Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
This bill amends the Public Health Service Act to establish several programs and entities relating to public health emergency preparedness and response, including:
The bill also reauthorizes for FY2019-FY2023 and revises several other programs and entities relating to public health emergencies, including the National Disaster Medical System, the Volunteer Medical Reserve Corps, and the Biomedical Advanced Research and Development Authority.
The bill also expands the responsibilities of the Assistant Secretary for Preparedness and Response (ASPR) and the scope of the National Health Security Strategy.
ASPR must also develop a strategy to reunify children and parents who were separated at the U.S.-Mexico border under a specified immigration enforcement policy (i.e., the "zero-tolerance" policy) and submit weekly reports on the status and welfare of children awaiting reunification.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6378 Introduced in House (IH)]
<DOC>
115th CONGRESS
2d Session
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 16, 2018
Mrs. Brooks of Indiana (for herself, Ms. Eshoo, Mr. Walden, and Mr.
Pallone) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
the Judiciary, Veterans' Affairs, and Homeland Security, for a period
to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
Sec. 101. Coordination of preparedness for and response to all-hazards
public health emergencies.
Sec. 102. Public health emergency medical countermeasures enterprise.
Sec. 103. National Health Security Strategy.
Sec. 104. Improving emergency preparedness and response considerations
for children.
Sec. 105. Reauthorizing the National Advisory Committee on Children and
Disasters.
Sec. 106. National Disaster Medical System.
Sec. 107. Volunteer Medical Reserve Corps.
Sec. 108. Continuing the role of the Department of Veterans Affairs.
Sec. 109. Authorizing the National Advisory Committee on Seniors and
Disasters.
Sec. 110. National Advisory Committee on Individuals with Disabilities
in All-Hazards Emergencies.
Sec. 111. Consideration for at-risk individuals.
Sec. 112. Public health surveillance.
Sec. 113. GAO study and report on disaster medical assistance teams.
Sec. 114. Military and civilian partnership for trauma readiness grant
program.
Sec. 115. Improvement of loan repayment program for prevention
activities.
Sec. 116. Report on adequate national blood supply.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
Sec. 201. Public health emergencies.
Sec. 202. Improving State and local public health security.
Sec. 203. Strengthening the hospital preparedness program.
Sec. 204. Improving benchmarks and standards for preparedness and
response.
Sec. 205. Authorization of appropriations for revitalizing the Centers
for Disease Control and Prevention.
Sec. 206. Authorization of appropriations for Emergency System for
Advanced Registration of Volunteer Health
Professionals.
Sec. 207. Regional health care emergency preparedness and response
systems.
Sec. 208. National Academy of Medicine evaluation and report on the
preparedness of hospitals, long-term care
facilities, dialysis centers, and other
medical facilities for public health
emergencies.
Sec. 209. Limitation on liability for volunteer health care
professionals.
TITLE III--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
Sec. 301. Strategic national stockpile and security countermeasure
procurement.
Sec. 302. Biomedical advanced research and development authority.
Sec. 303. Report on the development of vaccines to prevent future
epidemics.
TITLE IV--MISCELLANEOUS PROVISIONS
Sec. 401. Cybersecurity.
Sec. 402. Miscellaneous FDA amendments.
Sec. 403. Formal strategy relating to children separated from parents
and guardians as a result of zero tolerance
policy.
Sec. 404. Biological threat detection.
Sec. 405. Strengthening Mosquito Abatement for Safety and Health.
Sec. 406. Additional strategies for combating antibiotic resistance.
Sec. 407. Additional purposes for grants for certain trauma centers.
TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC
HEALTH EMERGENCIES
SEC. 101. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS
PUBLIC HEALTH EMERGENCIES.
(a) In General.--Section 2811 of the Public Health Service Act (42
U.S.C. 300hh-10) is amended--
(1) in subsection (b)--
(A) in paragraph (4)--
(i) in subparagraph (G)--
(I) by inserting ``the pandemic
influenza and emerging infectious
disease program established under
section 319L(d), or'' before ``all-
hazards medical and public health
preparedness and response''; and
(II) by adding at the end (after
and below clause (ii)) the following:
``Such drills and operations exercises shall be
comprehensive, synchronized, and mutually
supportive.''; and
(ii) by adding at the end the following new
subparagraph:
``(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.'';
(B) in paragraph (5), 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 declared by the Secretary pursuant to
section 319, or an emergency or major disaster declared
by the President pursuant to 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.'';
(C) in paragraph (7)--
(i) in the matter preceding subparagraph
(A)--
(I) by inserting ``the research and
development activities of the pandemic
influenza and emerging infectious
disease program established under
section 319L(d) with respect to
qualified pandemic or epidemic products
(as defined in section 319F-3), and''
before ``the medical countermeasure
priorities described in subsection
(d)''; and
(II) by striking ``Develop, and
update not later than March 1 of each
year'' and inserting ``Develop, by not
later than September 30, 2019, and
update no later than every two years
after the initial development,''; and
(ii) in each of subparagraphs (D) and (E),
by striking ``not later than March 15 of each
year'' and inserting in each such place ``not
later than 14 days after each biennial
development date''; and
(D) by adding at the end the following new
paragraph:
``(8) Reporting.--The Assistant Secretary for Preparedness
and Response shall, beginning on the date of the enactment of
this paragraph, submit to the Committee on Energy and Commerce
of the House of Representatives 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.'';
(2) in subsection (c), in the matter preceding paragraph
(1), by striking ``shall'' and inserting ``shall, utilizing
experience related to public health emergency preparedness and
response, biodefense, medical countermeasures, and other
relevant topics''; and
(3) in subsection (d)--
(A) in paragraph (1), by striking ``Not later than
180 days after the date of enactment of this
subsection, and every year thereafter'' and inserting
``Not later than September 30, 2019, and every second
year thereafter'';
(B) in paragraph (2)(C), by inserting after
``products'' the following: ``, and ancillary medical
supplies to assist with the utilization of such
products,''; and
(C) in paragraph (2)(J)(v), by striking ``the one-
year period for which the report is submitted'' and
inserting ``the two-year period for which the report is
submitted''.
(b) Countermeasures Budget Plan.--Section 2811(b)(7) of the Public
Health Service Act (42 U.S.C. 300hh-10(b)(7)) is amended--
(1) by striking subparagraph (A) and inserting the
following:
``(A) include consideration of the entire medical
countermeasures enterprise, including--
``(i) basic research and advanced research
and development;
``(ii) approval, clearance, licensure, and
authorized uses of products;
``(iii) procurement, stockpiling,
maintenance, and potential replenishment
(including manufacturing capabilities) of all
products in the Strategic National Stockpile;
and
``(iv) the availability of technologies
that may assist in the advanced research and
development of countermeasures and
opportunities to use such technologies to
accelerate and navigate challenges unique to
countermeasure research and development;'';
(2) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively; and
(3) 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. 102. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.
Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh-10 et seq.) is amended--
(1) by redesignating section 2811A as 2811B; and
(2) by inserting after section 2811 the following:
``SEC. 2811A. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.
``(a) In General.--The Secretary shall establish and the Assistant
Secretary for Preparedness and Response may convene an interagency
panel of advisors to be known as the Public Health Emergency Medical
Countermeasures Enterprise (in this section referred to as the
`PHEMCE').
``(b) Members.--
``(1) In general.--In addition to the Assistant Secretary
for Preparedness and Response, who shall serve as chair, the
PHEMCE shall include the voting members described in paragraph
(2) and the non-voting members described in paragraph (3).
``(2) Voting members.--For purposes of paragraph (1), the
voting members described in this paragraph are following
members:
``(A) The Director of the Biomedical Advanced
Research and Development Authority (or the Director's
designee).
``(B) The Director of the Centers for Disease
Control and Prevention (or the Director's designee).
``(C) The Director of the National Institutes of
Health (or the Director's designee).
``(D) The Commissioner of Food and Drugs (or the
Commissioner's designee).
``(E) The Secretary of Defense (or the Secretary's
designee).
