[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2852 Introduced in Senate (IS)]
<DOC>
115th CONGRESS
2d Session
S. 2852
To reauthorize certain programs under the Pandemic and All-Hazards
Preparedness Reauthorization Act.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 15, 2018
Mr. Burr (for himself, Mr. Casey, Mr. Alexander, and Mrs. Murray)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To reauthorize certain programs under the Pandemic and All-Hazards
Preparedness Reauthorization Act.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2018''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. References in Act.
TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY
Sec. 101. National Health Security Strategy.
TITLE II--IMPROVING PREPAREDNESS AND RESPONSE
Sec. 201. Improving benchmarks and standards for preparedness and
response.
Sec. 202. Amendments to preparedness and response programs.
Sec. 203. Regional health care emergency preparedness and response
systems.
Sec. 204. Public health and health care system situational awareness
and biosurveillance capabilities.
Sec. 205. Strengthening and supporting the public health emergency
rapid response fund.
Sec. 206. Improving preparedness for and response to all-hazards by
public health emergency volunteers.
TITLE III--REACHING ALL COMMUNITIES
Sec. 301. Strengthening and assessing the emergency response workforce.
Sec. 302. Health system infrastructure to improve preparedness and
response.
Sec. 303. Considerations for at-risk individuals.
Sec. 304. Improving emergency preparedness and response considerations
for children.
Sec. 305. Reauthorizing the National Advisory Committee on Children and
Disasters.
Sec. 306. Guidance for participation in exercises and drills.
TITLE IV--PRIORITIZING A THREAT-BASED APPROACH
Sec. 401. Assistant Secretary for Preparedness and Response.
Sec. 402. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 403. Strategic National Stockpile.
Sec. 404. Preparing for pandemic influenza, antimicrobial resistance,
and other significant threats.
Sec. 405. Reporting on the Federal Select Agent Program.
TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH AND DEVELOPMENT
Sec. 501. Medical countermeasure budget plan.
Sec. 502. Material threat and medical countermeasure notifications.
Sec. 503. Availability of regulatory management plans.
Sec. 504. The Biomedical Advanced Research and Development Authority
and the BioShield Special Reserve Fund.
TITLE VI--ADVANCING TECHNOLOGIES FOR MEDICAL COUNTERMEASURES
Sec. 601. Administration of countermeasures.
Sec. 602. Medical countermeasure master files.
Sec. 603. Animal rule report.
TITLE VII--MISCELLANEOUS PROVISIONS
Sec. 701. Reauthorizations and extensions.
Sec. 702. Technical amendments.
SEC. 2. REFERENCES IN ACT.
Except as otherwise specified, amendments made by this Act to a
section or other provision of law are amendments to such section or
other provision of the Public Health Service Act (42 U.S.C. 201 et
seq.).
TITLE I--STRENGTHENING THE NATIONAL HEALTH SECURITY STRATEGY
SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.
Section 2802 (42 U.S.C. 300hh-1) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``2014'' and inserting
``2018''; and
(ii) by striking the second sentence and
inserting the following: ``Such National Health
Security Strategy shall describe potential
emergency health security threats and identify
the process for achieving the preparedness
goals described in subsection (b) to be
prepared to identify and respond to such
threats and shall be consistent with the
national preparedness goal (as described in
section 504(a)(19) of the Homeland Security Act
of 2002), the National Incident Management
System (as defined in section 501(7) of such
Act), and the National Response Plan developed
pursuant to section 504 of such Act, or any
successor plan.'';
(B) in paragraph (2), by inserting before the
period at the end of the second sentence the following:
``, and an analysis of any changes to the evidence-
based benchmarks and objective standards under sections
319C-1 and 319C-2''; and
(C) in paragraph (3)--
(i) by striking ``2009'' and inserting
``2022'';
(ii) by inserting ``(including gaps in the
environmental health workforce), describing the
status of such workforce'' after ``gaps in such
workforce'';
(iii) by striking ``and identifying
strategies'' and inserting ``identifying
strategies''; and
(iv) by inserting before the period at the
end ``, and identifying current capabilities to
meet the requirements of section 2803''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``and
investigation'' and inserting ``investigation,
and related information technology
activities'';
(ii) in subparagraph (B), by striking ``and
decontamination'' and inserting
``decontamination, relevant health care
services and supplies, and transportation and
disposal of medical waste''; and
(iii) by adding at the end the following:
``(E) Response to environmental hazards.'';
(B) in paragraph (3)(F), by inserting ``or
exposures to agents that could cause a public health
emergency'' before the period;
(C) in paragraph (5), by inserting ``and other
applicable compacts'' after ``Compact''; and
(D) by adding at the end the following:
``(9) Zoonotic disease, food, and agriculture.--In
consultation with the Secretary of Agriculture, improving
coordination among Federal, State, local, tribal, and
territorial entities to prevent, detect, and respond to
outbreaks of plant or animal disease (including zoonotic
disease) that could compromise national security resulting from
a deliberate attack, a naturally occurring threat, the
intentional adulteration of food, or other public health
threats, taking into account interactions between animal
health, human health, and animals' and humans' shared
environment as directly related to public health emergency
preparedness and response capabilities, as applicable.
