[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1379 Enrolled Bill (ENR)]
S.1379
One Hundred Sixteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the third day of January, two thousand and nineteen
An Act
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,

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(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019''.
(b) Table of Contents.--The table of contents for this Act is as
follows:

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ae22ccd7fc2d400e6b22b528466b4390a4b50000a53d2c1c334a66c0762d3c48

TITLE II

-IMPROVING PREPAREDNESS AND RESPONSE

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693f17be38a2f2c881dd25c90c74bab442caea88b663f840c6fa9d3e56f701f9

4cdf35ed0760a73810443c69c56df3c285ad695a49c67eb440ef97c948459066

4422be7330d8aba773f5500dcf714582029dcc55481fe2edcee943712c086bf2

13d1410cdeb81a2f832a70a462d3bb4a3ae1c849b8769e36b90fae830e1bfac9

capabilities and capacities of hospitals, long-term care
facilities, and other health care facilities.

6a1fff6c6d0105b60e037a7c466b5c97065fc4707df3e2b0ceedbba9eb862ac5

TITLE III

-REACHING ALL COMMUNITIES

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69665d9cda8f3cce11c978e20119d222bf9a4dfb0bb35d71a2dd7f9c4249f673

TITLE IV

-PRIORITIZING A THREAT-BASED APPROACH

beb5b2fa77d060d652adcaaeaa1de3254349de657a669f3f91efa16ff3738a6a

f16f26070ff73d344434c87f8e4511225426210a964b339c398a9e8d96067866

TITLE V

-INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED

their potential role in national security.

081a4b77dcba8ec25e5400743e869ad8b2a6c2ede3d51545f311402b15aa7e27

TITLE VI

-ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

Except as otherwise specified, amendments made by this Act to a
section or other provision of law are amendments to such section or
other provision of the Public Health Service Act (42 U.S.C. 201 et
seq.).

2a0d5dc240fff1031fb46eff342edc8243deadef4a3380c6c6ea27c7223ab920

TITLE VII

-MISCELLANEOUS PROVISIONS

Section 2802 (42 U.S.C. 300hh-1) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``2014'' and inserting ``2018''; and
(ii) by striking the second sentence and inserting the
following: ``Such National Health Security Strategy shall
describe potential emergency health security threats and
identify the process for achieving the preparedness goals
described in subsection (b) to be prepared to identify and
respond to such threats and shall be consistent with the
national preparedness goal (as described in section
504(a)(19) of the Homeland Security Act of 2002), the
National Incident Management System (as defined in section
501(7) of such Act), and the National Response Plan
developed pursuant to section 504 of such Act, or any
successor plan.'';
(B) in paragraph (2), by inserting before the period at the
end of the second sentence the following: ``, and an analysis
of any changes to the evidence-based benchmarks and objective
standards under sections 319C-1 and 319C-2''; and
(C) in paragraph (3)--
(i) by striking ``2009'' and inserting ``2022'';
(ii) by inserting ``(including gaps in the
environmental health and animal health workforces, as
applicable), describing the status of such workforce''
after ``gaps in such workforce'';
(iii) by striking ``and identifying strategies'' and
inserting ``identifying strategies''; and
(iv) by inserting before the period at the end ``, and
identifying current capabilities to meet the requirements
of section 2803''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``and
investigation'' and inserting ``investigation, and related
information technology activities'';
(ii) in subparagraph (B), by striking ``and
decontamination'' and inserting ``decontamination, relevant
health care services and supplies, and transportation and
disposal of medical waste''; and
(iii) by adding at the end the following:
``(E) Response to environmental hazards.'';
(B) in paragraph (3)--
(i) in the matter preceding subparagraph (A), by
striking ``including mental health'' and inserting
``including pharmacies, mental health facilities,''; and
(ii) in subparagraph (F), by inserting ``or exposures
to agents that could cause a public health emergency''
before the period;
(C) in paragraph (5), by inserting ``and other applicable
compacts'' after ``Compact''; and
(D) by adding at the end the following:
``(9) Zoonotic disease, food, and agriculture.--Improving
coordination among Federal, State, local, Tribal, and territorial
entities (including through consultation with the Secretary of
Agriculture) to prevent, detect, and respond to outbreaks of plant
or animal disease (including zoonotic disease) that could
compromise national security resulting from a deliberate attack, a
naturally occurring threat, the intentional adulteration of food,
or other public health threats, taking into account interactions
between animal health, human health, and animals' and humans'
shared environment as directly related to public health emergency
preparedness and response capabilities, as applicable.
``(10) Global health security.--Assessing current or potential
health security threats from abroad to inform domestic public
health preparedness and response capabilities.''.

62264b1dfc5f8aed288104196f5b24340db74fa2b93f9b33ad3b849499f32a1e

TITLE I

-STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

RESPONSE.
(a) Evaluating Measurable Evidence-Based Benchmarks and Objective
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting
after subsection (j) the following:
``(k) Evaluation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 and every 2 years thereafter, the
Secretary shall conduct an evaluation of the evidence-based
benchmarks and objective standards required under subsection (g).
Such evaluation shall be submitted to the congressional committees
of jurisdiction together with the National Health Security Strategy
under section 2802, at such time as such strategy is submitted.
``(2) Content.--The evaluation under this paragraph shall
include--
``(A) a review of evidence-based benchmarks and objective
standards, and associated metrics and targets;
``(B) a discussion of changes to any evidence-based
benchmarks and objective standards, and the effect of such
changes on the ability to track whether entities are meeting or
making progress toward the goals under this section and, to the
extent practicable, the applicable goals of the National Health
Security Strategy under section 2802;
``(C) a description of amounts received by eligible
entities described in subsection (b) and section 319C-2(b), and
amounts received by subrecipients and the effect of such
funding on meeting evidence-based benchmarks and objective
standards; and
``(D) recommendations, as applicable and appropriate, to
improve evidence-based benchmarks and objective standards to
more accurately assess the ability of entities receiving awards
under this section to better achieve the goals under this
section and section 2802.''.
(b) Evaluating the Partnership for State and Regional Hospital
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section
319C-1(g), (i), (j), and (k)''.

fe04ca94142da18d484d1d562a07b53ad2aa2a4c929a41450e308bba1faaeac2

(a) Cooperative Agreement Applications for Improving State and
Local Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is
amended--
(1) in subsection (a), by inserting ``, acting through the
Director of the Centers for Disease Control and Prevention,'' after
``the Secretary''; and
(2) in subsection (b)(2)(A)--
(A) in clause (vi), by inserting ``, including public
health agencies with specific expertise that may be relevant to
public health security, such as environmental health
agencies,'' after ``stakeholders'';
(B) by redesignating clauses (vii) through (ix) as clauses
(viii) through (x);
(C) by inserting after clause (vi) the following:
``(vii) a description of how, as applicable, such
entity may integrate information to account for individuals
with behavioral health needs following a public health
emergency;'';
(D) in clause (ix), as so redesignated, by striking ``;
and'' and inserting a semicolon; and
(E) by adding at the end the following:
``(xi) a description of how the entity will partner
with health care facilities, including hospitals and
nursing homes and other long-term care facilities, to
promote and improve public health preparedness and
response; and
``(xii) a description of how, as appropriate and
practicable, the entity will include critical
infrastructure partners, such as utility companies within
the entity's jurisdiction, in planning pursuant to this
subparagraph to help ensure that critical infrastructure
will remain functioning during, or return to function as
soon as practicable after, a public health emergency;''.
(b) Exception Relating to Application of Certain Requirements.--
(1) In general.--Section 319C-1(g) (42 U.S.C. 247d-3a(g)) is
amended--
(A) in paragraph (5)--
(i) in the matter preceding subparagraph (A), by
striking ``Beginning with fiscal year 2009'' and inserting
``Beginning with fiscal year 2019''; and
(ii) in subparagraph (A)--
(I) by striking ``for the immediately preceding
fiscal year'' and inserting ``for either of the 2
immediately preceding fiscal years''; and
(II) by striking ``2008'' and inserting ``2018'';
and
(B) in paragraph (6), by amending subparagraph (A) to read
as follows:
``(A) In general.--The amounts described in this paragraph
are the following amounts that are payable to an entity for
activities described in this section or section 319C-2:
``(i) For no more than one of each of the first 2
fiscal years immediately following a fiscal year in which
an entity experienced a failure described in subparagraph
(A) or (B) of paragraph (5), an amount equal to 10 percent
of the amount the entity was eligible to receive for the
respective fiscal year.
``(ii) For no more than one of the first 2 fiscal years
immediately following the third consecutive fiscal year in
which an entity experienced such a failure, in lieu of
applying clause (i), an amount equal to 15 percent of the
amount the entity was eligible to receive for the
respective fiscal year.''.
(2) Effective date.--The amendments made by paragraph (1) shall
apply with respect to cooperative agreements awarded on or after
the date of enactment of this Act.
(c) Partnership for State and Regional Hospital Preparedness To
Improve Surge Capacity.--Section 319C-2 (42 U.S.C. 247d-3b) is
amended--
(1) in subsection (a)--
(A) by inserting ``, acting through the Assistant Secretary
for Preparedness and Response,'' after ``The Secretary''; and
(B) by striking ``preparedness for public health
emergencies'' and inserting ``preparedness for, and response
to, public health emergencies in accordance with subsection
(c)'';
(2) in subsection (b)(1)(A)--
(A) by striking ``partnership consisting of'' and inserting
``coalition that includes'';
(B) in clause (ii), by striking ``; and'' and inserting a
semicolon; and
(C) by adding at the end the following:
``(iv) one or more emergency medical service organizations
or emergency management organizations; and'';
(3) in subsection (d)--
(A) in paragraph (1)(B), by striking ``partnership'' each
place it appears and inserting ``coalition''; and
(B) in paragraph (2)(C), by striking ``medical
preparedness'' and inserting ``preparedness and response'';
(4) in subsection (f), by striking ``partnership'' and
inserting ``coalition'';
(5) in subsection (g)(2)--
(A) by striking ``Partnerships'' and inserting
``Coalitions'';
(B) by striking ``partnerships'' and inserting
``coalitions''; and
(C) by inserting ``and response'' after ``preparedness'';
and
(6) in subsection (i)(1)--
(A) by striking ``An entity'' and inserting ``A
coalition''; and
(B) by striking ``such partnership'' and inserting ``such
coalition''.
(d) Public Health Security Grants Authorization of
Appropriations.--Section 319C-1(h)(1)(A) (42 U.S.C. 247d-3a(h)(1)(A))
is amended by striking ``$641,900,000 for fiscal year 2014'' and all
that follows through the period at the end and inserting ``$685,000,000
for each of fiscal years 2019 through 2023 for awards pursuant to
paragraph (3) (subject to the authority of the Secretary to make awards
pursuant to paragraphs (4) and (5)).''.
(e) Partnership for State and Regional Hospital Preparedness
Authorization of Appropriations.--Section 319C-2(j) (42 U.S.C. 247d-
3b(j)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) In general.--
``(A) Authorization of appropriations.--For purposes of
carrying out this section and section 319C-3, in accordance
with subparagraph (B), there is authorized to be appropriated
$385,000,000 for each of fiscal years 2019 through 2023.
``(B) Reservation of amounts for regional systems.--
``(i) In general.--Subject to clause (ii), of the
amount appropriated under subparagraph (A) for a fiscal
year, the Secretary may reserve up to 5 percent for the
purpose of carrying out section 319C-3.
``(ii) Reservation contingent on continued
appropriations for this section.--If for fiscal year 2019
or a subsequent fiscal year, the amount appropriated under
subparagraph (A) is such that, after application of clause
(i), the amount remaining for the purpose of carrying out
this section would be less than the amount available for
such purpose for the previous fiscal year, the amount that
may be reserved under clause (i) shall be reduced such that
the amount remaining for the purpose of carrying out this
section is not less than the amount available for such
purpose for the previous fiscal year.
``(iii) Sunset.--The authority to reserve amounts under
clause (i) shall expire on September 30, 2023.'';
(2) in paragraph (2), by striking ``paragraph (1) for a fiscal
year'' and inserting ``paragraph (1)(A) for a fiscal year and not
reserved for the purpose described in paragraph (1)(B)(i)''; and
(3) in paragraph (3)(A), by striking ``paragraph (1) and not
reserved under paragraph (2)'' and inserting ``paragraph (1)(A) and
not reserved under paragraph (1)(B)(i) or (2)''.