``(F) The Secretary of Homeland Security (or the
Secretary's designee).
``(G) The Secretary of Agriculture (or the
Secretary's designee).
``(H) The Secretary of Veterans Affairs (or the
Secretary's designee).
``(I) Representatives of any other Federal
agencies, as the Assistant Secretary for Preparedness
and Response determines appropriate.
``(3) Non-voting members.--For purposes of paragraph (1),
the non-voting members described in this paragraph are the
following members:
``(A) The Secretary of State (or the Secretary's
designee).
``(B) The Director of National Intelligence (or the
Director's designee).
``(C) The Director of the Central Intelligence
Agency (or the Director's designee).
``(c) Functions.--The PHEMCE shall--
``(1) advise the Assistant Secretary for Preparedness and
Response regarding research, development, and procurement of
security countermeasures (as defined in section 319F-2(c))
based on the health security needs of the United States; and
``(2) assist the Assistant Secretary for Preparedness and
Response in the identification of gaps in public health
preparedness and response related to such security
countermeasures and challenges to addressing such needs
(including any regulatory challenges).''.
SEC. 103. 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,'';
(ii) in subparagraph (F), by inserting ``or
exposures to agents that could cause a public
health emergency'' before the period; and
(iii) by amending subparagraph (G) to read
as follows:
``(G) Optimizing a coordinated and flexible
approach to the emergency response and medical surge
capacity of hospitals, other health care facilities,
critical care, trauma care (which may include trauma
centers), and emergency medical systems, which may
include the implementation of guidelines for regional
health care emergency preparedness and response systems
under section 319C-3.'';
(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.''.
SEC. 104. 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. 105. REAUTHORIZING THE NATIONAL ADVISORY COMMITTEE ON CHILDREN AND
DISASTERS.
Section 2811B of the Public Health Service Act, as redesignated by
section 102(1), is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and
inserting ``25''; and
(B) by striking paragraph (2) and inserting the
following:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals to perform the duties
described in subsections (b) and (c), including--
``(A) at least 2 non-Federal professionals with
expertise in pediatric medical disaster planning,
preparedness, response, or recovery;
``(B) at least 2 representatives from State, local,
tribal, or territorial agencies with expertise in
pediatric disaster planning, preparedness, response, or
recovery;
``(C) at least 4 members representing health care
professionals, which may include members with expertise
in pediatric emergency medicine; pediatric trauma,
critical care, or surgery; the treatment of pediatric
patients affected by chemical, biological,
radiological, or nuclear agents and emerging infectious
diseases; pediatric mental or behavioral health related
to children affected by a public health emergency; or
pediatric primary care; and
``(D) other members as the Secretary determines
appropriate, of whom--
``(i) at least one such member shall
represent a children's hospital;
``(ii) at least one such member shall be an
individual with expertise in schools or child
care settings;
``(iii) at least one such member shall be
an individual with expertise in children and
youth with special health care needs; and
``(iv) at least one such member shall be an
individual with expertise in the needs of
parents or family caregivers, including the
parents or caregivers of children with
disabilities.
``(3) Federal members.--The Advisory Committee under
paragraph (1) shall include the following Federal members or
their designees:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced
Research and Development Authority.
``(C) The Director of the Centers for Disease
Control and Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of
Health.
``(F) The Assistant Secretary of the Administration
for Children and Families.
``(G) The Administrator of the Health Resources and
Services Administration.
``(H) The Administrator of the Federal Emergency
Management Agency.
``(I) The Administrator of the Administration for
Community Living.
``(J) The Secretary of Education.
``(K) Representatives from such Federal agencies
(such as the Substance Abuse and Mental Health Services
Administration and the Department of Homeland Security)
as the Secretary determines appropriate to fulfill the
duties of the Advisory Committee under subsections (b)
and (c).
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a term
of 3 years, except that the Secretary may adjust the terms of
the Advisory Committee appointees serving on the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, or appointees who are
initially appointed after such date of enactment, in order to
provide for a staggered term of appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than 2 of which may be
served consecutively.'';
(3) in subsection (e), by adding at the end ``At least one
meeting per year shall be an in-person meeting.'';
(4) by redesignating subsection (f) as subsection (g);
(5) by inserting after subsection (e) the following:
``(f) Coordination.--The Secretary shall coordinate activities
authorized under this section and section 2811C, in accordance with
section 2811C(d).''; and
(6) in subsection (g), as so redesignated, by striking
``2018'' and inserting ``2023''.
SEC. 106. NATIONAL DISASTER MEDICAL SYSTEM.
(a) Purpose of 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.''.
(b) 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 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.''.
(c) Direct Hire Authority.--Section 2812(c)(1) of the Public Health
Service Act (42 U.S.C. 300hh-11(c)(1)) is amended by inserting ``(or,
for the period beginning on the date of the enactment of the Pandemic
and All-Hazards Preparedness Reauthorization Act of 2018 and ending on
September 30, 2021, without regard to those provisions of title 5,
United States Code, governing appointments in the competitive
service)'' after ``in accordance with applicable civil service laws and
regulations''.
(d) Service Benefit; Notification of Shortage.--Section 2812(c) (42
U.S.C. 300hh-11(c)) is amended by adding at the end the following:
``(3) Service benefit.--Individuals appointed to serve
under this subsection shall be considered public safety
officers under part L of title I of the Omnibus Crime Control
and Safe Streets Act of 1968. The Secretary shall provide
notification to eligible individuals of any effect such
designation may have on other benefits for which such
individuals are eligible, including benefits from private
entities.
``(4) Notification.--Not later than 30 days after the date
on which the Secretary determines the number of intermittent
disaster-response personnel of 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.''.
(e) Death Benefits.--Section 1204(9) of the Omnibus Crime Control
and Safe Streets Act of 1968 (34 U.S.C. 10284(9)) is amended--
(1) in subparagraph (C), by striking ``or'' at the end;
(2) in subparagraph (D), by striking the period at the end
and inserting ``; or''; and
(3) by adding at the end the following:
``(E) an individual appointed to assist the
National Disaster Medical System pursuant to section
2812(c)(1) of the Public Health Service Act.''.
(f) 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''.
SEC. 107. VOLUNTEER MEDICAL RESERVE CORPS.
Section 2813 of the Public Health Service Act (42 U.S.C. 300hh-15))
is amended--
(1) in subsection (a), by amending the second sentence to
read as follows: ``The Secretary may appoint a Director to head
the Corps and oversee the activities of the Corps chapters that
exist at the State, local, and tribal levels.''; and
(2) in subsection (i), by striking ``$11,200,000 for each
of fiscal years 2014 through 2018'' and inserting ``$6,000,000
for each of fiscal years 2019 through 2023''.
SEC. 108. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS AFFAIRS.
Section 8117(g) of title 38, United States Code, is amended by
striking ``$155,300,000 for each of fiscal years 2014 through 2018''
and inserting ``$126,800,000 for each of fiscal years 2019 through
2023''.
SEC. 109. 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.), as amended by section 102, is further amended by
inserting after section 2811B the following:
``SEC. 2811C. 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.--
``(1) In general.--The Advisory Committee shall--
``(A) provide advice and consultation with respect
to the activities carried out pursuant to section 2814,
as applicable and appropriate;
``(B) evaluate and provide input with respect to
the medical and public health needs of seniors related
to the preparation for, response to, and recovery from
all-hazards emergencies; and
``(C) provide advice and consultation with respect
to State emergency preparedness and response activities
and seniors, including related drills and exercises
pursuant to the preparedness goals under section
2802(b).
``(2) 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.
``(3) Membership.--
``(A) In general.--The Secretary, in consultation
with such other heads of agencies as appropriate, shall
appoint not more than 15 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.
