II 
115TH CONGRESS 
2D SESSION 
H. R. 7328 
IN THE SENATE OF THE UNITED STATES 
DECEMBER 20, 2018 
Received 
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, to clarify the regulatory 
framework with respect to certain nonprescription drugs 
that are marketed without an approved drug application, 
and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pandemic and All-Hazards Preparedness and Advancing 
Innovation Act of 2018’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
DIVISION A—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND 
ADVANCING INNOVATION 
Sec. 100. References in division. 
TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY 
STRATEGY 
Sec. 101. National Health Security Strategy. 
TITLE II—IMPROVING PREPAREDNESS AND RESPONSE 
Sec. 201. Improving benchmarks and standards for preparedness and response. 
Sec. 202. Amendments to preparedness and response programs. 
Sec. 203. Regional health care emergency preparedness and response systems. 
Sec. 204. Military and civilian partnership for trauma readiness. 
Sec. 205. Public health and health care system situational awareness and bio-
surveillance capabilities. 
Sec. 206. Strengthening and supporting the public health emergency rapid re-
sponse fund. 
Sec. 207. Improving all-hazards preparedness and response by public health 
emergency volunteers. 
Sec. 208. Clarifying State liability law for volunteer health care professionals. 
Sec. 209. Report on adequate national blood supply. 
Sec. 210. Report on the public health preparedness and response capabilities 
and capacities of hospitals, long-term care facilities, and other 
health care facilities. 
TITLE III—REACHING ALL COMMUNITIES 
Sec. 301. Strengthening and assessing the emergency response workforce. 
Sec. 302. Health system infrastructure to improve preparedness and response. 
Sec. 303. Considerations for at-risk individuals. 
Sec. 304. Improving emergency preparedness and response considerations for 
children. 
Sec. 305. National advisory committees on disasters. 
Sec. 306. Guidance for participation in exercises and drills. 
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TITLE IV—PRIORITIZING A THREAT-BASED APPROACH 
Sec. 401. Assistant Secretary for Preparedness and Response. 
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. 
Sec. 403. Strategic National Stockpile. 
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other 
significant threats. 
Sec. 405. Reporting on the Federal Select Agent Program. 
TITLE V—INCREASING COMMUNICATION IN MEDICAL 
COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT 
Sec. 501. Medical countermeasure budget plan. 
Sec. 502. Material threat and medical countermeasure notifications. 
Sec. 503. Availability of regulatory management plans. 
Sec. 504. The Biomedical Advanced Research and Development Authority and 
the BioShield Special Reserve Fund. 
Sec. 505. Additional strategies for combating antibiotic resistance. 
TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 
COUNTERMEASURES 
Sec. 601. Administration of countermeasures. 
Sec. 602. Updating definitions of other transactions. 
Sec. 603. Medical countermeasure master files. 
Sec. 604. Animal rule report. 
Sec. 605. Review of the benefits of genomic engineering technologies and their 
potential role in national security. 
Sec. 606. Report on vaccines development. 
Sec. 607. Strengthening mosquito abatement for safety and health. 
TITLE VII—MISCELLANEOUS PROVISIONS 
Sec. 701. Reauthorizations and extensions. 
Sec. 702. Location of materials in the stockpile. 
Sec. 703. Cybersecurity. 
Sec. 704. Strategy and report. 
Sec. 705. Technical amendments. 
DIVISION B—OVER-THE-COUNTER MONOGRAPH SAFETY, 
INNOVATION, AND REFORM 
Sec. 1000. Short title; references in division. 
TITLE I—OTC DRUG REVIEW 
Sec. 1001. Regulation of certain nonprescription drugs that are marketed with-
out an approved drug application. 
Sec. 1002. Misbranding. 
Sec. 1003. Drugs excluded from the over-the-counter drug review. 
Sec. 1004. Treatment of Sunscreen Innovation Act. 
Sec. 1005. Annual update to Congress on appropriate pediatric indication for 
certain OTC cough and cold drugs. 
Sec. 1006. Technical corrections. 
TITLE II—USER FEES 
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Sec. 2001. Short title; finding. 
Sec. 2002. Fees relating to over-the-counter drugs. 
DIVISION 
A—PANDEMIC 
AND 
ALL-HAZARDS 
PREPARED-
NESS AND ADVANCING INNO-
VATION 
SEC. 100. REFERENCES IN DIVISION. 
Except as otherwise specified— 
(1) amendments made by this division to a sec-
tion 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.); and 
(2) any reference to ‘‘this Act’’ contained in 
this division shall be treated as referring only to the 
provisions of this division. 
TITLE I—STRENGTHENING THE 
NATIONAL HEALTH SECURITY 
STRATEGY 
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 
Section 2802 (42 U.S.C. 300hh–1) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by striking ‘‘2014’’ and inserting 
‘‘2018’’; and 
(ii) by striking the second sentence 
and inserting the following: ‘‘Such Na-
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tional Health Security Strategy shall de-
scribe potential emergency health security 
threats and identify the process for achiev-
ing 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 pur-
suant to section 504 of such Act, or any 
successor plan.’’; 
(B) in paragraph (2), by inserting before 
the period at the end of the second sentence the 
following: ‘‘, and an analysis of any changes to 
the evidence-based benchmarks and objective 
standards under sections 319C–1 and 319C–2’’; 
and 
(C) in paragraph (3)— 
(i) by striking ‘‘2009’’ and inserting 
‘‘2022’’; 
(ii) by inserting ‘‘(including gaps in 
the environmental health and animal 
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(i) in the matter preceding subpara-
graph (A), by striking ‘‘including mental 
health’’ and inserting ‘‘including phar-
macies, mental health facilities,’’; and 
(ii) in subparagraph (F), by inserting 
‘‘or exposures to agents that could cause a 
public health emergency’’ before the pe-
riod; 
(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
AGRI-
CULTURE.—Improving coordination among Federal, 
State, local, tribal, and territorial entities (including 
through consultation with the Secretary of Agri-
culture) to prevent, detect, and respond to outbreaks 
of plant or animal disease (including zoonotic dis-
ease) that could compromise national security result-
ing from a deliberate attack, a naturally occurring 
threat, the intentional adulteration of food, or other 
public health threats, taking into account inter-
actions between animal health, human health, and 
animals’ and humans’ shared environment as di-
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rectly related to public health emergency prepared-
ness and response capabilities, as applicable. 
‘‘(10) GLOBAL HEALTH SECURITY.—Assessing 
current or potential health security threats from 
abroad to inform domestic public health prepared-
ness and response capabilities.’’. 
TITLE II—IMPROVING 
PREPAREDNESS AND RESPONSE 
SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 
PREPAREDNESS AND RESPONSE. 
(a) EVALUATING MEASURABLE EVIDENCE-BASED 
BENCHMARKS
AND
OBJECTIVE
STANDARDS.—Section 
319C–1 (42 U.S.C. 247d–3a) is amended by inserting 
after subsection (j) the following: 
‘‘(k) EVALUATION.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018 and every 2 years thereafter, the Sec-
retary shall conduct an evaluation of the evidence- 
based benchmarks and objective standards required 
under subsection (g). Such evaluation shall be sub-
mitted to the congressional committees of jurisdic-
tion together with the National Health Security 
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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 bench-
marks and objective standards, and associated 
metrics and targets; 
‘‘(B) a discussion of changes to any evi-
dence-based benchmarks and objective stand-
ards, and the effect of such changes on the abil-
ity to track whether entities are meeting or 
making progress toward the goals under this 
section and, to the extent practicable, the appli-
cable 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 objec-
tive standards; and 
‘‘(D) recommendations, as applicable and 
appropriate, to improve evidence-based bench-
marks and objective standards to more accu-
rately assess the ability of entities receiving 
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awards under this section to better achieve the 
goals under this section and section 2802.’’. 
(b) EVALUATING THE PARTNERSHIP FOR STATE AND 
REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 
2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 
‘‘section 319C–1(g), (i), and (j)’’ and inserting ‘‘section 
319C–1(g), (i), (j), and (k)’’. 
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE-
SPONSE PROGRAMS. 
(a) COOPERATIVE AGREEMENT APPLICATIONS FOR 
IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU-
RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend-
ed— 
(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); 
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(C) by inserting after clause (vi) the fol-
lowing: 
‘‘(vii) a description of how, as applica-
ble, such entity may integrate information 
to account for individuals with behavioral 
health needs following a public health 
emergency;’’; 
(D) in clause (ix), as so redesignated, by 
striking ‘‘; and’’ and inserting a semicolon; and 
(E) by adding at the end the following: 
‘‘(xi) a description of how the entity 
will partner with health care facilities, in-
cluding 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 appro-
priate and practicable, the entity will in-
clude critical infrastructure partners, such 
as utility companies within the entity’s ju-
risdiction, in planning pursuant to this 
subparagraph to help ensure that critical 
infrastructure will remain functioning dur-
ing, or return to function as soon as prac-
ticable after, a public health emergency;’’. 