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SYSTEMS.
(a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is
amended by inserting after section 319C-2 the following:
``SEC. 319C-3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY
PREPAREDNESS AND RESPONSE SYSTEMS.
``(a) Purpose.--It is the purpose of this section to identify and
provide guidelines for regional systems of hospitals, health care
facilities, and other public and private sector entities, with varying
levels of capability to treat patients and increase medical surge
capacity during, in advance of, and immediately following a public
health emergency, including threats posed by one or more chemical,
biological, radiological, or nuclear agents, including emerging
infectious diseases.
``(b) Guidelines.--The Assistant Secretary for Preparedness and
Response, in consultation with the Director of the Centers for Disease
Control and Prevention, the Administrator of the Centers for Medicare &
Medicaid Services, the Administrator of the Health Resources and
Services Administration, the Commissioner of Food and Drugs, the
Assistant Secretary for Mental Health and Substance Use, the Assistant
Secretary of Labor for Occupational Safety and Health, the Secretary of
Veterans Affairs, the heads of such other Federal agencies as the
Secretary determines to be appropriate, and State, local, Tribal, and
territorial public health officials, shall, not later than 2 years
after the date of enactment of this section--
``(1) identify and develop a set of guidelines relating to
practices and protocols for all-hazards public health emergency
preparedness and response for hospitals and health care facilities
to provide appropriate patient care during, in advance of, or
immediately following, a public health emergency, resulting from
one or more chemical, biological, radiological, or nuclear agents,
including emerging infectious diseases (which may include existing
practices, such as trauma care and medical surge capacity and
capabilities), with respect to--
``(A) a regional approach to identifying hospitals and
health care facilities based on varying capabilities and
capacity to treat patients affected by such emergency,
including--
``(i) the manner in which the system will coordinate
with and integrate the partnerships and health care
coalitions established under section 319C-2(b); and
``(ii) informing and educating appropriate first
responders and health care supply chain partners of the
regional emergency preparedness and response capabilities
and medical surge capacity of such hospitals and health
care facilities in the community;
``(B) physical and technological infrastructure, laboratory
capacity, staffing, blood supply, and other supply chain needs,
taking into account resiliency, geographic considerations, and
rural considerations;
``(C) protocols or best practices for the safety and
personal protection of workers who handle human remains and
health care workers (including with respect to protective
equipment and supplies, waste management processes, and
decontamination), sharing of specialized experience among the
health care workforce, behavioral health, psychological
resilience, and training of the workforce, as applicable;
``(D) in a manner that allows for disease containment
(within the meaning of section 2802(b)(2)(B)), coordinated
medical triage, treatment, and transportation of patients,
based on patient medical need (including patients in rural
areas), to the appropriate hospitals or health care facilities
within the regional system or, as applicable and appropriate,
between systems in different States or regions; and
``(E) the needs of children and other at-risk individuals;
``(2) make such guidelines available on the internet website of
the Department of Health and Human Services in a manner that does
not compromise national security; and
``(3) update such guidelines as appropriate, including based on
input received pursuant to subsections (c) and (e) and information
resulting from applicable reports required under the Pandemic and
All-Hazards Preparedness and Advancing Innovation Act of 2019
(including any amendments made by such Act), to address new and
emerging public health threats.
``(c) Considerations.--In identifying, developing, and updating
guidelines under subsection (b), the Assistant Secretary for
Preparedness and Response shall--
``(1) include input from hospitals and health care facilities
(including health care coalitions under section 319C-2), State,
local, Tribal, and territorial public health departments, and
health care or subject matter experts (including experts with
relevant expertise in chemical, biological, radiological, or
nuclear threats, including emerging infectious diseases), as the
Assistant Secretary determines appropriate, to meet the goals under
section 2802(b)(3);
``(2) consult and engage with appropriate health care providers
and professionals, including physicians, nurses, first responders,
health care facilities (including hospitals, primary care clinics,
community health centers, mental health facilities, ambulatory care
facilities, and dental health facilities), pharmacies, emergency
medical providers, trauma care providers, environmental health
agencies, public health laboratories, poison control centers, blood
banks, tissue banks, and other experts that the Assistant Secretary
determines appropriate, to meet the goals under section 2802(b)(3);
``(3) consider feedback related to financial implications for
hospitals, health care facilities, public health agencies,
laboratories, blood banks, tissue banks, and other entities engaged
in regional preparedness planning to implement and follow such
guidelines, as applicable; and
``(4) consider financial requirements and potential incentives
for entities to prepare for, and respond to, public health
emergencies as part of the regional health care emergency
preparedness and response system.
``(d) Technical Assistance.--The Assistant Secretary for
Preparedness and Response, in consultation with the Director of the
Centers for Disease Control and Prevention and the Assistant Secretary
of Labor for Occupational Safety and Health, may provide technical
assistance and consultation toward meeting the guidelines described in
subsection (b).
``(e) Demonstration Project for Regional Health Care Preparedness
and Response Systems.--
``(1) In general.--The Assistant Secretary for Preparedness and
Response may establish a demonstration project pursuant to the
development and implementation of guidelines under subsection (b)
to award grants to improve medical surge capacity for all hazards,
build and integrate regional medical response capabilities, improve
specialty care expertise for all-hazards response, and coordinate
medical preparedness and response across State, local, Tribal,
territorial, and regional jurisdictions.
``(2) Sunset.--The authority under this subsection shall expire
on September 30, 2023.''.
(b) GAO Report to Congress.--
(1) Report.--Not later than 3 years after the date of enactment
of this Act, the Comptroller General of the United States (referred
to in this subsection as the ``Comptroller General'') shall submit
to the Committee on Health, Education, Labor, and Pensions and the
Committee on Finance of the Senate and the Committee on Energy and
Commerce and the Committee on Ways and Means of the House of
Representatives, a report on the extent to which hospitals and
health care facilities have implemented the recommended guidelines
under section 319C-3(b) of the Public Health Service Act (as added
by subsection (a)), including an analysis and evaluation of any
challenges hospitals or health care facilities experienced in
implementing such guidelines.
(2) Content.--The Comptroller General shall include in the
report under paragraph (1)--
(A) data on the preparedness and response capabilities that
have been informed by the guidelines under section 319C-3(b) of
the Public Health Service Act to improve regional emergency
health care preparedness and response capability, including
hospital and health care facility capacity and medical surge
capabilities to prepare for, and respond to, public health
emergencies; and
(B) recommendations to reduce gaps in incentives for
regional health partners, including hospitals and health care
facilities, to improve capacity and medical surge capabilities
to prepare for, and respond to, public health emergencies,
consistent with subsection (a), which may include consideration
of facilities participating in programs under section 319C-2 of
the Public Health Service Act (42 U.S.C. 247d-3b) or in
programs under the Centers for Medicare & Medicaid Services
(including innovative health care delivery and payment models),
and input from private sector financial institutions.
(3) Consultation.--In carrying out paragraphs (1) and (2), the
Comptroller General shall consult with the heads of appropriate
Federal agencies, including--
(A) the Assistant Secretary for Preparedness and Response;
(B) the Director of the Centers for Disease Control and
Prevention;
(C) the Administrator of the Centers for Medicare &
Medicaid Services;
(D) the Assistant Secretary for Mental Health and Substance
Use;
(E) the Assistant Secretary of Labor for Occupational
Safety and Health; and
(F) the Secretary of Veterans Affairs.
(c) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-3b(i)(1))
is amended by inserting after the first sentence the following: ``In
submitting reports under this paragraph, a coalition shall include
information on the progress that the coalition has made toward the
implementation of section 319C-3 (or barriers to progress, if any).''.
(d) National Health Security Strategy Incorporation of Regionalized
Emergency Preparedness and Response.--Subparagraph (G) of section
2802(b)(3) (42 U.S.C. 300hh-1(b)(3)) is amended to read as follows:
``(G) Optimizing a coordinated and flexible approach to the
emergency response and medical surge capacity of hospitals,
other health care facilities, critical care, trauma care (which
may include trauma centers), and emergency medical systems.''.
(e) Improving State and Local Public Health Security.--
(1) State and local security.--Section 319C-1(e) (42 U.S.C.
247d-3a(e)) is amended by striking ``, and local emergency plans.''
and inserting ``, local emergency plans, and any regional health
care emergency preparedness and response system established
pursuant to the applicable guidelines under section 319C-3.''.
(2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
3b(d)(1)(A)) is amended--
(A) in clause (i), by striking ``; and'' and inserting
``;'';
(B) by redesignating clause (ii) as clause (iii); and
(C) by inserting after clause (i) the following:
``(ii) among one or more facilities in a regional
health care emergency system under section 319C-3; and''.

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Title XII (42 U.S.C. 300d et seq.) is amended by adding at the end
the following new part:
``PART I--MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT
PROGRAM
``SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS
GRANT PROGRAM.
``(a) Military Trauma Team Placement Program.--
``(1) In general.--The Secretary, acting through the Assistant
Secretary for Preparedness and Response and in consultation with
the Secretary of Defense, shall award grants to not more than 20
eligible high-acuity trauma centers to enable military trauma teams
to provide, on a full-time basis, trauma care and related acute
care at such trauma centers.
``(2) Limitations.--In the case of a grant awarded under
paragraph (1) to an eligible high-acuity trauma center, such
grant--
``(A) shall be for a period of at least 3 years and not
more than 5 years (and may be renewed at the end of such
period); and
``(B) shall be in an amount that does not exceed $1,000,000
per year.
``(3) Availability of funds.--Notwithstanding section 1552 of
title 31, United States Code, or any other provision of law, funds
available to the Secretary for obligation for a grant under this
subsection shall remain available for expenditure for 100 days
after the last day of the performance period of such grant.
``(b) Military Trauma Care Provider Placement Program.--
``(1) In general.--The Secretary, acting through the Assistant
Secretary for Preparedness and Response and in consultation with
the Secretary of Defense, shall award grants to eligible trauma
centers to enable military trauma care providers to provide trauma
care and related acute care at such trauma centers.
``(2) Limitations.--In the case of a grant awarded under
paragraph (1) to an eligible trauma center, such grant--
``(A) shall be for a period of at least 1 year and not more
than 3 years (and may be renewed at the end of such period);
and
``(B) shall be in an amount that does not exceed, in a
year--
``(i) $100,000 for each military trauma care provider
that is a physician at such eligible trauma center; and
``(ii) $50,000 for each other military trauma care
provider at such eligible trauma center.
``(c) Grant Requirements.--
``(1) Deployment and public health emergencies.--As a condition
of receipt of a grant under this section, a grant recipient shall
agree to allow military trauma care providers providing care
pursuant to such grant to--
``(A) be deployed by the Secretary of Defense for military
operations, for training, or for response to a mass casualty
incident; and
``(B) be deployed by the Secretary of Defense, in
consultation with the Secretary of Health and Human Services,
for response to a public health emergency pursuant to section
319.
``(2) Use of funds.--Grants awarded under this section to an
eligible trauma center may be used to train and incorporate
military trauma care providers into such trauma center, including
incorporation into operational exercises and training drills
related to public health emergencies, expenditures for malpractice
insurance, office space, information technology, specialty
education and supervision, trauma programs, research, and
applicable license fees for such military trauma care providers.
``(d) Rule of Construction.--Nothing in this section shall be
construed to affect any other provision of law that preempts State
licensing requirements for health care professionals, including with
respect to military trauma care providers.
``(e) Reporting Requirements.--
``(1) Report to the secretary and the secretary of defense.--
Each eligible trauma center or eligible high-acuity trauma center
awarded a grant under subsection (a) or (b) for a year shall submit
to the Secretary and the Secretary of Defense a report for such
year that includes information on--
``(A) the number and types of trauma cases managed by
military trauma teams or military trauma care providers
pursuant to such grant during such year;
``(B) the ability to maintain the integration of the
military trauma providers or teams of providers as part of the
trauma center, including the financial effect of such grant on
the trauma center;
``(C) the educational effect on resident trainees in
centers where military trauma teams are assigned;
``(D) any research conducted during such year supported by
such grant; and
``(E) any other information required by the Secretaries for
the purpose of evaluating the effect of such grant.
``(2) Report to congress.--Not less than once every 2 years,
the Secretary, in consultation with the Secretary of Defense, shall
submit a report to the congressional committees of jurisdiction
that includes information on the effect of placing military trauma
care providers in trauma centers awarded grants under this section
on--
``(A) maintaining military trauma care providers' readiness
and ability to respond to and treat battlefield injuries;
``(B) providing health care to civilian trauma patients in
urban and rural settings;
``(C) the capability of trauma centers and military trauma
care providers to increase medical surge capacity, including as
a result of a large-scale event;
``(D) the ability of grant recipients to maintain the
integration of the military trauma providers or teams of
providers as part of the trauma center;
``(E) efforts to incorporate military trauma care providers
into operational exercises and training and drills for public
health emergencies; and
``(F) the capability of military trauma care providers to
participate as part of a medical response during or in advance
of a public health emergency, as determined by the Secretary,
or a mass casualty incident.
``(f) Definitions.--For purposes of this part:
``(1) Eligible high-acuity trauma center.--The term `eligible
high-acuity trauma center' means a Level I trauma center that
satisfies each of the following:
``(A) Such trauma center has an agreement with the
Secretary of Defense to enable military trauma teams to provide
trauma care and related acute care at such trauma center.
``(B) At least 20 percent of patients treated at such
trauma center in the most recent 3-month period for which data
are available are treated for a major trauma at such trauma
center.
``(C) Such trauma center utilizes a risk-adjusted
benchmarking system and metrics to measure performance,
quality, and patient outcomes.
``(D) Such trauma center is an academic training center--
``(i) affiliated with a medical school;
``(ii) that maintains residency programs and
fellowships in critical trauma specialties and
subspecialties, and provides education and supervision of
military trauma team members according to those specialties
and subspecialties; and
``(iii) that undertakes research in the prevention and
treatment of traumatic injury.
``(E) Such trauma center serves as a medical and public
health preparedness and response leader for its community, such
as by participating in a partnership for State and regional
hospital preparedness established under section 319C-2 or 319C-
3.
``(2) Eligible trauma center.--The term `eligible trauma
center' means a Level I, II, or III trauma center that satisfies
each of the following:
``(A) Such trauma center has an agreement with the
Secretary of Defense to enable military trauma care providers
to provide trauma care and related acute care at such trauma
center.
``(B) Such trauma center utilizes a risk-adjusted
benchmarking system and metrics to measure performance,
quality, and patient outcomes.
``(C) Such trauma center demonstrates a need for integrated
military trauma care providers to maintain or improve the
trauma clinical capability of such trauma center.
``(3) Major trauma.--The term `major trauma' means an injury
that is greater than or equal to 15 on the injury severity score.
``(4) Military trauma team.--The term `military trauma team'
means a complete military trauma team consisting of military trauma
care providers.
``(5) Military trauma care provider.--The term `military trauma
care provider' means a member of the Armed Forces who furnishes
emergency, critical care, and other trauma acute care services
(including a physician, surgeon, physician assistant, nurse, nurse
practitioner, respiratory therapist, flight paramedic, combat
medic, or enlisted medical technician) or other military trauma
care provider as the Secretary determines appropriate.
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $11,500,000 for each of fiscal
years 2019 through 2023.''.

