calities, tribes, and territories receiving an award 
under this subsection regarding interoperability and 
the technical standards set forth by the Secretary.’’; 
(6) by redesignating subsections (f) and (g) as 
subsections (i) and (j), respectively; and 
(7) by inserting after subsection (e) the fol-
lowing: 
‘‘(f) PERSONNEL AUTHORITIES.— 
‘‘(1) SPECIALLY
QUALIFIED
PERSONNEL.—In 
addition to any other personnel authorities, to carry 
out subsections (b) and (c), the Secretary may— 
‘‘(A) appoint highly qualified individuals to 
scientific or professional positions at the Cen-
ters for Disease Control and Prevention, not to 
exceed 30 such employees at any time (specific 
to positions authorized by this subsection), with 
expertise in capabilities relevant to biosurveil-
lance and situational awareness, such as experts 
in informatics and data analytics (including ex-
perts in prediction, modeling, or forecasting), 
and other related scientific or technical fields; 
and 
‘‘(B) compensate individuals appointed 
under subparagraph (A) in the same manner 
and subject to the same terms and conditions in 
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which individuals appointed under 9903 of title 
5, United States Code, are compensated, with-
out regard to the provisions of chapter 51 and 
subchapter III of chapter 53 of such title relat-
ing to classification and General Schedule pay 
rates. 
‘‘(2) LIMITATIONS.—The Secretary shall exer-
cise the authority under paragraph (1) in a manner 
that is consistent with the limitations described in 
section 319F–1(e)(2). 
‘‘(g) TIMELINE.—The Secretary shall accomplish the 
purposes under subsections (b) and (c) no later than Sep-
tember 30, 2023, and shall provide a justification to the 
congressional committees of jurisdiction for any missed or 
delayed implementation of measurable steps identified 
under subsection (c)(6)(A)(iii). 
‘‘(h) INDEPENDENT EVALUATION.—Not later than 3 
years after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation Act 
of 2018, the Comptroller General of the United States 
shall conduct an independent evaluation and submit to the 
Secretary and the congressional committees of jurisdiction 
a report concerning the activities conducted under sub-
sections (b) and (c), and provide recommendations, as ap-
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plicable and appropriate, on necessary improvements to 
the biosurveillance and situational awareness network.’’. 
(b) AUTHORIZATION
OF
APPROPRIATIONS.—Sub-
section (i) of section 319D (42 U.S.C. 247d–4), as redes-
ignated by subsection (a)(6), is amended by striking 
‘‘$138,300,000 for each of fiscal years 2014 through 
2018’’ and inserting ‘‘$161,800,000 for each of fiscal 
years 2019 through 2023’’. 
(c) BIOLOGICAL THREAT DETECTION REPORT.—The 
Secretary of Health and Human Services shall, in coordi-
nation with the Secretary of Defense and the Secretary 
of Homeland Security, not later than 180 days after the 
date of enactment of this Act, report to the Committee 
on Energy and Commerce, the Committee on Armed Serv-
ices, and the Committee on Homeland Security of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions, the Committee on Armed 
Services, and the Committee on Homeland Security and 
Governmental Affairs of the Senate on the state of Fed-
eral biological threat detection efforts, including the fol-
lowing— 
(1) an identification of technological, oper-
ational, and programmatic successes and failures of 
domestic detection programs supported by Federal 
departments and agencies for intentionally-intro-
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duced or accidentally-released biological threat 
agents and naturally occurring infectious diseases; 
(2) a description of Federal efforts to facilitate 
the exchange of information related to the informa-
tion described in paragraph (1) among Federal de-
partments and agencies that utilize biological threat 
detection technology; 
(3) a description of the capabilities of detection 
systems in use by Federal departments and agencies 
including the capability to— 
(A) rapidly detect, identify, characterize, 
and confirm the presence of biological threat 
agents; 
(B) recover live biological agents from col-
lection devices; 
(C) determine the geographical distribution 
of biological agents; 
(D) determine the extent of environmental 
contamination and persistence of biological 
agents; and 
(E) provide advanced molecular diagnostics 
to State, local, tribal, and territorial public 
health and other laboratories that support bio-
logical threat detection activities; 
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(4) a description of Federal interagency coordi-
nation related to biological threat detection; 
(5) a description of efforts by Federal depart-
ments and agencies that utilize biological threat de-
tection technology to collaborate with State, local, 
tribal, and territorial public health laboratories and 
other users of biological threat detection systems, in-
cluding collaboration regarding the development of— 
(A) biological threat detection require-
ments or standards; 
(B) a standardized integration strategy; 
(C) training requirements or guidelines; 
(D) guidelines for a coordinated public 
health response, including preparedness capa-
bilities, and, as applicable, for coordination with 
public health surveillance systems; and 
(E) a coordinated environmental remedi-
ation plan, as applicable; and 
(6) recommendations related to research, ad-
vanced research, development, and procurement for 
Federal departments and agencies to improve and 
enhance biological threat detection systems, includ-
ing recommendations on the transfer of biological 
threat detection technology among Federal depart-
ments and agencies, as necessary and appropriate. 
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SEC. 206. STRENGTHENING AND SUPPORTING THE PUBLIC 
HEALTH 
EMERGENCY 
RAPID 
RESPONSE 
FUND. 
Section 319 (42 U.S.C. 247d) is amended— 
(1) in subsection (b)— 
(A) in paragraph (1)— 
(i) in the first sentence, by inserting 
‘‘or if the Secretary determines there is the 
significant potential for a public health 
emergency, to allow the Secretary to rap-
idly respond to the immediate needs result-
ing from such public health emergency or 
potential public health emergency’’ before 
the period; and 
(ii) by inserting ‘‘The Secretary shall 
plan for the expedited distribution of funds 
to appropriate agencies and entities.’’ after 
the first sentence; 
(B) by redesignating paragraph (2) as 
paragraph (3); 
(C) by inserting after paragraph (1) the 
following: 
‘‘(2) USES.—The Secretary may use amounts 
in the Fund established under paragraph (1), to— 
‘‘(A) facilitate coordination between and 
among Federal, State, local, tribal, and terri-
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torial entities and public and private health 
care entities that the Secretary determines may 
be affected by a public health emergency or po-
tential public health emergency referred to in 
paragraph (1) (including communication of 
such entities with relevant international enti-
ties, as applicable); 
‘‘(B) make grants, provide for awards, 
enter into contracts, and conduct supportive in-
vestigations pertaining to a public health emer-
gency or potential public health emergency, in-
cluding further supporting programs under sec-
tion 319C–1, 319C–2, or 319C–3; 
‘‘(C) facilitate and accelerate, as applica-
ble, advanced research and development of secu-
rity countermeasures (as defined in section 
319F–2), qualified countermeasures (as defined 
in section 319F–1), or qualified pandemic or 
epidemic products (as defined in section 319F– 
3), that are applicable to the public health 
emergency or potential public health emergency 
under paragraph (1); 
‘‘(D) strengthen biosurveillance capabilities 
and laboratory capacity to identify, collect, and 
analyze information regarding such public 
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health emergency or potential public health 
emergency, including the systems under section 
319D; 
‘‘(E) support initial emergency operations 
and assets related to preparation and deploy-
ment of intermittent disaster response per-
sonnel under section 2812 and the Medical Re-
serve Corps under section 2813; and 
‘‘(F) carry out other activities, as the Sec-
retary determines applicable and appropriate.’’; 
and 
(D) by inserting after paragraph (3), as so 
redesignated, the following: 
‘‘(4) REVIEW.—Not later than 2 years after the 
date of enactment of the Pandemic and All-Hazards 
Preparedness and Advancing Innovation Act of 
2018, the Secretary, in coordination with the Assist-
ant Secretary for Preparedness and Response, shall 
conduct a review of the Fund under this section and 
provide recommendations to the Committee on 
Health, Education, Labor, and Pensions and the 
Committee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the Com-
mittee on Appropriations of the House of Represent-
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atives on policies to improve such Fund for the uses 
described in paragraph (2). 
‘‘(5) GAO REPORT.—Not later than 4 years 
after the date of enactment of the Pandemic and 
All-Hazards Preparedness and Advancing Innovation 
Act of 2018, the Comptroller General of the United 
States shall— 
‘‘(A) conduct a review of the Fund under 
this section, including its uses and the re-
sources available in the Fund; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce 
of the House of Representatives a report on 
such review, including recommendations related 
to such review, as applicable.’’; and 
(2) in subsection (c)— 
(A) by inserting ‘‘rapidly respond to public 
health emergencies or potential public health 
emergencies and’’ after ‘‘used to’’; and 
(B) by striking ‘‘section.’’ and inserting 
‘‘Act or funds otherwise provided for emergency 
response.’’. 
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SEC. 207. IMPROVING ALL-HAZARDS PREPAREDNESS AND 
RESPONSE BY PUBLIC HEALTH EMERGENCY 
VOLUNTEERS. 
(a) IN GENERAL.—Section 319I (42 U.S.C. 247d– 
7b) is amended— 
(1) in the section heading, by striking 
‘‘HEALTH PROFESSIONS VOLUNTEERS’’ and in-
serting ‘‘VOLUNTEER HEALTH PROFESSIONAL’’; 
(2) in subsection (a), by adding at the end the 
following: ‘‘Such health care professionals may in-
clude members of the National Disaster Medical 
System, members of the Medical Reserve Corps, and 
individual health care professionals.’’; 
(3) in subsection (i) by adding at the end ‘‘In 
order to inform the development of such mechanisms 
by States, the Secretary shall make available infor-
mation and material provided by States that have 
developed mechanisms to waive the application of li-
censing requirements to applicable health profes-
sionals seeking to provide medical services during a 
public health emergency. Such information shall be 
made publicly available in a manner that does not 
compromise national security.’’; and 
(4) in subsection (k) by striking ‘‘2014 through 
2018’’ and inserting ‘‘2019 through 2023’’. 
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(b) ALL-HAZARDS PUBLIC HEALTH EMERGENCY 
PREPAREDNESS AND RESPONSE PLAN.—Section 319C– 
1(b)(2)(A)(iv) 
(42 
U.S.C. 
247d–3a(b)(2)(A)(iv)) 
is 
amended to read as follows: 
‘‘(iv) a description of the mechanism the 
entity will implement to utilize the Emergency 
Management Assistance Compact, or other mu-
tual aid agreement, for medical and public 
health mutual aid, and, as appropriate, the ac-
tivities such entity will implement pursuant to 
section 319I to improve enrollment and coordi-
nation of volunteer health care professionals 
seeking to provide medical services during a 
public health emergency, which may include— 
‘‘(I) providing a public method of 
communication for purposes of volunteer 
coordination (such as a phone number); 
‘‘(II) providing for optional registra-
tion to participate in volunteer services 
during processes related to State medical 
licensing, registration, or certification or 
renewal of such licensing, registration or 
certification; or 
‘‘(III) other mechanisms as the State 
determines appropriate;’’. 
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SEC. 208. CLARIFYING STATE LIABILITY LAW FOR VOLUN-
TEER HEALTH CARE PROFESSIONALS. 
(a) IN GENERAL.—Title II (42 U.S.C. 202 et seq.) 
is amended by inserting after section 224 the following: 
‘‘SEC. 225. HEALTH CARE PROFESSIONALS ASSISTING DUR-
ING A PUBLIC HEALTH EMERGENCY. 