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(b) EXCEPTION RELATING TO APPLICATION OF CER-
TAIN 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 subpara-
graph (A), by striking ‘‘Beginning with fis-
cal year 2009’’ and inserting ‘‘Beginning 
with fiscal year 2019’’; and 
(ii) in subparagraph (A)— 
(I) by striking ‘‘for the imme-
diately preceding fiscal year’’ and in-
serting ‘‘for either of the 2 imme-
diately preceding fiscal years’’; and 
(II) by striking ‘‘2008’’ and in-
serting ‘‘2018’’; and 
(B) in paragraph (6), by amending sub-
paragraph (A) to read as follows: 
‘‘(A) IN
GENERAL.—The amounts de-
scribed in this paragraph are the following 
amounts that are payable to an entity for ac-
tivities described in this section or section 
319C–2: 
‘‘(i) For no more than 1 of each of 
the first 2 fiscal years immediately fol-
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lowing a fiscal year in which an entity ex-
perienced a failure described in subpara-
graph (A) or (B) of paragraph (5), an 
amount equal to 10 percent of the amount 
the entity was eligible to receive for the re-
spective fiscal year. 
‘‘(ii) For no more than 1 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 eligi-
ble to receive for the respective fiscal 
year.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply with respect to cooper-
ative agreements awarded on or after the date of en-
actment of this Act. 
(c) PARTNERSHIP FOR STATE AND REGIONAL HOS-
PITAL 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 As-
sistant Secretary for Preparedness and Re-
sponse,’’ after ‘‘The Secretary’’; and 
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(B) by striking ‘‘preparedness for public 
health emergencies’’ and inserting ‘‘prepared-
ness for, and response to, public health emer-
gencies 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 serv-
ice organizations or emergency management or-
ganizations; and’’; 
(3) in subsection (d)— 
(A) in paragraph (1)(B), by striking ‘‘part-
nership’’ each place it appears and inserting 
‘‘coalition’’; and 
(B) in paragraph (2)(C), by striking ‘‘med-
ical 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 insert-
ing ‘‘Coalitions’’; 
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(B) by striking ‘‘partnerships’’ and insert-
ing ‘‘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 in-
serting ‘‘such coalition’’. 
(d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA-
TION
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 au-
thority of the Secretary to make awards pursuant to para-
graphs (4) and (5)).’’. 
(e) PARTNERSHIP FOR STATE AND REGIONAL HOS-
PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA-
TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 
amended— 
(1) by amending paragraph (1) to read as fol-
lows: 
‘‘(1) IN GENERAL.— 
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‘‘(A) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For purposes of carrying out this sec-
tion and section 319C–3, in accordance with 
subparagraph (B), there is authorized to be ap-
propriated $385,000,000 for each of fiscal years 
2019 through 2023. 
‘‘(B) RESERVATION OF AMOUNTS FOR RE-
GIONAL SYSTEMS.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), of the amount appropriated under sub-
paragraph (A) for a fiscal year, the Sec-
retary 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 sub-
sequent fiscal year, the amount appro-
priated under subparagraph (A) is such 
that, after application of clause (i), the 
amount remaining for the purpose of car-
rying 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 
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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 re-
serve 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 pur-
pose described in paragraph (1)(B)(i)’’; and 
(3) in paragraph (3)(A), by striking ‘‘paragraph 
(1) and not reserved under paragraph (2)’’ and in-
serting ‘‘paragraph (1)(A) and not reserved under 
paragraph (1)(B)(i) or (2)’’. 
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE-
PAREDNESS AND RESPONSE SYSTEMS. 
(a) IN GENERAL.—Part B of title III (42 U.S.C. 243 
et seq.) is amended by inserting after section 319C–2 the 
following: 
‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE 
EMERGENCY PREPAREDNESS AND RESPONSE 
SYSTEMS. 
‘‘(a) PURPOSE.—It is the purpose of this section to 
identify and provide guidelines for regional systems of hos-
pitals, health care facilities, and other public and private 
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sector entities, with varying levels of capability to treat 
patients and increase medical surge capacity during, in ad-
vance of, and immediately following a public health emer-
gency, including threats posed by one or more chemical, 
biological, radiological, or nuclear agents, including emerg-
ing infectious diseases. 
‘‘(b) GUIDELINES.—The Assistant Secretary for Pre-
paredness and Response, in consultation with the Director 
of the Centers for Disease Control and Prevention, the Ad-
ministrator of the Centers for Medicare & Medicaid Serv-
ices, the Administrator of the Health Resources and Serv-
ices Administration, the Commissioner of Food and 
Drugs, the Assistant Secretary for Mental Health and 
Substance Use, the Assistant Secretary of Labor for Occu-
pational Safety and Health, the Secretary of Veterans Af-
fairs, the heads of such other Federal agencies as the Sec-
retary determines to be appropriate, and State, local, trib-
al, 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 re-
lating to practices and protocols for all-hazards pub-
lic health emergency preparedness and response for 
hospitals and health care facilities to provide appro-
priate patient care during, in advance of, or imme-
diately following, a public health emergency, result-
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ing from one or more chemical, biological, radio-
logical, or nuclear agents, including emerging infec-
tious 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 pa-
tients affected by such emergency, including— 
‘‘(i) the manner in which the system 
will coordinate with and integrate the part-
nerships and health care coalitions estab-
lished under section 319C–2(b); and 
‘‘(ii) informing and educating appro-
priate first responders and health care sup-
ply chain partners of the regional emer-
gency preparedness and response capabili-
ties and medical surge capacity of such 
hospitals and health care facilities in the 
community; 
‘‘(B) physical and technological infrastruc-
ture, laboratory capacity, staffing, blood supply, 
and other supply chain needs, taking into ac-
count resiliency, geographic considerations, and 
rural considerations; 
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‘‘(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 experi-
ence among the health care workforce, behav-
ioral health, psychological resilience, and train-
ing 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 sys-
tems 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 com-
promise national security; and 
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‘‘(3) update such guidelines as appropriate, in-
cluding based on input received pursuant to sub-
sections (c) and (e) and information resulting from 
applicable reports required under the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018 (including any amendments made by 
such Act), to address new and emerging public 
health threats. 
‘‘(c) CONSIDERATIONS.—In identifying, developing, 
and updating guidelines under subsection (b), the Assist-
ant 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 sub-
ject matter experts (including experts with relevant 
expertise in chemical, biological, radiological, or nu-
clear threats, including emerging infectious dis-
eases), as the Assistant Secretary determines appro-
priate, 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 fa-
cilities (including hospitals, primary care clinics, 
community health centers, mental health facilities, 
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ambulatory care facilities, and dental health facili-
ties), pharmacies, emergency medical providers, 
trauma care providers, environmental health agen-
cies, public health laboratories, poison control cen-
ters, blood banks, tissue banks, and other experts 
that the Assistant Secretary determines appropriate, 
to meet the goals under section 2802(b)(3); 
‘‘(3) consider feedback related to financial im-
plications for hospitals, health care facilities, public 
health agencies, laboratories, blood banks, tissue 
banks, and other entities engaged in regional pre-
paredness planning to implement and follow such 
guidelines, as applicable; and 
‘‘(4) consider financial requirements and poten-
tial incentives for entities to prepare for, and re-
spond to, public health emergencies as part of the 
regional health care emergency preparedness and re-
sponse system. 
‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec-
retary for Preparedness and Response, in consultation 
with the Director of the Centers for Disease Control and 
Prevention and the Assistant Secretary of Labor for Occu-
pational Safety and Health, may provide technical assist-
ance and consultation toward meeting the guidelines de-
scribed in subsection (b). 
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‘‘(e) DEMONSTRATION
PROJECT
FOR
REGIONAL 
HEALTH CARE PREPAREDNESS
AND RESPONSE SYS-
TEMS.— 
‘‘(1) IN GENERAL.—The Assistant Secretary for 
Preparedness and Response may establish a dem-
onstration 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 re-
sponse capabilities, improve specialty care expertise 
for all-hazards response, and coordinate medical pre-
paredness and response across State, local, tribal, 
territorial, and regional jurisdictions. 
‘‘(2) SUNSET.—The authority under this sub-
section 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 Gen-
eral of the United States (referred to in this sub-
section as the ‘‘Comptroller General’’) shall submit 
to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Finance of the Sen-
ate 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 
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which hospitals and health care facilities have imple-
mented 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 guide-
lines. 
(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 Pub-
lic Health Service Act to improve regional emer-
gency 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 in-
centives for regional health partners, including 
hospitals and health care facilities, to improve 
capacity and medical surge capabilities to pre-
pare for, and respond to, public health emer-
gencies, consistent with subsection (a), which 
may include consideration of facilities partici-
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pating 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 inno-
vative health care delivery and payment mod-
els), and input from private sector financial in-
stitutions. 
(3) CONSULTATION.—In carrying out para-
graphs (1) and (2), the Comptroller General shall 
consult with the heads of appropriate Federal agen-
cies, including— 
(A) the Assistant Secretary for Prepared-
ness 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 
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this paragraph, a coalition shall include information on the 
progress that the coalition has made toward the implemen-
tation of section 319C–3 (or barriers to progress, if 
any).’’. 