``(B) Required members.--The members appointed
under paragraph (1) shall include--
``(i) the Assistant Secretary for
Preparedness and Response;
``(ii) the Director of the Biomedical
Advanced Research and Development Authority;
``(iii) the Director of the Centers for
Disease Control and Prevention;
``(iv) the Commissioner of Food and Drugs;
``(v) the Director of the National
Institutes of Health;
``(vi) the Administrator of the Centers for
Medicare & Medicaid Services;
``(vii) the Administrator of the
Administration for Community Living;
``(viii) the Administrator of the Federal
Emergency Management Agency;
``(ix) the Under Secretary for Health of
the Department of Veterans Affairs;
``(x) at least 2 non-Federal health care
professionals with expertise in medical
disaster planning, preparedness, response, or
recovery;
``(xi) at least 2 representatives of State,
local, territorial, or tribal agencies with
expertise in disaster planning, preparedness,
response, or recovery; and
``(xii) 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.
``(c) Meetings.--The Advisory Committee shall meet not less
frequently than biannually.
``(d) Advisory Committee Coordination.--
``(1) In general.--The Secretary shall coordinate
activities authorized under this section and section 2811B, and
make efforts to reduce unnecessary or duplication of meetings,
recommendations, and reporting under such sections. Members of
the advisory committees under this section and section 2811B,
or their designees, shall meet periodically, and not less than
annually, to--
``(A) review the recommendations developed by such
committees to coordinate, as appropriate, the
implementation of recommendations, in order to reduce
gaps, overlap, and duplication of effort in Federal
programs or by Federal grantees; and
``(B) align preparedness and response programs or
activities to address the dual or overlapping needs of
children and seniors and any challenges in preparing
for and responding to such needs.
``(2) Notification.--The Secretary shall notify the
congressional committees of jurisdiction upon the convening of
each meeting under paragraph (1), and provide minutes from such
meeting not later than 90 days after the meeting.
``(e) Sunset.--The Advisory Committee shall terminate on September
30, 2023.''.
SEC. 110. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES
IN ALL-HAZARDS EMERGENCIES.
Subtitle B of title XXVIII of the Public Health Service Act (42
U.S.C. 300hh et seq.), as amended by sections 102 and 109, is further
amended by inserting after section 2811C the following:
``SEC. 2811D. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH
DISABILITIES IN ALL-HAZARDS EMERGENCIES.
``(a) Establishment.--Not later than 90 days after the date of this
section, the Secretary shall establish a national advisory committee to
be known as the National Advisory Committee on Individuals with
Disabilities in All-Hazards Emergencies (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 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).
``(c) Report.--Not later than February 1, 2020, the Advisory
Committee shall submit to the Secretary, the Committee on Energy and
Commerce of the House of Representatives, the Committee on Homeland
Security of the House of Representatives, the Committee on Veterans'
Affairs of the House of Representatives, the Committee on Health,
Education, Labor, and Pensions of the Senate, the Committee on
Veterans' Affairs of the Senate, and the Committee on Homeland Security
and Governmental Affairs of the Senate a report that evaluates the
extent to which individuals with disabilities are thoroughly included
in disaster preparedness planning and disaster recovery. Such report
shall--
``(1) 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.
``(d) Composition.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies and departments as may be appropriate,
shall appoint not to exceed 25 members to the Advisory
Committee.
``(2) Required members.--In carrying out paragraph (1), the
Secretary shall appoint to the Advisory Committee such
individuals as may be appropriate to perform the duties
described in subsections (b), which shall include--
``(A) the Assistant Secretary for Preparedness and
Response (or their designee);
``(B) the Director of the Administration for
Community Living (or their designee);
``(C) the Director of the Biomedical Advanced
Research and Development Authority (or their designee);
``(D) the Director of the Centers for Disease
Control and Prevention (or their designee);
``(E) the Commissioner of Food and Drugs (or their
designee);
``(F) the Director of the National Institutes of
Health (or their designee);
``(G) the Administrator of the Federal Emergency
Management Agency (or their designee);
``(H) the Director of Office of Disability
Integration and Coordination (or their designee);
``(I) the Officer for Civil Rights and Civil
Liberties of the Department of Homeland Security (or
their designee);
``(J) the Chair of the National Council on
Disability (or their designee);
``(K) the Chair of the United States Access Board
(or their designee);
``(L) the Director of the Disability Rights Section
of the Department of Justice (or their designee);
``(M) the Secretary of the Department of Education
(or their designee);
``(N) the Secretary of the Department of
Transportation (or their designee);
``(O) the Secretary of the Department of Housing
and Urban Development (or their designee);
``(P) a representative from the Department of
Veterans Affairs Health Administration's Office of
Emergency Management;
``(Q) the Director of the Bureau of Prisons (or
their designee);
``(R) at least four representatives who are
individuals with disabilities that have substantive
expertise in disability inclusive emergency management
policy and operations;
``(S) 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
``(T) at least two representatives from State,
local, territorial, or tribal agencies with expertise
in disability-inclusive disaster planning,
preparedness, response, or recovery.
``(e) Meetings.--The Advisory Committee shall meet not less than
biannually.
``(f) 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.
``(g) Termination of Committee.--
``(1) In general.--The Advisory Committee shall terminate
on September 30, 2023.
``(2) Recommendation.--Not later than March 30, 2023, the
Secretary shall submit to Congress a recommendation on whether
the Advisory Committee should be extended.''.
SEC. 111. CONSIDERATION FOR AT-RISK INDIVIDUALS.
(a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended by
striking ``this section and sections 319C-1, 319F, and 319L'' and
inserting ``this Act''.
(b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C.
247d-7e(c)(6)) is amended--
(1) by striking ``elderly'' and inserting ``senior
citizens''; and
(2) by inserting ``with relevant characteristics that
warrant consideration during the process of researching and
developing such countermeasures and products'' before the
period at the end.
SEC. 112. PUBLIC HEALTH SURVEILLANCE.
(a) Goal.--Section 2802(b) of the Public Health Service Act (42
U.S.C. 300hh-1(b)), as amended by sections 103 and 111, is further
amended by adding at the end the following:
``(11) Public health surveillance.--Strengthening the
ability of State, tribal, territorial, and local health
departments to adapt and expand existing public health
surveillance infrastructure to develop a robust national
surveillance capacity to capture data on the impact of emerging
public health threats. Such capacity shall include emerging
threats to pregnant and postpartum women and infants, including
through monitoring birth defects, developmental disabilities,
and other short-term and long-term adverse outcomes.''.
(b) Assurance of Confidentiality.--Section 308(d) of the Public
Health Service Act (42 U.S.C. 242m(d)) is amended--
(1) by striking ``or 307'' and inserting ``307, or
2802(b)(11)''; and
(2) by striking ``or 306'' and inserting ``306, or
2802(b)(11)''.
SEC. 113. GAO STUDY AND REPORT ON DISASTER MEDICAL ASSISTANCE TEAMS.
(a) Study and Report.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the mission readiness of disaster
medical assistance teams with respect to current and emerging
natural and manmade threats.
(2) Components.--The study conducted pursuant to paragraph
(1) shall include an assessment, in relation to disaster
medical assistance teams, of--
(A) whether the mission readiness of such teams,
and the needs relating to such readiness, have changed
over time;
(B) the standards the Assistant Secretary for
Preparedness and Response of the Department of Health
and Human Services uses to determine--
(i) the training needs of such teams; and
(ii) whether such teams are mission ready;
(C) how to improve the determinations described in
subparagraph (B);
(D) the extent to which the provision of additional
resources (including personnel, training, and
equipment) has addressed mission readiness concerns;
and
(E) the extent to which the Assistant Secretary has
developed plans to address mission readiness issues.
(3) Report.--Not later than one year after the date of
enactment of this Act, the Comptroller General 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 report containing--
(A) the findings of the study conducted pursuant to
paragraph (1); and
(B) related recommendations.
(b) Disaster Medical Assistance Team Defined.--In this section, the
term ``disaster medical assistance team'' means a disaster medical
assistance team operating pursuant to the National Disaster Medical
System established under section 2812 of the Public Health Service Act
(42 U.S.C. 300hh-11).
SEC. 114. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT
PROGRAM.
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 shall award grants to not
more than 20 eligible high-acuity trauma centers to enable
military trauma teams to provide, on a full-time basis, trauma
care and related acute care at such trauma centers.
