I 
115TH CONGRESS 
2D SESSION 
H. R. 7328 
To reauthorize certain programs under the Public Health Service Act and 
the Federal Food, Drug, and Cosmetic Act with respect to public health 
security and all-hazards preparedness and response, to clarify the regu-
latory framework with respect to certain nonprescription drugs that are 
marketed without an approved drug application, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 19, 2018 
Mrs. BROOKS of Indiana (for herself, Ms. ESHOO, Mr. LATTA, Ms. DEGETTE, 
Mr. GUTHRIE, and Mrs. DINGELL) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committees on Veterans’ Affairs, the Judiciary, and Homeland Se-
curity, for a period to be subsequently determined by the Speaker, in each 
case for consideration of such provisions as fall within the jurisdiction of 
the committee concerned 
A BILL 
To reauthorize certain programs under the Public Health 
Service Act and the Federal Food, Drug, and Cosmetic 
Act with respect to public health security and all-hazards 
preparedness and response, to clarify the regulatory 
framework with respect to certain nonprescription drugs 
that are marketed without an approved drug application, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Pandemic and All-Hazards Preparedness and Advancing 
Innovation Act of 2018’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
DIVISION A—PANDEMIC AND ALL-HAZARDS PREPAREDNESS AND 
ADVANCING INNOVATION 
Sec. 100. References in division. 
TITLE I—STRENGTHENING THE NATIONAL HEALTH SECURITY 
STRATEGY 
Sec. 101. National Health Security Strategy. 
TITLE II—IMPROVING PREPAREDNESS AND RESPONSE 
Sec. 201. Improving benchmarks and standards for preparedness and response. 
Sec. 202. Amendments to preparedness and response programs. 
Sec. 203. Regional health care emergency preparedness and response systems. 
Sec. 204. Military and civilian partnership for trauma readiness. 
Sec. 205. Public health and health care system situational awareness and bio-
surveillance capabilities. 
Sec. 206. Strengthening and supporting the public health emergency rapid re-
sponse fund. 
Sec. 207. Improving all-hazards preparedness and response by public health 
emergency volunteers. 
Sec. 208. Clarifying State liability law for volunteer health care professionals. 
Sec. 209. Report on adequate national blood supply. 
Sec. 210. Report on the public health preparedness and response capabilities 
and capacities of hospitals, long-term care facilities, and other 
health care facilities. 
TITLE III—REACHING ALL COMMUNITIES 
Sec. 301. Strengthening and assessing the emergency response workforce. 
Sec. 302. Health system infrastructure to improve preparedness and response. 
Sec. 303. Considerations for at-risk individuals. 
Sec. 304. Improving emergency preparedness and response considerations for 
children. 
Sec. 305. National advisory committees on disasters. 
Sec. 306. Guidance for participation in exercises and drills. 
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. 
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Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other 
significant threats. 
Sec. 405. Reporting on the Federal Select Agent Program. 
TITLE V—INCREASING COMMUNICATION IN MEDICAL 
COUNTERMEASURE ADVANCED RESEARCH AND DEVELOPMENT 
Sec. 501. Medical countermeasure budget plan. 
Sec. 502. Material threat and medical countermeasure notifications. 
Sec. 503. Availability of regulatory management plans. 
Sec. 504. The Biomedical Advanced Research and Development Authority and 
the BioShield Special Reserve Fund. 
Sec. 505. Additional strategies for combating antibiotic resistance. 
TITLE VI—ADVANCING TECHNOLOGIES FOR MEDICAL 
COUNTERMEASURES 
Sec. 601. Administration of countermeasures. 
Sec. 602. Updating definitions of other transactions. 
Sec. 603. Medical countermeasure master files. 
Sec. 604. Animal rule report. 
Sec. 605. Review of the benefits of genomic engineering technologies and their 
potential role in national security. 
Sec. 606. Report on vaccines development. 
Sec. 607. Strengthening mosquito abatement for safety and health. 
TITLE VII—MISCELLANEOUS PROVISIONS 
Sec. 701. Reauthorizations and extensions. 
Sec. 702. Location of materials in the stockpile. 
Sec. 703. Cybersecurity. 
Sec. 704. Strategy and report. 
Sec. 705. Technical amendments. 
DIVISION B—OVER-THE-COUNTER MONOGRAPH SAFETY, 
INNOVATION, AND REFORM 
Sec. 1000. Short title; references in division. 
TITLE I—OTC DRUG REVIEW 
Sec. 1001. Regulation of certain nonprescription drugs that are marketed with-
out an approved drug application. 
Sec. 1002. Misbranding. 
Sec. 1003. Drugs excluded from the over-the-counter drug review. 