‘‘(a) LIMITATION ON LIABILITY.—Notwithstanding 
any other provision of law, a health care professional who 
is a member of the Medical Reserve Corps under section 
2813 or who is included in the Emergency System for Ad-
vance Registration of Volunteer Health Professionals 
under section 319I and who— 
‘‘(1) is responding— 
‘‘(A) to a public health emergency deter-
mined under section 319(a), during the initial 
period of not more than 90 days (as determined 
by the Secretary) of the public health emer-
gency determination (excluding any period cov-
ered by a renewal of such determination); or 
‘‘(B) to a major disaster or an emergency 
as declared by the President under section 401 
of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5170) or 
under section 201 of the National Emergencies 
Act (50 U.S.C.1621) during the initial period of 
such declaration; and 
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‘‘(2) is alleged to be liable for an act or omis-
sion— 
‘‘(A) during the initial period of a deter-
mination or declaration described in paragraph 
(1) and related to the treatment of individuals 
in need of health care services due to such pub-
lic health emergency, major disaster, or emer-
gency; 
‘‘(B) in the State or States for which such 
determination or declaration is made; 
‘‘(C) in the health care professional’s ca-
pacity as a member of the Medical Reserve 
Corps or a professional included in the Emer-
gency System for Advance Registration of Vol-
unteer Health Professionals under section 319I; 
and 
‘‘(D) in the course of providing services 
that are within the scope of the license, reg-
istration, or certification of the professional, as 
defined by the State of licensure, registration, 
or certification; and 
‘‘(3) prior to the rendering of such act or omis-
sion, was authorized by the State’s authorization of 
deploying such State’s Emergency System for Ad-
vance Registration of Volunteer Health Professionals 
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described in section 319I or the Medical Reserve 
Corps established under section 2813, to provide 
health care services, 
shall be subject only to the State liability laws of the State 
in which such act or omission occurred, in the same man-
ner and to the same extent as a similar health care profes-
sional who is a resident of such State would be subject 
to such State laws, except with respect to the licensure, 
registration, and certification of such individual. 
‘‘(b) VOLUNTEER PROTECTION ACT.—Nothing in 
this section shall be construed to affect an individual’s 
right to protections under the Volunteer Protection Act 
of 1997. 
‘‘(c) PREEMPTION.—This section shall supersede the 
laws of any State that would subject a health care profes-
sional described in subsection (a) to the liability laws of 
any State other than the State liability laws to which such 
individual is subject pursuant to such subsection. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) The term ‘health care professional’ means 
an individual licensed, registered, or certified under 
Federal or State laws or regulations to provide 
health care services. 
‘‘(2) The term ‘health care services’ means any 
services provided by a health care professional, or by 
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any individual working under the supervision of a 
health care professional, that relate to— 
‘‘(A) the diagnosis, prevention, or treat-
ment of any human disease or impairment; or 
‘‘(B) the assessment or care of the health 
of human beings. 
‘‘(e) EFFECTIVE DATE.— 
‘‘(1) IN GENERAL.—This section shall take ef-
fect 90 days after the date of the enactment of the 
Pandemic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018. 
‘‘(2) APPLICATION.—This section shall apply to 
a claim for harm only if the act or omission that 
caused such harm occurred on or after the effective 
date described in paragraph (1).’’. 
(b) GAO STUDY.—Not later than one year after the 
date of enactment of this Act, the Comptroller General 
of the United States shall conduct a review of— 
(1) the number of health care providers who 
register under the Emergency System for Advance 
Registration of Volunteer Health Professionals 
under section 319I of the Public Health Service Act 
(42 U.S.C. 247d–7b) in advance to provide services 
during a public health emergency; 
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(2) the number of health care providers who are 
credentialed to provide services during the period of 
a public health emergency declaration, including 
those who are credentialed though programs estab-
lished in the Emergency System for Advance Reg-
istration of Volunteer Health Professionals under 
such section 319I and those credentialed by authori-
ties within the State in which the emergency oc-
curred; 
(3) the average time to verify the credentials of 
a health care provider during the period of a public 
health emergency declaration, including the average 
time pursuant to the Emergency System for Ad-
vance Registration of Volunteer Health Professionals 
under such section 319I and for an individual’s cre-
dentials to be verified by an authority within the 
State; and 
(4) the Emergency System for Advance Reg-
istration of Volunteer Health Professionals program 
in States, including whether physician or medical 
groups, associations, or other relevant provider orga-
nizations utilize such program for purposes of volun-
teering during public health emergencies. 
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SEC. 209. REPORT ON ADEQUATE NATIONAL BLOOD SUP-
PLY. 
Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services 
shall submit to Congress a report containing recommenda-
tions related to maintaining an adequate national blood 
supply, including— 
(1) challenges associated with the continuous 
recruitment of blood donors (including those newly 
eligible to donate); 
(2) ensuring the adequacy of the blood supply 
in the case of public health emergencies; 
(3) implementation of the transfusion trans-
mission monitoring system; and 
(4) other measures to promote safety and inno-
vation, such as the development, use, or implementa-
tion of new technologies, processes, and procedures 
to improve the safety and reliability of the blood 
supply. 
SEC. 210. REPORT ON THE PUBLIC HEALTH PREPARED-
NESS AND RESPONSE CAPABILITIES AND CA-
PACITIES OF HOSPITALS, LONG-TERM CARE 
FACILITIES, AND OTHER HEALTH CARE FA-
CILITIES. 
(a) STUDY.— 
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(1) IN
GENERAL.—Not later than one year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall enter 
into an agreement with an appropriate entity to con-
duct a study regarding the public health prepared-
ness and response capabilities and medical surge ca-
pacities of hospitals, long-term care facilities, and 
other health care facilities to prepare for, and re-
spond to, public health emergencies, including nat-
ural disasters. 
(2) CONSULTATION.—In conducting the study 
under paragraph (1), the entity shall consult with 
Federal, State, local, tribal, and territorial public 
health officials (as appropriate), and health care 
providers and facilities with experience in public 
health preparedness and response activities. 
(3) EVALUATION.—The study under paragraph 
(1) shall include— 
(A) an evaluation of the current bench-
marks and objective standards, as applicable, 
related to programs that support hospitals, 
long-term care facilities, and other health care 
facilities, and their effect on improving public 
health preparedness and response capabilities 
and medical surge capacities, including the 
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Hospital Preparedness Program, the Public 
Health Emergency Preparedness cooperative 
agreements, and the Regional Health Care 
Emergency Preparedness and Response Sys-
tems under section 319C–3 of the Public 
Health Service Act (as added by section 203); 
(B) the identification of gaps in prepared-
ness, including with respect to such benchmarks 
and objective standards, such as those identified 
during recent public health emergencies, for 
hospitals, long-term care facilities, and other 
health care facilities to address future potential 
public health threats; 
(C) an evaluation of coordination efforts 
between the recipients of Federal funding for 
programs described in subparagraph (A) and 
entities with expertise in emergency power sys-
tems and other critical infrastructure partners 
during a public health emergency, to ensure a 
functioning critical infrastructure, to the great-
est extent practicable, during a public health 
emergency; 
(D) an evaluation of coordination efforts 
between the recipients of Federal funding for 
programs described in subparagraph (A) and 
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environmental health agencies with expertise in 
emergency preparedness and response planning 
for hospitals, long-term care facilities, and other 
health care facilities; and 
(E) an evaluation of current public health 
preparedness and response capabilities and 
medical surge capacities related to at-risk indi-
viduals during public health emergencies, in-
cluding an identification of gaps in such pre-
paredness as they relate to such individuals. 
(b) REPORT.— 
(1) IN GENERAL.—The agreement under sub-
section (a) shall require the entity to submit to the 
Secretary of Health and Human Services and the 
congressional committees of jurisdiction, not later 
than 3 years after the date of enactment of this Act, 
a report on the results of the study conducted pur-
suant to this section. 
(2) CONTENTS.—The report under paragraph 
(1) shall— 
(A) describe the findings and conclusions 
of the evaluation conducted pursuant to sub-
section (a); and 
(B) provide recommendations for improv-
ing public health preparedness and response ca-
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pability and medical surge capacity for hos-
pitals, long-term care facilities, and other health 
care facilities, including— 
(i) improving the existing benchmarks 
and objective standards for the Federal 
grant programs described in subsection 
(a)(3)(A) or developing new benchmarks 
and standards for such programs; and 
(ii) identifying best practices for im-
proving public health preparedness and re-
sponse programs and medical surge capac-
ity at hospitals, long-term care facilities, 
and other health care facilities, including 
recommendations for the evaluation under 
subparagraphs (C) and (D) of subsection 
(a)(3). 
TITLE III—REACHING ALL 
COMMUNITIES 
SEC. 301. STRENGTHENING AND ASSESSING THE EMER-
GENCY RESPONSE WORKFORCE. 
(a) NATIONAL DISASTER MEDICAL SYSTEM.— 
(1) STRENGTHENING THE NATIONAL DISASTER 
MEDICAL
SYSTEM.—Clause 
(ii) 
of 
section 
2812(a)(3)(A) (42 U.S.C. 300hh–11(a)(3)(A)) is 
amended to read as follows: 
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‘‘(ii) be present at locations, and for 
limited periods of time, specified by the 
Secretary on the basis that the Secretary 
has determined that a location is at risk of 
a public health emergency during the time 
specified, or there is a significant potential 
for a public health emergency.’’. 
(2) REVIEW OF THE NATIONAL DISASTER MED-
ICAL
SYSTEM.—Section 2812(b)(2) (42 U.S.C. 
300hh–11(b)(2)) is amended to read as follows: 
‘‘(2) JOINT REVIEW AND MEDICAL SURGE CA-
PACITY STRATEGIC PLAN.— 
‘‘(A) REVIEW.—Not later than 180 days 
after the date of enactment of the Pandemic 
and All-Hazards Preparedness and Advancing 
Innovation Act of 2018, the Secretary, in co-
ordination with the Secretary of Homeland Se-
curity, the Secretary of Defense, and the Sec-
retary of Veterans Affairs, shall conduct a joint 
review of the National Disaster Medical System. 
Such review shall include— 
‘‘(i) an evaluation of medical surge ca-
pacity, as described in section 2803(a); 
‘‘(ii) an assessment of the available 
workforce of the intermittent disaster re-
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sponse personnel described in subsection 
(c); 
‘‘(iii) the capacity of the workforce de-
scribed in clause (ii) to respond to all haz-
ards, including capacity to simultaneously 
respond to multiple public health emer-
gencies and the capacity to respond to a 
nationwide public health emergency; 
‘‘(iv) the effectiveness of efforts to re-
cruit, retain, and train such workforce; and 
‘‘(v) gaps that may exist in such 
workforce and recommendations for ad-
dressing such gaps. 
‘‘(B) UPDATES.—As part of the National 
Health Security Strategy under section 2802, 
the Secretary shall update the findings from the 
review under subparagraph (A) and provide rec-
ommendations to modify the policies of the Na-
tional Disaster Medical System as necessary.’’. 