``(2) Limitations.--In the case of a grant awarded under
paragraph (1) to an eligible high-acuity trauma center, such
grant--
``(A) shall be for a period of at least 3 years and
not more than 5 years (and may be renewed at the end of
such period); and
``(B) shall be in an amount that does not exceed
$1,000,000 per year.
``(3) Availability of funds after performance period.--
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 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.--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 be deployed by the Secretary of Defense for military
operations, for training, or for response to a mass casualty
incident.
``(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 expenditures for malpractice insurance, office space,
information technology, specialty education and supervision,
trauma programs, research, and State license fees for such
military trauma care providers.
``(d) Rule of Construction.--Nothing in this section shall be
construed to affect the extent to which State licensing requirements
for health care professionals are preempted by other Federal law from
applying 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 financial impact of such grant on the
trauma center;
``(C) the educational impact 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 Congress that includes
information on the effect of placing military trauma care
providers in trauma centers awarded grants under this section
on--
``(A) maintaining readiness of military trauma care
providers for battlefield injuries;
``(B) providing health care to civilian trauma
patients in both urban and rural settings;
``(C) the capability to respond to surges in trauma
cases, including as a result of a large scale event;
and
``(D) the financial State of the trauma centers.
``(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 to measure performance and
outcomes, such as the Trauma Quality Improvement
Program of the American College of Surgeons.
``(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 of such
trauma center in the most recent 3-month period for
which data is available are treated for a major trauma
at such trauma center.
``(C) Such trauma center utilizes a risk-adjusted
benchmarking system to measure performance and
outcomes, such as the Trauma Quality Improvement
Program of the American College of Surgeons.
``(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 disaster
response leader for its community, such as by
participating in a partnership for State and regional
hospital preparedness established under section 319C-2.
``(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, including a physician, military surgeon, physician
assistant, nurse, respiratory therapist, flight paramedic,
combat medic, or enlisted medical technician.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $15,000,000 for each of fiscal
years 2019 through 2023, of which--
``(1) $10,000,000 shall be for carrying out subsection (a);
and
``(2) $5,000,000 shall be for carrying out subsection
(b).''.
SEC. 115. IMPROVEMENT OF LOAN REPAYMENT PROGRAM FOR PREVENTION
ACTIVITIES.
Section 317F of the Public Health Service Act (42 U.S.C. Sec. 247b-
7) is amended--
(1) in subsection (a)(1)--
(A) by inserting after ``conduct prevention
activities'' the following: ``, including rapid
response to major health threats,''; and
(B) by striking ``$35,000'' and inserting
``$50,000'';
(2) in subsection (a)(2)(B), by striking ``3 years'' and
inserting ``2 years''; and
(3) in subsection (c), by striking ``$500,000'' and all
that follows through the period at the end and inserting
``$1,000,000 for each of the fiscal years 2019 through 2023.''.
SEC. 116. 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 challenges associated with continuous
recruitment of blood donors, ensuring adequacy of blood supply in the
case of public health emergencies, and implementation of safety
measures and innovation.
TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND
RESPONSE
SEC. 201. PUBLIC HEALTH EMERGENCIES.
(a) 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
before the period the following: ``, 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''; and
(ii) by inserting after the first sentence
the following: ``The Secretary shall plan for
the expedited distribution of amounts in the
Fund to appropriate agencies and entities.'';
(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)--
``(A) to 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) to make grants, provide for awards, enter
into contracts, and conduct supportive investigations
pertaining to such a public health emergency or
potential public health emergency, including further
supporting programs under sections 319C-1 and 319C-2;
``(C) to 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 such
a public health emergency or potential public health
emergency;
``(D) to strengthen biosurveillance capabilities
and laboratory capacity to identify, collect, and
analyze information regarding such a public health
emergency or potential public health emergency,
including the systems under section 319D;
``(E) to 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) to carry out other activities, as the
Secretary determines applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so
redesignated, the following:
``(4) Review.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2018, the Secretary, in coordination
with the Assistant Secretary for Preparedness and Response,
shall conduct a review of the Fund under this subsection, 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 review and report.--The Comptroller General of
the United States shall conduct a review of the Fund under this
subsection, including the uses and the resources available in
the Fund. Not later than 4 years after the date of enactment of
the Pandemic and All-Hazards Preparedness Reauthorization Act
of 2018, the Comptroller General 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 report on such review, including recommendations
related to such review.''; and
(2) in subsection (c), by striking ``section.'' and
inserting ``section or funds otherwise provided for emergency
response.''.
(b) Temporary Reassignment of Federally Funded Personnel.--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''.
SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.
(a) In General.--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'';
(2) in subsection (b)(2)(A)--
(A) in clause (viii), by striking at the end
``and'';
(B) in clause (ix), by adding at the end ``and'';
and
(C) by inserting after clause (ix) the following
new clause:
``(x) a description of--
``(I) the measures the entity will
have in place to prioritize nursing
facilities and skilled nursing
facilities with respect to public
health emergency preparedness in the
same manner as such plan will
prioritize hospitals, while ensuring
that, in prioritizing nursing
facilities, skilled nursing facilities,
and hospitals, the entity will retain
the discretion to prioritize among such
facilities; and
``(II) the plans that each electric
utility company within the entity's
jurisdiction has in place to ensure
that each such company will remain
functioning or return to functioning as
soon as practicable during power
outages caused by natural or manmade
disasters;'';
(3) in subsection (e), 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.''; and
(4) in subsection (h)(1)(A), by striking ``$641,900,000 for
fiscal year 2014 for awards pursuant to paragraph (3) (subject
to the authority of the Secretary to make awards pursuant to
paragraphs (4) and (5)), and $641,900,000 for each of fiscal
years 2015 through 2018'' and inserting ``$670,000,000 for each
of fiscal years 2019 through 2023''.
(b) Effective Date.--The amendments made by subsection (a) shall
take effect on the date of enactment of this Act and apply with respect
to cooperative agreements awarded on or after such date of enactment.
SEC. 203. STRENGTHENING THE HOSPITAL PREPAREDNESS PROGRAM.
Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b)
is amended--
(1) by amending the section heading to read as follows:
``state and regional health care preparedness and response to
improve surge capacity'';
(2) in subsection (a), by striking ``hospital preparedness
for'' and inserting ``health care preparedness for and response
to'';
(3) in subsection (b)(1)(A)--
(A) in the matter preceding clause (i)--
(i) by striking ``partnership'' and
inserting ``coalition''; and
(ii) by striking ``consisting of'' and
inserting ``that includes'';
(B) in clause (ii), by striking ``and'' at the end;
(C) in clause (iii)(III), by striking ``and'' at
the end; and
(D) by adding at the end the following:
``(iv) an emergency medical service
organization; and
``(v) an emergency management organization;
and'';
(4) in subsection (c), by inserting after ``preparedness''
the following: ``and response'';
(5) in subsection (d)--
(A) in paragraph (1)(A)--
(i) in clause (i), by striking ``; and''
and inserting a semicolon;
(ii) by redesignating clause (ii) as clause
(iii); and
(iii) by inserting after clause (i) the
following:
``(ii) among one or more facilities in a
regional health care emergency system under
section 319C-3; and'';
(B) in paragraph (1)(B), by striking
``partnership'' each place it appears and inserting
``coalition''; and
(C) in paragraph (2)(C), by striking ``medical
preparedness'' and inserting ``preparedness and
response'';
(6) in subsection (f), by striking ``partnership'' and
inserting ``coalition'';
(7) in subsection (g)(2)--
(A) by striking ``Partnerships'' and inserting
``Coalitions'';
(B) by striking ``partnerships'' and inserting
``coalitions''; and
(C) by inserting after ``preparedness'' the
following: ``and response'';
(8) in subsection (i)--
(A) in paragraph (1)--
(i) by striking ``The requirements'' and
inserting ``Except as provided in paragraph
(2), the requirements'';
(ii) by striking ``An entity'' and
inserting ``A coalition'';
(iii) by striking ``such partnership'' and
inserting ``such coalition''; and
(iv) by adding at the end the following:
``In submitting reports pursuant to this
paragraph, an entity shall include information
on the progress (if any) that the entity has
made towards the implementation of section
319C-3.'';
(B) by redesignating paragraph (2) as paragraph
(3); and
(C) by inserting after paragraph (1) the following:
``(2) Exception relating to application of certain
requirements.--Beginning with fiscal year 2019, and in each
succeeding fiscal year, with respect to entities receiving
awards under this section--
``(A) paragraph (5)(A) of section 319C-1(g) shall
be applied--
``(i) by substituting `for the immediately
preceding fiscal year' with the following: `for
either of the two immediately preceding fiscal
years'; and
``(ii) by substituting `2019' for `2008';
and
``(B) paragraph (6)(A) of section 319C-1(g) shall
be applied by substituting--
``(i) clause (i) of such paragraph with the
following: `For each 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 each such fiscal year.';
``(ii) clause (ii) of such paragraph with
the following: `For each of the first two
fiscal years immediately following two
consecutive fiscal years in which an entity
experienced such a failure, an amount equal to
15 percent of the amount the entity was
eligible to receive for each of such first two
fiscal years, disregarding any withholding of
funds that would have been made in each such
year by virtue of clause (i). The amount
determined pursuant to the previous sentence
shall be in lieu of any amount that would have
been withheld for each such year by virtue of
clause (i).';
``(iii) clause (iii) of such paragraph with
the following: `For each of the first two
fiscal years immediately following three
consecutive fiscal years in which an entity
experienced such a failure, an amount equal to
20 percent of the amount the entity was
eligible to receive for each of such first two
fiscal years, disregarding any withholding of
funds that would have been made in each such
year by virtue of clauses (i) and (ii). The
amount determined pursuant to the previous
sentence shall be in lieu of any amount that
would have been withheld for each such year by
virtue of clauses (i) and (ii).'; and
``(iv) clause (iv) of such paragraph with
the following: `For each of the first two
fiscal years immediately following four
consecutive fiscal years in which an entity
experienced such a failure, an amount equal to
25 percent of the amount the entity was
eligible to receive for each of such first two
fiscal years, disregarding any withholding of
funds that would have been made in each such
year by virtue of clauses (i), (ii), and (iii).
The amount determined pursuant to the previous
sentence shall be in lieu of any amount that
would have been withheld for each such year by
virtue of clauses (i), (ii), and (iii).'.'';
and
(9) in subsection (j)(2), in the paragraph heading, by
striking ``Partnerships'' and inserting ``Coalitions''.
SEC. 204. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS AND
RESPONSE.
(a) Evaluating Measurable Evidence-Based Benchmarks and Objective
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting
after subsection (j) the following:
``(k) Evaluation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018 and every 2 years thereafter,
the Secretary shall conduct an evaluation of the evidence-based
benchmarks and objective standards required under subsection
(g). Such evaluation shall be submitted to the congressional
committees of jurisdiction together with the National Health
Security Strategy under section 2802, at such time as such
strategy is submitted.
``(2) Content.--The evaluation under this paragraph shall
include--
``(A) a review of evidence-based benchmarks and
objective standards, and associated metrics and
targets;
``(B) a discussion of changes to any evidence-based
benchmarks and objective standards, and the effect of
such changes on the ability to track whether entities
are meeting or making progress toward the goals under
this section and, to the extent practicable, the
applicable goals of the National Health Security
Strategy under section 2802;
``(C) a description of amounts received by eligible
entities, as described in subsection (b) and section
319C-2(b), and amounts received by subrecipients and
the effect of such funding on meeting evidence-based
benchmarks and objective standards; and
``(D) recommendations, as applicable and
appropriate, to improve evidence-based benchmarks and
objective standards to more accurately assess the
ability of entities receiving awards under this section
to better achieve the goals under this section and
section 2802.''.
(b) Evaluating the Partnership for State and Regional Hospital
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)), as
amended by section 203, is further amended by striking ``section 319C-
1(g), (i), and (j)'' and inserting ``section 319C-1(g), (i), (j), and
(k)''.
SEC. 205. AUTHORIZATION OF APPROPRIATIONS FOR REVITALIZING THE CENTERS
FOR DISEASE CONTROL AND PREVENTION.
Section 319D(f) of the Public Health Service Act (42 U.S.C. 247d-
4(f)) is amended by striking ``$138,300,000 for each of fiscal years
2014 through 2018'' and inserting ``$161,800,000 for each of fiscal
years 2019 through 2023''.
SEC. 206. AUTHORIZATION OF APPROPRIATIONS FOR EMERGENCY SYSTEM FOR
ADVANCED REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS.
Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d-
7b(k)) is amended by striking ``fiscal years 2014 through 2018'' and
inserting ``fiscal years 2019 through 2023''.
SEC. 207. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
SYSTEMS.
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 new
section:
``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, and nuclear agents, including emerging
infectious diseases.
``(b) Guidelines.--The Assistant Secretary for Preparedness and
Response, in consultation with the Director of the Centers for Disease
Control and Prevention, the Administrator of the Centers for Medicare &
Medicaid Services, the Administrator of the Health Resources and
Services Administration, the Commissioner of Food and Drugs, the
Assistant Secretary for Mental Health and Substance Use, the Assistant
Secretary of Labor for Occupational Safety and Health, the Secretary of
Veterans Affairs, the heads of such other Federal agencies as the
Secretary determines to be appropriate, and State, local, tribal, and
territorial public health officials, shall, not later than 2 years
after the date of enactment of this section--
``(1) identify and develop a set of guidelines relating to
practices and protocols for all-hazards public health emergency
preparedness and response for hospitals and health care
facilities to provide appropriate patient care during, in
advance of, or immediately following, a public health
emergency, resulting from one or more chemical, biological,
radiological, or nuclear agents, including emerging infectious
diseases (which may include existing practices, such as trauma
care and medical surge capacity and capabilities), with respect
to--
``(A) a regional approach to identifying hospitals
and health care facilities based on varying
capabilities and capacity to treat patients affected by
such emergency, including--
``(i) the manner in which the system will
coordinate with and integrate the health care
coalitions and entities described in 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 public 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 (f), to
address new and emerging public health threats.
``(c) Considerations.--In identifying, developing, and updating
guidelines under subsection (b), the Assistant Secretary for
Preparedness and Response shall--
``(1) include input from hospitals and health care
facilities (including health care coalitions under section
319C-2), State, local, tribal, and territorial public health
departments, and health care or subject matter experts
(including experts with relevant expertise in chemical,
biological, radiological, or nuclear threats, and emerging
infectious disease), as the Assistant Secretary determines
appropriate, to meet the goals under section 2802(b)(3);
``(2) consult and engage with appropriate health care
providers and professionals, including physicians, nurses,
first responders, health care facilities (including hospitals,
primary care clinics, community health centers, mental health
facilities, ambulatory care facilities, and dental health
facilities), pharmacies, emergency medical providers, trauma
care providers, environmental health agencies, public health
laboratories, poison control centers, blood banks, and other
experts that the Assistant Secretary determines appropriate, to
meet the goals under section 2802(b)(3);
``(3) consider feedback related to financial implications
for hospitals, health care facilities, public health agencies,
laboratories, blood 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 towards meeting the guidelines described in
subsection (b).
``(e) Demonstration Project for Regional Health Care Preparedness
and Response Systems.--
``(1) In general.--The Assistant Secretary for Preparedness
and Response may establish a demonstration project pursuant to
the development and implementation of guidelines under
subsection (b) to 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.
``(f) GAO Report to Congress.--
``(1) Report.--Not later than 3 years after the date of
enactment of this section, the Comptroller General of the
United States (referred to in this subsection as the
`Comptroller General') shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on Finance of
the Senate and the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of Representatives a
report on the extent to which hospitals and health care
facilities have implemented the recommended guidelines under
subsection (b), including an analysis and evaluation of any
challenges hospitals or health care facilities experienced in
implementing such guidelines.