Sec. 1004. Treatment of Sunscreen Innovation Act. 
Sec. 1005. Annual update to Congress on appropriate pediatric indication for 
certain OTC cough and cold drugs. 
Sec. 1006. Technical corrections. 
TITLE II—USER FEES 
Sec. 2001. Short title; finding. 
Sec. 2002. Fees relating to over-the-counter drugs. 
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DIVISION 
A—PANDEMIC 
AND 
ALL-HAZARDS 
PREPARED-
NESS AND ADVANCING INNO-
VATION 
SEC. 100. REFERENCES IN DIVISION. 
Except as otherwise specified— 
(1) amendments made by this division to a sec-
tion or other provision of law are amendments to 
such section or other provision of the Public Health 
Service Act (42 U.S.C. 201 et seq.); and 
(2) any reference to ‘‘this Act’’ contained in 
this division shall be treated as referring only to the 
provisions of this division. 
TITLE I—STRENGTHENING THE 
NATIONAL HEALTH SECURITY 
STRATEGY 
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 
Section 2802 (42 U.S.C. 300hh–1) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by striking ‘‘2014’’ and inserting 
‘‘2018’’; and 
(ii) by striking the second sentence 
and inserting the following: ‘‘Such Na-
tional Health Security Strategy shall de-
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scribe potential emergency health security 
threats and identify the process for achiev-
ing the preparedness goals described in 
subsection (b) to be prepared to identify 
and respond to such threats and shall be 
consistent with the national preparedness 
goal (as described in section 504(a)(19) of 
the Homeland Security Act of 2002), the 
National Incident Management System (as 
defined in section 501(7) of such Act), and 
the National Response Plan developed pur-
suant to section 504 of such Act, or any 
successor plan.’’; 
(B) in paragraph (2), by inserting before 
the period at the end of the second sentence the 
following: ‘‘, and an analysis of any changes to 
the evidence-based benchmarks and objective 
standards under sections 319C–1 and 319C–2’’; 
and 
(C) in paragraph (3)— 
(i) by striking ‘‘2009’’ and inserting 
‘‘2022’’; 
(ii) by inserting ‘‘(including gaps in 
the environmental health and animal 
health workforces, as applicable), describ-
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ing the status of such workforce’’ after 
‘‘gaps in such workforce’’; 
(iii) by striking ‘‘and identifying strat-
egies’’ and inserting ‘‘identifying strate-
gies’’; and 
(iv) by inserting before the period at 
the end ‘‘, and identifying current capabili-
ties 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 ‘‘inves-
tigation, and related information tech-
nology activities’’; 
(ii) in subparagraph (B), by striking 
‘‘and decontamination’’ and inserting ‘‘de-
contamination, relevant health care serv-
ices and supplies, and transportation and 
disposal of medical waste’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(E) Response to environmental hazards.’’; 
(B) in paragraph (3)— 
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(i) in the matter preceding subpara-
graph (A), by striking ‘‘including mental 
health’’ and inserting ‘‘including phar-
macies, mental health facilities,’’; and 
(ii) in subparagraph (F), by inserting 
‘‘or exposures to agents that could cause a 
public health emergency’’ before the pe-
riod; 
(C) in paragraph (5), by inserting ‘‘and 
other applicable compacts’’ after ‘‘Compact’’; 
and 
(D) by adding at the end the following: 
‘‘(9) ZOONOTIC
DISEASE, FOOD, AND
AGRI-
CULTURE.—Improving coordination among Federal, 
State, local, tribal, and territorial entities (including 
through consultation with the Secretary of Agri-
culture) to prevent, detect, and respond to outbreaks 
of plant or animal disease (including zoonotic dis-
ease) that could compromise national security result-
ing from a deliberate attack, a naturally occurring 
threat, the intentional adulteration of food, or other 
public health threats, taking into account inter-
actions between animal health, human health, and 
animals’ and humans’ shared environment as di-
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rectly related to public health emergency prepared-
ness and response capabilities, as applicable. 
‘‘(10) GLOBAL HEALTH SECURITY.—Assessing 
current or potential health security threats from 
abroad to inform domestic public health prepared-
ness and response capabilities.’’. 
TITLE II—IMPROVING 
PREPAREDNESS AND RESPONSE 
SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR 
PREPAREDNESS AND RESPONSE. 
