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agent with a significant potential to become a pan-
demic), that pose a significant level of risk to public 
health and national security based on the character-
istics of such threat. Such initiatives shall include 
activities to— 
‘‘(A) accelerate and support the advanced 
research, development, manufacturing capacity, 
procurement, 
and 
stockpiling 
of 
counter-
measures, including initiatives under section 
319L(c)(4)(F); 
‘‘(B) support the development and manu-
facturing of virus seeds, clinical trial lots, and 
stockpiles of novel virus strains; and 
‘‘(C) maintain or improve preparedness ac-
tivities, including for pandemic influenza. 
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(A) IN GENERAL.—To carry out this sub-
section, there is authorized to be appropriated 
$250,000,000 for each of fiscal years 2019 
through 2023. 
‘‘(B) SUPPLEMENT, 
NOT
SUPPLANT.— 
Amounts appropriated under this paragraph 
shall be used to supplement and not supplant 
funds provided under sections 319L(d) and 
319F–2(g). 
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‘‘(C) DOCUMENTATION
REQUIRED.—The 
Assistant Secretary for Preparedness and Re-
sponse, in accordance with subsection (b)(7), 
shall document amounts expended for purposes 
of carrying out this subsection, including 
amounts appropriated under the heading ‘Pub-
lic Health and Social Services Emergency 
Fund’ under the heading ‘Office of the Sec-
retary’ under title II of division H of the Con-
solidated Appropriations Act, 2018 (Public Law 
115–141) and allocated to carrying out section 
319L(c)(4)(F).’’. 
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT 
PROGRAM. 
Section 351A(k) (42 U.S.C. 262a(k)) is amended— 
(1) by striking ‘‘The Secretary’’ and inserting 
the following: 
‘‘(1) IN GENERAL.—The Secretary’’; and 
(2) by adding at the end the following: 
‘‘(2) IMPLEMENTATION OF RECOMMENDATIONS 
OF
THE
FEDERAL
EXPERTS
SECURITY
ADVISORY 
PANEL AND THE FAST TRACK ACTION COMMITTEE 
ON SELECT AGENT REGULATIONS.— 
‘‘(A) IN GENERAL.—Not later than 1 year 
after the date of the enactment of the Pan-
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demic and All-Hazards Preparedness and Ad-
vancing Innovation Act of 2018, the Secretary 
shall report to the congressional committees of 
jurisdiction on the implementation of rec-
ommendations of the Federal Experts Security 
Advisory Panel concerning the select agent pro-
gram. 
‘‘(B) CONTINUED
UPDATES.—The Sec-
retary shall report to the congressional commit-
tees of jurisdiction annually following the sub-
mission of the report under subparagraph (A) 
until the recommendations described in such 
subparagraph are fully implemented, or a jus-
tification is provided for the delay in, or lack of, 
implementation.’’. 
TITLE V—INCREASING COMMU-
NICATION IN MEDICAL COUN-
TERMEASURE ADVANCED RE-
SEARCH AND DEVELOPMENT 
SEC. 501. MEDICAL COUNTERMEASURE BUDGET PLAN. 
Section 2811(b)(7) (42 U.S.C. 300hh–10(b)(7)) is 
amended— 
(1) in the matter preceding subparagraph (A), 
by striking ‘‘March 1’’ and inserting ‘‘March 15’’; 
(2) in subparagraph (A)— 
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(A) in clause (ii), by striking ‘‘; and’’ and 
inserting ‘‘;’’; and 
(B) by striking clause (iii) and inserting 
the following: 
‘‘(iii) procurement, stockpiling, main-
tenance, and potential replenishment (in-
cluding manufacturing capabilities) of all 
products in the Strategic National Stock-
pile; 
‘‘(iv) the availability of technologies 
that may assist in the advanced research 
and development of countermeasures and 
opportunities to use such technologies to 
accelerate and navigate challenges unique 
to countermeasure research and develop-
ment; and 
‘‘(v) potential deployment, distribu-
tion, and utilization of medical counter-
measures; development of clinical guidance 
and emergency use instructions for the use 
of medical countermeasures; and, as appli-
cable, potential post-deployment activities 
related to medical countermeasures;’’; 
(3) by redesignating subparagraphs (D) and 
(E) as subparagraphs (E) and (F), respectively; and 
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(4) by inserting after subparagraph (C), the fol-
lowing: 
‘‘(D) identify the full range of anticipated 
medical countermeasure needs related to re-
search and development, procurement, and 
stockpiling, including the potential need for in-
dications, dosing, and administration tech-
nologies, and other countermeasure needs as 
applicable and appropriate;’’. 
SEC. 502. MATERIAL THREAT AND MEDICAL COUNTER-
MEASURE NOTIFICATIONS. 
(a) CONGRESSIONAL NOTIFICATION OF MATERIAL 
THREAT DETERMINATION.—Section 319F–2(c)(2)(C) (42 
U.S.C. 247d–6b(c)(2)(C)) is amended by striking ‘‘The 
Secretary and the Homeland Security Secretary shall 
promptly notify the appropriate committees of Congress’’ 
and inserting ‘‘The Secretary and the Secretary of Home-
land Security shall send to Congress, on an annual basis, 
all current material threat determinations and shall 
promptly notify the Committee on Health, Education, 
Labor, and Pensions and the Committee on Homeland Se-
curity and Governmental Affairs of the Senate and the 
Committee on Energy and Commerce and the Committee 
on Homeland Security of the House of Representatives’’. 
