S. 1379 

One Hundred Sixteenth Congress 

of the 

United States of America 

AT THE FIRST SESSION 

Begun and held at the City of Washington on Thursday, 

the third day of January, two thousand and nineteen 

An Act 

To reauthorize certain programs under the Public Health Service Act and the 

Federal Food, Drug, and Cosmetic Act with respect to public health security 

and all-hazards preparedness and response, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘Pandemic 

and All-Hazards Preparedness and Advancing Innovation Act of 

2019’’. 

(b) TABLE OF CONTENTS.—The table of contents for this Act 

is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. References in Act. 

TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY 

Sec. 101. National Health Security Strategy. 

TITLE II—IMPROVING PREPAREDNESS AND RESPONSE 

Sec. 201. Improving benchmarks and standards for preparedness and response. 

Sec. 202. Amendments to preparedness and response programs. 

Sec. 203. Regional health care emergency preparedness and response systems. 

Sec. 204. Military and civilian partnership for trauma readiness. 

Sec. 205. Public health and health care system situational awareness and biosurveillance capabilities. 

Sec. 206. Strengthening and supporting the public health emergency rapid response fund. 

Sec. 207. Improving all-hazards preparedness and response by public health emergency volunteers. 

Sec. 208. Clarifying State liability law for volunteer health care professionals. 

Sec. 209. Report on adequate national blood supply. 

Sec. 210. Report on the public health preparedness and response capabilities and 

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

facilities. 

TITLE III—REACHING ALL COMMUNITIES 

Sec. 301. Strengthening and assessing the emergency response workforce. 

Sec. 302. Health system infrastructure to improve preparedness and response. 

Sec. 303. Considerations for at-risk individuals. 

Sec. 304. Improving emergency preparedness and response considerations for children. 

Sec. 305. National advisory committees on disasters. 

Sec. 306. Guidance for participation in exercises and drills. 

TITLE IV—PRIORITIZING A THREAT-BASED APPROACH 

Sec. 401. Assistant Secretary for Preparedness and Response. 

Sec. 402. Public Health Emergency Medical Countermeasures Enterprise. 

Sec. 403. Strategic National Stockpile. 

Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other significant threats. 
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Sec. 405. Reporting on the Federal Select Agent Program. 

TITLE V—INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE 

ADVANCED RESEARCH AND DEVELOPMENT 

Sec. 501. Medical countermeasure budget plan. 

Sec. 502. Material threat and medical countermeasure notifications. 

Sec. 503. Availability of regulatory management plans. 

Sec. 504. The Biomedical Advanced Research and Development Authority and the 

BioShield Special Reserve Fund. Sec. 505. Additional strategies for combating antibiotic resistance. 

TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 

COUNTERMEASURES 

Sec. 601. Administration of countermeasures. 

Sec. 602. Updating definitions of other transactions. 

Sec. 603. Medical countermeasure master files. 

Sec. 604. Animal rule report. 

Sec. 605. Review of the benefits of genomic engineering technologies and their potential role in national security. Sec. 606. Report on vaccines development. 

Sec. 607. Strengthening mosquito abatement for safety and health. 

TITLE VII—MISCELLANEOUS PROVISIONS 

Sec. 701. Reauthorizations and extensions. 

Sec. 702. Location of materials in the stockpile. 

Sec. 703. Cybersecurity. 

Sec. 704. Strategy and report. 

Sec. 705. Technical amendments. 

SEC. 2. REFERENCES IN ACT. 

Except as otherwise specified, amendments made by this Act 

to a section or other provision of law are amendments to such 

section or other provision of the Public Health Service Act (42 

U.S.C. 201 et seq.). 

TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY 

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

Section 2802 (42 U.S.C. 300hh–1) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) by striking ‘‘2014’’ and inserting ‘‘2018’’; and 

(ii) by striking the second sentence and inserting 

the following: ‘‘Such National Health Security Strategy 

shall describe potential emergency health security 

threats and identify the process for achieving the 

preparedness goals described in subsection (b) to be 

prepared to identify and respond to such threats and 

shall be consistent with the national preparedness goal 

(as described in section 504(a)(19) of the Homeland 

Security Act of 2002), the National Incident Management System (as defined in section 501(7) of such 

Act), and the National Response Plan developed pursuant to section 504 of such Act, or any successor plan.’’; 

(B) in paragraph (2), by inserting before the period 

at the end of the second sentence the following: ‘‘, and 

an analysis of any changes to the evidence-based benchmarks and objective standards under sections 319C–1 and 

319C–2’’; and 
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(C) in paragraph (3)— 

(i) by striking ‘‘2009’’ and inserting ‘‘2022’’; 

(ii) by inserting ‘‘(including gaps in the environmental health and animal health workforces, as 

applicable), describing the status of such workforce’’ 

after ‘‘gaps in such workforce’’; 

(iii) by striking ‘‘and identifying strategies’’ and 

inserting ‘‘identifying strategies’’; and 

(iv) by inserting before the period at the end ‘‘, 

and identifying current capabilities to meet the 

requirements of section 2803’’; and 

(2) in subsection (b)— 

(A) in paragraph (2)— 

(i) in subparagraph (A), by striking ‘‘and investigation’’ and inserting ‘‘investigation, and related information technology activities’’; 

(ii) in subparagraph (B), by striking ‘‘and decontamination’’ and inserting ‘‘decontamination, relevant 

health care services and supplies, and transportation 

and disposal of medical waste’’; and 

(iii) by adding at the end the following: 

‘‘(E) Response to environmental hazards.’’; 

(B) in paragraph (3)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘including mental health’’ and inserting 

‘‘including pharmacies, mental health facilities,’’; and 

(ii) in subparagraph (F), by inserting ‘‘or exposures 

to agents that could cause a public health emergency’’ 

before the period; 

(C) in paragraph (5), by inserting ‘‘and other applicable 

compacts’’ after ‘‘Compact’’; and 

(D) by adding at the end the following: 

‘‘(9) ZOONOTIC DISEASE, FOOD, AND AGRICULTURE.— Improving coordination among Federal, State, local, Tribal, and 

territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) 

that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional 

adulteration of food, or other public health threats, taking 

into account interactions between animal health, human health, 

and animals’ and humans’ shared environment as directly 

related to public health emergency preparedness and response 

capabilities, as applicable. 

‘‘(10) GLOBAL HEALTH SECURITY.—Assessing current or 

potential health security threats from abroad to inform domestic 

public health preparedness and response capabilities.’’. 

TITLE II—IMPROVING PREPAREDNESS 

AND RESPONSE 

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

(a) EVALUATING MEASURABLE EVIDENCE-BASED BENCHMARKS

AND OBJECTIVE STANDARDS.—Section 319C–1 (42 U.S.C. 247d–3a) 

is amended by inserting after subsection (j) the following: 
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‘‘(k) EVALUATION.— ‘‘(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of the Pandemic and All-Hazards Preparedness 

and Advancing Innovation Act of 2019 and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidencebased benchmarks and objective standards required under subsection (g). Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National 

Health Security Strategy under section 2802, at such time 

as such strategy is submitted. 

‘‘(2) CONTENT.—The evaluation under this paragraph shall 

include— 

‘‘(A) a review of evidence-based benchmarks and objective standards, and associated metrics and targets; 

‘‘(B) a discussion of changes to any evidence-based 

benchmarks and objective standards, and the effect of such 

changes on the ability to track whether entities are meeting 

or making progress toward the goals under this section 

and, to the extent practicable, the applicable goals of the 

National Health Security Strategy under section 2802; 

‘‘(C) a description of amounts received by eligible entities described in subsection (b) and section 319C–2(b), and 

amounts received by subrecipients and the effect of such 

funding on meeting evidence-based benchmarks and objective standards; and 

‘‘(D) recommendations, as applicable and appropriate, 

to improve evidence-based benchmarks and objective standards to more accurately assess the ability of entities 

receiving awards under this section to better achieve the 

goals under this section and section 2802.’’. 

(b) EVALUATING THE PARTNERSHIP FOR STATE AND REGIONAL

HOSPITAL PREPAREDNESS.—Section 319C–2(i)(1) (42 U.S.C. 247– 

3b(i)(1)) is amended by striking ‘‘section 319C–1(g), (i), and (j)’’ 

and inserting ‘‘section 319C–1(g), (i), (j), and (k)’’. 

SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS. 

(a) COOPERATIVE AGREEMENT APPLICATIONS FOR IMPROVING

STATE AND LOCAL PUBLIC HEALTH SECURITY.—Section 319C–1 (42 

U.S.C. 247d–3a) is amended— 

(1) in subsection (a), by inserting ‘‘, acting through the 

Director of the Centers for Disease Control and Prevention,’’ 

after ‘‘the Secretary’’; and 

(2) in subsection (b)(2)(A)— 

(A) in clause (vi), by inserting ‘‘, including public health 

agencies with specific expertise that may be relevant to 

public health security, such as environmental health agencies,’’ after ‘‘stakeholders’’; 

(B) by redesignating clauses (vii) through (ix) as clauses 

(viii) through (x); 

(C) by inserting after clause (vi) the following: 

‘‘(vii) a description of how, as applicable, such 

entity may integrate information to account for individuals with behavioral health needs following a public 

health emergency;’’; 

(D) in clause (ix), as so redesignated, by striking ‘‘; 

and’’ and inserting a semicolon; and 
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(E) by adding at the end the following: 

‘‘(xi) a description of how the entity will partner 

with health care facilities, including hospitals and 

nursing homes and other long-term care facilities, to 

promote and improve public health preparedness and 

response; and 

‘‘(xii) a description of how, as appropriate and practicable, the entity will include critical infrastructure 

partners, such as utility companies within the entity’s 

jurisdiction, in planning pursuant to this subparagraph 

to help ensure that critical infrastructure will remain 

functioning during, or return to function as soon as 

practicable after, a public health emergency;’’. 

(b) EXCEPTION RELATING TO APPLICATION OF CERTAIN REQUIRE- MENTS.— 

(1) IN GENERAL.—Section 319C–1(g) (42 U.S.C. 247d–3a(g)) 

is amended— 

(A) in paragraph (5)— 

(i) in the matter preceding subparagraph (A), by 

striking ‘‘Beginning with fiscal year 2009’’ and 

inserting ‘‘Beginning with fiscal year 2019’’; and 

(ii) in subparagraph (A)— 

(I) by striking ‘‘for the immediately preceding 

fiscal year’’ and inserting ‘‘for either of the 2 immediately preceding fiscal years’’; and 

(II) by striking ‘‘2008’’ and inserting ‘‘2018’’; 

and 

(B) in paragraph (6), by amending subparagraph (A) 

to read as follows: 

‘‘(A) IN GENERAL.—The amounts described in this paragraph are the following amounts that are payable to an 

entity for activities described in this section or section 

319C–2: 

‘‘(i) For no more than one of each of the first 

2 fiscal years immediately following a fiscal year in 

which an entity experienced a failure described in 

subparagraph (A) or (B) of paragraph (5), an amount 

equal to 10 percent of the amount the entity was 

eligible to receive for the respective fiscal year. 

‘‘(ii) For no more than one of the first 2 fiscal 

years immediately following the third consecutive fiscal 

year in which an entity experienced such a failure, 

in lieu of applying clause (i), an amount equal to 15 

percent of the amount the entity was eligible to receive 

for the respective fiscal year.’’. 

(2) EFFECTIVE DATE.—The amendments made by paragraph 

(1) shall apply with respect to cooperative agreements awarded 

on or after the date of enactment of this Act. 

(c) PARTNERSHIP FOR STATE AND REGIONAL HOSPITAL

PREPAREDNESS TO IMPROVE SURGE CAPACITY.—Section 319C–2 (42 

U.S.C. 247d–3b) is amended— 

(1) in subsection (a)— 

(A) by inserting ‘‘, acting through the Assistant Secretary for Preparedness and Response,’’ after ‘‘The Secretary’’; and 

(B) by striking ‘‘preparedness for public health emergencies’’ and inserting ‘‘preparedness for, and response to, 
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public health emergencies in accordance with subsection 

(c)’’; 

(2) in subsection (b)(1)(A)— 

(A) by striking ‘‘partnership consisting of’’ and inserting 

‘‘coalition that includes’’; 

(B) in clause (ii), by striking ‘‘; and’’ and inserting 

a semicolon; and 

(C) by adding at the end the following: 

‘‘(iv) one or more emergency medical service organizations or emergency management organizations; and’’; 

(3) in subsection (d)— 

(A) in paragraph (1)(B), by striking ‘‘partnership’’ each 

place it appears and inserting ‘‘coalition’’; and 

(B) in paragraph (2)(C), by striking ‘‘medical preparedness’’ and inserting ‘‘preparedness and response’’; 

(4) in subsection (f), by striking ‘‘partnership’’ and inserting 

‘‘coalition’’; 

(5) in subsection (g)(2)— 

(A) by striking ‘‘Partnerships’’ and inserting ‘‘Coalitions’’; 

(B) by striking ‘‘partnerships’’ and inserting ‘‘coalitions’’; and 

(C) by inserting ‘‘and response’’ after ‘‘preparedness’’; 

and 

(6) in subsection (i)(1)— 

(A) by striking ‘‘An entity’’ and inserting ‘‘A coalition’’; 

and 

(B) by striking ‘‘such partnership’’ and inserting ‘‘such 

coalition’’. 

(d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZATION OF

APPROPRIATIONS.—Section 319C–1(h)(1)(A) (42 U.S.C. 247d– 

3a(h)(1)(A)) is amended by striking ‘‘$641,900,000 for fiscal year 

2014’’ and all that follows through the period at the end and 

inserting ‘‘$685,000,000 for each of fiscal years 2019 through 2023 

for awards pursuant to paragraph (3) (subject to the authority 

of the Secretary to make awards pursuant to paragraphs (4) and 

(5)).’’. 

(e) PARTNERSHIP FOR STATE AND REGIONAL HOSPITAL

PREPAREDNESS AUTHORIZATION OF APPROPRIATIONS.—Section 319C– 

2(j) (42 U.S.C. 247d–3b(j)) is amended— 

(1) by amending paragraph (1) to read as follows: 

‘‘(1) IN GENERAL.— 

‘‘(A) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section and section 319C–3, in 

accordance with subparagraph (B), there is authorized to 

be appropriated $385,000,000 for each of fiscal years 2019 

through 2023. 

‘‘(B) RESERVATION OF AMOUNTS FOR REGIONAL SYSTEMS.— 

‘‘(i) IN GENERAL.—Subject to clause (ii), of the 

amount appropriated under subparagraph (A) for a 

fiscal year, the Secretary may reserve up to 5 percent 

for the purpose of carrying out section 319C–3. 

‘‘(ii) RESERVATION CONTINGENT ON CONTINUED

APPROPRIATIONS FOR THIS SECTION.—If for fiscal year 

2019 or a subsequent fiscal year, the amount appropriated under subparagraph (A) is such that, after 
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application of clause (i), the amount remaining for 

the purpose of carrying out this section would be less 

than the amount available for such purpose for the 

previous fiscal year, the amount that may be reserved 

under clause (i) shall be reduced such that the amount 

remaining for the purpose of carrying out this section 

is not less than the amount available for such purpose 

for the previous fiscal year. 

‘‘(iii) SUNSET.—The authority to reserve amounts 

under clause (i) shall expire on September 30, 2023.’’; 

(2) in paragraph (2), by striking ‘‘paragraph (1) for a fiscal 

year’’ and inserting ‘‘paragraph (1)(A) for a fiscal year and 

not reserved for the purpose described in paragraph (1)(B)(i)’’; 

and 

(3) in paragraph (3)(A), by striking ‘‘paragraph (1) and 

not reserved under paragraph (2)’’ and inserting ‘‘paragraph 

(1)(A) and not reserved under paragraph (1)(B)(i) or (2)’’. 

SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND 

RESPONSE SYSTEMS. 

(a) IN GENERAL.—Part B of title III (42 U.S.C. 243 et seq.) 

is amended by inserting after section 319C–2 the following: 

‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY 

PREPAREDNESS AND RESPONSE SYSTEMS. 

‘‘(a) PURPOSE.—It is the purpose of this section to identify 

and provide guidelines for regional systems of hospitals, health 

care facilities, and other public and private sector entities, with 

varying levels of capability to treat patients and increase medical 

surge capacity during, in advance of, and immediately following 

a public health emergency, including threats posed by one or more 

chemical, biological, radiological, or nuclear agents, including 

emerging infectious diseases. 

‘‘(b) GUIDELINES.—The Assistant Secretary for Preparedness 

and Response, in consultation with the Director of the Centers 

for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Administrator of the 

Health Resources and Services Administration, the Commissioner 

of Food and Drugs, the Assistant Secretary for Mental Health 

and Substance Use, the Assistant Secretary of Labor for Occupational Safety and Health, the Secretary of Veterans Affairs, the 

heads of such other Federal agencies as the Secretary determines 

to be appropriate, and State, local, Tribal, and territorial public 

health officials, shall, not later than 2 years after the date of 

enactment of this section— 

‘‘(1) identify and develop a set of guidelines relating to 

practices and protocols for all-hazards public health emergency 

preparedness and response for hospitals and health care facilities to provide appropriate patient care during, in advance 

of, or immediately following, a public health emergency, 

resulting from one or more chemical, biological, radiological, 

or nuclear agents, including emerging infectious diseases (which 

may include existing practices, such as trauma care and medical 

surge capacity and capabilities), with respect to— 

‘‘(A) a regional approach to identifying hospitals and 

health care facilities based on varying capabilities and 

capacity to treat patients affected by such emergency, 

including— 
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‘‘(i) the manner in which the system will coordinate 

with and integrate the partnerships and health care 

coalitions established under section 319C–2(b); and 

‘‘(ii) informing and educating appropriate first 

responders and health care supply chain partners of 

the regional emergency preparedness and response 

capabilities and medical surge capacity of such hospitals and health care facilities in the community; 

‘‘(B) physical and technological infrastructure, laboratory capacity, staffing, blood supply, and other supply chain 

needs, taking into account resiliency, geographic considerations, and rural considerations; 

‘‘(C) protocols or best practices for the safety and personal protection of workers who handle human remains 

and health care workers (including with respect to protective equipment and supplies, waste management processes, 

and decontamination), sharing of specialized experience 

among the health care workforce, behavioral health, 

psychological resilience, and training of the workforce, as 

applicable; 

‘‘(D) in a manner that allows for disease containment 

(within the meaning of section 2802(b)(2)(B)), coordinated 

medical triage, treatment, and transportation of patients, 

based on patient medical need (including patients in rural 

areas), to the appropriate hospitals or health care facilities 

within the regional system or, as applicable and appropriate, between systems in different States or regions; and 

‘‘(E) the needs of children and other at-risk individuals; 

‘‘(2) make such guidelines available on the internet website 

of the Department of Health and Human Services in a manner 

that does not compromise national security; and 

‘‘(3) update such guidelines as appropriate, including based 

on input received pursuant to subsections (c) and (e) and 

information resulting from applicable reports required under 

the Pandemic and All-Hazards Preparedness and Advancing 

Innovation Act of 2019 (including any amendments made by 

such Act), to address new and emerging public health threats. 