(d) NATIONAL HEALTH SECURITY STRATEGY INCOR-
PORATION OF REGIONALIZED EMERGENCY PREPARED-
NESS
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 med-
ical 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.’’. 
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(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) inserting after clause (i), the following: 
‘‘(ii) among one or more facilities in a 
regional health care emergency system 
under section 319C–3; and’’. 
SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 
TRAUMA READINESS. 
Title XII (42 U.S.C. 300d et seq.) is amended by 
adding at the end the following new part: 
‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 
FOR TRAUMA READINESS GRANT PROGRAM 
‘‘SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR 
TRAUMA READINESS GRANT PROGRAM. 
‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO-
GRAM.— 
‘‘(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 
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trauma teams to provide, on a full-time basis, trau-
ma care and related acute care at such trauma cen-
ters. 
‘‘(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.—Notwith-
standing 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 pe-
riod of such grant. 
‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACE-
MENT 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 
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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 re-
newed 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 trau-
ma 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 trau-
ma center. 
‘‘(c) GRANT REQUIREMENTS.— 
‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER-
GENCIES.—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 De-
fense for military operations, for training, or 
for response to a mass casualty incident; and 
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‘‘(B) be deployed by the Secretary of De-
fense, in consultation with the Secretary of 
Health and Human Services, for response to a 
public health emergency pursuant to section 
319. 
‘‘(2) USE OF FUNDS.—Grants awarded under 
this section to an eligible trauma center may be used 
to train and incorporate military trauma care pro-
viders into such trauma center, including incorpora-
tion into operational exercises and training drills re-
lated 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 sec-
tion 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 
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submit to the Secretary and the Secretary of De-
fense a report for such year that includes informa-
tion 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, includ-
ing 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 ef-
fect 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 
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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 trau-
ma patients in urban and rural settings; 
‘‘(C) the capability of trauma centers and 
military trauma care providers to increase med-
ical 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 emer-
gencies; and 
‘‘(F) the capability of military trauma care 
providers to participate as part of a medical re-
sponse during or in advance of a public health 
emergency, as determined by the Secretary, or 
a mass casualty incident. 
‘‘(f) DEFINITIONS.—For purposes of this part: 
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‘‘(1) ELIGIBLE
TRAUMA
CENTER.—The term 
‘eligible trauma center’ means a Level I, II, or III 
trauma center that satisfies each of the following: 
‘‘(A) Such trauma center has an agree-
ment with the Secretary of Defense to enable 
military trauma care providers to provide trau-
ma care and related acute care at such trauma 
center. 
‘‘(B) Such trauma center utilizes a risk-ad-
justed benchmarking system and metrics to 
measure performance, quality, and patient out-
comes. 
‘‘(C) Such trauma center demonstrates a 
need for integrated military trauma care pro-
viders to maintain or improve the trauma clin-
ical capability of such trauma center. 
‘‘(2) ELIGIBLE
HIGH
ACUITY
TRAUMA
CEN-
TER.—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 agree-
ment with the Secretary of Defense to enable 
military trauma teams to provide trauma care 
and related acute care at such trauma center. 
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‘‘(B) At least 20 percent of patients treat-
ed 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 cen-
ter. 
‘‘(C) Such trauma center utilizes a risk-ad-
justed benchmarking system and metrics to 
measure performance, quality, and patient out-
comes. 
‘‘(D) Such trauma center is an academic 
training center— 
‘‘(i) affiliated with a medical school; 
‘‘(ii) that maintains residency pro-
grams and fellowships in critical trauma 
specialties and subspecialties, and provides 
education and supervision of military trau-
ma team members according to those spe-
cialties and subspecialties; and 
‘‘(iii) that undertakes research in the 
prevention and treatment of traumatic in-
jury. 
‘‘(E) Such trauma center serves as a med-
ical and public health preparedness and re-
sponse leader for its community, such as by 
participating in a partnership for State and re-
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gional hospital preparedness established under 
section 319C–2 or 319C–3. 
‘‘(3) MAJOR TRAUMA.—The term ‘major trau-
ma’ 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 pro-
viders. 
‘‘(5) MILITARY TRAUMA CARE PROVIDER.—The 
term ‘military trauma care provider’ means a mem-
ber of the Armed Forces who furnishes emergency, 
critical care, and other trauma acute care services 
(including a physician, surgeon, physician assistant, 
nurse, nurse practitioner, respiratory therapist, 
flight paramedic, combat medic, or enlisted medical 
technician) or other military trauma care provider as 
the Secretary determines appropriate. 
‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $11,500,000 for each of fiscal years 2019 through 
2023.’’. 
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SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SIT-
UATIONAL 
AWARENESS 
AND 
BIOSURVEIL-
LANCE CAPABILITIES. 
(a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE 
CAPABILITIES.—Section 319D (42 U.S.C. 247d–4) is 
amended— 
(1) in the section heading, by striking ‘‘REVI-
TALIZING’’ and inserting ‘‘FACILITIES AND CA-
PACITIES 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 im-
proved’’ and inserting ‘‘, improved, and appro-
priately maintained’’; 
(C) in paragraph (3), in the matter pre-
ceding 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 con-
duct a study on Federal spending in fiscal years 
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2013 through 2018 for activities authorized under 
this subsection. Such study shall include a review 
and assessment of obligations and expenditures di-
rectly related to each activity under paragraphs (2) 
and (3), including a specific accounting of, and de-
lineation between, obligations and expenditures in-
curred 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 net-
work 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 ‘‘im-
munization information systems,’’ after ‘‘cen-
ters,’’; and 
(C) in paragraph (2)— 
(i) by inserting ‘‘develop a plan to, 
and’’ after ‘‘The Secretary shall’’; and 
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(ii) by inserting ‘‘and in a form read-
ily 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 Pan-
demic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018, the Secretary, 
in cooperation with health care providers, State, 
local, tribal, and territorial public health offi-
cials, and relevant Federal agencies (including 
the Office of the National Coordinator for 
Health Information Technology and the Na-
tional Institute of Standards and Technology), 
shall, as necessary, adopt technical and report-
ing standards, including standards for inter-
operability as defined by section 3000, for net-
works 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 se-
curity. 
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‘‘(B) DEFERENCE TO STANDARDS DEVEL-
OPMENT ORGANIZATIONS.—In adopting and im-
plementing standards under this subsection and 
subsection (c), the Secretary shall give def-
erence to standards published by standards de-
velopment organizations and voluntary con-
sensus-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 Pan-
demic and All-Hazards Preparedness Re-
authorization Act of 2013, the Secretary’’ 
and inserting ‘‘The Secretary’’; 
(ii) by inserting ‘‘, and improve as ap-
plicable and appropriate,’’ after ‘‘shall es-
tablish’’; 
(iii) by striking ‘‘of rapid’’ and insert-
ing ‘‘of, rapid’’; and 
(iv) by striking ‘‘such connectivity’’ 
and inserting ‘‘such interoperability’’; 
(B) by amending paragraph (2) to read as 
follows: 
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‘‘(2) COORDINATION AND CONSULTATION.—In 
establishing and improving the network under para-
graph (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 biosurveil-
lance 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 Informa-
tion Technology), and public health emergency 
preparedness and response; and 
‘‘(B) consult with the Secretary of Agri-
culture, 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)— 
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(i) by redesignating subparagraphs 
(A) through (E) as clauses (i) through (v), 
respectively, and adjusting the margins ac-
cordingly; 
(ii) in clause (iv), as so redesig-
nated— 
(I) by inserting ‘‘immunization 
information systems,’’ after ‘‘poison 
control,’’; and 
(II) by striking ‘‘and clinical lab-
oratories’’ 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 fol-
lowing: 
‘‘(B) REVIEW.—Not later than 2 years 
after the date of the enactment of the Pan-
demic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018 and every 6 
years thereafter, the Secretary shall conduct a 
review of the elements described in subpara-
graph (A). Such review shall include a discus-
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sion of the addition of any elements pursuant to 
clause (v), including elements added to advanc-
ing new technologies, and identify any chal-
lenges 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 mar-
gins accordingly; 
(ii) by striking ‘‘In establishing’’ and 
inserting the following: 
‘‘(A) IN GENERAL.—In establishing’’; 
(iii) by adding at the end the fol-
lowing: 
‘‘(B) PUBLIC MEETING.— 
‘‘(i) IN
GENERAL.—Not later than 
180 days after the date of enactment of 
the Pandemic and All-Hazards Prepared-
ness and Advancing Innovation Act of 
2018, the Secretary shall convene a public 
meeting for purposes of discussing and 
providing input on the potential goals, 
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functions, and uses of the network de-
scribed 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 Coordi-
nator for Health Information Technology 
and the National Institute of Standards 
and Technology); State, local, tribal, and 
territorial public health officials; stake-
holders 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 rep-
resentatives as the Secretary determines 
appropriate. 
