this kind of vaccine research and development.
I am also pleased that HR 6378 creates an emerging
infectious disease program within the Biomedical Advanced
Research and Development Authority (BARDA) [Section 302].
CEPI would welcome the opportunity to partner with BARDA on
future vaccine candidates for emerging infectious diseases of
global significance. In addition, the codification of the
Public Health Emergency Medical Countermeasure Enterprise
(PHEMCE) is another important feature of this bill [Section
101]. The PHEMCE works to ensure that medical countermeasure
development is aligned across the government and that
bottlenecks can be anticipated and prevented, which is
important to prevent costly duplication of work and other
inefficiencies.
In summary, I believe that HR 6378 will strengthen US
public health preparedness, particularly when it comes to
vaccines and medical countermeasure development and
coordination, and I am pleased that it will be considered by
your committee.
Sincerely,
Richard Hatchett, CEO.

Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters
in the Record.

Cerus,

Concord, CA, July 17, 2018.
Hon. Greg Walden,
Chairman, House Energy and Commerce Committee, House of
Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Energy & Commerce Committee, House of
Representatives, Washington, DC,
Dear Chairman Walden and Ranking Member Pallone: As you
review and deliberate over H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018, we
wanted to provide our support for the efforts in the
legislation to preserve and protect the nation's blood
supply--especially in a public health emergency.
As you know, the American public expects the nation's blood
supply is safe and available every day, but especially in
situations of natural or man-made disasters. Blood
transfusions can be lifesaving measures, but this depends on
our collective ability to ensure the safety and availability
of the blood supply. Though the danger of transfusion-
transmitted infections has decreased in recent years due to
improved blood testing for specific pathogens such as HIV and
hepatitis, these tests do not detect the presence of all
viruses, bacteria, and parasites known to contaminate blood
donations. In 2015 at the height of the Zika epidemic in
Puerto Rico, the FDA released guidance calling for the use of
blood treatment pathogen reduction technology as an option to
reduce the risk of transfusion-transmission of Zika. This
pathogen reduction technology helped ensure that very ill
patients would have adequate access to safe blood and that
they would not contract Zika virus infection from their
therapeutic blood transfusions.
Section 116 is critical to ensuring the blood collection
community, in concert with the Department of Health and Human
Services, begins to cohesively examine the challenges with
preserving capacity in the nation's blood supply for major
emergency care, addressing issues like recruiting sufficient
donors to ensure the adequacy of the current supply to meet
public health emergencies and implementation of innovative
and best safety practices.
The inclusion of blood banks in Section 203 is also
critical for ensuring the blood banking community has an
opportunity to engage along with hospitals, health care
facilities, public agencies and others to provide input into
our nation's new ``Healthcare Preparedness and it Response
Program.'' The inclusion of blood banks is critical in
providing feedback on the financial implications for the
program as the industry faces many challenges in ensuring a
transfusion-ready blood supply.
I sincerely appreciate the time and effort that both of
you, your fellow Committee members and the staff have placed
in drafting, reviewing, and deliberation over H.R. 6378. I
look forward to continuing to work with all of you in
supporting our nation's ability to respond in public health
emergencies.
Sincerely,
Dr. Laurence Corash, MD
Chief Scientific Officer, Cerus.
____

July 19, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce, Washington, DC.
Hon. Susan W. Brooks,
Washington, DC.
Hon. Frank Pallone, Jr.,
Ranking Member, Committee on Energy and Commerce, Washington,
DC.
Hon. Anna Eshoo,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, and
Representatives Brooks and Eshoo: Child Care Aware of America
cares deeply about the health and well-being of children and
their success in child care. We would like to thank you for
your bipartisan commitment to reauthorizing the Pandemic and
All-Hazards Preparedness Act. As the Pandemic and All-Hazards
Preparedness (PAHPA) and Advancing Innovation Act of 2018
moves forward, we want to voice our support for extending and
expanding the authorization of the National Advisory
Committee on Children and Disasters (NACCD) to address the
ongoing gaps in our nation's preparedness and response for
children. Recent natural disasters such as Hurricanes Harvey,
Irma and Maria have demonstrated that our nation still is not
fully prepared to respond to the child care needs of
children.
We also appreciate the proposed additional expertise to the
NACCD to include non-federal experts in pediatric mental or
behavioral health, pediatric infectious disease, children's
hospitals, and children and youth with special health care
needs, and particularly, professionals with expertise in
child care or school settings.
The NACCD was established to provide advice and
consultation to the Department of Health and Human Services
(HHS) Secretary and the Assistant Secretary for Preparedness
and Response (ASPR) on issues related to the medical and
public health needs of children before, during, and after
disasters. The NACCD has completed several reports in recent
years focused on youth leadership, surge capacity, and the
provision of human services. Their expertise has been
invaluable in ensuring that children are protected during
public health emergencies and disasters.
Our organization learned that after Hurricane Irma, 22% of
the child care facilities in the state of Florida were closed
due to the storm. In the Miami-Dade-Monroe area specifically,
32% of facilities were closed. Following Hurricane Harvey,
18% of child care facilities were closed in the Houston area.
This means that thousands of children and their families were
left without child care. This carries an incredible burden on
families as they struggle to find child care when they are
needed at work. Furthermore, the interruption of normalcy can
cause stress on children leading to negative consequences for
brain development. Including expertise in child care will
help in making sure that the needs of the 11 million children
in child care will be met before, during, and after a
disaster.
Children are not little adults. They have specialized needs
that must be considered when planning for, responding to, and
recovering from a disaster. This includes having a strong,
well-funded public health and medical system. We thank you
considering the many needs of children and including them