‘‘(c) CONSIDERATIONS.—In identifying, developing, and updating 

guidelines under subsection (b), the Assistant Secretary for 

Preparedness and Response shall— 

‘‘(1) include input from hospitals and health care facilities 

(including health care coalitions under section 319C–2), State, 

local, Tribal, and territorial public health departments, and 

health care or subject matter experts (including experts with 

relevant expertise in chemical, biological, radiological, or 

nuclear threats, including emerging infectious diseases), as the 

Assistant Secretary determines appropriate, to meet the goals 

under section 2802(b)(3); 

‘‘(2) consult and engage with appropriate health care providers and professionals, including physicians, nurses, first 

responders, health care facilities (including hospitals, primary 

care clinics, community health centers, mental health facilities, 

ambulatory care facilities, and dental health facilities), pharmacies, emergency medical providers, trauma care providers, 

environmental health agencies, public health laboratories, poison control centers, blood banks, tissue banks, and other experts 
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that the Assistant Secretary determines appropriate, to meet 

the goals under section 2802(b)(3); 

‘‘(3) consider feedback related to financial implications for 

hospitals, health care facilities, public health agencies, laboratories, blood banks, tissue banks, and other entities engaged 

in regional preparedness planning to implement and follow 

such guidelines, as applicable; and 

‘‘(4) consider financial requirements and potential incentives for entities to prepare for, and respond to, public health 

emergencies as part of the regional health care emergency 

preparedness and response system. 

‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Secretary for 

Preparedness and Response, in consultation with the Director of 

the Centers for Disease Control and Prevention and the Assistant 

Secretary of Labor for Occupational Safety and Health, may provide 

technical assistance and consultation toward meeting the guidelines 

described in subsection (b). 

‘‘(e) DEMONSTRATION PROJECT FOR REGIONAL HEALTH CARE

PREPAREDNESS AND RESPONSE SYSTEMS.— 

‘‘(1) IN GENERAL.—The Assistant Secretary for Preparedness and Response may establish a demonstration project 

pursuant to the development and implementation of guidelines 

under subsection (b) to award grants to improve medical surge 

capacity for all hazards, build and integrate regional medical 

response capabilities, improve specialty care expertise for allhazards response, and coordinate medical preparedness and 

response across State, local, Tribal, territorial, and regional 

jurisdictions. 

‘‘(2) SUNSET.—The authority under this subsection shall 

expire on September 30, 2023.’’. 

(b) GAO REPORT TO CONGRESS.— 

(1) REPORT.—Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States 

(referred to in this subsection as the ‘‘Comptroller General’’) 

shall submit to the Committee on Health, Education, Labor, 

and Pensions and the Committee on Finance of the Senate 

and the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives, 

a report on the extent to which hospitals and health care 

facilities have implemented the recommended guidelines under 

section 319C–3(b) of the Public Health Service Act (as added 

by subsection (a)), including an analysis and evaluation of 

any challenges hospitals or health care facilities experienced 

in implementing such guidelines. 

(2) CONTENT.—The Comptroller General shall include in 

the report under paragraph (1)— 

(A) data on the preparedness and response capabilities 

that have been informed by the guidelines under section 

319C–3(b) of the Public Health Service Act to improve 

regional emergency health care preparedness and response 

capability, including hospital and health care facility 

capacity and medical surge capabilities to prepare for, and 

respond to, public health emergencies; and 

(B) recommendations to reduce gaps in incentives for 

regional health partners, including hospitals and health 

care facilities, to improve capacity and medical surge 

capabilities to prepare for, and respond to, public health 
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emergencies, consistent with subsection (a), which may 

include consideration of facilities participating in programs 

under section 319C–2 of the Public Health Service Act 

(42 U.S.C. 247d–3b) or in programs under the Centers 

for Medicare & Medicaid Services (including innovative 

health care delivery and payment models), and input from 

private sector financial institutions. 

(3) CONSULTATION.—In carrying out paragraphs (1) and 

(2), the Comptroller General shall consult with the heads of 

appropriate Federal agencies, including— 

(A) the Assistant Secretary for Preparedness and 

Response; 

(B) the Director of the Centers for Disease Control 

and Prevention; 

(C) the Administrator of the Centers for Medicare & 

Medicaid Services; 

(D) the Assistant Secretary for Mental Health and 

Substance Use; 

(E) the Assistant Secretary of Labor for Occupational 

Safety and Health; and 

(F) the Secretary of Veterans Affairs. 

(c) ANNUAL REPORTS.—Section 319C–2(i)(1) (42 U.S.C. 247d– 

3b(i)(1)) is amended by inserting after the first sentence the following: ‘‘In submitting reports under this paragraph, a coalition 

shall include information on the progress that the coalition has 

made toward the implementation of section 319C–3 (or barriers 

to progress, if any).’’. 

(d) NATIONAL HEALTH SECURITY STRATEGY INCORPORATION OF

REGIONALIZED EMERGENCY PREPAREDNESS AND RESPONSE.— 

Subparagraph (G) of section 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) 

is amended to read as follows: 

‘‘(G) Optimizing a coordinated and flexible approach 

to the emergency response and medical surge capacity of 

hospitals, other health care facilities, critical care, trauma 

care (which may include trauma centers), and emergency 

medical systems.’’. 

(e) IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.— 

(1) STATE AND LOCAL SECURITY.—Section 319C–1(e) (42 

U.S.C. 247d–3a(e)) is amended by striking ‘‘, and local emergency plans.’’ and inserting ‘‘, local emergency plans, and any 

regional health care emergency preparedness and response 

system established pursuant to the applicable guidelines under 

section 319C–3.’’. 

(2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) (42 U.S.C. 

247d–3b(d)(1)(A)) is amended— 

(A) in clause (i), by striking ‘‘; and’’ and inserting 

‘‘;’’; 

(B) by redesignating clause (ii) as clause (iii); and 

(C) by inserting after clause (i) the following: 

‘‘(ii) among one or more facilities in a regional 

health care emergency system under section 319C– 

3; and’’. 

SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS. 

Title XII (42 U.S.C. 300d et seq.) is amended by adding at 

the end the following new part: 
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‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM 

‘‘SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA 

READINESS GRANT PROGRAM. 

‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PROGRAM.— ‘‘(1) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response and in consultation with the Secretary of Defense, shall award grants to not 

more than 20 eligible high-acuity trauma centers to enable 

military trauma teams to provide, on a full-time basis, trauma 

care and related acute care at such trauma centers. 

‘‘(2) LIMITATIONS.—In the case of a grant awarded under 

paragraph (1) to an eligible high-acuity trauma center, such 

grant— 

‘‘(A) shall be for a period of at least 3 years and 

not more than 5 years (and may be renewed at the end 

of such period); and 

‘‘(B) shall be in an amount that does not exceed 

$1,000,000 per year. 

‘‘(3) AVAILABILITY OF FUNDS.—Notwithstanding section 

1552 of title 31, United States Code, or any other provision 

of law, funds available to the Secretary for obligation for a 

grant under this subsection shall remain available for expenditure for 100 days after the last day of the performance period 

of such grant. 

‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACEMENT PROGRAM.— ‘‘(1) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response and in consultation with the Secretary of Defense, shall award grants to eligible 

trauma centers to enable military trauma care providers to 

provide trauma care and related acute care at such trauma 

centers. 

‘‘(2) LIMITATIONS.—In the case of a grant awarded under 

paragraph (1) to an eligible trauma center, such grant— 

‘‘(A) shall be for a period of at least 1 year and not 

more than 3 years (and may be renewed at the end of 

such period); and 

‘‘(B) shall be in an amount that does not exceed, in 

a year— ‘‘(i) $100,000 for each military trauma care provider that is a physician at such eligible trauma center; 

and 

‘‘(ii) $50,000 for each other military trauma care 

provider at such eligible trauma center. 

‘‘(c) GRANT REQUIREMENTS.— 

‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As 

a condition of receipt of a grant under this section, a grant 

recipient shall agree to allow military trauma care providers 

providing care pursuant to such grant to— 

‘‘(A) be deployed by the Secretary of Defense for military operations, for training, or for response to a mass 

casualty incident; and 

‘‘(B) be deployed by the Secretary of Defense, in consultation with the Secretary of Health and Human Services, 
S. 1379—12 

for response to a public health emergency pursuant to 

section 319. 

‘‘(2) USE OF FUNDS.—Grants awarded under this section 

to an eligible trauma center may be used to train and incorporate military trauma care providers into such trauma center, 

including incorporation into operational exercises and training 

drills related to public health emergencies, expenditures for 

malpractice insurance, office space, information technology, specialty education and supervision, trauma programs, research, 

and applicable license fees for such military trauma care providers. 

‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall 

be construed to affect any other provision of law that preempts 

State licensing requirements for health care professionals, including 

with respect to military trauma care providers. 

‘‘(e) REPORTING REQUIREMENTS.— 

‘‘(1) REPORT TO THE SECRETARY AND THE SECRETARY OF

DEFENSE.—Each eligible trauma center or eligible high-acuity 

trauma center awarded a grant under subsection (a) or (b) 

for a year shall submit to the Secretary and the Secretary 

of Defense a report for such year that includes information 

on— 

‘‘(A) the number and types of trauma cases managed 

by military trauma teams or military trauma care providers 

pursuant to such grant during such year; 

‘‘(B) the ability to maintain the integration of the military trauma providers or teams of providers as part of 

the trauma center, including the financial effect of such 

grant on the trauma center; 

‘‘(C) the educational effect on resident trainees in centers where military trauma teams are assigned; 

‘‘(D) any research conducted during such year supported by such grant; and 

‘‘(E) any other information required by the Secretaries 

for the purpose of evaluating the effect of such grant. 

‘‘(2) REPORT TO CONGRESS.—Not less than once every 2 

years, the Secretary, in consultation with the Secretary of 

Defense, shall submit a report to the congressional committees 

of jurisdiction that includes information on the effect of placing 

military trauma care providers in trauma centers awarded 

grants under this section on— 

‘‘(A) maintaining military trauma care providers’ readiness and ability to respond to and treat battlefield injuries; 

‘‘(B) providing health care to civilian trauma patients 

in urban and rural settings; 

‘‘(C) the capability of trauma centers and military 

trauma care providers to increase medical surge capacity, 

including as a result of a large-scale event; 

‘‘(D) the ability of grant recipients to maintain the 

integration of the military trauma providers or teams of 

providers as part of the trauma center; 

‘‘(E) efforts to incorporate military trauma care providers into operational exercises and training and drills 

for public health emergencies; and 

‘‘(F) the capability of military trauma care providers 

to participate as part of a medical response during or 
S. 1379—13 

in advance of a public health emergency, as determined 

by the Secretary, or a mass casualty incident. 

‘‘(f) DEFINITIONS.—For purposes of this part: 

‘‘(1) ELIGIBLE HIGH-ACUITY TRAUMA CENTER.—The term 

‘eligible high-acuity trauma center’ means a Level I trauma 

center that satisfies each of the following: 

‘‘(A) Such trauma center has an agreement with the 

Secretary of Defense to enable military trauma teams to 

provide trauma care and related acute care at such trauma 

center. 

‘‘(B) At least 20 percent of patients treated at such 

trauma center in the most recent 3-month period for which 

data are available are treated for a major trauma at such 

trauma center. 

‘‘(C) Such trauma center utilizes a risk-adjusted 

benchmarking system and metrics to measure performance, 

quality, and patient outcomes. 

‘‘(D) Such trauma center is an academic training 

center— 

‘‘(i) affiliated with a medical school; 

‘‘(ii) that maintains residency programs and fellowships in critical trauma specialties and subspecialties, 

and provides education and supervision of military 

trauma team members according to those specialties 

and subspecialties; and 

‘‘(iii) that undertakes research in the prevention 

and treatment of traumatic injury. 

‘‘(E) Such trauma center serves as a medical and public 

health preparedness and response leader for its community, 

such as by participating in a partnership for State and 

regional hospital preparedness established under section 

319C–2 or 319C–3. 

‘‘(2) ELIGIBLE TRAUMA CENTER.—The term ‘eligible trauma 

center’ means a Level I, II, or III trauma center that satisfies 

each of the following: 

‘‘(A) Such trauma center has an agreement with the 

Secretary of Defense to enable military trauma care providers to provide trauma care and related acute care at 

such trauma center. 

‘‘(B) Such trauma center utilizes a risk-adjusted 

benchmarking system and metrics to measure performance, 

quality, and patient outcomes. 

‘‘(C) Such trauma center demonstrates a need for 

integrated military trauma care providers to maintain or 

improve the trauma clinical capability of such trauma 

center. 

‘‘(3) MAJOR TRAUMA.—The term ‘major trauma’ means an 

injury that is greater than or equal to 15 on the injury severity 

score. 

‘‘(4) MILITARY TRAUMA TEAM.—The term ‘military trauma 

team’ means a complete military trauma team consisting of 

military trauma care providers. 

‘‘(5) MILITARY TRAUMA CARE PROVIDER.—The term ‘military 

trauma care provider’ means a member of the Armed Forces 

who furnishes emergency, critical care, and other trauma acute 
S. 1379—14 

care services (including a physician, surgeon, physician assistant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic, or enlisted medical technician) or other 

military trauma care provider as the Secretary determines 

appropriate. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this 

section, there is authorized to be appropriated $11,500,000 for each 

of fiscal years 2019 through 2023.’’. 

SEC. 205. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL 

AWARENESS AND BIOSURVEILLANCE CAPABILITIES. 

(a) FACILITIES, CAPACITIES, AND BIOSURVEILLANCE CAPABILITIES.—Section 319D (42 U.S.C. 247d–4) is amended— 

(1) in the section heading, by striking ‘‘REVITALIZING’’ and 

inserting ‘‘FACILITIES AND CAPACITIES OF’’; 

(2) in subsection (a)— 

(A) in the subsection heading, by striking ‘‘FACILITIES; 

CAPACITIES’’ and inserting ‘‘IN GENERAL’’; 

(B) in paragraph (1), by striking ‘‘and improved’’ and 

inserting ‘‘, improved, and appropriately maintained’’; 

(C) in paragraph (3), in the matter preceding subparagraph (A), by striking ‘‘expand, enhance, and improve’’ 

and inserting ‘‘expand, improve, enhance, and appropriately 

maintain’’; and 

(D) by adding at the end the following: 

‘‘(4) STUDY OF RESOURCES FOR FACILITIES AND CAPACITIES.— Not later than June 1, 2022, the Comptroller General of the 

United States shall conduct a study on Federal spending in 

fiscal years 2013 through 2018 for activities authorized under 

this subsection. Such study shall include a review and assessment of obligations and expenditures directly related to each 

activity under paragraphs (2) and (3), including a specific 

accounting of, and delineation between, obligations and 

expenditures incurred for the construction, renovation, equipping, and security upgrades of facilities and associated contracts 

under this subsection, and the obligations and expenditures 

incurred to establish and improve the situational awareness 

and biosurveillance network under subsection (b), and shall 

identify the agency or agencies incurring such obligations and 

expenditures.’’; 

(3) in subsection (b)— 

(A) in the subsection heading, by striking ‘‘NATIONAL’’ 

and inserting ‘‘ESTABLISHMENT OF SYSTEMS OF PUBLIC

HEALTH’’; 

(B) in paragraph (1)(B), by inserting ‘‘immunization 

information systems,’’ after ‘‘centers,’’; 

(C) in paragraph (2)— 

(i) by inserting ‘‘develop a plan to, and’’ after ‘‘The 

Secretary shall’’; and 

(ii) by inserting ‘‘and in a form readily usable 

for analytical approaches’’ after ‘‘in a secure manner’’; 

and 

(D) by amending paragraph (3) to read as follows: 

‘‘(3) STANDARDS.— 

‘‘(A) IN GENERAL.—Not later than 1 year after the 

date of the enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019, the 
S. 1379—15 

Secretary, in cooperation with health care providers, State, 

local, Tribal, and territorial public health officials, and 

relevant Federal agencies (including the Office of the 

National Coordinator for Health Information Technology 

and the National Institute of Standards and Technology), 

shall, as necessary, adopt technical and reporting standards, including standards for interoperability as defined 

by section 3000, for networks under paragraph (1) and 

update such standards as necessary. Such standards shall 

be made available on the internet website of the Department of Health and Human Services, in a manner that 

does not compromise national security. 