``(2) Content.--The Comptroller General shall include in
the report under paragraph (1)--
``(A) data on the preparedness and response
capabilities that have been informed by the guidelines
under subsection (b) to improve regional emergency
health care preparedness and response capability,
including hospital and health care facility capacity
and medical surge capabilities to prepare for, and
respond to, public health emergencies; and
``(B) recommendations to reduce gaps in incentives
for regional health partners, including hospitals and
health care facilities, to improve capacity and medical
surge capabilities to prepare for, and respond to,
public health emergencies, consistent with subsection
(a), which may include consideration of facilities
participating in programs under section 319C-2,
programs under the Centers for Medicare & Medicaid
Services (including innovative health care delivery and
payment models), and input from private sector
financial institutions.
``(3) Consultation.--In carrying out paragraphs (1) and
(2), the Comptroller General shall consult with the heads of
appropriate Federal agencies, including--
``(A) the Assistant Secretary for Preparedness and
Response;
``(B) the Director of the Centers for Disease
Control and Prevention;
``(C) the Administrator of the Centers for Medicare
& Medicaid Services;
``(D) the Assistant Secretary for Mental Health and
Substance Use;
``(E) the Assistant Secretary of Labor for
Occupational Safety and Health;
``(F) the Secretary of Veterans Affairs; and
``(G) the heads of such other Federal agencies as
the Secretary determines appropriate.''.
SEC. 208. NATIONAL ACADEMY OF MEDICINE EVALUATION AND REPORT ON THE
PREPAREDNESS OF HOSPITALS, LONG-TERM CARE FACILITIES,
DIALYSIS CENTERS, AND OTHER MEDICAL FACILITIES FOR PUBLIC
HEALTH EMERGENCIES.
(a) Evaluation.--
(1) In general.--Not later than 60 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall enter into an arrangement with the National
Academy of Medicine or, if the National Academy declines to
enter into such an arrangement, another appropriate entity
under which the National Academy (or other appropriate entity)
agrees to evaluate the preparedness of hospitals, long-term
care facilities, dialysis centers, and other medical facilities
nationwide for public health emergencies, including natural
disasters.
(2) Specific matters evaluated.--The arrangement under
paragraph (1) shall require the National Academy of Medicine
(or other appropriate entity)--
(A) to catalogue, review, and evaluate the efficacy
of current rules and regulations for hospitals, long-
term care facilities, dialysis centers, and medical
facilities regarding emergency preparedness planning;
(B) to identify and prioritize options to implement
policies for hospitals, long-term care facilities,
dialysis centers, and other medical facilities
nationwide that address future threats;
(C) to review all Federal grant programs that
affect the preparedness of hospitals, long-term care
facilities, dialysis centers, or other medical
facilities for public health emergencies and provide
recommendations for improving such preparedness by--
(i) improving such existing Federal grant
programs; or
(ii) creating new Federal grant programs;
(D) to review, identify, and recommend best
practices for improving emergency preparedness at
hospitals, long-term care facilities, dialysis centers,
and other medical facilities;
(E) to identify and recommend best sources and
guidelines for alterative or emergency power systems,
including renewable sources, battery storage, and
generators; and
(F) to identify and recommend best practices and
guidelines for emergency preparedness planning related
to access to clean water at hospitals, long-term care
facilities, dialysis centers, and other medical
facilities.
(b) Report.--
(1) In general.--The arrangement under subsection (a)(1)
shall require the National Academy of Medicine (or other
appropriate entity) to submit to the Secretary of Health and
Human Services and the Congress, not later than 18 months after
the date of enactment of this Act, a report on the results of
the evaluation 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 this section; and
(B) include a strategy for improving the
preparedness of hospitals, long-term care facilities,
dialysis centers, and other medical facilities
nationwide for public health emergencies, including
natural disasters.
SEC. 209. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
PROFESSIONALS.
(a) In General.--Title II of the Public Health Service Act is
amended by inserting after section 224 (42 U.S.C. 233) the following
new section:
``SEC. 224A. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE
PROFESSIONALS.
``(a) Limitation on Liability.--Except as provided in subsection
(b), a health care professional serving, for purposes of responding to
a disaster, as a volunteer shall not be liable under Federal or State
law for any harm caused by an act or omission of the professional in
the provision of health care services if the act or omission occurs--
``(1) during the period of the disaster;
``(2) in the State or States for which the disaster is
declared;
``(3) while the health care professional is acting in the
professional's capacity as a volunteer;
``(4) in the course of providing health care services that
are within the scope of the license, registration, or
certification of the volunteer, as defined by the State of
licensure, registration, or certification; and
``(5) while the health care professional is acting in a
good faith belief that the individual being provided such
health care services is in need of such health care services.
``(b) Exceptions.--Subsection (a) does not apply with respect to
harm caused by an act or omission of a health care professional in the
provision of health care services as described in such subsection if--
``(1) the harm was caused by an act or omission
constituting willful or criminal misconduct, gross negligence,
reckless misconduct, or a conscious flagrant indifference to
the rights or safety of the individual harmed by the health
care professional; or
``(2) the health care professional provided such health
care services under the influence (as determined pursuant to
applicable State law) of alcohol or an intoxicating drug.
``(c) Preemption.--No State or political subdivision of a State may
establish or continue in effect any laws relating to the liability for
acts or omissions relating to the provision of health care services by
health care professionals serving, for purposes of responding to a
disaster, as volunteers that are inconsistent with this section, unless
such laws provide greater protection from such liability.
``(d) Relationship to Volunteer Protection Act of 1997.--The
protections from liability under this section are in addition to the
protections from liability under the Volunteer Protection Act of 1997.
``(e) Definitions.--In this section:
``(1) The term `disaster' means--
``(A) a national emergency declared by the
President under the National Emergencies Act;
``(B) an emergency or major disaster declared by
the President under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act; or
``(C) a public health emergency that is determined
by the Secretary under section 319 of this Act with
respect to one or more States specified in such
determination--
``(i) during only the initial period
covered by such determination; and
``(ii) excluding any period covered by a
renewal of such determination.
``(2) The term `harm' includes physical, nonphysical,
economic, and noneconomic losses.
``(3) The term `health care professional' means an
individual who is licensed, registered, or certified under
Federal or State law to provide health care services.
``(4) 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 a
human being.
``(5) The term `State' includes each of the several States,
the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa, the Northern Mariana
Islands, and any other territory or possession of the United
States.
``(6)(A) The term `volunteer' means a health care
professional who, in providing health care services in response
to a disaster, does not receive--
``(i) compensation; or
``(ii) any other thing of value in lieu of
compensation, in excess of $500 per year.
``(B) For purposes of subparagraph (A), the term
`compensation'--
``(i) includes payment under any insurance policy
or health plan, or under any Federal health care
program (as defined in section 1128B(f) of the Social
Security Act) or State health benefits program; and
``(ii) excludes--
``(I) reasonable reimbursement or allowance
for expenses actually incurred;
``(II) receipt of paid leave; and
``(III) receipt of items to be used
exclusively for providing the health care
services referred to in subparagraph (A).''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply with respect to claims for relief for which the act or omission
giving rise to the claim occurred on or after the date that is 90 days
after the date of the enactment of this Act.
(c) Sense of Congress.--It is the sense of the Congress that--
(1) health care professionals should be encouraged, to
register with the Emergency System for Advance Registration of
Volunteer Health Professionals (ESARVHP), and States should
employ online registration with the promptest processing
possible of such registrations to foster the rapid deployment
and utilization of volunteer health care professionals
following a disaster;
(2) Federal and State agencies and licensing boards should
cooperate to facilitate the timely movement of properly
licensed volunteer health care professionals to areas affected
by a disaster; and
(3) the appropriate licensing entities should verify the
licenses of volunteer health care professionals serving
disaster victims as soon as is reasonably practical following a
disaster.
TITLE III--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND
DEVELOPMENT
SEC. 301. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE
PROCUREMENT.