``(10) Global health security.--Assessing current or
potential health security threats from abroad to inform
domestic public health preparedness and response
capabilities.''.
TITLE II--IMPROVING PREPAREDNESS AND RESPONSE
SEC. 201. IMPROVING BENCHMARKS AND STANDARDS FOR PREPAREDNESS AND
RESPONSE.
(a) Evaluating Measurable Evidence-Based Benchmarks and Objective
Standards.--Section 319C-1 (42 U.S.C. 247d-3a) is amended by inserting
after subsection (j) the following:
``(k) Evaluation.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018 and every 2 years thereafter,
the Secretary shall conduct an evaluation of the evidence-based
benchmarks and objective standards required under subsection
(g). Such evaluation shall be submitted to the congressional
committees of jurisdiction together with the National Health
Security Strategy under section 2802, at such time as such
strategy is submitted.
``(2) Content.--The evaluation under this paragraph shall
include--
``(A) a review of evidence-based benchmarks and
objective standards, and associated metrics and
targets;
``(B) a discussion of changes to any evidence-based
benchmarks and objective standards, and the effect of
such changes on the ability to track whether entities
are meeting or making progress toward the goals under
this section and, to the extent practicable, the
applicable goals of the National Health Security
Strategy under section 2802;
``(C) a description of amounts received by eligible
entities, as described in subsection (b) and section
319C-2(b), and amounts received by sub-recipients and
the effect of such funding on meeting evidence-based
benchmarks and objective standards; and
``(D) recommendations, as applicable and
appropriate, to improve evidence-based benchmarks and
objective standards to more accurately assess the
ability of entities receiving awards under this section
to better achieve the goals under this section and
section 2802.''.
(b) Evaluating the Partnership for State and Regional Hospital
Preparedness.--Section 319C-2(i)(1) (42 U.S.C. 247-3b(i)(1)) is amended
by striking ``section 319C-1(g), (i), and (j)'' and inserting ``section
319C-1(g), (i), (j), and (k)''.
SEC. 202. AMENDMENTS TO PREPAREDNESS AND RESPONSE PROGRAMS.
(a) Cooperative Agreement Applications for Improving State and
Local Public Health Security.--Section 319C-1 (42 U.S.C. 247d-3a) is
amended--
(1) in subsection (a), by inserting ``, acting through the
Director of the Centers for Disease Control and Prevention,''
after ``the Secretary''; and
(2) in subsection (b)(2)(A)--
(A) in clause (vi), by inserting ``, including
public health agencies with specific expertise that may
be relevant to public health security, such as
environmental health agencies,'' after
``stakeholders'';
(B) by redesignating clauses (vii) through (ix) as
clauses (viii) through (x); and
(C) by inserting after clause (vi) the following:
``(vii) a description of how, as
applicable, such entity may integrate
information to account for individuals with
behavioral health needs following a public
health emergency;''.
(b) Partnership for State and Regional Hospital Preparedness To
Improve Surge Capacity.--Section 319C-2 (42 U.S.C. 247d-3b) is
amended--
(1) in subsection (a)--
(A) by inserting ``, acting through the Assistant
Secretary for Preparedness and Response,'' after ``The
Secretary''; and
(B) by striking ``preparedness for public health
emergencies'' and inserting ``preparedness for, and
response to, public health emergencies in accordance
with subsection (c)''; and
(2) in subsection (b)(1)(A)--
(A) in clause (iii), by redesignating subclauses
(I) through (III) as items (aa) through (cc),
respectively, and adjusting the margins accordingly;
(B) by redesignating clauses (i) through (iii) as
subclauses (I) through (III) respectively, and
adjusting the margins accordingly;
(C) by striking ``partnership consisting of--'' and
inserting ``partnership--
``(i) consisting of--''; and
(D) by adding at the end the following:
``(ii) that may include one or more
emergency medical service organizations or
emergency management organizations; and''.
