[United States Statutes at Large, Volume 133, 116th Congress, 1st Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


Public Law 116-22
116th Congress

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, <>
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.
Sec. 2. References in Act.

TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

Sec. 101. National Health Security Strategy.

TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

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

TITLE III--REACHING ALL COMMUNITIES

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

TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance,
and other significant threats.

[[Page 906]]

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

TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT

Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority and
the BioShield Special Reserve Fund.
Sec. 505. Additional strategies for combating antibiotic resistance.

TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

Sec. 601. Administration of countermeasures.
Sec. 602. Updating definitions of other transactions.
Sec. 603. Medical countermeasure master files.
Sec. 604. Animal rule report.
Sec. 605. Review of the benefits of genomic engineering technologies and
their potential role in national security.
Sec. 606. Report on vaccines development.
Sec. 607. Strengthening mosquito abatement for safety and health.

TITLE VII--MISCELLANEOUS PROVISIONS

Sec. 701. Reauthorizations and extensions.
Sec. 702. Location of materials in the stockpile.
Sec. 703. Cybersecurity.
Sec. 704. Strategy and report.
Sec. 705. Technical amendments.

SEC. 2. REFERENCES IN ACT.

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

TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

Section 2802 (42 U.S.C. 300hh-1) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``2014'' and inserting
``2018''; and
(ii) by striking the second sentence and
inserting the following: ``Such National Health
Security Strategy shall describe potential
emergency health security threats and identify the
process for achieving the preparedness goals
described in subsection (b) to be prepared to
identify and respond to such threats and shall be
consistent with the national preparedness goal (as
described in section 504(a)(19) of the Homeland
Security Act of 2002), the National Incident
Management System (as defined in section 501(7) of
such Act), and the National Response Plan
developed pursuant to section 504 of such Act, or
any successor plan.'';
(B) in paragraph (2), by inserting before the period
at the end of the second sentence the following: ``, and
an analysis of any changes to the evidence-based
benchmarks and objective standards under sections 319C-1
and 319C-2''; and

[[Page 907]]

(C) in paragraph (3)--
(i) by striking ``2009'' and inserting
``2022'';
(ii) by inserting ``(including gaps in the
environmental health and animal health workforces,
as applicable), describing the status of such
workforce'' after ``gaps in such workforce'';
(iii) by striking ``and identifying
strategies'' and inserting ``identifying
strategies''; and
(iv) by inserting before the period at the end
``, and identifying current capabilities to meet
the requirements of section 2803''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``and
investigation'' and inserting ``investigation, and
related information technology activities'';
(ii) in subparagraph (B), by striking ``and
decontamination'' and inserting ``decontamination,
relevant health care services and supplies, and
transportation and disposal of medical waste'';
and
(iii) by adding at the end the following:
``(E) Response to environmental hazards.'';
(B) in paragraph (3)--
(i) in the matter preceding subparagraph (A),
by striking ``including mental health'' and
inserting ``including pharmacies, mental health
facilities,''; and
(ii) in subparagraph (F), by inserting ``or
exposures to agents that could cause a public
health emergency'' before the period;
(C) in paragraph (5), by inserting ``and other
applicable compacts'' after ``Compact''; and
(D) by adding at the end the following:
``(9) Zoonotic disease, food, and agriculture.--Improving
coordination <>  among
Federal, State, local, Tribal, and territorial entities
(including through consultation with the Secretary of
Agriculture) to prevent, detect, and respond to outbreaks of
plant or animal disease (including zoonotic disease) that could
compromise national security resulting from a deliberate attack,
a naturally occurring threat, the intentional adulteration of
food, or other public health threats, taking into account
interactions between animal health, human health, and animals'
and humans' shared environment as directly related to public
health emergency preparedness and response capabilities, as
applicable.
``(10) <>  Global health security.--
Assessing current or potential health security threats from
abroad to inform domestic public health preparedness and
response capabilities.''.

TITLE II--IMPROVING PREPAREDNESS AND RESPONSE

SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS AND
RESPONSE.

(a) Evaluating Measurable Evidence-Based Benchmarks and Objective
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting
after subsection (j) the following:

[[Page 908]]

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

(b) Evaluating the Partnership for State and Regional Hospital
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section
319C-1(g), (i), (j), and (k)''.
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.

(a) Cooperative Agreement Applications for Improving State and Local
Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is amended--
(1) in subsection (a), by inserting ``, acting through the
Director of the Centers for Disease Control and Prevention,''
after ``the Secretary''; and
(2) in subsection (b)(2)(A)--
(A) in clause (vi), by inserting ``, including
public health agencies with specific expertise that may
be relevant to public health security, such as
environmental health agencies,'' after ``stakeholders'';
(B) by redesignating clauses (vii) through (ix) as
clauses (viii) through (x);
(C) by inserting after clause (vi) the following:
``(vii) a description of how, as applicable,
such entity may integrate information to account
for individuals with behavioral health needs
following a public health emergency;'';
(D) in clause (ix), as so redesignated, by striking
``; and'' and inserting a semicolon; and

[[Page 909]]

(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,

[[Page 910]]

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

[[Page 911]]

application of clause (i), the amount remaining
for the purpose of carrying out this section would
be less than the amount available for such purpose
for the previous fiscal year, the amount that may
be reserved under clause (i) shall be reduced such
that the amount remaining for the purpose of
carrying out this section is not less than the
amount available for such purpose for the previous
fiscal year.
``(iii) Sunset.--The authority to reserve
amounts under clause (i) shall expire on September
30, 2023.'';
(2) in paragraph (2), by striking ``paragraph (1) for a
fiscal year'' and inserting ``paragraph (1)(A) for a fiscal year
and not reserved for the purpose described in paragraph
(1)(B)(i)''; and
(3) in paragraph (3)(A), by striking ``paragraph (1) and not
reserved under paragraph (2)'' and inserting ``paragraph (1)(A)
and not reserved under paragraph (1)(B)(i) or (2)''.
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
SYSTEMS.

(a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is
amended by inserting after section 319C-2 the following:
``SEC. 319C-3. <>  GUIDELINES FOR REGIONAL
HEALTH CARE EMERGENCY PREPAREDNESS
AND RESPONSE SYSTEMS.

``(a) Purpose.--It is the purpose of this section to identify and
provide guidelines for regional systems of hospitals, health care
facilities, and other public and private sector entities, with varying
levels of capability to treat patients and increase medical surge
capacity during, in advance of, and immediately following a public
health emergency, including threats posed by one or more chemical,
biological, radiological, or nuclear agents, including emerging
infectious diseases.
``(b) <>  Guidelines.--The Assistant
Secretary for Preparedness and Response, in consultation with the
Director of the Centers for Disease Control and Prevention, the
Administrator of the Centers for Medicare & Medicaid Services, the
Administrator of the Health Resources and Services Administration, the
Commissioner of Food and Drugs, the Assistant Secretary for Mental
Health and Substance Use, the Assistant Secretary of Labor for
Occupational Safety and Health, the Secretary of Veterans Affairs, the
heads of such other Federal agencies as the Secretary determines to be
appropriate, and State, local, Tribal, and territorial public health
officials, shall, not later than 2 years after the date of enactment of
this section--
``(1) identify and develop a set of guidelines relating to
practices and protocols for all-hazards public health emergency
preparedness and response for hospitals and health care
facilities to provide appropriate patient care during, in
advance of, or immediately following, a public health emergency,
resulting from one or more chemical, biological, radiological,
or nuclear agents, including emerging infectious diseases (which
may include existing practices, such as trauma care and medical
surge capacity and capabilities), with respect to--
``(A) a regional approach to identifying hospitals
and health care facilities based on varying capabilities
and capacity to treat patients affected by such
emergency, including--