[[Page H8787]]

in the Pandemic and All-Hazards Preparedness (PAHPA) and
Advancing Innovation Act of 2018.
Sincerely,
Child Care Aware of America.
____

CHIME & AEHIS,

July 23, 2018.
Re Inclusion of Cybersecurity in the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018
Hon. Greg Walden,
Chairman, House Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Hon. Frank Pallone,
Ranking Member, House Committee on Energy and Commerce, House
of Representatives, Washington, DC.
Dear Chairman Walden and Ranking Member Pallone: The
College of Healthcare Information Management Executives
(CHIME) and the Association for Executives in Healthcare
Information Security (AEHIS) sincerely appreciate the
inclusion of cybersecurity provisions in section 401 of the
Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018. This critical section of legislation
recognizes the importance of ensuring the nation's health
systems are better prepared and better able to respond in the
event of a cybersecurity incident.
CHIME is an executive organization dedicated to serving
chief information officers (CIOs), chief medical information
officers (CMIOs), chief nursing information officers (CNIOs)
and other senior healthcare IT leaders. Consisting of more
than 2,600 members in 51 countries, our members are
responsible for the selection and implementation of clinical
and business technology systems that are facilitating
healthcare transformation. CHIME members are among the
nation's foremost health IT experts, including on the topic
of cybersecurity. Launched by CHIME in 2014, AEHIS represents
more than 850 chief information security officers (CISOs) and
provides education and networking for senior IT security
leaders in healthcare. CHIME and AEHIS members take their
responsibility to protect the privacy and security of patient
data and devices networked to their system very seriously.
The widespread attacks experienced by health systems
worldwide during the spring of 2017 highlighted the need to
consider the cybersecurity readiness of the healthcare sector
and demonstrated the importance of increased preparedness and
rapid response in the event of an incident. Cybersecurity
threats are growing in frequency and sophistication coming
from a variety of actors seeking to send our country's
healthcare system into disarray. Our members continue to
worry about the threats to patient care and safety posed by
cybersecurity attacks.
CHIME and AEHIS appreciate the inclusion of cybersecurity
in the Pandemic All Hazards Preparedness Reauthorization Act
of 2018. We agree that cybersecurity threats and the
recognition of their potential to disrupt healthcare delivery
is of the utmost importance to patient safety and therefore,
needs to be a part of the National Health Security Strategy.
CHIME and AEHIS believe it is imperative that cybersecurity
is treated as a threat to our nation in similarity to other
hazards. We also appreciate the designation of the Assistant
Secretary for Preparedness and Response (ASPR) as the leader
within the Department of Health and Human Services (HHS) in
the event of a cybersecurity incident. Our members have
repeatedly cited confusion, leading to frustration, about
which operating division within HHS has responsibility over
cybersecurity and serves as a liaison to the industry.
We appreciate your continued interest and leadership on
this important and increasingly urgent subject. We stand
ready to work with you and your colleagues to pursue
legislative solutions to improve the cybersecurity readiness
of the nation's healthcare sector.
Sincerely,
Cletis Earle,
Chair, CHIME Board of Trustees Vice President, CIO
Information Technology,
Kaleida Health.
Erik Decker,
Chair, AEHIS Board CISO and Chief Privacy Officer,
University of Chicago Medicine.
____