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(b) CONTRACTING COMMUNICATION.—Section 319F– 
2(c)(7)(B)(ii)(III) (42 U.S.C. 247d–6b(c)(7)(B)(ii)(III)) 
is amended by adding at the end the following: ‘‘The Sec-
retary shall notify the vendor within 90 days of a deter-
mination by the Secretary to renew, extend, or terminate 
such contract.’’. 
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT 
PLANS. 
Section 565(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–4(f)) is amended— 
(1) by redesignating paragraphs (3) through 
(6) as paragraphs (4) through (7), respectively; 
(2) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) PUBLICATION.—The Secretary shall make 
available on the internet website of the Food and 
Drug Administration information regarding regu-
latory management plans, including— 
‘‘(A) the process by which an applicant 
may submit a request for a regulatory manage-
ment plan; 
‘‘(B) the timeframe by which the Secretary 
is required to respond to such request; 
‘‘(C) the information required for the sub-
mission of such request; 
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‘‘(D) a description of the types of develop-
ment milestones and performance targets that 
could be discussed and included in such plans; 
and 
‘‘(E) contact information for beginning the 
regulatory management plan process.’’; 
(3) in paragraph (6), as so redesignated, in the 
matter preceding subparagraph (A)— 
(A) by striking ‘‘paragraph (4)(A)’’ and in-
serting ‘‘paragraph (5)(A)’’; and 
(B) by striking ‘‘paragraph (4)(B)’’ and 
inserting ‘‘paragraph (5)(B)’’; and 
(4) in paragraph (7)(A), as so redesignated, by 
striking ‘‘paragraph (3)(A)’’ and inserting ‘‘para-
graph (4)(A)’’. 
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DE-
VELOPMENT 
AUTHORITY 
AND 
THE 
BIO-
SHIELD SPECIAL RESERVE FUND. 
(a) BIOSHIELD SPECIAL RESERVE FUND.—Section 
319F–2(g)(1) (42 U.S.C. 247d–6b(g)(1)) is amended— 
(1) by striking ‘‘$2,800,000,000 for the period 
of fiscal years 2014 through 2018’’ and inserting 
‘‘$7,100,000,000 for the period of fiscal years 2019 
through 2028, to remain available until expended’’; 
and 
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(2) by striking the second sentence. 
(b) THE BIOMEDICAL ADVANCED RESEARCH AND 
DEVELOPMENT
AUTHORITY.—Section 319L(d)(2) (42 
U.S.C. 
247d–7e(d)(2)) 
is 
amended 
by 
striking 
‘‘$415,000,000 for each of fiscal years 2014 through 
2018’’ and inserting ‘‘$611,700,000 for each of fiscal 
years 2019 through 2023’’. 
SEC. 505. ADDITIONAL STRATEGIES FOR COMBATING ANTI-
BIOTIC RESISTANCE. 
(a) ADVISORY COUNCIL.—The Secretary of Health 
and Human Services (referred to in this section as the 
‘‘Secretary’’) may continue the Presidential Advisory 
Council on Combating Antibiotic-Resistant Bacteria, re-
ferred to in this section as the ‘‘Advisory Council’’. 
(b) DUTIES.—The Advisory Council shall advise and 
provide information and recommendations to the Sec-
retary regarding programs and policies intended to reduce 
or combat antibiotic-resistant bacteria that may present 
a public health threat and improve capabilities to prevent, 
diagnose, mitigate, or treat such resistance. Such advice, 
information, and recommendations may be related to im-
proving— 
(1) the effectiveness of antibiotics; 
(2) research and advanced research on, and the 
development of, improved and innovative methods 
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for combating or reducing antibiotic resistance, in-
cluding 
new 
treatments, 
rapid 
point-of-care 
diagnostics, alternatives to antibiotics, including al-
ternatives to animal antibiotics, and antimicrobial 
stewardship activities; 
(3) surveillance of antibiotic-resistant bacterial 
infections, including publicly available and up-to- 
date information on resistance to antibiotics; 
(4) education for health care providers and the 
public with respect to up-to-date information on an-
tibiotic resistance and ways to reduce or combat 
such resistance to antibiotics related to humans and 
animals; 
(5) methods to prevent or reduce the trans-
mission of antibiotic-resistant bacterial infections, 
including stewardship programs; and 
(6) coordination with respect to international 
efforts in order to inform and advance United States 
capabilities to combat antibiotic resistance. 
(c) MEETINGS AND COORDINATION.— 
(1) MEETINGS.—The Advisory Council shall 
meet not less than biannually and, to the extent 
practicable, in coordination with meetings of the 
Antimicrobial Resistance Task Force established in 
section 319E(a) of the Public Health Service Act. 
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(2) COORDINATION.—The Advisory Council 
shall, to the greatest extent practicable, coordinate 
activities carried out by the Council with the Anti-
microbial Resistance Task Force established under 
section 319E(a) of the Public Health Service Act 
(42 U.S.C. 247d–5(a)). 
(d) FACA.—The Federal Advisory Committee Act (5 
U.S.C. App.) shall apply to the activities and duties of 
the Advisory Council. 
(e) EXTENSION OF ADVISORY COUNCIL.—Not later 
than October 1, 2022, the Secretary shall submit to the 
Committee on Health, Education, Labor, and Pensions of 
the Senate and the Committee on Energy and Commerce 
of the House of Representatives a recommendation on 
whether the Advisory Council should be extended, and in 
addition, identify whether there are other committees, 
councils, or task forces that have overlapping or similar 
duties to that of the Advisory Council, and whether such 
committees, councils, or task forces should be combined, 
including with respect to section 319E(a) of the Public 
Health Service Act (42 U.S.C. 247d–5(a)). 