(a) EVALUATING MEASURABLE EVIDENCE-BASED 
BENCHMARKS
AND
OBJECTIVE
STANDARDS.—Section 
319C–1 (42 U.S.C. 247d–3a) is amended by inserting 
after subsection (j) the following: 
‘‘(k) EVALUATION.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018 and every 2 years thereafter, the Sec-
retary shall conduct an evaluation of the evidence- 
based benchmarks and objective standards required 
under subsection (g). Such evaluation shall be sub-
mitted to the congressional committees of jurisdic-
tion together with the National Health Security 
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Strategy under section 2802, at such time as such 
strategy is submitted. 
‘‘(2) CONTENT.—The evaluation under this 
paragraph shall include— 
‘‘(A) a review of evidence-based bench-
marks and objective standards, and associated 
metrics and targets; 
‘‘(B) a discussion of changes to any evi-
dence-based benchmarks and objective stand-
ards, and the effect of such changes on the abil-
ity to track whether entities are meeting or 
making progress toward the goals under this 
section and, to the extent practicable, the appli-
cable goals of the National Health Security 
Strategy under section 2802; 
‘‘(C) a description of amounts received by 
eligible entities described in subsection (b) and 
section 319C–2(b), and amounts received by 
subrecipients and the effect of such funding on 
meeting evidence-based benchmarks and objec-
tive standards; and 
‘‘(D) recommendations, as applicable and 
appropriate, to improve evidence-based bench-
marks and objective standards to more accu-
rately assess the ability of entities receiving 
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awards under this section to better achieve the 
goals under this section and section 2802.’’. 
(b) EVALUATING THE PARTNERSHIP FOR STATE AND 
REGIONAL HOSPITAL PREPAREDNESS.—Section 319C– 
2(i)(1) (42 U.S.C. 247–3b(i)(1)) is amended by striking 
‘‘section 319C–1(g), (i), and (j)’’ and inserting ‘‘section 
319C–1(g), (i), (j), and (k)’’. 
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RE-
SPONSE PROGRAMS. 
(a) COOPERATIVE AGREEMENT APPLICATIONS FOR 
IMPROVING STATE AND LOCAL PUBLIC HEALTH SECU-
RITY.—Section 319C–1 (42 U.S.C. 247d–3a) is amend-
ed— 
(1) in subsection (a), by inserting ‘‘, acting 
through the Director of the Centers for Disease 
Control and Prevention,’’ after ‘‘the Secretary’’; and 
(2) in subsection (b)(2)(A)— 
(A) in clause (vi), by inserting ‘‘, including 
public health agencies with specific expertise 
that may be relevant to public health security, 
such as environmental health agencies,’’ after 
‘‘stakeholders’’; 
(B) by redesignating clauses (vii) through 
(ix) as clauses (viii) through (x); 
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(C) by inserting after clause (vi) the fol-
lowing: 
‘‘(vii) a description of how, as applica-
ble, such entity may integrate information 
to account for individuals with behavioral 
health needs following a public health 
emergency;’’; 
(D) in clause (ix), as so redesignated, by 
striking ‘‘; and’’ and inserting a semicolon; and 
(E) by adding at the end the following: 
‘‘(xi) a description of how the entity 
will partner with health care facilities, in-
cluding hospitals and nursing homes and 
other long-term care facilities, to promote 
and improve public health preparedness 
and response; and 
‘‘(xii) a description of how, as appro-
priate and practicable, the entity will in-
clude critical infrastructure partners, such 
as utility companies within the entity’s ju-
risdiction, in planning pursuant to this 
subparagraph to help ensure that critical 
infrastructure will remain functioning dur-
ing, or return to function as soon as prac-
ticable after, a public health emergency;’’. 
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(b) EXCEPTION RELATING TO APPLICATION OF CER-
TAIN REQUIREMENTS.— 
(1) IN
GENERAL.—Section 319C–1(g) (42 
U.S.C. 247d–3a(g)) is amended— 
(A) in paragraph (5)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘Beginning with fis-
cal year 2009’’ and inserting ‘‘Beginning 
with fiscal year 2019’’; and 
(ii) in subparagraph (A)— 
(I) by striking ‘‘for the imme-
diately preceding fiscal year’’ and in-
serting ‘‘for either of the 2 imme-
diately preceding fiscal years’’; and 
(II) by striking ‘‘2008’’ and in-
serting ‘‘2018’’; and 
(B) in paragraph (6), by amending sub-
paragraph (A) to read as follows: 
‘‘(A) IN
GENERAL.—The amounts de-
scribed in this paragraph are the following 
amounts that are payable to an entity for ac-
tivities described in this section or section 
319C–2: 
‘‘(i) For no more than 1 of each of 
the first 2 fiscal years immediately fol-
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lowing a fiscal year in which an entity ex-
perienced a failure described in subpara-
graph (A) or (B) of paragraph (5), an 
amount equal to 10 percent of the amount 
the entity was eligible to receive for the re-
spective fiscal year. 