Emergent BioSolutions,

July 17, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Greg Walden,
Washington, DC.
Hon. Anna Eshoo,
Washington, DC.
Hon. Frank Pallone,
Washington, DC.
Dear Reps. Brooks, Eshoo, Walden, and Pallone: Thank you to
you and your staff for your hard work in introducing H.R.
6378, the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018. This legislation, like PAHPRA and
PAHPA before it, is vital to ensuring our nation is safe from
and prepared for both human-deployed and natural chemical,
biological, radiological, and nuclear (CBRN) threats.
Emergent is pleased to support PAHPAI.
We are appreciative of your staff for taking the time to
meet with us and solicit feedback about the PAHPAI. Thank you
for your leadership in ensuring the legislation further
strengthens our nation's preparedness for biological threats.
Funding Levels: Emergent strongly supports the robust
funding levels authorized in PAHPAI. This funding is needed
to continue to grow the public-private partnership Congress
created to ensure the U.S. is adequately prepared for CBRN
threats. Sustained and expanded investment in these programs
is a vital market pull to ensure private partners produce
medical countermeasures for the most serious threats we face
as a nation, such as anthrax, smallpox, and chemical threats.
If the government fails to adequately support the Special
Reserve Fund, BARDA, and the SNS, the nation faces the dual
risk of squandering resources already invested into research
and preparedness, while also being underprepared or
unprepared for material threats to our national security.
Identified Authorization Funding Levels for Key Programs:
Emergent is strongly supportive of the inclusion of specific
funding authorization that breaks out the minimum amounts for
the critical Pandemic Influenza and Emerging Infectious
Disease (EID) activities supported through BARDA. Specific
authorizations help ensure that BARDA's priorities receive
consistent funding needed to drive the development of
countermeasures to respond to material threats, pandemic
influenza, emerging infectious diseases, and other public
health hazards.
Other Transaction (OT) Authority: We appreciate your
efforts to update the medical countermeasure enterprise's OT
authority and harmonize it with the OT authority of other
agencies. These changes will provide the enterprise needed
flexibility to better prepare for manmade and naturally-
occurring biological threats.
The public health threat matrix is real and growing.
Reauthorization of PAHPAI is vital to ensuring our nation is
prepared for the most severe threats facing the country. As
introduced, PAHPAI will greatly enhance our nation's
biosecurity preparedness. We believe that Emergent is
uniquely positioned to enable the U.S. and allied governments
to address many of these threats based on our growing
portfolio of medical countermeasures, decades of experience
and expertise in government partnering and contracting, and
our broad and deep manufacturing capabilities. We hope we can
be a resource as the committee continues to work towards
passage of PAHPAI.
Sincerely,
Chris Frech,
Senior Vice President, Global Government Affairs, Emergent
BioSolutions, Inc.
____

Genentech,

Washington, DC, 17 July 2018.
Hon. Anna G. Eshoo,
House of Representatives,
Washington, DC.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Hon. Susan W. Brooks,
House of Representatives,
Washington, DC.
Hon. Frank Pallone, Jr.,
Ranking Member, Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Dear Representatives Eshoo and Brooks, Chairman Walden, and
Ranking Member Pallone: Genentech, Inc. (Genentech) would
like to express our strong support for H.R. 6378--The
Pandemic and All Hazards Preparedness and Advancing
Innovation Act of 2018. We applaud your shared leadership and
bipartisan efforts to strengthen the nation's public health
preparedness and response programs. We are particularly
appreciative that H.R. 6378 authorizes a specific Pandemic
Influenza program at the Biomedical Advanced Research and
Development Authority (BARDA) to support research and
development activities to enhance a rapid response to
pandemic influenza.
As you continue your work toward reauthorization, Genentech
welcomes the opportunity to share our relevant experience and
provide any needed feedback.
Sincerely,
David Burt,
Senior Director, Federal Government Affairs.
____

Grifols Public Affairs,

Washington, DC, July 24, 2018.
Hon. Susan Brooks,
House of Representatives,
Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Congresswoman Brooks and Congresswoman Eshoo: Thank
you for your leadership on healthcare issues in the Congress.
Grifols is proud to join the public health and infectious
disease communities in expressing our strong support for H.R.
6378, the ``Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018.'' This legislation is
critical to maintaining our national preparedness in response
to public health emergencies.
Grifols is a global healthcare company with a 75-year
history of producing plasma-derived medicines, diagnostic
tools and hospital pharmacy products. Grifols is a leader in
transfusion medicine as a supplier of blood and plasma
infectious disease screening systems that are critical to
safeguarding the U.S. blood supply.