(c) Public Health Security Grants Authorization of
Appropriations.--Section 319C-1(h)(1)(A) (42 U.S.C. 247d-3a(h)(1)(A))
is amended by striking ``$641,900,000 for fiscal year 2014'' and all
that follows through the period at the end and inserting ``$685,000,000
for each of fiscal years 2019 through 2023 for awards pursuant to
paragraph (3) (subject to the authority of the Secretary to make awards
pursuant to paragraphs (4) and (5)).''.
(d) Partnership for State and Regional Hospital Preparedness
Authorization of Appropriations.--Section 319C-2(j) (42 U.S.C. 247d-
3b(j)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) In general.--
``(A) Authorization of appropriations.--For
purposes of carrying out this section and section 319C-
3, in accordance with subparagraph (B), there is
authorized to be appropriated $385,000,000 for each of
fiscal years 2019 through 2023.
``(B) Reservations of amounts for regional
systems.--
``(i) In general.--Subject to clause (ii),
of the amount appropriated under subparagraph
(A) for a fiscal year, the Secretary may
reserve up to 5 percent for the purpose of
carrying out section 319C-3.
``(ii) Reservations contingent on continued
appropriations.--If the amount appropriated
under subparagraph (A) for fiscal year 2019 or
a subsequent fiscal year is less than or equal
the amount so appropriated for the previous
fiscal year, the amount that may be reserved
under clause (i) shall be reduced such that the
amount remaining for the purpose of carrying
out this section is not less than the amount
available for such purpose for the previous
fiscal year.'';
(2) in paragraph (2), by striking ``paragraph (1) for a
fiscal year'' and inserting ``paragraph (1)(A) for a fiscal
year and not reserved for the purpose described in paragraph
(1)(B)(i)''; and
(3) in paragraph (3)(A), by striking ``paragraph (1) and
not reserved under paragraph (2)'' and inserting ``paragraph
(1)(A) and not reserved under paragraph (1)(B)(i) or (2)''.
SEC. 203. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
SYSTEMS.
(a) In General.--Part B of title III (42 U.S.C. 243 et seq.) is
amended by inserting after section 319C-2 the following:
``SEC. 319C-3. GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY
PREPAREDNESS AND RESPONSE SYSTEMS.
``(a) Purpose.--It is the purpose of this section to identify and
provide guidelines for regional systems of hospitals, health care
facilities, and other public and private sector entities, with varying
levels of capability to treat patients and increase medical surge
capacity during, and in advance of, a public health emergency,
including threats posed by one or more chemical, biological,
radiological, and nuclear agents, including emerging infectious
diseases.
``(b) Guidelines.--The Assistant Secretary for Preparedness and
Response, in consultation with the Director of the Centers for Disease
Control and Prevention, the Administrator of the Centers for Medicare &
Medicaid Services, the Administrator of the Health Resources and
Services Administration, the Commissioner of Food and Drugs, the
Assistant Secretary for Mental Health and Substance Use, the Assistant
Secretary of Labor for Occupational Safety and Health, the Secretary of
Veterans Affairs, heads of such other Federal agencies as the Secretary
determines to be appropriate, and State, local, tribal, and territorial
public health officials, shall, not later than 2 years after the date
of enactment of this section--
``(1) identify and develop a set of guidelines relating to
practices and protocols for all-hazards public health emergency
preparedness and response for hospitals and health care
facilities to provide appropriate patient care during, in
advance of, or immediately following, a public health
emergency, resulting from one or more chemical, biological,
radiological, or nuclear agents, including emerging infectious
diseases (which may include existing practices, such as trauma
care and medical surge capacity and capabilities), with respect
to--
``(A) a regional approach to identifying hospitals
and health care facilities based on varying
capabilities and capacity to treat patients affected by
such emergency, including--
``(i) the manner in which the system will
coordinate with and integrate the partnerships
established under section 319C-2(b); and
``(ii) informing and educating appropriate
first responders and health care supply chain
partners of the regional emergency preparedness
and response capabilities and medical surge
capacity of such hospitals and health care
facilities in the community;
``(B) physical and technological infrastructure,
laboratory capacity, staffing, blood supply, and other
supply chain needs, taking into account resiliency,
geographic considerations, and rural considerations;
``(C) protocols or best practices for the safety
and personal protection of workers who handle human
remains and health care workers (including with respect
to protective equipment and supplies, waste management
processes, and decontamination), sharing of specialized
experience among the health care workforce, behavioral
health, psychological resilience, and training of the
workforce, as applicable;
``(D) in a manner that allows for disease
containment (within the meaning of section
2802(b)(2)(B)), coordinated medical triage, treatment,
and transportation of patients, based on patient
medical need (including patients in rural areas), to
the appropriate hospitals or health care facilities
within the regional system or, as applicable and
appropriate, between systems in different States or
regions; and
``(E) the needs of children and other at-risk
individuals;
``(2) make such guidelines available on the internet
website of the Department of Health and Human Services in a
manner that does not compromise national security; and
``(3) update such guidelines as appropriate, including
based on input received pursuant to subsections (c), (e), and
(f), to address new and emerging public health threats.