[[Page 912]]

``(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

[[Page 913]]

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

[[Page 914]]

emergencies, consistent with subsection (a), which may
include consideration of facilities participating in
programs under section 319C-2 of the Public Health
Service Act (42 U.S.C. 247d-3b) or in programs under the
Centers for Medicare & Medicaid Services (including
innovative health care delivery and payment models), and
input from private sector financial institutions.
(3) Consultation.--In carrying out paragraphs (1) and (2),
the Comptroller General shall consult with the heads of
appropriate Federal agencies, including--
(A) the Assistant Secretary for Preparedness and
Response;
(B) the Director of the Centers for Disease Control
and Prevention;
(C) the Administrator of the Centers for Medicare &
Medicaid Services;
(D) the Assistant Secretary for Mental Health and
Substance Use;
(E) the Assistant Secretary of Labor for
Occupational Safety and Health; and
(F) the Secretary of Veterans Affairs.

(c) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-3b(i)(1))
is amended by inserting after the first sentence the following: ``In
submitting reports under this paragraph, a coalition shall include
information on the progress that the coalition has made toward the
implementation of section 319C-3 (or barriers to progress, if any).''.
(d) National Health Security Strategy Incorporation of Regionalized
Emergency Preparedness and Response.--Subparagraph (G) of section
2802(b)(3) (42 U.S.C. 300hh-1(b)(3)) is amended to read as follows:
``(G) Optimizing a coordinated and flexible approach
to the emergency response and medical surge capacity of
hospitals, other health care facilities, critical care,
trauma care (which may include trauma centers), and
emergency medical systems.''.

(e) Improving State and Local Public Health Security.--
(1) State and local security.--Section 319C-1(e) (42 U.S.C.
247d-3a(e)) is amended by striking ``, and local emergency
plans.'' and inserting ``, local emergency plans, and any
regional health care emergency preparedness and response system
established pursuant to the applicable guidelines under section
319C-3.''.
(2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
3b(d)(1)(A)) is amended--
(A) in clause (i), by striking ``; and'' and
inserting ``;'';
(B) by redesignating clause (ii) as clause (iii);
and
(C) by inserting after clause (i) the following:
``(ii) among one or more facilities in a
regional health care emergency system under
section 319C-3; and''.
SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.

Title XII (42 U.S.C. 300d et seq.) is amended by adding at the end
the following new part:

[[Page 915]]

``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,

[[Page 916]]

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

[[Page 917]]

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

[[Page 918]]

care services (including a physician, surgeon, physician
assistant, nurse, nurse practitioner, respiratory therapist,
flight paramedic, combat medic, or enlisted medical technician)
or other military trauma care provider as the Secretary
determines appropriate.

``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $11,500,000 for each of fiscal
years 2019 through 2023.''.
SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL
AWARENESS AND BIOSURVEILLANCE
CAPABILITIES.

(a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
(1) in the section heading, by striking ``revitalizing'' and
inserting ``facilities and capacities of'';
(2) in subsection (a)--
(A) in the subsection heading, by striking
``Facilities; Capacities'' and inserting ``In General'';
(B) in paragraph (1), by striking ``and improved''
and inserting ``, improved, and appropriately
maintained'';
(C) in paragraph (3), in the matter preceding
subparagraph (A), by striking ``expand, enhance, and
improve'' and inserting ``expand, improve, enhance, and
appropriately maintain''; and
(D) by adding at the end the following:
``(4) <>  Study of resources
for facilities and capacities.--Not later than June 1, 2022, the
Comptroller General of the United States shall conduct a study
on Federal spending in fiscal years 2013 through 2018 for
activities authorized under this
subsection. <>  Such study shall
include a review and assessment of obligations and expenditures
directly related to each activity under paragraphs (2) and (3),
including a specific accounting of, and delineation between,
obligations and expenditures incurred for the construction,
renovation, equipping, and security upgrades of facilities and
associated contracts under this subsection, and the obligations
and expenditures incurred to establish and improve the
situational awareness and biosurveillance network under
subsection (b), and shall identify the agency or agencies
incurring such obligations and expenditures.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking
``National'' and inserting ``Establishment of Systems of
Public Health'';
(B) in paragraph (1)(B), by inserting ``immunization
information systems,'' after ``centers,'';
(C) in paragraph (2)--
(i) by inserting ``develop a plan to, and''
after ``The Secretary shall''; and
(ii) by inserting ``and in a form readily
usable for analytical approaches'' after ``in a
secure manner''; and
(D) by amending paragraph (3) to read as follows:
``(3) Standards.--
``(A) <>  In general.--Not later
than 1 year after the date of the enactment of the
Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, the

[[Page 919]]

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

[[Page 920]]

(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,

[[Page 921]]

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;

[[Page 922]]

``(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

[[Page 923]]

(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

[[Page 924]]

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

[[Page 925]]

(E) provide advanced molecular diagnostics to State,
local, Tribal, and territorial public health and other
laboratories that support biological threat detection
activities.
(4) A description of Federal interagency coordination
related to biological threat detection.
(5) A description of efforts by Federal departments and
agencies that utilize biological threat detection technology to
collaborate with State, local, Tribal, and territorial public
health laboratories and other users of biological threat
detection systems, including collaboration regarding the
development of--
(A) biological threat detection requirements or
standards;
(B) a standardized integration strategy;
(C) training requirements or guidelines;
(D) guidelines for a coordinated public health
response, including preparedness capabilities, and, as
applicable, for coordination with public health
surveillance systems; and
(E) a coordinated environmental remediation plan, as
applicable.
(6) <>  Recommendations related to
research, advanced research, development, and procurement for
Federal departments and agencies to improve and enhance
biological threat detection systems, including recommendations
on the transfer of biological threat detection technology among
Federal departments and agencies, as necessary and appropriate.
SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH EMERGENCY
RAPID RESPONSE FUND.

Section 319 (42 U.S.C. 247d) is amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the first sentence, by inserting ``or
if the Secretary determines there is the
significant potential for a public health
emergency, to allow the Secretary to rapidly
respond to the immediate needs resulting from such
public health emergency or potential public health
emergency'' before the period; and
(ii) by inserting ``The Secretary shall plan
for the expedited distribution of funds to
appropriate agencies and entities.'' after the
first sentence;
(B) by redesignating paragraph (2) as paragraph (3);
(C) by inserting after paragraph (1) the following:
``(2) Uses.--The Secretary may use amounts in the Fund
established under paragraph (1), to--
``(A) facilitate coordination between and among
Federal, State, local, Tribal, and territorial entities
and public and private health care entities that the
Secretary determines may be affected by a public health
emergency or potential public health emergency referred
to in paragraph (1) (including communication of such
entities with relevant international entities, as
applicable);
``(B) make grants, provide for awards, enter into
contracts, and conduct supportive investigations
pertaining to a public health emergency or potential
public health emergency, including further supporting
programs under section 319C-1, 319C-2, or 319C-3;

[[Page 926]]