[[Page H8788]]

The Nation's experience with emerging infectious diseases,
such as Zika, demonstrates the need for a coordinated
response to public health threats. In a report commissioned
by the Department of Health and Human Services Office of the
Assistant Secretary of Health, the RAND Corporation found
there are 86 emerging or recently emerged pathogens that
threaten the safety of the blood supply. The threat posed by
these emerging infectious diseases exhibits the need to plan
for managing potential outbreaks.
In particular, Grifols is supportive of the provisions in
H.R. 6378 to aid the development and appropriate utilization
of multiuse platform technologies for diagnostics, vaccines,
and therapeutics; virus seeds; clinical trial lots; novel
virus strains; and antigen and adjuvant material; as well as
the provisions aimed at strengthening the U.S. blood supply:
Requiring a report on the adequacy of the national blood
supply
Establish guidelines, in consultation with health care
providers--including blood banks, relating to emergency
preparedness which consider the needs of the blood supply,
taking into account resiliency, geographic and rural
considerations, as well as the financial implications of
implementing such guidelines
Seeking input from all blood supply stakeholders in the
development of emergency preparedness guidelines will help
strengthen the public health infrastructure by ensuring that
the unique needs of the blood supply are met.
In the interests of U.S. public health, we encourage
Congress to pass H.R. 6378 to ensure a robust response to
public health threats.
Sincerely,
Christopher Healey,
Vice President.

Mrs. BROOKS of Indiana. Mr. Speaker, I include the following letters
in the Record.

July 18, 2018.
Hon. Susan Brooks,
Washington, DC.
Hon. Anna Eshoo,
Washington, DC.
Dear Representatives Brooks and Eshoo: I am writing on
behalf of Roche Diagnostics Corporation in support of H.R.
6378, Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2018. Congratulations on advancing this
legislation out of the Energy and Commerce Committee.
We applaud your efforts in improving the nation's overall
preparedness and response capabilities. We especially
appreciate the Committee's recognition that diagnostics can
play a key role in responding to public health and medical
emergencies.
We look forward to continuing to work with you as this
legislation advances in Congress.
Sincerely,

Russell C. Ring,

Vice President, Government Affairs,
Roche Diagnostics Corporation.
____

Strategic Health Information

Exchange Collaborative,

July 18, 2018.
Reps. Brooks and Eshoo and Members of the Energy and
Commerce Committee: On behalf of the Strategic Health
Information Exchange Collaborative (SHIEC), which represents
more than 60 Health Information Exchanges (HIEs) across the
nation, thank you for your leadership on the reauthorization
of the Pandemic and All Hazards Preparedness Act (PAHPAI).
SHIEC HIEs have played an important role across the country
and have a strong interest in emergency preparedness and
disaster relief. SHIEC HIEs have demonstrated the important
role they play in federal, state, and local governments. In
2017 SHIEC HIEs in Texas partnered with local providers and
patients to access critical medical information in the wake
of Hurricane Harvey, and SHIEC HIEs in New York helped to
thwart a ransomware attack and safeguard patient information.
SHIEC is a recognized leader in medical record
interoperability via the Patient Centered Data Home. This
initiative allows patients, no matter where they are--whether
caught up in emergencies while traveling or displaced by
disasters--access to their medical information when and where
they need it.
SHIEC is pleased with the proposed direction for this
reauthorization of PAHPAI, particularly the broadened scope
of Title II regarding ``Optimizing State and Local All-
Hazards Preparedness and Response.'' State and local agencies
and hospitals are not the only healthcare stakeholders during
a crisis. There are many entities that should be consulted in
emergency-planning. Addressing the problems and solutions
more broadly allows state and local agencies and hospitals to
better prepare and handle disasters.
To this end SHIEC applauds the Committee's inclusion of not
just the brick and mortar infrastructure, but also the
``technological infrastructure'' while developing guidelines
and protocols. SHIEC is also happy to see the broad reference
to ``healthcare or subject matter experts'' which replaces a
more restrictive reference to healthcare providers and
agencies.
SHIEC recommends inclusion of HIEs specifically. As the
data trustees in a community, SHIEC HIEs offer vital services
to support a community in crisis. Awareness and realization
of this full benefit has yet to be achieved in some areas.
Without inclusion of clarifying language, SHIEC is concerned
HIEs may still be left out of planning. SHIEC hopes however,
that the broader, more inclusive language that the Committee
has proposed will be expansive enough to ensure HIEs a seat
at the emergency preparedness and disaster relief table.
Thank you,
Kelly Hoover Thompson,
CEO.
____