(a) In General.--
(1) Coordination with the aspr.--Subsection (a)(1) of
section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended by inserting ``the Assistant Secretary for
Preparedness and Response and'' before ``the Director of the
Centers for Disease Control and Prevention''.
(2) Conforming amendments.--Subsection (c) of section 2811
of the Public Health Service Act (42 U.S.C. 300hh-10), as
amended by section 101, is further amended--
(A) in paragraph (2)--
(i) by redesignating subparagraphs (C)
through (F) as subparagraphs (D) through (G),
respectively; and
(ii) by inserting after subparagraph (B)
the following new subparagraph:
``(C) the Strategic National Stockpile pursuant to
section 319F-2;''; and
(B) in paragraph (3)--
(i) in subparagraph (A), by adding ``and''
at the end;
(ii) by striking subparagraph (B); and
(iii) by redesignating subparagraph (C) as
subparagraph (B).
(b) Congressional Notification of Material Threat Determination.--
Section 319F-2(c)(2)(C) (42 U.S.C. 247d-6b(c)(2)(C)) is amended by
striking ``The Secretary and the Homeland Security Secretary shall
promptly notify the appropriate committees of Congress'' and inserting
``The Secretary and the Secretary of Homeland Security shall send to
Congress, on an annual basis, all current material threat
determinations and shall promptly notify the Committee on Health,
Education, Labor, and Pensions and the Committee on Homeland Security
and Government Affairs of the Senate and the Committee on Energy and
Commerce and the Committee on Homeland Security of the House of
Representatives''.
(c) Authorization of Appropriations.--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''.
(d) Bioshield Special Reserve Fund.--Paragraph (1) of section 319F-
2(g) of the Public Health Service Act (42 U.S.C. 247d-6b(g)) is amended
to read as follows:
``(1) Authorization of appropriations.--In addition to
amounts appropriated to the special reserve fund prior to the
date of the enactment of this subsection, there is authorized
to be appropriated, for the procurement of security
countermeasures under subsection (c) and for carrying out
section 319L (relating to the Biomedical Advanced Research and
Development Authority), $7,100,000,000 for the fiscal years
2019 through 2028. Funds authorized by the preceding sentence
for fiscal years 2020 through 2027 may be provided by advance
appropriation, to be obligated at a rate of not less than
$710,000,000 per year. Amounts appropriated pursuant to this
paragraph are authorized to remain available until expended.''.
SEC. 302. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.
(a) Preparing for Pandemic Influenza, Antimicrobial Resistance, and
Other Significant Threats.--Section 319L(c)(4) of the Public Health
Service Act (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 grants supporting innovative candidate
products in preclinical and clinical development, to
address priority, naturally occurring and man-made
threats that, as determined by the Secretary, pose a
significant level of risk to national security based on
the characteristics of a chemical, biological,
radiological or nuclear threat, or existing
capabilities to respond to such a threat (including
medical response and treatment capabilities and
manufacturing infrastructure). Such initiatives shall
accelerate and support the advanced research,
development, and procurement of, countermeasures and
products, as applicable, to address areas including--
``(i) chemical, biological, radiological,
or nuclear threats, including emerging
infectious diseases, for which insufficient
approved, licensed, or authorized
countermeasures exist, or for which such
threat, or the result of an exposure to such
threat, may become resistant to countermeasures
or existing countermeasures may be rendered
ineffective;
``(ii) threats that consistently exist or
continually circulate and have significant
potential to become a pandemic, such as
pandemic influenza, which may include the
advanced research and development,
manufacturing, and appropriate stockpiling of
qualified pandemic or epidemic products, and
products, technologies, or processes to support
the advanced research and development of such
countermeasures (including multiuse platform
technologies for diagnostics, vaccines, and
therapeutics; virus seeds; clinical trial lots;
novel virus strains; and antigen and adjuvant
material); and
``(iii) threats that may result primarily
or secondarily from a chemical, biological,
radiological, or nuclear agent, or emerging
infectious disease, and which may present
increased treatment complications such as the
occurrence of resistance to available
countermeasures or potential countermeasures,
including antimicrobial resistant pathogens.''.
(b) Transaction Authorities.--Section 319L(c)(5)(A) of the Public
Health Service Act (42 U.S.C. 247d-7e(c)(5)(A)) is amended--
(1) by amending clause (i) to read as follows:
``(i) In general.--The Secretary shall have
the authority to engage in transactions other
than a contract, grant, or cooperative
agreement with respect to projects under this
section.''; and
(2) in clause (ii)--
(A) by amending subclause (I) to read as follows:
``(I) To the maximum extent
practicable, competitive procedures
shall be used when entering into
agreements to carry out projects under
this section.''; and
(B) in subclause (II), by striking ``$20,000,000''
and inserting ``$100,000,000''.
(c) Pandemic Influenza Program.--Section 319L of the Public Health
Service Act (42 U.S.C. 247d-7e) is amended--
(1) by redesignating subsections (d) through (f) as
subsections (f) through (h), respectively; and
(2) by inserting after subsection (c) the following new
subsections:
``(d) Pandemic Influenza Program.--The Secretary, acting through
the Director of BARDA, shall establish and implement a program that--
``(1) supports research and development activities for
qualified pandemic or epidemic products (as defined in section
319F-3(i)), including by developing innovative technologies to
enhance rapid response to threats relating to pandemic
influenza;
``(2) ensures 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; and
``(3) sustains and replenishes pandemic stockpiles of bulk
antigen and adjuvant material, including annually testing the
potency and shelf-life potential of all existing pandemic
stockpiles held by the Department of Health and Human Services.
``(e) Emerging Infectious Disease Program.--The Secretary, acting
through the Director of BARDA, shall establish and implement a program
that supports research and development, and manufacturing
infrastructure, activities with respect to an emerging infectious
disease.''.
(d) Funding.--Subsection (f) of section 319L of the Public Health
Service Act (42 U.S.C. 247d-7e), as redesignated by subsection (b)(1),
is amended--
(1) in paragraph (2)--
(A) by inserting ``(other than subsections (d) and
(e))'' after ``purposes of this section''; and
(B) by striking ``$415,000,000 for each of fiscal
years 2014 through 2018'' and inserting ``$536,700,000
for each of fiscal years 2019 through 2023''; and
(2) by adding at the end the following new paragraphs:
``(3) Funding for pandemic influenza program.--
``(A) In general.--To carry out the purposes of
subsection (d), 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 the purposes of subsection (d).
``(4) Funding for emerging infectious disease program.--
``(A) In general.--To carry out the purposes of
subsection (e), 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 the purposes of subsection
(e).''.
SEC. 303. REPORT ON THE DEVELOPMENT OF VACCINES TO PREVENT FUTURE
EPIDEMICS.
Not later than one year after the date of the enactment of this
Act, the Secretary of Health and Human Services shall submit to
Congress a report detailing the activities carried out by the
Department of Health and Human Services to support the development of
vaccines to prevent future epidemics, including work carried out
through domestic and global public-private partnerships and other
collaborations intended to spur the development of such vaccines. Such
report shall include information related to the provision of any
funding or technical assistance to such entities.
TITLE IV--MISCELLANEOUS PROVISIONS
SEC. 401. CYBERSECURITY.
(a) National Health Security Strategy.--Section 2802(a) of the
Public Health Service Act (42 U.S.C. 300h-1(a)) is amended by adding at
the end the following:
``(4) Cybersecurity threats.--In the next version of the
National Health Security Strategy prepared after the date of
the enactment of this paragraph, the National Health Security
Strategy shall include a national strategy focused on
addressing cybersecurity threats to the public health and
health care system, including--
``(A) defining the functions, capabilities, and
gaps in such system; and
``(B) identifying strategies to strengthen the
preparedness and response of such system to
cybersecurity threats and incidents, including with
respect to continuity of care and risk mitigation to
prevent harm to human health in case of a cybersecurity
incident.''.