‘‘(B) DEFERENCE TO STANDARDS DEVELOPMENT

ORGANIZATIONS.—In adopting and implementing standards 

under this subsection and subsection (c), the Secretary 

shall give deference to standards published by standards 

development organizations and voluntary consensus-based 

standards entities.’’; 

(4) in subsection (c)— 

(A) in paragraph (1)— 

(i) by striking ‘‘Not later than 2 years after the 

date of enactment of the Pandemic and All-Hazards 

Preparedness Reauthorization Act of 2013, the Secretary’’ and inserting ‘‘The Secretary’’; 

(ii) by inserting ‘‘, and improve as applicable and 

appropriate,’’ after ‘‘shall establish’’; 

(iii) by striking ‘‘of rapid’’ and inserting ‘‘of, rapid’’; 

and 

(iv) by striking ‘‘such connectivity’’ and inserting 

‘‘such interoperability’’; 

(B) by amending paragraph (2) to read as follows: 

‘‘(2) COORDINATION AND CONSULTATION.—In establishing 

and improving the network under paragraph (1), the Secretary 

shall— 

‘‘(A) facilitate coordination among agencies within the 

Department of Health and Human Services that provide, 

or have the potential to provide, information and data 

to, and analyses for, the situational awareness and biosurveillance network under paragraph (1), including 

coordination among relevant agencies related to health care 

services, the facilitation of health information exchange 

(including the Office of the National Coordinator for Health 

Information Technology), and public health emergency 

preparedness and response; and 

‘‘(B) consult with the Secretary of Agriculture, the Secretary of Commerce (and the Director of the National 

Institute of Standards and Technology), the Secretary of 

Defense, the Secretary of Homeland Security, the Secretary 

of Veterans Affairs, and the heads of other Federal agencies, as the Secretary determines appropriate.’’; 

(C) in paragraph (3)— 

(i) by redesignating subparagraphs (A) through (E) 

as clauses (i) through (v), respectively, and adjusting 

the margins accordingly; 

(ii) in clause (iv), as so redesignated— 

(I) by inserting ‘‘immunization information 

systems,’’ after ‘‘poison control,’’; and 
S. 1379—16 

(II) by striking ‘‘and clinical laboratories’’ and 

inserting ‘‘, clinical laboratories, and public 

environmental health agencies’’; 

(iii) by striking ‘‘The network’’ and inserting the 

following: 

‘‘(A) IN GENERAL.—The network’’; and 

(iv) by adding at the end the following: 

‘‘(B) REVIEW.—Not later than 2 years after the date 

of the enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019 and 

every 6 years thereafter, the Secretary shall conduct a 

review of the elements described in subparagraph (A). Such 

review shall include a discussion of the addition of any 

elements pursuant to clause (v), including elements added 

to advancing new technologies, and identify any challenges 

in the incorporation of elements under subparagraph (A). 

The Secretary shall provide such review to the congressional committees of jurisdiction.’’; 

(D) in paragraph (5)— 

(i) by redesignating subparagraphs (A) through (D) 

as clauses (i) through (iv), respectively, and adjusting 

the margins accordingly; 

(ii) by striking ‘‘In establishing’’ and inserting the 

following: 

‘‘(A) IN GENERAL.—In establishing’’; 

(iii) by adding at the end the following: 

‘‘(B) PUBLIC MEETING.— 

‘‘(i) IN GENERAL.—Not later than 180 days after 

the date of enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019, 

the Secretary shall convene a public meeting for purposes of discussing and providing input on the potential 

goals, functions, and uses of the network described 

in paragraph (1) and incorporating the elements 

described in paragraph (3)(A). 

‘‘(ii) EXPERTS.—The public meeting shall include 

representatives of relevant Federal agencies (including 

representatives from the Office of the National Coordinator for Health Information Technology and the 

National Institute of Standards and Technology); State, 

local, Tribal, and territorial public health officials; 

stakeholders with expertise in biosurveillance and 

situational awareness; stakeholders with expertise in 

capabilities relevant to biosurveillance and situational 

awareness, such as experts in informatics and data 

analytics (including experts in prediction, modeling, 

or forecasting); and other representatives as the Secretary determines appropriate. 

‘‘(iii) TOPICS.—Such public meeting shall include 

a discussion of— 

‘‘(I) data elements, including minimal or essential data elements, that are voluntarily provided 

for such network, which may include elements 

from public health and public and private health 

care entities, to the extent practicable; 

‘‘(II) standards and implementation specifications that may improve the collection, analysis, 
S. 1379—17 

and interpretation of data during a public health 

emergency; 

‘‘(III) strategies to encourage the access, 

exchange, and use of information; 

‘‘(IV) considerations for State, local, Tribal, 

and territorial capabilities and infrastructure 

related to data exchange and interoperability; 

‘‘(V) privacy and security protections provided 

at the Federal, State, local, Tribal, and territorial 

levels, and by nongovernmental stakeholders; and 

‘‘(VI) opportunities for the incorporation of 

innovative technologies to improve the network.’’; 

and 

(iv) in subparagraph (A), as so designated by clause 

(ii)— 

(I) in clause (i), as so redesignated— 

(aa) by striking ‘‘as determined’’ and 

inserting ‘‘as adopted’’; and 

(bb) by inserting ‘‘and the National 

Institute of Standards and Technology’’ after 

‘‘Office of the National Coordinator for Health 

Information Technology’’; 

(II) in clause (iii), as so redesignated, by 

striking ‘‘; and’’ and inserting a semicolon; 

(III) in clause (iv), as so redesignated, by 

striking the period and inserting ‘‘; and’’; and 

(IV) by adding at the end the following: 

‘‘(v) pilot test standards and implementation specifications, consistent with the process described in section 3002(b)(3)(C), which State, local, Tribal, and territorial public health entities may utilize, on a voluntary 

basis, as a part of the network.’’; 

(E) by redesignating paragraph (6) as paragraph (7); 

(F) by inserting after paragraph (5) the following: 

‘‘(6) STRATEGY AND IMPLEMENTATION PLAN.— ‘‘(A) IN GENERAL.—Not later than 18 months after the 

date of enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019, the 

Secretary shall submit to the congressional committees 

of jurisdiction a coordinated strategy and an accompanying 

implementation plan that— 

‘‘(i) is informed by the public meeting under paragraph (5)(B); 

‘‘(ii) includes a review and assessment of existing 

capabilities of the network and related infrastructure, 

including input provided by the public meeting under 

paragraph (5)(B); 

‘‘(iii) identifies and demonstrates the measurable 

steps the Secretary will carry out to— 

‘‘(I) develop, implement, and evaluate the network described in paragraph (1), utilizing elements 

described in paragraph (3)(A); 

‘‘(II) modernize and enhance biosurveillance 

activities, including strategies to include innovative technologies and analytical approaches 

(including prediction and forecasting for pandemics 

and all-hazards) from public and private entities; 
S. 1379—18 

‘‘(III) improve information sharing, coordination, and communication among disparate biosurveillance systems supported by the Department 

of Health and Human Services, including the 

identification of methods to improve accountability, 

better utilize resources and workforce capabilities, 

and incorporate innovative technologies within and 

across agencies; and 

‘‘(IV) test and evaluate capabilities of the interoperable network of systems to improve situational 

awareness and biosurveillance capabilities; 

‘‘(iv) includes performance measures and the 

metrics by which performance measures will be 

assessed with respect to the measurable steps under 

clause (iii); and 

‘‘(v) establishes dates by which each measurable 

step under clause (iii) will be implemented. 

‘‘(B) ANNUAL BUDGET PLAN.—Not later than 2 years 

after the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 

and on an annual basis thereafter, in accordance with 

the strategy and implementation plan under this paragraph, the Secretary shall, taking into account recommendations provided by the National Biodefense Science 

Board, develop a budget plan based on the strategy and 

implementation plan under this section. Such budget plan 

shall include— 

‘‘(i) a summary of resources previously expended 

to establish, improve, and utilize the nationwide public 

health situational awareness and biosurveillance network under paragraph (1); 

‘‘(ii) estimates of costs and resources needed to 

establish and improve the network under paragraph 

(1) according to the strategy and implementation plan 

under subparagraph (A); 

‘‘(iii) the identification of gaps and inefficiencies 

in nationwide public health situational awareness and 

biosurveillance capabilities, resources, and authorities 

needed to address such gaps; and 

‘‘(iv) a strategy to minimize and address such gaps 

and improve inefficiencies.’’; 

(G) in paragraph (7), as so redesignated— 

(i) in subparagraph (A), by inserting ‘‘(taking into 

account zoonotic disease, including gaps in scientific 

understanding of the interactions between human, 

animal, and environmental health)’’ after ‘‘human 

health’’; 

(ii) in subparagraph (B)— 

(I) by inserting ‘‘and gaps in surveillance programs’’ after ‘‘surveillance programs’’; and 

(II) by striking ‘‘; and’’ and inserting a semicolon; 

(iii) in subparagraph (C)— 

(I) by inserting ‘‘, animal health organizations 

related to zoonotic disease,’’ after ‘‘health care entities’’; and 
S. 1379—19 

(II) by striking the period and inserting ‘‘; 

and’’; and 

(iv) by adding at the end the following: 

‘‘(D) provide recommendations to the Secretary on policies and procedures to complete the steps described in 

this paragraph in a manner that is consistent with section 

2802.’’; and 

(H) by adding at the end the following: 

‘‘(8) SITUATIONAL AWARENESS AND BIOSURVEILLANCE AS A

NATIONAL SECURITY PRIORITY.—The Secretary, on a periodic 

basis as applicable and appropriate, shall meet with the 

Director of National Intelligence to inform the development 

and capabilities of the nationwide public health situational 

awareness and biosurveillance network.’’; 

(5) in subsection (d)— 

(A) in paragraph (1)— 

(i) by inserting ‘‘environmental health agencies,’’ 

after ‘‘public health agencies,’’; and 

(ii) by inserting ‘‘immunization programs,’’ after 

‘‘poison control centers,’’; 

(B) in paragraph (2)— 

(i) in subparagraph (B), by striking ‘‘and’’ at the 

end; 

(ii) in subparagraph (C), by striking the period 

and inserting ‘‘; and’’; and 

(iii) by adding after subparagraph (C) the following: 

‘‘(D) an implementation plan that may include measurable steps to achieve the purposes described in paragraph 

(1).’’; and 

(C) by striking paragraph (5) and inserting the following: 

‘‘(5) TECHNICAL ASSISTANCE.—The Secretary may provide 

technical assistance to States, localities, Tribes, and territories 

or a consortium of States, localities, Tribes, and territories 

receiving an award under this subsection regarding interoperability and the technical standards set forth by the Secretary.’’; 

(6) by redesignating subsections (f) and (g) as subsections 

(i) and (j), respectively; and 

(7) by inserting after subsection (e) the following: 

‘‘(f) PERSONNEL AUTHORITIES.— 

‘‘(1) SPECIALLY QUALIFIED PERSONNEL.—In addition to any 

other personnel authorities, to carry out subsections (b) and 

(c), the Secretary may— 

‘‘(A) appoint highly qualified individuals to scientific 

or professional positions at the Centers for Disease Control 

and Prevention, not to exceed 30 such employees at any 

time (specific to positions authorized by this subsection), 

with expertise in capabilities relevant to biosurveillance 

and situational awareness, such as experts in informatics 

and data analytics (including experts in prediction, modeling, or forecasting), and other related scientific or technical fields; and 

‘‘(B) compensate individuals appointed under subparagraph (A) in the same manner and subject to the same 

terms and conditions in which individuals appointed under 
S. 1379—20 

9903 of title 5, United States Code, are compensated, without regard to the provisions of chapter 51 and subchapter 

III of chapter 53 of such title relating to classification 

and General Schedule pay rates. 

‘‘(2) LIMITATIONS.—The Secretary shall exercise the 

authority under paragraph (1) in a manner that is consistent 

with the limitations described in section 319F–1(e)(2). 

‘‘(g) TIMELINE.—The Secretary shall accomplish the purposes 

under subsections (b) and (c) no later than September 30, 2023, 

and shall provide a justification to the congressional committees 

of jurisdiction for any missed or delayed implementation of measurable steps identified under subsection (c)(6)(A)(iii). 

‘‘(h) INDEPENDENT EVALUATION.—Not later than 3 years after 

the date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Comptroller General of the United States shall conduct an independent evaluation 

and submit to the Secretary and the congressional committees 

of jurisdiction a report concerning the activities conducted under 

subsections (b) and (c), and provide recommendations, as applicable 

and appropriate, on necessary improvements to the biosurveillance 

and situational awareness network.’’. 

(b) AUTHORIZATION OF APPROPRIATIONS.—Subsection (i) of section 319D (42 U.S.C. 247d–4), as redesignated by subsection (a)(6), 

is amended by striking ‘‘$138,300,000 for each of fiscal years 2014 

through 2018’’ and inserting ‘‘$161,800,000 for each of fiscal years 

2019 through 2023’’. 

(c) BIOLOGICAL THREAT DETECTION REPORT.—The Secretary of 

Health and Human Services shall, in coordination with the Secretary of Defense and the Secretary of Homeland Security, not 

later than 180 days after the date of enactment of this Act, report 

to the Committee on Energy and Commerce, the Committee on 

Armed Services, and the Committee on Homeland Security of the 

House of Representatives and the Committee on Health, Education, 

Labor, and Pensions, the Committee on Armed Services, and the 

Committee on Homeland Security and Governmental Affairs of 

the Senate on the state of Federal biological threat detection efforts, 

including the following: 

(1) An identification of technological, operational, and programmatic successes and failures of domestic detection programs supported by Federal departments and agencies for 

intentionally introduced or accidentally released biological 

threat agents and naturally occurring infectious diseases. 

(2) A description of Federal efforts to facilitate the exchange 

of information related to the information described in paragraph 

(1) among Federal departments and agencies that utilize 

biological threat detection technology. 

(3) A description of the capabilities of detection systems 

in use by Federal departments and agencies including the 

capability to— 

(A) rapidly detect, identify, characterize, and confirm 

the presence of biological threat agents; 

(B) recover live biological agents from collection 

devices; 

(C) determine the geographical distribution of 

biological agents; 

(D) determine the extent of environmental contamination and persistence of biological agents; and 
S. 1379—21 

(E) provide advanced molecular diagnostics to State, 

local, Tribal, and territorial public health and other laboratories that support biological threat detection activities. 

(4) A description of Federal interagency coordination 

related to biological threat detection. 

(5) A description of efforts by Federal departments and 

agencies that utilize biological threat detection technology to 

collaborate with State, local, Tribal, and territorial public health 

laboratories and other users of biological threat detection systems, including collaboration regarding the development of— 

(A) biological threat detection requirements or standards; 

(B) a standardized integration strategy; 

(C) training requirements or guidelines; 

(D) guidelines for a coordinated public health response, 

including preparedness capabilities, and, as applicable, for 

coordination with public health surveillance systems; and 

(E) a coordinated environmental remediation plan, as 

applicable. 

(6) Recommendations related to research, advanced 

research, development, and procurement for Federal departments and agencies to improve and enhance biological threat 

detection systems, including recommendations on the transfer 

of biological threat detection technology among Federal departments and agencies, as necessary and appropriate. 

SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH 

EMERGENCY RAPID RESPONSE FUND. 

Section 319 (42 U.S.C. 247d) is amended— 

(1) in subsection (b)— 

(A) in paragraph (1)— 

(i) in the first sentence, by inserting ‘‘or if the 

Secretary determines there is the significant potential 

for a public health emergency, to allow the Secretary 

to rapidly respond to the immediate needs resulting 

from such public health emergency or potential public 

health emergency’’ before the period; and 

(ii) by inserting ‘‘The Secretary shall plan for the 

expedited distribution of funds to appropriate agencies 

and entities.’’ after the first sentence; 

(B) by redesignating paragraph (2) as paragraph (3); 

(C) by inserting after paragraph (1) the following: 

‘‘(2) USES.—The Secretary may use amounts in the Fund 

established under paragraph (1), to— 

‘‘(A) facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public 

and private health care entities that the Secretary determines may be affected by a public health emergency or 

potential public health emergency referred to in paragraph 

(1) (including communication of such entities with relevant 

international entities, as applicable); 

‘‘(B) make grants, provide for awards, enter into contracts, and conduct supportive investigations pertaining 

to a public health emergency or potential public health 

emergency, including further supporting programs under 

section 319C–1, 319C–2, or 319C–3; 
S. 1379—22 

‘‘(C) facilitate and accelerate, as applicable, advanced 

research and development of security countermeasures (as 

defined in section 319F–2), qualified countermeasures (as 

defined in section 319F–1), or qualified pandemic or epidemic products (as defined in section 319F–3), that are 

applicable to the public health emergency or potential 

public health emergency under paragraph (1); 

‘‘(D) strengthen biosurveillance capabilities and laboratory capacity to identify, collect, and analyze information 

regarding such public health emergency or potential public 

health emergency, including the systems under section 

319D; 

‘‘(E) support initial emergency operations and assets 

related to preparation and deployment of intermittent disaster response personnel under section 2812 and the Medical Reserve Corps under section 2813; and 

‘‘(F) carry out other activities, as the Secretary determines applicable and appropriate.’’; and 

(D) by inserting after paragraph (3), as so redesignated, 

the following: 

‘‘(4) REVIEW.—Not later than 2 years after the date of 

enactment of the Pandemic and All-Hazards Preparedness and 

Advancing Innovation Act of 2019, the Secretary, in coordination with the Assistant Secretary for Preparedness and 

Response, shall conduct a review of the Fund under this section 

and provide recommendations to the Committee on Health, 

Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and 

Commerce and the Committee on Appropriations of the House 

of Representatives on policies to improve such Fund for the 

uses described in paragraph (2). 

‘‘(5) GAO REPORT.—Not later than 4 years after the date 

of enactment of the Pandemic and All-Hazards Preparedness 

and Advancing Innovation Act of 2019, the Comptroller General 

of the United States shall— 

‘‘(A) conduct a review of the Fund under this section, 

including its uses and the resources available in the Fund; 

and 

‘‘(B) submit to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives 

a report on such review, including recommendations related 

to such review, as applicable.’’; and 

(2) in subsection (c)— 

(A) by inserting ‘‘rapidly respond to public health emergencies or potential public health emergencies and’’ after 

‘‘used to’’; and 

(B) by striking ‘‘section.’’ and inserting ‘‘Act or funds 

otherwise provided for emergency response.’’. 

SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND RESPONSE 

BY PUBLIC HEALTH EMERGENCY VOLUNTEERS. 

(a) IN GENERAL.—Section 319I (42 U.S.C. 247d–7b) is 

amended— 

(1) in the section heading, by striking ‘‘HEALTH PROFESSIONS VOLUNTEERS’’ and inserting ‘‘VOLUNTEER HEALTH

PROFESSIONAL’’; 
S. 1379—23 

(2) in subsection (a), by adding at the end the following: 

‘‘Such health care professionals may include members of the 

National Disaster Medical System, members of the Medical 

Reserve Corps, and individual health care professionals.’’; 

(3) in subsection (i), by adding at the end the following: 

‘‘In order to inform the development of such mechanisms by 

States, the Secretary shall make available information and 

material provided by States that have developed mechanisms 

to waive the application of licensing requirements to applicable 

health professionals seeking to provide medical services during 

a public health emergency. Such information shall be made 

publicly available in a manner that does not compromise 

national security.’’; and 

(4) in subsection (k), by striking ‘‘2014 through 2018’’ and 

inserting ‘‘2019 through 2023’’. 