da4d3d2eb6a097f84046475993900abce5371df155a7d4f3258a24078b91406d

AWARENESS AND BIOSURVEILLANCE CAPABILITIES.
(a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
(1) in the section heading, by striking ``revitalizing'' and
inserting ``facilities and capacities of'';
(2) in subsection (a)--
(A) in the subsection heading, by striking ``Facilities;
Capacities'' and inserting ``In General'';
(B) in paragraph (1), by striking ``and improved'' and
inserting ``, improved, and appropriately maintained'';
(C) in paragraph (3), in the matter preceding subparagraph
(A), by striking ``expand, enhance, and improve'' and inserting
``expand, improve, enhance, and appropriately maintain''; and
(D) by adding at the end the following:
``(4) Study of resources for facilities and capacities.--Not
later than June 1, 2022, the Comptroller General of the United
States shall conduct a study on Federal spending in fiscal years
2013 through 2018 for activities authorized under this subsection.
Such study shall include a review and assessment of obligations and
expenditures directly related to each activity under paragraphs (2)
and (3), including a specific accounting of, and delineation
between, obligations and expenditures incurred for the
construction, renovation, equipping, and security upgrades of
facilities and associated contracts under this subsection, and the
obligations and expenditures incurred to establish and improve the
situational awareness and biosurveillance network under subsection
(b), and shall identify the agency or agencies incurring such
obligations and expenditures.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking ``National'' and
inserting ``Establishment of Systems of Public Health'';
(B) in paragraph (1)(B), by inserting ``immunization
information systems,'' after ``centers,'';
(C) in paragraph (2)--
(i) by inserting ``develop a plan to, and'' after ``The
Secretary shall''; and
(ii) by inserting ``and in a form readily usable for
analytical approaches'' after ``in a secure manner''; and
(D) by amending paragraph (3) to read as follows:
``(3) Standards.--
``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in cooperation
with health care providers, State, local, Tribal, and
territorial public health officials, and relevant Federal
agencies (including the Office of the National Coordinator for
Health Information Technology and the National Institute of
Standards and Technology), shall, as necessary, adopt technical
and reporting standards, including standards for
interoperability as defined by section 3000, for networks under
paragraph (1) and update such standards as necessary. Such
standards shall be made available on the internet website of
the Department of Health and Human Services, in a manner that
does not compromise national security.
``(B) Deference to standards development organizations.--In
adopting and implementing standards under this subsection and
subsection (c), the Secretary shall give deference to standards
published by standards development organizations and voluntary
consensus-based standards entities.'';
(4) in subsection (c)--
(A) in paragraph (1)--
(i) by striking ``Not later than 2 years after the date
of enactment of the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2013, the Secretary'' and inserting
``The Secretary'';
(ii) by inserting ``, and improve as applicable and
appropriate,'' after ``shall establish'';
(iii) by striking ``of rapid'' and inserting ``of,
rapid''; and
(iv) by striking ``such connectivity'' and inserting
``such interoperability'';
(B) by amending paragraph (2) to read as follows:
``(2) Coordination and consultation.--In establishing and
improving the network under paragraph (1), the Secretary shall--
``(A) facilitate coordination among agencies within the
Department of Health and Human Services that provide, or have
the potential to provide, information and data to, and analyses
for, the situational awareness and biosurveillance network
under paragraph (1), including coordination among relevant
agencies related to health care services, the facilitation of
health information exchange (including the Office of the
National Coordinator for Health Information Technology), and
public health emergency preparedness and response; and
``(B) consult with the Secretary of Agriculture, the
Secretary of Commerce (and the Director of the National
Institute of Standards and Technology), the Secretary of
Defense, the Secretary of Homeland Security, the Secretary of
Veterans Affairs, and the heads of other Federal agencies, as
the Secretary determines appropriate.'';
(C) in paragraph (3)--
(i) by redesignating subparagraphs (A) through (E) as
clauses (i) through (v), respectively, and adjusting the
margins accordingly;
(ii) in clause (iv), as so redesignated--
(I) by inserting ``immunization information
systems,'' after ``poison control,''; and
(II) by striking ``and clinical laboratories'' and
inserting ``, clinical laboratories, and public
environmental health agencies'';
(iii) by striking ``The network'' and inserting the
following:
``(A) In general.--The network''; and
(iv) by adding at the end the following:
``(B) Review.--Not later than 2 years after the date of the
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 and every 6 years thereafter,
the Secretary shall conduct a review of the elements described
in subparagraph (A). Such review shall include a discussion of
the addition of any elements pursuant to clause (v), including
elements added to advancing new technologies, and identify any
challenges in the incorporation of elements under subparagraph
(A). The Secretary shall provide such review to the
congressional committees of jurisdiction.'';
(D) in paragraph (5)--
(i) by redesignating subparagraphs (A) through (D) as
clauses (i) through (iv), respectively, and adjusting the
margins accordingly;
(ii) by striking ``In establishing'' and inserting the
following:
``(A) In general.--In establishing'';
(iii) by adding at the end the following:
``(B) Public meeting.--
``(i) In general.--Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019, the
Secretary shall convene a public meeting for purposes of
discussing and providing input on the potential goals,
functions, and uses of the network described in paragraph
(1) and incorporating the elements described in paragraph
(3)(A).
``(ii) Experts.--The public meeting shall include
representatives of relevant Federal agencies (including
representatives from the Office of the National Coordinator
for Health Information Technology and the National
Institute of Standards and Technology); State, local,
Tribal, and territorial public health officials;
stakeholders with expertise in biosurveillance and
situational awareness; stakeholders with expertise in
capabilities relevant to biosurveillance and situational
awareness, such as experts in informatics and data
analytics (including experts in prediction, modeling, or
forecasting); and other representatives as the Secretary
determines appropriate.
``(iii) Topics.--Such public meeting shall include a
discussion of--
``(I) data elements, including minimal or essential
data elements, that are voluntarily provided for such
network, which may include elements from public health
and public and private health care entities, to the
extent practicable;
``(II) standards and implementation specifications
that may improve the collection, analysis, and
interpretation of data during a public health
emergency;
``(III) strategies to encourage the access,
exchange, and use of information;
``(IV) considerations for State, local, Tribal, and
territorial capabilities and infrastructure related to
data exchange and interoperability;
``(V) privacy and security protections provided at
the Federal, State, local, Tribal, and territorial
levels, and by nongovernmental stakeholders; and
``(VI) opportunities for the incorporation of
innovative technologies to improve the network.''; and
(iv) in subparagraph (A), as so designated by clause
(ii)--
(I) in clause (i), as so redesignated--
(aa) by striking ``as determined'' and
inserting ``as adopted''; and
(bb) by inserting ``and the National Institute
of Standards and Technology'' after ``Office of the
National Coordinator for Health Information
Technology'';
(II) in clause (iii), as so redesignated, by
striking ``; and'' and inserting a semicolon;
(III) in clause (iv), as so redesignated, by
striking the period and inserting ``; and''; and
(IV) by adding at the end the following:
``(v) pilot test standards and implementation
specifications, consistent with the process described in
section 3002(b)(3)(C), which State, local, Tribal, and
territorial public health entities may utilize, on a
voluntary basis, as a part of the network.'';
(E) by redesignating paragraph (6) as paragraph (7);
(F) by inserting after paragraph (5) the following:
``(6) Strategy and implementation plan.--
``(A) In general.--Not later than 18 months after the date
of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary shall submit to
the congressional committees of jurisdiction a coordinated
strategy and an accompanying implementation plan that--
``(i) is informed by the public meeting under paragraph
(5)(B);
``(ii) includes a review and assessment of existing
capabilities of the network and related infrastructure,
including input provided by the public meeting under
paragraph (5)(B);
``(iii) identifies and demonstrates the measurable
steps the Secretary will carry out to--
``(I) develop, implement, and evaluate the network
described in paragraph (1), utilizing elements
described in paragraph (3)(A);
``(II) modernize and enhance biosurveillance
activities, including strategies to include innovative
technologies and analytical approaches (including
prediction and forecasting for pandemics and all-
hazards) from public and private entities;
``(III) improve information sharing, coordination,
and communication among disparate biosurveillance
systems supported by the Department of Health and Human
Services, including the identification of methods to
improve accountability, better utilize resources and
workforce capabilities, and incorporate innovative
technologies within and across agencies; and
``(IV) test and evaluate capabilities of the
interoperable network of systems to improve situational
awareness and biosurveillance capabilities;
``(iv) includes performance measures and the metrics by
which performance measures will be assessed with respect to
the measurable steps under clause (iii); and
``(v) establishes dates by which each measurable step
under clause (iii) will be implemented.
``(B) Annual budget plan.--Not later than 2 years after the
date of enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019 and on an annual basis
thereafter, in accordance with the strategy and implementation
plan under this paragraph, the Secretary shall, taking into
account recommendations provided by the National Biodefense
Science Board, develop a budget plan based on the strategy and
implementation plan under this section. Such budget plan shall
include--
``(i) a summary of resources previously expended to
establish, improve, and utilize the nationwide public
health situational awareness and biosurveillance network
under paragraph (1);
``(ii) estimates of costs and resources needed to
establish and improve the network under paragraph (1)
according to the strategy and implementation plan under
subparagraph (A);
``(iii) the identification of gaps and inefficiencies
in nationwide public health situational awareness and
biosurveillance capabilities, resources, and authorities
needed to address such gaps; and
``(iv) a strategy to minimize and address such gaps and
improve inefficiencies.'';
(G) in paragraph (7), as so redesignated--
(i) in subparagraph (A), by inserting ``(taking into
account zoonotic disease, including gaps in scientific
understanding of the interactions between human, animal,
and environmental health)'' after ``human health'';
(ii) in subparagraph (B)--
(I) by inserting ``and gaps in surveillance
programs'' after ``surveillance programs''; and
(II) by striking ``; and'' and inserting a
semicolon;
(iii) in subparagraph (C)--
(I) by inserting ``, animal health organizations
related to zoonotic disease,'' after ``health care
entities''; and
(II) by striking the period and inserting ``;
and''; and
(iv) by adding at the end the following:
``(D) provide recommendations to the Secretary on policies
and procedures to complete the steps described in this
paragraph in a manner that is consistent with section 2802.'';
and
(H) by adding at the end the following:
``(8) Situational awareness and biosurveillance as a national
security priority.--The Secretary, on a periodic basis as
applicable and appropriate, shall meet with the Director of
National Intelligence to inform the development and capabilities of
the nationwide public health situational awareness and
biosurveillance network.'';
(5) in subsection (d)--
(A) in paragraph (1)--
(i) by inserting ``environmental health agencies,''
after ``public health agencies,''; and
(ii) by inserting ``immunization programs,'' after
``poison control centers,'';
(B) in paragraph (2)--
(i) in subparagraph (B), by striking ``and'' at the
end;
(ii) in subparagraph (C), by striking the period and
inserting ``; and''; and
(iii) by adding after subparagraph (C) the following:
``(D) an implementation plan that may include measurable
steps to achieve the purposes described in paragraph (1).'';
and
(C) by striking paragraph (5) and inserting the following:
``(5) Technical assistance.--The Secretary may provide
technical assistance to States, localities, Tribes, and territories
or a consortium of States, localities, Tribes, and territories
receiving an award under this subsection regarding interoperability
and the technical standards set forth by the Secretary.'';
(6) by redesignating subsections (f) and (g) as subsections (i)
and (j), respectively; and
(7) by inserting after subsection (e) the following:
``(f) Personnel Authorities.--
``(1) Specially qualified personnel.--In addition to any other
personnel authorities, to carry out subsections (b) and (c), the
Secretary may--
``(A) appoint highly qualified individuals to scientific or
professional positions at the Centers for Disease Control and
Prevention, not to exceed 30 such employees at any time
(specific to positions authorized by this subsection), with
expertise in capabilities relevant to biosurveillance and
situational awareness, such as experts in informatics and data
analytics (including experts in prediction, modeling, or
forecasting), and other related scientific or technical fields;
and
``(B) compensate individuals appointed under subparagraph
(A) in the same manner and subject to the same terms and
conditions in which individuals appointed under 9903 of title
5, United States Code, are compensated, without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of
such title relating to classification and General Schedule pay
rates.
``(2) Limitations.--The Secretary shall exercise the authority
under paragraph (1) in a manner that is consistent with the
limitations described in section 319F-1(e)(2).
``(g) Timeline.--The Secretary shall accomplish the purposes under
subsections (b) and (c) no later than September 30, 2023, and shall
provide a justification to the congressional committees of jurisdiction
for any missed or delayed implementation of measurable steps identified
under subsection (c)(6)(A)(iii).
``(h) Independent Evaluation.--Not later than 3 years after the
date of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Comptroller General of the United
States shall conduct an independent evaluation and submit to the
Secretary and the congressional committees of jurisdiction a report
concerning the activities conducted under subsections (b) and (c), and
provide recommendations, as applicable and appropriate, on necessary
improvements to the biosurveillance and situational awareness
network.''.
(b) Authorization of Appropriations.--Subsection (i) of section
319D (42 U.S.C. 247d-4), as redesignated by subsection (a)(6), is
amended by striking ``$138,300,000 for each of fiscal years 2014
through 2018'' and inserting ``$161,800,000 for each of fiscal years
2019 through 2023''.
(c) Biological Threat Detection Report.--The Secretary of Health
and Human Services shall, in coordination with the Secretary of Defense
and the Secretary of Homeland Security, not later than 180 days after
the date of enactment of this Act, report to the Committee on Energy
and Commerce, the Committee on Armed Services, and the Committee on
Homeland Security of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions, the Committee on Armed
Services, and the Committee on Homeland Security and Governmental
Affairs of the Senate on the state of Federal biological threat
detection efforts, including the following:
(1) An identification of technological, operational, and
programmatic successes and failures of domestic detection programs
supported by Federal departments and agencies for intentionally
introduced or accidentally released biological threat agents and
naturally occurring infectious diseases.
(2) A description of Federal efforts to facilitate the exchange
of information related to the information described in paragraph
(1) among Federal departments and agencies that utilize biological
threat detection technology.
(3) A description of the capabilities of detection systems in
use by Federal departments and agencies including the capability
to--
(A) rapidly detect, identify, characterize, and confirm the
presence of biological threat agents;
(B) recover live biological agents from collection devices;
(C) determine the geographical distribution of biological
agents;
(D) determine the extent of environmental contamination and
persistence of biological agents; and
(E) provide advanced molecular diagnostics to State, local,
Tribal, and territorial public health and other laboratories
that support biological threat detection activities.
(4) A description of Federal interagency coordination related
to biological threat detection.
(5) A description of efforts by Federal departments and
agencies that utilize biological threat detection technology to
collaborate with State, local, Tribal, and territorial public
health laboratories and other users of biological threat detection
systems, including collaboration regarding the development of--
(A) biological threat detection requirements or standards;
(B) a standardized integration strategy;
(C) training requirements or guidelines;
(D) guidelines for a coordinated public health response,
including preparedness capabilities, and, as applicable, for
coordination with public health surveillance systems; and
(E) a coordinated environmental remediation plan, as
applicable.
(6) Recommendations related to research, advanced research,
development, and procurement for Federal departments and agencies
to improve and enhance biological threat detection systems,
including recommendations on the transfer of biological threat
detection technology among Federal departments and agencies, as
necessary and appropriate.

ae4aae3bff483db30d21b243b6f412bda5317ec98f7800d5c569952d2c998361

RAPID RESPONSE FUND.
Section 319 (42 U.S.C. 247d) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the first sentence, by inserting ``or if the
Secretary determines there is the significant potential for
a public health emergency, to allow the Secretary to
rapidly respond to the immediate needs resulting from such
public health emergency or potential public health
emergency'' before the period; and
(ii) by inserting ``The Secretary shall plan for the
expedited distribution of funds to appropriate agencies and
entities.'' after the first sentence;
(B) by redesignating paragraph (2) as paragraph (3);
(C) by inserting after paragraph (1) the following:
``(2) Uses.--The Secretary may use amounts in the Fund
established under paragraph (1), to--
``(A) facilitate coordination between and among Federal,
State, local, Tribal, and territorial entities and public and
private health care entities that the Secretary determines may
be affected by a public health emergency or potential public
health emergency referred to in paragraph (1) (including
communication of such entities with relevant international
entities, as applicable);
``(B) make grants, provide for awards, enter into
contracts, and conduct supportive investigations pertaining to
a public health emergency or potential public health emergency,
including further supporting programs under section 319C-1,
319C-2, or 319C-3;
``(C) facilitate and accelerate, as applicable, advanced
research and development of security countermeasures (as
defined in section 319F-2), qualified countermeasures (as
defined in section 319F-1), or qualified pandemic or epidemic
products (as defined in section 319F-3), that are applicable to
the public health emergency or potential public health
emergency under paragraph (1);
``(D) strengthen biosurveillance capabilities and
laboratory capacity to identify, collect, and analyze
information regarding such public health emergency or potential
public health emergency, including the systems under section
319D;
``(E) support initial emergency operations and assets
related to preparation and deployment of intermittent disaster
response personnel under section 2812 and the Medical Reserve
Corps under section 2813; and
``(F) carry out other activities, as the Secretary
determines applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so redesignated,
the following:
``(4) Review.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in coordination
with the Assistant Secretary for Preparedness and Response, shall
conduct a review of the Fund under this section and provide
recommendations to the Committee on Health, Education, Labor, and
Pensions and the Committee on Appropriations of the Senate and the
Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives on policies to
improve such Fund for the uses described in paragraph (2).
``(5) GAO report.--Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Comptroller General of the
United States shall--
``(A) conduct a review of the Fund under this section,
including its uses and the resources available in the Fund; and
``(B) submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report on such
review, including recommendations related to such review, as
applicable.''; and
(2) in subsection (c)--
(A) by inserting ``rapidly respond to public health
emergencies or potential public health emergencies and'' after
``used to''; and
(B) by striking ``section.'' and inserting ``Act or funds
otherwise provided for emergency response.''.

3d9d2ac3b7fcb6b8e1162c01e9294641c37b6b8d2bed0935e11ed631db291f89

HEALTH EMERGENCY VOLUNTEERS.
(a) In General.--Section 319I (42 U.S.C. 247d-7b) is amended--
(1) in the section heading, by striking ``health professions
volunteers'' and inserting ``volunteer health professional'';
(2) in subsection (a), by adding at the end the following:
``Such health care professionals may include members of the
National Disaster Medical System, members of the Medical Reserve
Corps, and individual health care professionals.'';
(3) in subsection (i), by adding at the end the following: ``In
order to inform the development of such mechanisms by States, the
Secretary shall make available information and material provided by
States that have developed mechanisms to waive the application of
licensing requirements to applicable health professionals seeking
to provide medical services during a public health emergency. Such
information shall be made publicly available in a manner that does
not compromise national security.''; and
(4) in subsection (k), by striking ``2014 through 2018'' and
inserting ``2019 through 2023''.
(b) All-Hazards Public Health Emergency Preparedness and Response
Plan.--Section 319C-1(b)(2)(A)(iv) (42 U.S.C. 247d-3a(b)(2)(A)(iv)) is
amended to read as follows:
``(iv) a description of the mechanism the entity will
implement to utilize the Emergency Management Assistance
Compact, or other mutual aid agreement, for medical and public
health mutual aid, and, as appropriate, the activities such
entity will implement pursuant to section 319I to improve
enrollment and coordination of volunteer health care
professionals seeking to provide medical services during a
public health emergency, which may include--
``(I) providing a public method of communication for
purposes of volunteer coordination (such as a phone
number);
``(II) providing for optional registration to
participate in volunteer services during processes related
to State medical licensing, registration, or certification
or renewal of such licensing, registration, or
certification; or
``(III) other mechanisms as the State determines
appropriate;''.

