‘‘(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 of the Public Health Service Act (42 
U.S.C. 300hh et seq.), as amended by subsection (b), is 
further amended by inserting after section 2811B the fol-
lowing: 
‘‘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-
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. 
‘‘(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. 
‘‘(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, territorial, or tribal 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.— 
‘‘(1) IN
GENERAL.—The Advisory Committee 
shall terminate on September 30, 2023.
100 
‘‘(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 of the Public Health Service Act 
(42 U.S.C. 300hh et seq.), as amended by subsection (c), 
is further amended by inserting after section 2811C the 
following: 
‘‘SEC. 2811D. ADVISORY COMMITTEE COORDINATION. 
‘‘(a) IN GENERAL.—The Secretary shall coordinate 
duties and activities authorized under sections 2811A, 
2811B, and 2811C, and make efforts to reduce 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 
meetings under any of sections 2811A(e), 2811B(e), or 
2811C(d).
101 
‘‘(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 
countermeasure distribution and administration, and pre-
paring for and responding to identified threats for that
102 
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 of the Public Health Service Act (42 
U.S.C. 300hh–10) is amended— 
(1) in subsection (b)— 
(A) 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 
(B) in paragraph (4) by adding at the end 
the following:
103 
‘‘(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.’’; and 
(2) by adding at the end the following: 
‘‘(f) PROTECTION OF NATIONAL SECURITY FROM 
THREATS.— 
‘‘(1) IN GENERAL.—In carrying out the duties 
under subsection (b)(3), the Assistant Secretary for 
Preparedness and Response shall implement stra-
tegic initiatives or activities to address threats, in-
cluding pandemic influenza, that pose a significant 
level of risk to public health and national security 
based on the characteristics of such threat, which 
may also include a chemical, biological, radiological, 
or nuclear agent, including threats with a significant
104 
potential to become a pandemic. Such initiatives 
shall include activities to accelerate and support the 
advanced research, development, manufacturing ca-
pacity, procurement, and stockpiling of counter-
measures, 
including 
initiatives 
under 
section 
319L(c)(4)(F). Such activities may also include 
those related to readiness to respond to pandemic in-
fluenza threats by supporting the development and 
manufacturing of influenza virus seeds, clinical trial 
lots, and stockpiles of novel influenza strains. 
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) IN GENERAL.—For purposes of car-
rying out this subsection, there is authorized to 
be appropriated $250,000,000 for each of fiscal 
years 2019 through 2023. 
‘‘(B) SUPPLEMENT, 
NOT
SUPPLANT.— 
Funds appropriated under this subsection shall 
be used to supplement and not supplant funds 
provided under section 319L(e) and section 
319F–2(g). 
‘‘(C) DOCUMENTATION
REQUIRED.—The 
Assistant Secretary for Preparedness and Re-
sponse shall, as required under subsection 
(b)(7), document amounts expended for pur-
poses of carrying out this subsection, including
105 
amounts appropriated to the Public Health and 
Social Services Emergency Fund under title II 
of Division H of the Consolidated Appropria-
tions Act, 2018 (Public Law 115–141), as ap-
plicable to section 319L(c)(4)(F).’’. 
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE. 
(a) IN GENERAL.—Title XXVIII is amended by in-
serting after section 2811 of the Public Health Service 
Act (42 U.S.C. 300hh–10) the following: 
‘‘SEC. 
2811–1. 
PUBLIC 
HEALTH 
EMERGENCY 
MEDICAL 
COUNTERMEASURES ENTERPRISE. 
‘‘(a) IN GENERAL.—The Secretary shall establish the 
Public Health Emergency Medical Countermeasures En-
terprise (referred to in this section as the ‘PHEMCE’). 
The Assistant Secretary for Preparedness and Response 
shall serve as chair of the PHEMCE. 
‘‘(b) MEMBERS.—The PHEMCE shall include each 
of the following members, or the designee of such mem-
bers: 
‘‘(1) The Assistant Secretary for Preparedness 
and Response. 
‘‘(2) The Director of the Centers for Disease 
Control and Prevention.
106 
‘‘(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. 