(b) ALL-HAZARDS PUBLIC HEALTH EMERGENCY PREPAREDNESS

AND RESPONSE PLAN.—Section 319C–1(b)(2)(A)(iv) (42 U.S.C. 247d– 

3a(b)(2)(A)(iv)) is amended to read as follows: 

‘‘(iv) a description of the mechanism the entity will 

implement to utilize the Emergency Management Assistance Compact, or other mutual aid agreement, for medical 

and public health mutual aid, and, as appropriate, the 

activities such entity will implement pursuant to section 

319I to improve enrollment and coordination of volunteer 

health care professionals seeking to provide medical services during a public health emergency, which may include— 

‘‘(I) providing a public method of communication 

for purposes of volunteer coordination (such as a phone 

number); 

‘‘(II) providing for optional registration to participate in volunteer services during processes related to 

State medical licensing, registration, or certification 

or renewal of such licensing, registration, or certification; or 

‘‘(III) other mechanisms as the State determines 

appropriate;’’. 

SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUNTEER HEALTH 

CARE PROFESSIONALS. 

(a) IN GENERAL.—Title II (42 U.S.C. 202 et seq.) is amended 

by inserting after section 224 the following: 

‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DURING A 

PUBLIC HEALTH EMERGENCY. 

‘‘(a) LIMITATION ON LIABILITY.—Notwithstanding any other 

provision of law, a health care professional who is a member of 

the Medical Reserve Corps under section 2813 or who is included 

in the Emergency System for Advance Registration of Volunteer 

Health Professionals under section 319I and who— 

‘‘(1) is responding— 

‘‘(A) to a public health emergency determined under 

section 319(a), during the initial period of not more than 

90 days (as determined by the Secretary) of the public 

health emergency determination (excluding any period covered by a renewal of such determination); or 

‘‘(B) to a major disaster or an emergency as declared 

by the President under section 401 of the Robert T. Stafford 

Disaster Relief and Emergency Assistance Act (42 U.S.C. 
S. 1379—24 

5170) or under section 201 of the National Emergencies 

Act (50 U.S.C. 1621) during the initial period of such declaration; 

‘‘(2) is alleged to be liable for an act or omission— 

‘‘(A) during the initial period of a determination or 

declaration described in paragraph (1) and related to the 

treatment of individuals in need of health care services 

due to such public health emergency, major disaster, or 

emergency; 

‘‘(B) in the State or States for which such determination 

or declaration is made; 

‘‘(C) in the health care professional’s capacity as a 

member of the Medical Reserve Corps or a professional 

included in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I; 

and 

‘‘(D) in the course of providing services that are within 

the scope of the license, registration, or certification of 

the professional, as defined by the State of licensure, registration, or certification; and 

‘‘(3) prior to the rendering of such act or omission, was 

authorized by the State’s authorization of deploying such State’s 

Emergency System for Advance Registration of Volunteer 

Health Professionals described in section 319I or the Medical 

Reserve Corps established under section 2813, to provide health 

care services, 

shall be subject only to the State liability laws of the State in 

which such act or omission occurred, in the same manner and 

to the same extent as a similar health care professional who is 

a resident of such State would be subject to such State laws, 

except with respect to the licensure, registration, and certification 

of such individual. 

‘‘(b) VOLUNTEER PROTECTION ACT.—Nothing in this section shall 

be construed to affect an individual’s right to protections under 

the Volunteer Protection Act of 1997. 

‘‘(c) PREEMPTION.—This section shall supersede the laws of 

any State that would subject a health care professional described 

in subsection (a) to the liability laws of any State other than 

the State liability laws to which such individual is subject pursuant 

to such subsection. 

‘‘(d) DEFINITIONS.—In this section: 

‘‘(1) The term ‘health care professional’ means an individual 

licensed, registered, or certified under Federal or State laws 

or regulations to provide health care services. 

‘‘(2) The term ‘health care services’ means any services 

provided by a health care professional, or by any individual 

working under the supervision of a health care professional, 

that relate to— 

‘‘(A) the diagnosis, prevention, or treatment of any 

human disease or impairment; or 

‘‘(B) the assessment or care of the health of human 

beings. 

‘‘(e) EFFECTIVE DATE.— 

‘‘(1) IN GENERAL.—This section shall take effect 90 days 

after the date of the enactment of the Pandemic and AllHazards Preparedness and Advancing Innovation Act of 2019. 
S. 1379—25 

‘‘(2) APPLICATION.—This section shall apply to a claim for 

harm only if the act or omission that caused such harm occurred 

on or after the effective date described in paragraph (1).’’. 

(b) GAO STUDY.—Not later than one year after the date of 

enactment of this Act, the Comptroller General of the United States 

shall conduct a review of— 

(1) the number of health care providers who register under 

the Emergency System for Advance Registration of Volunteer 

Health Professionals under section 319I of the Public Health 

Service Act (42 U.S.C. 247d–7b) in advance to provide services 

during a public health emergency; 

(2) the number of health care providers who are 

credentialed to provide services during the period of a public 

health emergency declaration, including those who are 

credentialed though programs established in the Emergency 

System for Advance Registration of Volunteer Health Professionals under such section 319I and those credentialed by 

authorities within the State in which the emergency occurred; 

(3) the average time to verify the credentials of a health 

care provider during the period of a public health emergency 

declaration, including the average time pursuant to the Emergency System for Advance Registration of Volunteer Health 

Professionals under such section 319I and for an individual’s 

credentials to be verified by an authority within the State; 

and 

(4) the Emergency System for Advance Registration of Volunteer Health Professionals program in States, including 

whether physician or medical groups, associations, or other 

relevant provider organizations utilize such program for purposes of volunteering during public health emergencies. 

SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUPPLY. 

Not later than 1 year after the date of the enactment of this 

Act, the Secretary of Health and Human Services shall submit 

to Congress a report containing recommendations related to 

maintaining an adequate national blood supply, including— 

(1) challenges associated with the continuous recruitment 

of blood donors (including those newly eligible to donate); 

(2) ensuring the adequacy of the blood supply in the case 

of public health emergencies; 

(3) implementation of the transfusion transmission monitoring system; and 

(4) other measures to promote safety and innovation, such 

as the development, use, or implementation of new technologies, 

processes, and procedures to improve the safety and reliability 

of the blood supply. 

SEC. 210. REPORT ON THE PUBLIC HEALTH PREPAREDNESS AND 

RESPONSE CAPABILITIES AND CAPACITIES OF HOSPITALS, 

LONG-TERM CARE FACILITIES, AND OTHER HEALTH CARE 

FACILITIES. 

(a) STUDY.— 

(1) IN GENERAL.—Not later than one year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services shall enter into an agreement with an appropriate 

entity to conduct a study regarding the public health preparedness and response capabilities and medical surge capacities 

of hospitals, long-term care facilities, and other health care 
S. 1379—26 

facilities to prepare for, and respond to, public health emergencies, including natural disasters. 

(2) CONSULTATION.—In conducting the study under paragraph (1), the entity shall consult with Federal, State, local, 

Tribal, and territorial public health officials (as appropriate), 

and health care providers and facilities with experience in 

public health preparedness and response activities. 

(3) EVALUATION.—The study under paragraph (1) shall 

include— 

(A) an evaluation of the current benchmarks and objective standards, as applicable, related to programs that support hospitals, long-term care facilities, and other health 

care facilities, and their effect on improving public health 

preparedness and response capabilities and medical surge 

capacities, including the Hospital Preparedness Program, 

the Public Health Emergency Preparedness cooperative 

agreements, and the Regional Health Care Emergency 

Preparedness and Response Systems under section 319C– 

3 of the Public Health Service Act (as added by section 

203); 

(B) the identification of gaps in preparedness, including 

with respect to such benchmarks and objective standards, 

such as those identified during recent public health emergencies, for hospitals, long-term care facilities, and other 

health care facilities to address future potential public 

health threats; 

(C) an evaluation of coordination efforts between the 

recipients of Federal funding for programs described in 

subparagraph (A) and entities with expertise in emergency 

power systems and other critical infrastructure partners 

during a public health emergency, to ensure a functioning 

critical infrastructure, to the greatest extent practicable, 

during a public health emergency; 

(D) an evaluation of coordination efforts between the 

recipients of Federal funding for programs described in 

subparagraph (A) and environmental health agencies with 

expertise in emergency preparedness and response planning for hospitals, long-term care facilities, and other 

health care facilities; and 

(E) an evaluation of current public health preparedness 

and response capabilities and medical surge capacities 

related to at-risk individuals during public health emergencies, including an identification of gaps in such 

preparedness as they relate to such individuals. 

(b) REPORT.— 

(1) IN GENERAL.—The agreement under subsection (a) shall 

require the entity to submit to the Secretary of Health and 

Human Services and the congressional committees of jurisdiction, not later than 3 years after the date of enactment of 

this Act, a report on the results of the study conducted pursuant 

to this section. 

(2) CONTENTS.—The report under paragraph (1) shall— 

(A) describe the findings and conclusions of the evaluation conducted pursuant to subsection (a); and 

(B) provide recommendations for improving public 

health preparedness and response capability and medical 
S. 1379—27 

surge capacity for hospitals, long-term care facilities, and 

other health care facilities, including— 

(i) improving the existing benchmarks and objective standards for the Federal grant programs 

described in subsection (a)(3)(A) or developing new 

benchmarks and standards for such programs; and 

(ii) identifying best practices for improving public 

health preparedness and response programs and medical surge capacity at hospitals, long-term care facilities, and other health care facilities, including recommendations for the evaluation under subparagraphs 

(C) and (D) of subsection (a)(3). 

TITLE III—REACHING ALL 

COMMUNITIES 

SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY 

RESPONSE WORKFORCE. 

(a) NATIONAL DISASTER MEDICAL SYSTEM.— (1) STRENGTHENING THE NATIONAL DISASTER MEDICAL

SYSTEM.—Clause (ii) of section 2812(a)(3)(A) (42 U.S.C. 300hh– 

11(a)(3)(A)) is amended to read as follows: 

‘‘(ii) be present at locations, and for limited periods 

of time, specified by the Secretary on the basis that 

the Secretary has determined that a location is at 

risk of a public health emergency during the time 

specified, or there is a significant potential for a public 

health emergency.’’. 

(2) REVIEW OF THE NATIONAL DISASTER MEDICAL SYSTEM.— Section 2812(b)(2) (42 U.S.C. 300hh–11(b)(2)) is amended to 

read as follows: 

‘‘(2) JOINT REVIEW AND MEDICAL SURGE CAPACITY STRATEGIC

PLAN.— ‘‘(A) REVIEW.—Not later than 180 days after the date 

of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, the Secretary, 

in coordination with the Secretary of Homeland Security, 

the Secretary of Defense, and the Secretary of Veterans 

Affairs, shall conduct a joint review of the National Disaster 

Medical System. Such review shall include— 

‘‘(i) an evaluation of medical surge capacity, as 

described in section 2803(a); 

‘‘(ii) an assessment of the available workforce of 

the intermittent disaster response personnel described 

in subsection (c); 

‘‘(iii) the capacity of the workforce described in 

clause (ii) to respond to all hazards, including capacity 

to simultaneously respond to multiple public health 

emergencies and the capacity to respond to a nationwide public health emergency; 

‘‘(iv) the effectiveness of efforts to recruit, retain, 

and train such workforce; and 

‘‘(v) gaps that may exist in such workforce and 

recommendations for addressing such gaps. 

‘‘(B) UPDATES.—As part of the National Health Security 

Strategy under section 2802, the Secretary shall update 
S. 1379—28 

the findings from the review under subparagraph (A) and 

provide recommendations to modify the policies of the 

National Disaster Medical System as necessary.’’. 

(3) NOTIFICATION OF SHORTAGE.—Section 2812(c) (42 U.S.C. 

300hh–11(c)) is amended by adding at the end the following: 

‘‘(3) NOTIFICATION.—Not later than 30 days after the date 

on which the Secretary determines the number of intermittent 

disaster-response personnel of the National Disaster Medical 

System is insufficient to address a public health emergency 

or potential public health emergency, the Secretary shall submit 

to the congressional committees of jurisdiction a notification 

detailing— 

‘‘(A) the impact such shortage could have on meeting 

public health needs and emergency medical personnel 

needs during a public health emergency; and 

‘‘(B) any identified measures to address such shortage. 

‘‘(4) CERTAIN APPOINTMENTS.— 

‘‘(A) IN GENERAL.—If the Secretary determines that 

the number of intermittent disaster response personnel 

within the National Disaster Medical System under this 

section is insufficient to address a public health emergency 

or potential public health emergency, the Secretary may 

appoint candidates directly to personnel positions for intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant or 

unfilled positions within such system to the congressional 

committees of jurisdiction each quarter for which this 

authority is in effect. 

‘‘(B) SUNSET.—The authority under this paragraph 

shall expire on September 30, 2021.’’. 

(4) AUTHORIZATION OF APPROPRIATIONS.—Section 2812(g) 

(42 U.S.C. 300hh–11(g)) is amended by striking ‘‘$52,700,000 

for each of fiscal years 2014 through 2018’’ and inserting 

‘‘$57,400,000 for each of fiscal years 2019 through 2023’’. 

(b) VOLUNTEER MEDICAL RESERVE CORPS.— 

(1) IN GENERAL.—Section 2813(a) (42 U.S.C. 42 U.S.C. 

300hh–15(a)) is amended by striking the second sentence and 

inserting ‘‘The Secretary may appoint a Director to head the 

Corps and oversee the activities of the Corps chapters that 

exist at the State, local, Tribal, and territorial levels.’’. 

(2) AUTHORIZATION OF APPROPRIATIONS.—Section 2813(i) 

(42 U.S.C. 300hh–15(i)) is amended by striking ‘‘2014 through 

2018’’ and inserting ‘‘2019 through 2023’’. 

(c) STRENGTHENING THE EPIDEMIC INTELLIGENCE SERVICE.— 

Section 317F (42 U.S.C. Sec. 247b–7) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) by inserting ‘‘or preparedness and response 

activities, including rapid response to public health 

emergencies and significant public health threats’’ after 

‘‘conduct prevention activities’’; and 

(ii) by striking ‘‘$35,000’’ and inserting ‘‘$50,000’’; 

and 

(B) in paragraph (2)(B), by striking ‘‘3 years’’ and 

inserting ‘‘2 years’’; and 

(2) in subsection (c)— 
S. 1379—29 

(A) by striking ‘‘For the purpose of carrying out this 

section’’ and inserting the following: 

‘‘(1) IN GENERAL.—For the purpose of carrying out this 

section, except as described in paragraph (2)’’; and 

(B) by adding at the end the following: 

‘‘(2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For purposes of carrying out this section with respect to qualified 

health professionals serving in the Epidemic Intelligence 

Service, as authorized under section 317G, there is authorized 

to be appropriated $1,000,000 for each of fiscal years 2019 

through 2023.’’. 

(d) SERVICE BENEFIT FOR NATIONAL DISASTER MEDICAL SYSTEM

VOLUNTEERS.— 

(1) IN GENERAL.—Section 2812(c) (42 U.S.C. 300hh–11(c)), 

as amended by subsection (a)(3), is further amended by adding 

at the end the following: 

‘‘(5) SERVICE BENEFIT.—Individuals appointed to serve 

under this subsection shall be considered eligible for benefits 

under part L of title I of the Omnibus Crime Control and 

Safe Streets Act of 1968. The Secretary shall provide notification to any eligible individual of any effect such designation 

may have on other benefits for which such individual is eligible, 

including benefits from private entities.’’. 

(2) PUBLIC SAFETY OFFICER BENEFITS.—Section 1204(9) of 

title I of the Omnibus Crime Control and Safe Streets Act 

of 1968 (34 U.S.C. 10284(9)) is amended— 

(A) in subparagraph (C)(ii), by striking ‘‘or’’ at the 

end; 

(B) in subparagraph (D), by striking the period and 

inserting ‘‘; or’’; and 

(C) by inserting after subparagraph (D) the following: 

‘‘(E) an individual appointed to the National Disaster 

Medical System under section 2812 of the Public Health 

Service Act (42 U.S.C. 300hh–11) who is performing official 

duties of the Department of Health and Human Services, 

if those official duties are— 

‘‘(i) related to responding to a public health emergency or potential public health emergency, or other 

activities for which the Secretary of Health and Human 

Services has activated such National Disaster Medical 

System; and 

‘‘(ii) determined by the Secretary of Health and 

Human Services to be hazardous.’’. 

(3) SUNSET.—The amendments made by paragraphs (1) 

and (2) shall cease to have force or effect on October 1, 2021. 

(e) MISSION READINESS REPORT TO CONGRESS.— 

(1) REPORT.—Not later than one year after the date of 

enactment of this section, the Comptroller General of the United 

States (referred to in this subsection as the ‘‘Comptroller General’’) shall submit to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives, a report 

on the medical surge capacity of the United States in the 

event of a public health emergency, including the capacity 

and capability of the current health care workforce to prepare 

for, and respond to, the full range of public health emergencies 
S. 1379—30 

or potential public health emergencies, and recommendations 

to address any gaps identified in such workforce. 

(2) CONTENTS.—The Comptroller General shall include in 

the report under paragraph (1)— 

(A) the number of health care providers who have 

volunteered to provide health care services during a public 

health emergency, including members of the National Disaster Medical System, the Disaster Medical Assistant 

Teams, the Medical Reserve Corps, and other volunteer 

health care professionals in the verification network pursuant to section 319I of the Public Health Service Act (42 

U.S.C. 247d–7b); 

(B) the capacity of the workforce described in subparagraph (A) to respond to a public health emergency or potential public health emergency, including the capacity to 

respond to multiple concurrent public health emergencies 

and the capacity to respond to a nationwide public health 

emergency; 

(C) the preparedness and response capabilities and 

mission readiness of the workforce described in subparagraph (A) taking into account areas of health care expertise 

and considerations for at-risk individuals (as defined in 

section 2802(b)(4)(B) of the Public Health Service Act (42 

U.S.C. 300hh–1(b)(4)(B))); 

(D) an assessment of the effectiveness of efforts to 

recruit, retain, and train such workforce; and 

(E) identification of gaps that may exist in such 

workforce and recommendations for addressing such gaps, 

the extent to which the Assistant Secretary for Preparedness and Response plans to address such gaps, and any 

recommendations from the Comptroller General to address 

such gaps. 