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TITLE 
VI—ADVANCING 
TECH-
NOLOGIES 
FOR 
MEDICAL 
COUNTERMEASURES 
SEC. 601. ADMINISTRATION OF COUNTERMEASURES. 
Section 
319L(c)(4)(D)(iii) 
(42 
U.S.C. 
247d– 
7e(c)(4)(D)(iii)) is amended by striking ‘‘and platform 
technologies’’ and inserting ‘‘platform technologies, tech-
nologies to administer countermeasures, and technologies 
to improve storage and transportation of counter-
measures’’. 
SEC. 602. UPDATING DEFINITIONS OF OTHER TRANS-
ACTIONS. 
Section 319L (42 U.S.C. 247d–7e) is amended— 
(1) in subsection (a)(3), by striking ‘‘, such as’’ 
and all that follows through ‘‘Code’’; and 
(2) in subsection (c)(5)(A)— 
(A) in clause (i), by striking ‘‘under this 
subsection’’ and all that follows through ‘‘Code’’ 
and inserting ‘‘(as defined in subsection (a)(3)) 
under this subsection’’; and 
(B) in clause (ii)— 
(i) by amending subclause (I) to read 
as follows: 
‘‘(I) IN GENERAL.—To the max-
imum extent practicable, competitive 
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procedures shall be used when enter-
ing into transactions to carry out 
projects under this subsection.’’; and 
(ii) in subclause (II)— 
(I) by striking ‘‘$20,000,000’’ 
and inserting ‘‘$100,000,000’’; 
(II) by striking ‘‘senior procure-
ment executive for the Department 
(as designated for purpose of section 
16(c) of the Office of Federal Pro-
curement Policy Act (41 U.S.C. 
414(c)))’’ and inserting ‘‘Assistant 
Secretary for Financial Resources’’; 
and 
(III) by striking ‘‘senior procure-
ment executive under’’ and inserting 
‘‘Assistant Secretary for Financial Re-
sources under’’. 
SEC. 603. MEDICAL COUNTERMEASURE MASTER FILES. 
(a) IN GENERAL.—The purpose of this section (in-
cluding section 565B of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (b)) is to support and 
advance the development or manufacture of security coun-
termeasures, qualified countermeasures, and qualified 
pandemic or epidemic products by facilitating and encour-
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aging submission of data and information to support the 
development of such products, and through clarifying the 
authority to cross-reference to data and information pre-
viously submitted to the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), 
including data and information submitted to medical coun-
termeasure master files or other master files. 
(b) MEDICAL COUNTERMEASURE MASTER FILES.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 565A the following: 
‘‘SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES. 
‘‘(a) APPLICABILITY OF REFERENCE.— 
‘‘(1) IN GENERAL.—A person may submit data 
and information in a master file to the Secretary 
with the intent to reference, or to authorize, in writ-
ing, another person to reference, such data or infor-
mation to support a medical countermeasure submis-
sion (including a supplement or amendment to any 
such submission), without requiring the master file 
holder to disclose the data and information to any 
such persons authorized to reference the master file. 
Such data and information shall be available for ref-
erence by the master file holder or by a person au-
thorized by the master file holder, in accordance 
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with applicable privacy and confidentiality protocols 
and regulations. 
‘‘(2) 
REFERENCE
OF
CERTAIN
MASTER 
FILES.—In the case that data or information within 
a medical countermeasure master file is used only to 
support the conditional approval of an application 
filed under section 571, such master file may be re-
lied upon to support the effectiveness of a product 
that is the subject of a subsequent medical counter-
measure submission only if such application is sup-
plemented by additional data or information to sup-
port review and approval in a manner consistent 
with the standards applicable to such review and ap-
proval for such countermeasure, qualified counter-
measure, or qualified pandemic or epidemic product. 
‘‘(b) MEDICAL COUNTERMEASURE MASTER FILE 
CONTENT.— 
‘‘(1) IN GENERAL.—A master file under this 
section may include data or information to sup-
port— 
‘‘(A) the development of medical counter-
measure submissions to support the approval, 
licensure, classification, clearance, conditional 
approval, or authorization of one or more secu-
rity 
countermeasures, 
qualified 
counter-
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measures, or qualified pandemic or epidemic 
products; and 
‘‘(B) the manufacture of security counter-
measures, qualified countermeasures, or quali-
fied pandemic or epidemic products. 
‘‘(2) REQUIRED UPDATES.—The Secretary may 
require, as appropriate, that the master file holder 
ensure that the contents of such master file are up-
dated during the time such master file is referenced 
for a medical countermeasure submission. 
‘‘(c) SPONSOR REFERENCE.— 
‘‘(1) IN GENERAL.—Each incorporation of data 
or information within a medical countermeasure 
master file shall describe the incorporated material 
in a manner in which the Secretary determines ap-
propriate and that permits the review of such infor-
mation within such master file without necessitating 
re-submission of such data or information. Master 
files shall be submitted in an electronic format in ac-
cordance with sections 512(b)(4), 571(a)(4), and 
745A, as applicable, and as specified in applicable 
guidance. 
‘‘(2) REFERENCE BY A MASTER FILE HOLD-
ER.—A master file holder that is the sponsor of a 
medical countermeasure submission shall notify the 
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Secretary in writing of the intent to reference the 
medical countermeasure master file as a part of the 
submission. 
‘‘(3) REFERENCE
BY
AN
AUTHORIZED
PER-
SON.—A person submitting an application for review 
may, where the Secretary determines appropriate, 
incorporate by reference all or part of the contents 
of a medical countermeasure master file, if the mas-
ter file holder authorizes the incorporation in writ-
ing. 