‘‘(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
107 
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 
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-
108 
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) of the Public Health 
Service Act (42 U.S.C. 300hh–10(d)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘Not later than 180 days 
after the date of enactment of this subsection, 
and every year thereafter’’ and inserting ‘‘Not 
later than March 15, 2020, and biennially 
thereafter’’; and 
(B) by striking ‘‘Director of Biomedical’’ 
and all that follows through ‘‘Food and Drugs’’ 
and inserting ‘‘Public Health Emergency Med-
ical Countermeasures Enterprise established 
under section 2811–1’’; and
109 
(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) of the Public 
Health Service Act (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 
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:
110 
‘‘(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 annually, beginning on 
March 15, 2019, to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the 
Committee on Appropriations of the House of 
Representatives, in a manner that does not 
compromise national security. 
‘‘(B) ADDITIONS, 
MODIFICATIONS, 
AND 
REPLENISHMENTS.—Each annual threat-based 
review under subparagraph (A) shall, for each 
new or modified countermeasure procurement 
or replenishment, provide—
111 
‘‘(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 
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;
112 
‘‘(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-
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
113 
(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 
‘‘(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
114 
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 
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;
115 
(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 
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
116 
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; 
‘‘(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
117 
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-
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-
118 
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 
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
119 
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-
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-
120 
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 and products receive or 
had received funding under section 319L of the Public 
Health Service Act (42 U.S.C. 247d–7e), and whether 
such countermeasures and products are the most appro-
priate to meet the emergency health security needs of the 
United States. 
(c) AUTHORIZATION
OF APPROPRIATIONS, STRA-
TEGIC NATIONAL STOCKPILE.—Section 319F–2(f)(1) of 
the Public Health Service Act (42 U.S.C. 247d–6b(f)(1)) 
is amended by striking ‘‘$533,800,000 for each of fiscal 
years 2014 through 2018’’ and inserting ‘‘$610,000,000 
for each of fiscal years 2019 through 2023, to remain 
available until expended’’. 
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:
121 
‘‘(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 
(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,
122 
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 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 
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
123 
to available countermeasures or potential 
countermeasures, including antimicrobial 
resistant pathogens.’’. 
(b) EMERGING INFECTIOUS DISEASE PROGRAM.— 
Section 319L of the Public Health Service Act (42 U.S.C. 
247d–7e) is amended— 
(1) by redesignating subsections (d), (e), and 
(f) as subsections (e), (f), and (g), respectively; and 
(2) by inserting after subsection (c) the fol-
lowing new subsections: 
‘‘(d) EMERGING INFECTIOUS DISEASE PROGRAM.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of BARDA, shall establish and 
implement a program that supports— 
‘‘(A) advanced research and development 
activities for qualified pandemic or epidemic 
products; and 
‘‘(B) manufacturing infrastructure activi-
ties with respect to an emerging infectious dis-
ease. 
‘‘(2) FUNDING.— 
‘‘(A) IN
GENERAL.—To carry out para-
graph (1), there is authorized to be appro-
priated $250,000,000 for each of fiscal years
124 
2019 through 2023, to remain available until 
expended. 
‘‘(B) SUPPLEMENT NOT SUPPLANT.—Any 
funds provided to the Secretary under this 
paragraph shall be used to supplement and not 
supplant any other Federal funds provided to 
carry out paragraph (1).’’. 
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 
PROGRAM. 
Section 351A(k) of the Public Health Service Act (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-
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-
125 
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) of the Public Health Service Act 
(42 U.S.C. 300hh–10(b)(7)) is amended— 
(1) in the matter preceding subparagraph (A), 
by striking ‘‘March 1’’ and inserting ‘‘March 15’’; 
(2) in subparagraph (A)— 
(A) in clause (ii), by striking ‘‘; and’’ and 
inserting ‘‘;’’; and 
(B) by striking clause (iii) and inserting 
the following:
126 
‘‘(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 
(4) by inserting after subparagraph (C), the fol-
lowing: 
‘‘(D) identify the full range of anticipated 
medical countermeasure needs related to re-
127 
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) of 
the Public Health Service Act (42 U.S.C. 247d– 
6b(c)(2)(C)) is amended by striking ‘‘The Secretary and 
the Homeland Security Secretary shall promptly notify the 
appropriate committees of Congress’’ and inserting ‘‘The 
Secretary and the Secretary of Homeland Security shall 
send to Congress, on an annual basis, all current material 
threat determinations and shall promptly notify the Com-
mittee on Health, Education, Labor, and Pensions and the 
Committee on Homeland Security and Governmental Af-
fairs of the Senate and the Committee on Energy and 
Commerce and the Committee on Homeland Security of 
the House of Representatives’’. 