‘‘(iii) TOPICS.—Such public meeting 
shall include a discussion of— 
‘‘(I) data elements, including 
minimal or essential data elements, 
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that are voluntarily provided for such 
network, which may include elements 
from public health and public and pri-
vate health care entities, to the extent 
practicable; 
‘‘(II) standards and implementa-
tion specifications that may improve 
the collection, analysis, and interpre-
tation of data during a public health 
emergency; 
‘‘(III) strategies to encourage the 
access, exchange, and use of informa-
tion; 
‘‘(IV) considerations for State, 
local, tribal, and territorial capabilities 
and infrastructure related to data ex-
change and interoperability; 
‘‘(V) privacy and security protec-
tions provided at the Federal, State, 
local, tribal, and territorial levels, and 
by nongovernmental stakeholders; and 
‘‘(VI) opportunities for the incor-
poration of innovative technologies to 
improve the network.’’; and 
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(iv) in subparagraph (A), as so des-
ignated by clause (ii)— 
(I) in clause (i), as so redesig-
nated— 
(aa) by striking ‘‘as deter-
mined’’ and inserting ‘‘as adopt-
ed’’; 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 redesig-
nated, by striking ‘‘; and’’ and insert-
ing a semicolon; 
(III) in clause (iv), as so redesig-
nated, by striking the period and in-
serting ‘‘; and’’; and 
(IV) by adding at the end the fol-
lowing: 
‘‘(v) pilot test standards and imple-
mentation specifications, consistent with 
the 
process 
described 
in 
section 
3002(b)(3)(C), which State, local, tribal, 
and territorial public health entities may 
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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 Pan-
demic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018, the Secretary 
shall submit to the congressional committees of 
jurisdiction a coordinated strategy and an ac-
companying 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 pro-
vided by the public meeting under para-
graph (5)(B); 
‘‘(iii) identifies and demonstrates the 
measurable steps the Secretary will carry 
out to— 
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‘‘(I) develop, implement, and 
evaluate the network described in 
paragraph (1), utilizing elements de-
scribed in paragraph (3)(A); 
‘‘(II) modernize and enhance bio-
surveillance activities, including strat-
egies to include innovative tech-
nologies and analytical approaches 
(including prediction and forecasting 
for pandemics and all-hazards) from 
public and private entities; 
‘‘(III) improve information shar-
ing, coordination, and communication 
among disparate biosurveillance sys-
tems supported by the Department of 
Health and Human Services, includ-
ing the identification of methods to 
improve accountability, better utilize 
resources and workforce capabilities, 
and 
incorporate 
innovative 
tech-
nologies within and across agencies; 
and 
‘‘(IV) test and evaluate capabili-
ties of the interoperable network of 
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systems to improve situational aware-
ness and biosurveillance capabilities; 
‘‘(iv) includes performance measures 
and the metrics by which performance 
measures will be assessed with respect to 
the measurable steps under clause (iii); 
and 
‘‘(v) establishes dates by which each 
measurable step under clause (iii) will be 
implemented. 
‘‘(B) ANNUAL BUDGET PLAN.—Not later 
than 2 years after the date of enactment of the 
Pandemic and All-Hazards Preparedness and 
Advancing Innovation Act of 2018 and on an 
annual basis thereafter, in accordance with the 
strategy and implementation plan under this 
paragraph, the Secretary shall, taking into ac-
count recommendations provided by the Na-
tional Biodefense Science Board, develop a 
budget plan based on the strategy and imple-
mentation plan under this section. Such budget 
plan shall include— 
‘‘(i) a summary of resources pre-
viously expended to establish, improve, and 
utilize the nationwide public health situa-
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tional awareness and biosurveillance net-
work under paragraph (1); 
‘‘(ii) estimates of costs and resources 
needed to establish and improve the net-
work under paragraph (1) according to the 
strategy and implementation plan under 
subparagraph (A); 
‘‘(iii) the identification of gaps and in-
efficiencies in nationwide public health sit-
uational awareness and biosurveillance ca-
pabilities, resources, and authorities need-
ed to address such gaps; and 
‘‘(iv) a strategy to minimize and ad-
dress such gaps and improve inefficien-
cies.’’; 
(G) in paragraph (7), as so redesignated— 
(i) in subparagraph (A), by inserting 
‘‘(taking into account zoonotic disease, in-
cluding gaps in scientific understanding of 
the interactions between human, animal, 
and environmental health)’’ after ‘‘human 
health’’; 
(ii) in subparagraph (B)— 
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(I) by inserting ‘‘and gaps in sur-
veillance programs’’ after ‘‘surveil-
lance programs’’; and 
(II) by striking ‘‘; and’’ and in-
serting a semicolon; 
(iii) in subparagraph (C)— 
(I) by inserting ‘‘, animal health 
organizations related to zoonotic dis-
ease,’’ after ‘‘health care entities’’; 
and 
(II) by striking the period and 
inserting ‘‘; and’’; and 
(iv) by adding at the end the fol-
lowing: 
‘‘(D) provide recommendations to the Sec-
retary on policies and procedures to complete 
the steps described in this paragraph in a man-
ner that is consistent with section 2802.’’; and 
(H) by adding at the end the following: 
‘‘(8) 
SITUATIONAL
AWARENESS
AND
BIO-
SURVEILLANCE
AS
A
NATIONAL
SECURITY
PRI-
ORITY.—The Secretary, on a periodic basis as appli-
cable and appropriate, shall meet with the Director 
of National Intelligence to inform the development 
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and capabilities of the nationwide public health situ-
ational 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 pro-
grams,’’ after ‘‘poison control centers,’’; 
and 
(B) in paragraph (2)— 
(i) in subparagraph (B), by striking 
‘‘and’’ at the end; 
(ii) in subparagraph (C), by striking 
the period and inserting ‘‘; and’’; and 
(iii) by adding after subparagraph (C) 
the following: 
‘‘(D) an implementation plan that may in-
clude measurable steps to achieve the purposes 
described in paragraph (1).’’; and 
(C) by striking paragraph (5) and insert-
ing the following: 
‘‘(5) TECHNICAL ASSISTANCE.—The Secretary 
may provide technical assistance to States, localities, 
tribes, and territories or a consortium of States, lo-
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calities, 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 fol-
lowing: 
‘‘(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 Cen-
ters 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 biosurveil-
lance and situational awareness, such as experts 
in informatics and data analytics (including ex-
perts 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 
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which individuals appointed under 9903 of title 
5, United States Code, are compensated, with-
out regard to the provisions of chapter 51 and 
subchapter III of chapter 53 of such title relat-
ing to classification and General Schedule pay 
rates. 
‘‘(2) LIMITATIONS.—The Secretary shall exer-
cise 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 Sep-
tember 30, 2023, and shall provide a justification to the 
congressional committees of jurisdiction for any missed or 
delayed implementation of measurable steps identified 
under subsection (c)(6)(A)(iii). 
‘‘(h) INDEPENDENT EVALUATION.—Not later than 3 
years after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation Act 
of 2018, the Comptroller General of the United States 
shall conduct an independent evaluation and submit to the 
Secretary and the congressional committees of jurisdiction 
a report concerning the activities conducted under sub-
sections (b) and (c), and provide recommendations, as ap-
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plicable and appropriate, on necessary improvements to 
the biosurveillance and situational awareness network.’’. 
(b) AUTHORIZATION
OF
APPROPRIATIONS.—Sub-
section (i) of section 319D (42 U.S.C. 247d–4), as redes-
ignated 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 coordi-
nation 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 Serv-
ices, 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 Fed-
eral biological threat detection efforts, including the fol-
lowing— 
(1) an identification of technological, oper-
ational, and programmatic successes and failures of 
domestic detection programs supported by Federal 
departments and agencies for intentionally-intro-
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duced 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 informa-
tion described in paragraph (1) among Federal de-
partments 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 col-
lection devices; 
(C) determine the geographical distribution 
of biological agents; 
(D) determine the extent of environmental 
contamination and persistence of biological 
agents; and 
(E) provide advanced molecular diagnostics 
to State, local, tribal, and territorial public 
health and other laboratories that support bio-
logical threat detection activities; 
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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 rap-
idly respond to the immediate needs result-
ing 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 terri-
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torial entities and public and private health 
care entities that the Secretary determines may 
be affected by a public health emergency or po-
tential public health emergency referred to in 
paragraph (1) (including communication of 
such entities with relevant international enti-
ties, as applicable); 
‘‘(B) make grants, provide for awards, 
enter into contracts, and conduct supportive in-
vestigations pertaining to a public health emer-
gency or potential public health emergency, in-
cluding further supporting programs under sec-
tion 319C–1, 319C–2, or 319C–3; 
‘‘(C) facilitate and accelerate, as applica-
ble, advanced research and development of secu-
rity 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 
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health emergency or potential public health 
emergency, including the systems under section 
319D; 
‘‘(E) support initial emergency operations 
and assets related to preparation and deploy-
ment of intermittent disaster response per-
sonnel under section 2812 and the Medical Re-
serve Corps under section 2813; and 
‘‘(F) carry out other activities, as the Sec-
retary 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 
2018, the Secretary, in coordination with the Assist-
ant 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 Com-
mittee on Appropriations of the House of Represent-
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atives on policies to improve such Fund for the uses 
described in paragraph (2). 
