149 
(3) TOPICS.—The meeting under paragraph (1) 
shall include a discussion of— 
(A) the current state of the science of 
genomic engineering technologies related to na-
tional health security, including— 
(i) medical countermeasure develop-
ment, including potential efficiencies in the 
development pathway and detection tech-
nologies; and 
(ii) the international and domestic 
regulation of products utilizing genome ed-
iting technologies; and 
(B) national security implications, includ-
ing— 
(i) capabilities of the United States to 
leverage genomic engineering technologies 
as a part of the medical countermeasure 
enterprise, including current applicable re-
search, development, and application ef-
forts underway within the Department of 
Defense; 
(ii) the potential for state and non- 
state actors to utilize genomic engineering 
technologies as a national health security 
threat; and
150 
(iii) security measures to monitor and 
assess the potential threat that may result 
from utilization of genomic engineering 
technologies and related technologies for 
the purpose of compromising national 
health security. 
(b) REPORT.—Not later than 270 days after the 
meeting described in subsection (a) is held, the Assistant 
Secretary for Preparedness and Response shall issue a 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
151 
during recent public health emergencies with respect to 
the research and advanced research on, and development 
of, qualified pandemic or epidemic products (as defined 
in section 319F–3 of the Public Health Service Act (42 
U.S.C. 247d–6d)). Such report may include information 
regarding relevant work carried out under section 
319L(c)(5)(E) of the Public Health Service Act (42 
U.S.C. 247d–7e(c)(5)(E)), through public-private 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 of 
the Public Health Service Act (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
152 
(B) by inserting ‘‘or improving existing 
control programs’’ before the period at the end; 
(2) in subsection (b)— 
(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
153 
‘‘(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.’’; 
(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-
154 
comes for the human population jus-
tify the waiver.’’; and 
(D) by amending paragraph (6) to read as 
follows: 
‘‘(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 heading, by striking ‘‘2004’’ 
and inserting ‘‘2019’’; and 
(ii) by striking ‘‘2004’’ and inserting 
‘‘2019’’.
155 
(b) 
EPIDEMIOLOGY-LABORATORY
CAPACITY 
GRANTS.—Section 2821 of the Public Health Service Act 
(42 U.S.C. 300hh–31) is amended— 
(1) in subsection (a)(1), by inserting ‘‘, includ-
ing mosquito and other vector-borne diseases,’’ after 
‘‘infectious diseases’’; and 
(2) by amending subsection (b) to read as fol-
lows: 
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$40,000,000 for each of fiscal years 2019 through 2023.’’. 
TITLE VII—MISCELLANEOUS 
PROVISIONS 
SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 
(a) VACCINE TRACKING AND DISTRIBUTION.—Sec-
tion 319A(e) of the Public Health Service Act (42 U.S.C. 
247d–1(e)) is amended by striking ‘‘2014 through 2018’’ 
and inserting ‘‘2019 through 2023’’. 
(b) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 
of the Public Health Service Act (42 U.S.C. 247d(e)(8)) 
is amended by striking ‘‘2018’’ and inserting ‘‘2023’’. 
(c) STRATEGIC
INNOVATION
PARTNER.—Section 
319L(c)(4)(E)(ix) of the Public Health Service Act (42 
U.S.C. 247d–7e(c)(4)(E)(ix)) is amended by striking 
‘‘2022’’ and inserting ‘‘2023’’.
156 
(d) LIMITED ANTITRUST EXEMPTION.— 
(1) IN GENERAL.—Section 405 of the Pandemic 
and All-Hazards Preparedness Act (42 U.S.C. 
247d–6a note) is amended— 
(A) by redesignating such section as sec-
tion 319L–1; 
(B) by transferring such section to the 
Public Health Service Act (42 U.S.C. 201 et 
seq.), to appear after section 319L of such Act 
(42 U.S.C. 247d–7e); 
(C) in subsection (a)(1)(A)— 
(i) by striking ‘‘Secretary of Health 
and Human Services (referred to in this 
subsection as the ‘Secretary’)’’ and insert-
ing ‘‘Secretary’’; 
(ii) by striking ‘‘of the Public Health 
Service Act (42 U.S.C. 247d–6b)) (as 
amended by this Act’’; 
(iii) by striking ‘‘of the Public Health 
Service Act (42 U.S.C. 247d– 6a)) (as 
amended by this Act’’; and 
(iv) by striking ‘‘of the Public Health 
Service Act (42 U.S.C. 247d–6d)’’; and 
(D) in subsection (b), by striking ‘‘12- 
year’’ and inserting ‘‘17-year’’.