‘‘(d) ACKNOWLEDGMENT OF AND RELIANCE UPON A 
MASTER FILE BY THE SECRETARY.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
the master file holder with a written notification in-
dicating that the Secretary has reviewed and relied 
upon specified data or information within a master 
file and the purposes for which such data or infor-
mation was incorporated by reference if the Sec-
retary has reviewed and relied upon such specified 
data or information to support the approval, classi-
fication, conditional approval, clearance, licensure, or 
authorization of a security countermeasure, qualified 
countermeasure, or qualified pandemic or epidemic 
product. The Secretary may rely upon the data and 
information within the medical countermeasure mas-
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ter file for which such written notification was pro-
vided in additional applications, as applicable and 
appropriate and upon the request of the master file 
holder so notified in writing or by an authorized per-
son of such holder. 
‘‘(2) CERTAIN APPLICATIONS.—If the Secretary 
has reviewed and relied upon specified data or infor-
mation within a medical countermeasure master file 
to support the conditional approval of an application 
under section 571 to subsequently support the ap-
proval, clearance, licensure, or authorization of a se-
curity countermeasure, qualified countermeasure, or 
qualified pandemic or epidemic product, the Sec-
retary shall provide a brief written description to the 
master file holder regarding the elements of the ap-
plication fulfilled by the data or information within 
the master file and how such data or information 
contained in such application meets the standards of 
evidence under subsection (c) or (d) of section 505, 
subsection (d) of section 512, or section 351 of the 
Public Health Service Act (as applicable), which 
shall not include any trade secret or confidential 
commercial information. 
‘‘(e) RULES OF CONSTRUCTION.—Nothing in this 
section shall be construed to— 
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‘‘(1) limit the authority of the Secretary to ap-
prove, license, clear, conditionally approve, or au-
thorize drugs, biological products, or devices pursu-
ant to, as applicable, this Act or section 351 of the 
Public Health Service Act (as such applicable Act is 
in effect on the day before the date of enactment of 
the Pandemic and All-Hazards Preparedness and 
Advancing Innovation Act of 2018), including the 
standards of evidence, and applicable conditions, for 
approval under the applicable Act; 
‘‘(2) alter the standards of evidence with re-
spect to approval, licensure, or clearance, as applica-
ble, of drugs, biological products, or devices under 
this Act or section 351 of the Public Health Service 
Act, including, as applicable, the substantial evi-
dence standards under sections 505(d) and 512(d) 
or this Act and section 351(a) of the Public Health 
Service Act; or 
‘‘(3) alter the authority of the Secretary under 
this Act or the Public Health Service Act to deter-
mine the types of data or information previously 
submitted by a sponsor or any other person that 
may be incorporated by reference in an application, 
request, or notification for a drug, biological prod-
uct, or device submitted under sections 505(i), 
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a new animal drug under section 571, an investiga-
tional device application under section 520(g), an 
application with respect to a device under section 
515(c), a request for classification of a device under 
section 513(f)(2), a notification with respect to a de-
vice under section 510(k), or a request for an emer-
gency use authorization under section 564 to sup-
port— 
‘‘(A) the approval, licensure, classification, 
clearance, conditional approval, or authorization 
of a security countermeasure, qualified counter-
measure, or qualified pandemic or epidemic 
product; or 
‘‘(B) a new indication to an approved secu-
rity countermeasure, qualified countermeasure, 
or qualified pandemic or epidemic product. 
‘‘(3) The terms ‘qualified countermeasure’, ‘se-
curity countermeasure’, and ‘qualified pandemic or 
epidemic product’ have the meanings given such 
terms in sections 319F–1, 319F–2, and 319F–3, re-
spectively, of the Public Health Service Act.’’. 
(c) STAKEHOLDER
INPUT.—Not later than 18 
months after the date of enactment of this Act, the Sec-
retary, acting through the Commissioner of Food and 
Drugs and in consultation with the Assistant Secretary 
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for Preparedness and Response, shall solicit input from 
stakeholders, including stakeholders developing security 
countermeasures, qualified countermeasures, or qualified 
pandemic or epidemic products, and stakeholders devel-
oping technologies to assist in the development of such 
countermeasures with respect to how the Food and Drug 
Administration can advance the use of tools and tech-
nologies to support and advance the development or manu-
facture of security countermeasures, qualified counter-
measures, and qualified pandemic or epidemic products, 
including through reliance on cross-referenced data and 
information contained within master files and submissions 
previously submitted to the Secretary as set forth in sec-
tion 565B of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (b). 
(d) GUIDANCE.—Not later than 2 years after the 
date of enactment of this Act, the Secretary, acting 
through the Commissioner of Food and Drugs, shall pub-
lish draft guidance about how reliance on cross-referenced 
data and information contained within master files under 
section 565B of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (b) or submissions otherwise 
submitted to the Secretary may be used for specific tools 
or technologies (including platform technologies) that have 
the potential to support and advance the development or 
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manufacture of security countermeasures, qualified coun-
termeasures, and qualified pandemic or epidemic products. 
The Secretary, acting through the Commissioner of Food 
and Drugs, shall publish the final guidance not later than 
3 years after the enactment of this Act. 