‘‘(5) GAO REPORT.—Not later than 4 years 
after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018, the Comptroller General of the United 
States shall— 
‘‘(A) conduct a review of the Fund under 
this section, including its uses and the re-
sources 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.’’. 
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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 in-
serting ‘‘VOLUNTEER HEALTH PROFESSIONAL’’; 
(2) in subsection (a), by adding at the end the 
following: ‘‘Such health care professionals may in-
clude members of the National Disaster Medical 
System, members of the Medical Reserve Corps, and 
individual health care professionals.’’; 
(3) in subsection (i) by adding at the end ‘‘In 
order to inform the development of such mechanisms 
by States, the Secretary shall make available infor-
mation and material provided by States that have 
developed mechanisms to waive the application of li-
censing requirements to applicable health profes-
sionals 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’’. 
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(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 mu-
tual aid agreement, for medical and public 
health mutual aid, and, as appropriate, the ac-
tivities such entity will implement pursuant to 
section 319I to improve enrollment and coordi-
nation 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 registra-
tion 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;’’. 
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SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN-
TEER HEALTH CARE PROFESSIONALS. 
(a) IN GENERAL.—Title II (42 U.S.C. 202 et seq.) 
is amended by inserting after section 224 the following: 
‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DUR-
ING 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 Ad-
vance Registration of Volunteer Health Professionals 
under section 319I and who— 
‘‘(1) is responding— 
‘‘(A) to a public health emergency deter-
mined under section 319(a), during the initial 
period of not more than 90 days (as determined 
by the Secretary) of the public health emer-
gency determination (excluding any period cov-
ered by a renewal of such determination); or 
‘‘(B) to a major disaster or an emergency 
as declared by the President under section 401 
of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5170) or 
under section 201 of the National Emergencies 
Act (50 U.S.C.1621) during the initial period of 
such declaration; and 
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‘‘(2) is alleged to be liable for an act or omis-
sion— 
‘‘(A) during the initial period of a deter-
mination or declaration described in paragraph 
(1) and related to the treatment of individuals 
in need of health care services due to such pub-
lic health emergency, major disaster, or emer-
gency; 
‘‘(B) in the State or States for which such 
determination or declaration is made; 
‘‘(C) in the health care professional’s ca-
pacity as a member of the Medical Reserve 
Corps or a professional included in the Emer-
gency System for Advance Registration of Vol-
unteer Health Professionals under section 319I; 
and 
‘‘(D) in the course of providing services 
that are within the scope of the license, reg-
istration, 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 omis-
sion, was authorized by the State’s authorization of 
deploying such State’s Emergency System for Ad-
vance Registration of Volunteer Health Professionals 
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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 man-
ner and to the same extent as a similar health care profes-
sional 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 profes-
sional 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 
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any individual working under the supervision of a 
health care professional, that relate to— 
‘‘(A) the diagnosis, prevention, or treat-
ment 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 ef-
fect 90 days after the date of the enactment of the 
Pandemic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018. 
‘‘(2) APPLICATION.—This section shall apply to 
a claim for harm only if the act or omission that 
caused such harm occurred on or after the effective 
date described in paragraph (1).’’. 
(b) GAO STUDY.—Not later than one year after the 
date of enactment of this Act, the Comptroller General 
of the United States shall conduct a review of— 
(1) the number of health care providers who 
register under the Emergency System for Advance 
Registration of Volunteer Health Professionals 
under section 319I of the Public Health Service Act 
(42 U.S.C. 247d–7b) in advance to provide services 
during a public health emergency; 
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(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 estab-
lished in the Emergency System for Advance Reg-
istration of Volunteer Health Professionals under 
such section 319I and those credentialed by authori-
ties within the State in which the emergency oc-
curred; 
(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 Ad-
vance Registration of Volunteer Health Professionals 
under such section 319I and for an individual’s cre-
dentials to be verified by an authority within the 
State; and 
(4) the Emergency System for Advance Reg-
istration of Volunteer Health Professionals program 
in States, including whether physician or medical 
groups, associations, or other relevant provider orga-
nizations utilize such program for purposes of volun-
teering during public health emergencies. 
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SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUP-
PLY. 
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 recommenda-
tions 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 trans-
mission monitoring system; and 
(4) other measures to promote safety and inno-
vation, such as the development, use, or implementa-
tion of new technologies, processes, and procedures 
to improve the safety and reliability of the blood 
supply. 
SEC. 210. REPORT ON THE PUBLIC HEALTH PREPARED-
NESS AND RESPONSE CAPABILITIES AND CA-
PACITIES OF HOSPITALS, LONG-TERM CARE 
FACILITIES, AND OTHER HEALTH CARE FA-
CILITIES. 
(a) STUDY.— 
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(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall enter 
into an agreement with an appropriate entity to con-
duct a study regarding the public health prepared-
ness and response capabilities and medical surge ca-
pacities of hospitals, long-term care facilities, and 
other health care facilities to prepare for, and re-
spond to, public health emergencies, including nat-
ural 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 bench-
marks 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 
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Hospital Preparedness Program, the Public 
Health Emergency Preparedness cooperative 
agreements, and the Regional Health Care 
Emergency Preparedness and Response Sys-
tems under section 319C–3 of the Public 
Health Service Act (as added by section 203); 
(B) the identification of gaps in prepared-
ness, 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 sys-
tems and other critical infrastructure partners 
during a public health emergency, to ensure a 
functioning critical infrastructure, to the great-
est 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 
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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 indi-
viduals during public health emergencies, in-
cluding an identification of gaps in such pre-
paredness as they relate to such individuals. 
(b) REPORT.— 
(1) IN GENERAL.—The agreement under sub-
section (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 pur-
suant to this section. 
(2) CONTENTS.—The report under paragraph 
(1) shall— 
(A) describe the findings and conclusions 
of the evaluation conducted pursuant to sub-
section (a); and 
(B) provide recommendations for improv-
ing public health preparedness and response ca-
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pability and medical surge capacity for hos-
pitals, 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 im-
proving public health preparedness and re-
sponse programs and medical surge capac-
ity at hospitals, long-term care facilities, 
and other health care facilities, including 
recommendations for the evaluation under 
subparagraphs (C) and (D) of subsection 
(a)(3). 
TITLE III—REACHING ALL 
COMMUNITIES 
SEC. 301. STRENGTHENING AND ASSESSING THE EMER-
GENCY RESPONSE WORKFORCE. 
(a) NATIONAL DISASTER MEDICAL SYSTEM.— 
(1) STRENGTHENING THE NATIONAL DISASTER 
MEDICAL
SYSTEM.—Clause 
(ii) 
of 
section 
2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is 
amended to read as follows: 
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‘‘(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 MED-
ICAL
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 CA-
PACITY STRATEGIC PLAN.— 
‘‘(A) REVIEW.—Not later than 180 days 
after the date of enactment of the Pandemic 
and All-Hazards Preparedness and Advancing 
Innovation Act of 2018, the Secretary, in co-
ordination with the Secretary of Homeland Se-
curity, the Secretary of Defense, and the Sec-
retary of Veterans Affairs, shall conduct a joint 
review of the National Disaster Medical System. 
Such review shall include— 
‘‘(i) an evaluation of medical surge ca-
pacity, as described in section 2803(a); 
‘‘(ii) an assessment of the available 
workforce of the intermittent disaster re-
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sponse personnel described in subsection 
(c); 
‘‘(iii) the capacity of the workforce de-
scribed in clause (ii) to respond to all haz-
ards, including capacity to simultaneously 
respond to multiple public health emer-
gencies and the capacity to respond to a 
nationwide public health emergency; 
‘‘(iv) the effectiveness of efforts to re-
cruit, retain, and train such workforce; and 
‘‘(v) gaps that may exist in such 
workforce and recommendations for ad-
dressing such gaps. 
‘‘(B) UPDATES.—As part of the National 
Health Security Strategy under section 2802, 
the Secretary shall update the findings from the 
review under subparagraph (A) and provide rec-
ommendations to modify the policies of the Na-
tional 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 
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of the National Disaster Medical System is insuffi-
cient to address a public health emergency or poten-
tial public health emergency, the Secretary shall sub-
mit 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 deter-
mines that the number of intermittent disaster 
response personnel within the National Disaster 
Medical System under this section is insuffi-
cient 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 po-
sitions within such system to the congressional 
committees of jurisdiction each quarter for 
which this authority is in effect. 
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‘‘(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 amend-
ed 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)— 
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(i) by inserting ‘‘or preparedness and 
response activities, including rapid re-
sponse to public health emergencies and 
significant public health threats’’ after 
‘‘conduct prevention activities’’; and 
(ii) by striking ‘‘$35,000’’ and insert-
ing ‘‘$50,000’’; and 
(B) in paragraph (2)(B), by striking ‘‘3 
years’’ and inserting ‘‘2 years’’; and 
(2) in subsection (c)— 
(A) by striking ‘‘For the purpose of car-
rying out this section’’ and inserting the fol-
lowing: 
‘‘(1) IN
GENERAL.—For the purpose of car-
rying out this section, except as described in para-
graph (2)’’; and 
(B) by adding at the end the following: 
‘‘(2) EPIDEMIC
INTELLIGENCE
SERVICE
PRO-
GRAM.—For purposes of carrying out this section 
with respect to qualified health professionals serving 
in the Epidemic Intelligence Service, as authorized 
under section 317G, there are authorized to be ap-
propriated $1,000,000 for each of fiscal years 2019 
through 2023.’’. 