``(C) facilitate and accelerate, as applicable,
advanced research and development of security
countermeasures (as defined in section 319F-2),
qualified countermeasures (as defined in section 319F-
1), or qualified pandemic or epidemic products (as
defined in section 319F-3), that are applicable to the
public health emergency or potential public health
emergency under paragraph (1);
``(D) strengthen biosurveillance capabilities and
laboratory capacity to identify, collect, and analyze
information regarding such public health emergency or
potential public health emergency, including the systems
under section 319D;
``(E) support initial emergency operations and
assets related to preparation and deployment of
intermittent disaster response personnel under section
2812 and the Medical Reserve Corps under section 2813;
and
``(F) carry out other activities, as the Secretary
determines applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so
redesignated, the following:
``(4) <>
Review.--Not later than 2 years after the date of enactment of
the Pandemic and All-Hazards Preparedness and Advancing
Innovation Act of 2019, the Secretary, in coordination with the
Assistant Secretary for Preparedness and Response, shall conduct
a review of the Fund under this section and provide
recommendations to the Committee on Health, Education, Labor,
and Pensions and the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and the Committee on
Appropriations of the House of Representatives on policies to
improve such Fund for the uses described in paragraph (2).
``(5) GAO report.--Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2019, the Comptroller General of the
United States shall--
``(A) <>  conduct a review of the
Fund under this section, including its uses and the
resources available in the Fund; and
``(B) <>  submit to the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives a report on such review,
including recommendations related to such review, as
applicable.''; and
(2) in subsection (c)--
(A) by inserting ``rapidly respond to public health
emergencies or potential public health emergencies and''
after ``used to''; and
(B) by striking ``section.'' and inserting ``Act or
funds otherwise provided for emergency response.''.
SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE BY
PUBLIC HEALTH EMERGENCY VOLUNTEERS.

(a) In General.--Section 319I (42 U.S.C. 247d-7b) is amended--
(1) in the section heading, by striking ``health professions
volunteers'' and inserting ``volunteer health professional'';

[[Page 927]]

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

(a) In General.--Title II (42 U.S.C. 202 et seq.) is amended by
inserting after section 224 the following:
``SEC. 225. <>  HEALTH CARE PROFESSIONALS
ASSISTING DURING A PUBLIC HEALTH
EMERGENCY.

``(a) Limitation on Liability.--Notwithstanding any other provision
of law, a health care professional who is a member of the Medical
Reserve Corps under section 2813 or who is included in the Emergency
System for Advance Registration of Volunteer Health Professionals under
section 319I and who--
``(1) is responding--
``(A) <>  to a
public health emergency determined under section 319(a),
during the initial period of not more than 90 days (as
determined by the Secretary) of the public health
emergency determination (excluding any period covered by
a renewal of such determination); or
``(B) to a major disaster or an emergency as
declared by the President under section 401 of the
Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C.

[[Page 928]]

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.

[[Page 929]]

``(2) Application.--This section shall apply to a claim for
harm only if the act or omission that caused such harm occurred
on or after the effective date described in paragraph (1).''.

(b) <>  GAO Study.--Not later than one year
after the date of enactment of this Act, the Comptroller General of the
United States shall conduct a review of--
(1) the number of health care providers who register under
the Emergency System for Advance Registration of Volunteer
Health Professionals under section 319I of the Public Health
Service Act (42 U.S.C. 247d-7b) in advance to provide services
during a public health emergency;
(2) the number of health care providers who are credentialed
to provide services during the period of a public health
emergency declaration, including those who are credentialed
though programs established in the Emergency System for Advance
Registration of Volunteer Health Professionals under such
section 319I and those credentialed by authorities within the
State in which the emergency occurred;
(3) the average time to verify the credentials of a health
care provider during the period of a public health emergency
declaration, including the average time pursuant to the
Emergency System for Advance Registration of Volunteer Health
Professionals under such section 319I and for an individual's
credentials to be verified by an authority within the State; and
(4) the Emergency System for Advance Registration of
Volunteer Health Professionals program in States, including
whether physician or medical groups, associations, or other
relevant provider organizations utilize such program for
purposes of volunteering during public health emergencies.
SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY.

Not <>  later than 1 year after the date
of the enactment of this Act, the Secretary of Health and Human Services
shall submit to Congress a report containing recommendations related to
maintaining an adequate national blood supply, including--
(1) challenges associated with the continuous recruitment of
blood donors (including those newly eligible to donate);
(2) ensuring the adequacy of the blood supply in the case of
public health emergencies;
(3) implementation of the transfusion transmission
monitoring system; and
(4) other measures to promote safety and innovation, such as
the development, use, or implementation of new technologies,
processes, and procedures to improve the safety and reliability
of the blood supply.
SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND RESPONSE
CAPABILITIES AND CAPACITIES OF HOSPITALS,
LONG-TERM CARE FACILITIES, AND OTHER
HEALTH CARE FACILITIES.

(a) Study.--
(1) <>  In general.--Not later than one
year after the date of enactment of this Act, the Secretary of
Health and Human Services shall enter into an agreement with an
appropriate entity to conduct a study regarding the public
health preparedness and response capabilities and medical surge
capacities of hospitals, long-term care facilities, and other
health care

[[Page 930]]

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

[[Page 931]]

surge capacity for hospitals, long-term care facilities,
and other health care facilities, including--
(i) improving the existing benchmarks and
objective standards for the Federal grant programs
described in subsection (a)(3)(A) or developing
new benchmarks and standards for such programs;
and
(ii) identifying best practices for improving
public health preparedness and response programs
and medical surge capacity at hospitals, long-term
care facilities, and other health care facilities,
including recommendations for the evaluation under
subparagraphs (C) and (D) of subsection (a)(3).

TITLE III--REACHING ALL COMMUNITIES

SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE
WORKFORCE.

(a) National Disaster Medical System.--
(1) Strengthening the national disaster medical system.--
Clause (ii) of section 2812(a)(3)(A) (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

[[Page 932]]

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)--

[[Page 933]]

(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

[[Page 934]]

or potential public health emergencies, and recommendations to
address any gaps identified in such workforce.
(2) Contents.--The Comptroller General shall include in the
report under paragraph (1)--
(A) the number of health care providers who have
volunteered to provide health care services during a
public health emergency, including members of the
National Disaster Medical System, the Disaster Medical
Assistant Teams, the Medical Reserve Corps, and other
volunteer health care professionals in the verification
network pursuant to section 319I of the Public Health
Service Act (42 U.S.C. 247d-7b);
(B) the capacity of the workforce described in
subparagraph (A) to respond to a public health emergency
or potential public health emergency, including the
capacity to respond to multiple concurrent public health
emergencies and the capacity to respond to a nationwide
public health emergency;
(C) the preparedness and response capabilities and
mission readiness of the workforce described in
subparagraph (A) taking into account areas of health
care expertise and considerations for at-risk
individuals (as defined in section 2802(b)(4)(B) of the
Public Health Service Act (42 U.S.C. 300hh-1(b)(4)(B)));
(D) an assessment of the effectiveness of efforts to
recruit, retain, and train such workforce; and
(E) <>  identification of
gaps that may exist in such workforce and
recommendations for addressing such gaps, the extent to
which the Assistant Secretary for Preparedness and
Response plans to address such gaps, and any
recommendations from the Comptroller General to address
such gaps.
SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE PREPAREDNESS AND
RESPONSE.

(a) Coordination of Preparedness.--Section 2811(b)(5) (42 U.S.C.
300hh-10(b)(5)) is amended by adding at the end the following:
``Such <>  logistical support shall include
working with other relevant Federal, State, local, Tribal, and
territorial public health officials and private sector entities to
identify the critical infrastructure assets, systems, and networks
needed for the proper functioning of the health care and public health
sectors that need to be maintained through any emergency or disaster,
including entities capable of assisting with, responding to, and
mitigating the effect of a public health emergency, including a public
health emergency determined by the Secretary pursuant to section 319(a)
or an emergency or major disaster declared by the President under the
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''.