3bcb1f510e1dafe5ecda9df97d21cb1715722ce095704cd7611c367961b70aec

PROFESSIONALS.
(a) In General.--Title II (42 U.S.C. 202 et seq.) is amended by
inserting after section 224 the following:
``SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DURING A PUBLIC
HEALTH EMERGENCY.
``(a) Limitation on Liability.--Notwithstanding any other provision
of law, a health care professional who is a member of the Medical
Reserve Corps under section 2813 or who is included in the Emergency
System for Advance Registration of Volunteer Health Professionals under
section 319I and who--
``(1) is responding--
``(A) to a public health emergency determined under section
319(a), during the initial period of not more than 90 days (as
determined by the Secretary) of the public health emergency
determination (excluding any period covered by a renewal of
such determination); or
``(B) to a major disaster or an emergency as declared by
the President under section 401 of the Robert T. Stafford
Disaster Relief and Emergency Assistance Act (42 U.S.C. 5170)
or under section 201 of the National Emergencies Act (50 U.S.C.
1621) during the initial period of such declaration;
``(2) is alleged to be liable for an act or omission--
``(A) during the initial period of a determination or
declaration described in paragraph (1) and related to the
treatment of individuals in need of health care services due to
such public health emergency, major disaster, or emergency;
``(B) in the State or States for which such determination
or declaration is made;
``(C) in the health care professional's capacity as a
member of the Medical Reserve Corps or a professional included
in the Emergency System for Advance Registration of Volunteer
Health Professionals under section 319I; and
``(D) in the course of providing services that are within
the scope of the license, registration, or certification of the
professional, as defined by the State of licensure,
registration, or certification; and
``(3) prior to the rendering of such act or omission, was
authorized by the State's authorization of deploying such State's
Emergency System for Advance Registration of Volunteer Health
Professionals described in section 319I or the Medical Reserve
Corps established under section 2813, to provide health care
services,
shall be subject only to the State liability laws of the State in which
such act or omission occurred, in the same manner and to the same
extent as a similar health care professional who is a resident of such
State would be subject to such State laws, except with respect to the
licensure, registration, and certification of such individual.
``(b) Volunteer Protection Act.--Nothing in this section shall be
construed to affect an individual's right to protections under the
Volunteer Protection Act of 1997.
``(c) Preemption.--This section shall supersede the laws of any
State that would subject a health care professional described in
subsection (a) to the liability laws of any State other than the State
liability laws to which such individual is subject pursuant to such
subsection.
``(d) Definitions.--In this section:
``(1) The term `health care professional' means an individual
licensed, registered, or certified under Federal or State laws or
regulations to provide health care services.
``(2) The term `health care services' means any services
provided by a health care professional, or by any individual
working under the supervision of a health care professional, that
relate to--
``(A) the diagnosis, prevention, or treatment of any human
disease or impairment; or
``(B) the assessment or care of the health of human beings.
``(e) Effective Date.--
``(1) In general.--This section shall take effect 90 days after
the date of the enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2019.
``(2) Application.--This section shall apply to a claim for
harm only if the act or omission that caused such harm occurred on
or after the effective date described in paragraph (1).''.
(b) GAO Study.--Not later than one year after the date of enactment
of this Act, the Comptroller General of the United States shall conduct
a review of--
(1) the number of health care providers who register under the
Emergency System for Advance Registration of Volunteer Health
Professionals under section 319I of the Public Health Service Act
(42 U.S.C. 247d-7b) in advance to provide services during a public
health emergency;
(2) the number of health care providers who are credentialed to
provide services during the period of a public health emergency
declaration, including those who are credentialed though programs
established in the Emergency System for Advance Registration of
Volunteer Health Professionals under such section 319I and those
credentialed by authorities within the State in which the emergency
occurred;
(3) the average time to verify the credentials of a health care
provider during the period of a public health emergency
declaration, including the average time pursuant to the Emergency
System for Advance Registration of Volunteer Health Professionals
under such section 319I and for an individual's credentials to be
verified by an authority within the State; and
(4) the Emergency System for Advance Registration of Volunteer
Health Professionals program in States, including whether physician
or medical groups, associations, or other relevant provider
organizations utilize such program for purposes of volunteering
during public health emergencies.

bde80dbdea291c09e1068b387bc2c5237e6ba067525e4866756139cf63c07785

Not later than 1 year after the date of the enactment of this Act,
the Secretary of Health and Human Services shall submit to Congress a
report containing recommendations related to maintaining an adequate
national blood supply, including--
(1) challenges associated with the continuous recruitment of
blood donors (including those newly eligible to donate);
(2) ensuring the adequacy of the blood supply in the case of
public health emergencies;
(3) implementation of the transfusion transmission monitoring
system; and
(4) other measures to promote safety and innovation, such as
the development, use, or implementation of new technologies,
processes, and procedures to improve the safety and reliability of
the blood supply.

d1e0447de611e7505cd1a29290e0d35383731bdaba6a4979753c3788820fdc38

CAPABILITIES AND CAPACITIES OF HOSPITALS, LONG-TERM CARE
FACILITIES, AND OTHER HEALTH CARE FACILITIES.
(a) Study.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human Services
shall enter into an agreement with an appropriate entity to conduct
a study regarding the public health preparedness and response
capabilities and medical surge capacities of hospitals, long-term
care facilities, and other health care facilities to prepare for,
and respond to, public health emergencies, including natural
disasters.
(2) Consultation.--In conducting the study under paragraph (1),
the entity shall consult with Federal, State, local, Tribal, and
territorial public health officials (as appropriate), and health
care providers and facilities with experience in public health
preparedness and response activities.
(3) Evaluation.--The study under paragraph (1) shall include--
(A) an evaluation of the current benchmarks and objective
standards, as applicable, related to programs that support
hospitals, long-term care facilities, and other health care
facilities, and their effect on improving public health
preparedness and response capabilities and medical surge
capacities, including the Hospital Preparedness Program, the
Public Health Emergency Preparedness cooperative agreements,
and the Regional Health Care Emergency Preparedness and
Response Systems under section 319C-3 of the Public Health
Service Act (as added by section 203);
(B) the identification of gaps in preparedness, including
with respect to such benchmarks and objective standards, such
as those identified during recent public health emergencies,
for hospitals, long-term care facilities, and other health care
facilities to address future potential public health threats;
(C) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and entities with expertise in emergency power
systems and other critical infrastructure partners during a
public health emergency, to ensure a functioning critical
infrastructure, to the greatest extent practicable, during a
public health emergency;
(D) an evaluation of coordination efforts between the
recipients of Federal funding for programs described in
subparagraph (A) and environmental health agencies with
expertise in emergency preparedness and response planning for
hospitals, long-term care facilities, and other health care
facilities; and
(E) an evaluation of current public health preparedness and
response capabilities and medical surge capacities related to
at-risk individuals during public health emergencies, including
an identification of gaps in such preparedness as they relate
to such individuals.
(b) Report.--
(1) In general.--The agreement under subsection (a) shall
require the entity to submit to the Secretary of Health and Human
Services and the congressional committees of jurisdiction, not
later than 3 years after the date of enactment of this Act, a
report on the results of the study conducted pursuant to this
section.
(2) Contents.--The report under paragraph (1) shall--
(A) describe the findings and conclusions of the evaluation
conducted pursuant to subsection (a); and
(B) provide recommendations for improving public health
preparedness and response capability and medical surge capacity
for hospitals, long-term care facilities, and other health care
facilities, including--
(i) improving the existing benchmarks and objective
standards for the Federal grant programs described in
subsection (a)(3)(A) or developing new benchmarks and
standards for such programs; and
(ii) identifying best practices for improving public
health preparedness and response programs and medical surge
capacity at hospitals, long-term care facilities, and other
health care facilities, including recommendations for the
evaluation under subparagraphs (C) and (D) of subsection
(a)(3).

791cdcad3db391b924fa35906d57bff95b5d65244022f5fb13282571113fe0ae

WORKFORCE.
(a) National Disaster Medical System.--
(1) Strengthening the national disaster medical system.--Clause
(ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh-11(a)(3)(A)) is
amended to read as follows:
``(ii) be present at locations, and for limited periods
of time, specified by the Secretary on the basis that the
Secretary has determined that a location is at risk of a
public health emergency during the time specified, or there
is a significant potential for a public health
emergency.''.
(2) Review of the national disaster medical system.--Section
2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to read as
follows:
``(2) Joint review and medical surge capacity strategic plan.--
``(A) Review.--Not later than 180 days after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary, in
coordination with the Secretary of Homeland Security, the
Secretary of Defense, and the Secretary of Veterans Affairs,
shall conduct a joint review of the National Disaster Medical
System. Such review shall include--
``(i) an evaluation of medical surge capacity, as
described in section 2803(a);
``(ii) an assessment of the available workforce of the
intermittent disaster response personnel described in
subsection (c);
``(iii) the capacity of the workforce described in
clause (ii) to respond to all hazards, including capacity
to simultaneously respond to multiple public health
emergencies and the capacity to respond to a nationwide
public health emergency;
``(iv) the effectiveness of efforts to recruit, retain,
and train such workforce; and
``(v) gaps that may exist in such workforce and
recommendations for addressing such gaps.
``(B) Updates.--As part of the National Health Security
Strategy under section 2802, the Secretary shall update the
findings from the review under subparagraph (A) and provide
recommendations to modify the policies of the National Disaster
Medical System as necessary.''.
(3) Notification of shortage.--Section 2812(c) (42 U.S.C.
300hh-11(c)) is amended by adding at the end the following:
``(3) Notification.--Not later than 30 days after the date on
which the Secretary determines the number of intermittent disaster-
response personnel of the National Disaster Medical System is
insufficient to address a public health emergency or potential
public health emergency, the Secretary shall submit to the
congressional committees of jurisdiction a notification detailing--
``(A) the impact such shortage could have on meeting public
health needs and emergency medical personnel needs during a
public health emergency; and
``(B) any identified measures to address such shortage.
``(4) Certain appointments.--
``(A) In general.--If the Secretary determines that the
number of intermittent disaster response personnel within the
National Disaster Medical System under this section is
insufficient to address a public health emergency or potential
public health emergency, the Secretary may appoint candidates
directly to personnel positions for intermittent disaster
response within such system. The Secretary shall provide
updates on the number of vacant or unfilled positions within
such system to the congressional committees of jurisdiction
each quarter for which this authority is in effect.
``(B) Sunset.--The authority under this paragraph shall
expire on September 30, 2021.''.
(4) Authorization of appropriations.--Section 2812(g) (42
U.S.C. 300hh-11(g)) is amended by striking ``$52,700,000 for each
of fiscal years 2014 through 2018'' and inserting ``$57,400,000 for
each of fiscal years 2019 through 2023''.
(b) Volunteer Medical Reserve Corps.--
(1) In general.--Section 2813(a) (42 U.S.C. 42 U.S.C. 300hh-
15(a)) is amended by striking the second sentence and inserting
``The Secretary may appoint a Director to head the Corps and
oversee the activities of the Corps chapters that exist at the
State, local, Tribal, and territorial levels.''.
(2) Authorization of appropriations.--Section 2813(i) (42
U.S.C. 300hh-15(i)) is amended by striking ``2014 through 2018''
and inserting ``2019 through 2023''.
(c) Strengthening the Epidemic Intelligence Service.--Section 317F
(42 U.S.C. Sec. 247b-7) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by inserting ``or preparedness and response
activities, including rapid response to public health
emergencies and significant public health threats'' after
``conduct prevention activities''; and
(ii) by striking ``$35,000'' and inserting ``$50,000'';
and
(B) in paragraph (2)(B), by striking ``3 years'' and
inserting ``2 years''; and
(2) in subsection (c)--
(A) by striking ``For the purpose of carrying out this
section'' and inserting the following:
``(1) In general.--For the purpose of carrying out this
section, except as described in paragraph (2)''; and
(B) by adding at the end the following:
``(2) Epidemic intelligence service program.--For purposes of
carrying out this section with respect to qualified health
professionals serving in the Epidemic Intelligence Service, as
authorized under section 317G, there is authorized to be
appropriated $1,000,000 for each of fiscal years 2019 through
2023.''.
(d) Service Benefit for National Disaster Medical System
Volunteers.--
(1) In general.--Section 2812(c) (42 U.S.C. 300hh-11(c)), as
amended by subsection (a)(3), is further amended by adding at the
end the following:
``(5) Service benefit.--Individuals appointed to serve under
this subsection shall be considered eligible for benefits under
part L of title I of the Omnibus Crime Control and Safe Streets Act
of 1968. The Secretary shall provide notification to any eligible
individual of any effect such designation may have on other
benefits for which such individual is eligible, including benefits
from private entities.''.
(2) Public safety officer benefits.--Section 1204(9) of title I
of the Omnibus Crime Control and Safe Streets Act of 1968 (34
U.S.C. 10284(9)) is amended--
(A) in subparagraph (C)(ii), by striking ``or'' at the end;
(B) in subparagraph (D), by striking the period and
inserting ``; or''; and
(C) by inserting after subparagraph (D) the following:
``(E) an individual appointed to the National Disaster
Medical System under section 2812 of the Public Health Service
Act (42 U.S.C. 300hh-11) who is performing official duties of
the Department of Health and Human Services, if those official
duties are--
``(i) related to responding to a public health
emergency or potential public health emergency, or other
activities for which the Secretary of Health and Human
Services has activated such National Disaster Medical
System; and
``(ii) determined by the Secretary of Health and Human
Services to be hazardous.''.
(3) Sunset.--The amendments made by paragraphs (1) and (2)
shall cease to have force or effect on October 1, 2021.
(e) Mission Readiness Report to Congress.--
(1) Report.--Not later than one year after the date of
enactment of this section, the Comptroller General of the United
States (referred to in this subsection as the ``Comptroller
General'') shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a report on the medical
surge capacity of the United States in the event of a public health
emergency, including the capacity and capability of the current
health care workforce to prepare for, and respond to, the full
range of public health emergencies or potential public health
emergencies, and recommendations to address any gaps identified in
such workforce.
(2) Contents.--The Comptroller General shall include in the
report under paragraph (1)--
(A) the number of health care providers who have
volunteered to provide health care services during a public
health emergency, including members of the National Disaster
Medical System, the Disaster Medical Assistant Teams, the
Medical Reserve Corps, and other volunteer health care
professionals in the verification network pursuant to section
319I of the Public Health Service Act (42 U.S.C. 247d-7b);
(B) the capacity of the workforce described in subparagraph
(A) to respond to a public health emergency or potential public
health emergency, including the capacity to respond to multiple
concurrent public health emergencies and the capacity to
respond to a nationwide public health emergency;
(C) the preparedness and response capabilities and mission
readiness of the workforce described in subparagraph (A) taking
into account areas of health care expertise and considerations
for at-risk individuals (as defined in section 2802(b)(4)(B) of
the Public Health Service Act (42 U.S.C. 300hh-1(b)(4)(B)));
(D) an assessment of the effectiveness of efforts to
recruit, retain, and train such workforce; and
(E) identification of gaps that may exist in such workforce
and recommendations for addressing such gaps, the extent to
which the Assistant Secretary for Preparedness and Response
plans to address such gaps, and any recommendations from the
Comptroller General to address such gaps.