(b) CONTRACTING COMMUNICATION.—Section 319F– 
2(c)(7)(B)(ii)(III) of the Public Health Service Act (42 
U.S.C. 247d–6b(c)(7)(B)(ii)(III)) is amended by adding 
at the end the following: ‘‘The Secretary shall notify the
128 
vendor within 90 days of a determination by the Secretary 
to renew, extend, or terminate such contract.’’. 
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 
PLANS. 
Section 565(f) of the Federal Food, Drug, and 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; 
‘‘(D) a description of the types of develop-
ment milestones and performance targets that 
could be discussed and included in such plans; 
and
129 
‘‘(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) of the Public Health Service Act (42 U.S.C. 
247d–6b(g)(1)) is amended— 
(1) by striking ‘‘$2,800,000,000 for the period 
of fiscal years 2014 through 2018’’ and inserting 
‘‘$7,100,000,000 for the period of fiscal years 2019 
through 2028, to remain available until expended’’; 
and 
(2) by striking the second sentence. 
(b) THE BIOMEDICAL ADVANCED RESEARCH AND 
DEVELOPMENT AUTHORITY.—Subsection (e)(2) of section
130 
319L of the Public Health Service Act (42 U.S.C. 247d– 
7e), as redesignated by section 404(b), 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. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 319E the following: 
‘‘SEC. 319E–1. ADVISORY COUNCIL ON COMBATING ANTI-
BIOTIC-RESISTANT BACTERIA. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ACTION PLAN.—The term ‘Action Plan’ 
means the Action Plan described in section 
319E(a)(1). 
‘‘(2) ADVISORY COUNCIL.—The term ‘Advisory 
Council’ means the Presidential Advisory Council on 
Combating Antibiotic-Resistant Bacteria established 
by Executive Order 13676 of September 18, 2014 
(79 Fed. Reg. 56931; relating to combating anti-
biotic-resistant bacteria). 
‘‘(3) NATIONAL
STRATEGY.—The term ‘Na-
tional Strategy’ means the National Strategy for 
Combating Antibiotic-Resistant Bacteria issued by
131 
the White House in September 2014, and any subse-
quent update to such strategy or a successor strat-
egy. 
‘‘(b) ADVISORY COUNCIL.—The Advisory Council 
shall provide advice, information, and recommendations to 
the Secretary regarding programs and policies intended to 
support and evaluate the implementation of Executive 
Order 13676 of September 18, 2014 (79 Fed. Reg. 56931; 
relating to combating antibiotic-resistant bacteria), includ-
ing the National Strategy, and the Action Plan. 
‘‘(c) MEETINGS AND DUTIES.— 
‘‘(1) MEETINGS.—The Advisory Council shall 
meet as the Chair determines appropriate but not 
less than twice per year, and, to the extent prac-
ticable, in conjunction with meetings of the task 
force described in section 319E. 
‘‘(2) RECOMMENDATIONS.—The Advisory Coun-
cil shall make recommendations to the Secretary, in 
consultation with the Secretary of Agriculture and 
the Secretary of Defense, regarding programs and 
policies intended to— 
‘‘(A) preserve the effectiveness of anti-
biotics by optimizing their use; 
‘‘(B) advance research to develop improved 
methods for combating antibiotic resistance and
132 
conducting antimicrobial stewardship, as de-
fined in section 319E(h)(3); 
‘‘(C) strengthen surveillance of antibiotic- 
resistant bacterial infections; 
‘‘(D) prevent the transmission of anti-
biotic-resistant bacterial infections; 
‘‘(E) advance the development of rapid 
point-of-care and agricultural diagnostics; 
‘‘(F) further research on new treatments 
for bacterial infections; 
‘‘(G) develop alternatives to antibiotics for 
animal health purposes; 
‘‘(H) maximize the dissemination of up-to- 
date information on the appropriate and proper 
use of antibiotics to the general public and 
human and animal health care providers; and 
‘‘(I) improve international coordination of 
efforts to combat antibiotic resistance. 