(3) NOTIFICATION
OF
SHORTAGE.—Section 
2812(c) (42 U.S.C. 300hh–11(c)) is amended by 
adding at the end the following: 
‘‘(3) NOTIFICATION.—Not later than 30 days 
after the date on which the Secretary determines the 
number of intermittent disaster-response personnel 
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of the National Disaster Medical System is insuffi-
cient to address a public health emergency or poten-
tial public health emergency, the Secretary shall sub-
mit to the congressional committees of jurisdiction a 
notification detailing— 
‘‘(A) the impact such shortage could have 
on meeting public health needs and emergency 
medical personnel needs during a public health 
emergency; and 
‘‘(B) any identified measures to address 
such shortage. 
‘‘(4) CERTAIN APPOINTMENTS.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines that the number of intermittent disaster 
response personnel within the National Disaster 
Medical System under this section is insuffi-
cient to address a public health emergency or 
potential public health emergency, the Secretary 
may appoint candidates directly to personnel 
positions for intermittent disaster response 
within such system. The Secretary shall provide 
updates on the number of vacant or unfilled po-
sitions within such system to the congressional 
committees of jurisdiction each quarter for 
which this authority is in effect. 
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‘‘(B) SUNSET.—The authority under this 
paragraph shall expire on September 30, 
2021.’’. 
(4) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 2812(g) (42 U.S.C. 300hh–11(g)) is amend-
ed by striking ‘‘$52,700,000 for each of fiscal years 
2014 through 2018’’ and inserting ‘‘$57,400,000 for 
each of fiscal years 2019 through 2023’’. 
(b) VOLUNTEER MEDICAL RESERVE CORPS.— 
(1) IN GENERAL.—Section 2813(a) (42 U.S.C. 
42 U.S.C. 300hh–15(a)) is amended by striking the 
second sentence and inserting ‘‘The Secretary may 
appoint a Director to head the Corps and oversee 
the activities of the Corps chapters that exist at the 
State, local, tribal, and territorial levels.’’. 
(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 2813(i) (42 U.S.C. 300hh–15(i)) is amended 
by striking ‘‘2014 through 2018’’ and inserting 
‘‘2019 through 2023’’. 
(c) STRENGTHENING THE EPIDEMIC INTELLIGENCE 
SERVICE.—Section 317F (42 U.S.C. Sec. 247b–7) is 
amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
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(i) by inserting ‘‘or preparedness and 
response activities, including rapid re-
sponse to public health emergencies and 
significant public health threats’’ after 
‘‘conduct prevention activities’’; and 
(ii) by striking ‘‘$35,000’’ and insert-
ing ‘‘$50,000’’; and 
(B) in paragraph (2)(B), by striking ‘‘3 
years’’ and inserting ‘‘2 years’’; and 
(2) in subsection (c)— 
(A) by striking ‘‘For the purpose of car-
rying out this section’’ and inserting the fol-
lowing: 
‘‘(1) IN
GENERAL.—For the purpose of car-
rying out this section, except as described in para-
graph (2)’’; and 
(B) by adding at the end the following: 
‘‘(2) EPIDEMIC
INTELLIGENCE
SERVICE
PRO-
GRAM.—For purposes of carrying out this section 
with respect to qualified health professionals serving 
in the Epidemic Intelligence Service, as authorized 
under section 317G, there are authorized to be ap-
propriated $1,000,000 for each of fiscal years 2019 
through 2023.’’. 
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(d) SERVICE BENEFIT
FOR NATIONAL DISASTER 
MEDICAL SYSTEM VOLUNTEERS.— 
(1) IN GENERAL.—Section 2812(c) (42 U.S.C. 
300hh–11(c)), as amended by subsection (a)(3), is 
further amended by adding at the end the following: 
‘‘(5) SERVICE BENEFIT.—Individuals appointed 
to serve under this subsection shall be considered eli-
gible for benefits under part L of title I of the Om-
nibus Crime Control and Safe Streets Act of 1968. 
The Secretary shall provide notification to any eligi-
ble individual of any effect such designation may 
have on other benefits for which such individual is 
eligible, including benefits from private entities.’’. 
(2) PUBLIC SAFETY OFFICER BENEFITS.—Sec-
tion 1204(9) of title I of the Omnibus Crime Control 
and Safe Streets Act of 1968 (34 U.S.C. 10284(9)) 
is amended— 
(A) in subparagraph (C)(ii), by striking 
‘‘or’’ at the end; 
(B) in subparagraph (D), by striking the 
period and inserting ‘‘; or’’; and 
(C) by inserting after subparagraph (D) 
the following: 
‘‘(E) an individual appointed to the Na-
tional Disaster Medical System under section 
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2812 of the Public Health Service Act (42 
U.S.C. 300hh–11) who is performing official 
duties of the Department of Health and Human 
Services, if those official duties are— 
‘‘(i) related to responding to a public 
health emergency or potential public health 
emergency, or other activities for which the 
Secretary of Health and Human Services 
has activated such National Disaster Med-
ical System; and 
‘‘(ii) determined by the Secretary of 
Health and Human Services to be haz-
ardous.’’. 
(3) SUNSET.—The amendments made by para-
graphs (1) and (2) shall cease to have force or effect 
on October 1, 2021. 
(e) MISSION READINESS REPORT TO CONGRESS.— 
(1) REPORT.—Not later than one year after the 
date of enactment of this section, the Comptroller 
General of the United States (referred to in this 
subsection as the ‘‘Comptroller General’’) shall sub-
mit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives, a report on the medical surge capacity of the 
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United States in the event of a public health emer-
gency, including the capacity and capability of the 
current health care workforce to prepare for, and re-
spond to the full range of public health emergencies 
or potential public health emergencies, and rec-
ommendations to address any gaps identified in such 
workforce. 
(2) CONTENTS.—The Comptroller General shall 
include in the report under paragraph (1)— 
(A) the number of health care providers 
who have volunteered to provide health care 
services during a public health emergency, in-
cluding members of the National Disaster Med-
ical System, the Disaster Medical Assistant 
Teams, the Medical Reserve Corps, and other 
volunteer health care professionals in the 
verification network pursuant to section 319I of 
the Public Health Service Act (42 U.S.C. 
247d–7b); 
(B) the capacity of the workforce described 
in subparagraph (A) to respond to a public 
health emergency or potential public health 
emergency, including the capacity to respond to 
multiple concurrent public health emergencies 
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and the capacity to respond to a nationwide 
public health emergency; 
(C) the preparedness and response capa-
bilities and mission readiness of the workforce 
described in subparagraph (A) taking into ac-
count areas of health care expertise and consid-
erations for at-risk individuals (as defined in 
section 2802(b)(4)(B) of the Public Health 
Service Act (42 U.S.C. 300hh–1(b)(4)(B))); 
(D) an assessment of the effectiveness of 
efforts to recruit, retain, and train such work-
force; and 
(E) identification of gaps that may exist in 
such workforce and recommendations for ad-
dressing such gaps, the extent to which the As-
sistant Secretary for Preparedness and Re-
sponse plans to address such gaps, and any rec-
ommendations from the Comptroller General to 
address such gaps. 
SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE 
PREPAREDNESS AND RESPONSE. 
(a) COORDINATION
OF
PREPAREDNESS.—Section 
2811(b)(5) (42 U.S.C. 300hh–10(b)(5)) is amended by 
adding at the end the following: ‘‘Such logistical support 
shall include working with other relevant Federal, State, 
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local, tribal, and territorial public health officials and pri-
vate sector entities to identify the critical infrastructure 
assets, systems, and networks needed for the proper func-
tioning of the health care and public health sectors that 
need to be maintained through any emergency or disaster, 
including entities capable of assisting with, responding to, 
and mitigating the effect of a public health emergency, 
including a public health emergency determined by the 
Secretary pursuant to section 319(a) or an emergency or 
major disaster declared by the President under the Robert 
T. Stafford Disaster Relief and Emergency Assistance Act 
or the National Emergencies Act, including by estab-
lishing methods to exchange critical information and de-
liver products consumed or used to preserve, protect, or 
sustain life, health, or safety, and sharing of specialized 
expertise.’’. 
(b) 
MANUFACTURING
CAPACITY.—Section 
2811(d)(2)(C) (42 U.S.C. 300hh–10(d)(2)(C)) is amended 
by inserting ‘‘, and ancillary medical supplies to assist 
with the utilization of such countermeasures or products,’’ 
after ‘‘products’’. 
(c) EVALUATION OF BARRIERS TO RAPID DELIVERY 
OF MEDICAL COUNTERMEASURES.— 
(1) RAPID
DELIVERY
STUDY.—The Assistant 
Secretary for Preparedness and Response may con-
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duct a study on issues that have the potential to ad-
versely affect the handling and rapid delivery of 
medical countermeasures to individuals during public 
health emergencies occurring in the United States. 
(2) NOTICE TO CONGRESS.—Not later than 9 
months after the date of the enactment of this Act, 
the Assistant Secretary for Preparedness and Re-
sponse shall notify the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate if the Assistant Secretary for 
Preparedness and Response does not plan to conduct 
the study under paragraph (1) and shall provide 
such committees a summary explanation for such de-
cision. 
(3) REPORT TO CONGRESS.—Not later than 1 
year after the Assistant Secretary for Preparedness 
and Response conducts the study under paragraph 
(1), such Assistant Secretary shall submit a report 
to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate containing the findings of such study. 
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SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS. 
(a) AT-RISK
INDIVIDUALS
IN
THE
NATIONAL 
HEALTH SECURITY STRATEGY.—Section 2802(b)(4)(B) 
(42 U.S.C. 300hh–1(b)(4)(B)) is amended— 
(1) by striking ‘‘this section and sections 319C– 
1, 319F, and 319L,’’ and inserting ‘‘this Act,’’; and 
(2) by striking ‘‘special’’ and inserting ‘‘access 
or functional’’. 
(b) COUNTERMEASURE CONSIDERATIONS.—Section 
319L(c)(6) (42 U.S.C. 247d–7e(c)(6)) is amended— 
(1) by striking ‘‘elderly’’ and inserting ‘‘older 
adults’’; and 
(2) by inserting ‘‘with relevant characteristics 
that warrant consideration during the process of re-
searching and developing such countermeasures and 
products’’ before the period. 
(c) 
BIOSURVEILLANCE
OF
EMERGING
PUBLIC 
HEALTH THREATS.—Section 2814 is amended— 
(1) in paragraph (7), by striking ‘‘; and’’ and 
inserting a semicolon; 
(2) in paragraph (8), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(9) facilitate coordination to ensure that, in 
implementing the situational awareness and bio-
surveillance network under section 319D, the Sec-
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retary considers incorporating data and information 
from Federal, State, local, tribal, and territorial 
public health officials and entities relevant to detect-
ing emerging public health threats that may affect 
at-risk individuals, such as pregnant and postpartum 
women and infants, including adverse health out-
comes of such populations related to such emerging 
public health threats.’’. 
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND 
RESPONSE 
CONSIDERATIONS 
FOR 
CHIL-
DREN. 
Part B of title III (42 U.S.C. 243 et seq.) is amended 
by inserting after section 319D the following: 
‘‘SEC. 319D–1. CHILDREN’S PREPAREDNESS UNIT. 
‘‘(a) ENHANCING EMERGENCY PREPAREDNESS FOR 
CHILDREN.—The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention (re-
ferred to in this subsection as the ‘Director’), shall main-
tain an internal team of experts, to be known as the Chil-
dren’s Preparedness Unit (referred to in this subsection 
as the ‘Unit’), to work collaboratively to provide guidance 
on the considerations for, and the specific needs of, chil-
dren before, during, and after public health emergencies. 