[[Page 935]]

(c) Evaluation of Barriers to Rapid Delivery of Medical
Countermeasures.--
(1) Rapid delivery study.--The Assistant Secretary for
Preparedness and Response may conduct a study on issues that
have the potential to adversely affect the handling and rapid
delivery of medical countermeasures to individuals during public
health emergencies occurring in the United States.
(2) <>  Notice to congress.--Not
later than 9 months after the date of the enactment of this Act,
the Assistant Secretary for Preparedness and Response shall
notify the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate if the Assistant Secretary for
Preparedness and Response does not plan to conduct the study
under paragraph (1) and shall provide such committees a summary
explanation for such decision.
(3) Report to congress.--Not later than 1 year after the
Assistant Secretary for Preparedness and Response conducts the
study under paragraph (1), such Assistant Secretary shall submit
a report to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate containing the findings of such
study.
SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.

(a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
(1) by striking ``this section and sections 319C-1, 319F,
and 319L,'' and inserting ``this Act,''; and
(2) by striking ``special'' and inserting ``access or
functional''.

(b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C.
247d-7e(c)(6)) is amended--
(1) by striking ``elderly'' and inserting ``older adults'';
and
(2) by inserting ``with relevant characteristics that
warrant consideration during the process of researching and
developing such countermeasures and products'' before the
period.

(c) Biosurveillance of Emerging Public Health Threats.--Section 2814
is amended--
(1) in paragraph (7), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (8), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(9) facilitate coordination to ensure that, in
implementing the situational awareness and biosurveillance
network under section 319D, the Secretary considers
incorporating data and information from Federal, State, local,
Tribal, and territorial public health officials and entities
relevant to detecting emerging public health threats that may
affect at-risk individuals, such as pregnant and postpartum
women and infants, including adverse health outcomes of such
populations related to such emerging public health threats.''.
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE
CONSIDERATIONS FOR CHILDREN.

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

[[Page 936]]

``SEC. 319D-1. <>  CHILDREN'S PREPAREDNESS
UNIT.

``(a) Enhancing Emergency Preparedness for Children.--The Secretary,
acting through the Director of the Centers for Disease Control and
Prevention (referred to in this subsection as the `Director'), shall
maintain an internal team of experts, to be known as the Children's
Preparedness Unit (referred to in this subsection as the `Unit'), to
work collaboratively to provide guidance on the considerations for, and
the specific needs of, children before, during, and after public health
emergencies. The Unit shall inform the Director regarding emergency
preparedness and response efforts pertaining to children at the Centers
for Disease Control and Prevention.
``(b) Expertise.--The team described in subsection (a) shall include
one or more pediatricians, which may be a developmental-behavioral
pediatrician, and may also include behavioral scientists, child
psychologists, epidemiologists, biostatisticians, health communications
staff, and individuals with other areas of expertise, as the Secretary
determines appropriate.
``(c) Duties.--The team described in subsection (a) may--
``(1) assist State, local, Tribal, and territorial emergency
planning and response activities related to children, which may
include developing, identifying, and sharing best practices;
``(2) provide technical assistance, training, and
consultation to Federal, State, local, Tribal, and territorial
public health officials to improve preparedness and response
capabilities with respect to the needs of children, including
providing such technical assistance, training, and consultation
to eligible entities in order to support the achievement of
measurable evidence-based benchmarks and objective standards
applicable to sections 319C-1 and 319C-2;
``(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public
health emergency, including public awareness of such methods;
``(4) coordinate with, and improve, public-private
partnerships, such as health care coalitions pursuant to
sections 319C-2 and 319C-3, to address gaps and inefficiencies
in emergency preparedness and response efforts for children;
``(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies, including pursuant to section 319C-3; and
``(6) carry out other duties related to preparedness and
response activities for children, as the Secretary determines
appropriate.''.
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS.

(a) Reauthorizing the National Advisory Committee on Children and
Disasters.--Section 2811A (42 U.S.C. 300hh-10a) is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and
inserting ``25''; and
(B) by striking paragraph (2) and inserting the
following:

[[Page 937]]

``(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).

[[Page 938]]

``(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.

[[Page 939]]

``(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--

[[Page 940]]

``(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.

[[Page 941]]

``(f) Coordination.--The Secretary shall coordinate duties and
activities authorized under this section in accordance with section
2811D.
``(g) Sunset.--
``(1) In general.--The Advisory Committee shall terminate on
September 30, 2023.
``(2) <>  Recommendation.--Not later than
October 1, 2022, the Secretary shall submit to Congress a
recommendation on whether the Advisory Committee should be
extended.''.

(d) Advisory Committee Coordination.--Subtitle B of title XXVIII (42
U.S.C. 300hh et seq.), as amended by subsection (c), is further amended
by inserting after section 2811C the following:
``SEC. 2811D. <>  ADVISORY COMMITTEE
COORDINATION.

``(a) In General.--The Secretary shall coordinate duties and
activities authorized under sections 2811A, 2811B, and 2811C, and make
efforts to reduce unnecessary or duplicative reporting, or unnecessary
duplicative meetings and recommendations under such sections, as
practicable. <>  Members of the advisory
committees authorized under such sections, or their designees, shall
annually meet to coordinate any recommendations, as appropriate, that
may be similar, duplicative, or overlapping with respect to addressing
the needs of children, seniors, and individuals with disabilities during
public health emergencies. If such coordination occurs through an in-
person meeting, it shall not be considered the required in-person
meetings under any of sections 2811A(e), 2811B(e), or 2811C(d).

``(b) Coordination and Alignment.--The Secretary, acting through the
employee designated pursuant to section 2814, shall align preparedness
and response programs or activities to address similar, dual, or
overlapping needs of children, seniors, and individuals with
disabilities, and any challenges in preparing for and responding to such
needs.
``(c) <>  Notification.--The Secretary
shall annually notify the congressional committees of jurisdiction
regarding the steps taken to coordinate, as appropriate, the
recommendations under this section, and provide a summary description of
such coordination.''.
SEC. 306. <>  GUIDANCE FOR
PARTICIPATION IN EXERCISES AND DRILLS.

Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue final guidance
regarding the ability of personnel funded by programs authorized under
this Act (including the amendments made by this Act) to participate in
drills and operational exercises related to all-hazards medical and
public health preparedness and response. Such drills and operational
exercises may include activities that incorporate medical surge capacity
planning, medical countermeasure distribution and administration, and
preparing for and responding to identified threats for that region. Such
personnel 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.

[[Page 942]]

TITLE IV--PRIORITIZING A THREAT-BASED APPROACH

SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``utilize experience related to public health emergency
preparedness and response, biodefense, medical countermeasures,
and other relevant topics to'' after ``shall''; and
(2) in paragraph (4), by adding at the end the following:
``(I) <>  Threat
awareness.--Coordinate with the Director of the Centers
for Disease Control and Prevention, the Director of
National Intelligence, the Secretary of Homeland
Security, the Assistant to the President for National
Security Affairs, the Secretary of Defense, and other
relevant Federal officials, such as the Secretary of
Agriculture, to maintain a current assessment of
national security threats and inform preparedness and
response capabilities based on the range of the threats
that have the potential to result in a public health
emergency.''.
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.

(a) In General.--Title XXVIII is amended by inserting after section
2811 (42 U.S.C. 300hh-10) the following:
``SEC. 2811-1. <>  PUBLIC HEALTH
EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.