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(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 eli-
gible for benefits under part L of title I of the Om-
nibus Crime Control and Safe Streets Act of 1968. 
The Secretary shall provide notification to any eligi-
ble 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.—Sec-
tion 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 Na-
tional Disaster Medical System under section 
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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 Med-
ical System; and 
‘‘(ii) determined by the Secretary of 
Health and Human Services to be haz-
ardous.’’. 
(3) SUNSET.—The amendments made by para-
graphs (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 sub-
mit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives, a report on the medical surge capacity of the 
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United States in the event of a public health emer-
gency, including the capacity and capability of the 
current health care workforce to prepare for, and re-
spond to the full range of public health emergencies 
or potential public health emergencies, and rec-
ommendations 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, in-
cluding members of the National Disaster Med-
ical 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 
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and the capacity to respond to a nationwide 
public health emergency; 
(C) the preparedness and response capa-
bilities and mission readiness of the workforce 
described in subparagraph (A) taking into ac-
count areas of health care expertise and consid-
erations 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 work-
force; and 
(E) identification of gaps that may exist in 
such workforce and recommendations for ad-
dressing such gaps, the extent to which the As-
sistant Secretary for Preparedness and Re-
sponse plans to address such gaps, and any rec-
ommendations from the Comptroller General to 
address such gaps. 
SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 
PREPAREDNESS AND RESPONSE. 
(a) COORDINATION
OF
PREPAREDNESS.—Section 
2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by 
adding at the end the following: ‘‘Such logistical support 
shall include working with other relevant Federal, State, 
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local, tribal, and territorial public health officials and pri-
vate sector entities to identify the critical infrastructure 
assets, systems, and networks needed for the proper func-
tioning 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 estab-
lishing methods to exchange critical information and de-
liver products consumed or used to preserve, protect, or 
sustain life, health, or safety, and sharing of specialized 
expertise.’’. 
(b) 
MANUFACTURING
CAPACITY.—Section 
2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 
by inserting ‘‘, and ancillary medical supplies to assist 
with the utilization of such countermeasures or products,’’ 
after ‘‘products’’. 
(c) EVALUATION OF BARRIERS TO RAPID DELIVERY 
OF MEDICAL COUNTERMEASURES.— 
(1) RAPID
DELIVERY
STUDY.—The Assistant 
Secretary for Preparedness and Response may con-
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duct a study on issues that have the potential to ad-
versely 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 Re-
sponse shall notify the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions 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 de-
cision. 
(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 Sen-
ate containing the findings of such study. 
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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 re-
searching 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 bio-
surveillance network under section 319D, the Sec-
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retary considers incorporating data and information 
from Federal, State, local, tribal, and territorial 
public health officials and entities relevant to detect-
ing emerging public health threats that may affect 
at-risk individuals, such as pregnant and postpartum 
women and infants, including adverse health out-
comes of such populations related to such emerging 
public health threats.’’. 
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 
RESPONSE 
CONSIDERATIONS 
FOR 
CHIL-
DREN. 
Part B of title III (42 U.S.C. 243 et seq.) is amended 
by inserting after section 319D the following: 
‘‘SEC. 319D–1. CHILDREN’S PREPAREDNESS UNIT. 
‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR 
CHILDREN.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention (re-
ferred to in this subsection as the ‘Director’), shall main-
tain an internal team of experts, to be known as the Chil-
dren’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, chil-
dren before, during, and after public health emergencies. 
The Unit shall inform the Director regarding emergency 
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preparedness and response efforts pertaining to children 
at the Centers for Disease Control and Prevention. 
‘‘(b) EXPERTISE.—The team described in subsection 
(a) shall include one or more pediatricians, which may be 
a developmental-behavioral pediatrician, and may also in-
clude behavioral scientists, child psychologists, epidemiolo-
gists, 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, identi-
fying, and sharing best practices; 
‘‘(2) provide technical assistance, training, and 
consultation to Federal, State, local, tribal, and ter-
ritorial public health officials to improve prepared-
ness and response capabilities with respect to the 
needs of children, including providing such technical 
assistance, training, and consultation to eligible enti-
ties in order to support the achievement of measur-
able evidence-based benchmarks and objective stand-
ards applicable to sections 319C–1 and 319C–2; 
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‘‘(3) improve the utilization of methods to in-
corporate 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-pri-
vate partnerships, such as health care coalitions pur-
suant 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 de-
velopment of guidance and clinical recommendations 
to address the needs of children when preparing for, 
and responding to, public health emergencies, includ-
ing pursuant to section 319C–3; and 
‘‘(6) carry out other duties related to prepared-
ness and response activities for children, as the Sec-
retary determines appropriate.’’. 
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISAS-
TERS. 
(a) REAUTHORIZING THE NATIONAL ADVISORY COM-
MITTEE 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)— 
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(A) in paragraph (1), by striking ‘‘15’’ and 
inserting ‘‘25’’; and 
(B) by striking paragraph (2) and insert-
ing the following: 
‘‘(2) REQUIRED NON-FEDERAL MEMBERS.—The 
Secretary, in consultation with such other heads of 
Federal agencies as may be appropriate, shall ap-
point 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 exper-
tise in pediatric disaster planning, prepared-
ness, 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 sur-
gery; the treatment of pediatric patients af-
fected by chemical, biological, radiological, or 
nuclear agents, including emerging infectious 
diseases; pediatric mental or behavioral health 
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related to children affected by a public health 
emergency; or pediatric primary care; and 
‘‘(D) other members as the Secretary de-
termines 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 Com-
mittee under paragraph (1) shall include the fol-
lowing Federal members or their designees (who 
may be non-voting members, as determined by the 
Secretary): 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
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‘‘(B) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
‘‘(C) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(D) The Commissioner of Food and 
Drugs. 
‘‘(E) The Director of the National Insti-
tutes of Health. 
‘‘(F) The Assistant Secretary of the Ad-
ministration for Children and Families. 
‘‘(G) The Administrator of the Health Re-
sources and Services Administration. 
‘‘(H) The Administrator of the Federal 
Emergency Management Agency. 
‘‘(I) The Administrator of the Administra-
tion 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 Sec-
retary determines appropriate to fulfill the du-
ties of the Advisory Committee under sub-
sections (b) and (c).’’. 
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‘‘(4) TERM OF APPOINTMENT.—Each member 
of the Advisory Committee appointed under para-
graph (2) shall serve for a term of 3 years, except 
that the Secretary may adjust the terms of the Advi-
sory Committee appointees serving on the date of 
enactment of the Pandemic and All-Hazards Pre-
paredness and Advancing Innovation Act of 2018, or 
appointees who are initially appointed after such 
date of enactment, in order to provide for a stag-
gered term of appointment for all members. 
‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM 
TERMS.—A member appointed under paragraph (2) 
may serve not more than 3 terms on the Advisory 
Committee, and not more than 2 of such terms may 
be served consecutively.’’; 
(3) in subsection (e), by adding at the end ‘‘At 
least one meeting per year shall be an in-person 
meeting.’’; 
(4) by redesignating subsection (f) as sub-
section (g); 
(5) by inserting after subsection (e) the fol-
lowing: 
‘‘(f) COORDINATION.—The Secretary shall coordinate 
duties and activities authorized under this section in ac-
cordance with section 2811D.’’; and 
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(6) in subsection (g), as so redesignated, by 
striking ‘‘2018’’ and inserting ‘‘2023’’. 
(b) AUTHORIZING THE NATIONAL ADVISORY COM-
MITTEE ON SENIORS AND DISASTERS.—Subtitle B of title 
XXVIII (42 U.S.C. 300hh et seq.) is amended by inserting 
after section 2811A the following: 
‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SEN-
IORS AND DISASTERS. 
‘‘(a) ESTABLISHMENT.—The Secretary, in consulta-
tion with the Secretary of Homeland Security and the Sec-
retary of Veterans Affairs, shall establish an advisory com-
mittee 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 re-
spect 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 re-
lated to preparation for, response to, and recovery 
from all-hazards emergencies; and 
‘‘(3) provide advice and consultation with re-
spect to State emergency preparedness and response 
activities relating to seniors, including related drills 
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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 pre-
paredness and response activities under this title and title 
III. 
‘‘(d) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with such other heads of agencies as appro-
priate, shall appoint not more than 17 members to 
the Advisory Committee. In appointing such mem-
bers, the Secretary shall ensure that the total mem-
bership of the Advisory Committee is an odd num-
ber. 
‘‘(2) 
REQUIRED
MEMBERS.—The 
Advisory 
Committee shall include Federal members or their 
designees (who may be non-voting members, as de-
termined by the Secretary) and non-Federal mem-
bers, as follows: 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
‘‘(B) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
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‘‘(C) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(D) The Commissioner of Food and 
Drugs. 