Takeda,

Cambridge, MA, July 20, 2018.
Hon. Greg Walden,
Chariman, House Energy and Commerce Committee,
House of Representatives,
Washington, DC.
Hon. Susan W. Brooks,
House of Representatives,
Washington, DC.
Hon. Frank Pallone, Jr.,
Ranking Member, House and Energy and Commerce Committee,
House of Representatives,
Washington, DC.
Hon. Anna G. Eshoo,
House of Representatives,
Washington, DC.
Chairman Walden, Ranking Member Pallone, and
Representatives Brooks and Eshoo: Takeda Vaccines appreciates
the opportunity to support H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018.
The legislation contains important provisions to improve the
nation's ability to respond to public health emergencies and
to accelerate research and development of medical
countermeasures. Of particular note is the creation of the
Emerging Infectious Disease Program within the Biomedical
Advanced Research and Development Authority (``BARDA'') that
will support research and development and manufacturing
infrastructure with respect to emerging infectious diseases.
Takeda is a global, research and development-driven
pharmaceutical company committed to bringing better health
and a brighter future to patients by translating science into
life-changing medicines. In addition to its efforts in
oncology, gastroenterology, and neuroscience, Takeda is
actively engaged in the research and development of vaccines
including one for the deadly Zika virus. We appreciate the
collaboration with BARDA to advance innovation in this
disease state.
Takeda applauds the action of the House Energy and Commerce
Committee to pass H.R. 6378 on July 18, 2018, and thanks the
Members and staff for their hard work on this critical bill.
Sincerely,
Rajeev Venkayya, M.D.,
President, Global Vaccines Business Unit, Takeda
Pharmaceutical Company Limited.
____

Trauma Center Association of America,

July 24, 2018.
Hon. Greg Walden,
Chairman, House Committee on Energy & Commerce,
Washington, DC.
Hon. Susan Brooks,
House of Representatives,
Washington, DC.
Hon. Frank Pallone, Jr.,
Ranking Member, House Committee on Energy & Commerce,
Washington, DC.
Hon. Anna Eshoo,
House of Representatives,
Washington, DC.
Dear Chairman Walden, Ranking Member Pallone, Rep. Brooks
and Rep. Eshoo: The Trauma Center Association of America
(``TCAA'') strongly supports H.R. 6378, the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018. We
applaud your bipartisan leadership in developing this
legislation that will help improve and strengthen the
preparedness and response capabilities of our nation's trauma
care system.
We appreciate your willingness to work with TCAA and our
members as you crafted this important piece of legislation.
Specifically, we are pleased to see that the bill
reauthorizes federal grant funding to support the core
missions of trauma centers to offset the cost of activities
such as patient stabilization and transfer, trauma education
and outreach, coordination with local and regional trauma
systems, essential personnel, trauma staff recruitment and
retention, ensuring surge capacity, and trauma-related
emotional and mental health services.
Additionally, TCAA has long advocated for the MISSION ZERO
Act, and we strongly support the inclusion of language to
establish a grant program for military-civilian partnerships
in trauma care that will allow both sectors to benefit from
the others' expertise and experience. This will benefit
patients both on and off the battlefield and we look forward
to continuing to work with you to implement this program.
Finally, we were pleased to see that the bill requires the
development of guidelines, and the authorization of a
demonstration program, to promote coordination and surge
capacity among regional systems of hospitals and other public
health facilities during a public health emergency. This will
help improve our nation's response capabilities and give more
patients access to high quality trauma care.
We look forward to passage of H.R. 6378 and continued work
with the Senate to ensure that this legislation becomes law.
Again, thank you for your hard work and commitment to
preparing and equipping our

[[Page H8789]]

healthcare system for future disasters and public health
emergencies.
Eileen Whalen, MHA, BSN, RN,
Chair, Board of Directors. Trauma Center Association of
America.
Jennifer Ward, MBA, BSN, RN,
President, Trauma Center Association of America.

The SPEAKER pro tempore. The question is on the motion offered by the
gentlewoman from Indiana (Mrs. Brooks) that the House suspend the rules
and pass the bill, H.R. 6378, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
The title of the bill was amended so as to read: ``A bill to
reauthorize certain programs under the Pandemic and All-Hazards
Preparedness Reauthorization Act.''.
A motion to reconsider was laid on the table.

____________________