``(a) <>  In General.--The Secretary shall
establish the Public Health Emergency Medical Countermeasures Enterprise
(referred to in this section as the `PHEMCE'). The Assistant Secretary
for Preparedness and Response shall serve as chair of the PHEMCE.

``(b) Members.--The PHEMCE shall include each of the following
members, or the designee of such members:
``(1) The Assistant Secretary for Preparedness and Response.
``(2) The Director of the Centers for Disease Control and
Prevention.
``(3) The Director of the National Institutes of Health.
``(4) The Commissioner of Food and Drugs.
``(5) The Secretary of Defense.
``(6) The Secretary of Homeland Security.
``(7) The Secretary of Agriculture.
``(8) The Secretary of Veterans Affairs.
``(9) The Director of National Intelligence.
``(10) Representatives of any other Federal agency, which
may include the Director of the Biomedical Advanced Research and
Development Authority, the Director of the Strategic National
Stockpile, the Director of the National Institute of Allergy and
Infectious Diseases, and the Director of the Office of Public
Health Preparedness and Response, as the Secretary determines
appropriate.

``(c) Functions.--
``(1) In general.--The functions of the PHEMCE shall include
the following:

[[Page 943]]

``(A) <>
Utilize a process to make recommendations to the
Secretary regarding research, advanced research,
development, procurement, stockpiling, deployment,
distribution, and utilization with respect to
countermeasures, as defined in section 319F-2(c),
including prioritization based on the health security
needs of the United States. Such recommendations shall
be informed by, when available and practicable, the
National Health Security Strategy pursuant to section
2802, the Strategic National Stockpile needs pursuant to
section 319F-2, and assessments of current national
security threats, including chemical, biological,
radiological, and nuclear threats, including emerging
infectious diseases. <>  In the
event that members of the PHEMCE do not agree upon a
recommendation, the Secretary shall provide a
determination regarding such recommendation.
``(B) <>  Identify
national health security needs, including gaps in public
health preparedness and response related to
countermeasures and challenges to addressing such needs
(including any regulatory challenges), and support
alignment of countermeasure procurement with
recommendations to address such needs under subparagraph
(A).
``(C) <>  Assist the Secretary in
developing strategies related to logistics, deployment,
distribution, dispensing, and use of countermeasures
that may be applicable to the activities of the
strategic national stockpile under section 319F-2(a).
``(D) <>  Provide consultation
for the development of the strategy and implementation
plan under section 2811(d).
``(2) Input.--In carrying out subparagraphs (B) and (C) of
paragraph (1), the PHEMCE shall solicit and consider input from
State, local, Tribal, and territorial public health departments
or officials, as appropriate.''.

(b) Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.--Section 2811(d) (42 U.S.C. 300hh-
10(d)) is amended--
(1) in paragraph (1)--
(A) by striking ``Not later than 180 days after the
date of enactment of this subsection, and every year
thereafter'' and inserting ``Not later than March 15,
2020, and biennially thereafter''; and
(B) by striking ``Director of the Biomedical'' and
all that follows through ``Food and Drugs'' and
inserting ``Public Health Emergency Medical
Countermeasures Enterprise established under section
2811-1''; and
(2) in paragraph (2)(J)(v), by striking ``one-year period''
and inserting ``2-year period''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.

(a) In General.--Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is
amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) in paragraph (1)--
(A) by inserting ``the Assistant Secretary for
Preparedness and Response and'' after ``collaboration
with'';

[[Page 944]]

(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

[[Page 945]]

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:

[[Page 946]]

``(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

[[Page 947]]

(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''.

[[Page 948]]

SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL
RESISTANCE, AND OTHER SIGNIFICANT THREATS.

(a) Strategic Initiatives.--Section 319L(c)(4) (247d-7e(c)(4)) is
amended by adding at the end the following:
``(F) <>  Strategic
initiatives.--The Secretary, acting through the Director
of BARDA, may implement strategic initiatives, including
by building on existing programs and by awarding
contracts, grants, and cooperative agreements, or
entering into other transactions, to support innovative
candidate products in preclinical and clinical
development that address priority, naturally occurring
and man-made threats that, as determined by the
Secretary, pose a significant level of risk to national
security based on the characteristics of a chemical,
biological, radiological or nuclear threat, or existing
capabilities to respond to such a threat (including
medical response and treatment capabilities and
manufacturing infrastructure). Such initiatives shall
accelerate and support the advanced research,
development, and procurement of countermeasures and
products, as applicable, to address areas including--
``(i) chemical, biological, radiological, or
nuclear threats, including emerging infectious
diseases, for which insufficient approved,
licensed, or authorized countermeasures exist, or
for which such threat, or the result of an
exposure to such threat, may become resistant to
countermeasures or existing countermeasures may be
rendered ineffective;
``(ii) threats that consistently exist or
continually circulate and have a significant
potential to become a pandemic, such as pandemic
influenza, which may include the advanced research
and development, manufacturing, and appropriate
stockpiling of qualified pandemic or epidemic
products, and products, technologies, or processes
to support the advanced research and development
of such countermeasures (including multiuse
platform technologies for diagnostics, vaccines,
and therapeutics; virus seeds; clinical trial
lots; novel virus strains; and antigen and
adjuvant material); and
``(iii) threats that may result primarily or
secondarily from a chemical, biological,
radiological, or nuclear agent, or emerging
infectious diseases, and which may present
increased treatment complications such as the
occurrence of resistance to available
countermeasures or potential countermeasures,
including antimicrobial resistant pathogens.''.

(b) Protection of National Security From Threats.--Section 2811 (42
U.S.C. 300hh-10) is amended by adding at the end the following:
``(f) Protection of National Security From Threats.--
``(1) In general.--In carrying out subsection (b)(3), the
Assistant Secretary for Preparedness and Response shall
implement strategic initiatives or activities to address
threats, including pandemic influenza and which may include a
chemical, biological, radiological, or nuclear agent (including
any such agent with a significant potential to become a
pandemic), that pose a significant level of risk to public
health and national

[[Page 949]]

security based on the characteristics of such threat. Such
initiatives shall include activities to--
``(A) accelerate and support the advanced research,
development, manufacturing capacity, procurement, and
stockpiling of countermeasures, including initiatives
under section 319L(c)(4)(F);
``(B) support the development and manufacturing of
virus seeds, clinical trial lots, and stockpiles of
novel virus strains; and
``(C) maintain or improve preparedness activities,
including for pandemic influenza.
``(2) Authorization of appropriations.--
``(A) In general.--To carry out this subsection,
there is authorized to be appropriated $250,000,000 for
each of fiscal years 2019 through 2023.
``(B) Supplement, not supplant.--Amounts
appropriated under this paragraph shall be used to
supplement and not supplant funds provided under
sections 319L(d) and 319F-2(g).
``(C) Documentation required.--The Assistant
Secretary for Preparedness and Response, in accordance
with subsection (b)(7), shall document amounts expended
for purposes of carrying out this subsection, including
amounts appropriated under the heading `Public Health
and Social Services Emergency Fund' under the heading
`Office of the Secretary' under title II of division H
of the Consolidated Appropriations Act, 2018 (Public Law
115-141) and allocated to carrying out section
319L(c)(4)(F).''.
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.

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

[[Page 950]]

TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT

SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN.