The Unit shall inform the Director regarding emergency 
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preparedness and response efforts pertaining to children 
at the Centers for Disease Control and Prevention. 
‘‘(b) EXPERTISE.—The team described in subsection 
(a) shall include one or more pediatricians, which may be 
a developmental-behavioral pediatrician, and may also in-
clude behavioral scientists, child psychologists, epidemiolo-
gists, biostatisticians, health communications staff, and 
individuals with other areas of expertise, as the Secretary 
determines appropriate. 
‘‘(c) DUTIES.—The team described in subsection (a) 
may— 
‘‘(1) assist State, local, tribal, and territorial 
emergency planning and response activities related 
to children, which may include developing, identi-
fying, and sharing best practices; 
‘‘(2) provide technical assistance, training, and 
consultation to Federal, State, local, tribal, and ter-
ritorial public health officials to improve prepared-
ness and response capabilities with respect to the 
needs of children, including providing such technical 
assistance, training, and consultation to eligible enti-
ties in order to support the achievement of measur-
able evidence-based benchmarks and objective stand-
ards applicable to sections 319C–1 and 319C–2; 
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‘‘(3) improve the utilization of methods to in-
corporate the needs of children in planning for and 
responding to a public health emergency, including 
public awareness of such methods; 
‘‘(4) coordinate with, and improve, public-pri-
vate partnerships, such as health care coalitions pur-
suant to sections 319C–2 and 319C–3, to address 
gaps and inefficiencies in emergency preparedness 
and response efforts for children; 
‘‘(5) provide expertise and input during the de-
velopment of guidance and clinical recommendations 
to address the needs of children when preparing for, 
and responding to, public health emergencies, includ-
ing pursuant to section 319C–3; and 
‘‘(6) carry out other duties related to prepared-
ness and response activities for children, as the Sec-
retary determines appropriate.’’. 
SEC. 305. NATIONAL ADVISORY COMMITTEES ON DISAS-
TERS. 
(a) REAUTHORIZING THE NATIONAL ADVISORY COM-
MITTEE ON CHILDREN AND DISASTERS.—Section 2811A 
(42 U.S.C. 300hh–10a) is amended— 
(1) in subsection (b)(2), by inserting ‘‘, mental 
and behavioral,’’ after ‘‘medical’’; 
(2) in subsection (d)— 
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(A) in paragraph (1), by striking ‘‘15’’ and 
inserting ‘‘25’’; and 
(B) by striking paragraph (2) and insert-
ing the following: 
‘‘(2) REQUIRED NON-FEDERAL MEMBERS.—The 
Secretary, in consultation with such other heads of 
Federal agencies as may be appropriate, shall ap-
point to the Advisory Committee under paragraph 
(1) at least 13 individuals, including— 
‘‘(A) at least 2 non-Federal professionals 
with expertise in pediatric medical disaster 
planning, preparedness, response, or recovery; 
‘‘(B) at least 2 representatives from State, 
local, tribal, or territorial agencies with exper-
tise in pediatric disaster planning, prepared-
ness, response, or recovery; 
‘‘(C) at least 4 members representing 
health care professionals, which may include 
members with expertise in pediatric emergency 
medicine; pediatric trauma, critical care, or sur-
gery; the treatment of pediatric patients af-
fected by chemical, biological, radiological, or 
nuclear agents, including emerging infectious 
diseases; pediatric mental or behavioral health 
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related to children affected by a public health 
emergency; or pediatric primary care; and 
‘‘(D) other members as the Secretary de-
termines appropriate, of whom— 
‘‘(i) at least one such member shall 
represent a children’s hospital; 
‘‘(ii) at least one such member shall 
be an individual with expertise in schools 
or child care settings; 
‘‘(iii) at least one such member shall 
be an individual with expertise in children 
and youth with special health care needs; 
and 
‘‘(iv) at least one such member shall 
be an individual with expertise in the needs 
of parents or family caregivers, including 
the parents or caregivers of children with 
disabilities.’’. 
‘‘(3) FEDERAL MEMBERS.—The Advisory Com-
mittee under paragraph (1) shall include the fol-
lowing Federal members or their designees (who 
may be non-voting members, as determined by the 
Secretary): 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
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‘‘(B) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
‘‘(C) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(D) The Commissioner of Food and 
Drugs. 
‘‘(E) The Director of the National Insti-
tutes of Health. 
‘‘(F) The Assistant Secretary of the Ad-
ministration for Children and Families. 
‘‘(G) The Administrator of the Health Re-
sources and Services Administration. 
‘‘(H) The Administrator of the Federal 
Emergency Management Agency. 
‘‘(I) The Administrator of the Administra-
tion for Community Living. 
‘‘(J) The Secretary of Education. 
‘‘(K) Representatives from such Federal 
agencies (such as the Substance Abuse and 
Mental Health Services Administration and the 
Department of Homeland Security) as the Sec-
retary determines appropriate to fulfill the du-
ties of the Advisory Committee under sub-
sections (b) and (c).’’. 
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‘‘(4) TERM OF APPOINTMENT.—Each member 
of the Advisory Committee appointed under para-
graph (2) shall serve for a term of 3 years, except 
that the Secretary may adjust the terms of the Advi-
sory Committee appointees serving on the date of 
enactment of the Pandemic and All-Hazards Pre-
paredness and Advancing Innovation Act of 2018, or 
appointees who are initially appointed after such 
date of enactment, in order to provide for a stag-
gered term of appointment for all members. 
‘‘(5) CONSECUTIVE APPOINTMENTS; MAXIMUM 
TERMS.—A member appointed under paragraph (2) 
may serve not more than 3 terms on the Advisory 
Committee, and not more than 2 of such terms may 
be served consecutively.’’; 
(3) in subsection (e), by adding at the end ‘‘At 
least one meeting per year shall be an in-person 
meeting.’’; 
(4) by redesignating subsection (f) as sub-
section (g); 
(5) by inserting after subsection (e) the fol-
lowing: 
‘‘(f) COORDINATION.—The Secretary shall coordinate 
duties and activities authorized under this section in ac-
cordance with section 2811D.’’; and 
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(6) in subsection (g), as so redesignated, by 
striking ‘‘2018’’ and inserting ‘‘2023’’. 
(b) AUTHORIZING THE NATIONAL ADVISORY COM-
MITTEE ON SENIORS AND DISASTERS.—Subtitle B of title 
XXVIII (42 U.S.C. 300hh et seq.) is amended by inserting 
after section 2811A the following: 
‘‘SEC. 2811B. NATIONAL ADVISORY COMMITTEE ON SEN-
IORS AND DISASTERS. 
‘‘(a) ESTABLISHMENT.—The Secretary, in consulta-
tion with the Secretary of Homeland Security and the Sec-
retary of Veterans Affairs, shall establish an advisory com-
mittee to be known as the National Advisory Committee 
on Seniors and Disasters (referred to in this section as 
the ‘Advisory Committee’). 
‘‘(b) DUTIES.—The Advisory Committee shall— 
‘‘(1) provide advice and consultation with re-
spect to the activities carried out pursuant to section 
2814, as applicable and appropriate; 
‘‘(2) evaluate and provide input with respect to 
the medical and public health needs of seniors re-
lated to preparation for, response to, and recovery 
from all-hazards emergencies; and 
‘‘(3) provide advice and consultation with re-
spect to State emergency preparedness and response 
activities relating to seniors, including related drills 
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and exercises pursuant to the preparedness goals 
under section 2802(b). 
‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 
may provide advice and recommendations to the Secretary 
with respect to seniors and the medical and public health 
grants and cooperative agreements as applicable to pre-
paredness and response activities under this title and title 
III. 
‘‘(d) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with such other heads of agencies as appro-
priate, shall appoint not more than 17 members to 
the Advisory Committee. In appointing such mem-
bers, the Secretary shall ensure that the total mem-
bership of the Advisory Committee is an odd num-
ber. 
‘‘(2) 
REQUIRED
MEMBERS.—The 
Advisory 
Committee shall include Federal members or their 
designees (who may be non-voting members, as de-
termined by the Secretary) and non-Federal mem-
bers, as follows: 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
‘‘(B) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
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‘‘(C) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(D) The Commissioner of Food and 
Drugs. 
‘‘(E) The Director of the National Insti-
tutes of Health. 
‘‘(F) The Administrator of the Centers for 
Medicare & Medicaid Services. 
‘‘(G) The Administrator of the Administra-
tion for Community Living. 
‘‘(H) The Administrator of the Federal 
Emergency Management Agency. 
‘‘(I) The Under Secretary for Health of 
the Department of Veterans Affairs. 
‘‘(J) At least 2 non-Federal health care 
professionals with expertise in geriatric medical 
disaster planning, preparedness, response, or 
recovery. 
‘‘(K) At least 2 representatives of State, 
local, tribal, or territorial agencies with exper-
tise in geriatric disaster planning, preparedness, 
response, or recovery. 
‘‘(L) Representatives of such other Federal 
agencies (such as the Department of Energy 
and the Department of Homeland Security) as 
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the Secretary determines necessary to fulfill the 
duties of the Advisory Committee. 
‘‘(e) MEETINGS.—The Advisory Committee shall 
meet not less frequently than biannually. At least one 
meeting per year shall be an in-person meeting. 
‘‘(f) COORDINATION.—The Secretary shall coordinate 
duties and activities authorized under this section in ac-
cordance with section 2811D. 
‘‘(g) SUNSET.— 
‘‘(1) IN
GENERAL.—The Advisory Committee 
shall terminate on September 30, 2023. 
‘‘(2) EXTENSION
OF
COMMITTEE.—Not later 
than October 1, 2022, the Secretary shall submit to 
Congress a recommendation on whether the Advisory 
Committee should be extended.’’. 
(c) NATIONAL ADVISORY COMMITTEE ON INDIVID-
UALS WITH DISABILITIES AND DISASTERS.—Subtitle B 
of title XXVIII (42 U.S.C. 300hh et seq.), as amended 
by subsection (b), is further amended by inserting after 
section 2811B the following: 
‘‘SEC. 2811C. NATIONAL ADVISORY COMMITTEE ON INDIVID-
UALS WITH DISABILITIES AND DISASTERS. 
‘‘(a) ESTABLISHMENT.—The Secretary, in consulta-
tion with the Secretary of Homeland Security, shall estab-
lish a national advisory committee to be known as the Na-
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tional Advisory Committee on Individuals with Disabilities 
and Disasters (referred to in this section as the ‘Advisory 
Committee’). 
‘‘(b) DUTIES.—The Advisory Committee shall— 
‘‘(1) provide advice and consultation with re-
spect to activities carried out pursuant to section 
2814, as applicable and appropriate; 
‘‘(2) evaluate and provide input with respect to 
the medical, public health, and accessibility needs of 
individuals with disabilities related to preparation 
for, response to, and recovery from all-hazards emer-
gencies; and 
‘‘(3) provide advice and consultation with re-
spect to State emergency preparedness and response 
activities, including related drills and exercises pur-
suant to the preparedness goals under section 
2802(b). 
‘‘(c) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with such other heads of agencies and depart-
ments as appropriate, shall appoint not more than 
17 members to the Advisory Committee. In appoint-
ing such members, the Secretary shall ensure that 
the total membership of the Advisory Committee is 
an odd number. 
