Attachment A-PL

PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 905

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:

June 24, 2019
[S. 1379]

Pandemic and
All-Hazards
Preparedness
and Advancing
Innovation Act
of 2019.
42 USC 201 note.

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.
Sec.
Sec.
Sec.
Sec.

201.
202.
203.
204.
205.

Sec. 206.
Sec. 207.
Sec. 208.
Sec. 209.
Sec. 210.

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

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TITLE III—REACHING ALL COMMUNITIES
Strengthening and assessing the emergency response workforce.
Health system infrastructure to improve preparedness and response.
Considerations for at-risk individuals.
Improving emergency preparedness and response considerations for children.
Sec. 305. National advisory committees on disasters.
Sec. 306. Guidance for participation in exercises and drills.

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Sec.
Sec.
Sec.
Sec.

301.
302.
303.
304.

Sec.
Sec.
Sec.
Sec.

401.
402.
403.
404.

TITLE IV—PRIORITIZING A THREAT-BASED APPROACH
Assistant Secretary for Preparedness and Response.
Public Health Emergency Medical Countermeasures Enterprise.
Strategic National Stockpile.
Preparing for pandemic influenza, antimicrobial resistance, and other significant threats.

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133 STAT. 906

PUBLIC LAW 116–22—JUNE 24, 2019

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.

Sec. 606.
Sec. 607.

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL
COUNTERMEASURES
Administration of countermeasures.
Updating definitions of other transactions.
Medical countermeasure master files.
Animal rule report.
Review of the benefits of genomic engineering technologies and their potential role in national security.
Report on vaccines development.
Strengthening mosquito abatement for safety and health.

Sec.
Sec.
Sec.
Sec.
Sec.

TITLE VII—MISCELLANEOUS PROVISIONS
Reauthorizations and extensions.
Location of materials in the stockpile.
Cybersecurity.
Strategy and report.
Technical amendments.

Sec.
Sec.
Sec.
Sec.
Sec.

601.
602.
603.
604.
605.

701.
702.
703.
704.
705.

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

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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

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133 STAT. 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.’’.

Coordination.
Consultation.

Assessment.

TITLE II—IMPROVING PREPAREDNESS
AND RESPONSE

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

(a) EVALUATING MEASURABLE EVIDENCE-BASED BENCHMARKS
OBJECTIVE STANDARDS.—Section 319C–1 (42 U.S.C. 247d–3a)
is amended by inserting after subsection (j) the following:

AND

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133 STAT. 908
Deadlines.

Review.

Recommendations.

PUBLIC LAW 116–22—JUNE 24, 2019

‘‘(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 evidencebased 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)’’.

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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

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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,

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Time periods.

42 USC 247d–3a
note.

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133 STAT. 910

PUBLIC LAW 116–22—JUNE 24, 2019

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

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133 STAT. 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:

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‘‘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—

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42 USC 247d–3c.

Consultation.
Deadline.

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Coordination.

Web posting.

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Consultation.

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‘‘(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

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133 STAT. 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 allhazards 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

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Consultation.

Grants.
Coordination.

Analysis.
Evaluation.

Recommendations.

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PUBLIC LAW 116–22—JUNE 24, 2019

emergencies, consistent with subsection (a), which may
include consideration of facilities participating in programs
under section 319C–2 of the Public Health Service Act
(42 U.S.C. 247d–3b) or in programs under the Centers
for Medicare & Medicaid Services (including innovative
health care delivery and payment models), and input from
private sector financial institutions.
(3) CONSULTATION.—In carrying out paragraphs (1) and
(2), the Comptroller General shall consult with the heads of
appropriate Federal agencies, including—
(A) the Assistant Secretary for Preparedness and
Response;
(B) the Director of the Centers for Disease Control
and Prevention;
(C) the Administrator of the Centers for Medicare &
Medicaid Services;
(D) the Assistant Secretary for Mental Health and
Substance Use;
(E) the Assistant Secretary of Labor for Occupational
Safety and Health; and
(F) the Secretary of Veterans Affairs.
(c) ANNUAL REPORTS.—Section 319C–2(i)(1) (42 U.S.C. 247d–
3b(i)(1)) is amended by inserting after the first sentence the following: ‘‘In submitting reports under this paragraph, a coalition
shall include information on the progress that the coalition has
made toward the implementation of section 319C–3 (or barriers
to progress, if any).’’.
(d) NATIONAL HEALTH SECURITY STRATEGY INCORPORATION OF
REGIONALIZED EMERGENCY PREPAREDNESS AND RESPONSE.—
Subparagraph (G) of section 2802(b)(3) (42 U.S.C. 300hh–1(b)(3))
is amended to read as follows:
‘‘(G) Optimizing a coordinated and flexible approach
to the emergency response and medical surge capacity of
hospitals, other health care facilities, critical care, trauma
care (which may include trauma centers), and emergency
medical systems.’’.
(e) IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.—
(1) STATE AND LOCAL SECURITY.—Section 319C–1(e) (42
U.S.C. 247d–3a(e)) is amended by striking ‘‘, and local emergency plans.’’ and inserting ‘‘, local emergency plans, and any
regional health care emergency preparedness and response
system established pursuant to the applicable guidelines under
section 319C–3.’’.
(2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) (42 U.S.C.
247d–3b(d)(1)(A)) is amended—
(A) in clause (i), by striking ‘‘; and’’ and inserting
‘‘;’’;
(B) by redesignating clause (ii) as clause (iii); and
(C) by inserting after clause (i) the following:
‘‘(ii) among one or more facilities in a regional
health care emergency system under section 319C–
3; and’’.

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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:

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133 STAT. 915

‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM

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‘‘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,

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42 USC 300d–91.
Time periods.
Consultation.

Consultation.