862629712131cf6bc4545859ac825d69efa586fab422a0a61a0644cd10eb73d1

RESPONSE.
(a) Coordination of Preparedness.--Section 2811(b)(5) (42 U.S.C.
300hh-10(b)(5)) is amended by adding at the end the following: ``Such
logistical support shall include working with other relevant Federal,
State, local, Tribal, and territorial public health officials and
private sector entities to identify the critical infrastructure assets,
systems, and networks needed for the proper functioning of the health
care and public health sectors that need to be maintained through any
emergency or disaster, including entities capable of assisting with,
responding to, and mitigating the effect of a public health emergency,
including a public health emergency determined by the Secretary
pursuant to section 319(a) or an emergency or major disaster declared
by the President under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act or the National Emergencies Act, including by
establishing methods to exchange critical information and deliver
products consumed or used to preserve, protect, or sustain life,
health, or safety, and sharing of specialized expertise.''.
(b) Manufacturing Capacity.--Section 2811(d)(2)(C) (42 U.S.C.
300hh-10(d)(2)(C)) is amended by inserting ``, and ancillary medical
supplies to assist with the utilization of such countermeasures or
products,'' after ``products''.
(c) Evaluation of Barriers to Rapid Delivery of Medical
Countermeasures.--
(1) Rapid delivery study.--The Assistant Secretary for
Preparedness and Response may conduct a study on issues that have
the potential to adversely affect the handling and rapid delivery
of medical countermeasures to individuals during public health
emergencies occurring in the United States.
(2) Notice to congress.--Not later than 9 months after the date
of the enactment of this Act, the Assistant Secretary for
Preparedness and Response shall notify the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate if the
Assistant Secretary for Preparedness and Response does not plan to
conduct the study under paragraph (1) and shall provide such
committees a summary explanation for such decision.
(3) Report to congress.--Not later than 1 year after the
Assistant Secretary for Preparedness and Response conducts the
study under paragraph (1), such Assistant Secretary shall submit a
report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate containing the findings of such study.

a1619adfbfea7ed4bad7ff70b56123a645eab076dd4f000e29988aa539f8e726

(a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
(1) by striking ``this section and sections 319C-1, 319F, and
319L,'' and inserting ``this Act,''; and
(2) by striking ``special'' and inserting ``access or
functional''.
(b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C.
247d-7e(c)(6)) is amended--
(1) by striking ``elderly'' and inserting ``older adults''; and
(2) by inserting ``with relevant characteristics that warrant
consideration during the process of researching and developing such
countermeasures and products'' before the period.
(c) Biosurveillance of Emerging Public Health Threats.--Section
2814 is amended--
(1) in paragraph (7), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (8), by striking the period and inserting ``;
and''; and
(3) by adding at the end the following:
``(9) facilitate coordination to ensure that, in implementing
the situational awareness and biosurveillance network under section
319D, the Secretary considers incorporating data and information
from Federal, State, local, Tribal, and territorial public health
officials and entities relevant to detecting emerging public health
threats that may affect at-risk individuals, such as pregnant and
postpartum women and infants, including adverse health outcomes of
such populations related to such emerging public health threats.''.

ec341a2d3b6e7e7d885b8f02c6a4352c81e5b799e0520475cd7809573c20df2e

CONSIDERATIONS FOR CHILDREN.
Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting
after section 319D the following:
``SEC. 319D-1. CHILDREN'S PREPAREDNESS UNIT.
``(a) Enhancing Emergency Preparedness for Children.--The
Secretary, acting through the Director of the Centers for Disease
Control and Prevention (referred to in this subsection as the
`Director'), shall maintain an internal team of experts, to be known as
the Children's Preparedness Unit (referred to in this subsection as the
`Unit'), to work collaboratively to provide guidance on the
considerations for, and the specific needs of, children before, during,
and after public health emergencies. The Unit shall inform the Director
regarding emergency preparedness and response efforts pertaining to
children at the Centers for Disease Control and Prevention.
``(b) Expertise.--The team described in subsection (a) shall
include one or more pediatricians, which may be a developmental-
behavioral pediatrician, and may also include behavioral scientists,
child psychologists, epidemiologists, biostatisticians, health
communications staff, and individuals with other areas of expertise, as
the Secretary determines appropriate.
``(c) Duties.--The team described in subsection (a) may--
``(1) assist State, local, Tribal, and territorial emergency
planning and response activities related to children, which may
include developing, identifying, and sharing best practices;
``(2) provide technical assistance, training, and consultation
to Federal, State, local, Tribal, and territorial public health
officials to improve preparedness and response capabilities with
respect to the needs of children, including providing such
technical assistance, training, and consultation to eligible
entities in order to support the achievement of measurable
evidence-based benchmarks and objective standards applicable to
sections 319C-1 and 319C-2;
``(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public health
emergency, including public awareness of such methods;
``(4) coordinate with, and improve, public-private
partnerships, such as health care coalitions pursuant to sections
319C-2 and 319C-3, to address gaps and inefficiencies in emergency
preparedness and response efforts for children;
``(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies, including pursuant to section 319C-3; and
``(6) carry out other duties related to preparedness and
response activities for children, as the Secretary determines
appropriate.''.

12fcff86781250d30b35cd4a5a7edb1f56bf6e83afcb60f85a787e58338adf1a

(a) Reauthorizing the National Advisory Committee on Children and
Disasters.--Section 2811A (42 U.S.C. 300hh-10a) is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and inserting
``25''; and
(B) by striking paragraph (2) and inserting the following:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may be
appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals, including--
``(A) at least 2 non-Federal professionals with expertise
in pediatric medical disaster planning, preparedness, response,
or recovery;
``(B) at least 2 representatives from State, local, Tribal,
or territorial agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery;
``(C) at least 4 members representing health care
professionals, which may include members with expertise in
pediatric emergency medicine; pediatric trauma, critical care,
or surgery; the treatment of pediatric patients affected by
chemical, biological, radiological, or nuclear agents,
including emerging infectious diseases; pediatric mental or
behavioral health related to children affected by a public
health emergency; or pediatric primary care; and
``(D) other members as the Secretary determines
appropriate, of whom--
``(i) at least one such member shall represent a
children's hospital;
``(ii) at least one such member shall be an individual
with expertise in schools or child care settings;
``(iii) at least one such member shall be an individual
with expertise in children and youth with special health
care needs; and
``(iv) at least one such member shall be an individual
with expertise in the needs of parents or family
caregivers, including the parents or caregivers of children
with disabilities.
``(3) Federal members.--The Advisory Committee under paragraph
(1) shall include the following Federal members or their designees
(who may be nonvoting members, as determined by the Secretary):
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced Research and
Development Authority.
``(C) The Director of the Centers for Disease Control and
Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of Health.
``(F) The Assistant Secretary of the Administration for
Children and Families.
``(G) The Administrator of the Health Resources and
Services Administration.
``(H) The Administrator of the Federal Emergency Management
Agency.
``(I) The Administrator of the Administration for Community
Living.
``(J) The Secretary of Education.
``(K) Representatives from such Federal agencies (such as
the Substance Abuse and Mental Health Services Administration
and the Department of Homeland Security) as the Secretary
determines appropriate to fulfill the duties of the Advisory
Committee under subsections (b) and (c).
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a term of 3
years, except that the Secretary may adjust the terms of the
Advisory Committee appointees serving on the date of enactment of
the Pandemic and All-Hazards Preparedness and Advancing Innovation
Act of 2019, or appointees who are initially appointed after such
date of enactment, in order to provide for a staggered term of
appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms on
the Advisory Committee, and not more than two of such terms may be
served consecutively.'';
(3) in subsection (e), by adding at the end ``At least one
meeting per year shall be an in-person meeting.'';
(4) by redesignating subsection (f) as subsection (g);
(5) by inserting after subsection (e) the following:
``(f) Coordination.--The Secretary shall coordinate duties and
activities authorized under this section in accordance with section
2811D.''; and
(6) in subsection (g), as so redesignated, by striking ``2018''
and inserting ``2023''.
(b) Authorizing the National Advisory Committee on Seniors and
Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.) is
amended by inserting after section 2811A the following:
``SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.
``(a) Establishment.--The Secretary, in consultation with the
Secretary of Homeland Security and the Secretary of Veterans Affairs,
shall establish an advisory committee to be known as the National
Advisory Committee on Seniors and Disasters (referred to in this
section as the `Advisory Committee').
``(b) Duties.--The Advisory Committee shall--
``(1) provide advice and consultation with respect to the
activities carried out pursuant to section 2814, as applicable and
appropriate;
``(2) evaluate and provide input with respect to the medical
and public health needs of seniors related to preparation for,
response to, and recovery from all-hazards emergencies; and
``(3) provide advice and consultation with respect to State
emergency preparedness and response activities relating to seniors,
including related drills and exercises pursuant to the preparedness
goals under section 2802(b).
``(c) Additional Duties.--The Advisory Committee may provide advice
and recommendations to the Secretary with respect to seniors and the
medical and public health grants and cooperative agreements as
applicable to preparedness and response activities under this title and
title III.
``(d) Membership.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies as appropriate, shall appoint not more than
17 members to the Advisory Committee. In appointing such members,
the Secretary shall ensure that the total membership of the
Advisory Committee is an odd number.
``(2) Required members.--The Advisory Committee shall include
Federal members or their designees (who may be nonvoting members,
as determined by the Secretary) and non-Federal members, as
follows:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced Research and
Development Authority.
``(C) The Director of the Centers for Disease Control and
Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of Health.
``(F) The Administrator of the Centers for Medicare &
Medicaid Services.
``(G) The Administrator of the Administration for Community
Living.
``(H) The Administrator of the Federal Emergency Management
Agency.
``(I) The Under Secretary for Health of the Department of
Veterans Affairs.
``(J) At least 2 non-Federal health care professionals with
expertise in geriatric medical disaster planning, preparedness,
response, or recovery.
``(K) At least 2 representatives of State, local, Tribal,
or territorial agencies with expertise in geriatric disaster
planning, preparedness, response, or recovery.
``(L) Representatives of such other Federal agencies (such
as the Department of Energy and the Department of Homeland
Security) as the Secretary determines necessary to fulfill the
duties of the Advisory Committee.
``(e) Meetings.--The Advisory Committee shall meet not less
frequently than biannually. At least one meeting per year shall be an
in-person meeting.
``(f) Coordination.--The Secretary shall coordinate duties and
activities authorized under this section in accordance with section
2811D.
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate on
September 30, 2023.
``(2) Extension of committee.--Not later than October 1, 2022,
the Secretary shall submit to Congress a recommendation on whether
the Advisory Committee should be extended.''.
(c) National Advisory Committee on Individuals With Disabilities
and Disasters.--Subtitle B of title XXVIII (42 U.S.C. 300hh et seq.),
as amended by subsection (b), is further amended by inserting after
section 2811B the following:
``SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH
DISABILITIES AND DISASTERS.
``(a) Establishment.--The Secretary, in consultation with the
Secretary of Homeland Security, shall establish a national advisory
committee to be known as the National Advisory Committee on Individuals
with Disabilities and Disasters (referred to in this section as the
`Advisory Committee').
``(b) Duties.--The Advisory Committee shall--
``(1) provide advice and consultation with respect to
activities carried out pursuant to section 2814, as applicable and
appropriate;
``(2) evaluate and provide input with respect to the medical,
public health, and accessibility needs of individuals with
disabilities related to preparation for, response to, and recovery
from all-hazards emergencies; and
``(3) provide advice and consultation with respect to State
emergency preparedness and response activities, including related
drills and exercises pursuant to the preparedness goals under
section 2802(b).
``(c) Membership.--
``(1) In general.--The Secretary, in consultation with such
other heads of agencies and departments as appropriate, shall
appoint not more than 17 members to the Advisory Committee. In
appointing such members, the Secretary shall ensure that the total
membership of the Advisory Committee is an odd number.
``(2) Required members.--The Advisory Committee shall include
Federal members or their designees (who may be nonvoting members,
as determined by the Secretary) and non-Federal members, as
follows:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Administrator of the Administration for Community
Living.
``(C) The Director of the Biomedical Advanced Research and
Development Authority.
``(D) The Director of the Centers for Disease Control and
Prevention.
``(E) The Commissioner of Food and Drugs.
``(F) The Director of the National Institutes of Health.
``(G) The Administrator of the Federal Emergency Management
Agency.
``(H) The Chair of the National Council on Disability.
``(I) The Chair of the United States Access Board.
``(J) The Under Secretary for Health of the Department of
Veterans Affairs.
``(K) At least 2 non-Federal health care professionals with
expertise in disability accessibility before, during, and after
disasters, medical and mass care disaster planning,
preparedness, response, or recovery.
``(L) At least 2 representatives from State, local, Tribal,
or territorial agencies with expertise in disaster planning,
preparedness, response, or recovery for individuals with
disabilities.
``(M) At least 2 individuals with a disability with
expertise in disaster planning, preparedness, response, or
recovery for individuals with disabilities.
``(d) Meetings.--The Advisory Committee shall meet not less
frequently than biannually. At least one meeting per year shall be an
in-person meeting.
``(e) Disability Defined.--For purposes of this section, the term
`disability' has the meaning given such term in section 3 of the
Americans with Disabilities Act of 1990.
``(f) Coordination.--The Secretary shall coordinate duties and
activities authorized under this section in accordance with section
2811D.
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate on
September 30, 2023.
``(2) Recommendation.--Not later than October 1, 2022, the
Secretary shall submit to Congress a recommendation on whether the
Advisory Committee should be extended.''.
(d) Advisory Committee Coordination.--Subtitle B of title XXVIII
(42 U.S.C. 300hh et seq.), as amended by subsection (c), is further
amended by inserting after section 2811C the following:
``SEC. 2811D. ADVISORY COMMITTEE COORDINATION.
``(a) In General.--The Secretary shall coordinate duties and
activities authorized under sections 2811A, 2811B, and 2811C, and make
efforts to reduce unnecessary or duplicative reporting, or unnecessary
duplicative meetings and recommendations under such sections, as
practicable. Members of the advisory committees authorized under such
sections, or their designees, shall annually meet to coordinate any
recommendations, as appropriate, that may be similar, duplicative, or
overlapping with respect to addressing the needs of children, seniors,
and individuals with disabilities during public health emergencies. If
such coordination occurs through an in-person meeting, it shall not be
considered the required in-person meetings under any of sections
2811A(e), 2811B(e), or 2811C(d).
``(b) Coordination and Alignment.--The Secretary, acting through
the employee designated pursuant to section 2814, shall align
preparedness and response programs or activities to address similar,
dual, or overlapping needs of children, seniors, and individuals with
disabilities, and any challenges in preparing for and responding to
such needs.
``(c) Notification.--The Secretary shall annually notify the
congressional committees of jurisdiction regarding the steps taken to
coordinate, as appropriate, the recommendations under this section, and
provide a summary description of such coordination.''.

0767f003b88e8297acaacaff4daa21b2e87d68369a1431b50e2d58fe15593ef3

Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue final guidance
regarding the ability of personnel funded by programs authorized under
this Act (including the amendments made by this Act) to participate in
drills and operational exercises related to all-hazards medical and
public health preparedness and response. Such drills and operational
exercises may include activities that incorporate medical surge
capacity planning, medical countermeasure distribution and
administration, and preparing for and responding to identified threats
for that region. Such personnel may include State, local, Tribal, and
territorial public health department or agency personnel funded under
this Act (including the amendments made by this Act). The Secretary
shall consult with the Department of Homeland Security, the Department
of Defense, the Department of Veterans Affairs, and other applicable
Federal departments and agencies as necessary and appropriate in the
development of such guidance. The Secretary shall make the guidance
available on the internet website of the Department of Health and Human
Services.

5d70f54039969d4e43584494c809f919844bf2ef8ed6339b1d6172148390586e

Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``utilize experience related to public health emergency
preparedness and response, biodefense, medical countermeasures, and
other relevant topics to'' after ``shall''; and
(2) in paragraph (4), by adding at the end the following:
``(I) Threat awareness.--Coordinate with the Director of
the Centers for Disease Control and Prevention, the Director of
National Intelligence, the Secretary of Homeland Security, the
Assistant to the President for National Security Affairs, the
Secretary of Defense, and other relevant Federal officials,
such as the Secretary of Agriculture, to maintain a current
assessment of national security threats and inform preparedness
and response capabilities based on the range of the threats
that have the potential to result in a public health
emergency.''.

d680f48da46dbf7b0e46d96ccce4c7570c7413f9d054c993c09d45d2b6aa4584

ENTERPRISE.
(a) In General.--Title XXVIII is amended by inserting after section
2811 (42 U.S.C. 300hh-10) the following:
``SEC. 2811-1. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.
``(a) In General.--The Secretary shall establish the Public Health
Emergency Medical Countermeasures Enterprise (referred to in this
section as the `PHEMCE'). The Assistant Secretary for Preparedness and
Response shall serve as chair of the PHEMCE.
``(b) Members.--The PHEMCE shall include each of the following
members, or the designee of such members:
``(1) The Assistant Secretary for Preparedness and Response.
``(2) The Director of the Centers for Disease Control and
Prevention.
``(3) The Director of the National Institutes of Health.
``(4) The Commissioner of Food and Drugs.
``(5) The Secretary of Defense.
``(6) The Secretary of Homeland Security.
``(7) The Secretary of Agriculture.
``(8) The Secretary of Veterans Affairs.
``(9) The Director of National Intelligence.
``(10) Representatives of any other Federal agency, which may
include the Director of the Biomedical Advanced Research and
Development Authority, the Director of the Strategic National
Stockpile, the Director of the National Institute of Allergy and
Infectious Diseases, and the Director of the Office of Public
Health Preparedness and Response, as the Secretary determines
appropriate.
``(c) Functions.--
``(1) In general.--The functions of the PHEMCE shall include
the following:
``(A) Utilize a process to make recommendations to the
Secretary regarding research, advanced research, development,
procurement, stockpiling, deployment, distribution, and
utilization with respect to countermeasures, as defined in
section 319F-2(c), including prioritization based on the health
security needs of the United States. Such recommendations shall
be informed by, when available and practicable, the National
Health Security Strategy pursuant to section 2802, the
Strategic National Stockpile needs pursuant to section 319F-2,
and assessments of current national security threats, including
chemical, biological, radiological, and nuclear threats,
including emerging infectious diseases. In the event that
members of the PHEMCE do not agree upon a recommendation, the
Secretary shall provide a determination regarding such
recommendation.
``(B) Identify national health security needs, including
gaps in public health preparedness and response related to
countermeasures and challenges to addressing such needs
(including any regulatory challenges), and support alignment of
countermeasure procurement with recommendations to address such
needs under subparagraph (A).
``(C) Assist the Secretary in developing strategies related
to logistics, deployment, distribution, dispensing, and use of
countermeasures that may be applicable to the activities of the
strategic national stockpile under section 319F-2(a).
``(D) Provide consultation for the development of the
strategy and implementation plan under section 2811(d).
``(2) Input.--In carrying out subparagraphs (B) and (C) of
paragraph (1), the PHEMCE shall solicit and consider input from
State, local, Tribal, and territorial public health departments or
officials, as appropriate.''.
(b) Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.--Section 2811(d) (42 U.S.C. 300hh-
10(d)) is amended--
(1) in paragraph (1)--
(A) by striking ``Not later than 180 days after the date of
enactment of this subsection, and every year thereafter'' and
inserting ``Not later than March 15, 2020, and biennially
thereafter''; and
(B) by striking ``Director of the Biomedical'' and all that
follows through ``Food and Drugs'' and inserting ``Public
Health Emergency Medical Countermeasures Enterprise established
under section 2811-1''; and
(2) in paragraph (2)(J)(v), by striking ``one-year period'' and
inserting ``2-year period''.