‘‘(ii) For no more than 1 of the first 
2 fiscal years immediately following the 
third consecutive fiscal year in which an 
entity experienced such a failure, in lieu of 
applying clause (i), an amount equal to 15 
percent of the amount the entity was eligi-
ble to receive for the respective fiscal 
year.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply with respect to cooper-
ative agreements awarded on or after the date of en-
actment of this Act. 
(c) PARTNERSHIP FOR STATE AND REGIONAL HOS-
PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 
Section 319C–2 (42 U.S.C. 247d–3b) is amended— 
(1) in subsection (a)— 
(A) by inserting ‘‘, acting through the As-
sistant Secretary for Preparedness and Re-
sponse,’’ after ‘‘The Secretary’’; and 
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(B) by striking ‘‘preparedness for public 
health emergencies’’ and inserting ‘‘prepared-
ness for, and response to, public health emer-
gencies in accordance with subsection (c)’’; 
(2) in subsection (b)(1)(A)— 
(A) by striking ‘‘partnership consisting of’’ 
and inserting ‘‘coalition that includes’’; 
(B) in clause (ii), by striking ‘‘; and’’ and 
inserting a semicolon; and 
(C) by adding at the end the following: 
‘‘(iv) one or more emergency medical serv-
ice organizations or emergency management or-
ganizations; and’’; 
(3) in subsection (d)— 
(A) in paragraph (1)(B), by striking ‘‘part-
nership’’ each place it appears and inserting 
‘‘coalition’’; and 
(B) in paragraph (2)(C), by striking ‘‘med-
ical preparedness’’ and inserting ‘‘preparedness 
and response’’; 
(4) in subsection (f), by striking ‘‘partnership’’ 
and inserting ‘‘coalition’’; 
(5) in subsection (g)(2)— 
(A) by striking ‘‘Partnerships’’ and insert-
ing ‘‘Coalitions’’; 
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(B) by striking ‘‘partnerships’’ and insert-
ing ‘‘coalitions’’; and 
(C) by inserting ‘‘and response’’ after 
‘‘preparedness’’; and 
(6) in subsection (i)(1)— 
(A) by striking ‘‘An entity’’ and inserting 
‘‘A coalition’’; and 
(B) by striking ‘‘such partnership’’ and in-
serting ‘‘such coalition’’. 
(d) PUBLIC HEALTH SECURITY GRANTS AUTHORIZA-
TION
OF
APPROPRIATIONS.—Section 319C–1(h)(1)(A) 
(42 U.S.C. 247d–3a(h)(1)(A)) is amended by striking 
‘‘$641,900,000 for fiscal year 2014’’ and all that follows 
through 
the 
period 
at 
the 
end 
and 
inserting 
‘‘$685,000,000 for each of fiscal years 2019 through 2023 
for awards pursuant to paragraph (3) (subject to the au-
thority of the Secretary to make awards pursuant to para-
graphs (4) and (5)).’’. 
(e) PARTNERSHIP FOR STATE AND REGIONAL HOS-
PITAL PREPAREDNESS AUTHORIZATION OF APPROPRIA-
TIONS.—Section 319C–2(j) (42 U.S.C. 247d–3b(j)) is 
amended— 
(1) by amending paragraph (1) to read as fol-
lows: 
‘‘(1) IN GENERAL.— 
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‘‘(A) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For purposes of carrying out this sec-
tion and section 319C–3, in accordance with 
subparagraph (B), there is authorized to be ap-
propriated $385,000,000 for each of fiscal years 
2019 through 2023. 
‘‘(B) RESERVATION OF AMOUNTS FOR RE-
GIONAL SYSTEMS.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), of the amount appropriated under sub-
paragraph (A) for a fiscal year, the Sec-
retary may reserve up to 5 percent for the 
purpose of carrying out section 319C–3. 
‘‘(ii) RESERVATION
CONTINGENT
ON 
CONTINUED
APPROPRIATIONS
FOR
THIS 
SECTION.—If for fiscal year 2019 or a sub-
sequent fiscal year, the amount appro-
priated under subparagraph (A) is such 
that, after application of clause (i), the 
amount remaining for the purpose of car-
rying out this section would be less than 
the amount available for such purpose for 
the previous fiscal year, the amount that 
may be reserved under clause (i) shall be 
reduced such that the amount remaining 
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for the purpose of carrying out this section 
is not less than the amount available for 
such purpose for the previous fiscal year. 