SEC. 604. ANIMAL RULE REPORT. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study on the application of the re-
quirements under subsections (c) and (d) of section 565 
of the of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–4) (referred to in this section as the ‘‘ani-
mal rule’’) as a component of medical countermeasure ad-
vanced development under the Biomedical Advanced Re-
search and Development Authority and regulatory review 
by the Food and Drug Administration. In conducting such 
study, the Comptroller General shall examine the fol-
lowing: 
(1) The extent to which advanced development 
and review of a medical countermeasure are coordi-
nated between the Biomedical Advanced Research 
and Development Authority and the Food and Drug 
Administration, including activities that facilitate 
appropriate and efficient design of studies to sup-
port approval, licensure, and authorization under the 
animal rule, consistent with the recommendations in 
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the animal rule guidance, issued pursuant to section 
565(c) of the Federal Food Drug and Cosmetic Act 
(21 U.S.C. 360bbb–4(c)) and entitled ‘‘Product De-
velopment Under the Animal Rule: Guidance for In-
dustry’’ (issued in October 2015), to resolve discrep-
ancies in the design of adequate and well-controlled 
efficacy studies conducted in animal models related 
to the provision of substantial evidence of effective-
ness for the product approved, licensed, or author-
ized under the animal rule. 
(2) The consistency of the application of the 
animal rule among and between review divisions 
within the Food and Drug Administration. 
(3) The flexibility pursuant to the animal rule 
to address variations in countermeasure development 
and review processes, including the extent to which 
qualified animal models are adopted and used within 
the Food and Drug Administration in regulatory de-
cisionmaking with respect to medical counter-
measures. 
(4) The extent to which the guidance issued 
under section 565(c) of the Federal Food Drug and 
Cosmetic Act (21 U.S.C. 360bbb–4(c)), entitled, 
‘‘Product Development Under the Animal Rule: 
Guidance for Industry’’ (issued in October 2015), 
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has assisted in achieving the purposes described in 
paragraphs (1), (2), and (3). 
(b) CONSULTATIONS.—In conducting the study under 
subsection (a), the Comptroller General of the United 
States shall consult with— 
(1) the Federal agencies responsible for advanc-
ing, reviewing, and procuring medical counter-
measures, including the Office of the Assistant Sec-
retary for Preparedness and Response, the Bio-
medical Advanced Research and Development Au-
thority, the Food and Drug Administration, and the 
Department of Defense; 
(2) manufacturers involved in the research and 
development of medical countermeasures to address 
biological, chemical, radiological, or nuclear threats; 
and 
(3) other biodefense stakeholders, as applicable. 
(c) REPORT.—Not later than 3 years after the date 
of enactment of this Act, the Comptroller General of the 
United States shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report containing the results of the 
study conducted under subsection (a) and recommenda-
tions to improve the application and consistency of the re-
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quirements under subsections (c) and (d) of section 565 
of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
360bbb–4) to support and expedite the research and devel-
opment of medical countermeasures, as applicable. 
(d) PROTECTION
OF NATIONAL SECURITY.—The 
Comptroller General of the United States shall conduct 
the study and issue the assessment and report under this 
section in a manner that does not compromise national 
security. 
SEC. 605. REVIEW OF THE BENEFITS OF GENOMIC ENGI-
NEERING TECHNOLOGIES AND THEIR POTEN-
TIAL ROLE IN NATIONAL SECURITY. 
(a) MEETING.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sec-
tion as the ‘‘Secretary’’) shall convene a meeting to 
discuss the potential role advancements in genomic 
engineering technologies (including genome editing 
technologies) may have in advancing national health 
security. Such meeting shall be held in a manner 
that does not compromise national security. 
(2) ATTENDEES.—The attendees of the meeting 
under paragraph (1)— 
(A) shall include— 
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(i) representatives from the Office of 
the Assistant Secretary for Preparedness 
and Response, the National Institutes of 
Health, the Centers for Disease Control 
and Prevention, and the Food and Drug 
Administration; and 
(ii) representatives from academic, 
private, and nonprofit entities with exper-
tise in genome engineering technologies, 
biopharmaceuticals, 
medicine, 
or 
bio-
defense, and other relevant stakeholders; 
and 
(B) may include— 
(i) other representatives from the De-
partment of Health and Human Services, 
as the Secretary determines appropriate; 
and 
(ii) representatives from the Depart-
ment of Homeland Security, the Depart-
ment of Defense, the Department of Agri-
culture, and other departments, as the Sec-
retary may request for the meeting. 
(3) TOPICS.—The meeting under paragraph (1) 
shall include a discussion of— 
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from utilization of genomic engineering 
technologies and related technologies for 
the purpose of compromising national 
health security. 
(b) REPORT.—Not later than 270 days after the 
meeting described in subsection (a) is held, the Assistant 
Secretary for Preparedness and Response shall issue a re-
port to the congressional committees of jurisdiction on the 
topics discussed at such meeting, and provide rec-
ommendations, as applicable, to utilize innovations in 
genomic engineering (including genome editing) and re-
lated technologies as a part of preparedness and response 
activities to advance national health security. Such report 
shall be issued in a manner that does not compromise na-
tional security. 
SEC. 606. REPORT ON VACCINES DEVELOPMENT. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives a report describing efforts and activities to 
coordinate with other countries and international partners 
during recent public health emergencies with respect to 
the research and advanced research on, and development 
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of, qualified pandemic or epidemic products (as defined 
in section 319F–3 of the Public Health Service Act (42 
U.S.C. 247d–6d)). Such report may include information 
regarding relevant work carried out under section 
319L(c)(5)(E) of the Public Health Service Act (42 
U.S.C. 247d–7e(c)(5)(E)), through public-private partner-
ships, and through collaborations with other countries to 
assist with or expedite the research and development of 
qualified pandemic or epidemic products. Such report shall 
not include information that may compromise national se-
curity. 
SEC. 607. STRENGTHENING MOSQUITO ABATEMENT FOR 
SAFETY AND HEALTH. 