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

(a) COORDINATION OF PREPAREDNESS.—Section 2811(b)(5) (42 

U.S.C. 300hh–10(b)(5)) is amended by adding at the end the following: ‘‘Such logistical support shall include working with other 

relevant Federal, State, local, Tribal, and territorial public health 

officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need 

to be maintained through any emergency or disaster, including 

entities capable of assisting with, responding to, and mitigating 

the effect of a public health emergency, including a public health 

emergency determined by the Secretary pursuant to section 319(a) 

or an emergency or major disaster declared by the President under 

the Robert T. Stafford Disaster Relief and Emergency Assistance 

Act or the National Emergencies Act, including by establishing 

methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, 

and sharing of specialized expertise.’’. 

(b) MANUFACTURING CAPACITY.—Section 2811(d)(2)(C) (42 

U.S.C. 300hh–10(d)(2)(C)) is amended by inserting ‘‘, and ancillary 

medical supplies to assist with the utilization of such countermeasures or products,’’ after ‘‘products’’. 
S. 1379—31 

(c) EVALUATION OF BARRIERS TO RAPID DELIVERY OF MEDICAL

COUNTERMEASURES.— (1) RAPID DELIVERY STUDY.—The Assistant Secretary for 

Preparedness and Response may conduct a study on issues 

that have the potential to adversely affect the handling and 

rapid delivery of medical countermeasures to individuals during 

public health emergencies occurring in the United States. 

(2) NOTICE TO CONGRESS.—Not later than 9 months after 

the date of the enactment of this Act, the Assistant Secretary 

for Preparedness and Response shall notify the Committee 

on Energy and Commerce of the House of Representatives 

and the Committee on Health, Education, Labor, and Pensions 

of the Senate if the Assistant Secretary for Preparedness and 

Response does not plan to conduct the study under paragraph 

(1) and shall provide such committees a summary explanation 

for such decision. 

(3) REPORT TO CONGRESS.—Not later than 1 year after 

the Assistant Secretary for Preparedness and Response conducts the study under paragraph (1), such Assistant Secretary 

shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee 

on Health, Education, Labor, and Pensions of the Senate containing the findings of such study. 

SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS. 

(a) AT-RISK INDIVIDUALS IN THE NATIONAL HEALTH SECURITY

STRATEGY.—Section 2802(b)(4)(B) (42 U.S.C. 300hh–1(b)(4)(B)) is 

amended— 

(1) by striking ‘‘this section and sections 319C–1, 319F, 

and 319L,’’ and inserting ‘‘this Act,’’; and 

(2) by striking ‘‘special’’ and inserting ‘‘access or functional’’. 

(b) COUNTERMEASURE CONSIDERATIONS.—Section 319L(c)(6) (42 

U.S.C. 247d–7e(c)(6)) is amended— 

(1) by striking ‘‘elderly’’ and inserting ‘‘older adults’’; and 

(2) by inserting ‘‘with relevant characteristics that warrant 

consideration during the process of researching and developing 

such countermeasures and products’’ before the period. 

(c) BIOSURVEILLANCE OF EMERGING PUBLIC HEALTH THREATS.— Section 2814 is amended— 

(1) in paragraph (7), by striking ‘‘; and’’ and inserting 

a semicolon; 

(2) in paragraph (8), by striking the period and inserting 

‘‘; and’’; and 

(3) by adding at the end the following: 

‘‘(9) facilitate coordination to ensure that, in implementing 

the situational awareness and biosurveillance network under 

section 319D, the Secretary considers incorporating data and 

information from Federal, State, local, Tribal, and territorial 

public health officials and entities relevant to detecting 

emerging public health threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, 

including adverse health outcomes of such populations related 

to such emerging public health threats.’’. 

SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE 

CONSIDERATIONS FOR CHILDREN. 

Part B of title III (42 U.S.C. 243 et seq.) is amended by 

inserting after section 319D the following: 
S. 1379—32 

‘‘SEC. 319D–1. CHILDREN’S PREPAREDNESS UNIT. 

‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.— 

The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the 

‘Director’), shall maintain an internal team of experts, to be known 

as the Children’s Preparedness Unit (referred to in this subsection 

as the ‘Unit’), to work collaboratively to provide guidance on the 

considerations for, and the specific needs of, children before, during, 

and after public health emergencies. The Unit shall inform the 

Director regarding emergency preparedness and response efforts 

pertaining to children at the Centers for Disease Control and 

Prevention. 

‘‘(b) EXPERTISE.—The team described in subsection (a) shall 

include one or more pediatricians, which may be a developmentalbehavioral pediatrician, and may also include behavioral scientists, 

child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as 

the Secretary determines appropriate. 

‘‘(c) DUTIES.—The team described in subsection (a) may— 

‘‘(1) assist State, local, Tribal, and territorial emergency 

planning and response activities related to children, which may 

include developing, identifying, and sharing best practices; 

‘‘(2) provide technical assistance, training, and consultation 

to Federal, State, local, Tribal, and territorial public health 

officials to improve preparedness and response capabilities with 

respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities 

in order to support the achievement of measurable evidencebased benchmarks and objective standards applicable to sections 319C–1 and 319C–2; 

‘‘(3) improve the utilization of methods to incorporate the 

needs of children in planning for and responding to a public 

health emergency, including public awareness of such methods; 

‘‘(4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections 319C– 

2 and 319C–3, to address gaps and inefficiencies in emergency 

preparedness and response efforts for children; 

‘‘(5) provide expertise and input during the development 

of guidance and clinical recommendations to address the needs 

of children when preparing for, and responding to, public health 

emergencies, including pursuant to section 319C–3; and 

‘‘(6) carry out other duties related to preparedness and 

response activities for children, as the Secretary determines 

appropriate.’’. 

SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISASTERS. 

(a) REAUTHORIZING THE NATIONAL ADVISORY COMMITTEE ON

CHILDREN AND DISASTERS.—Section 2811A (42 U.S.C. 300hh–10a) 

is amended— 

(1) in subsection (b)(2), by inserting ‘‘, mental and behavioral,’’ after ‘‘medical’’; 

(2) in subsection (d)— 

(A) in paragraph (1), by striking ‘‘15’’ and inserting 

‘‘25’’; and 

(B) by striking paragraph (2) and inserting the following: 
S. 1379—33 

‘‘(2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in 

consultation with such other heads of Federal agencies as may 

be appropriate, shall appoint to the Advisory Committee under 

paragraph (1) at least 13 individuals, including— 

‘‘(A) at least 2 non-Federal professionals with expertise 

in pediatric medical disaster planning, preparedness, 

response, or recovery; 

‘‘(B) at least 2 representatives from State, local, Tribal, 

or territorial agencies with expertise in pediatric disaster 

planning, preparedness, response, or recovery; 

‘‘(C) at least 4 members representing health care 

professionals, which may include members with expertise 

in pediatric emergency medicine; pediatric trauma, critical 

care, or surgery; the treatment of pediatric patients affected 

by chemical, biological, radiological, or nuclear agents, 

including emerging infectious diseases; pediatric mental 

or behavioral health related to children affected by a public 

health emergency; or pediatric primary care; and 

‘‘(D) other members as the Secretary determines appropriate, of whom— 

‘‘(i) at least one such member shall represent a 

children’s hospital; 

‘‘(ii) at least one such member shall be an individual with expertise in schools or child care settings; 

‘‘(iii) at least one such member shall be an individual with expertise in children and youth with special 

health care needs; and 

‘‘(iv) at least one such member shall be an individual with expertise in the needs of parents or family 

caregivers, including the parents or caregivers of children with disabilities. 

‘‘(3) FEDERAL MEMBERS.—The Advisory Committee under 

paragraph (1) shall include the following Federal members 

or their designees (who may be nonvoting members, as determined by the Secretary): 

‘‘(A) The Assistant Secretary for Preparedness and 

Response. 

‘‘(B) The Director of the Biomedical Advanced Research 

and Development Authority. 

‘‘(C) The Director of the Centers for Disease Control 

and Prevention. 

‘‘(D) The Commissioner of Food and Drugs. 

‘‘(E) The Director of the National Institutes of Health. 

‘‘(F) The Assistant Secretary of the Administration for 

Children and Families. 

‘‘(G) The Administrator of the Health Resources and 

Services Administration. 

‘‘(H) The Administrator of the Federal Emergency 

Management Agency. 

‘‘(I) The Administrator of the Administration for 

Community Living. 

‘‘(J) The Secretary of Education. 

‘‘(K) Representatives from such Federal agencies (such 

as the Substance Abuse and Mental Health Services 

Administration and the Department of Homeland Security) 

as the Secretary determines appropriate to fulfill the duties 

of the Advisory Committee under subsections (b) and (c). 
S. 1379—34 

‘‘(4) TERM OF APPOINTMENT.—Each member of the Advisory 

Committee appointed under paragraph (2) shall serve for a 

term of 3 years, except that the Secretary may adjust the 

terms of the Advisory Committee appointees serving on the 

date of enactment of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, or appointees 

who are initially appointed after such date of enactment, in 

order to provide for a staggered term of appointment for all 

members. 

‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A 

member appointed under paragraph (2) may serve not more 

than 3 terms on the Advisory Committee, and not more than 

two of such terms may be served consecutively.’’; 

(3) in subsection (e), by adding at the end ‘‘At least one 

meeting per year shall be an in-person meeting.’’; 

(4) by redesignating subsection (f) as subsection (g); 

(5) by inserting after subsection (e) the following: 

‘‘(f) COORDINATION.—The Secretary shall coordinate duties and 

activities authorized under this section in accordance with section 

2811D.’’; and 

(6) in subsection (g), as so redesignated, by striking ‘‘2018’’ 

and inserting ‘‘2023’’. 

(b) AUTHORIZING THE NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.—Subtitle B of title XXVIII (42 U.S.C. 300hh 

et seq.) is amended by inserting after section 2811A the following: 

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

DISASTERS. 

‘‘(a) ESTABLISHMENT.—The Secretary, in consultation with the 

Secretary of Homeland Security and the Secretary of Veterans 

Affairs, shall establish an advisory committee to be known as the 

National Advisory Committee on Seniors and Disasters (referred 

to in this section as the ‘Advisory Committee’). 

‘‘(b) DUTIES.—The Advisory Committee shall— 

‘‘(1) provide advice and consultation with respect to the 

activities carried out pursuant to section 2814, as applicable 

and appropriate; 

‘‘(2) evaluate and provide input with respect to the medical 

and public health needs of seniors related to preparation for, 

response to, and recovery from all-hazards emergencies; and 

‘‘(3) provide advice and consultation with respect to State 

emergency preparedness and response activities relating to seniors, including related drills and exercises pursuant to the 

preparedness goals under section 2802(b). 

‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee may provide 

advice and recommendations to the Secretary with respect to seniors 

and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under 

this title and title III. 

‘‘(d) MEMBERSHIP.— 

‘‘(1) IN GENERAL.—The Secretary, in consultation with such 

other heads of agencies as appropriate, shall appoint not more 

than 17 members to the Advisory Committee. In appointing 

such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number. 
S. 1379—35 

‘‘(2) REQUIRED MEMBERS.—The Advisory Committee shall 

include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and nonFederal members, as follows: 

‘‘(A) The Assistant Secretary for Preparedness and 

Response. 

‘‘(B) The Director of the Biomedical Advanced Research 

and Development Authority. 

‘‘(C) The Director of the Centers for Disease Control 

and Prevention. 

‘‘(D) The Commissioner of Food and Drugs. 

‘‘(E) The Director of the National Institutes of Health. 

‘‘(F) The Administrator of the Centers for Medicare 

& Medicaid Services. 

‘‘(G) The Administrator of the Administration for 

Community Living. 

‘‘(H) The Administrator of the Federal Emergency 

Management Agency. 

‘‘(I) The Under Secretary for Health of the Department 

of Veterans Affairs. 

‘‘(J) At least 2 non-Federal health care professionals 

with expertise in geriatric medical disaster planning, 

preparedness, response, or recovery. 

‘‘(K) At least 2 representatives of State, local, Tribal, 

or territorial agencies with expertise in geriatric disaster 

planning, preparedness, response, or recovery. 

‘‘(L) Representatives of such other Federal agencies 

(such as the Department of Energy and the Department 

of Homeland Security) as the Secretary determines necessary to fulfill the duties of the Advisory Committee. 

‘‘(e) MEETINGS.—The Advisory Committee shall meet not less 

frequently than biannually. At least one meeting per year shall 

be an in-person meeting. 

‘‘(f) COORDINATION.—The Secretary shall coordinate duties and 

activities authorized under this section in accordance with section 

2811D. 

‘‘(g) SUNSET.— 

‘‘(1) IN GENERAL.—The Advisory Committee shall terminate 

on September 30, 2023. 

‘‘(2) EXTENSION OF COMMITTEE.—Not later than October 

1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.’’. 

(c) NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH

DISABILITIES AND DISASTERS.—Subtitle B of title XXVIII (42 U.S.C. 

300hh et seq.), as amended by subsection (b), is further amended 

by inserting after section 2811B the following: 

‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH 

DISABILITIES AND DISASTERS. 

‘‘(a) ESTABLISHMENT.—The Secretary, in consultation with the 

Secretary of Homeland Security, shall establish a national advisory 

committee to be known as the National Advisory Committee on 

Individuals with Disabilities and Disasters (referred to in this section as the ‘Advisory Committee’). 

‘‘(b) DUTIES.—The Advisory Committee shall— 
S. 1379—36 

‘‘(1) provide advice and consultation with respect to activities carried out pursuant to section 2814, as applicable and 

appropriate; 

‘‘(2) evaluate and provide input with respect to the medical, 

public health, and accessibility needs of individuals with 

disabilities related to preparation for, response to, and recovery 

from all-hazards emergencies; and 

‘‘(3) provide advice and consultation with respect to State 

emergency preparedness and response activities, including 

related drills and exercises pursuant to the preparedness goals 

under section 2802(b). 

‘‘(c) MEMBERSHIP.— 

‘‘(1) IN GENERAL.—The Secretary, in consultation with such 

other heads of agencies and departments as appropriate, shall 

appoint not more than 17 members to the Advisory Committee. 

In appointing such members, the Secretary shall ensure that 

the total membership of the Advisory Committee is an odd 

number. 

‘‘(2) REQUIRED MEMBERS.—The Advisory Committee shall 

include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and nonFederal members, as follows: 

‘‘(A) The Assistant Secretary for Preparedness and 

Response. 

‘‘(B) The Administrator of the Administration for 

Community Living. 

‘‘(C) The Director of the Biomedical Advanced Research 

and Development Authority. 

‘‘(D) The Director of the Centers for Disease Control 

and Prevention. 

‘‘(E) The Commissioner of Food and Drugs. 

‘‘(F) The Director of the National Institutes of Health. 

‘‘(G) The Administrator of the Federal Emergency 

Management Agency. 

‘‘(H) The Chair of the National Council on Disability. 

‘‘(I) The Chair of the United States Access Board. 

‘‘(J) The Under Secretary for Health of the Department 

of Veterans Affairs. 

‘‘(K) At least 2 non-Federal health care professionals 

with expertise in disability accessibility before, during, and 

after disasters, medical and mass care disaster planning, 

preparedness, response, or recovery. 

‘‘(L) At least 2 representatives from State, local, Tribal, 

or territorial agencies with expertise in disaster planning, 

preparedness, response, or recovery for individuals with 

disabilities. 

‘‘(M) At least 2 individuals with a disability with expertise in disaster planning, preparedness, response, or 

recovery for individuals with disabilities. 

‘‘(d) MEETINGS.—The Advisory Committee shall meet not less 

frequently than biannually. At least one meeting per year shall 

be an in-person meeting. 

‘‘(e) DISABILITY DEFINED.—For purposes of this section, the 

term ‘disability’ has the meaning given such term in section 3 

of the Americans with Disabilities Act of 1990. 
S. 1379—37 

‘‘(f) COORDINATION.—The Secretary shall coordinate duties and 

activities authorized under this section in accordance with section 

2811D. 

‘‘(g) SUNSET.— ‘‘(1) IN GENERAL.—The Advisory Committee shall terminate 

on September 30, 2023. 

‘‘(2) RECOMMENDATION.—Not later than October 1, 2022, 

the Secretary shall submit to Congress a recommendation on 

whether the Advisory Committee should be extended.’’. 

(d) ADVISORY COMMITTEE COORDINATION.—Subtitle B of title 

XXVIII (42 U.S.C. 300hh et seq.), as amended by subsection (c), 

is further amended by inserting after section 2811C the following: 

‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 

‘‘(a) IN GENERAL.—The Secretary shall coordinate duties and 

activities authorized under sections 2811A, 2811B, and 2811C, and 

make efforts to reduce unnecessary or duplicative reporting, or 

unnecessary duplicative meetings and recommendations under such 

sections, as practicable. Members of the advisory committees 

authorized under such sections, or their designees, shall annually 

meet to coordinate any recommendations, as appropriate, that may 

be similar, duplicative, or overlapping with respect to addressing 

the needs of children, seniors, and individuals with disabilities 

during public health emergencies. If such coordination occurs 

through an in-person meeting, it shall not be considered the 

required in-person meetings under any of sections 2811A(e), 

2811B(e), or 2811C(d). 

‘‘(b) COORDINATION AND ALIGNMENT.—The Secretary, acting 

through the employee designated pursuant to section 2814, shall 

align preparedness and response programs or activities to address 

similar, dual, or overlapping needs of children, seniors, and individuals with disabilities, and any challenges in preparing for and 

responding to such needs. 

‘‘(c) NOTIFICATION.—The Secretary shall annually notify the 

congressional committees of jurisdiction regarding the steps taken 

to coordinate, as appropriate, the recommendations under this section, and provide a summary description of such coordination.’’. 

SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS. 

Not later than 2 years after the date of enactment of this 

Act, the Secretary of Health and Human Services shall issue final 

guidance regarding the ability of personnel funded by programs 

authorized under this Act (including the amendments made by 

this Act) to participate in drills and operational exercises related 

to all-hazards medical and public health preparedness and response. 

Such drills and operational exercises may include activities that 

incorporate medical surge capacity planning, medical countermeasure distribution and administration, and preparing for and 

responding to identified threats for that region. Such personnel 

may include State, local, Tribal, and territorial public health department or agency personnel funded under this Act (including the 

amendments made by this Act). The Secretary shall consult with 

the Department of Homeland Security, the Department of Defense, 

the Department of Veterans Affairs, and other applicable Federal 

departments and agencies as necessary and appropriate in the 

development of such guidance. The Secretary shall make the guidance available on the internet website of the Department of Health 

and Human Services. 
S. 1379—38 

TITLE IV—PRIORITIZING A THREATBASED APPROACH 

SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

RESPONSE. 