Section 2811(b)(7) (42 U.S.C. 300hh-10(b)(7)) is amended--
(1) in the matter preceding subparagraph (A), by striking
``March 1'' and inserting ``March 15'';
(2) in subparagraph (A)--
(A) in clause (ii), by striking ``; and'' and
inserting ``;''; and
(B) by striking clause (iii) and inserting the
following:
``(iii) procurement, stockpiling, maintenance,
and potential replenishment (including
manufacturing capabilities) of all products in the
Strategic National Stockpile;
``(iv) the availability of technologies that
may assist in the advanced research and
development of countermeasures and opportunities
to use such technologies to accelerate and
navigate challenges unique to countermeasure
research and development; and
``(v) potential deployment, distribution, and
utilization of medical countermeasures;
development of clinical guidance and emergency use
instructions for the use of medical
countermeasures; and, as applicable, potential
postdeployment activities related to medical
countermeasures;'';
(3) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively; and
(4) by inserting after subparagraph (C), the following:
``(D) identify the full range of anticipated medical
countermeasure needs related to research and
development, procurement, and stockpiling, including the
potential need for indications, dosing, and
administration technologies, and other countermeasure
needs as applicable and appropriate;''.
SEC. 502. <>  MATERIAL THREAT AND MEDICAL
COUNTERMEASURE NOTIFICATIONS.

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

[[Page 951]]

vendor within 90 days of a determination by the Secretary to renew,
extend, or terminate such contract.''.
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.

Section 565(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4(f)) is amended--
(1) by redesignating paragraphs (3) through (6) as
paragraphs (4) through (7), respectively;
(2) by inserting after paragraph (2) the following:
``(3) <>  Publication.--The Secretary
shall make available on the internet website of the Food and
Drug Administration information regarding regulatory management
plans, including--
``(A) the process by which an applicant may submit a
request for a regulatory management plan;
``(B) the timeframe by which the Secretary is
required to respond to such request;
``(C) the information required for the submission of
such request;
``(D) a description of the types of development
milestones and performance targets that could be
discussed and included in such plans; and
``(E) contact information for beginning the
regulatory management plan process.'';
(3) in paragraph (6), as so redesignated, in the matter
preceding subparagraph (A)--
(A) by striking ``paragraph (4)(A)'' and inserting
``paragraph (5)(A)''; and
(B) by striking ``paragraph (4)(B)'' and inserting
``paragraph (5)(B)''; and
(4) in paragraph (7)(A), as so redesignated, by striking
``paragraph (3)(A)'' and inserting ``paragraph (4)(A)''.
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY AND THE BIOSHIELD SPECIAL
RESERVE FUND.

(a) BioShield Special Reserve Fund.--Section 319F-2(g)(1) (42 U.S.C.
247d-6b(g)(1)) is amended--
(1) by striking ``$2,800,000,000 for the period of fiscal
years 2014 through 2018'' and inserting ``$7,100,000,000 for the
period of fiscal years 2019 through 2028, to remain available
until expended''; and
(2) by striking the second sentence.

(b) The Biomedical Advanced Research and Development Authority.--
Section 319L(d)(2) (42 U.S.C. 247d-7e(d)(2)) is amended by striking
``$415,000,000 for each of fiscal years 2014 through 2018'' and
inserting ``$611,700,000 for each of fiscal years 2019 through 2023''.
SEC. 505. <>  ADDITIONAL STRATEGIES FOR
COMBATING ANTIBIOTIC RESISTANCE.

(a) <>  Advisory Council.--The Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') may continue the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria, referred to in this section as
the ``Advisory Council''.

(b) <>  Duties.--The Advisory Council
shall advise and provide information and recommendations to the
Secretary regarding programs and policies intended to reduce or combat
antibiotic-resistant

[[Page 952]]

bacteria that may present a public health threat and improve
capabilities to prevent, diagnose, mitigate, or treat such resistance.
Such advice, information, and recommendations may be related to
improving--
(1) the effectiveness of antibiotics;
(2) research and advanced research on, and the development
of, improved and innovative methods for combating or reducing
antibiotic resistance, including new treatments, rapid point-of-
care diagnostics, alternatives to antibiotics, including
alternatives to animal antibiotics, and antimicrobial
stewardship activities;
(3) surveillance of antibiotic-resistant bacterial
infections, including publicly available and up-to-date
information on resistance to antibiotics;
(4) education for health care providers and the public with
respect to up-to-date information on antibiotic resistance and
ways to reduce or combat such resistance to antibiotics related
to humans and animals;
(5) methods to prevent or reduce the transmission of
antibiotic-resistant bacterial infections, including stewardship
programs; and
(6) <>  coordination with respect to
international efforts in order to inform and advance United
States capabilities to combat antibiotic resistance.

(c) Meetings and Coordination.--
(1) Meetings.--The Advisory Council shall meet not less than
biannually and, to the extent practicable, in coordination with
meetings of the Antimicrobial Resistance Task Force established
in section 319E(a) of the Public Health Service Act.
(2) Coordination.--The Advisory Council shall, to the
greatest extent practicable, coordinate activities carried out
by the Council with the Antimicrobial Resistance Task Force
established under section 319E(a) of the Public Health Service
Act (42 U.S.C. 247d-5(a)).

(d) <>  FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the activities and duties of the
Advisory Council.

(e) <>  Extension of Advisory
Council.--Not later than October 1, 2022, the Secretary shall submit to
the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives
a recommendation on whether the Advisory Council should be extended, and
in addition, identify whether there are other committees, councils, or
task forces that have overlapping or similar duties to that of the
Advisory Council, and whether such committees, councils, or task forces
should be combined, including with respect to section 319E(a) of the
Public Health Service Act (42 U.S.C. 247d-5(a)).

TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES

SEC. 601. ADMINISTRATION OF COUNTERMEASURES.

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

[[Page 953]]

SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS.

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''.
SEC. 603. <>  MEDICAL COUNTERMEASURE
MASTER FILES.

(a) In General.--The purpose of this section (including section 565B
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b))
is to support and advance the development or manufacture of security
countermeasures, qualified countermeasures, and qualified pandemic or
epidemic products by facilitating and encouraging submission of data and
information to support the development of such products, and through
clarifying the authority to cross-reference to data and information
previously submitted to the Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), including data and
information submitted to medical countermeasure master files or other
master files.
(b) Medical Countermeasure Master Files.--Chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 565A the following:
``SEC. 565B. <>  MEDICAL COUNTERMEASURE
MASTER FILES.

``(a) Applicability of Reference.--
``(1) In general.--A person may submit data and information
in a master file to the Secretary with the intent to reference,
or to authorize, in writing, another person to reference, such
data or information to support a medical countermeasure
submission (including a supplement or amendment to any such
submission), without requiring the master file holder to
disclose the data and information to any such persons authorized
to reference the master file. Such data and information shall be
available for reference by the master file holder or by a person
authorized by the master file holder, in accordance with
applicable privacy and confidentiality protocols and
regulations.

[[Page 954]]

``(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

[[Page 955]]

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).

[[Page 956]]

``(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.

[[Page 957]]

SEC. 604. ANIMAL RULE REPORT.