``(c) Considerations.--In identifying, developing, and updating
guidelines under subsection (b), the Assistant Secretary for
Preparedness and Response shall--
``(1) include input from hospitals and health care
facilities, including health care coalitions under section
319C-2, State, local, tribal, and territorial public health
departments, and health care or subject matter experts,
including experts with relevant expertise in chemical,
biological, radiological, or nuclear threats, and emerging
infectious disease as the Assistant Secretary determines
appropriate, to meet the goals under section 2802(b)(3);
``(2) consult and engage with appropriate health care
providers and professionals, including physicians, nurses,
first responders, health care facilities (including hospitals,
primary care clinics, community health centers, mental health
facilities, ambulatory care facilities, and dental health
facilities), pharmacies, emergency medical providers, trauma
care providers, environmental health agencies, public health
laboratories, poison control centers, blood banks, and other
experts that the Assistant Secretary determines appropriate, to
meet the goals under section 2802(b)(3);
``(3) consider feedback related to financial implications
for hospitals, health care facilities, public health agencies,
laboratories, and other entities engaged in regional
preparedness planning to implement and follow such guidelines,
as applicable; and
``(4) consider financial requirements and potential
incentives for entities to prepare for, and respond to, public
health emergencies as part of the regional health care
emergency preparedness and response system.
``(d) Technical Assistance.--The Assistant Secretary for
Preparedness and Response, in consultation with the Director of the
Centers for Disease Control and Prevention and the Assistant Secretary
of Labor for Occupational Safety and Health, may provide technical
assistance and consultation towards meeting the guidelines described in
subsection (b).
``(e) Demonstration Project for Regional Health Care Preparedness
and Response Systems.--
``(1) In general.--The Assistant Secretary for Preparedness
and Response may establish a demonstration project pursuant to
the development and implementation of guidelines under
subsection (b) to improve medical surge capacity for all
hazards, build and integrate regional medical response
capabilities, improve specialty care expertise for all-hazards
response, and coordinate medical preparedness and response
across State, local, tribal, territorial, and regional
jurisdictions.
``(2) Sunset.--The authority under this subsection shall
expire on September 30, 2023.
``(f) GAO Report to Congress.--
``(1) Report.--Not later than 3 years after the date of
enactment of this section, the Comptroller General of the
United States (referred to in this subsection as the
`Comptroller General') shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on Finance of
the Senate and the Committee on Energy and Commerce and the
Committee on Ways and Means of the House of Representatives, a
report on the extent to which hospitals and health care
facilities have implemented the recommended guidelines under
subsection (b), including an analysis and evaluation of any
challenges hospitals or health care facilities experienced in
implementing such guidelines.
``(2) Content.--The Comptroller General shall include in
the report under paragraph (1)--
``(A) data on the preparedness and response
capabilities that have been informed by the guidelines
under subsection (b) to improve regional emergency
health care preparedness and response capability,
including hospital and health care facility capacity
and medical surge capabilities to prepare for, and
respond to, public health emergencies; and
``(B) recommendations to reduce gaps in incentives
for regional health partners, including hospitals and
health care facilities to improve capacity and medical
surge capabilities to prepare for, and respond to,
public health emergencies, consistent with subsection
(a), which may include consideration of facilities
participating in programs under section 319C-2,
programs under the Centers for Medicare & Medicaid
Services (including innovative health care delivery and
payment models), and input from private sector
financial institutions.