(a) REAUTHORIZATION OF MOSQUITO ABATEMENT 
FOR SAFETY AND HEALTH PROGRAM.—Section 317S (42 
U.S.C. 247b–21) is amended— 
(1) in subsection (a)(1)(B)— 
(A) by inserting ‘‘including programs to 
address emerging infectious mosquito-borne dis-
eases,’’ after ‘‘subdivisions for control pro-
grams,’’; and 
(B) by inserting ‘‘or improving existing 
control programs’’ before the period at the end; 
(2) in subsection (b)— 
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(A) in paragraph (1), by inserting ‘‘, in-
cluding improvement,’’ after ‘‘operation’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) in clause (ii), by striking ‘‘or’’ 
at the end; 
(II) in clause (iii), by striking the 
semicolon at the end and inserting ‘‘, 
including an emerging infectious mos-
quito-borne disease that presents a se-
rious public health threat; or’’; and 
(III) by adding at the end the 
following: 
‘‘(iv) a public health emergency due to 
the incidence or prevalence of a mosquito- 
borne disease that presents a serious pub-
lic health threat;’’; and 
(ii) by amending subparagraph (D) to 
read as follows: 
‘‘(D)(i) is located in a State that has re-
ceived a grant under subsection (a); or 
‘‘(ii) that demonstrates to the Secretary 
that the control program is consistent with ex-
isting State mosquito control plans or policies, 
or other applicable State preparedness plans.’’; 
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(C) in paragraph (4)(C), by striking ‘‘that 
extraordinary’’ and all that follows through the 
period at the end and inserting the following: 
‘‘that— 
‘‘(i) extraordinary economic conditions 
in the political subdivision or consortium of 
political subdivisions involved justify the 
waiver; or 
‘‘(ii) the geographical area covered by 
a political subdivision or consortium for a 
grant under paragraph (1) has an extreme 
mosquito control need due to— 
‘‘(I) the size or density of the po-
tentially impacted human population; 
‘‘(II) the size or density of a 
mosquito population that requires 
heightened control; or 
‘‘(III) the severity of the mos-
quito-borne disease, such that ex-
pected serious adverse health out-
comes for the human population jus-
tify the waiver.’’; and 
(D) by amending paragraph (6) to read as 
follows: 
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‘‘(6) NUMBER OF GRANTS.—A political subdivi-
sion or a consortium of political subdivisions may 
not receive more than one grant under paragraph 
(1).’’; and 
(3) in subsection (f)— 
(A) in paragraph (1) by striking ‘‘for fiscal 
year 2003, and such sums as may be necessary 
for each of fiscal years 2004 through 2007’’ 
and inserting ‘‘for each of fiscal years 2019 
through 2023’’; 
(B) in paragraph (2), by striking ‘‘the 
Public Health Security and Bioterrorism Pre-
paredness and Response Act of 2002’’ and in-
serting ‘‘this Act and other medical and public 
health preparedness and response laws’’; and 
(C) in paragraph (3)— 
(i) in the paragraph heading, by strik-
ing ‘‘2004’’ and inserting ‘‘2019’’; and 
(ii) by striking ‘‘2004,’’ and inserting 
‘‘2019,’’. 
(b) 
EPIDEMIOLOGY-LABORATORY
CAPACITY 
GRANTS.—Section 2821 (42 U.S.C. 300hh–31) is amend-
ed— 
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(1) in subsection (a)(1), by inserting ‘‘, includ-
ing mosquito and other vector-borne diseases,’’ after 
‘‘infectious diseases’’; and 
(2) in subsection (b), by striking ‘‘2010 through 
2013’’ and inserting ‘‘2019 through 2023’’. 
TITLE VII—MISCELLANEOUS 
PROVISIONS 
SEC. 701. REAUTHORIZATIONS AND EXTENSIONS. 
(a) VETERANS AFFAIRS.—Section 8117(g) of title 
38, United States Code, is amended by striking ‘‘2014 
through 2018’’ and inserting ‘‘2019 through 2023’’. 
(b) VACCINE TRACKING AND DISTRIBUTION.—Sec-
tion 319A(e) (42 U.S.C. 247d–1(e)) is amended by strik-
ing ‘‘2014 through 2018’’ and inserting ‘‘2019 through 
2023’’. 
(c) TEMPORARY REASSIGNMENT.—Section 319(e)(8) 
(42 U.S.C. 247d(e)(8)) is amended by striking ‘‘2018’’ 
and inserting ‘‘2023’’. 
(d) STRATEGIC
INNOVATION
PARTNER.—Section 
319L(c)(4)(E)(ix) (42 U.S.C. 247d–7e(c)(4)(E)(ix)) is 
amended by striking ‘‘2022’’ and inserting ‘‘2023’’. 
(e) LIMITED ANTITRUST EXEMPTION.— 
(1) IN GENERAL.—Section 405 of the Pandemic 
and All-Hazards Preparedness Act (Public Law 
109–417; 42 U.S.C. 247d–6a note) is amended— 
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(f) INAPPLICABILITY
OF CERTAIN PROVISIONS.— 
Subsection (e)(1) of section 319L (42 U.S.C. 247d– 
7e(e)(1)) is amended— 
(1) by amending subparagraph (A) to read as 
follows: 
‘‘(A) 
NON-DISCLOSURE
OF
INFORMA-
TION.— 
‘‘(i) IN
GENERAL.—Information de-
scribed in clause (ii) shall be deemed to be 
information described in section 552(b)(3) 
of title 5, United States Code. 