‘‘(iii) SUNSET.—The authority to re-
serve amounts under clause (i) shall expire 
on September 30, 2023.’’; 
(2) in paragraph (2), by striking ‘‘paragraph 
(1) for a fiscal year’’ and inserting ‘‘paragraph 
(1)(A) for a fiscal year and not reserved for the pur-
pose described in paragraph (1)(B)(i)’’; and 
(3) in paragraph (3)(A), by striking ‘‘paragraph 
(1) and not reserved under paragraph (2)’’ and in-
serting ‘‘paragraph (1)(A) and not reserved under 
paragraph (1)(B)(i) or (2)’’. 
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PRE-
PAREDNESS AND RESPONSE SYSTEMS. 
(a) IN GENERAL.—Part B of title III (42 U.S.C. 243 
et seq.) is amended by inserting after section 319C–2 the 
following: 
‘‘SEC. 319C–3. GUIDELINES FOR REGIONAL HEALTH CARE 
EMERGENCY PREPAREDNESS AND RESPONSE 
SYSTEMS. 
‘‘(a) PURPOSE.—It is the purpose of this section to 
identify and provide guidelines for regional systems of hos-
pitals, health care facilities, and other public and private 
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sector entities, with varying levels of capability to treat 
patients and increase medical surge capacity during, in ad-
vance of, and immediately following a public health emer-
gency, including threats posed by one or more chemical, 
biological, radiological, or nuclear agents, including emerg-
ing infectious diseases. 
‘‘(b) GUIDELINES.—The Assistant Secretary for Pre-
paredness and Response, in consultation with the Director 
of the Centers for Disease Control and Prevention, the Ad-
ministrator of the Centers for Medicare & Medicaid Serv-
ices, the Administrator of the Health Resources and Serv-
ices Administration, the Commissioner of Food and 
Drugs, the Assistant Secretary for Mental Health and 
Substance Use, the Assistant Secretary of Labor for Occu-
pational Safety and Health, the Secretary of Veterans Af-
fairs, the heads of such other Federal agencies as the Sec-
retary determines to be appropriate, and State, local, trib-
al, and territorial public health officials, shall, not later 
than 2 years after the date of enactment of this section— 
‘‘(1) identify and develop a set of guidelines re-
lating to practices and protocols for all-hazards pub-
lic health emergency preparedness and response for 
hospitals and health care facilities to provide appro-
priate patient care during, in advance of, or imme-
diately following, a public health emergency, result-
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ing from one or more chemical, biological, radio-
logical, or nuclear agents, including emerging infec-
tious diseases (which may include existing practices, 
such as trauma care and medical surge capacity and 
capabilities), with respect to— 
‘‘(A) a regional approach to identifying 
hospitals and health care facilities based on 
varying capabilities and capacity to treat pa-
tients affected by such emergency, including— 
‘‘(i) the manner in which the system 
will coordinate with and integrate the part-
nerships and health care coalitions estab-
lished under section 319C–2(b); and 
‘‘(ii) informing and educating appro-
priate first responders and health care sup-
ply chain partners of the regional emer-
gency preparedness and response capabili-
ties and medical surge capacity of such 
hospitals and health care facilities in the 
community; 
‘‘(B) physical and technological infrastruc-
ture, laboratory capacity, staffing, blood supply, 
and other supply chain needs, taking into ac-
count resiliency, geographic considerations, and 
rural considerations; 
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‘‘(C) protocols or best practices for the 
safety and personal protection of workers who 
handle human remains and health care workers 
(including with respect to protective equipment 
and supplies, waste management processes, and 
decontamination), sharing of specialized experi-
ence among the health care workforce, behav-
ioral health, psychological resilience, and train-
ing of the workforce, as applicable; 
‘‘(D) in a manner that allows for disease 
containment (within the meaning of section 
2802(b)(2)(B)), coordinated medical triage, 
treatment, and transportation of patients, based 
on patient medical need (including patients in 
rural areas), to the appropriate hospitals or 
health care facilities within the regional system 
or, as applicable and appropriate, between sys-
tems in different States or regions; and 
‘‘(E) the needs of children and other at- 
risk individuals; 
‘‘(2) make such guidelines available on the 
internet website of the Department of Health and 
Human Services in a manner that does not com-
promise national security; and 
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‘‘(3) update such guidelines as appropriate, in-
cluding based on input received pursuant to sub-
sections (c) and (e) and information resulting from 
applicable reports required under the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018 (including any amendments made by 
such Act), to address new and emerging public 
health threats. 