Section 2811(b) (42 U.S.C. 300hh–10(b)) is amended— 

(1) in the matter preceding paragraph (1), by inserting 

‘‘utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and 

other relevant topics to’’ after ‘‘shall’’; and 

(2) in paragraph (4), by adding at the end the following: 

‘‘(I) THREAT AWARENESS.—Coordinate with the Director 

of the Centers for Disease Control and Prevention, the 

Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National 

Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, 

to maintain a current assessment of national security 

threats and inform preparedness and response capabilities 

based on the range of the threats that have the potential 

to result in a public health emergency.’’. 

SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES 

ENTERPRISE. 

(a) IN GENERAL.—Title XXVIII is amended by inserting after 

section 2811 (42 U.S.C. 300hh–10) the following: 

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

‘‘(a) IN GENERAL.—The Secretary shall establish the Public 

Health Emergency Medical Countermeasures Enterprise (referred 

to in this section as the ‘PHEMCE’). The Assistant Secretary for 

Preparedness and Response shall serve as chair of the PHEMCE. 

‘‘(b) MEMBERS.—The PHEMCE shall include each of the following members, or the designee of such members: 

‘‘(1) The Assistant Secretary for Preparedness and 

Response. 

‘‘(2) The Director of the Centers for Disease Control and 

Prevention. 

‘‘(3) The Director of the National Institutes of Health. 

‘‘(4) The Commissioner of Food and Drugs. 

‘‘(5) The Secretary of Defense. 

‘‘(6) The Secretary of Homeland Security. 

‘‘(7) The Secretary of Agriculture. 

‘‘(8) The Secretary of Veterans Affairs. 

‘‘(9) The Director of National Intelligence. 

‘‘(10) Representatives of any other Federal agency, which 

may include the Director of the Biomedical Advanced Research 

and Development Authority, the Director of the Strategic 

National Stockpile, the Director of the National Institute of 

Allergy and Infectious Diseases, and the Director of the Office 

of Public Health Preparedness and Response, as the Secretary 

determines appropriate. 

‘‘(c) FUNCTIONS.— 

‘‘(1) IN GENERAL.—The functions of the PHEMCE shall 

include the following: 
S. 1379—39 

‘‘(A) Utilize a process to make recommendations to 

the Secretary regarding research, advanced research, 

development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, 

as defined in section 319F–2(c), including prioritization 

based on the health security needs of the United States. 

Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy 

pursuant to section 2802, the Strategic National Stockpile 

needs pursuant to section 319F–2, and assessments of current national security threats, including chemical, 

biological, radiological, and nuclear threats, including 

emerging infectious diseases. In the event that members 

of the PHEMCE do not agree upon a recommendation, 

the Secretary shall provide a determination regarding such 

recommendation. 

‘‘(B) Identify national health security needs, including 

gaps in public health preparedness and response related 

to countermeasures and challenges to addressing such 

needs (including any regulatory challenges), and support 

alignment of countermeasure procurement with recommendations to address such needs under subparagraph 

(A). 

‘‘(C) Assist the Secretary in developing strategies 

related to logistics, deployment, distribution, dispensing, 

and use of countermeasures that may be applicable to 

the activities of the strategic national stockpile under section 319F–2(a). 

‘‘(D) Provide consultation for the development of the 

strategy and implementation plan under section 2811(d). 

‘‘(2) INPUT.—In carrying out subparagraphs (B) and (C) 

of paragraph (1), the PHEMCE shall solicit and consider input 

from State, local, Tribal, and territorial public health departments or officials, as appropriate.’’. 

(b) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES

ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—Section 

2811(d) (42 U.S.C. 300hh–10(d)) is amended— 

(1) in paragraph (1)— 

(A) by striking ‘‘Not later than 180 days after the 

date of enactment of this subsection, and every year thereafter’’ and inserting ‘‘Not later than March 15, 2020, and 

biennially thereafter’’; and 

(B) by striking ‘‘Director of the Biomedical’’ and all 

that follows through ‘‘Food and Drugs’’ and inserting 

‘‘Public Health Emergency Medical Countermeasures 

Enterprise established under section 2811–1’’; and 

(2) in paragraph (2)(J)(v), by striking ‘‘one-year period’’ 

and inserting ‘‘2-year period’’. 

SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

(a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 247d–6b(a)) is 

amended— 

(1) by redesignating paragraphs (2) and (3) as paragraphs 

(3) and (4), respectively; and 

(2) in paragraph (1)— 

(A) by inserting ‘‘the Assistant Secretary for Preparedness and Response and’’ after ‘‘collaboration with’’; 
S. 1379—40 

(B) by inserting ‘‘and optimize’’ after ‘‘provide for’’; 

(C) by inserting ‘‘and, as informed by existing recommendations of, or consultations with, the Public Health 

Emergency Medical Countermeasure Enterprise established under section 2811–1, make necessary additions or 

modifications to the contents of such stockpile or stockpiles 

based on the review conducted under paragraph (2)’’ before 

the period of the first sentence; and 

(D) by striking the second sentence; 

(3) by inserting after paragraph (1) the following: 

‘‘(2) THREAT-BASED REVIEW.— ‘‘(A) IN GENERAL.—The Secretary shall conduct an 

annual threat-based review (taking into account at-risk 

individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in 

consultation with the Public Health Emergency Medical 

Countermeasures Enterprise established under section 

2811–1, review contents within the stockpile and assess 

whether such contents are consistent with the recommendations made pursuant to section 2811–1(c)(1)(A). Such review 

shall be submitted on June 15, 2019, and on March 15 

of each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and 

Commerce and the Committee on Appropriations of the 

House of Representatives, in a manner that does not compromise national security. 

‘‘(B) ADDITIONS, MODIFICATIONS, AND REPLENISHMENTS.—Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure 

procurement or replenishment, provide— 

‘‘(i) information regarding— 

‘‘(I) the quantities of the additional or modified 

countermeasure procured for, or contracted to be 

procured for, the stockpile; 

‘‘(II) planning considerations for appropriate 

manufacturing capacity and capability to meet the 

goals of such additions or modifications (without 

disclosing proprietary information), including 

consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health 

care system; 

‘‘(III) the presence or lack of a commercial 

market for the countermeasure at the time of 

procurement; 

‘‘(IV) the emergency health security threat or 

threats such countermeasure procurement is 

intended to address, including whether such 

procurement is consistent with meeting emergency 

health security needs associated with such threat 

or threats; 

‘‘(V) an assessment of whether the emergency 

health security threat or threats described in subclause (IV) could be addressed in a manner that 

better utilizes the resources of the stockpile and 

permits the greatest possible increase in the level 
S. 1379—41 

of emergency preparedness to address such 

threats; 

‘‘(VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is 

a different countermeasure with the same indication that is replacing an expiring or expired 

countermeasure, or is a new addition to the stockpile; 

‘‘(VII) a description of how such additions or 

modifications align with projected investments 

under previous countermeasures budget plans 

under section 2811(b)(7), including expected lifecycle costs, expenditures related to countermeasure 

procurement to address the threat or threats 

described in subclause (IV), replenishment dates 

(including the ability to extend the maximum shelf 

life of a countermeasure), and the manufacturing 

capacity required to replenish such countermeasure; and 

‘‘(VIII) appropriate protocols and processes for 

the deployment, distribution, or dispensing of the 

countermeasure at the State and local level, 

including plans for relevant capabilities of State 

and local entities to dispense, distribute, and 

administer the countermeasure; and 

‘‘(ii) an assurance, which need not be provided 

in advance of procurement, that for each countermeasure procured or replenished under this subsection, 

the Secretary completed a review addressing each item 

listed under this subsection in advance of such procurement or replenishment.’’; 

(4) in paragraph (3), as so redesignated— 

(A) in subparagraph (A), by inserting ‘‘and the Public 

Health Emergency Medical Countermeasures Enterprise 

established under section 2811–1’’ before the semicolon; 

(B) in subparagraph (C), by inserting ‘‘, and the availability, deployment, dispensing, and administration of 

countermeasures’’ before the semicolon; 

(C) by amending subparagraph (E) to read as follows: 

‘‘(E) devise plans for effective and timely supply-chain 

management of the stockpile, in consultation with the 

Director of the Centers for Disease Control and Prevention, 

the Assistant Secretary for Preparedness and Response, 

the Secretary of Transportation, the Secretary of Homeland 

Security, the Secretary of Veterans Affairs, and the heads 

of other appropriate Federal agencies; State, local, Tribal, 

and territorial agencies; and the public and private health 

care infrastructure, as applicable, taking into account the 

manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;’’; 

(D) in subparagraph (G), by striking ‘‘; and’’ and 

inserting a semicolon; 

(E) in subparagraph (H), by striking the period and 

inserting a semicolon; and 

(F) by adding at the end the following: 
S. 1379—42 

‘‘(I) ensure that each countermeasure or product under 

consideration for procurement pursuant to this subsection 

receives the same consideration regardless of whether such 

countermeasure or product receives or had received funding 

under section 319L, including with respect to whether the 

countermeasure or product is most appropriate to meet 

the emergency health security needs of the United States; 

and 

‘‘(J) provide assistance, including technical assistance, 

to maintain and improve State and local public health 

preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as 

appropriate.’’; and 

(5) by adding at the end the following: 

‘‘(5) GAO REPORT.— ‘‘(A) IN GENERAL.—Not later than 3 years after the 

date of enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019, and 

every 5 years thereafter, the Comptroller General of the 

United States shall conduct a review of any changes to 

the contents or management of the stockpile since January 

1, 2015. Such review shall include— 

‘‘(i) an assessment of the comprehensiveness and 

completeness of each annual threat-based review under 

paragraph (2), including whether all newly procured 

or replenished countermeasures within the stockpile 

were described in each annual review, and whether, 

consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of 

such procurement or replenishment; 

‘‘(ii) an assessment of whether the Secretary established health security and science-based justifications, 

and a description of such justifications for procurement 

decisions related to health security needs with respect 

to the identified threat, for additions or modifications 

to the stockpile based on the information provided 

in such reviews under paragraph (2)(B), including 

whether such review was conducted prior to procurement, modification, or replenishment; 

‘‘(iii) an assessment of the plans developed by the 

Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or 

replenished under paragraph (1), including whether 

such plans were developed prior to procurement, modification, or replenishment; 

‘‘(iv) an accounting of countermeasures procured, 

modified, or replenished under paragraph (1) that 

received advanced research and development funding 

from the Biomedical Advanced Research and Development Authority; 

‘‘(v) an analysis of how such procurement decisions 

made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1); 

‘‘(vi) a description of the resources expended 

related to the procurement of countermeasures 
S. 1379—43 

(including additions, modifications, and replenishments) in the stockpile, and how such expenditures 

relate to the ability of the stockpile to meet emergency 

health security needs; 

‘‘(vii) an assessment of the extent to which additions, modifications, and replenishments reviewed 

under paragraph (2) align with previous relevant 

reports or reviews by the Secretary or the Comptroller 

General; 

‘‘(viii) with respect to any change in the Federal 

organizational management of the stockpile, an assessment and comparison of the processes affected by such 

change, including planning for potential countermeasure deployment, distribution, or dispensing 

capabilities and processes related to procurement 

decisions, use of stockpiled countermeasures, and use 

of resources for such activities; and 

‘‘(ix) an assessment of whether the processes and 

procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under 

consideration for procurement pursuant to subsection 

(a) receive the same consideration regardless of 

whether such countermeasures and products receive 

or had received funding under section 319L, including 

with respect to whether such countermeasures and 

products are most appropriate to meet the emergency 

health security needs of the United States. 

‘‘(B) SUBMISSION.—Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an 

unclassified version of the review to the congressional 

committees of jurisdiction.’’. 

(b) ADDITIONAL REPORTING.—In the first threat-based review 

submitted after the date of enactment of this Act pursuant to 

paragraph (2) of section 319F–2(a) of the Public Health Service 

Act (42 U.S.C. 247d–6b(a)), as amended by subsection (a), the 

Secretary shall include a description of the processes and procedures 

through which the Director of the Strategic National Stockpile 

and the Director of the Biomedical Advanced Research and Development Authority coordinate with respect to countermeasures and 

products procured under such section 319F–2(a), including such 

processes and procedures in place to ensure countermeasures and 

products under consideration for procurement pursuant to such 

section 319F–2(a) receive the same consideration regardless of 

whether such countermeasures or products receive or had received 

funding under section 319L of the Public Health Service Act (42 

U.S.C. 247d–7e), and whether such countermeasures and products 

are the most appropriate to meet the emergency health security 

needs of the United States. 

(c) AUTHORIZATION OF APPROPRIATIONS, STRATEGIC NATIONAL

STOCKPILE.—Section 319F–2(f)(1) (42 U.S.C. 247d–6b(f)(1)) is 

amended by striking ‘‘$533,800,000 for each of fiscal years 2014 

through 2018’’ and inserting ‘‘$610,000,000 for each of fiscal years 

2019 through 2023, to remain available until expended’’. 
S. 1379—44 

SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL 

RESISTANCE, AND OTHER SIGNIFICANT THREATS. 

(a) STRATEGIC INITIATIVES.—Section 319L(c)(4) (247d–7e(c)(4)) 

is amended by adding at the end the following: 

‘‘(F) STRATEGIC INITIATIVES.—The Secretary, acting 

through the Director of BARDA, may implement strategic 

initiatives, including by building on existing programs and 

by awarding contracts, grants, and cooperative agreements, 

or entering into other transactions, to support innovative 

candidate products in preclinical and clinical development 

that address priority, naturally occurring and man-made 

threats that, as determined by the Secretary, pose a significant level of risk to national security based on the 

characteristics of a chemical, biological, radiological or 

nuclear threat, or existing capabilities to respond to such 

a threat (including medical response and treatment 

capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, 

development, and procurement of countermeasures and 

products, as applicable, to address areas including— 

‘‘(i) chemical, biological, radiological, or nuclear 

threats, including emerging infectious diseases, for 

which insufficient approved, licensed, or authorized 

countermeasures exist, or for which such threat, or 

the result of an exposure to such threat, may become 

resistant to countermeasures or existing countermeasures may be rendered ineffective; 

‘‘(ii) threats that consistently exist or continually 

circulate and have a significant potential to become 

a pandemic, such as pandemic influenza, which may 

include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, 

or processes to support the advanced research and 

development of such countermeasures (including 

multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; 

novel virus strains; and antigen and adjuvant material); and 

‘‘(iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or 

nuclear agent, or emerging infectious diseases, and 

which may present increased treatment complications 

such as the occurrence of resistance to available 

countermeasures or potential countermeasures, 

including antimicrobial resistant pathogens.’’. 

(b) PROTECTION OF NATIONAL SECURITY FROM THREATS.—Section 2811 (42 U.S.C. 300hh–10) is amended by adding at the end 

the following: 

‘‘(f) PROTECTION OF NATIONAL SECURITY FROM THREATS.— 

‘‘(1) IN GENERAL.—In carrying out subsection (b)(3), the 

Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, 

including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any 

such agent with a significant potential to become a pandemic), 

that pose a significant level of risk to public health and national 
S. 1379—45 

security based on the characteristics of such threat. Such initiatives shall include activities to— 

‘‘(A) accelerate and support the advanced research, 

development, manufacturing capacity, procurement, and 

stockpiling of countermeasures, including initiatives under 

section 319L(c)(4)(F); 

‘‘(B) support the development and manufacturing of 

virus seeds, clinical trial lots, and stockpiles of novel virus 

strains; and 

‘‘(C) maintain or improve preparedness activities, 

including for pandemic influenza. 

‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

‘‘(A) IN GENERAL.—To carry out this subsection, there 

is authorized to be appropriated $250,000,000 for each 

of fiscal years 2019 through 2023. 

‘‘(B) SUPPLEMENT, NOT SUPPLANT.—Amounts appropriated under this paragraph shall be used to supplement 

and not supplant funds provided under sections 319L(d) 

and 319F–2(g). 

‘‘(C) DOCUMENTATION REQUIRED.—The Assistant Secretary for Preparedness and Response, in accordance with 

subsection (b)(7), shall document amounts expended for 

purposes of carrying out this subsection, including amounts 

appropriated under the heading ‘Public Health and Social 

Services Emergency Fund’ under the heading ‘Office of 

the Secretary’ under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and 

allocated to carrying out section 319L(c)(4)(F).’’. 

SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM. 

Section 351A(k) (42 U.S.C. 262a(k)) is amended— 

(1) by striking ‘‘The Secretary’’ and inserting the following: 

‘‘(1) IN GENERAL.—The Secretary’’; and 

(2) by adding at the end the following: 

‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS OF THE FEDERAL EXPERTS SECURITY ADVISORY PANEL AND THE FAST TRACK

ACTION COMMITTEE ON SELECT AGENT REGULATIONS.— 

‘‘(A) IN GENERAL.—Not later than 1 year after the 

date of the enactment of the Pandemic and All-Hazards 

Preparedness and Advancing Innovation Act of 2019, the 

Secretary shall report to the congressional committees of 

jurisdiction on the implementation of recommendations of 

the Federal Experts Security Advisory Panel concerning 

the select agent program. 

‘‘(B) CONTINUED UPDATES.—The Secretary shall report 

to the congressional committees of jurisdiction annually 

following the submission of the report under subparagraph 

(A) until the recommendations described in such subparagraph are fully implemented, or a justification is provided 

for the delay in, or lack of, implementation.’’. 
S. 1379—46 

TITLE V—INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE 

ADVANCED RESEARCH AND DEVELOPMENT 

SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 

Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is amended— 

(1) in the matter preceding subparagraph (A), by striking 

‘‘March 1’’ and inserting ‘‘March 15’’; 

(2) in subparagraph (A)— 

(A) in clause (ii), by striking ‘‘; and’’ and inserting 

‘‘;’’; and 

(B) by striking clause (iii) and inserting the following: 

‘‘(iii) procurement, stockpiling, maintenance, and 

potential replenishment (including manufacturing 

capabilities) of all products in the Strategic National 

Stockpile; 

‘‘(iv) the availability of technologies that may assist 

in the advanced research and development of countermeasures and opportunities to use such technologies 

to accelerate and navigate challenges unique to 

countermeasure research and development; and 

‘‘(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the 

use of medical countermeasures; and, as applicable, 

potential postdeployment activities related to medical 

countermeasures;’’; 

(3) by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively; and 

(4) by inserting after subparagraph (C), the following: 

‘‘(D) identify the full range of anticipated medical 

countermeasure needs related to research and development, 

procurement, and stockpiling, including the potential need 

for indications, dosing, and administration technologies, 

and other countermeasure needs as applicable and appropriate;’’. 

SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE 

NOTIFICATIONS. 

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

amended by striking ‘‘The Secretary and the Homeland Security 

Secretary shall promptly notify the appropriate committees of Congress’’ and inserting ‘‘The Secretary and the Secretary of Homeland 

Security shall send to Congress, on an annual basis, all current 

material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the 

Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives’’. 

(b) CONTRACTING COMMUNICATION.—Section 319F– 

2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) is amended by 

adding at the end the following: ‘‘The Secretary shall notify the 
S. 1379—47 

vendor within 90 days of a determination by the Secretary to 

renew, extend, or terminate such contract.’’. 

SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS. 

Section 565(f) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–4(f)) is amended— 

(1) by redesignating paragraphs (3) through (6) as paragraphs (4) through (7), respectively; 

(2) by inserting after paragraph (2) the following: 

‘‘(3) PUBLICATION.—The Secretary shall make available on 

the internet website of the Food and Drug Administration 

information regarding regulatory management plans, 

including— 

‘‘(A) the process by which an applicant may submit 

a request for a regulatory management plan; 

‘‘(B) the timeframe by which the Secretary is required 

to respond to such request; 

‘‘(C) the information required for the submission of 

such request; 

‘‘(D) a description of the types of development milestones and performance targets that could be discussed 

and included in such plans; and 

‘‘(E) contact information for beginning the regulatory 

management plan process.’’; 

(3) in paragraph (6), as so redesignated, in the matter 

preceding subparagraph (A)— 

(A) by striking ‘‘paragraph (4)(A)’’ and inserting ‘‘paragraph (5)(A)’’; and 

(B) by striking ‘‘paragraph (4)(B)’’ and inserting ‘‘paragraph (5)(B)’’; and 

(4) in paragraph (7)(A), as so redesignated, by striking 

‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’. 

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

FUND. 

(a) BIOSHIELD SPECIAL RESERVE FUND.—Section 319F–2(g)(1) 

(42 U.S.C. 247d–6b(g)(1)) is amended— 

(1) by striking ‘‘$2,800,000,000 for the period of fiscal years 

2014 through 2018’’ and inserting ‘‘$7,100,000,000 for the period 

of fiscal years 2019 through 2028, to remain available until 

expended’’; and 

(2) by striking the second sentence. 

(b) THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT

AUTHORITY.—Section 319L(d)(2) (42 U.S.C. 247d–7e(d)(2)) is 

amended by striking ‘‘$415,000,000 for each of fiscal years 2014 

through 2018’’ and inserting ‘‘$611,700,000 for each of fiscal years 

2019 through 2023’’. 

SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTIBIOTIC 

RESISTANCE. 

(a) ADVISORY COUNCIL.—The Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) may continue 

the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, referred to in this section as the ‘‘Advisory Council’’. 

(b) DUTIES.—The Advisory Council shall advise and provide 

information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant 
S. 1379—48 

bacteria that may present a public health threat and improve 

capabilities to prevent, diagnose, mitigate, or treat such resistance. 

Such advice, information, and recommendations may be related 

to improving— 

(1) the effectiveness of antibiotics; 

(2) research and advanced research on, and the development of, improved and innovative methods for combating or 

reducing antibiotic resistance, including new treatments, rapid 

point-of-care diagnostics, alternatives to antibiotics, including 

alternatives to animal antibiotics, and antimicrobial stewardship activities; 

(3) surveillance of antibiotic-resistant bacterial infections, 

including publicly available and up-to-date information on 

resistance to antibiotics; 

(4) education for health care providers and the public with 

respect to up-to-date information on antibiotic resistance and 

ways to reduce or combat such resistance to antibiotics related 

to humans and animals; 

(5) methods to prevent or reduce the transmission of antibiotic-resistant bacterial infections, including stewardship programs; and 

(6) coordination with respect to international efforts in 

order to inform and advance United States capabilities to combat antibiotic resistance. 

(c) MEETINGS AND COORDINATION.— (1) MEETINGS.—The Advisory Council shall meet not less 

than biannually and, to the extent practicable, in coordination 

with meetings of the Antimicrobial Resistance Task Force established in section 319E(a) of the Public Health Service Act. 

(2) COORDINATION.—The Advisory Council shall, to the 

greatest extent practicable, coordinate activities carried out 

by the Council with the Antimicrobial Resistance Task Force 

established under section 319E(a) of the Public Health Service 

Act (42 U.S.C. 247d–5(a)). 

(d) FACA.—The Federal Advisory Committee Act (5 U.S.C. 

App.) shall apply to the activities and duties of the Advisory Council. 

(e) EXTENSION OF ADVISORY COUNCIL.—Not later than October 

1, 2022, the Secretary shall submit to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives a recommendation on whether the Advisory Council should be extended, 

and in addition, identify whether there are other committees, councils, or task forces that have overlapping or similar duties to that 

of the Advisory Council, and whether such committees, councils, 

or task forces should be combined, including with respect to section 

319E(a) of the Public Health Service Act (42 U.S.C. 247d–5(a)). 

TITLE VI—ADVANCING TECHNOLOGIES 

FOR MEDICAL COUNTERMEASURES 

SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 

Section 319L(c)(4)(D)(iii) (42 U.S.C. 247d–7e(c)(4)(D)(iii)) is 

amended by striking ‘‘and platform technologies’’ and inserting 

‘‘platform technologies, technologies to administer countermeasures, 

and technologies to improve storage and transportation of countermeasures’’. 
S. 1379—49 

SEC. 602. UPDATING DEFINITIONS OF OTHER TRANSACTIONS. 

Section 319L (42 U.S.C. 247d–7e) is amended— 

(1) in subsection (a)(3), by striking ‘‘, such as’’ and all 

that follows through ‘‘Code’’; and 

(2) in subsection (c)(5)(A)— 

(A) in clause (i), by striking ‘‘under this subsection’’ 

and all that follows through ‘‘Code’’ and inserting ‘‘(as 

defined in subsection (a)(3)) under this subsection’’; and 

(B) in clause (ii)— 

(i) by amending subclause (I) to read as follows: 

‘‘(I) IN GENERAL.—To the maximum extent 

practicable, competitive procedures shall be used 

when entering into transactions to carry out 

projects under this subsection.’’; and 

(ii) in subclause (II)— 

(I) by striking ‘‘$20,000,000’’ and inserting 

‘‘$100,000,000’’; 

(II) by striking ‘‘senior procurement executive 

for the Department (as designated for purpose of 

section 16(c) of the Office of Federal Procurement 

Policy Act (41 U.S.C. 414(c)))’’ and inserting 

‘‘Assistant Secretary for Financial Resources’’; and 

(III) by striking ‘‘senior procurement executive 

under’’ and inserting ‘‘Assistant Secretary for 

Financial Resources under’’. 

SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 

(a) IN GENERAL.—The purpose of this section (including section 

565B of the Federal Food, Drug, and Cosmetic Act, as added by 

subsection (b)) is to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and 

qualified pandemic or epidemic products by facilitating and encouraging submission of data and information to support the development of such products, and through clarifying the authority to 

cross-reference to data and information previously submitted to 

the Secretary of Health and Human Services (referred to in this 

section as the ‘‘Secretary’’), including data and information submitted to medical countermeasure master files or other master 

files. 

(b) MEDICAL COUNTERMEASURE MASTER FILES.—Chapter V of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 

is amended by inserting after section 565A the following: 

‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 

‘‘(a) APPLICABILITY OF REFERENCE.— 

‘‘(1) IN GENERAL.—A person may submit data and information in a master file to the Secretary with the intent to reference, or to authorize, in writing, another person to reference, 

such data or information to support a medical countermeasure 

submission (including a supplement or amendment to any such 

submission), without requiring the master file holder to disclose 

the data and information to any such persons authorized to 

reference the master file. Such data and information shall 

be available for reference by the master file holder or by a 

person authorized by the master file holder, in accordance 

with applicable privacy and confidentiality protocols and regulations. 
S. 1379—50 

‘‘(2) REFERENCE OF CERTAIN MASTER FILES.—In the case 

that data or information within a medical countermeasure 

master file is used only to support the conditional approval 

of an application filed under section 571, such master file 

may be relied upon to support the effectiveness of a product 

that is the subject of a subsequent medical countermeasure 

submission only if such application is supplemented by additional data or information to support review and approval in 

a manner consistent with the standards applicable to such 

review and approval for such countermeasure, qualified 

countermeasure, or qualified pandemic or epidemic product. 

‘‘(b) MEDICAL COUNTERMEASURE MASTER FILE CONTENT.— 

‘‘(1) IN GENERAL.—A master file under this section may 

include data or information to support— 

‘‘(A) the development of medical countermeasure 

submissions to support the approval, licensure, classification, clearance, conditional approval, or authorization of 

one or more security countermeasures, qualified countermeasures, or qualified pandemic or epidemic products; and 

‘‘(B) the manufacture of security countermeasures, 

qualified countermeasures, or qualified pandemic or epidemic products. 

‘‘(2) REQUIRED UPDATES.—The Secretary may require, as 

appropriate, that the master file holder ensure that the contents 

of such master file are updated during the time such master 

file is referenced for a medical countermeasure submission. 

‘‘(c) SPONSOR REFERENCE.— 

‘‘(1) IN GENERAL.—Each incorporation of data or information within a medical countermeasure master file shall describe 

the incorporated material in a manner in which the Secretary 

determines appropriate and that permits the review of such 

information within such master file without necessitating 

resubmission of such data or information. Master files shall 

be submitted in an electronic format in accordance with sections 

512(b)(4), 571(a)(4), and 745A, as applicable, and as specified 

in applicable guidance. 

‘‘(2) REFERENCE BY A MASTER FILE HOLDER.—A master file 

holder that is the sponsor of a medical countermeasure submission shall notify the Secretary in writing of the intent to reference the medical countermeasure master file as a part of 

the submission. 

‘‘(3) REFERENCE BY AN AUTHORIZED PERSON.—A person 

submitting an application for review may, where the Secretary 

determines appropriate, incorporate by reference all or part 

of the contents of a medical countermeasure master file, if 

the master file holder authorizes the incorporation in writing. 

‘‘(d) ACKNOWLEDGMENT OF AND RELIANCE UPON A MASTER FILE

BY THE SECRETARY.— 

‘‘(1) IN GENERAL.—The Secretary shall provide the master 

file holder with a written notification indicating that the Secretary has reviewed and relied upon specified data or information within a master file and the purposes for which such 

data or information was incorporated by reference if the Secretary has reviewed and relied upon such specified data or 

information to support the approval, classification, conditional 

approval, clearance, licensure, or authorization of a security 
S. 1379—51 

countermeasure, qualified countermeasure, or qualified pandemic or epidemic product. The Secretary may rely upon the 

data and information within the medical countermeasure 

master file for which such written notification was provided 

in additional applications, as applicable and appropriate and 

upon the request of the master file holder so notified in writing 

or by an authorized person of such holder. 

‘‘(2) CERTAIN APPLICATIONS.—If the Secretary has reviewed 

and relied upon specified data or information within a medical 

countermeasure master file to support the conditional approval 

of an application under section 571 to subsequently support 

the approval, clearance, licensure, or authorization of a security 

countermeasure, qualified countermeasure, or qualified pandemic or epidemic product, the Secretary shall provide a brief 

written description to the master file holder regarding the 

elements of the application fulfilled by the data or information 

within the master file and how such data or information contained in such application meets the standards of evidence 

under subsection (c) or (d) of section 505, subsection (d) of 

section 512, or section 351 of the Public Health Service Act 

(as applicable), which shall not include any trade secret or 

confidential commercial information. 

‘‘(e) RULES OF CONSTRUCTION.—Nothing in this section shall 

be construed to— 

‘‘(1) limit the authority of the Secretary to approve, license, 

clear, conditionally approve, or authorize drugs, biological products, or devices pursuant to, as applicable, this Act or section 

351 of the Public Health Service Act (as such applicable Act 

is in effect on the day before the date of enactment of the 

Pandemic and All-Hazards Preparedness and Advancing 

Innovation Act of 2019), including the standards of evidence, 

and applicable conditions, for approval under the applicable 

Act; 

‘‘(2) alter the standards of evidence with respect to 

approval, licensure, or clearance, as applicable, of drugs, 

biological products, or devices under this Act or section 351 

of the Public Health Service Act, including, as applicable, the 

substantial evidence standards under sections 505(d) and 512(d) 

or this Act and section 351(a) of the Public Health Service 

Act; or 

‘‘(3) alter the authority of the Secretary under this Act 

or the Public Health Service Act to determine the types of 

data or information previously submitted by a sponsor or any 

other person that may be incorporated by reference in an 

application, request, or notification for a drug, biological 

product, or device submitted under sections 505(i), 505(b), 

505(j), 512(b)(1), 512(b)(2), 512(j), 564, 571, 520(g), 515(c), 

513(f)(2), or 510(k) of this Act, or subsection (a) or (k) of section 

351 of the Public Health Service Act, including a supplement 

or amendment to any such submission, and the requirements 

associated with such reference. 

‘‘(f) DEFINITIONS.—In this section: 

‘‘(1) The term ‘master file holder’ means a person who 

submits data and information to the Secretary with the intent 

to reference or authorize another person to reference such data 

or information to support a medical countermeasure submission, as described in subsection (a). 
S. 1379—52 

‘‘(2) The term ‘medical countermeasure submission’ means 

an investigational new drug application under section 505(i), 

a new drug application under section 505(b), or an abbreviated 

new drug application under section 505(j) of this Act, a 

biological product license application under section 351(a) of 

the Public Health Service Act or a biosimilar biological product 

license application under section 351(k) of the Public Health 

Service Act, a new animal drug application under section 

512(b)(1) or abbreviated new animal drug application under 

section 512(b)(2), an application for conditional approval of 

a new animal drug under section 571, an investigational device 

application under section 520(g), an application with respect 

to a device under section 515(c), a request for classification 

of a device under section 513(f)(2), a notification with respect 

to a device under section 510(k), or a request for an emergency 

use authorization under section 564 to support— 

‘‘(A) the approval, licensure, classification, clearance, 

conditional approval, or authorization of a security countermeasure, qualified countermeasure, or qualified pandemic 

or epidemic product; or 

‘‘(B) a new indication to an approved security countermeasure, qualified countermeasure, or qualified pandemic 

or epidemic product. 

‘‘(3) The terms ‘qualified countermeasure’, ‘security countermeasure’, and ‘qualified pandemic or epidemic product’ have 

the meanings given such terms in sections 319F–1, 319F–2, 

and 319F–3, respectively, of the Public Health Service Act.’’. 

(c) STAKEHOLDER INPUT.—Not later than 18 months after the 

date of enactment of this Act, the Secretary, acting through the 

Commissioner of Food and Drugs and in consultation with the 

Assistant Secretary for Preparedness and Response, shall solicit 

input from stakeholders, including stakeholders developing security 

countermeasures, qualified countermeasures, or qualified pandemic 

or epidemic products, and stakeholders developing technologies to 

assist in the development of such countermeasures with respect 

to how the Food and Drug Administration can advance the use 

of tools and technologies to support and advance the development 

or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products, including 

through reliance on cross-referenced data and information contained 

within master files and submissions previously submitted to the 

Secretary as set forth in section 565B of the Federal Food, Drug, 

and Cosmetic Act, as added by subsection (b). 

(d) GUIDANCE.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner 

of Food and Drugs, shall publish draft guidance about how reliance 

on cross-referenced data and information contained within master 

files under section 565B of the Federal Food, Drug, and Cosmetic 

Act, as added by subsection (b) or submissions otherwise submitted 

to the Secretary may be used for specific tools or technologies 

(including platform technologies) that have the potential to support 

and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or 

epidemic products. The Secretary, acting through the Commissioner 

of Food and Drugs, shall publish the final guidance not later than 

3 years after the enactment of this Act. 
S. 1379—53 

SEC. 604. ANIMAL RULE REPORT. 

(a) STUDY.—The Comptroller General of the United States shall 

conduct a study on the application of the requirements under subsections (c) and (d) of section 565 of the of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) (referred to in this 

section as the ‘‘animal rule’’) as a component of medical countermeasure advanced development under the Biomedical Advanced 

Research and Development Authority and regulatory review by 

the Food and Drug Administration. In conducting such study, the 

Comptroller General shall examine the following: 

(1) The extent to which advanced development and review 

of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and 

the Food and Drug Administration, including activities that 

facilitate appropriate and efficient design of studies to support 

approval, licensure, and authorization under the animal rule, 

consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360bbb–4(c)) and entitled 

‘‘Product Development Under the Animal Rule: Guidance for 

Industry’’ (issued in October 2015), to resolve discrepancies 

in the design of adequate and well-controlled efficacy studies 

conducted in animal models related to the provision of substantial evidence of effectiveness for the product approved, licensed, 

or authorized under the animal rule. 

(2) The consistency of the application of the animal rule 

among and between review divisions within the Food and Drug 

Administration. 

(3) The flexibility pursuant to the animal rule to address 

variations in countermeasure development and review processes, including the extent to which qualified animal models 

are adopted and used within the Food and Drug Administration 

in regulatory decisionmaking with respect to medical countermeasures. 

(4) The extent to which the guidance issued under section 

565(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

360bbb–4(c)), entitled, ‘‘Product Development Under the Animal 

Rule: Guidance for Industry’’ (issued in October 2015), has 

assisted in achieving the purposes described in paragraphs 

(1), (2), and (3). 

(b) CONSULTATIONS.—In conducting the study under subsection 

(a), the Comptroller General of the United States shall consult 

with— 

(1) the Federal agencies responsible for advancing, 

reviewing, and procuring medical countermeasures, including 

the Office of the Assistant Secretary for Preparedness and 

Response, the Biomedical Advanced Research and Development 

Authority, the Food and Drug Administration, and the Department of Defense; 

(2) manufacturers involved in the research and development of medical countermeasures to address biological, chemical, radiological, or nuclear threats; and 

(3) other biodefense stakeholders, as applicable. 