(a) Study.--The Comptroller General of the United States shall
conduct a study on the application of the requirements under subsections
(c) and (d) of section 565 of the of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-4) (referred to in this section as the
``animal rule'') as a component of medical countermeasure advanced
development under the Biomedical Advanced Research and Development
Authority and regulatory review by the Food and Drug
Administration. <>  In conducting such study, the
Comptroller General shall examine the following:
(1) The extent to which advanced development and review of a
medical countermeasure are coordinated between the Biomedical
Advanced Research and Development Authority and the Food and
Drug Administration, including activities that facilitate
appropriate and efficient design of studies to support approval,
licensure, and authorization under the animal rule, consistent
with the recommendations in the animal rule guidance, issued
pursuant to section 565(c) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-4(c)) and entitled ``Product
Development Under the Animal Rule: Guidance for Industry''
(issued in October 2015), to resolve discrepancies in the design
of adequate and well-controlled efficacy studies conducted in
animal models related to the provision of substantial evidence
of effectiveness for the product approved, licensed, or
authorized under the animal rule.
(2) The consistency of the application of the animal rule
among and between review divisions within the Food and Drug
Administration.
(3) The flexibility pursuant to the animal rule to address
variations in countermeasure development and review processes,
including the extent to which qualified animal models are
adopted and used within the Food and Drug Administration in
regulatory decisionmaking with respect to medical
countermeasures.
(4) The extent to which the guidance issued under section
565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4(c)), entitled, ``Product Development Under the Animal
Rule: Guidance for Industry'' (issued in October 2015), has
assisted in achieving the purposes described in paragraphs (1),
(2), and (3).

(b) Consultations.--In conducting the study under subsection (a),
the Comptroller General of the United States shall consult with--
(1) the Federal agencies responsible for advancing,
reviewing, and procuring medical countermeasures, including the
Office of the Assistant Secretary for Preparedness and Response,
the Biomedical Advanced Research and Development Authority, the
Food and Drug Administration, and the Department of Defense;
(2) manufacturers involved in the research and development
of medical countermeasures to address biological, chemical,
radiological, or nuclear threats; and
(3) other biodefense stakeholders, as applicable.

(c) <>  Report.--Not later than 3 years
after the date of enactment of this Act, the Comptroller General of the
United States shall submit to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and Commerce of

[[Page 958]]

the House of Representatives a report containing the results of the
study conducted under subsection (a) and recommendations to improve the
application and consistency of the requirements under subsections (c)
and (d) of section 565 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4) to support and expedite the research and development of
medical countermeasures, as applicable.

(d) Protection of National Security.--The Comptroller General of the
United States shall conduct the study and issue the assessment and
report under this section in a manner that does not compromise national
security.
SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING
TECHNOLOGIES AND THEIR POTENTIAL ROLE IN
NATIONAL SECURITY.

(a) Meeting.--
(1) <>  In general.--Not later than 1 year
after the date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this section as the
``Secretary'') shall convene a meeting to discuss the potential
role advancements in genomic engineering technologies (including
genome editing technologies) may have in advancing national
health security. Such meeting shall be held in a manner that
does not compromise national security.
(2) Attendees.--The attendees of the meeting under paragraph
(1)--
(A) shall include--
(i) representatives from the Office of the
Assistant Secretary for Preparedness and Response,
the National Institutes of Health, the Centers for
Disease Control and Prevention, and the Food and
Drug Administration; and
(ii) representatives from academic, private,
and nonprofit entities with expertise in genome
engineering technologies, biopharmaceuticals,
medicine, or biodefense, and other relevant
stakeholders; and
(B) may include--
(i) other representatives from the Department
of Health and Human Services, as the Secretary
determines appropriate; and
(ii) representatives from the Department of
Homeland Security, the Department of Defense, the
Department of Agriculture, and other departments,
as the Secretary may request for the meeting.
(3) Topics.--The meeting under paragraph (1) shall include a
discussion of--
(A) the current state of the science of genomic
engineering technologies related to national health
security, including--
(i) medical countermeasure development,
including potential efficiencies in the
development pathway and detection technologies;
and
(ii) the international and domestic regulation
of products utilizing genome editing technologies;
and
(B) national security implications, including--

[[Page 959]]

(i) capabilities of the United States to
leverage genomic engineering technologies as a
part of the medical countermeasure enterprise,
including current applicable research,
development, and application efforts underway
within the Department of Defense;
(ii) the potential for state and non-state
actors to utilize genomic engineering technologies
as a national health security threat; and
(iii) security measures to monitor and assess
the potential threat that may result from
utilization of genomic engineering technologies
and related technologies for the purpose of
compromising national health security.

(b) <>  Report.--Not later than 270 days
after the meeting described in subsection (a) is held, the Assistant
Secretary for Preparedness and Response shall issue a report to the
congressional committees of jurisdiction on the topics discussed at such
meeting, and provide recommendations, as applicable, to utilize
innovations in genomic engineering (including genome editing) and
related technologies as a part of preparedness and response activities
to advance national health security. Such report shall be issued in a
manner that does not compromise national security.
SEC. 606. REPORT ON VACCINES DEVELOPMENT.

Not later than one year after the date of the enactment of this Act,
the Secretary of Health and Human Services shall submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a
report describing efforts and activities to coordinate with other
countries and international partners during recent public health
emergencies with respect to the research and advanced research on, and
development of, qualified pandemic or epidemic products (as defined in
section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d)).
Such report may include information regarding relevant work carried out
under section 319L(c)(5)(E) of the Public Health Service Act (42 U.S.C.
247d-7e(c)(5)(E)), through public-private partnerships, and through
collaborations with other countries to assist with or expedite the
research and development of qualified pandemic or epidemic products.
Such report shall not include information that may compromise national
security.
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND HEALTH.

(a) Reauthorization of Mosquito Abatement for Safety and Health
Program.--Section 317S (42 U.S.C. 247b-21) is amended--
(1) in subsection (a)(1)(B)--
(A) by inserting ``including programs to address
emerging infectious mosquito-borne diseases,'' after
``subdivisions for control programs,''; and
(B) by inserting ``or improving existing control
programs'' before the period at the end;
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``, including
improvement,'' after ``operation'';
(B) in paragraph (2)--
(i) in subparagraph (A)--

[[Page 960]]

(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

[[Page 961]]

(2) in subsection (b), by striking ``2010 through 2013'' and
inserting ``2019 through 2023''.

TITLE VII--MISCELLANEOUS PROVISIONS

SEC. 701. REAUTHORIZATIONS AND EXTENSIONS.

(a) Veterans Affairs.--Section 8117(g) of title 38, United States
Code, is amended by striking ``2014 through 2018'' and inserting ``2019
through 2023''.
(b) Vaccine Tracking and Distribution.--Section 319A(e) (42 U.S.C.
247d-1(e)) is amended by striking ``2014 through 2018'' and inserting
``2019 through 2023''.
(c) Temporary Reassignment.--Section 319(e)(8) (42 U.S.C.
247d(e)(8)) is amended by striking ``2018'' and inserting ``2023''.
(d) Strategic Innovation Partner.--Section 319L(c)(4)(E)(ix) (42
U.S.C. 247d-7e(c)(4)(E)(ix)) is amended by striking ``2022'' and
inserting ``2023''.
(e) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-Hazards
Preparedness Act (Public Law 109-417; 42 U.S.C. 247d-6a note) is
amended--
(A) in subsection (a)(1)(A)--
(i) by striking ``Secretary of Health and
Human Services (referred to in this subsection as
the `Secretary')'' and inserting ``Secretary'';
(ii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6b)) (as amended by
this Act'';
(iii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6a)) (as amended by
this Act''; and
(iv) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6d)'';
(B) in subsection (b), by striking ``12-year'' and
inserting ``17-year'';
(C) by redesignating such section 405 as section
319L-1; and
(D) <>  by transferring such
section 319L-1, as redesignated, to the Public Health
Service Act (42 U.S.C. 201 et seq.), to appear after
section 319L of such Act (42 U.S.C. 247d-7e).
(2) Conforming amendments.--
(A) Table of contents.--The table of contents in
section 1(b) of the Pandemic and All-Hazards
Preparedness Act (Public Law 109-417) is amended by
striking the item related to section 405.
(B) Reference.--Section 319L(c)(4)(A)(iii) (42
U.S.C. 247d-7e) is amended by striking ``section 405 of
the Pandemic and All-Hazards Preparedness Act'' and
inserting ``section 319L-1''.