``(3) Consultation.--In carrying out paragraphs (1) and
(2), the Comptroller General shall consult with the heads of
appropriate Federal agencies, including--
``(A) the Assistant Secretary for Preparedness and
Response;
``(B) the Director of the Centers for Disease
Control and Prevention;
``(C) the Administrator of the Centers for Medicare
& Medicaid Services;
``(D) the Assistant Secretary for Mental Health and
Substance Use;
``(E) the Assistant Secretary of Labor for
Occupational Safety and Health;
``(F) the Secretary of Veterans Affairs; and
``(G) the heads of such other Federal agencies as
the Secretary determines appropriate.''.
(b) Annual Reports.--Section 319C-2(i)(1) (42 U.S.C. 247d-3b(i)(1))
is amended by inserting after the first sentence the following ``The
reports submitted under this paragraph shall also include progress
towards the implementation of section 319C-3.''.
(c) National Health Security Strategy Incorporation of Regionalized
Emergency Preparedness and Response.--Section 2802(b)(3) (42 U.S.C.
300hh-1(b)(3)) is amended--
(1) in the matter preceding subparagraph (A), by striking
``including mental health'' and inserting ``including
pharmacies, mental health facilities,''; and
(2) by amending subparagraph (G) to read as follows:
``(G) Optimizing a coordinated and flexible
approach to the emergency response and medical surge
capacity of hospitals, other health care facilities,
critical care, trauma care (which may include trauma
centers), and emergency medical systems, which may
include the implementation of guidelines for regional
health care emergency preparedness and response systems
under section 319C-3.''.
(d) Improving State and Local Public Health Security.--
(1) State and local security.--Section 319C-1(e) (42 U.S.C.
247d-3a(e)) is amended by striking ``, and local emergency
plans.'' and inserting ``, local emergency plans, and any
regional health care emergency preparedness and response system
established pursuant to the applicable guidelines under section
319C-3.''.
(2) Partnerships.--Section 319C-2(d)(1)(A) (42 U.S.C. 247d-
3b(d)(1)(A)) is amended--
(A) in clause (i), by striking ``; and'' and
inserting ``;'';
(B) by redesignating clause (ii) as clause (iii);
and
(C) inserting after clause (i), the following:
``(ii) among one or more facilities in a
regional health care emergency system under
section 319C-3; and''.
SEC. 204. PUBLIC HEALTH AND HEALTH CARE SYSTEM SITUATIONAL AWARENESS
AND BIOSURVEILLANCE CAPABILITIES.
(a) Facilities, Capacities, and Biosurveillance Capabilities.--
Section 319D (42 U.S.C. 247d-4) is amended--
(1) in the section heading, by striking ``revitalizing''
and inserting ``facilities and capacities of'';
(2) in subsection (a)--
(A) in the subsection heading, by striking
``Facilities; Capacities'' and inserting ``In
General'';
(B) in paragraph (1), by striking ``and improved''
and inserting ``, improved, and appropriately
maintained'';
(C) in paragraph (3), in the matter preceding
subparagraph (A), by striking ``expand, enhance, and
improve'' and inserting ``expand, improve, enhance, and
appropriately maintain''; and
(D) by adding at the end the following:
``(4) Study of resources for facilities and capacities.--
Not later than June 1, 2022, the Comptroller General of the
United States shall conduct a study on Federal spending in
fiscal years 2013 through 2018 for activities authorized under
this subsection. Such study shall include a review and
assessment of obligations and expenditures directly related to
each activity under paragraphs (2) and (3), including a
specific accounting of, and delineation between, obligations
and expenditures incurred for the construction, renovation,
equipping, and security upgrades of facilities and associated
contracts under this subsection, and the obligations and
expenditures incurred to establish and improve the situational
awareness and biosurveillance network under subsection (b), and
shall identify the agency or agencies incurring such
obligations and expenditures.'';
(3) in subsection (b)--
(A) in the subsection heading, by striking
``National'' and inserting ``Establishment of Systems
of Public Health '';
(B) in paragraph (1)(B), by inserting
``immunization information systems,'' after
``centers,'';
(C) in paragraph (2)--
(i) by inserting ``develop a plan to, and''
after ``The Secretary shall''; and
(ii) by inserting ``and in a form readily
usable for analytical approaches'' after ``in a
secure manner''; and
(D) by amending paragraph (3) to read as follows:
``(3) Standards.--
``(A) In general.--Not later than 1 year after the
date of the enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018, the
Secretary, in cooperation with health care providers,
State, local, tribal, and territorial public health
officials, and relevant Federal agencies (including the
Office of the National Coordinator for Health
Information Technology and the National Institute of
Standards and Technology), shall, as necessary, adopt
technical and reporting standards, including standards
for interoperability as defined by section 3000, for
networks under paragraph (1) and update such standards
as necessary. Such standards shall be made available on
the internet website of the Department of Health and
Human Services, in a manner that does not compromise
national security.