fc502e8f5e99c58c4d4c2c8be3de0e2441dbacf730bc7a4c87206d2f7c68a01d

(a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is
amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs (3)
and (4), respectively; and
(2) in paragraph (1)--
(A) by inserting ``the Assistant Secretary for Preparedness
and Response and'' after ``collaboration with'';
(B) by inserting ``and optimize'' after ``provide for'';
(C) by inserting ``and, as informed by existing
recommendations of, or consultations with, the Public Health
Emergency Medical Countermeasure Enterprise established under
section 2811-1, make necessary additions or modifications to
the contents of such stockpile or stockpiles based on the
review conducted under paragraph (2)'' before the period of the
first sentence; and
(D) by striking the second sentence;
(3) by inserting after paragraph (1) the following:
``(2) Threat-based review.--
``(A) In general.--The Secretary shall conduct an annual
threat-based review (taking into account at-risk individuals)
of the contents of the stockpile under paragraph (1), including
non-pharmaceutical supplies, and, in consultation with the
Public Health Emergency Medical Countermeasures Enterprise
established under section 2811-1, review contents within the
stockpile and assess whether such contents are consistent with
the recommendations made pursuant to section 2811-1(c)(1)(A).
Such review shall be submitted on June 15, 2019, and on March
15 of each year thereafter, to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives, in a manner that does not compromise national
security.
``(B) Additions, modifications, and replenishments.--Each
annual threat-based review under subparagraph (A) shall, for
each new or modified countermeasure procurement or
replenishment, provide--
``(i) information regarding--
``(I) the quantities of the additional or modified
countermeasure procured for, or contracted to be
procured for, the stockpile;
``(II) planning considerations for appropriate
manufacturing capacity and capability to meet the goals
of such additions or modifications (without disclosing
proprietary information), including consideration of
the effect such additions or modifications may have on
the availability of such products and ancillary medical
supplies in the health care system;
``(III) the presence or lack of a commercial market
for the countermeasure at the time of procurement;
``(IV) the emergency health security threat or
threats such countermeasure procurement is intended to
address, including whether such procurement is
consistent with meeting emergency health security needs
associated with such threat or threats;
``(V) an assessment of whether the emergency health
security threat or threats described in subclause (IV)
could be addressed in a manner that better utilizes the
resources of the stockpile and permits the greatest
possible increase in the level of emergency
preparedness to address such threats;
``(VI) whether such countermeasure is replenishing
an expiring or expired countermeasure, is a different
countermeasure with the same indication that is
replacing an expiring or expired countermeasure, or is
a new addition to the stockpile;
``(VII) a description of how such additions or
modifications align with projected investments under
previous countermeasures budget plans under section
2811(b)(7), including expected life-cycle costs,
expenditures related to countermeasure procurement to
address the threat or threats described in subclause
(IV), replenishment dates (including the ability to
extend the maximum shelf life of a countermeasure), and
the manufacturing capacity required to replenish such
countermeasure; and
``(VIII) appropriate protocols and processes for
the deployment, distribution, or dispensing of the
countermeasure at the State and local level, including
plans for relevant capabilities of State and local
entities to dispense, distribute, and administer the
countermeasure; and
``(ii) an assurance, which need not be provided in
advance of procurement, that for each countermeasure
procured or replenished under this subsection, the
Secretary completed a review addressing each item listed
under this subsection in advance of such procurement or
replenishment.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A), by inserting ``and the Public
Health Emergency Medical Countermeasures Enterprise established
under section 2811-1'' before the semicolon;
(B) in subparagraph (C), by inserting ``, and the
availability, deployment, dispensing, and administration of
countermeasures'' before the semicolon;
(C) by amending subparagraph (E) to read as follows:
``(E) devise plans for effective and timely supply-chain
management of the stockpile, in consultation with the Director
of the Centers for Disease Control and Prevention, the
Assistant Secretary for Preparedness and Response, the
Secretary of Transportation, the Secretary of Homeland
Security, the Secretary of Veterans Affairs, and the heads of
other appropriate Federal agencies; State, local, Tribal, and
territorial agencies; and the public and private health care
infrastructure, as applicable, taking into account the
manufacturing capacity and other available sources of products
and appropriate alternatives to supplies in the stockpile;'';
(D) in subparagraph (G), by striking ``; and'' and
inserting a semicolon;
(E) in subparagraph (H), by striking the period and
inserting a semicolon; and
(F) by adding at the end the following:
``(I) ensure that each countermeasure or product under
consideration for procurement pursuant to this subsection
receives the same consideration regardless of whether such
countermeasure or product receives or had received funding
under section 319L, including with respect to whether the
countermeasure or product is most appropriate to meet the
emergency health security needs of the United States; and
``(J) provide assistance, including technical assistance,
to maintain and improve State and local public health
preparedness capabilities to distribute and dispense medical
countermeasures and products from the stockpile, as
appropriate.''; and
(5) by adding at the end the following:
``(5) GAO report.--
``(A) In general.--Not later than 3 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, and every 5 years thereafter,
the Comptroller General of the United States shall conduct a
review of any changes to the contents or management of the
stockpile since January 1, 2015. Such review shall include--
``(i) an assessment of the comprehensiveness and
completeness of each annual threat-based review under
paragraph (2), including whether all newly procured or
replenished countermeasures within the stockpile were
described in each annual review, and whether, consistent
with paragraph (2)(B), the Secretary conducted the
necessary internal review in advance of such procurement or
replenishment;
``(ii) an assessment of whether the Secretary
established health security and science-based
justifications, and a description of such justifications
for procurement decisions related to health security needs
with respect to the identified threat, for additions or
modifications to the stockpile based on the information
provided in such reviews under paragraph (2)(B), including
whether such review was conducted prior to procurement,
modification, or replenishment;
``(iii) an assessment of the plans developed by the
Secretary for the deployment, distribution, and dispensing
of countermeasures procured, modified, or replenished under
paragraph (1), including whether such plans were developed
prior to procurement, modification, or replenishment;
``(iv) an accounting of countermeasures procured,
modified, or replenished under paragraph (1) that received
advanced research and development funding from the
Biomedical Advanced Research and Development Authority;
``(v) an analysis of how such procurement decisions
made progress toward meeting emergency health security
needs related to the identified threats for countermeasures
added, modified, or replenished under paragraph (1);
``(vi) a description of the resources expended related
to the procurement of countermeasures (including additions,
modifications, and replenishments) in the stockpile, and
how such expenditures relate to the ability of the
stockpile to meet emergency health security needs;
``(vii) an assessment of the extent to which additions,
modifications, and replenishments reviewed under paragraph
(2) align with previous relevant reports or reviews by the
Secretary or the Comptroller General;
``(viii) with respect to any change in the Federal
organizational management of the stockpile, an assessment
and comparison of the processes affected by such change,
including planning for potential countermeasure deployment,
distribution, or dispensing capabilities and processes
related to procurement decisions, use of stockpiled
countermeasures, and use of resources for such activities;
and
``(ix) an assessment of whether the processes and
procedures described by the Secretary pursuant to section
403(b) of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019 are sufficient to ensure
countermeasures and products under consideration for
procurement pursuant to subsection (a) receive the same
consideration regardless of whether such countermeasures
and products receive or had received funding under section
319L, including with respect to whether such
countermeasures and products are most appropriate to meet
the emergency health security needs of the United States.
``(B) Submission.--Not later than 6 months after completing
a classified version of the review under subparagraph (A), the
Comptroller General shall submit an unclassified version of the
review to the congressional committees of jurisdiction.''.
(b) Additional Reporting.--In the first threat-based review
submitted after the date of enactment of this Act pursuant to paragraph
(2) of section 319F-2(a) of the Public Health Service Act (42 U.S.C.
247d-6b(a)), as amended by subsection (a), the Secretary shall include
a description of the processes and procedures through which the
Director of the Strategic National Stockpile and the Director of the
Biomedical Advanced Research and Development Authority coordinate with
respect to countermeasures and products procured under such section
319F-2(a), including such processes and procedures in place to ensure
countermeasures and products under consideration for procurement
pursuant to such section 319F-2(a) receive the same consideration
regardless of whether such countermeasures or products receive or had
received funding under section 319L of the Public Health Service Act
(42 U.S.C. 247d-7e), and whether such countermeasures and products are
the most appropriate to meet the emergency health security needs of the
United States.
(c) Authorization of Appropriations, Strategic National
Stockpile.--Section 319F-2(f)(1) (42 U.S.C. 247d-6b(f)(1)) is amended
by striking ``$533,800,000 for each of fiscal years 2014 through 2018''
and inserting ``$610,000,000 for each of fiscal years 2019 through
2023, to remain available until expended''.

5c4ad8266f2a6096f16b5cb0b699bf9edb50e9a4d898d71e591aac5a806ec359

RESISTANCE, AND OTHER SIGNIFICANT THREATS.
(a) Strategic Initiatives.--Section 319L(c)(4) (247d-7e(c)(4)) is
amended by adding at the end the following:
``(F) Strategic initiatives.--The Secretary, acting through
the Director of BARDA, may implement strategic initiatives,
including by building on existing programs and by awarding
contracts, grants, and cooperative agreements, or entering into
other transactions, to support innovative candidate products in
preclinical and clinical development that address priority,
naturally occurring and man-made threats that, as determined by
the Secretary, pose a significant level of risk to national
security based on the characteristics of a chemical,
biological, radiological or nuclear threat, or existing
capabilities to respond to such a threat (including medical
response and treatment capabilities and manufacturing
infrastructure). Such initiatives shall accelerate and support
the advanced research, development, and procurement of
countermeasures and products, as applicable, to address areas
including--
``(i) chemical, biological, radiological, or nuclear
threats, including emerging infectious diseases, for which
insufficient approved, licensed, or authorized
countermeasures exist, or for which such threat, or the
result of an exposure to such threat, may become resistant
to countermeasures or existing countermeasures may be
rendered ineffective;
``(ii) threats that consistently exist or continually
circulate and have a significant potential to become a
pandemic, such as pandemic influenza, which may include the
advanced research and development, manufacturing, and
appropriate stockpiling of qualified pandemic or epidemic
products, and products, technologies, or processes to
support the advanced research and development of such
countermeasures (including multiuse platform technologies
for diagnostics, vaccines, and therapeutics; virus seeds;
clinical trial lots; novel virus strains; and antigen and
adjuvant material); and
``(iii) threats that may result primarily or
secondarily from a chemical, biological, radiological, or
nuclear agent, or emerging infectious diseases, and which
may present increased treatment complications such as the
occurrence of resistance to available countermeasures or
potential countermeasures, including antimicrobial
resistant pathogens.''.
(b) Protection of National Security From Threats.--Section 2811 (42
U.S.C. 300hh-10) is amended by adding at the end the following:
``(f) Protection of National Security From Threats.--
``(1) In general.--In carrying out subsection (b)(3), the
Assistant Secretary for Preparedness and Response shall implement
strategic initiatives or activities to address threats, including
pandemic influenza and which may include a chemical, biological,
radiological, or nuclear agent (including any such agent with a
significant potential to become a pandemic), that pose a
significant level of risk to public health and national security
based on the characteristics of such threat. Such initiatives shall
include activities to--
``(A) accelerate and support the advanced research,
development, manufacturing capacity, procurement, and
stockpiling of countermeasures, including initiatives under
section 319L(c)(4)(F);
``(B) support the development and manufacturing of virus
seeds, clinical trial lots, and stockpiles of novel virus
strains; and
``(C) maintain or improve preparedness activities,
including for pandemic influenza.
``(2) Authorization of appropriations.--
``(A) In general.--To carry out this subsection, there is
authorized to be appropriated $250,000,000 for each of fiscal
years 2019 through 2023.
``(B) Supplement, not supplant.--Amounts appropriated under
this paragraph shall be used to supplement and not supplant
funds provided under sections 319L(d) and 319F-2(g).
``(C) Documentation required.--The Assistant Secretary for
Preparedness and Response, in accordance with subsection
(b)(7), shall document amounts expended for purposes of
carrying out this subsection, including amounts appropriated
under the heading `Public Health and Social Services Emergency
Fund' under the heading `Office of the Secretary' under title
II of division H of the Consolidated Appropriations Act, 2018
(Public Law 115-141) and allocated to carrying out section
319L(c)(4)(F).''.

2a14572c1b9d4fc2bfa7bdc2683795e8219e8487ca0cd826b511b0c982a281fd

Section 351A(k) (42 U.S.C. 262a(k)) is amended--
(1) by striking ``The Secretary'' and inserting the following:
``(1) In general.--The Secretary''; and
(2) by adding at the end the following:
``(2) Implementation of recommendations of the federal experts
security advisory panel and the fast track action committee on
select agent regulations.--
``(A) In general.--Not later than 1 year after the date of
the enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Secretary shall report to
the congressional committees of jurisdiction on the
implementation of recommendations of the Federal Experts
Security Advisory Panel concerning the select agent program.
``(B) Continued updates.--The Secretary shall report to the
congressional committees of jurisdiction annually following the
submission of the report under subparagraph (A) until the
recommendations described in such subparagraph are fully
implemented, or a justification is provided for the delay in,
or lack of, implementation.''.
RESEARCH AND DEVELOPMENT

e036a055c3cf4db3739b3066a2ccedbc17b0d053ff88b1aa53f1b7c9bf6330e6

Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
(1) in the matter preceding subparagraph (A), by striking
``March 1'' and inserting ``March 15'';
(2) in subparagraph (A)--
(A) in clause (ii), by striking ``; and'' and inserting
``;''; and
(B) by striking clause (iii) and inserting the following:
``(iii) procurement, stockpiling, maintenance, and
potential replenishment (including manufacturing
capabilities) of all products in the Strategic National
Stockpile;
``(iv) the availability of technologies that may assist
in the advanced research and development of countermeasures
and opportunities to use such technologies to accelerate
and navigate challenges unique to countermeasure research
and development; and
``(v) potential deployment, distribution, and
utilization of medical countermeasures; development of
clinical guidance and emergency use instructions for the
use of medical countermeasures; and, as applicable,
potential postdeployment activities related to medical
countermeasures;'';
(3) by redesignating subparagraphs (D) and (E) as subparagraphs
(E) and (F), respectively; and
(4) by inserting after subparagraph (C), the following:
``(D) identify the full range of anticipated medical
countermeasure needs related to research and development,
procurement, and stockpiling, including the potential need for
indications, dosing, and administration technologies, and other
countermeasure needs as applicable and appropriate;''.