(f) Inapplicability of Certain Provisions.--Subsection (e)(1) of
section 319L (42 U.S.C. 247d-7e(e)(1)) is amended--
(1) by amending subparagraph (A) to read as follows:
``(A) Nondisclosure of information.--
``(i) In general.--Information described in
clause (ii) shall be deemed to be information
described in section 552(b)(3) of title 5, United
States Code.

[[Page 962]]

``(ii) Information described.--The information
described in this clause is information relevant
to programs of the Department of Health and Human
Services that could compromise national security
and reveal significant and not otherwise publicly
known vulnerabilities of existing medical or
public health defenses against chemical,
biological, radiological, or nuclear threats, and
is comprised of--
``(I) specific technical data or
scientific information that is created
or obtained during the countermeasure
and product advanced research and
development carried out under subsection
(c);
``(II) information pertaining to the
location security, personnel, and
research materials and methods of high-
containment laboratories conducting
research with select agents, toxins, or
other agents with a material threat
determination under section 319F-
2(c)(2); or
``(III) security and vulnerability
assessments.'';
(2) by redesignating subparagraph (C) as subparagraph (D);
(3) by inserting after subparagraph (B) the following:
``(C) Reporting.--One year after the date of
enactment of the Pandemic and All-Hazards Preparedness
and Advancing Innovation Act of 2019, and annually
thereafter, the Secretary shall report to the Committee
on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of
Representatives on the number of instances in which the
Secretary has used the authority under this subsection
to withhold information from disclosure, as well as the
nature of any request under section 552 of title 5,
United States Code that was denied using such
authority.''; and
(4) in subparagraph (D), as so redesignated, by striking
``12'' and inserting ``17''.
SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE.

Subsection (d) of section 319F-2 (42 U.S.C. 247d-6b) is amended to
read as follows:
``(d) Disclosures.--No Federal agency may disclose under section 552
of title 5, United States Code any information identifying the location
at which materials in the stockpile described in subsection (a) are
stored, or other information regarding the contents or deployment
capability of the stockpile that could compromise national security.''.
SEC. 703. CYBERSECURITY.

(a) Strategy for Public Health Preparedness and Response to
Cybersecurity Threats.--
(1) <>  Strategy.--Not later than 18 months
after the date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this section as the
``Secretary'') shall prepare and submit to the relevant
committees of Congress a strategy for public health preparedness
and response to address cybersecurity threats (as defined in
section 102 of Cybersecurity Information Sharing Act of 2015 (6
U.S.C. 1501)) that present a threat to national health security.
Such strategy shall include--

[[Page 963]]

(A) identifying the duties, functions, and
preparedness goals for which the Secretary is
responsible in order to prepare for and respond to such
cybersecurity threats, including metrics by which to
measure success in meeting preparedness goals;
(B) identifying gaps in public health capabilities
to achieve such preparedness goals; and
(C) strategies to address identified gaps and
strengthen public health emergency preparedness and
response capabilities to address such cybersecurity
threats.
(2) Protection of national security.--The Secretary shall
make such strategy available to the Committee on Health,
Education, Labor, and Pensions of the Senate, the Committee on
Energy and Commerce of the House of Representatives, and other
congressional committees of jurisdiction, in a manner that does
not compromise national security.

(b) Coordination of Preparedness for and Response to All-Hazards
Public Health Emergencies.--Subparagraph (D) of section 2811(b)(4) (42
U.S.C. 300hh-10(b)(4)) is amended to read as follows:
``(D) Policy coordination and strategic direction.--
Provide integrated policy coordination and strategic
direction, before, during, and following public health
emergencies, with respect to all matters related to
Federal public health and medical preparedness and
execution and deployment of the Federal response for
public health emergencies and incidents covered by the
National Response Plan described in section 504(a)(6) of
the Homeland Security Act of 2002 (6 U.S.C. 314(a)(6)),
or any successor plan; and such Federal responses
covered by the National Cybersecurity Incident Response
Plan developed under section 228(c) of the Homeland
Security Act of 2002 (6 U.S.C. 149(c)), including public
health emergencies or incidents related to cybersecurity
threats that present a threat to national health
security.''.
SEC. 704. STRATEGY AND REPORT.

Not <>  later than 14
days after the date of the enactment of this Act, the Secretary of
Health and Human Services, in coordination 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;

[[Page 964]]

(B) <>  as of the date of the
enactment of this Act, remains in the care of the
Department of Health and Human Services; and
(C) can be safely reunited with such parent or
guardian; and
(2) a report on challenges and deficiencies related to the
oversight of, and care for, unaccompanied alien children and
appropriately reuniting such children with their parents or
guardians, and the actions taken to address any challenges and
deficiencies related to unaccompanied alien children in the
custody of the Department of Health and Human Services,
including deficiencies identified and publicly reported by
Congress, the Government Accountability Office, or the
inspectors general of the Department of Health and Human
Services or other Federal departments.
SEC. 705. TECHNICAL AMENDMENTS.

(a) Public Health Service Act.--Title III (42 U.S.C. 241 et seq.) is
amended--
(1) in paragraphs (1) and (5) of section 319F-1(a) (42
U.S.C. 247d-6a(a)), by striking ``section 319F(h)'' each place
such term appears and inserting ``section 319F(e)''; and
(2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking
``section 319F(h)(4)'' and inserting ``section 319F(e)(4)''.

(b) Public Health Security Grants.--Section 319C-1(b)(2) (42 U.S.C.
247d-3a(b)(2)) is amended--
(1) in subparagraph (C), by striking ``individuals,,'' and
inserting ``individuals,''; and
(2) in subparagraph (F), by striking ``make satisfactory
annual improvement and describe'' and inserting ``makes
satisfactory annual improvement and describes''.

(c) Emergency Use Instructions.--Subparagraph (A) of section
564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3a(e)(2)) is amended by striking ``subsection (a)(1)(C)(i)'' and
inserting ``subsection (a)(1)(C)''.
(d) Products Held for Emergency Use.--Section 564B(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3b) is amended--
(1) in subparagraph (B), by inserting a comma after ``505'';
and
(2) in subparagraph (C), by inserting ``or section 564A''
before the period at the end.

(e) Transparency.--Section 507(c)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 357(c)(3)) is amended--
(1) by striking ``Nothing in'' and inserting the following:
``(A) In general.--Nothing in'';
(2) by inserting ``or directing'' after ``authorizing'';
(3) by striking ``disclose any'' and inserting ``disclose--
``(i) any'';
(4) by striking the period and inserting ``; or''; and
(5) by adding at the end the following:
``(ii) in the case of a drug development tool
that may be used to support the development of a
qualified countermeasure, security countermeasure,
or qualified pandemic or epidemic product, as
defined in sections 319F-1, 319F-2, and 319F-3,
respectively, of the Public Health Service Act,
any information that the

[[Page 965]]

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).''.

Approved June 24, 2019.

LEGISLATIVE HISTORY--S. 1379:
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CONGRESSIONAL RECORD, Vol. 165 (2019):
May 16, considered and passed Senate.
June 4, considered and passed House.