‘‘(E) The Director of the National Insti-
tutes of Health. 
‘‘(F) The Administrator of the Centers for 
Medicare & Medicaid Services. 
‘‘(G) The Administrator of the Administra-
tion 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 exper-
tise 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 
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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 ac-
cordance 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 INDIVID-
UALS WITH DISABILITIES AND DISASTERS.—Subtitle B 
of title XXVIII (42 U.S.C. 300hh et seq.), as amended 
by subsection (b), is further amended by inserting after 
section 2811B the following: 
‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVID-
UALS WITH DISABILITIES AND DISASTERS. 
‘‘(a) ESTABLISHMENT.—The Secretary, in consulta-
tion with the Secretary of Homeland Security, shall estab-
lish a national advisory committee to be known as the Na-
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tional Advisory Committee on Individuals with Disabilities 
and Disasters (referred to in this section as the ‘Advisory 
Committee’). 
‘‘(b) DUTIES.—The Advisory Committee shall— 
‘‘(1) provide advice and consultation with re-
spect 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 emer-
gencies; and 
‘‘(3) provide advice and consultation with re-
spect to State emergency preparedness and response 
activities, including related drills and exercises pur-
suant to the preparedness goals under section 
2802(b). 
‘‘(c) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with such other heads of agencies and depart-
ments as appropriate, shall appoint not more than 
17 members to the Advisory Committee. In appoint-
ing such members, the Secretary shall ensure that 
the total membership of the Advisory Committee is 
an odd number. 
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‘‘(2) 
REQUIRED
MEMBERS.—The 
Advisory 
Committee shall include Federal members or their 
designees (who may be non-voting members, as de-
termined by the Secretary) and non-Federal mem-
bers, as follows: 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
‘‘(B) The Administrator of the Administra-
tion for Community Living. 
‘‘(C) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
‘‘(D) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(E) The Commissioner of Food and 
Drugs. 
‘‘(F) The Director of the National Insti-
tutes 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. 
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‘‘(K) At least 2 non-Federal health care 
professionals with expertise in disability accessi-
bility before, during, and after disasters, med-
ical and mass care disaster planning, prepared-
ness, response, or recovery. 
‘‘(L) At least 2 representatives from State, 
local, tribal, or territorial agencies with exper-
tise in disaster planning, preparedness, re-
sponse, or recovery for individuals with disabil-
ities. 
‘‘(M) At least 2 individuals with a dis-
ability with expertise in disaster planning, pre-
paredness, response, or recovery for individuals 
with disabilities. 
‘‘(d) MEETINGS.—The Advisory Committee shall 
meet not less frequently than biannually. At least one 
meeting per year shall be an in-person meeting. 
‘‘(e) DISABILITY DEFINED.—For purposes of this 
section, the term ‘disability’ has the meaning given such 
term in section 3 of the Americans with Disabilities Act 
of 1990. 
‘‘(f) COORDINATION.—The Secretary shall coordinate 
duties and activities authorized under this section in ac-
cordance with section 2811D. 
‘‘(g) SUNSET.— 
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‘‘(1) IN
GENERAL.—The Advisory Committee 
shall terminate on September 30, 2023. 
‘‘(2) RECOMMENDATION.—Not later than Octo-
ber 1, 2022, the Secretary shall submit to Congress 
a recommendation on whether the Advisory Com-
mittee should be extended.’’. 
(d) ADVISORY COMMITTEE COORDINATION.—Sub-
title B of title XXVIII (42 U.S.C. 300hh et seq.), as 
amended by subsection (c), is further amended by insert-
ing 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 unneces-
sary or duplicative reporting, or unnecessary duplicative 
meetings and recommendations under such sections, as 
practicable. Members of the advisory committees author-
ized under such sections, or their designees, shall annually 
meet to coordinate any recommendations, as appropriate, 
that may be similar, duplicative, or overlapping with re-
spect to addressing the needs of children, seniors, and in-
dividuals with disabilities during public health emer-
gencies. If such coordination occurs through an in-person 
meeting, it shall not be considered the required in-person 
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meetings under any of sections 2811A(e), 2811B(e), or 
2811C(d). 
‘‘(b) COORDINATION
AND ALIGNMENT.—The Sec-
retary, acting through the employee designated pursuant 
to section 2814, shall align preparedness and response 
programs or activities to address similar, dual, or overlap-
ping needs of children, seniors, and individuals with dis-
abilities, and any challenges in preparing for and respond-
ing to such needs. 
‘‘(c) NOTIFICATION.—The Secretary shall annually 
notify the congressional committees of jurisdiction regard-
ing the steps taken to coordinate, as appropriate, the rec-
ommendations under this section, and provide a summary 
description of such coordination.’’. 
SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 
AND DRILLS. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall issue final guidance regarding the ability of per-
sonnel funded by programs authorized under this Act (in-
cluding 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 
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countermeasure distribution and administration, and pre-
paring for and responding to identified threats for that 
region. Such personnel may include State, local, tribal, 
and territorial public health department or agency per-
sonnel 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 inter-
net website of the Department of Health and Human 
Services. 
TITLE IV—PRIORITIZING A 
THREAT-BASED APPROACH 
SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 
RESPONSE. 
Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend-
ed— 
(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 
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(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 Na-
tional Intelligence, the Secretary of Homeland 
Security, the Assistant to the President for Na-
tional Security Affairs, the Secretary of De-
fense, 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 capabili-
ties based on the range of the threats that have 
the potential to result in a public health emer-
gency.’’. 
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE. 
(a) IN GENERAL.—Title XXVIII is amended by in-
serting after section 2811 (42 U.S.C. 300hh–10) the fol-
lowing: 
‘‘SEC. 
2811–1. 
PUBLIC 
HEALTH 
EMERGENCY 
MEDICAL 
COUNTERMEASURES ENTERPRISE. 
‘‘(a) IN GENERAL.—The Secretary shall establish the 
Public Health Emergency Medical Countermeasures En-
terprise (referred to in this section as the ‘PHEMCE’). 
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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 mem-
bers: 
‘‘(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 Bio-
medical Advanced Research and Development Au-
thority, the Director of the Strategic National Stock-
pile, the Director of the National Institute of Allergy 
and Infectious Diseases, and the Director of the Of-
fice of Public Health Preparedness and Response, as 
the Secretary determines appropriate. 
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‘‘(c) FUNCTIONS.— 
‘‘(1) IN
GENERAL.—The functions of the 
PHEMCE shall include the following: 
‘‘(A) Utilize a process to make rec-
ommendations to the Secretary regarding re-
search, advanced research, development, pro-
curement, 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 prac-
ticable, the National Health Security Strategy 
pursuant to section 2802, the Strategic Na-
tional 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 prepared-
ness and response related to countermeasures 
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and challenges to addressing such needs (in-
cluding 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, dis-
tribution, dispensing, and use of counter-
measures that may be applicable to the activi-
ties of the strategic national stockpile under 
section 319F–2(a). 
‘‘(D) Provide consultation for the develop-
ment 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 COUN-
TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN-
TATION PLAN.—Section 2811(d) (42 U.S.C. 300hh– 
10(d)) is amended— 
(1) in paragraph (1)— 
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(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 Bio-
medical’’ and all that follows through ‘‘Food 
and Drugs’’ and inserting ‘‘Public Health 
Emergency Medical Countermeasures Enter-
prise established under section 2811–1’’; and 
(2) in paragraph (2)(J)(v), by striking ‘‘one- 
year period’’ and inserting ‘‘2-year period’’. 
SEC. 403. STRATEGIC NATIONAL STOCKPILE. 
(a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 
247d–6b(a)) is amended— 
(1) by redesignating paragraphs (2) and (3) as 
paragraphs (3) and (4), respectively; and 
(2) in paragraph (1)— 
(A) by inserting ‘‘the Assistant Secretary 
for Preparedness and Response and’’ after ‘‘col-
laboration with’’; 
(B) by inserting ‘‘and optimize’’ after 
‘‘provide for’’; 
(C) by inserting ‘‘and, as informed by ex-
isting recommendations of, or consultations 
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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 fol-
lowing: 
‘‘(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 consulta-
tion 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 pur-
suant 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 Com-
mittee on Health, Education, Labor, and Pen-
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sions and the Committee on Appropriations of 
the Senate and the Committee on Energy and 
Commerce and the Committee on Appropria-
tions of the House of Representatives, in a 
manner that does not compromise national se-
curity. 