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‘‘(2) 
REQUIRED
MEMBERS.—The 
Advisory 
Committee shall include Federal members or their 
designees (who may be non-voting members, as de-
termined by the Secretary) and non-Federal mem-
bers, as follows: 
‘‘(A) The Assistant Secretary for Pre-
paredness and Response. 
‘‘(B) The Administrator of the Administra-
tion for Community Living. 
‘‘(C) The Director of the Biomedical Ad-
vanced Research and Development Authority. 
‘‘(D) The Director of the Centers for Dis-
ease Control and Prevention. 
‘‘(E) The Commissioner of Food and 
Drugs. 
‘‘(F) The Director of the National Insti-
tutes of Health. 
‘‘(G) The Administrator of the Federal 
Emergency Management Agency. 
‘‘(H) The Chair of the National Council on 
Disability. 
‘‘(I) The Chair of the United States Access 
Board. 
‘‘(J) The Under Secretary for Health of 
the Department of Veterans Affairs. 
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‘‘(K) At least 2 non-Federal health care 
professionals with expertise in disability accessi-
bility before, during, and after disasters, med-
ical and mass care disaster planning, prepared-
ness, response, or recovery. 
‘‘(L) At least 2 representatives from State, 
local, tribal, or territorial agencies with exper-
tise in disaster planning, preparedness, re-
sponse, or recovery for individuals with disabil-
ities. 
‘‘(M) At least 2 individuals with a dis-
ability with expertise in disaster planning, pre-
paredness, response, or recovery for individuals 
with disabilities. 
‘‘(d) MEETINGS.—The Advisory Committee shall 
meet not less frequently than biannually. At least one 
meeting per year shall be an in-person meeting. 
‘‘(e) DISABILITY DEFINED.—For purposes of this 
section, the term ‘disability’ has the meaning given such 
term in section 3 of the Americans with Disabilities Act 
of 1990. 
‘‘(f) COORDINATION.—The Secretary shall coordinate 
duties and activities authorized under this section in ac-
cordance with section 2811D. 
‘‘(g) SUNSET.— 
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‘‘(1) IN
GENERAL.—The Advisory Committee 
shall terminate on September 30, 2023. 
‘‘(2) RECOMMENDATION.—Not later than Octo-
ber 1, 2022, the Secretary shall submit to Congress 
a recommendation on whether the Advisory Com-
mittee should be extended.’’. 
(d) ADVISORY COMMITTEE COORDINATION.—Sub-
title B of title XXVIII (42 U.S.C. 300hh et seq.), as 
amended by subsection (c), is further amended by insert-
ing after section 2811C the following: 
‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 
‘‘(a) IN GENERAL.—The Secretary shall coordinate 
duties and activities authorized under sections 2811A, 
2811B, and 2811C, and make efforts to reduce unneces-
sary or duplicative reporting, or unnecessary duplicative 
meetings and recommendations under such sections, as 
practicable. Members of the advisory committees author-
ized under such sections, or their designees, shall annually 
meet to coordinate any recommendations, as appropriate, 
that may be similar, duplicative, or overlapping with re-
spect to addressing the needs of children, seniors, and in-
dividuals with disabilities during public health emer-
gencies. If such coordination occurs through an in-person 
meeting, it shall not be considered the required in-person 
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100 
meetings under any of sections 2811A(e), 2811B(e), or 
2811C(d). 
‘‘(b) COORDINATION
AND ALIGNMENT.—The Sec-
retary, acting through the employee designated pursuant 
to section 2814, shall align preparedness and response 
programs or activities to address similar, dual, or overlap-
ping needs of children, seniors, and individuals with dis-
abilities, and any challenges in preparing for and respond-
ing to such needs. 
‘‘(c) NOTIFICATION.—The Secretary shall annually 
notify the congressional committees of jurisdiction regard-
ing the steps taken to coordinate, as appropriate, the rec-
ommendations under this section, and provide a summary 
description of such coordination.’’. 
SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES 
AND DRILLS. 
Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall issue final guidance regarding the ability of per-
sonnel funded by programs authorized under this Act (in-
cluding the amendments made by this Act) to participate 
in drills and operational exercises related to all-hazards 
medical and public health preparedness and response. 
Such drills and operational exercises may include activities 
that incorporate medical surge capacity planning, medical 
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101 
countermeasure distribution and administration, and pre-
paring for and responding to identified threats for that 
region. Such personnel may include State, local, tribal, 
and territorial public health department or agency per-
sonnel funded under this Act (including the amendments 
made by this Act). The Secretary shall consult with the 
Department of Homeland Security, the Department of 
Defense, the Department of Veterans Affairs, and other 
applicable Federal departments and agencies as necessary 
and appropriate in the development of such guidance. The 
Secretary shall make the guidance available on the inter-
net website of the Department of Health and Human 
Services. 
TITLE IV—PRIORITIZING A 
THREAT-BASED APPROACH 
SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND 
RESPONSE. 
Section 2811(b) (42 U.S.C. 300hh–10(b)) is amend-
ed— 
(1) in the matter preceding paragraph (1) by 
inserting ‘‘utilize experience related to public health 
emergency preparedness and response, biodefense, 
medical countermeasures, and other relevant topics 
to’’ after ‘‘shall’’; and 
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102 
(2) in paragraph (4) by adding at the end the 
following: 
‘‘(I) 
THREAT
AWARENESS.—Coordinate 
with the Director of the Centers for Disease 
Control and Prevention, the Director of Na-
tional Intelligence, the Secretary of Homeland 
Security, the Assistant to the President for Na-
tional Security Affairs, the Secretary of De-
fense, and other relevant Federal officials, such 
as the Secretary of Agriculture, to maintain a 
current assessment of national security threats 
and inform preparedness and response capabili-
ties based on the range of the threats that have 
the potential to result in a public health emer-
gency.’’. 
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE. 
(a) IN GENERAL.—Title XXVIII is amended by in-
serting after section 2811 (42 U.S.C. 300hh–10) the fol-
lowing: 
‘‘SEC. 
2811–1. 
PUBLIC 
HEALTH 
EMERGENCY 
MEDICAL 
COUNTERMEASURES ENTERPRISE. 
‘‘(a) IN GENERAL.—The Secretary shall establish the 
Public Health Emergency Medical Countermeasures En-
terprise (referred to in this section as the ‘PHEMCE’). 
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103 
The Assistant Secretary for Preparedness and Response 
shall serve as chair of the PHEMCE. 
‘‘(b) MEMBERS.—The PHEMCE shall include each 
of the following members, or the designee of such mem-
bers: 
‘‘(1) The Assistant Secretary for Preparedness 
and Response. 
‘‘(2) The Director of the Centers for Disease 
Control and Prevention. 
‘‘(3) The Director of the National Institutes of 
Health. 
‘‘(4) The Commissioner of Food and Drugs. 
‘‘(5) The Secretary of Defense. 
‘‘(6) The Secretary of Homeland Security. 
‘‘(7) The Secretary of Agriculture. 
‘‘(8) The Secretary of Veterans Affairs. 
‘‘(9) The Director of National Intelligence. 
‘‘(10) Representatives of any other Federal 
agency, which may include the Director of the Bio-
medical Advanced Research and Development Au-
thority, the Director of the Strategic National Stock-
pile, the Director of the National Institute of Allergy 
and Infectious Diseases, and the Director of the Of-
fice of Public Health Preparedness and Response, as 
the Secretary determines appropriate. 
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104 
‘‘(c) FUNCTIONS.— 
‘‘(1) IN
GENERAL.—The functions of the 
PHEMCE shall include the following: 
‘‘(A) Utilize a process to make rec-
ommendations to the Secretary regarding re-
search, advanced research, development, pro-
curement, stockpiling, deployment, distribution, 
and utilization with respect to countermeasures, 
as defined in section 319F–2(c), including 
prioritization based on the health security needs 
of the United States. Such recommendations 
shall be informed by, when available and prac-
ticable, the National Health Security Strategy 
pursuant to section 2802, the Strategic Na-
tional Stockpile needs pursuant to section 
319F–2, and assessments of current national 
security threats, including chemical, biological, 
radiological, and nuclear threats, including 
emerging infectious diseases. In the event that 
members of the PHEMCE do not agree upon a 
recommendation, the Secretary shall provide a 
determination regarding such recommendation. 
‘‘(B) Identify national health security 
needs, including gaps in public health prepared-
ness and response related to countermeasures 
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105 
and challenges to addressing such needs (in-
cluding any regulatory challenges), and support 
alignment of countermeasure procurement with 
recommendations to address such needs under 
subparagraph (A). 
‘‘(C) Assist the Secretary in developing 
strategies related to logistics, deployment, dis-
tribution, dispensing, and use of counter-
measures that may be applicable to the activi-
ties of the strategic national stockpile under 
section 319F–2(a). 
‘‘(D) Provide consultation for the develop-
ment of the strategy and implementation plan 
under section 2811(d). 
‘‘(2) INPUT.—In carrying out subparagraphs 
(B) and (C) of paragraph (1), the PHEMCE shall 
solicit and consider input from State, local, tribal, 
and territorial public health departments or officials, 
as appropriate.’’. 
(b) PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN-
TATION PLAN.—Section 2811(d) (42 U.S.C. 300hh– 
10(d)) is amended— 
(1) in paragraph (1)— 
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106 
(A) by striking ‘‘Not later than 180 days 
after the date of enactment of this subsection, 
and every year thereafter’’ and inserting ‘‘Not 
later than March 15, 2020, and biennially 
thereafter’’; and 
(B) by striking ‘‘Director of the Bio-
medical’’ and all that follows through ‘‘Food 
and Drugs’’ and inserting ‘‘Public Health 
Emergency Medical Countermeasures Enter-
prise established under section 2811–1’’; and 
(2) in paragraph (2)(J)(v), by striking ‘‘one- 
year period’’ and inserting ‘‘2-year period’’. 
SEC. 403. STRATEGIC NATIONAL STOCKPILE. 
(a) IN GENERAL.—Section 319F–2(a) (42 U.S.C. 
247d–6b(a)) is amended— 
(1) by redesignating paragraphs (2) and (3) as 
paragraphs (3) and (4), respectively; and 
(2) in paragraph (1)— 
(A) by inserting ‘‘the Assistant Secretary 
for Preparedness and Response and’’ after ‘‘col-
laboration with’’; 
(B) by inserting ‘‘and optimize’’ after 
‘‘provide for’’; 
(C) by inserting ‘‘and, as informed by ex-
isting recommendations of, or consultations 
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107 
with, the Public Health Emergency Medical 
Countermeasure Enterprise established under 
section 2811–1, make necessary additions or 
modifications to the contents of such stockpile 
or stockpiles based on the review conducted 
under paragraph (2)’’ before the period of the 
first sentence; and 
(D) by striking the second sentence; 
(3) by inserting after paragraph (1) the fol-
lowing: 
‘‘(2) THREAT-BASED REVIEW.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
conduct an annual threat-based review (taking 
into account at-risk individuals) of the contents 
of the stockpile under paragraph (1), including 
non-pharmaceutical supplies, and, in consulta-
tion with the Public Health Emergency Medical 
Countermeasures Enterprise established under 
section 2811–1, review contents within the 
stockpile and assess whether such contents are 
consistent with the recommendations made pur-
suant to section 2811–1(c)(1)(A). Such review 
shall be submitted on June 15, 2019, and on 
March 15 of each year thereafter, to the Com-
mittee on Health, Education, Labor, and Pen-
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108 
sions and the Committee on Appropriations of 
the Senate and the Committee on Energy and 
Commerce and the Committee on Appropria-
tions of the House of Representatives, in a 
manner that does not compromise national se-
curity. 