(c) REPORT.—Not later than 3 years after the date of enactment 

of this Act, the Comptroller General of the United States shall 

submit to the Committee on Health, Education, Labor, and Pensions 

of the Senate and the Committee on Energy and Commerce of 
S. 1379—54 

the House of Representatives a report containing the results of 

the study conducted under subsection (a) and recommendations 

to improve the application and consistency of the requirements 

under subsections (c) and (d) of section 565 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) to support and expedite the research and development of medical countermeasures, 

as applicable. 

(d) PROTECTION OF NATIONAL SECURITY.—The Comptroller General of the United States shall conduct the study and issue the 

assessment and report under this section in a manner that does 

not compromise national security. 

SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGINEERING TECHNOLOGIES AND THEIR POTENTIAL ROLE IN NATIONAL 

SECURITY. 

(a) MEETING.— 

(1) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) shall 

convene a meeting to discuss the potential role advancements 

in genomic engineering technologies (including genome editing 

technologies) may have in advancing national health security. 

Such meeting shall be held in a manner that does not compromise national security. 

(2) ATTENDEES.—The attendees of the meeting under paragraph (1)— 

(A) shall include— 

(i) representatives from the Office of the Assistant 

Secretary for Preparedness and Response, the National 

Institutes of Health, the Centers for Disease Control 

and Prevention, and the Food and Drug Administration; and 

(ii) representatives from academic, private, and 

nonprofit entities with expertise in genome engineering 

technologies, biopharmaceuticals, medicine, or biodefense, and other relevant stakeholders; and 

(B) may include— 

(i) other representatives from the Department of 

Health and Human Services, as the Secretary determines appropriate; and 

(ii) representatives from the Department of Homeland Security, the Department of Defense, the Department of Agriculture, and other departments, as the 

Secretary may request for the meeting. 

(3) TOPICS.—The meeting under paragraph (1) shall include 

a discussion of— 

(A) the current state of the science of genomic 

engineering technologies related to national health security, 

including— 

(i) medical countermeasure development, including 

potential efficiencies in the development pathway and 

detection technologies; and 

(ii) the international and domestic regulation of 

products utilizing genome editing technologies; and 

(B) national security implications, including— 
S. 1379—55 

(i) capabilities of the United States to leverage 

genomic engineering technologies as a part of the medical countermeasure enterprise, including current 

applicable research, development, and application 

efforts underway within the Department of Defense; 

(ii) the potential for state and non-state actors 

to utilize genomic engineering technologies as a 

national health security threat; and 

(iii) security measures to monitor and assess the 

potential threat that may result from utilization of 

genomic engineering technologies and related technologies for the purpose of compromising national 

health security. 

(b) REPORT.—Not later than 270 days after the meeting 

described in subsection (a) is held, the Assistant Secretary for 

Preparedness and Response shall issue a report to the congressional 

committees of jurisdiction on the topics discussed at such meeting, 

and provide recommendations, as applicable, to utilize innovations 

in genomic engineering (including genome editing) and related technologies as a part of preparedness and response activities to advance 

national health security. Such report shall be issued in a manner 

that does not compromise national security. 

SEC. 606. REPORT ON VACCINES DEVELOPMENT. 

Not later than one year after the date of the enactment of 

this Act, the Secretary of Health and Human Services shall submit 

to the Committee on Health, Education, Labor, and Pensions of 

the Senate and the Committee on Energy and Commerce of the 

House of Representatives a report describing efforts and activities 

to coordinate with other countries and international partners during 

recent public health emergencies with respect to the research and 

advanced research on, and development of, qualified pandemic or 

epidemic products (as defined in section 319F–3 of the Public Health 

Service Act (42 U.S.C. 247d–6d)). Such report may include information regarding relevant work carried out under section 319L(c)(5)(E) 

of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)(E)), 

through public-private partnerships, and through collaborations 

with other countries to assist with or expedite the research and 

development of qualified pandemic or epidemic products. Such 

report shall not include information that may compromise national 

security. 

SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR SAFETY AND 

HEALTH. 

(a) REAUTHORIZATION OF MOSQUITO ABATEMENT FOR SAFETY

AND HEALTH PROGRAM.—Section 317S (42 U.S.C. 247b–21) is 

amended— 

(1) in subsection (a)(1)(B)— 

(A) by inserting ‘‘including programs to address 

emerging infectious mosquito-borne diseases,’’ after ‘‘subdivisions for control programs,’’; and 

(B) by inserting ‘‘or improving existing control programs’’ before the period at the end; 

(2) in subsection (b)— 

(A) in paragraph (1), by inserting ‘‘, including improvement,’’ after ‘‘operation’’; 

(B) in paragraph (2)— 

(i) in subparagraph (A)— 
S. 1379—56 

(I) in clause (ii), by striking ‘‘or’’ at the end; 

(II) in clause (iii), by striking the semicolon 

at the end and inserting ‘‘, including an emerging 

infectious mosquito-borne disease that presents a 

serious public health threat; or’’; and 

(III) by adding at the end the following: 

‘‘(iv) a public health emergency due to the 

incidence or prevalence of a mosquito-borne disease 

that presents a serious public health threat;’’; and 

(ii) by amending subparagraph (D) to read as follows: 

‘‘(D)(i) is located in a State that has received a grant 

under subsection (a); or 

‘‘(ii) that demonstrates to the Secretary that the control 

program is consistent with existing State mosquito control 

plans or policies, or other applicable State preparedness 

plans.’’; 

(C) in paragraph (4)(C), by striking ‘‘that extraordinary’’ and all that follows through the period at the 

end and inserting the following: ‘‘that— 

‘‘(i) extraordinary economic conditions in the political subdivision or consortium of political subdivisions 

involved justify the waiver; or 

‘‘(ii) the geographical area covered by a political 

subdivision or consortium for a grant under paragraph 

(1) has an extreme mosquito control need due to— 

‘‘(I) the size or density of the potentially 

impacted human population; 

‘‘(II) the size or density of a mosquito population that requires heightened control; or 

‘‘(III) the severity of the mosquito-borne disease, such that expected serious adverse health 

outcomes for the human population justify the 

waiver.’’; and 

(D) by amending paragraph (6) to read as follows: 

‘‘(6) NUMBER OF GRANTS.—A political subdivision or a 

consortium of political subdivisions may not receive more than 

one grant under paragraph (1).’’; and 

(3) in subsection (f)— 

(A) in paragraph (1) by striking ‘‘for fiscal year 2003, 

and such sums as may be necessary for each of fiscal 

years 2004 through 2007’’ and inserting ‘‘for each of fiscal 

years 2019 through 2023’’; 

(B) in paragraph (2), by striking ‘‘the Public Health 

Security and Bioterrorism Preparedness and Response Act 

of 2002’’ and inserting ‘‘this Act and other medical and 

public health preparedness and response laws’’; and 

(C) in paragraph (3)— 

(i) in the paragraph heading, by striking ‘‘2004’’ 

and inserting ‘‘2019’’; and 

(ii) by striking ‘‘2004,’’ and inserting ‘‘2019,’’. 

(b) EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS.—Section 

2821 (42 U.S.C. 300hh–31) is amended— 

(1) in subsection (a)(1), by inserting ‘‘, including mosquito 

and other vector-borne diseases,’’ after ‘‘infectious diseases’’; 

and 
S. 1379—57 

(2) in subsection (b), by striking ‘‘2010 through 2013’’ and 

inserting ‘‘2019 through 2023’’. 

TITLE VII—MISCELLANEOUS 

PROVISIONS 

SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 

(a) VETERANS AFFAIRS.—Section 8117(g) of title 38, United 

States Code, is amended by striking ‘‘2014 through 2018’’ and 

inserting ‘‘2019 through 2023’’. 

(b) VACCINE TRACKING AND DISTRIBUTION.—Section 319A(e) (42 

U.S.C. 247d–1(e)) is amended by striking ‘‘2014 through 2018’’ 

and inserting ‘‘2019 through 2023’’. 

(c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) (42 U.S.C. 

247d(e)(8)) is amended by striking ‘‘2018’’ and inserting ‘‘2023’’. 

(d) STRATEGIC INNOVATION PARTNER.—Section 319L(c)(4)(E)(ix) 

(42 U.S.C. 247d–7e(c)(4)(E)(ix)) is amended by striking ‘‘2022’’ and 

inserting ‘‘2023’’. 

(e) LIMITED ANTITRUST EXEMPTION.— (1) IN GENERAL.—Section 405 of the Pandemic and AllHazards Preparedness Act (Public Law 109–417; 42 U.S.C. 

247d–6a note) is amended— 

(A) in subsection (a)(1)(A)— 

(i) by striking ‘‘Secretary of Health and Human 

Services (referred to in this subsection as the ‘Secretary’)’’ and inserting ‘‘Secretary’’; 

(ii) by striking ‘‘of the Public Health Service Act 

(42 U.S.C. 247d–6b)) (as amended by this Act’’; 

(iii) by striking ‘‘of the Public Health Service Act 

(42 U.S.C. 247d–6a)) (as amended by this Act’’; and 

(iv) by striking ‘‘of the Public Health Service Act 

(42 U.S.C. 247d–6d)’’; 

(B) in subsection (b), by striking ‘‘12-year’’ and 

inserting ‘‘17-year’’; 

(C) by redesignating such section 405 as section 319L– 

1; and 

(D) by transferring such section 319L–1, as redesignated, to the Public Health Service Act (42 U.S.C. 201 

et seq.), to appear after section 319L of such Act (42 U.S.C. 

247d–7e). 

(2) CONFORMING AMENDMENTS.— (A) TABLE OF CONTENTS.—The table of contents in section 1(b) of the Pandemic and All-Hazards Preparedness 

Act (Public Law 109–417) is amended by striking the item 

related to section 405. 

(B) REFERENCE.—Section 319L(c)(4)(A)(iii) (42 U.S.C. 

247d–7e) is amended by striking ‘‘section 405 of the Pandemic and All-Hazards Preparedness Act’’ and inserting 

‘‘section 319L–1’’. 

(f) INAPPLICABILITY OF CERTAIN PROVISIONS.—Subsection (e)(1) 

of section 319L (42 U.S.C. 247d–7e(e)(1)) is amended— 

(1) by amending subparagraph (A) to read as follows: 

‘‘(A) NONDISCLOSURE OF INFORMATION.— 

‘‘(i) IN GENERAL.—Information described in clause 

(ii) shall be deemed to be information described in 

section 552(b)(3) of title 5, United States Code. 
S. 1379—58 

‘‘(ii) INFORMATION DESCRIBED.—The information 

described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal 

significant and not otherwise publicly known 

vulnerabilities of existing medical or public health 

defenses against chemical, biological, radiological, or 

nuclear threats, and is comprised of— 

‘‘(I) specific technical data or scientific 

information that is created or obtained during the 

countermeasure and product advanced research 

and development carried out under subsection (c); 

‘‘(II) information pertaining to the location 

security, personnel, and research materials and 

methods of high-containment laboratories conducting research with select agents, toxins, or 

other agents with a material threat determination 

under section 319F–2(c)(2); or 

‘‘(III) security and vulnerability assessments.’’; 

(2) by redesignating subparagraph (C) as subparagraph 

(D); 

(3) by inserting after subparagraph (B) the following: 

‘‘(C) REPORTING.—One year after the date of enactment 

of the Pandemic and All-Hazards Preparedness and 

Advancing Innovation Act of 2019, and annually thereafter, 

the Secretary shall report to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the 

Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to 

withhold information from disclosure, as well as the nature 

of any request under section 552 of title 5, United States 

Code that was denied using such authority.’’; and 

(4) in subparagraph (D), as so redesignated, by striking 

‘‘12’’ and inserting ‘‘17’’. 

SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE. 

Subsection (d) of section 319F–2 (42 U.S.C. 247d–6b) is 

amended to read as follows: 

‘‘(d) DISCLOSURES.—No Federal agency may disclose under section 552 of title 5, United States Code any information identifying 

the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents 

or deployment capability of the stockpile that could compromise 

national security.’’. 

SEC. 703. CYBERSECURITY. 

(a) STRATEGY FOR PUBLIC HEALTH PREPAREDNESS AND

RESPONSE TO CYBERSECURITY THREATS.— 

(1) STRATEGY.—Not later than 18 months after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’) shall 

prepare and submit to the relevant committees of Congress 

a strategy for public health preparedness and response to 

address cybersecurity threats (as defined in section 102 of 

Cybersecurity Information Sharing Act of 2015 (6 U.S.C. 1501)) 

that present a threat to national health security. Such strategy 

shall include— 
S. 1379—59 

(A) identifying the duties, functions, and preparedness 

goals for which the Secretary is responsible in order to 

prepare for and respond to such cybersecurity threats, 

including metrics by which to measure success in meeting 

preparedness goals; 

(B) identifying gaps in public health capabilities to 

achieve such preparedness goals; and 

(C) strategies to address identified gaps and strengthen 

public health emergency preparedness and response 

capabilities to address such cybersecurity threats. 

(2) PROTECTION OF NATIONAL SECURITY.—The Secretary 

shall make such strategy available to the Committee on Health, 

Education, Labor, and Pensions of the Senate, the Committee 

on Energy and Commerce of the House of Representatives, 

and other congressional committees of jurisdiction, in a manner 

that does not compromise national security. 

(b) COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO

ALL-HAZARDS PUBLIC HEALTH EMERGENCIES.—Subparagraph (D) 

of section 2811(b)(4) (42 U.S.C. 300hh–10(b)(4)) is amended to read 

as follows: 

‘‘(D) POLICY COORDINATION AND STRATEGIC DIRECTION.—Provide integrated policy coordination and strategic 

direction, before, during, and following public health emergencies, with respect to all matters related to Federal public 

health and medical preparedness and execution and deployment of the Federal response for public health emergencies 

and incidents covered by the National Response Plan 

described in section 504(a)(6) of the Homeland Security 

Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; 

and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 

228(c) of the Homeland Security Act of 2002 (6 U.S.C. 

149(c)), including public health emergencies or incidents 

related to cybersecurity threats that present a threat to 

national health security.’’. 

SEC. 704. STRATEGY AND REPORT. 

Not later than 14 days after the date of the enactment of 

this Act, the Secretary of Health and Human Services, in coordination with the Assistant Secretary for Preparedness and Response 

and the Assistant Secretary for the Administration on Children 

and Families or other appropriate office, and in collaboration with 

other departments, as appropriate, shall submit to the Committee 

on Energy and Commerce of the House of Representatives, the 

Committee on Health, Education, Labor, and Pensions of the 

Senate, and other relevant congressional committees— 

(1) a formal strategy, including interdepartmental actions 

and efforts to reunify children with their parents or guardians, 

in all cases in which such children have been separated from 

their parents or guardians as a result of the initiative 

announced on April 6, 2018, and due to prosecution under 

section 275(a) of the Immigration and Nationality Act (8 U.S.C. 

1325(a)), if the parent or guardian chooses such reunification 

and the child— 

(A) was separated from a parent or guardian and 

placed into a facility funded by the Department of Health 

and Human Services; 
S. 1379—60 

(B) as of the date of the enactment of this Act, remains 

in the care of the Department of Health and Human Services; and 

(C) can be safely reunited with such parent or 

guardian; and 

(2) a report on challenges and deficiencies related to the 

oversight of, and care for, unaccompanied alien children and 

appropriately reuniting such children with their parents or 

guardians, and the actions taken to address any challenges 

and deficiencies related to unaccompanied alien children in 

the custody of the Department of Health and Human Services, 

including deficiencies identified and publicly reported by Congress, the Government Accountability Office, or the inspectors 

general of the Department of Health and Human Services 

or other Federal departments. 

SEC. 705. TECHNICAL AMENDMENTS. 

(a) PUBLIC HEALTH SERVICE ACT.—Title III (42 U.S.C. 241 

et seq.) is amended— 

(1) in paragraphs (1) and (5) of section 319F–1(a) (42 U.S.C. 

247d–6a(a)), by striking ‘‘section 319F(h)’’ each place such term 

appears and inserting ‘‘section 319F(e)’’; and 

(2) in section 319K(a) (42 U.S.C. 247d–7d(a)), by striking 

‘‘section 319F(h)(4)’’ and inserting ‘‘section 319F(e)(4)’’. 

(b) PUBLIC HEALTH SECURITY GRANTS.—Section 319C–1(b)(2) 

(42 U.S.C. 247d–3a(b)(2)) is amended— 

(1) in subparagraph (C), by striking ‘‘individuals,,’’ and 

inserting ‘‘individuals,’’; and 

(2) in subparagraph (F), by striking ‘‘make satisfactory 

annual improvement and describe’’ and inserting ‘‘makes satisfactory annual improvement and describes’’. 

(c) EMERGENCY USE INSTRUCTIONS.—Subparagraph (A) of section 564A(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360bbb–3a(e)(2)) is amended by striking ‘‘subsection 

(a)(1)(C)(i)’’ and inserting ‘‘subsection (a)(1)(C)’’. 

(d) PRODUCTS HELD FOR EMERGENCY USE.—Section 564B(2) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

3b) is amended— 

(1) in subparagraph (B), by inserting a comma after ‘‘505’’; 

and 

(2) in subparagraph (C), by inserting ‘‘or section 564A’’ 

before the period at the end. 

(e) TRANSPARENCY.—Section 507(c)(3) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) is amended— 

(1) by striking ‘‘Nothing in’’ and inserting the following: 

‘‘(A) IN GENERAL.—Nothing in’’; 

(2) by inserting ‘‘or directing’’ after ‘‘authorizing’’; 

(3) by striking ‘‘disclose any’’ and inserting ‘‘disclose— 

‘‘(i) any’’; 

(4) by striking the period and inserting ‘‘; or’’; and 

(5) by adding at the end the following: 

‘‘(ii) in the case of a drug development tool that 

may be used to support the development of a qualified 

countermeasure, security countermeasure, or qualified 

pandemic or epidemic product, as defined in sections 

319F–1, 319F–2, and 319F–3, respectively, of the 

Public Health Service Act, any information that the 
S. 1379—61 

Secretary determines has a significant potential to 

affect national security. 

‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the case that the 

Secretary, pursuant to subparagraph (A)(ii), does not make 

information publicly available, the Secretary shall provide 

on the internet website of the Food and Drug Administration an acknowledgment of the information that has not 

been disclosed, pursuant to subparagraph (A)(ii).’’. 

Speaker of the House of Representatives. 

Vice President of the United States and

President of the Senate.