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Consultation.

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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

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133 STAT. 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

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PUBLIC LAW 116–22—JUNE 24, 2019

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,
TIES.—Section 319D

CAPACITIES, AND BIOSURVEILLANCE CAPABILI(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

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Assessment.

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133 STAT. 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

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133 STAT. 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,

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133 STAT. 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;

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Assessment.

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‘‘(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

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133 STAT. 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

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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

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(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.

Recommendations.

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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;

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PUBLIC LAW 116–22—JUNE 24, 2019
‘‘(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.’’.

Deadline.
Coordination.
Recommendations.

Review.

Recommendations.

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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’’;

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133 STAT. 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;’’.

Public
information.

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:

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‘‘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.

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42 USC 234.

Time period.
Determination.

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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 AllHazards Preparedness and Advancing Innovation Act of 2019.

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133 STAT. 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.

Deadline.
Review.

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.

Recommendations.

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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

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Contracts.

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133 STAT. 930

Recommendations.

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PUBLIC LAW 116–22—JUNE 24, 2019
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

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133 STAT. 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

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SEC.

301.

STRENGTHENING AND
RESPONSE WORKFORCE.

ASSESSING

THE

EMERGENCY

(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

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Deadline.
Coordination.

Evaluation.

Recommendations.
Recommendations.

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Deadline.

Determination.

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Time period.

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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)—

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(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

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Time periods.
Appropriation
authorization.

Notification.

Determination.
34 USC 10284
note.
Recommendations.

PUBL022

133 STAT. 934

PUBLIC LAW 116–22—JUNE 24, 2019
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.

Recommendations.

SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE PREPAREDNESS AND RESPONSE.

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Determination.

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(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’’.

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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.

Deadline.
Summary.

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.’’.
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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:

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133 STAT. 936
42 USC 247d–4b.

PUBLIC LAW 116–22—JUNE 24, 2019

‘‘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 developmentalbehavioral 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 evidencebased 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.’’.

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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:

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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).

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Consultation.
Appointments.

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133 STAT. 938

PUBLIC LAW 116–22—JUNE 24, 2019

‘‘(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:
42 USC
300hh–10c.

‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SENIORS AND
DISASTERS.

Consultation.

‘‘(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.

Consultations.

Evaluation.

Recommendations.

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Consultation.
Appointments.

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 939

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‘‘(2) REQUIRED MEMBERS.—The Advisory Committee shall
include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and nonFederal 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:

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Deadline.
Recommendation.

‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH
DISABILITIES AND DISASTERS.

42 USC
300hh–10d.

‘‘(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—

Consultation.

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Consultations.

PUBL022

133 STAT. 940

Evaluation.

Consultation.
Appointments.

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Determination.

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PUBLIC LAW 116–22—JUNE 24, 2019

‘‘(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 nonFederal 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.

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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.’’.

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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.

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Deadline.

42 USC
300hh–10e.

Recommendations.

Deadline.
Summary.

42 USC 300hh
note.
Deadline.

Consultation.

Web posting.

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133 STAT. 942

PUBLIC LAW 116–22—JUNE 24, 2019

TITLE IV—PRIORITIZING A THREATBASED APPROACH
SEC.

401.

ASSISTANT
RESPONSE.

SECRETARY

FOR

PREPAREDNESS

AND

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.’’.

Coordination.
Assessment.

SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.

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(a) IN GENERAL.—Title XXVIII is amended by inserting after
section 2811 (42 U.S.C. 300hh–10) the following:

VerDate Sep 11 2014

42 USC
300hh–10a.

‘‘SEC. 2811–1. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.

Establishment.

‘‘(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:

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133 STAT. 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’’.

Recommendations.
Assessments.

Determination.

Recommendations.

Strategies.

Consultation.

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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’’;

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(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

Consultation.
Assessment.

Deadlines.

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Assessment.

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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 lifecycle 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:

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133 STAT. 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

Deadline.
Time period.
Review.
Assessments.

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Analysis.

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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’’.

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Deadline.

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133 STAT. 948

PUBLIC LAW 116–22—JUNE 24, 2019

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

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Determination.

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(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

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PUBLIC LAW 116–22—JUNE 24, 2019

133 STAT. 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

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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.’’.

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133 STAT. 950

PUBLIC LAW 116–22—JUNE 24, 2019

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;’’.
Determinations.

SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE
NOTIFICATIONS.

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(a) CONGRESSIONAL NOTIFICATION OF MATERIAL THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 U.S.C. 247d–6b(c)(2)(C)) is

Deadline.

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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

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133 STAT. 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)’’.

Web posting.

SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY AND THE BIOSHIELD SPECIAL RESERVE
FUND.

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(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’’.

VerDate Sep 11 2014

SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC
RESISTANCE.

42 USC 247d–5
note.

(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

Continuation.

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Coordination.

Applicability.
Deadline.
Recommendation.

PUBLIC LAW 116–22—JUNE 24, 2019

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

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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’’.

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133 STAT. 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:

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‘‘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.

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21 USC
360bbb–4b.

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Notification.

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Notification.

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‘‘(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

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133 STAT. 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).

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Deadline.
Consultation.

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Deadlines.

Publication.

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‘‘(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.

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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

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Recommendations.

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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—

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(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.

Recommendations.

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
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)—

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AND

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PUBLIC LAW 116–22—JUNE 24, 2019

(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

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

TITLE VII—MISCELLANEOUS
PROVISIONS

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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 AllHazards 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.

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‘‘(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.

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(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—

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(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.’’.

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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;

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Deadline.
Coordination.
Collaboration.

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PUBLIC LAW 116–22—JUNE 24, 2019
(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.

Effective date.

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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

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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).’’.

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Approved June 24, 2019.

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

Æ

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