‘‘(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 addi-
tional or modified countermeasure 
procured for, or contracted to be pro-
cured for, the stockpile; 
‘‘(II) planning considerations for 
appropriate manufacturing capacity 
and capability to meet the goals of 
such additions or modifications (with-
out disclosing proprietary informa-
tion), including consideration of the 
effect such additions or modifications 
may have on the availability of such 
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products and ancillary medical sup-
plies in the health care system; 
‘‘(III) the presence or lack of a 
commercial market for the counter-
measure at the time of procurement; 
‘‘(IV) the emergency health secu-
rity threat or threats such counter-
measure procurement is intended to 
address, including whether such pro-
curement is consistent with meeting 
emergency health security needs asso-
ciated with such threat or threats; 
‘‘(V) an assessment of whether 
the emergency health security threat 
or threats described in subclause (IV) 
could be addressed in a manner that 
better utilizes the resources of the 
stockpile and permits the greatest 
possible increase in the level of emer-
gency preparedness to address such 
threats; 
‘‘(VI) 
whether 
such 
counter-
measure is replenishing an expiring or 
expired countermeasure, is a different 
countermeasure with the same indica-
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tion that is replacing an expiring or 
expired countermeasure, or is a new 
addition to the stockpile; 
‘‘(VII) a description of how such 
additions or modifications align with 
projected investments under previous 
countermeasures budget plans under 
section 2811(b)(7), including expected 
life-cycle costs, expenditures related to 
countermeasure procurement to ad-
dress the threat or threats described 
in subclause (IV), replenishment dates 
(including the ability to extend the 
maximum shelf life of a counter-
measure), and the manufacturing ca-
pacity required to replenish such 
countermeasure; and 
‘‘(VIII) appropriate protocols and 
processes for the deployment, distribu-
tion, or dispensing of the counter-
measure at the State and local level, 
including plans for relevant capabili-
ties of State and local entities to dis-
pense, distribute, and administer the 
countermeasure; and 
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‘‘(ii) an assurance, which need not be 
provided in advance of procurement, that 
for each countermeasure procured or re-
plenished under this subsection, the Sec-
retary completed a review addressing each 
item listed under this subsection in ad-
vance of such procurement or replenish-
ment.’’; 
(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 Assist-
ant Secretary for Preparedness and Response, 
the Secretary of Transportation, the Secretary 
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of Homeland Security, the Secretary of Vet-
erans Affairs, and the heads of other appro-
priate 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 appro-
priate alternatives to supplies in the stockpile;’’; 
(D) in subparagraph (G), by striking ‘‘; 
and’’ and inserting a semicolon; 
(E) in subparagraph (H), by striking the 
period and inserting a semicolon; and 
(F) by adding at the end the following: 
‘‘(I) ensure that each countermeasure or 
product under consideration for procurement 
pursuant to this subsection receives the same 
consideration regardless of whether such coun-
termeasure or product receives or had received 
funding under section 319L, including with re-
spect 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 
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distribute 
and 
dispense 
medical 
counter-
measures and products from the stockpile, as 
appropriate.’’; and 
(5) by adding at the end the following: 
‘‘(5) GAO REPORT.— 
‘‘(A) IN GENERAL.—Not later than 3 years 
after the date of enactment of the Pandemic 
and All-Hazards Preparedness and Advancing 
Innovation Act of 2018, and every 5 years 
thereafter, the Comptroller General of the 
United States shall conduct a review of any 
changes to the contents or management of the 
stockpile since January 1, 2015. Such review 
shall include— 
‘‘(i) an assessment of the comprehen-
siveness and completeness of each annual 
threat-based review under paragraph (2), 
including whether all newly procured or re-
plenished 
countermeasures 
within 
the 
stockpile were described in each annual re-
view, and whether, consistent with para-
graph (2)(B), the Secretary conducted the 
necessary internal review in advance of 
such procurement or replenishment; 
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‘‘(ii) an assessment of whether the 
Secretary established health security and 
science-based justifications, and a descrip-
tion 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 replenish-
ment; 
‘‘(iii) an assessment of the plans de-
veloped by the Secretary for the deploy-
ment, distribution, and dispensing of coun-
termeasures procured, modified, or replen-
ished under paragraph (1), including 
whether such plans were developed prior to 
procurement, modification, or replenish-
ment; 
‘‘(iv) 
an 
accounting 
of 
counter-
measures procured, modified, or replen-
ished under paragraph (1) that received 
advanced research and development fund-
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ing from the Biomedical Advanced Re-
search and Development Authority; 
‘‘(v) an analysis of how such procure-
ment decisions made progress toward 
meeting emergency health security needs 
related to the identified threats for coun-
termeasures added, modified, or replen-
ished under paragraph (1); 
‘‘(vi) a description of the resources ex-
pended related to the procurement of coun-
termeasures (including additions, modifica-
tions, 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 replen-
ishments reviewed under paragraph (2) 
align with previous relevant reports or re-
views by the Secretary or the Comptroller 
General; 
‘‘(viii) with respect to any change in 
the Federal organizational management of 
the stockpile, an assessment and compari-
son of the processes affected by such 
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change, including planning for potential 
countermeasure deployment, distribution, 
or dispensing capabilities and processes re-
lated to procurement decisions, use of 
stockpiled countermeasures, and use of re-
sources 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 Prepared-
ness and Advancing Innovation Act of 
2018 are sufficient to ensure counter-
measures 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 Comp-
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troller General shall submit an unclassified 
version of the review to the congressional com-
mittees of jurisdiction.’’. 
(b) ADDITIONAL REPORTING.—In the first threat- 
based review submitted after the date of enactment of this 
Act pursuant to paragraph (2) of section 319F–2(a) of 
the Public Health Service Act (42 U.S.C. 247d–6b(a)), as 
amended by subsection (a), the Secretary shall include a 
description of the processes and procedures through which 
the Director of Strategic National Stockpile and the Di-
rector of the Biomedical Advanced Research and Develop-
ment Authority coordinate with respect to counter-
measures and products procured under such section 
319F–2(a), including such processes and procedures in 
place to ensure countermeasures and products under con-
sideration 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 coun-
termeasures and products are the most appropriate to 
meet the emergency health security needs of the United 
States. 
(c) AUTHORIZATION
OF APPROPRIATIONS, STRA-
TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 
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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 ex-
pended’’. 
SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI-
MICROBIAL RESISTANCE, AND OTHER SIG-
NIFICANT THREATS. 
(a) STRATEGIC INITIATIVES.—Section 319L(c)(4) 
(247d–7e(c)(4)) is amended by adding at the end the fol-
lowing: 
‘‘(F) STRATEGIC
INITIATIVES.—The Sec-
retary, acting through the Director of BARDA, 
may implement strategic initiatives, including 
by building on existing programs and by award-
ing contracts, grants, and cooperative agree-
ments, or entering into other transactions, to 
support innovative candidate products in pre-
clinical 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 secu-
rity based on the characteristics of a chemical, 
biological, radiological or nuclear threat, or ex-
isting capabilities to respond to such a threat 
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(including medical response and treatment ca-
pabilities and manufacturing infrastructure). 
Such initiatives shall accelerate and support the 
advanced research, development, and procure-
ment of, countermeasures and products, as ap-
plicable, to address areas including— 
‘‘(i) chemical, biological, radiological, 
or nuclear threats, including emerging in-
fectious diseases, for which insufficient ap-
proved, licensed, or authorized counter-
measures 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 ren-
dered 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, manu-
facturing, and appropriate stockpiling of 
qualified pandemic or epidemic products, 
and products, technologies, or processes to 
support the advanced research and devel-
opment of such countermeasures (including 
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multiuse 
platform 
technologies 
for 
diagnostics, vaccines, and therapeutics; 
virus seeds; clinical trial lots; novel virus 
strains; and antigen and adjuvant mate-
rial); and 
‘‘(iii) threats that may result pri-
marily or secondarily from a chemical, bio-
logical, radiological, or nuclear agent, or 
emerging infectious diseases, and which 
may present increased treatment complica-
tions 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 ac-
tivities to address threats, including pandemic influ-
enza and which may include a chemical, biological, 
radiological, or nuclear agent (including any such 
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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 re-
quirements associated with such reference. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘master file holder’ means a per-
son who submits data and information to the Sec-
retary with the intent to reference or authorize an-
other person to reference such data or information 
to support a medical countermeasure submission, as 
described in subsection (a). 
‘‘(2) The term ‘medical countermeasure submis-
sion’ means an investigational new drug application 
under section 505(i), a new drug application under 
section 505(b), or an abbreviated new drug applica-
tion 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 biologi-
cal 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 
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‘‘(i) the reordering of existing information 
in the drug facts label of an OTC monograph 
drug; 
‘‘(ii) the addition of information to the 
other information section of the drug facts label 
of an OTC monograph drug, as limited by sec-
tion 201.66(c)(7) of title 21, Code of Federal 
Regulations (or any successor regulations); 
‘‘(iii) modification to the directions for use 
section of the drug facts label of an OTC mono-
graph drug, if such changes conform to changes 
made pursuant to section 505G(c)(3)(A); 
‘‘(iv) the standardization of the concentra-
tion or dose of a specific finalized ingredient 
within a particular finalized monograph; 
‘‘(v) a change to ingredient nomenclature 
to align with nomenclature of a standards-set-
ting organization; or 
‘‘(vi) addition of an interchangeable term 
in accordance with section 330.1 of title 21, 
Code of Federal Regulations (or any successor 
regulations). 
‘‘(B) The Secretary may, based on program im-
plementation experience or other factors found ap-
propriate by the Secretary, characterize any OTC 
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