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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 
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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-
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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: 
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‘‘(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-
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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 
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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 
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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 
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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 
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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’).’’. 
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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: 
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‘‘(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-
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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-
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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-
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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 
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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 
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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. 
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‘‘(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, 
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request, or notification for a drug, biological prod-
uct, or device submitted under sections 505(i), 
505(b), 505(j), 512(b)(1), 512(b)(2), 512(j), 564, 
571, 520(g), 515(c), 513(f)(2), or 510(k) of this 
Act, or subsection (a) or (k) of section 351 of the 
Public Health Service Act, including a supplement 
or amendment to any such submission, and the 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 
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new 
animal 
drug 
application 
under 
section 
512(b)(2), an application for conditional approval of 
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-
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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 
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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-
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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, 
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‘‘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 
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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. 
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(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. 
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(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 
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(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 
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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 
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(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 
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‘‘(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-
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(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’’. 
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(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— 
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‘‘(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 
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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.— 
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(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 
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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 
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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’’. 
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‘‘(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-
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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-
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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: 
KAREN L. HAAS, 
Clerk. 
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