‘‘(c) CONSIDERATIONS.—In identifying, developing, 
and updating guidelines under subsection (b), the Assist-
ant Secretary for Preparedness and Response shall— 
‘‘(1) include input from hospitals and health 
care facilities (including health care coalitions under 
section 319C–2), State, local, tribal, and territorial 
public health departments, and health care or sub-
ject matter experts (including experts with relevant 
expertise in chemical, biological, radiological, or nu-
clear threats, including emerging infectious dis-
eases), as the Assistant Secretary determines appro-
priate, to meet the goals under section 2802(b)(3); 
‘‘(2) consult and engage with appropriate 
health care providers and professionals, including 
physicians, nurses, first responders, health care fa-
cilities (including hospitals, primary care clinics, 
community health centers, mental health facilities, 
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ambulatory care facilities, and dental health facili-
ties), pharmacies, emergency medical providers, 
trauma care providers, environmental health agen-
cies, public health laboratories, poison control cen-
ters, blood banks, tissue banks, and other experts 
that the Assistant Secretary determines appropriate, 
to meet the goals under section 2802(b)(3); 
‘‘(3) consider feedback related to financial im-
plications for hospitals, health care facilities, public 
health agencies, laboratories, blood banks, tissue 
banks, and other entities engaged in regional pre-
paredness planning to implement and follow such 
guidelines, as applicable; and 
‘‘(4) consider financial requirements and poten-
tial incentives for entities to prepare for, and re-
spond to, public health emergencies as part of the 
regional health care emergency preparedness and re-
sponse system. 
‘‘(d) TECHNICAL ASSISTANCE.—The Assistant Sec-
retary for Preparedness and Response, in consultation 
with the Director of the Centers for Disease Control and 
Prevention and the Assistant Secretary of Labor for Occu-
pational Safety and Health, may provide technical assist-
ance and consultation toward meeting the guidelines de-
scribed in subsection (b). 
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‘‘(e) DEMONSTRATION
PROJECT
FOR
REGIONAL 
HEALTH CARE PREPAREDNESS
AND RESPONSE SYS-
TEMS.— 
‘‘(1) IN GENERAL.—The Assistant Secretary for 
Preparedness and Response may establish a dem-
onstration project pursuant to the development and 
implementation of guidelines under subsection (b) to 
award grants to improve medical surge capacity for 
all hazards, build and integrate regional medical re-
sponse capabilities, improve specialty care expertise 
for all-hazards response, and coordinate medical pre-
paredness and response across State, local, tribal, 
territorial, and regional jurisdictions. 
‘‘(2) SUNSET.—The authority under this sub-
section shall expire on September 30, 2023.’’. 
(b) GAO REPORT TO CONGRESS.— 
(1) REPORT.—Not later than 3 years after the 
date of enactment of this Act, the Comptroller Gen-
eral of the United States (referred to in this sub-
section as the ‘‘Comptroller General’’) shall submit 
to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Finance of the Sen-
ate and the Committee on Energy and Commerce 
and the Committee on Ways and Means of the 
House of Representatives, a report on the extent to 
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which hospitals and health care facilities have imple-
mented the recommended guidelines under section 
319C–3(b) of the Public Health Service Act (as 
added by subsection (a)), including an analysis and 
evaluation of any challenges hospitals or health care 
facilities experienced in implementing such guide-
lines. 
(2) CONTENT.—The Comptroller General shall 
include in the report under paragraph (1)— 
(A) data on the preparedness and response 
capabilities that have been informed by the 
guidelines under section 319C–3(b) of the Pub-
lic Health Service Act to improve regional emer-
gency health care preparedness and response 
capability, including hospital and health care 
facility capacity and medical surge capabilities 
to prepare for, and respond to, public health 
emergencies; and 
(B) recommendations to reduce gaps in in-
centives for regional health partners, including 
hospitals and health care facilities, to improve 
capacity and medical surge capabilities to pre-
pare for, and respond to, public health emer-
gencies, consistent with subsection (a), which 
may include consideration of facilities partici-
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pating in programs under section 319C–2 of 
the Public Health Service Act (42 U.S.C. 
247d–3b) or in programs under the Centers for 
Medicare & Medicaid Services (including inno-
vative health care delivery and payment mod-
els), and input from private sector financial in-
stitutions. 
(3) CONSULTATION.—In carrying out para-
graphs (1) and (2), the Comptroller General shall 
consult with the heads of appropriate Federal agen-
cies, including— 
(A) the Assistant Secretary for Prepared-
ness and Response; 
(B) the Director of the Centers for Disease 
Control and Prevention; 
(C) the Administrator of the Centers for 
Medicare & Medicaid Services; 
(D) the Assistant Secretary for Mental 
Health and Substance Use; 
(E) the Assistant Secretary of Labor for 
Occupational Safety and Health; and 
(F) the Secretary of Veterans Affairs. 