(b) Coordination of Preparedness for and Response to All-Hazards
Public Health Emergencies.--Section 2811(c) of the Public Health
Service Act (42 U.S.C. 300hh-10), as amended by sections 101 and 301,
is further amended--
(1) by redesignating paragraph (4) as paragraph (5); and
(2) by inserting after paragraph (3) the following:
``(4) have lead responsibility within the Department of
Health and Human Services for ensuring the ability of the
health care sector to provide continuity of care during a
cybersecurity incident; and''.
SEC. 402. MISCELLANEOUS FDA AMENDMENTS.
(a) Drug Development Tools.--Section 507(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 357) is amended--
(1) by redesignating paragraph (3) as paragraph (4); and
(2) by inserting after paragraph (2) the following:
``(3) National security limitation.--In making information
publicly available pursuant to paragraph (1), the Secretary--
``(A) shall not disclose information that would
compromise national security; and
``(B) may make available summaries in lieu of data
and evidence contained in qualification submissions.''.
(b) 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)''.
(c) 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.
SEC. 403. 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 the enactment of this Act,
the Assistant Secretary for Preparedness and Response shall submit to
the Committee on Energy and Commerce of the House of Representatives a
formal strategy--
(1) to reunify with their parent or guardian each child
who, as a result of the ``zero tolerance'' policy, was
separated from their parent or guardian and placed into a
facility funded by the Department of Health and Human Services;
and
(2) to address deficiencies identified by the previous work
of the Committee, which began in 2014, regarding the oversight
of, and care for, unaccompanied alien children in the custody
of the Department.
SEC. 404. BIOLOGICAL THREAT DETECTION.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by section 104, is further amended by inserting
after section 319D-1 of such Act, the following new section:
``SEC. 319D-2. BIOLOGICAL THREAT DETECTION.
``(a) Exchange of Information.--
``(1) In general.--The Secretary of Health and Human
Services, in coordination with the Secretary of Defense and the
Secretary of Homeland Security, shall--
``(A) facilitate the identification by Federal
departments and agencies of technological, operational,
and programmatic successes and failures of domestic
detection programs for intentionally introduced,
accidentally released, and naturally occurring
infectious diseases;
``(B) facilitate the exchange of information
described in subparagraph (A) among Federal departments
and agencies that utilize biological threat detection
technology; and
``(C) make recommendations on research,
development, and procurement to Federal departments and
agencies to replace and enhance biological threat
detection systems in use, including recommendation for
the transfer of biological threat detection technology
among Federal departments and agencies.
``(2) Considerations.--In carrying out paragraph (1), the
Secretary of Health and Human Services shall take into
consideration the capabilities of the system with respect to
each of the following:
``(A) Rapidly detecting, identifying,
characterizing, and confirming the presence of
biological threat agents.
``(B) Recovering live biological agents from
collection devices.
``(C) Determining the geographical distribution of
biological agents.
``(D) Determining the extent of environmental
contamination and persistence of biological agents.
``(E) Providing advanced molecular diagnostics to
State, local, tribal, and territorial public health and
other laboratories that support biological threat
detection activities.
``(b) Collaboration.--The Secretary of Health and Human Services,
in consultation with Secretary of Defense, the Secretary of Homeland
Security, the Director of the Centers for Disease Control and
Prevention, and the heads of other Federal departments and agencies
that utilize biological threat detection technology, shall collaborate
with State, local, tribal, and territorial public health laboratories
and other users of current and future biological threat detection
systems to develop--
``(1) biological threat detection requirements, including--
``(A) technical, quality, and biosafety standards,
including the review of validation data prior to and
throughout deployment of a biological threat detection
system; and
``(B) requirements for--
``(i) the assessment of quality standards
and the development and deployment of
biological threat detection systems; and
``(ii) metrics for, collaborative
assessment of, and deployment of biosafety
standards;
``(2) a standardized integration strategy for--
``(A) the level to which biological threat
detection processes and systems are defined and
executed;
``(B) the locations at which such processes and
systems are performed; and
``(C) the extent to which data is shared among
State, local, tribal, and territorial public health
laboratories and Federal departments and agencies;
``(3) State, local, tribal, and territorial laboratory
training requirements for--
``(A) supporting and participating in biological
threat detection systems; and
``(B) addressing flexibility at the jurisdictional
level allowing for adoption of technology based on need
and assessment of the efficacy and local utility of
technology by the jurisdiction;
``(4) guidelines for a coordinated public health response
addressing all aspect of a response, including clinical and
epidemiological guidelines for utilizing information produced
by biological threat detection systems and responding to
intentionally introduced, accidentally released, and naturally
occurring infectious diseases; and
``(5) a coordinated remediation plan with Federal
departments and agencies and State and local public health
agencies to facilitate rapid, safe, and coordinated restoration
of facilities and localities after a contaminating biological
event.''.
SEC. 405. 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) demonstrates to the Secretary that the
control program for which a grant is sought is
consistent with existing State mosquito control plans
or policies, and 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 (d), by striking ``Amounts appropriated
under subsection (f)'' and inserting ``Amounts appropriated to
carry out this section''.
(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.''.
(c) GAO Study.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the state of surveillance and control
of mosquito-borne infectious diseases in the United States,
including Indian Country (as defined in section 1151 of title
18, United States Code) and territories, including the state of
preparedness for conducting such surveillance and control. The
study shall include--
(A) a description of the infrastructure and
programs for mosquito control in the United States
(including Indian Country (as so defined) and such
territories), including--
(i) how such infrastructure and programs
are organized and implemented at the Federal,
State and local levels, including with respect
to departments and agencies of the States, and
local organizations (including special
districts) involved in such control programs;
(ii) the role of the private sector in such
activities;
(iii) how the authority for mosquito
control impacts such activities; and
(iv) the funding sources for such
infrastructure and programs, including Federal,
State, and local funding sources;
(B) how mosquito-borne and other vector-borne
disease surveillance and control is integrated into
Federal, State, and local preparedness plans and
actions, including how zoonotic surveillance is
integrated into infectious disease surveillance to
support real-time situational surveillance and
awareness;
(C) Federal, State, and local laboratory capacity
for emerging vector-borne diseases, including mosquito-
borne and other zoonotic diseases; and
(D) any regulatory challenges for developing and
utilizing vector-control technologies and platforms as
part of mosquito control strategies.
(2) Consultations.--In conducting the study under paragraph
(1), the Comptroller General of the United States shall consult
with--
(A) State and local public health officials
involved in mosquito and other vector-borne disease
surveillance and control efforts;
(B) researchers and manufacturers of mosquito
control products;
(C) stakeholders involved in mosquito abatement
activities;
(D) infectious disease experts; and
(E) entomologists involved in mosquito-borne
disease surveillance and control efforts.
(3) Report.--Not later than 18 months 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--
(A) the results of the study conducted under
paragraph (1); and
(B) any relevant recommendations of the Comptroller
General for preparedness and response efforts with
respect to Zika virus and other mosquito-borne
diseases.
SEC. 406. 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 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 Transatlantic Taskforce on
Antimicrobial Resistence.''.
SEC. 407. ADDITIONAL PURPOSES FOR GRANTS FOR CERTAIN TRAUMA CENTERS.
Section 1241(a)(2) of the Public Health Service Act (42 U.S.C.
300d-41(a)(2)) is amended to read as follows:
``(2) to further the core missions of such trauma centers,
including by addressing costs associated with patient
stabilization and transfer, trauma education and outreach,
coordination with local and regional trauma systems, essential
personnel and other fixed costs, expenses associated with
employee and non-employee physician services, trauma staff
recruitment and retention, ensuring surge capacity, trauma-
related emotional and mental health services, and other
investments needed to implement and maintain Regional Health
Care Emergency Preparedness and Response Systems.''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Veterans' Affairs, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Veterans' Affairs, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Veterans' Affairs, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Veterans' Affairs, and Homeland Security, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Emergency Preparedness, Response and Communications.
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Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Mrs. Brooks (IN) moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H8759-8789)
DEBATE - The House proceeded with forty minutes of debate on H.R. 6378.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H8759-8775)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H8759-8775)
Motion to reconsider laid on the table Agreed to without objection.
The title of the measure was amended. Agreed to without objection.
Received in the Senate.