‘‘(B) ADDITIONS, 
MODIFICATIONS, 
AND 
REPLENISHMENTS.—Each annual threat-based 
review under subparagraph (A) shall, for each 
new or modified countermeasure procurement 
or replenishment, provide— 
‘‘(i) information regarding— 
‘‘(I) the quantities of the addi-
tional or modified countermeasure 
procured for, or contracted to be pro-
cured for, the stockpile; 
‘‘(II) planning considerations for 
appropriate manufacturing capacity 
and capability to meet the goals of 
such additions or modifications (with-
out disclosing proprietary informa-
tion), including consideration of the 
effect such additions or modifications 
may have on the availability of such 
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109 
products and ancillary medical sup-
plies in the health care system; 
‘‘(III) the presence or lack of a 
commercial market for the counter-
measure at the time of procurement; 
‘‘(IV) the emergency health secu-
rity threat or threats such counter-
measure procurement is intended to 
address, including whether such pro-
curement is consistent with meeting 
emergency health security needs asso-
ciated with such threat or threats; 
‘‘(V) an assessment of whether 
the emergency health security threat 
or threats described in subclause (IV) 
could be addressed in a manner that 
better utilizes the resources of the 
stockpile and permits the greatest 
possible increase in the level of emer-
gency preparedness to address such 
threats; 
‘‘(VI) 
whether 
such 
counter-
measure is replenishing an expiring or 
expired countermeasure, is a different 
countermeasure with the same indica-
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110 
tion that is replacing an expiring or 
expired countermeasure, or is a new 
addition to the stockpile; 
‘‘(VII) a description of how such 
additions or modifications align with 
projected investments under previous 
countermeasures budget plans under 
section 2811(b)(7), including expected 
life-cycle costs, expenditures related to 
countermeasure procurement to ad-
dress the threat or threats described 
in subclause (IV), replenishment dates 
(including the ability to extend the 
maximum shelf life of a counter-
measure), and the manufacturing ca-
pacity required to replenish such 
countermeasure; and 
‘‘(VIII) appropriate protocols and 
processes for the deployment, distribu-
tion, or dispensing of the counter-
measure at the State and local level, 
including plans for relevant capabili-
ties of State and local entities to dis-
pense, distribute, and administer the 
countermeasure; and 
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‘‘(ii) an assurance, which need not be 
provided in advance of procurement, that 
for each countermeasure procured or re-
plenished under this subsection, the Sec-
retary completed a review addressing each 
item listed under this subsection in ad-
vance of such procurement or replenish-
ment.’’; 
(4) in paragraph (3), as so redesignated— 
(A) in subparagraph (A), by inserting 
‘‘and the Public Health Emergency Medical 
Countermeasures Enterprise established under 
section 2811–1’’ before the semicolon; 
(B) in subparagraph (C), by inserting ‘‘, 
and the availability, deployment, dispensing, 
and administration of countermeasures’’ before 
the semicolon; 
(C) by amending subparagraph (E) to read 
as follows: 
‘‘(E) devise plans for effective and timely 
supply-chain management of the stockpile, in 
consultation with the Director of the Centers 
for Disease Control and Prevention, the Assist-
ant Secretary for Preparedness and Response, 
the Secretary of Transportation, the Secretary 
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112 
of Homeland Security, the Secretary of Vet-
erans Affairs, and the heads of other appro-
priate Federal agencies; State, local, tribal, and 
territorial agencies; and the public and private 
health care infrastructure, as applicable, taking 
into account the manufacturing capacity and 
other available sources of products and appro-
priate alternatives to supplies in the stockpile;’’; 
(D) in subparagraph (G), by striking ‘‘; 
and’’ and inserting a semicolon; 
(E) in subparagraph (H), by striking the 
period and inserting a semicolon; and 
(F) by adding at the end the following: 
‘‘(I) ensure that each countermeasure or 
product under consideration for procurement 
pursuant to this subsection receives the same 
consideration regardless of whether such coun-
termeasure or product receives or had received 
funding under section 319L, including with re-
spect to whether the countermeasure or product 
is most appropriate to meet the emergency 
health security needs of the United States; and 
‘‘(J) provide assistance, including technical 
assistance, to maintain and improve State and 
local public health preparedness capabilities to 
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distribute 
and 
dispense 
medical 
counter-
measures and products from the stockpile, as 
appropriate.’’; and 
(5) by adding at the end the following: 
‘‘(5) GAO REPORT.— 
‘‘(A) IN GENERAL.—Not later than 3 years 
after the date of enactment of the Pandemic 
and All-Hazards Preparedness and Advancing 
Innovation Act of 2018, and every 5 years 
thereafter, the Comptroller General of the 
United States shall conduct a review of any 
changes to the contents or management of the 
stockpile since January 1, 2015. Such review 
shall include— 
‘‘(i) an assessment of the comprehen-
siveness and completeness of each annual 
threat-based review under paragraph (2), 
including whether all newly procured or re-
plenished 
countermeasures 
within 
the 
stockpile were described in each annual re-
view, and whether, consistent with para-
graph (2)(B), the Secretary conducted the 
necessary internal review in advance of 
such procurement or replenishment; 
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‘‘(ii) an assessment of whether the 
Secretary established health security and 
science-based justifications, and a descrip-
tion of such justifications for procurement 
decisions related to health security needs 
with respect to the identified threat, for 
additions or modifications to the stockpile 
based on the information provided in such 
reviews under paragraph (2)(B), including 
whether such review was conducted prior 
to procurement, modification, or replenish-
ment; 
‘‘(iii) an assessment of the plans de-
veloped by the Secretary for the deploy-
ment, distribution, and dispensing of coun-
termeasures procured, modified, or replen-
ished under paragraph (1), including 
whether such plans were developed prior to 
procurement, modification, or replenish-
ment; 
‘‘(iv) 
an 
accounting 
of 
counter-
measures procured, modified, or replen-
ished under paragraph (1) that received 
advanced research and development fund-
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ing from the Biomedical Advanced Re-
search and Development Authority; 
‘‘(v) an analysis of how such procure-
ment decisions made progress toward 
meeting emergency health security needs 
related to the identified threats for coun-
termeasures added, modified, or replen-
ished under paragraph (1); 
‘‘(vi) a description of the resources ex-
pended related to the procurement of coun-
termeasures (including additions, modifica-
tions, and replenishments) in the stockpile, 
and how such expenditures relate to the 
ability of the stockpile to meet emergency 
health security needs; 
‘‘(vii) an assessment of the extent to 
which additions, modifications, and replen-
ishments reviewed under paragraph (2) 
align with previous relevant reports or re-
views by the Secretary or the Comptroller 
General; 
‘‘(viii) with respect to any change in 
the Federal organizational management of 
the stockpile, an assessment and compari-
son of the processes affected by such 
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change, including planning for potential 
countermeasure deployment, distribution, 
or dispensing capabilities and processes re-
lated to procurement decisions, use of 
stockpiled countermeasures, and use of re-
sources for such activities; and 
‘‘(ix) an assessment of whether the 
processes and procedures described by the 
Secretary pursuant to section 403(b) of 
the Pandemic and All-Hazards Prepared-
ness and Advancing Innovation Act of 
2018 are sufficient to ensure counter-
measures and products under consideration 
for procurement pursuant to subsection (a) 
receive the same consideration regardless 
of whether such countermeasures and 
products receive or had received funding 
under section 319L, including with respect 
to whether such countermeasures and 
products are most appropriate to meet the 
emergency health security needs of the 
United States. 
‘‘(B) SUBMISSION.—Not later than 6 
months after completing a classified version of 
the review under subparagraph (A), the Comp-
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troller General shall submit an unclassified 
version of the review to the congressional com-
mittees of jurisdiction.’’. 
(b) ADDITIONAL REPORTING.—In the first threat- 
based review submitted after the date of enactment of this 
Act pursuant to paragraph (2) of section 319F–2(a) of 
the Public Health Service Act (42 U.S.C. 247d–6b(a)), as 
amended by subsection (a), the Secretary shall include a 
description of the processes and procedures through which 
the Director of Strategic National Stockpile and the Di-
rector of the Biomedical Advanced Research and Develop-
ment Authority coordinate with respect to counter-
measures and products procured under such section 
319F–2(a), including such processes and procedures in 
place to ensure countermeasures and products under con-
sideration for procurement pursuant to such section 
319F–2(a) receive the same consideration regardless of 
whether such countermeasures or products receive or had 
received funding under section 319L of the Public Health 
Service Act (42 U.S.C. 247d–7e), and whether such coun-
termeasures and products are the most appropriate to 
meet the emergency health security needs of the United 
States. 
(c) AUTHORIZATION
OF APPROPRIATIONS, STRA-
TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) (42 
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U.S.C. 
247d–6b(f)(1)) 
is 
amended 
by 
striking 
‘‘$533,800,000 for each of fiscal years 2014 through 
2018’’ and inserting ‘‘$610,000,000 for each of fiscal 
years 2019 through 2023, to remain available until ex-
pended’’. 
SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTI-
MICROBIAL RESISTANCE, AND OTHER SIG-
NIFICANT THREATS. 
(a) STRATEGIC INITIATIVES.—Section 319L(c)(4) 
(247d–7e(c)(4)) is amended by adding at the end the fol-
lowing: 
‘‘(F) STRATEGIC
INITIATIVES.—The Sec-
retary, acting through the Director of BARDA, 
may implement strategic initiatives, including 
by building on existing programs and by award-
ing contracts, grants, and cooperative agree-
ments, or entering into other transactions, to 
support innovative candidate products in pre-
clinical and clinical development that address 
priority, naturally occurring and man-made 
threats that, as determined by the Secretary, 
pose a significant level of risk to national secu-
rity based on the characteristics of a chemical, 
biological, radiological or nuclear threat, or ex-
isting capabilities to respond to such a threat 
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(including medical response and treatment ca-
pabilities and manufacturing infrastructure). 
Such initiatives shall accelerate and support the 
advanced research, development, and procure-
ment of, countermeasures and products, as ap-
plicable, to address areas including— 
‘‘(i) chemical, biological, radiological, 
or nuclear threats, including emerging in-
fectious diseases, for which insufficient ap-
proved, licensed, or authorized counter-
measures exist, or for which such threat, 
or the result of an exposure to such threat, 
may become resistant to countermeasures 
or existing countermeasures may be ren-
dered ineffective; 
‘‘(ii) threats that consistently exist or 
continually circulate and have a significant 
potential to become a pandemic, such as 
pandemic influenza, which may include the 
advanced research and development, manu-
facturing, and appropriate stockpiling of 
qualified pandemic or epidemic products, 
and products, technologies, or processes to 
support the advanced research and devel-
opment of such countermeasures (including 
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multiuse 
platform 
technologies 
for 
diagnostics, vaccines, and therapeutics; 
virus seeds; clinical trial lots; novel virus 
strains; and antigen and adjuvant mate-
rial); and 
‘‘(iii) threats that may result pri-
marily or secondarily from a chemical, bio-
logical, radiological, or nuclear agent, or 
emerging infectious diseases, and which 
may present increased treatment complica-
tions such as the occurrence of resistance 
to available countermeasures or potential 
countermeasures, including antimicrobial 
resistant pathogens.’’. 