(c) ANNUAL REPORTS.—Section 319C–2(i)(1) (42 
U.S.C. 247d–3b(i)(1)) is amended by inserting after the 
first sentence the following: ‘‘In submitting reports under 
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this paragraph, a coalition shall include information on the 
progress that the coalition has made toward the implemen-
tation of section 319C–3 (or barriers to progress, if 
any).’’. 
(d) NATIONAL HEALTH SECURITY STRATEGY INCOR-
PORATION OF REGIONALIZED EMERGENCY PREPARED-
NESS
AND RESPONSE.—Subparagraph (G) of section 
2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended to read 
as follows: 
‘‘(G) Optimizing a coordinated and flexible 
approach to the emergency response and med-
ical surge capacity of hospitals, other health 
care facilities, critical care, trauma care (which 
may include trauma centers), and emergency 
medical systems.’’. 
(e) IMPROVING STATE AND LOCAL PUBLIC HEALTH 
SECURITY.— 
(1) STATE
AND
LOCAL
SECURITY.—Section 
319C–1(e) (42 U.S.C. 247d–3a(e)) is amended by 
striking ‘‘, and local emergency plans.’’ and inserting 
‘‘, local emergency plans, and any regional health 
care emergency preparedness and response system 
established pursuant to the applicable guidelines 
under section 319C–3.’’. 
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(2) PARTNERSHIPS.—Section 319C–2(d)(1)(A) 
(42 U.S.C. 247d–3b(d)(1)(A)) is amended— 
(A) in clause (i), by striking ‘‘; and’’ and 
inserting ‘‘;’’; 
(B) by redesignating clause (ii) as clause 
(iii); and 
(C) inserting after clause (i), the following: 
‘‘(ii) among one or more facilities in a 
regional health care emergency system 
under section 319C–3; and’’. 
SEC. 204. MILITARY AND CIVILIAN PARTNERSHIP FOR 
TRAUMA READINESS. 
Title XII (42 U.S.C. 300d et seq.) is amended by 
adding at the end the following new part: 
‘‘PART I—MILITARY AND CIVILIAN PARTNERSHIP 
FOR TRAUMA READINESS GRANT PROGRAM 
‘‘SEC. 1291. MILITARY AND CIVILIAN PARTNERSHIP FOR 
TRAUMA READINESS GRANT PROGRAM. 
‘‘(a) MILITARY TRAUMA TEAM PLACEMENT PRO-
GRAM.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Assistant Secretary for Preparedness 
and Response and in consultation with the Secretary 
of Defense, shall award grants to not more than 20 
eligible high acuity trauma centers to enable military 
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trauma teams to provide, on a full-time basis, trau-
ma care and related acute care at such trauma cen-
ters. 
‘‘(2) LIMITATIONS.—In the case of a grant 
awarded under paragraph (1) to an eligible high 
acuity trauma center, such grant— 
‘‘(A) shall be for a period of at least 3 
years and not more than 5 years (and may be 
renewed at the end of such period); and 
‘‘(B) shall be in an amount that does not 
exceed $1,000,000 per year. 
‘‘(3) 
AVAILABILITY
OF
FUNDS.—Notwith-
standing section 1552 of title 31, United States 
Code, or any other provision of law, funds available 
to the Secretary for obligation for a grant under this 
subsection shall remain available for expenditure for 
100 days after the last day of the performance pe-
riod of such grant. 
‘‘(b) MILITARY TRAUMA CARE PROVIDER PLACE-
MENT PROGRAM.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Assistant Secretary for Preparedness 
and Response and in consultation with the Secretary 
of Defense, shall award grants to eligible trauma 
centers to enable military trauma care providers to 
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provide trauma care and related acute care at such 
trauma centers. 
‘‘(2) LIMITATIONS.—In the case of a grant 
awarded under paragraph (1) to an eligible trauma 
center, such grant— 
‘‘(A) shall be for a period of at least 1 year 
and not more than 3 years (and may be re-
newed at the end of such period); and 
‘‘(B) shall be in an amount that does not 
exceed, in a year— 
‘‘(i) $100,000 for each military trau-
ma care provider that is a physician at 
such eligible trauma center; and 
‘‘(ii) $50,000 for each other military 
trauma care provider at such eligible trau-
ma center. 
‘‘(c) GRANT REQUIREMENTS.— 
‘‘(1) DEPLOYMENT AND PUBLIC HEALTH EMER-
GENCIES.—As a condition of receipt of a grant 
under this section, a grant recipient shall agree to 
allow military trauma care providers providing care 
pursuant to such grant to— 
‘‘(A) be deployed by the Secretary of De-
fense for military operations, for training, or 
for response to a mass casualty incident; and 
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‘‘(B) be deployed by the Secretary of De-
fense, in consultation with the Secretary of 
Health and Human Services, for response to a 
public health emergency pursuant to section 
319. 