‘‘(ii) INFORMATION DESCRIBED.—The 
information described in this clause is in-
formation relevant to programs of the De-
partment of Health and Human Services 
that could compromise national security 
and reveal significant and not otherwise 
publicly known vulnerabilities of existing 
medical or public health defenses against 
chemical, biological, radiological, or nuclear 
threats, and is comprised of— 
‘‘(I) specific technical data or sci-
entific information that is created or 
obtained during the countermeasure 
and product advanced research and 
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development carried out under sub-
section (c); 
‘‘(II) information pertaining to 
the location security, personnel, and 
research materials and methods of 
high-containment 
laboratories 
con-
ducting research with select agents, 
toxins, or other agents with a material 
threat determination under section 
319F–2(c)(2); or 
‘‘(III) security and vulnerability 
assessments.’’; 
(2) by redesignating subparagraph (C) as sub-
paragraph (D); 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) REPORTING.—One year after the 
date of enactment of the Pandemic and All- 
Hazards Preparedness and Advancing Innova-
tion Act of 2018, and annually thereafter, the 
Secretary shall report to the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives on the 
number of instances in which the Secretary has 
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used the authority under this subsection to 
withhold information from disclosure, as well as 
the nature of any request under section 552 of 
title 5, United States Code that was denied 
using such authority.’’; and 
(4) in subparagraph (D), as so redesignated, by 
striking ‘‘12’’ and inserting ‘‘17’’. 
SEC. 702. LOCATION OF MATERIALS IN THE STOCKPILE. 
Subsection (d) of section 319F–2 (42 U.S.C. 247d– 
6b) is amended to read as follows: 
‘‘(d) DISCLOSURES.—No Federal agency may dis-
close under section 552 of title 5, United States Code any 
information identifying the location at which materials in 
the stockpile described in subsection (a) are stored, or 
other information regarding the contents or deployment 
capability of the stockpile that could compromise national 
security.’’. 
SEC. 703. CYBERSECURITY. 
(a) STRATEGY FOR PUBLIC HEALTH PREPAREDNESS 
AND RESPONSE TO CYBERSECURITY THREATS.— 
(1) STRATEGY.—Not later than 18 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services (referred to in 
this section as the ‘‘Secretary’’) shall prepare and 
submit to the relevant committees of Congress a 
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strategy for public health preparedness and response 
to address cybersecurity threats (as defined in sec-
tion 102 of Cybersecurity Information Sharing Act 
of 2015 (6 U.S.C. 1501)) that present a threat to 
national health security. Such strategy shall in-
clude— 
(A) identifying the duties, functions, and 
preparedness goals for which the Secretary is 
responsible in order to prepare for and respond 
to such cybersecurity threats, including metrics 
by which to measure success in meeting pre-
paredness goals; 
(B) identifying gaps in public health capa-
bilities to achieve such preparedness goals; and 
(C) strategies to address identified gaps 
and strengthen public health emergency pre-
paredness and response capabilities to address 
such cybersecurity threats. 
(2) PROTECTION
OF
NATIONAL
SECURITY.— 
The Secretary shall make such strategy available to 
the Committee on Health, Education, Labor, and 
Pensions of the Senate, the Committee on Energy 
and Commerce of the House of Representatives, and 
other congressional committees of jurisdiction, in a 
manner that does not compromise national security. 
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(b) COORDINATION OF PREPAREDNESS FOR AND RE-
SPONSE
TO
ALL-HAZARDS
PUBLIC
HEALTH
EMER-
GENCIES.—Subparagraph (D) of section 2811(b)(4) (42 
U.S.C. 300hh–10(b)(4)) is amended to read as follows: 
‘‘(D) POLICY
COORDINATION
AND
STRA-
TEGIC
DIRECTION.—Provide integrated policy 
coordination and strategic direction, before, 
during, and following public health emergencies, 
with respect to all matters related to Federal 
public health and medical preparedness and 
execution and deployment of the Federal re-
sponse for public health emergencies and inci-
dents covered by the National Response Plan 
described in section 504(a)(6) of the Homeland 
Security Act of 2002 (6 U.S.C. 314(a)(6)), or 
any successor plan; and such Federal responses 
covered by the National Cybersecurity Incident 
Response Plan developed under section 228(c) 
of the Homeland Security Act of 2002 (6 
U.S.C. 149(c)), including public health emer-
gencies or incidents related to cybersecurity 
threats that present a threat to national health 
security.’’. 
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SEC. 704. STRATEGY AND REPORT. 
Not later than 14 days after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, in coordination with the Assistant Secretary for 
Preparedness and Response and the Assistant Secretary 
for the Administration on Children and Families or other 
appropriate office, and in collaboration with other depart-
ments, as appropriate, shall submit to the Committee on 
Energy and Commerce of the House of Representatives, 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate, and other relevant congressional com-
mittees— 
(1) a formal strategy, including interdepart-
mental actions and efforts to reunify children with 
their parents or guardians, in all cases in which such 
children have been separated from their parents or 
guardians as a result of the initiative announced on 
April 6, 2018, and due to prosecution under section 
275(a) of the Immigration and Nationality Act (8 
U.S.C. 1325(a)), if the parent or guardian chooses 
such reunification and the child— 
(A) was separated from a parent or guard-
ian and placed into a facility funded by the De-
partment of Health and Human Services; 
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(B) as of the date of the enactment of this 
Act, remains in the care of the Department of 
Health and Human Services; and 
(C) can be safely reunited with such parent 
or guardian; and 
(2) a report on challenges and deficiencies re-
lated to the oversight of, and care for, unaccom-
panied alien children and appropriately reuniting 
such children with their parents or guardians, and 
the actions taken to address any challenges and defi-
ciencies related to unaccompanied alien children in 
the custody of the Department of Health and 
Human Services, including deficiencies identified 
and publicly reported by Congress, the Government 
Accountability Office, or the Inspectors General of 
the Department of Health and Human Services or 
other Federal departments. 