(b) PROTECTION
OF NATIONAL SECURITY FROM 
THREATS.—Section 2811 (42 U.S.C. 300hh–10) is 
amended by adding at the end the following: 
‘‘(f) PROTECTION OF NATIONAL SECURITY FROM 
THREATS.— 
‘‘(1) IN GENERAL.—In carrying out subsection 
(b)(3), the Assistant Secretary for Preparedness and 
Response shall implement strategic initiatives or ac-
tivities to address threats, including pandemic influ-
enza and which may include a chemical, biological, 
radiological, or nuclear agent (including any such 
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agent with a significant potential to become a pan-
demic), that pose a significant level of risk to public 
health and national security based on the character-
istics of such threat. Such initiatives shall include 
activities to— 
‘‘(A) accelerate and support the advanced 
research, development, manufacturing capacity, 
procurement, 
and 
stockpiling 
of 
counter-
measures, including initiatives under section 
319L(c)(4)(F); 
‘‘(B) support the development and manu-
facturing of virus seeds, clinical trial lots, and 
stockpiles of novel virus strains; and 
‘‘(C) maintain or improve preparedness ac-
tivities, including for pandemic influenza. 
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) IN GENERAL.—To carry out this sub-
section, 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). 
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‘‘(C) DOCUMENTATION
REQUIRED.—The 
Assistant Secretary for Preparedness and Re-
sponse, in accordance with subsection (b)(7), 
shall document amounts expended for purposes 
of carrying out this subsection, including 
amounts appropriated under the heading ‘Pub-
lic Health and Social Services Emergency 
Fund’ under the heading ‘Office of the Sec-
retary’ under title II of division H of the Con-
solidated 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 Pan-
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demic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018, the Secretary 
shall report to the congressional committees of 
jurisdiction on the implementation of rec-
ommendations of the Federal Experts Security 
Advisory Panel concerning the select agent pro-
gram. 
‘‘(B) CONTINUED
UPDATES.—The Sec-
retary shall report to the congressional commit-
tees of jurisdiction annually following the sub-
mission of the report under subparagraph (A) 
until the recommendations described in such 
subparagraph are fully implemented, or a jus-
tification is provided for the delay in, or lack of, 
implementation.’’. 
TITLE V—INCREASING COMMU-
NICATION IN MEDICAL COUN-
TERMEASURE ADVANCED RE-
SEARCH 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)— 
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(A) in clause (ii), by striking ‘‘; and’’ and 
inserting ‘‘;’’; and 
(B) by striking clause (iii) and inserting 
the following: 
‘‘(iii) procurement, stockpiling, main-
tenance, and potential replenishment (in-
cluding manufacturing capabilities) of all 
products in the Strategic National Stock-
pile; 
‘‘(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 develop-
ment; and 
‘‘(v) potential deployment, distribu-
tion, and utilization of medical counter-
measures; development of clinical guidance 
and emergency use instructions for the use 
of medical countermeasures; and, as appli-
cable, potential post-deployment activities 
related to medical countermeasures;’’; 
(3) by redesignating subparagraphs (D) and 
(E) as subparagraphs (E) and (F), respectively; and 
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(4) by inserting after subparagraph (C), the fol-
lowing: 
‘‘(D) identify the full range of anticipated 
medical countermeasure needs related to re-
search and development, procurement, and 
stockpiling, including the potential need for in-
dications, dosing, and administration tech-
nologies, and other countermeasure needs as 
applicable and appropriate;’’. 
SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER-
MEASURE 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 Home-
land 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 Se-
curity and Governmental Affairs of the Senate and the 
Committee on Energy and Commerce and the Committee 
on Homeland Security of the House of Representatives’’. 
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(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 Sec-
retary shall notify the vendor within 90 days of a deter-
mination 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 Cos-
metic 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 fol-
lowing: 
‘‘(3) PUBLICATION.—The Secretary shall make 
available on the internet website of the Food and 
Drug Administration information regarding regu-
latory management plans, including— 
‘‘(A) the process by which an applicant 
may submit a request for a regulatory manage-
ment plan; 
‘‘(B) the timeframe by which the Secretary 
is required to respond to such request; 
‘‘(C) the information required for the sub-
mission of such request; 
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‘‘(D) a description of the types of develop-
ment 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 in-
serting ‘‘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 ‘‘para-
graph (4)(A)’’. 
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE-
VELOPMENT 
AUTHORITY 
AND 
THE 
BIO-
SHIELD 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 
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(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 ANTI-
BIOTIC 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, re-
ferred to in this section as the ‘‘Advisory Council’’. 
(b) DUTIES.—The Advisory Council shall advise and 
provide information and recommendations to the Sec-
retary regarding programs and policies intended to reduce 
or combat antibiotic-resistant 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 im-
proving— 
(1) the effectiveness of antibiotics; 
(2) research and advanced research on, and the 
development of, improved and innovative methods 
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for combating or reducing antibiotic resistance, in-
cluding 
new 
treatments, 
rapid 
point-of-care 
diagnostics, alternatives to antibiotics, including al-
ternatives 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 an-
tibiotic resistance and ways to reduce or combat 
such resistance to antibiotics related to humans and 
animals; 
(5) methods to prevent or reduce the trans-
mission 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. 
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(2) COORDINATION.—The Advisory Council 
shall, to the greatest extent practicable, coordinate 
activities carried out by the Council with the Anti-
microbial 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)). 
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TITLE 
VI—ADVANCING 
TECH-
NOLOGIES 
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, tech-
nologies to administer countermeasures, and technologies 
to improve storage and transportation of counter-
measures’’. 
SEC. 602. UPDATING DEFINITIONS OF OTHER TRANS-
ACTIONS. 
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 max-
imum extent practicable, competitive 
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procedures shall be used when enter-
ing 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 procure-
ment executive for the Department 
(as designated for purpose of section 
16(c) of the Office of Federal Pro-
curement Policy Act (41 U.S.C. 
414(c)))’’ and inserting ‘‘Assistant 
Secretary for Financial Resources’’; 
and 
(III) by striking ‘‘senior procure-
ment executive under’’ and inserting 
‘‘Assistant Secretary for Financial Re-
sources under’’. 
SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 
(a) IN GENERAL.—The purpose of this section (in-
cluding section 565B of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (b)) is to support and 
advance the development or manufacture of security coun-
termeasures, qualified countermeasures, and qualified 
pandemic or epidemic products by facilitating and encour-
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aging submission of data and information to support the 
development of such products, and through clarifying the 
authority to cross-reference to data and information pre-
viously submitted to the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), 
including data and information submitted to medical coun-
termeasure 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 sec-
tion 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 writ-
ing, another person to reference, such data or infor-
mation to support a medical countermeasure submis-
sion (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 ref-
erence by the master file holder or by a person au-
thorized by the master file holder, in accordance 
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with applicable privacy and confidentiality protocols 
and regulations. 
‘‘(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 re-
lied upon to support the effectiveness of a product 
that is the subject of a subsequent medical counter-
measure submission only if such application is sup-
plemented by additional data or information to sup-
port review and approval in a manner consistent 
with the standards applicable to such review and ap-
proval for such countermeasure, qualified counter-
measure, 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 sup-
port— 
‘‘(A) the development of medical counter-
measure submissions to support the approval, 
licensure, classification, clearance, conditional 
approval, or authorization of one or more secu-
rity 
countermeasures, 
qualified 
counter-
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measures, or qualified pandemic or epidemic 
products; and 
‘‘(B) the manufacture of security counter-
measures, qualified countermeasures, or quali-
fied 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 up-
dated 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 ap-
propriate and that permits the review of such infor-
mation within such master file without necessitating 
re-submission of such data or information. Master 
files shall be submitted in an electronic format in ac-
cordance with sections 512(b)(4), 571(a)(4), and 
745A, as applicable, and as specified in applicable 
guidance. 
‘‘(2) REFERENCE BY A MASTER FILE HOLD-
ER.—A master file holder that is the sponsor of a 
medical countermeasure submission shall notify the 
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Secretary in writing of the intent to reference the 
medical countermeasure master file as a part of the 
submission. 
‘‘(3) REFERENCE
BY
AN
AUTHORIZED
PER-
SON.—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 mas-
ter file holder authorizes the incorporation in writ-
ing. 
‘‘(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 in-
dicating that the Secretary has reviewed and relied 
upon specified data or information within a master 
file and the purposes for which such data or infor-
mation was incorporated by reference if the Sec-
retary has reviewed and relied upon such specified 
data or information to support the approval, classi-
fication, conditional approval, clearance, licensure, or 
authorization of a security countermeasure, qualified 
countermeasure, or qualified pandemic or epidemic 
product. The Secretary may rely upon the data and 
information within the medical countermeasure mas-
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ter file for which such written notification was pro-
vided in additional applications, as applicable and 
appropriate and upon the request of the master file 
holder so notified in writing or by an authorized per-
son of such holder. 
‘‘(2) CERTAIN APPLICATIONS.—If the Secretary 
has reviewed and relied upon specified data or infor-
mation within a medical countermeasure master file 
to support the conditional approval of an application 
under section 571 to subsequently support the ap-
proval, clearance, licensure, or authorization of a se-
curity countermeasure, qualified countermeasure, or 
qualified pandemic or epidemic product, the Sec-
retary shall provide a brief written description to the 
master file holder regarding the elements of the ap-
plication 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— 
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‘‘(1) limit the authority of the Secretary to ap-
prove, license, clear, conditionally approve, or au-
thorize drugs, biological products, or devices pursu-
ant 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 2018), including the 
standards of evidence, and applicable conditions, for 
approval under the applicable Act; 
‘‘(2) alter the standards of evidence with re-
spect to approval, licensure, or clearance, as applica-
ble, of drugs, biological products, or devices under 
this Act or section 351 of the Public Health Service 
Act, including, as applicable, the substantial evi-
dence 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 deter-
mine 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 prod-
uct, or device submitted under sections 505(i), 
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505(b), 505(j), 512(b)(1), 512(b)(2), 512(j), 564, 
571, 520(g), 515(c), 513(f)(2), or 510(k) of this 
Act, or subsection (a) or (k) of section 351 of the 
Public Health Service Act, including a supplement 
or amendment to any such submission, and the re-
quirements associated with such reference. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) The term ‘master file holder’ means a per-
son who submits data and information to the Sec-
retary with the intent to reference or authorize an-
other person to reference such data or information 
to support a medical countermeasure submission, as 
described in subsection (a). 
‘‘(2) The term ‘medical countermeasure submis-
sion’ means an investigational new drug application 
under section 505(i), a new drug application under 
section 505(b), or an abbreviated new drug applica-
tion under section 505(j) of this Act, a biological 
product license application under section 351(a) of 
the Public Health Service Act or a biosimilar biologi-
cal product license application under section 351(k) 
of the Public Health Service Act, a new animal drug 
application under section 512(b)(1) or abbreviated 
new 
animal 
drug 
application 
under 
section 
512(b)(2), an application for conditional approval of 
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a new animal drug under section 571, an investiga-
tional 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 de-
vice under section 510(k), or a request for an emer-
gency use authorization under section 564 to sup-
port— 
‘‘(A) the approval, licensure, classification, 
clearance, conditional approval, or authorization 
of a security countermeasure, qualified counter-
measure, or qualified pandemic or epidemic 
product; or 
‘‘(B) a new indication to an approved secu-
rity countermeasure, qualified countermeasure, 
or qualified pandemic or epidemic product. 