157 
(2) CONFORMING AMENDMENT.—The table of 
contents in section 1(b) of the Pandemic and All- 
Hazards Preparedness Act (Public Law 109–417) is 
amended by striking the item related to section 405. 
(e) INAPPLICABILITY
OF CERTAIN PROVISIONS.— 
Subsection (e)(1) of section 319L of the Public Health 
Service Act (42 U.S.C. 247d–7e) 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—
158 
‘‘(I) specific technical data or sci-
entific information that is created or 
obtained during the countermeasure 
and product advanced research and 
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
159 
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 
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 of the Public 
Health Service Act (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.—
160 
(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 
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
161 
the Committee on Health, Education, Labor, and 
Pensions of the Senate, the Committee on Energy 
and Commerce of the House of Representatives, and 
other congressional committees of jurisdiction, in a 
manner that does not compromise national security. 
(b) COORDINATION OF PREPAREDNESS FOR AND RE-
SPONSE
TO
ALL-HAZARDS
PUBLIC
HEALTH
EMER-
GENCIES.—Subparagraph (D) of section 2811(b)(4) of the 
Public Health Service Act (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
162 
U.S.C. 149(c)), including public health emer-
gencies or incidents related to cybersecurity 
threats that present a threat to national health 
security.’’. 
SEC. 704. TECHNICAL AMENDMENTS. 
(a) PUBLIC HEALTH SERVICE ACT.—Title III of the 
Public Health Service Act (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 
(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) of the Public Health Service Act (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’’.
163 
(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. 
(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 striking ‘‘disclose any’’ and inserting 
‘‘disclose or direct— 
‘‘(i) any’’; 
(3) by striking the period and inserting ‘‘; or’’; 
and 
(4) by adding at the end the following:
164 
‘‘(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. 
‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the 
case that the Secretary, pursuant to subpara-
graph (A), does not make information publicly 
available, the Secretary shall provide on the 
internet website of the Food and Drug Admin-
istration an acknowledgement of the informa-
tion that has not been disclosed, pursuant to 
subparagraph (A).’’. 
SEC. 705. FORMAL STRATEGY RELATING TO CHILDREN 
SEPARATED FROM PARENTS AND GUARD-
IANS AS A RESULT OF ZERO TOLERANCE POL-
ICY. 
Not later than 14 days after the date of enactment 
of this Act, the Assistant Secretary for Preparedness and 
Response and the Assistant Secretary for the Administra-
165 
tion on Children and Families shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a formal strategy to 
reunify with their parent or guardian, if the parent or 
guardian chooses such reunification, each child who— 
(1) as a result of the initiative announced on 
April 6, 2018, and due to prosecution under section 
1325(a) of title 8, United States Code; 
(2) was separated from their parent or guard-
ian and placed into a facility funded by the Depart-
ment of Health and Human Services; and 
(3) can be safely reunited with such parent or 
guardian. 
SEC. 706. REPORTING RELATING TO CHILDREN SEPARATED 
FROM PARENTS AND GUARDIANS AS A RE-
SULT OF ZERO TOLERANCE POLICY. 
Beginning on the date of enactment of this Act, the 
Assistant Secretary for Preparedness and Response and 
the Assistant Secretary for the Administration on Chil-
dren and Families shall submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate weekly reports on the status and wel-
fare of the children who, as a result of the ‘‘zero toler-
166 
ance’’ policy, were separated from their parent or guard-
ian and are awaiting reunification with their parent or 
guardian, as well as the number of such children in facili-
ties funded by the Department of Health and Human 
Services. 
SEC. 707. TECHNICAL CORRECTION. 
Section 801(e)(4)(E)(iii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 381(e)(4)(E)(iii)) is amend-
ed by striking ‘‘subparagraph’’ both places it appears in 
subclause (I) and subclause (II) and inserting ‘‘para-
graph’’. 
SEC. 708. SAVINGS CLAUSE. 
Nothing in this Act shall be construed as reducing 
or limiting the authorities vested in any other Federal 
agency by any other Federal law. 
Passed the House of Representatives September 25, 
2018. 
Attest: 
Clerk.
115TH CONGRESS 
2D SESSION 
H. R. 6378 
AN ACT 
To reauthorize certain programs under the Pan-
demic and All-Hazards Preparedness Reauthor-
ization Act.