SEC. 705. TECHNICAL AMENDMENTS. 
(a) PUBLIC HEALTH SERVICE ACT.—Title III (42 
U.S.C. 241 et seq.) is amended— 
(1) in paragraphs (1) and (5) of section 319F– 
1(a) (42 U.S.C. 247d–6a(a)), by striking ‘‘section 
319F(h)’’ each place such term appears and insert-
ing ‘‘section 319F(e)’’; and 
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(2) in section 319K(a) (42 U.S.C. 247d–7d(a)), 
by striking ‘‘section 319F(h)(4)’’ and inserting ‘‘sec-
tion 319F(e)(4)’’. 
(b) PUBLIC HEALTH SECURITY GRANTS.—Section 
319C–1(b)(2) (42 U.S.C. 247d–3a(b)(2)) is amended— 
(1) in subparagraph (C), by striking ‘‘individ-
uals,,’’ and inserting ‘‘individuals,’’; and 
(2) in subparagraph (F), by striking ‘‘make sat-
isfactory annual improvement and describe’’ and in-
serting ‘‘makes satisfactory annual improvement and 
describes’’. 
(c) EMERGENCY
USE
INSTRUCTIONS.—Subpara-
graph (A) of section 564A(e)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(e)(2)) is 
amended by striking ‘‘subsection (a)(1)(C)(i)’’ and insert-
ing ‘‘subsection (a)(1)(C)’’. 
(d) PRODUCTS HELD FOR EMERGENCY USE.—Sec-
tion 564B(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3b) is amended— 
(1) in subparagraph (B), by inserting a comma 
after ‘‘505’’; and 
(2) in subparagraph (C), by inserting ‘‘or sec-
tion 564A’’ before the period at the end. 
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(e) TRANSPARENCY.—Section 507(c)(3) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 357(c)(3)) 
is amended— 
(1) by striking ‘‘Nothing in’’ and inserting the 
following: 
‘‘(A) IN GENERAL.—Nothing in’’; 
(2) by inserting ‘‘or directing’’ after ‘‘author-
izing’’; 
(3) by striking ‘‘disclose any’’ and inserting 
‘‘disclose— 
‘‘(i) any’’; 
(4) by striking the period and inserting ‘‘; or’’; 
and 
(5) by adding at the end the following: 
‘‘(ii) in the case of a drug develop-
ment tool that may be used to support the 
development of a qualified countermeasure, 
security countermeasure, or qualified pan-
demic or epidemic product, as defined in 
sections 319F–1, 319F–2, and 319F–3, 
respectively, of the Public Health Service 
Act, any information that the Secretary 
determines has a significant potential to 
affect national security. 
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‘‘(B) PUBLIC ACKNOWLEDGMENT.—In the 
case that the Secretary, pursuant to subpara-
graph (A)(ii), does not make information pub-
licly available, the Secretary shall provide on 
the internet website of the Food and Drug Ad-
ministration an acknowledgment of the informa-
tion that has not been disclosed, pursuant to 
subparagraph (A)(ii).’’. 
DIVISION 
B—OVER-THE- 
COUNTER MONOGRAPH SAFE-
TY, 
INNOVATION, 
AND 
RE-
FORM 
SECTION 1000. SHORT TITLE; REFERENCES IN DIVISION. 
(a) SHORT TITLE.—This division may be cited as the 
‘‘Over-the-Counter Monograph Safety, Innovation, and 
Reform Act of 2018’’. 
(b) REFERENCES.—Except as otherwise specified, 
any reference to ‘‘this Act’’ contained in this division shall 
be treated as referring only to the provisions of this divi-
sion. 
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TITLE I—OTC DRUG REVIEW 
SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505F of such Act (21 U.S.C. 355g) the following: 
‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 
DRUGS THAT ARE MARKETED WITHOUT AN 
APPROVED DRUG APPLICATION. 
‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH-
OUT
AN
APPROVED
APPLICATION.—Nonprescription 
drugs marketed without an approved drug application 
under section 505, as of the date of the enactment of this 
section, shall be treated in accordance with this sub-
section. 
‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 
CATEGORY
I
DRUGS
SUBJECT
TO
A
TENTATIVE 
FINAL MONOGRAPH.—A drug is deemed to be gen-
erally recognized as safe and effective under section 
201(p)(1), not a new drug under section 201(p), and 
not subject to section 503(b)(1), if— 
‘‘(A) the drug is— 
‘‘(i) in conformity with the require-
ments for nonprescription use of a final 
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monograph issued under part 330 of title 
21, Code of Federal Regulations (except as 
provided in paragraph (2)), the general re-
quirements for nonprescription drugs, and 
conditions or requirements under sub-
sections (b), (c), and (k); and 
‘‘(ii) except as permitted by an order 
issued under subsection (b) or, in the case 
of a minor change in the drug, in con-
formity with an order issued under sub-
section (c), in a dosage form that, imme-
diately prior to the date of the enactment 
of this section, has been used to a material 
extent and for a material time under sec-
tion 201(p)(2); or 
‘‘(B) the drug is— 
‘‘(i) classified in category I for safety 
and effectiveness under a tentative final 
monograph that is the most recently appli-
cable proposal or determination issued 
under part 330 of title 21, Code of Federal 
Regulations; 
‘‘(ii) in conformity with the proposed 
requirements for nonprescription use of 
such tentative final monograph, any appli-
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