``(B) Deference to standards development
organizations.--In adopting and implementing standards
under this subsection and subsection (c), the Secretary
shall give deference to standards published by
standards development organizations and voluntary
consensus-based standards entities.'';
(4) in subsection (c)--
(A) in paragraph (1)--
(i) by striking ``Not later than 2 years
after the date of enactment of the Pandemic and
All-Hazards Preparedness Reauthorization Act of
2013, the Secretary'' and inserting ``The
Secretary'';
(ii) by inserting ``, and improve as
applicable and appropriate,'' after ``shall
establish'';
(iii) by striking ``of rapid'' and
inserting ``of, rapid''; and
(iv) by striking ``such connectivity'' and
inserting ``such interoperability'';
(B) by amending paragraph (2) to read as follows:
``(2) Coordination and consultation.--In establishing and
improving the network under paragraph (1) the Secretary shall--
``(A) facilitate coordination among agencies within
the Department of Health and Human Services that
provide or have the potential to provide information
and data to, and analyses for, the situational
awareness and biosurveillance network under paragraph
(1), including coordination among relevant agencies
related to health care services, the facilitation of
health information exchange (including the Office of
the National Coordinator for Health Information
Technology), and public health emergency preparedness
and response; and
``(B) consult with the Secretary of Agriculture,
the Secretary of Commerce (and the Director of the
National Institute of Standards and Technology), the
Secretary of Defense, the Secretary of Homeland
Security, and the Secretary of Veterans Affairs, and
the heads of other Federal agencies, as the Secretary
determines appropriate.'';
(C) in paragraph (3)--
(i) by redesignating subparagraphs (A)
through (E) as clauses (i) through (v),
respectively, and adjusting the margins
accordingly;
(ii) in clause (iv), as so redesignated--
(I) by inserting ``immunization
information programs,'' after ``poison
control,''; and
(II) by striking ``and clinical
laboratories'' and inserting ``,
clinical laboratories, and public
environmental health agencies'';
(iii) by striking ``The network'' and
inserting the following:
``(A) In general.--The network''; and
(iv) by adding at the end the following:
``(B) Review.--Not later than 2 years after the
date of the enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018 and
every 6 years thereafter, the Secretary shall conduct a
review of the elements described in subparagraph (A).
Such review shall include a discussion of the addition
of any elements pursuant to clause (v), including
elements added to advancing new technologies, and
identify any challenges in the incorporation of
elements under subparagraph (A). The Secretary shall
provide such review to the congressional committees of
jurisdiction.'';
(D) in paragraph (5)--
(i) by redesignating subparagraphs (A)
through (D) as clauses (i) through (iv),
respectively, and adjusting the margins
accordingly;
(ii) by striking ``In establishing'' and
inserting the following:
``(A) In general.--In establishing'';
(iii) by adding at the end the following:
``(B) Public meeting.--
``(i) In general.--Not later than 180 days
after the date of enactment of the Pandemic and
All-Hazards Preparedness and Advancing
Innovation Act of 2018, the Secretary shall
convene a public meeting for purposes of
discussing and providing input on the potential
goals, functions, and uses of the network
described in paragraph (1) and incorporating
the elements described in paragraph (3)(A).
``(ii) Experts.--The public meeting shall
include representatives of relevant Federal
agencies (including representatives from the
Office of the National Coordinator for Health
Information Technology and the National
Institute of Standards and Technology), State,
local, tribal, and territorial public health
officials, stakeholders with expertise in
biosurveillance and situational awareness, and
stakeholders with expertise in capabilities
relevant to biosurveillance and situational
awareness, such as experts in informatics and
data analytics (including experts in prediction
and forecasting), and other representatives as
the Secretary determines appropriate.