‘‘(3) The terms ‘qualified countermeasure’, ‘se-
curity countermeasure’, and ‘qualified pandemic or 
epidemic product’ have the meanings given such 
terms in sections 319F–1, 319F–2, and 319F–3, re-
spectively, of the Public Health Service Act.’’. 
(c) STAKEHOLDER
INPUT.—Not later than 18 
months after the date of enactment of this Act, the Sec-
retary, acting through the Commissioner of Food and 
Drugs and in consultation with the Assistant Secretary 
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for Preparedness and Response, shall solicit input from 
stakeholders, including stakeholders developing security 
countermeasures, qualified countermeasures, or qualified 
pandemic or epidemic products, and stakeholders devel-
oping 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 tech-
nologies to support and advance the development or manu-
facture of security countermeasures, qualified counter-
measures, 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 sec-
tion 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 pub-
lish 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 
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manufacture of security countermeasures, qualified coun-
termeasures, 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. 
SEC. 604. ANIMAL RULE REPORT. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study on the application of the re-
quirements 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 ‘‘ani-
mal rule’’) as a component of medical countermeasure ad-
vanced development under the Biomedical Advanced Re-
search and Development Authority and regulatory review 
by the Food and Drug Administration. In conducting such 
study, the Comptroller General shall examine the fol-
lowing: 
(1) The extent to which advanced development 
and review of a medical countermeasure are coordi-
nated 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 sup-
port approval, licensure, and authorization under the 
animal rule, consistent with the recommendations in 
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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 De-
velopment Under the Animal Rule: Guidance for In-
dustry’’ (issued in October 2015), to resolve discrep-
ancies in the design of adequate and well-controlled 
efficacy studies conducted in animal models related 
to the provision of substantial evidence of effective-
ness for the product approved, licensed, or author-
ized 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 de-
cisionmaking with respect to medical counter-
measures. 
(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), 
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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 advanc-
ing, reviewing, and procuring medical counter-
measures, including the Office of the Assistant Sec-
retary for Preparedness and Response, the Bio-
medical Advanced Research and Development Au-
thority, 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 the House of 
Representatives a report containing the results of the 
study conducted under subsection (a) and recommenda-
tions to improve the application and consistency of the re-
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quirements 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 devel-
opment 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 ENGI-
NEERING TECHNOLOGIES AND THEIR POTEN-
TIAL 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 sec-
tion 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— 
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(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 exper-
tise in genome engineering technologies, 
biopharmaceuticals, 
medicine, 
or 
bio-
defense, and other relevant stakeholders; 
and 
(B) may include— 
(i) other representatives from the De-
partment of Health and Human Services, 
as the Secretary determines appropriate; 
and 
(ii) representatives from the Depart-
ment of Homeland Security, the Depart-
ment of Defense, the Department of Agri-
culture, and other departments, as the Sec-
retary may request for the meeting. 
(3) TOPICS.—The meeting under paragraph (1) 
shall include a discussion of— 
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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 re-
port to the congressional committees of jurisdiction on the 
topics discussed at such meeting, and provide rec-
ommendations, as applicable, to utilize innovations in 
genomic engineering (including genome editing) and re-
lated 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 na-
tional security. 
SEC. 606. REPORT ON VACCINES DEVELOPMENT. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives 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 
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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 partner-
ships, 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 se-
curity. 
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 dis-
eases,’’ after ‘‘subdivisions for control pro-
grams,’’; and 
(B) by inserting ‘‘or improving existing 
control programs’’ before the period at the end; 
(2) in subsection (b)— 
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(A) in paragraph (1), by inserting ‘‘, in-
cluding improvement,’’ after ‘‘operation’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A)— 
(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 mos-
quito-borne disease that presents a se-
rious 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 pub-
lic health threat;’’; and 
(ii) by amending subparagraph (D) to 
read as follows: 
‘‘(D)(i) is located in a State that has re-
ceived a grant under subsection (a); or 
‘‘(ii) that demonstrates to the Secretary 
that the control program is consistent with ex-
isting State mosquito control plans or policies, 
or other applicable State preparedness plans.’’; 
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(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 po-
tentially impacted human population; 
‘‘(II) the size or density of a 
mosquito population that requires 
heightened control; or 
‘‘(III) the severity of the mos-
quito-borne disease, such that ex-
pected serious adverse health out-
comes for the human population jus-
tify the waiver.’’; and 
(D) by amending paragraph (6) to read as 
follows: 
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‘‘(6) NUMBER OF GRANTS.—A political subdivi-
sion 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 Pre-
paredness and Response Act of 2002’’ and in-
serting ‘‘this Act and other medical and public 
health preparedness and response laws’’; and 
(C) in paragraph (3)— 
(i) in the paragraph heading, by strik-
ing ‘‘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 amend-
ed— 
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(1) in subsection (a)(1), by inserting ‘‘, includ-
ing mosquito and other vector-borne diseases,’’ after 
‘‘infectious diseases’’; and 
(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.—Sec-
tion 319A(e) (42 U.S.C. 247d–1(e)) is amended by strik-
ing ‘‘2014 through 2018’’ and inserting ‘‘2019 through 
2023’’. 
(c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 
(42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ 
and inserting ‘‘2023’’. 
(d) STRATEGIC
INNOVATION
PARTNER.—Section 
319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 
amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 
(e) LIMITED ANTITRUST EXEMPTION.— 
(1) IN GENERAL.—Section 405 of the Pandemic 
and All-Hazards Preparedness Act (Public Law 
109–417; 42 U.S.C. 247d–6a note) is amended— 
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(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) 
NON-DISCLOSURE
OF
INFORMA-
TION.— 
‘‘(i) IN
GENERAL.—Information de-
scribed in clause (ii) shall be deemed to be 
information described in section 552(b)(3) 
of title 5, United States Code. 
‘‘(ii) INFORMATION DESCRIBED.—The 
information described in this clause is in-
formation relevant to programs of the De-
partment 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 sci-
entific information that is created or 
obtained during the countermeasure 
and product advanced research and 
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development carried out under sub-
section (c); 
‘‘(II) information pertaining to 
the location security, personnel, and 
research materials and methods of 
high-containment 
laboratories 
con-
ducting 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 sub-
paragraph (D); 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) REPORTING.—One year after the 
date of enactment of the Pandemic and All- 
Hazards Preparedness and Advancing Innova-
tion Act of 2018, 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 Com-
merce of the House of Representatives on the 
number of instances in which the Secretary has 
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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 dis-
close 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 Sec-
retary of Health and Human Services (referred to in 
this section as the ‘‘Secretary’’) shall prepare and 
submit to the relevant committees of Congress a 
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strategy for public health preparedness and response 
to address cybersecurity threats (as defined in sec-
tion 102 of Cybersecurity Information Sharing Act 
of 2015 (6 U.S.C. 1501)) that present a threat to 
national health security. Such strategy shall in-
clude— 
(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 pre-
paredness goals; 
(B) identifying gaps in public health capa-
bilities to achieve such preparedness goals; and 
(C) strategies to address identified gaps 
and strengthen public health emergency pre-
paredness 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. 
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(b) COORDINATION OF PREPAREDNESS FOR AND RE-
SPONSE
TO
ALL-HAZARDS
PUBLIC
HEALTH
EMER-
GENCIES.—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
STRA-
TEGIC
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 re-
sponse for public health emergencies and inci-
dents 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 emer-
gencies or incidents related to cybersecurity 
threats that present a threat to national health 
security.’’. 
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160 
SEC. 704. STRATEGY AND REPORT. 
Not later than 14 days after the date of the enact-
ment 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 depart-
ments, as appropriate, shall submit to the Committee on 
Energy and Commerce of the House of Representatives, 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate, and other relevant congressional com-
mittees— 
(1) a formal strategy, including interdepart-
mental 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 guard-
ian and placed into a facility funded by the De-
partment of Health and Human Services; 
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161 
(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 re-
lated to the oversight of, and care for, unaccom-
panied alien children and appropriately reuniting 
such children with their parents or guardians, and 
the actions taken to address any challenges and defi-
ciencies 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 insert-
ing ‘‘section 319F(e)’’; and 
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162 
(2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 
by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec-
tion 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 ‘‘individ-
uals,,’’ and inserting ‘‘individuals,’’; and 
(2) in subparagraph (F), by striking ‘‘make sat-
isfactory annual improvement and describe’’ and in-
serting ‘‘makes satisfactory annual improvement and 
describes’’. 
(c) EMERGENCY
USE
INSTRUCTIONS.—Subpara-
graph (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 insert-
ing ‘‘subsection (a)(1)(C)’’. 
(d) PRODUCTS HELD FOR EMERGENCY USE.—Sec-
tion 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 sec-
tion 564A’’ before the period at the end. 
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163 
(e) TRANSPARENCY.—Section 507(c)(3) of the Fed-
eral 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 ‘‘author-
izing’’; 
(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 develop-
ment tool that may be used to support the 
development of a qualified countermeasure, 
security countermeasure, or qualified pan-
demic 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 Secretary 
determines has a significant potential to 
affect national security. 
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164 
‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the 
case that the Secretary, pursuant to subpara-
graph (A)(ii), does not make information pub-
licly available, the Secretary shall provide on 
the internet website of the Food and Drug Ad-
ministration an acknowledgment of the informa-
tion that has not been disclosed, pursuant to 
subparagraph (A)(ii).’’. 
DIVISION 
B—OVER-THE- 
COUNTER MONOGRAPH SAFE-
TY, 
INNOVATION, 
AND 
RE-
FORM 
SEC. 1000. SHORT TITLE; REFERENCES IN DIVISION. 
(a) SHORT TITLE.—This division may be cited as the 
‘‘Over-the-Counter Monograph Safety, Innovation, and 
Reform Act of 2018’’. 
(b) REFERENCES.—Except as otherwise specified, 
any reference to ‘‘this Act’’ contained in this division shall 
be treated as referring only to the provisions of this divi-
sion. 
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165 
TITLE I—OTC DRUG REVIEW 
SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355g) the following: 
‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH-
OUT
AN
APPROVED
APPLICATION.—Nonprescription 
drugs marketed without an approved drug application 
under section 505, as of the date of the enactment of this 
section, shall be treated in accordance with this sub-
section. 
‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 
CATEGORY
I
DRUGS
SUBJECT
TO
A
TENTATIVE 
FINAL MONOGRAPH.—A drug is deemed to be gen-
erally recognized as safe and effective under section 
201(p)(1), not a new drug under section 201(p), and 
not subject to section 503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) in conformity with the require-
ments for nonprescription use of a final 
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monograph issued under part 330 of title 
21, Code of Federal Regulations (except as 
provided in paragraph (2)), the general re-
quirements for nonprescription drugs, and 
conditions or requirements under sub-
sections (b), (c), and (k); and 
‘‘(ii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
extent and for a material time under sec-
tion 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a tentative final 
monograph that is the most recently appli-
cable proposal or determination issued 
under part 330 of title 21, Code of Federal 
Regulations; 
‘‘(ii) in conformity with the proposed 
requirements for nonprescription use of 
such tentative final monograph, any appli-
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