d40471f970007d3550e1c70c3d8f0341fcea8e8a6315dbebb5207e202be6c88f

(a) Congressional Notification of Material Threat Determination.--
Section 319F-2(c)(2)(C) (42 U.S.C. 247d-6b(c)(2)(C)) is amended by
striking ``The Secretary and the Homeland Security Secretary shall
promptly notify the appropriate committees of Congress'' and inserting
``The Secretary and the Secretary of Homeland Security shall send to
Congress, on an annual basis, all current material threat
determinations and shall promptly notify the Committee on Health,
Education, Labor, and Pensions and the Committee on Homeland Security
and Governmental Affairs of the Senate and the Committee on Energy and
Commerce and the Committee on Homeland Security of the House of
Representatives''.
(b) Contracting Communication.--Section 319F-2(c)(7)(B)(ii)(III)
(42 U.S.C. 247d-6b(c)(7)(B)(ii)(III)) is amended by adding at the end
the following: ``The Secretary shall notify the vendor within 90 days
of a determination by the Secretary to renew, extend, or terminate such
contract.''.

a027f8f5667e30aca938a18f00fd7e98ea5599bad33f8696df707b4417360613

Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4(f)) is amended--
(1) by redesignating paragraphs (3) through (6) as paragraphs
(4) through (7), respectively;
(2) by inserting after paragraph (2) the following:
``(3) Publication.--The Secretary shall make available on the
internet website of the Food and Drug Administration information
regarding regulatory management plans, including--
``(A) the process by which an applicant may submit a
request for a regulatory management plan;
``(B) the timeframe by which the Secretary is required to
respond to such request;
``(C) the information required for the submission of such
request;
``(D) a description of the types of development milestones
and performance targets that could be discussed and included in
such plans; and
``(E) contact information for beginning the regulatory
management plan process.'';
(3) in paragraph (6), as so redesignated, in the matter
preceding subparagraph (A)--
(A) by striking ``paragraph (4)(A)'' and inserting
``paragraph (5)(A)''; and
(B) by striking ``paragraph (4)(B)'' and inserting
``paragraph (5)(B)''; and
(4) in paragraph (7)(A), as so redesignated, by striking
``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.

f0ed82850f400405503070c19b747f233597b0b6d9f0f6b1e622593df8615b92

AUTHORITY AND THE BIOSHIELD SPECIAL RESERVE FUND.
(a) BioShield Special Reserve Fund.--Section 319F-2(g)(1) (42
U.S.C. 247d-6b(g)(1)) is amended--
(1) by striking ``$2,800,000,000 for the period of fiscal years
2014 through 2018'' and inserting ``$7,100,000,000 for the period
of fiscal years 2019 through 2028, to remain available until
expended''; and
(2) by striking the second sentence.
(b) The Biomedical Advanced Research and Development Authority.--
Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) is amended by striking
``$415,000,000 for each of fiscal years 2014 through 2018'' and
inserting ``$611,700,000 for each of fiscal years 2019 through 2023''.

76609b5bdccf10bec09116f09675c1e818426a06b9e970edfbd6e0795da5f8cd

RESISTANCE.
(a) Advisory Council.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') may continue the
Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria, referred to in this section as the ``Advisory Council''.
(b) Duties.--The Advisory Council shall advise and provide
information and recommendations to the Secretary regarding programs and
policies intended to reduce or combat antibiotic-resistant bacteria
that may present a public health threat and improve capabilities to
prevent, diagnose, mitigate, or treat such resistance. Such advice,
information, and recommendations may be related to improving--
(1) the effectiveness of antibiotics;
(2) research and advanced research on, and the development of,
improved and innovative methods for combating or reducing
antibiotic resistance, including new treatments, rapid point-of-
care diagnostics, alternatives to antibiotics, including
alternatives to animal antibiotics, and antimicrobial stewardship
activities;
(3) surveillance of antibiotic-resistant bacterial infections,
including publicly available and up-to-date information on
resistance to antibiotics;
(4) education for health care providers and the public with
respect to up-to-date information on antibiotic resistance and ways
to reduce or combat such resistance to antibiotics related to
humans and animals;
(5) methods to prevent or reduce the transmission of
antibiotic-resistant bacterial infections, including stewardship
programs; and
(6) coordination with respect to international efforts in order
to inform and advance United States capabilities to combat
antibiotic resistance.
(c) Meetings and Coordination.--
(1) Meetings.--The Advisory Council shall meet not less than
biannually and, to the extent practicable, in coordination with
meetings of the Antimicrobial Resistance Task Force established in
section 319E(a) of the Public Health Service Act.
(2) Coordination.--The Advisory Council shall, to the greatest
extent practicable, coordinate activities carried out by the
Council with the Antimicrobial Resistance Task Force established
under section 319E(a) of the Public Health Service Act (42 U.S.C.
247d-5(a)).
(d) FACA.--The Federal Advisory Committee Act (5 U.S.C. App.) shall
apply to the activities and duties of the Advisory Council.
(e) Extension of Advisory Council.--Not later than October 1, 2022,
the Secretary shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a recommendation on whether
the Advisory Council should be extended, and in addition, identify
whether there are other committees, councils, or task forces that have
overlapping or similar duties to that of the Advisory Council, and
whether such committees, councils, or task forces should be combined,
including with respect to section 319E(a) of the Public Health Service
Act (42 U.S.C. 247d-5(a)).

085f58ca74bcd89fcb495360d015ab5a1eb65867b443714980e41b94eaa66a9c

Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d-7e(c)(4)(D)(iii)) is
amended by striking ``and platform technologies'' and inserting
``platform technologies, technologies to administer countermeasures,
and technologies to improve storage and transportation of
countermeasures''.

d433d04ab79c3c4846532cac5be8f65a5a2925bd612b2bd4e35f9c56d69e2f87

Section 319L (42 U.S.C. 247d-7e) is amended--
(1) in subsection (a)(3), by striking ``, such as'' and all
that follows through ``Code''; and
(2) in subsection (c)(5)(A)--
(A) in clause (i), by striking ``under this subsection''
and all that follows through ``Code'' and inserting ``(as
defined in subsection (a)(3)) under this subsection''; and
(B) in clause (ii)--
(i) by amending subclause (I) to read as follows:
``(I) In general.--To the maximum extent
practicable, competitive procedures shall be used when
entering into transactions to carry out projects under
this subsection.''; and
(ii) in subclause (II)--
(I) by striking ``$20,000,000'' and inserting
``$100,000,000'';
(II) by striking ``senior procurement executive for
the Department (as designated for purpose of section
16(c) of the Office of Federal Procurement Policy Act
(41 U.S.C. 414(c)))'' and inserting ``Assistant
Secretary for Financial Resources''; and
(III) by striking ``senior procurement executive
under'' and inserting ``Assistant Secretary for
Financial Resources under''.

533575b0a84f27488cecd07d90823b3f2acac3f7b05af88128b5f2165da3d033

(a) In General.--The purpose of this section (including section
565B of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b)) is to support and advance the development or
manufacture of security countermeasures, qualified countermeasures, and
qualified pandemic or epidemic products by facilitating and encouraging
submission of data and information to support the development of such
products, and through clarifying the authority to cross-reference to
data and information previously submitted to the Secretary of Health
and Human Services (referred to in this section as the ``Secretary''),
including data and information submitted to medical countermeasure
master files or other master files.
(b) Medical Countermeasure Master Files.--Chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 565A the following:
``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.
``(a) Applicability of Reference.--
``(1) In general.--A person may submit data and information in
a master file to the Secretary with the intent to reference, or to
authorize, in writing, another person to reference, such data or
information to support a medical countermeasure submission
(including a supplement or amendment to any such submission),
without requiring the master file holder to disclose the data and
information to any such persons authorized to reference the master
file. Such data and information shall be available for reference by
the master file holder or by a person authorized by the master file
holder, in accordance with applicable privacy and confidentiality
protocols and regulations.
``(2) Reference of certain master files.--In the case that data
or information within a medical countermeasure master file is used
only to support the conditional approval of an application filed
under section 571, such master file may be relied upon to support
the effectiveness of a product that is the subject of a subsequent
medical countermeasure submission only if such application is
supplemented by additional data or information to support review
and approval in a manner consistent with the standards applicable
to such review and approval for such countermeasure, qualified
countermeasure, or qualified pandemic or epidemic product.
``(b) Medical Countermeasure Master File Content.--
``(1) In general.--A master file under this section may include
data or information to support--
``(A) the development of medical countermeasure submissions
to support the approval, licensure, classification, clearance,
conditional approval, or authorization of one or more security
countermeasures, qualified countermeasures, or qualified
pandemic or epidemic products; and
``(B) the manufacture of security countermeasures,
qualified countermeasures, or qualified pandemic or epidemic
products.
``(2) Required updates.--The Secretary may require, as
appropriate, that the master file holder ensure that the contents
of such master file are updated during the time such master file is
referenced for a medical countermeasure submission.
``(c) Sponsor Reference.--
``(1) In general.--Each incorporation of data or information
within a medical countermeasure master file shall describe the
incorporated material in a manner in which the Secretary determines
appropriate and that permits the review of such information within
such master file without necessitating resubmission of such data or
information. Master files shall be submitted in an electronic
format in accordance with sections 512(b)(4), 571(a)(4), and 745A,
as applicable, and as specified in applicable guidance.
``(2) Reference by a master file holder.--A master file holder
that is the sponsor of a medical countermeasure submission shall
notify the Secretary in writing of the intent to reference the
medical countermeasure master file as a part of the submission.
``(3) Reference by an authorized person.--A person submitting
an application for review may, where the Secretary determines
appropriate, incorporate by reference all or part of the contents
of a medical countermeasure master file, if the master file holder
authorizes the incorporation in writing.
``(d) Acknowledgment of and Reliance Upon a Master File by the
Secretary.--
``(1) In general.--The Secretary shall provide the master file
holder with a written notification indicating that the Secretary
has reviewed and relied upon specified data or information within a
master file and the purposes for which such data or information was
incorporated by reference if the Secretary has reviewed and relied
upon such specified data or information to support the approval,
classification, conditional approval, clearance, licensure, or
authorization of a security countermeasure, qualified
countermeasure, or qualified pandemic or epidemic product. The
Secretary may rely upon the data and information within the medical
countermeasure master file for which such written notification was
provided in additional applications, as applicable and appropriate
and upon the request of the master file holder so notified in
writing or by an authorized person of such holder.
``(2) Certain applications.--If the Secretary has reviewed and
relied upon specified data or information within a medical
countermeasure master file to support the conditional approval of
an application under section 571 to subsequently support the
approval, clearance, licensure, or authorization of a security
countermeasure, qualified countermeasure, or qualified pandemic or
epidemic product, the Secretary shall provide a brief written
description to the master file holder regarding the elements of the
application fulfilled by the data or information within the master
file and how such data or information contained in such application
meets the standards of evidence under subsection (c) or (d) of
section 505, subsection (d) of section 512, or section 351 of the
Public Health Service Act (as applicable), which shall not include
any trade secret or confidential commercial information.
``(e) Rules of Construction.--Nothing in this section shall be
construed to--
``(1) limit the authority of the Secretary to approve, license,
clear, conditionally approve, or authorize drugs, biological
products, or devices pursuant to, as applicable, this Act or
section 351 of the Public Health Service Act (as such applicable
Act is in effect on the day before the date of enactment of the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act
of 2019), including the standards of evidence, and applicable
conditions, for approval under the applicable Act;
``(2) alter the standards of evidence with respect to approval,
licensure, or clearance, as applicable, of drugs, biological
products, or devices under this Act or section 351 of the Public
Health Service Act, including, as applicable, the substantial
evidence standards under sections 505(d) and 512(d) or this Act and
section 351(a) of the Public Health Service Act; or
``(3) alter the authority of the Secretary under this Act or
the Public Health Service Act to determine the types of data or
information previously submitted by a sponsor or any other person
that may be incorporated by reference in an application, request,
or notification for a drug, biological product, or device submitted
under sections 505(i), 505(b), 505(j), 512(b)(1), 512(b)(2),
512(j), 564, 571, 520(g), 515(c), 513(f)(2), or 510(k) of this Act,
or subsection (a) or (k) of section 351 of the Public Health
Service Act, including a supplement or amendment to any such
submission, and the requirements associated with such reference.
``(f) Definitions.--In this section:
``(1) The term `master file holder' means a person who submits
data and information to the Secretary with the intent to reference
or authorize another person to reference such data or information
to support a medical countermeasure submission, as described in
subsection (a).
``(2) The term `medical countermeasure submission' means an
investigational new drug application under section 505(i), a new
drug application under section 505(b), or an abbreviated new drug
application under section 505(j) of this Act, a biological product
license application under section 351(a) of the Public Health
Service Act or a biosimilar biological product license application
under section 351(k) of the Public Health Service Act, a new animal
drug application under section 512(b)(1) or abbreviated new animal
drug application under section 512(b)(2), an application for
conditional approval of a new animal drug under section 571, an
investigational device application under section 520(g), an
application with respect to a device under section 515(c), a
request for classification of a device under section 513(f)(2), a
notification with respect to a device under section 510(k), or a
request for an emergency use authorization under section 564 to
support--
``(A) the approval, licensure, classification, clearance,
conditional approval, or authorization of a security
countermeasure, qualified countermeasure, or qualified pandemic
or epidemic product; or
``(B) a new indication to an approved security
countermeasure, qualified countermeasure, or qualified pandemic
or epidemic product.
``(3) The terms `qualified countermeasure', `security
countermeasure', and `qualified pandemic or epidemic product' have
the meanings given such terms in sections 319F-1, 319F-2, and 319F-
3, respectively, of the Public Health Service Act.''.
(c) Stakeholder Input.--Not later than 18 months after the date of
enactment of this Act, the Secretary, acting through the Commissioner
of Food and Drugs and in consultation with the Assistant Secretary for
Preparedness and Response, shall solicit input from stakeholders,
including stakeholders developing security countermeasures, qualified
countermeasures, or qualified pandemic or epidemic products, and
stakeholders developing technologies to assist in the development of
such countermeasures with respect to how the Food and Drug
Administration can advance the use of tools and technologies to support
and advance the development or manufacture of security countermeasures,
qualified countermeasures, and qualified pandemic or epidemic products,
including through reliance on cross-referenced data and information
contained within master files and submissions previously submitted to
the Secretary as set forth in section 565B of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (b).
(d) Guidance.--Not later than 2 years after the date of enactment
of this Act, the Secretary, acting through the Commissioner of Food and
Drugs, shall publish draft guidance about how reliance on cross-
referenced data and information contained within master files under
section 565B of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b) or submissions otherwise submitted to the Secretary may
be used for specific tools or technologies (including platform
technologies) that have the potential to support and advance the
development or manufacture of security countermeasures, qualified
countermeasures, and qualified pandemic or epidemic products. The
Secretary, acting through the Commissioner of Food and Drugs, shall
publish the final guidance not later than 3 years after the enactment
of this Act.

df3d978d9d588dafc6fc7554bb780c812d90ae913af198ccbf31cd71ece4eb5e

(a) Study.--The Comptroller General of the United States shall
conduct a study on the application of the requirements under
subsections (c) and (d) of section 565 of the of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb-4) (referred to in this
section as the ``animal rule'') as a component of medical
countermeasure advanced development under the Biomedical Advanced
Research and Development Authority and regulatory review by the Food
and Drug Administration. In conducting such study, the Comptroller
General shall examine the following:
(1) The extent to which advanced development and review of a
medical countermeasure are coordinated between the Biomedical
Advanced Research and Development Authority and the Food and Drug
Administration, including activities that facilitate appropriate
and efficient design of studies to support approval, licensure, and
authorization under the animal rule, consistent with the
recommendations in the animal rule guidance, issued pursuant to
section 565(c) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4(c)) and entitled ``Product Development Under the
Animal Rule: Guidance for Industry'' (issued in October 2015), to
resolve discrepancies in the design of adequate and well-controlled
efficacy studies conducted in animal models related to the
provision of substantial evidence of effectiveness for the product
approved, licensed, or authorized under the animal rule.
(2) The consistency of the application of the animal rule among
and between review divisions within the Food and Drug
Administration.
(3) The flexibility pursuant to the animal rule to address
variations in countermeasure development and review processes,
including the extent to which qualified animal models are adopted
and used within the Food and Drug Administration in regulatory
decisionmaking with respect to medical countermeasures.
(4) The extent to which the guidance issued under section
565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4(c)), entitled, ``Product Development Under the Animal
Rule: Guidance for Industry'' (issued in October 2015), has
assisted in achieving the purposes described in paragraphs (1),
(2), and (3).
(b) Consultations.--In conducting the study under subsection (a),
the Comptroller General of the United States shall consult with--
(1) the Federal agencies responsible for advancing, reviewing,
and procuring medical countermeasures, including the Office of the
Assistant Secretary for Preparedness and Response, the Biomedical
Advanced Research and Development Authority, the Food and Drug
Administration, and the Department of Defense;
(2) manufacturers involved in the research and development of
medical countermeasures to address biological, chemical,
radiological, or nuclear threats; and
(3) other biodefense stakeholders, as applicable.
(c) Report.--Not later than 3 years after the date of enactment of
this Act, the Comptroller General of the United States shall submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives a report containing the results of the study conducted
under subsection (a) and recommendations to improve the application and
consistency of the requirements under subsections (c) and (d) of
section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4) to support and expedite the research and development of
medical countermeasures, as applicable.
(d) Protection of National Security.--The Comptroller General of
the United States shall conduct the study and issue the assessment and
report under this section in a manner that does not compromise national
security.