``(iii) Topics.--Such public meeting shall
include a discussion of--
``(I) data elements, including
minimal or essential data elements,
that are voluntarily provided for such
network, which may include elements
from public health and public and
private health care entities, to the
extent practicable;
``(II) standards and implementation
specifications that may improve the
collection, analysis, and
interpretation of data during a public
health emergency;
``(III) strategies to encourage the
access, exchange, and use of
information;
``(IV) considerations for State,
local, tribal, and territorial
capabilities and infrastructure related
to data exchange and interoperability;
``(V) privacy and security
protections provided at the Federal,
State, local, tribal, and territorial
levels, and by nongovernmental
stakeholders; and
``(VI) opportunities for the
incorporation of innovative
technologies to improve the network.'';
and
(iv) in subparagraph (A), as so designated
by clause (ii)--
(I) in clause (i), as so
redesignated--
(aa) by striking ``as
determined'' and inserting ``as
adopted''; and
(bb) by inserting ``and the
National Institute of Standards
and Technology'' after ``Office
of the National Coordinator for
Health Information
Technology'';
(II) in clause (iii), as so
redesignated, by striking ``; and'' and
inserting a semicolon;
(III) in clause (iv), as so
redesignated, by striking the period
and inserting ``; and''; and
(IV) by adding at the end the
following:
``(v) pilot test standards and
implementation specifications, consistent with
the process described in section 3002(b)(3)(C),
which State, local, tribal, and territorial
public health entities may utilize, on a
voluntary basis, as a part of the network.'';
(E) by redesignating paragraph (6) as paragraph
(7);
(F) by inserting after paragraph (5) the following:
``(6) Strategy and implementation plan.--
``(A) In general.--Not later than 18 months after
the date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018, the
Secretary shall submit to the appropriate committees of
Congress a coordinated strategy and an accompanying
implementation plan that--
``(i) is informed by the public meeting
under paragraph (5)(B);
``(ii) includes a review and assessment of
existing capabilities of the network and
related infrastructure, including input
provided by the public meeting under paragraph
(5)(B);
``(iii) identifies and demonstrates the
measurable steps the Secretary will carry out
to--
``(I) develop, implement, and
evaluate the network described in
paragraph (1), utilizing elements
described in paragraph (3)(A);
``(II) modernize and enhance
biosurveillance activities, including
strategies to include innovative
technologies and analytical approaches
(including prediction and forecasting
for pandemics and all-hazards) from
public and private entities;
``(III) improve information
sharing, coordination, and
communication among disparate
biosurveillance systems supported by
the Department of Health and Human
Services, including the identification
of methods to improve accountability,
better utilize resources and workforce
capabilities, and incorporate
innovative technologies within and
across agencies; and
``(IV) test and evaluate
capabilities of the interoperable
network of systems to improve
situational awareness and
biosurveillance capabilities;
``(iv) includes performance measures and
the metrics by which performance measures will
be assessed with respect to the measurable
steps under clause (iii); and
``(v) establishes dates by which each
measurable step under clause (iii) will be
implemented.''.
``(B) Annual budget plan.--Not later than 2 years
after the date of enactment of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of
2018 and on an annual basis thereafter, in accordance
with the strategy and implementation plan under this
paragraph, the Secretary shall, taking into account
recommendations provided by the National Biodefense
Science Board, develop a budget plan based on the
strategy and implementation plan under this section.