‘‘(2) USE OF FUNDS.—Grants awarded under 
this section to an eligible trauma center may be used 
to train and incorporate military trauma care pro-
viders into such trauma center, including incorpora-
tion into operational exercises and training drills re-
lated to public health emergencies, expenditures for 
malpractice insurance, office space, information 
technology, specialty education and supervision, 
trauma programs, research, and applicable license 
fees for such military trauma care providers. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to affect any other provision of law 
that preempts State licensing requirements for health care 
professionals, including with respect to military trauma 
care providers. 
‘‘(e) REPORTING REQUIREMENTS.— 
‘‘(1) REPORT
TO
THE
SECRETARY
AND
THE 
SECRETARY
OF
DEFENSE.—Each eligible trauma 
center or eligible high acuity trauma center awarded 
a grant under subsection (a) or (b) for a year shall 
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submit to the Secretary and the Secretary of De-
fense a report for such year that includes informa-
tion on— 
‘‘(A) the number and types of trauma 
cases managed by military trauma teams or 
military trauma care providers pursuant to such 
grant during such year; 
‘‘(B) the ability to maintain the integration 
of the military trauma providers or teams of 
providers as part of the trauma center, includ-
ing the financial effect of such grant on the 
trauma center; 
‘‘(C) the educational effect on resident 
trainees in centers where military trauma teams 
are assigned; 
‘‘(D) any research conducted during such 
year supported by such grant; and 
‘‘(E) any other information required by the 
Secretaries for the purpose of evaluating the ef-
fect of such grant. 
‘‘(2) REPORT
TO
CONGRESS.—Not less than 
once every 2 years, the Secretary, in consultation 
with the Secretary of Defense, shall submit a report 
to the congressional committees of jurisdiction that 
includes information on the effect of placing military 
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trauma care providers in trauma centers awarded 
grants under this section on— 
‘‘(A) maintaining military trauma care 
providers’ readiness and ability to respond to 
and treat battlefield injuries; 
‘‘(B) providing health care to civilian trau-
ma patients in urban and rural settings; 
‘‘(C) the capability of trauma centers and 
military trauma care providers to increase med-
ical surge capacity, including as a result of a 
large scale event; 
‘‘(D) the ability of grant recipients to 
maintain the integration of the military trauma 
providers or teams of providers as part of the 
trauma center; 
‘‘(E) efforts to incorporate military trauma 
care providers into operational exercises and 
training and drills for public health emer-
gencies; and 
‘‘(F) the capability of military trauma care 
providers to participate as part of a medical re-
sponse during or in advance of a public health 
emergency, as determined by the Secretary, or 
a mass casualty incident. 
‘‘(f) DEFINITIONS.—For purposes of this part: 
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‘‘(1) ELIGIBLE
TRAUMA
CENTER.—The term 
‘eligible trauma center’ means a Level I, II, or III 
trauma center that satisfies each of the following: 
‘‘(A) Such trauma center has an agree-
ment with the Secretary of Defense to enable 
military trauma care providers to provide trau-
ma care and related acute care at such trauma 
center. 
‘‘(B) Such trauma center utilizes a risk-ad-
justed benchmarking system and metrics to 
measure performance, quality, and patient out-
comes. 
‘‘(C) Such trauma center demonstrates a 
need for integrated military trauma care pro-
viders to maintain or improve the trauma clin-
ical capability of such trauma center. 
‘‘(2) ELIGIBLE
HIGH
ACUITY
TRAUMA
CEN-
TER.—The term ‘eligible high acuity trauma center’ 
means a Level I trauma center that satisfies each of 
the following: 
‘‘(A) Such trauma center has an agree-
ment with the Secretary of Defense to enable 
military trauma teams to provide trauma care 
and related acute care at such trauma center. 
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248 
more, DC–MD–VA–WV; Not Seasonally 
Adjusted; All items; Annual Index) for the 
first 3 years of the preceding 4 years of 
available data; and 
‘‘(ii) for each of fiscal years 2022 and 
2023, the sum of— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
years of the preceding 4 fiscal years, 
multiplied by the proportion of per-
sonnel 
compensation 
and 
benefits 
costs to total costs of OTC mono-
graph drug activities for the first 3 
years of the preceding 4 fiscal years; 
and 
‘‘(II) the average annual percent 
change that occurred in the Consumer 
Price Index for urban consumers 
(Washington-Baltimore, DC–MD–VA– 
WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 
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