9318112cc8fe104702d18ed2afcf5f2441450a119c3f97be7aebefb461cfe1fa

TECHNOLOGIES AND THEIR POTENTIAL ROLE IN NATIONAL SECURITY.
(a) Meeting.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall convene a
meeting to discuss the potential role advancements in genomic
engineering technologies (including genome editing technologies)
may have in advancing national health security. Such meeting shall
be held in a manner that does not compromise national security.
(2) Attendees.--The attendees of the meeting under paragraph
(1)--
(A) shall include--
(i) representatives from the Office of the Assistant
Secretary for Preparedness and Response, the National
Institutes of Health, the Centers for Disease Control and
Prevention, and the Food and Drug Administration; and
(ii) representatives from academic, private, and
nonprofit entities with expertise in genome engineering
technologies, biopharmaceuticals, medicine, or biodefense,
and other relevant stakeholders; and
(B) may include--
(i) other representatives from the Department of Health
and Human Services, as the Secretary determines
appropriate; and
(ii) representatives from the Department of Homeland
Security, the Department of Defense, the Department of
Agriculture, and other departments, as the Secretary may
request for the meeting.
(3) Topics.--The meeting under paragraph (1) shall include a
discussion of--
(A) the current state of the science of genomic engineering
technologies related to national health security, including--
(i) medical countermeasure development, including
potential efficiencies in the development pathway and
detection technologies; and
(ii) the international and domestic regulation of
products utilizing genome editing technologies; and
(B) national security implications, including--
(i) capabilities of the United States to leverage
genomic engineering technologies as a part of the medical
countermeasure enterprise, including current applicable
research, development, and application efforts underway
within the Department of Defense;
(ii) the potential for state and non-state actors to
utilize genomic engineering technologies as a national
health security threat; and
(iii) security measures to monitor and assess the
potential threat that may result from utilization of
genomic engineering technologies and related technologies
for the purpose of compromising national health security.
(b) Report.--Not later than 270 days after the meeting described in
subsection (a) is held, the Assistant Secretary for Preparedness and
Response shall issue a report to the congressional committees of
jurisdiction on the topics discussed at such meeting, and provide
recommendations, as applicable, to utilize innovations in genomic
engineering (including genome editing) and related technologies as a
part of preparedness and response activities to advance national health
security. Such report shall be issued in a manner that does not
compromise national security.

f6a9173552cd23935d131b3df53ed3964fe998e4fbde3a9109789d0a3c68aa11

Not later than one year after the date of the enactment of this
Act, the Secretary of Health and Human Services shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a
report describing efforts and activities to coordinate with other
countries and international partners during recent public health
emergencies with respect to the research and advanced research on, and
development of, qualified pandemic or epidemic products (as defined in
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)).
Such report may include information regarding relevant work carried out
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C.
247d-7e(c)(5)(E)), through public-private partnerships, and through
collaborations with other countries to assist with or expedite the
research and development of qualified pandemic or epidemic products.
Such report shall not include information that may compromise national
security.

bb7d944d852c08aabe3f1fadd431e7256f00cfd4cb0fe8ce07d490a1da6ac62d

(a) Reauthorization of Mosquito Abatement for Safety and Health
Program.--Section 317S (42 U.S.C. 247b-21) is amended--
(1) in subsection (a)(1)(B)--
(A) by inserting ``including programs to address emerging
infectious mosquito-borne diseases,'' after ``subdivisions for
control programs,''; and
(B) by inserting ``or improving existing control programs''
before the period at the end;
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``, including
improvement,'' after ``operation'';
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) in clause (ii), by striking ``or'' at the end;
(II) in clause (iii), by striking the semicolon at
the end and inserting ``, including an emerging
infectious mosquito-borne disease that presents a
serious public health threat; or''; and
(III) by adding at the end the following:
``(iv) a public health emergency due to the incidence
or prevalence of a mosquito-borne disease that presents a
serious public health threat;''; and
(ii) by amending subparagraph (D) to read as follows:
``(D)(i) is located in a State that has received a grant
under subsection (a); or
``(ii) that demonstrates to the Secretary that the control
program is consistent with existing State mosquito control
plans or policies, or other applicable State preparedness
plans.'';
(C) in paragraph (4)(C), by striking ``that extraordinary''
and all that follows through the period at the end and
inserting the following: ``that--
``(i) extraordinary economic conditions in the
political subdivision or consortium of political
subdivisions involved justify the waiver; or
``(ii) the geographical area covered by a political
subdivision or consortium for a grant under paragraph (1)
has an extreme mosquito control need due to--
``(I) the size or density of the potentially
impacted human population;
``(II) the size or density of a mosquito population
that requires heightened control; or
``(III) the severity of the mosquito-borne disease,
such that expected serious adverse health outcomes for
the human population justify the waiver.''; and
(D) by amending paragraph (6) to read as follows:
``(6) Number of grants.--A political subdivision or a
consortium of political subdivisions may not receive more than one
grant under paragraph (1).''; and
(3) in subsection (f)--
(A) in paragraph (1) by striking ``for fiscal year 2003,
and such sums as may be necessary for each of fiscal years 2004
through 2007'' and inserting ``for each of fiscal years 2019
through 2023'';
(B) in paragraph (2), by striking ``the Public Health
Security and Bioterrorism Preparedness and Response Act of
2002'' and inserting ``this Act and other medical and public
health preparedness and response laws''; and
(C) in paragraph (3)--
(i) in the paragraph heading, by striking ``2004'' and
inserting ``2019''; and
(ii) by striking ``2004,'' and inserting ``2019,''.
(b) Epidemiology-Laboratory Capacity Grants.--Section 2821 (42
U.S.C. 300hh-31) is amended--
(1) in subsection (a)(1), by inserting ``, including mosquito
and other vector-borne diseases,'' after ``infectious diseases'';
and
(2) in subsection (b), by striking ``2010 through 2013'' and
inserting ``2019 through 2023''.

8cbed1990d729f12cb81dd1daf56de1244c350b051e73c18d4e03970ec13b2c7

(a) Veterans Affairs.--Section 8117(g) of title 38, United States
Code, is amended by striking ``2014 through 2018'' and inserting ``2019
through 2023''.
(b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C.
247d-1(e)) is amended by striking ``2014 through 2018'' and inserting
``2019 through 2023''.
(c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
(d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42
U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and
inserting ``2023''.
(e) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-Hazards
Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a note) is
amended--
(A) in subsection (a)(1)(A)--
(i) by striking ``Secretary of Health and Human
Services (referred to in this subsection as the
`Secretary')'' and inserting ``Secretary'';
(ii) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6b)) (as amended by this Act'';
(iii) by striking ``of the Public Health Service Act
(42 U.S.C. 247d-6a)) (as amended by this Act''; and
(iv) by striking ``of the Public Health Service Act (42
U.S.C. 247d-6d)'';
(B) in subsection (b), by striking ``12-year'' and
inserting ``17-year'';
(C) by redesignating such section 405 as section 319L-1;
and
(D) by transferring such section 319L-1, as redesignated,
to the Public Health Service Act (42 U.S.C. 201 et seq.), to
appear after section 319L of such Act (42 U.S.C. 247d-7e).
(2) Conforming amendments.--
(A) Table of contents.--The table of contents in section
1(b) of the Pandemic and All-Hazards Preparedness Act (Public
Law 109-417) is amended by striking the item related to section
405.
(B) Reference.--Section 319L(c)(4)(A)(iii) (42 U.S.C. 247d-
7e) is amended by striking ``section 405 of the Pandemic and
All-Hazards Preparedness Act'' and inserting ``section 319L-
1''.
(f) Inapplicability of Certain Provisions.--Subsection (e)(1) of
section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) Nondisclosure of information.--
``(i) In general.--Information described in clause (ii)
shall be deemed to be information described in section
552(b)(3) of title 5, United States Code.
``(ii) Information described.--The information
described in this clause is information relevant to
programs of the Department of Health and Human Services
that could compromise national security and reveal
significant and not otherwise publicly known
vulnerabilities of existing medical or public health
defenses against chemical, biological, radiological, or
nuclear threats, and is comprised of--
``(I) specific technical data or scientific
information that is created or obtained during the
countermeasure and product advanced research and
development carried out under subsection (c);
``(II) information pertaining to the location
security, personnel, and research materials and methods
of high-containment laboratories conducting research
with select agents, toxins, or other agents with a
material threat determination under section 319F-
2(c)(2); or
``(III) security and vulnerability assessments.'';
(2) by redesignating subparagraph (C) as subparagraph (D);
(3) by inserting after subparagraph (B) the following:
``(C) Reporting.--One year after the date of enactment of
the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, and annually thereafter, the Secretary
shall report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives on the number of instances in
which the Secretary has used the authority under this
subsection to withhold information from disclosure, as well as
the nature of any request under section 552 of title 5, United
States Code that was denied using such authority.''; and
(4) in subparagraph (D), as so redesignated, by striking ``12''
and inserting ``17''.

270b4fc08c9c35e8f0b56a1b01401bae75e26345fa42704768272de2114200a5

Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is amended to
read as follows:
``(d) Disclosures.--No Federal agency may disclose under section
552 of title 5, United States Code any information identifying the
location at which materials in the stockpile described in subsection
(a) are stored, or other information regarding the contents or
deployment capability of the stockpile that could compromise national
security.''.

aa2a242840372ee68171d7369cf0ee3ff641f372e98363d9e67e1d031cd621a6

(a) Strategy for Public Health Preparedness and Response to
Cybersecurity Threats.--
(1) Strategy.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall prepare
and submit to the relevant committees of Congress a strategy for
public health preparedness and response to address cybersecurity
threats (as defined in section 102 of Cybersecurity Information
Sharing Act of 2015 (6 U.S.C. 1501)) that present a threat to
national health security. Such strategy shall include--
(A) identifying the duties, functions, and preparedness
goals for which the Secretary is responsible in order to
prepare for and respond to such cybersecurity threats,
including metrics by which to measure success in meeting
preparedness goals;
(B) identifying gaps in public health capabilities to
achieve such preparedness goals; and
(C) strategies to address identified gaps and strengthen
public health emergency preparedness and response capabilities
to address such cybersecurity threats.
(2) Protection of national security.--The Secretary shall make
such strategy available to the Committee on Health, Education,
Labor, and Pensions of the Senate, the Committee on Energy and
Commerce of the House of Representatives, and other congressional
committees of jurisdiction, in a manner that does not compromise
national security.
(b) Coordination of Preparedness for and Response to All-Hazards
Public Health Emergencies.--Subparagraph (D) of section 2811(b)(4) (42
U.S.C. 300hh-10(b)(4)) is amended to read as follows:
``(D) Policy coordination and strategic direction.--Provide
integrated policy coordination and strategic direction, before,
during, and following public health emergencies, with respect
to all matters related to Federal public health and medical
preparedness and execution and deployment of the Federal
response for public health emergencies and incidents covered by
the National Response Plan described in section 504(a)(6) of
the Homeland Security Act of 2002 (6 U.S.C. 314(a)(6)), or any
successor plan; and such Federal responses covered by the
National Cybersecurity Incident Response Plan developed under
section 228(c) of the Homeland Security Act of 2002 (6 U.S.C.
149(c)), including public health emergencies or incidents
related to cybersecurity threats that present a threat to
national health security.''.

9d16af959f7dad028038d80d83c99d72e0895d4c463039253f7386b834025327

Not later than 14 days after the date of the enactment of this Act,
the Secretary of Health and Human Services, in coordination with the
Assistant Secretary for Preparedness and Response and the Assistant
Secretary for the Administration on Children and Families or other
appropriate office, and in collaboration with other departments, as
appropriate, shall submit to the Committee on Energy and Commerce of
the House of Representatives, the Committee on Health, Education,
Labor, and Pensions of the Senate, and other relevant congressional
committees--
(1) a formal strategy, including interdepartmental actions and
efforts to reunify children with their parents or guardians, in all
cases in which such children have been separated from their parents
or guardians as a result of the initiative announced on April 6,
2018, and due to prosecution under section 275(a) of the
Immigration and Nationality Act (8 U.S.C. 1325(a)), if the parent
or guardian chooses such reunification and the child--
(A) was separated from a parent or guardian and placed into
a facility funded by the Department of Health and Human
Services;
(B) as of the date of the enactment of this Act, remains in
the care of the Department of Health and Human Services; and
(C) can be safely reunited with such parent or guardian;
and
(2) a report on challenges and deficiencies related to the
oversight of, and care for, unaccompanied alien children and
appropriately reuniting such children with their parents or
guardians, and the actions taken to address any challenges and
deficiencies related to unaccompanied alien children in the custody
of the Department of Health and Human Services, including
deficiencies identified and publicly reported by Congress, the
Government Accountability Office, or the inspectors general of the
Department of Health and Human Services or other Federal
departments.

a4b89a4b840ccdd2798fb3d5f22dd997277c3ba32b2502ffb1cbd917538e2cd8

(a) Public Health Service Act.--Title III (42 U.S.C. 241 et seq.)
is amended--
(1) in paragraphs (1) and (5) of section 319F-1(a) (42 U.S.C.
247d-6a(a)), by striking ``section 319F(h)'' each place such term
appears and inserting ``section 319F(e)''; and
(2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking
``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.
(b) Public Health Security Grants.--Section 319C-1(b)(2) (42 U.S.C.
247d-3a(b)(2)) is amended--
(1) in subparagraph (C), by striking ``individuals,,'' and
inserting ``individuals,''; and
(2) in subparagraph (F), by striking ``make satisfactory annual
improvement and describe'' and inserting ``makes satisfactory
annual improvement and describes''.
(c) Emergency Use Instructions.--Subparagraph (A) of section
564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3a(e)(2)) is amended by striking ``subsection (a)(1)(C)(i)'' and
inserting ``subsection (a)(1)(C)''.
(d) Products Held for Emergency Use.--Section 564B(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b) is amended--
(1) in subparagraph (B), by inserting a comma after ``505'';
and
(2) in subparagraph (C), by inserting ``or section 564A''
before the period at the end.
(e) Transparency.--Section 507(c)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(A) In general.--Nothing in'';
(2) by inserting ``or directing'' after ``authorizing'';
(3) by striking ``disclose any'' and inserting ``disclose--
``(i) any'';
(4) by striking the period and inserting ``; or''; and
(5) by adding at the end the following:
``(ii) in the case of a drug development tool that may
be used to support the development of a qualified
countermeasure, security countermeasure, or qualified
pandemic or epidemic product, as defined in sections 319F-
1, 319F-2, and 319F-3, respectively, of the Public Health
Service Act, any information that the Secretary determines
has a significant potential to affect national security.
``(B) Public acknowledgment.--In the case that the
Secretary, pursuant to subparagraph (A)(ii), does not make
information publicly available, the Secretary shall provide on
the internet website of the Food and Drug Administration an
acknowledgment of the information that has not been disclosed,
pursuant to subparagraph (A)(ii).''.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

ae216ec430a88ec17ccf1b51cb375dc05c514aa16a109a3ea87463c58d8c5ab5

Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

Other Sections