‘‘(3) 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) (commonly referred to as the ‘Com-
bating Antibiotic-Resistant Bacteria Task Force’).’’.
133 
TITLE 
VI—ADVANCING 
TECH-
NOLOGIES 
FOR 
MEDICAL 
COUNTERMEASURES 
SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 
Section 319L(c)(4)(D)(iii) of the Public Health Serv-
ice Act (42 U.S.C. 247d–7e(c)(4)(D)(iii)) is amended by 
striking ‘‘and platform technologies’’ and inserting ‘‘plat-
form technologies, technologies to administer counter-
measures, and technologies to improve storage and trans-
portation of countermeasures’’. 
SEC. 602. UPDATING DEFINITIONS OF OTHER TRANS-
ACTIONS. 
Section 319L of the Public Health Service Act (42 
U.S.C. 247d–7e) is amended— 
(1) in subsection (a)(3), by striking ‘‘, such as’’ 
and all that follows through ‘‘Code’’; 
(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:
134 
‘‘(I) IN GENERAL.—To the max-
imum extent practicable, competitive 
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 the purpose of sec-
tion 16(c) of the Office of Federal 
Procurement Policy Act (41 U.S.C. 
414(c)))’’ and inserting ‘‘Assistant 
Secretary for Financial Resources’’; 
and 
(III) by striking ‘‘senior 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-
135 
termeasures, qualified countermeasures, and qualified 
pandemic or epidemic products by facilitating and encour-
aging submission of data and information to support such 
products to medical countermeasure master files, and 
through clarifying the authority to cross-reference to data 
and information previously submitted to the Secretary of 
Health and Human Services (referred to in this section 
as the ‘‘Secretary’’). 
(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-
136 
thorized by the master file holder, in accordance 
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 help support the effectiveness of a prod-
uct that is the subject of a subsequent medical coun-
termeasure submission only if such application is 
supplemented by additional data or information to 
support review and approval in a manner consistent 
with the standards applicable to such review and 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-
137 
rity 
countermeasures, 
qualified 
counter-
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
138 
medical countermeasure submission shall notify the 
Secretary in writing of the intent to reference the 
medical countermeasure master file as a part of the 
submission. 
‘‘(3) REFERENCE
BY
AN
AUTHORIZED
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) ACKNOWLEDGEMENT OF THE 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
139 
information within the medical countermeasure mas-
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) unless 
such disclosure includes any trade secret or con-
fidential commercial information.
140 
‘‘(e) RULES OF CONSTRUCTION.—Nothing in this 
section shall be construed to— 
‘‘(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,
143 
retary, acting through the Commissioner of Food and 
Drugs and in consultation with the Assistant Secretary 
for Preparedness and Response, shall solicit input from 
stakeholders, including stakeholders developing security 
countermeasures, qualified countermeasures, or qualified 
pandemic or epidemic products, and stakeholders 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
144 
or technologies (including platform technologies) that have 
the potential to support and advance the development or 
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-
145 
port approval, licensure, and authorization under the 
animal rule, consistent with the recommendations in 
the animal rule guidance, issued pursuant to section 
565(c) of the Federal Food Drug and Cosmetic Act 
(21 U.S.C. 360bbb–4(c)) and entitled ‘‘Product 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,
146 
‘‘Product Development Under the Animal Rule: 
Guidance for Industry’’ (issued in October 2015), 
has assisted in achieving the purposes described in 
paragraphs (1), (2), and (3). 
(b) CONSULTATIONS.—In conducting the study under 
subsection (a), the Comptroller General of the United 
States shall consult with— 
(1) the Federal agencies responsible for 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
147 
study conducted under subsection (a) and recommenda-
tions to improve the application and consistency of the re-
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.
148 
(2) ATTENDEES.—The attendees of the meeting 
under paragraph (1)— 
(A) shall include— 
(i) representatives from the Office of 
the Assistant Secretary for Preparedness 
and Response, the National Institutes of 
Health, the Centers for Disease Control 
and Prevention, and the Food and Drug 
Administration; and 
(ii) representatives from academic, 
private, and nonprofit entities with 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.