Such budget plan shall include--
``(i) a summary of resources previously
expended to establish, improve, and utilize the
nationwide public health situational awareness
and biosurveillance network under paragraph
(1);
``(ii) estimates of costs and resources
needed to establish and improve the network
under paragraph (1) according to the strategy
and implementation plan under subparagraph (A);
``(iii) the identification of gaps and
inefficiencies in nationwide public health
situational awareness and biosurveillance
capabilities, resources, and authorities needed
to address such gaps; and
``(iv) a strategy to minimize and address
such gaps and improve inefficiencies.'';
(G) in paragraph (7), as so redesignated--
(i) in subparagraph (A), by inserting
``(taking into account zoonotic disease,
including gaps in scientific understanding of
the interactions between human, animal, and
environmental health)'' after ``human health'';
(ii) in subparagraph (B)--
(I) by inserting ``and gaps in
surveillance programs'' after
``surveillance programs''; and
(II) by striking ``; and'' and
inserting a semicolon;
(iii) in subparagraph (C)--
(I) by inserting ``, animal health
organizations related to zoonotic
disease,'' after ``health care
entities''; and
(II) by striking the period and
inserting ``; and''; and
(iv) by adding at the end the following:
``(D) provide recommendations to the Secretary on
policies and procedures to complete the steps described
in this paragraph in a manner that is consistent with
section 2802.''; and
(H) by adding at the end the following:
``(8) Situational awareness and biosurveillance as a
national security priority.--The Secretary, on a periodic basis
as applicable and appropriate, shall meet with the Director of
National Intelligence to inform the development and
capabilities of the nationwide public health situational
awareness and biosurveillance network.'';
(5) in subsection (d)--
(A) in paragraph (1)--
(i) by inserting ``environmental health
agencies,'' after ``public health agencies,'';
and
(ii) by inserting ``immunization
programs,'' after ``poison control centers,'';
and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking
``and'' at the end;
(ii) in subparagraph (C), by striking the
period and inserting ``; and''; and
(iii) by adding after subparagraph (C) the
following:
``(D) an implementation plan that may include
measurable steps to achieve the purposes described in
paragraph (1).''; and
(C) by striking paragraph (5) and inserting the
following:
``(5) Technical assistance.--The Secretary may provide
technical assistance to States, localities, tribes, and
territories or a consortium of States, localities, tribes, and
territories receiving an award under this subsection regarding
interoperability and the technical standards set forth by the
Secretary.'';
(6) by redesignating subsections (f) and (g) as subsections
(h) and (i), respectively; and
(7) by inserting after subsection (e) the following:
``(f) Timeline.--The Secretary shall accomplish the purposes under
subsections (b) and (c) no later than September 30, 2023, and shall
provide a justification to Congress for any missed or delayed
implementation of measurable steps identified under subsection
(c)(6)(A)(iii).
``(g) Independent Evaluation.--Not later than 3 years after the
date of enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Comptroller General of the United
States shall conduct an independent evaluation, and submit to the
Secretary and the appropriate committees of Congress a report
concerning the activities conducted under subsections (b) and (c), and
provide recommendations, as applicable and appropriate, on necessary
improvements to the biosurveillance and situational awareness
network.''.
(b) Authorization of Appropriations.--Subsection (h) of section
319D (42 U.S.C. 247d-4), as redesignated by subsection (a)(6), is
amended by striking ``$138,300,000 for each of fiscal years 2014
through 2018'' and inserting ``$161,800,000 for each of fiscal years
2019 through 2023''.
SEC. 205. STRENGTHENING AND SUPPORTING THE PUBLIC HEALTH EMERGENCY
RAPID RESPONSE FUND.
Section 319 of the Public Health Service Act (42 U.S.C. 247d) is
amended--
(1) in subsection (b)--
(A) in paragraph (1)--
(i) in the first sentence, by inserting
``or if the Secretary determines there is the
significant potential for a public health
emergency, to allow the Secretary to rapidly
respond to the immediate needs resulting from
such public health emergency or potential
public health emergency'' before the period;
and
(ii) by inserting ``The Secretary shall
plan for the expedited distribution of funds to
appropriate agencies and entities.'' after the
first sentence;
(B) by redesignating paragraph (2) as paragraph
(3);
(C) by inserting after paragraph (1) the following:
``(2) Uses.--The Secretary may use amounts in the Fund
established under paragraph (1), to--
``(A) facilitate coordination between and among
Federal, State, local, tribal, and territorial entities
and public and private health care entities that the
Secretary determines may be affected by a public health
emergency or potential public health emergency
(including communication of such entities with relevant
international entities, as applicable);
``(B) make grants, provide for awards, enter into
contracts, and conduct supportive investigations
pertaining to a public health emergency or potential
public health emergency, including further supporting
programs under section 319C-1 or 319C-2;
``(C) facilitate and accelerate, as applicable,
advanced research and development of security
countermeasures (as defined in section 319F-2),
qualified countermeasures (as defined in section 319F-
1), or qualified pandemic or epidemic products (as
defined in section 319F-3), that are applicable to the
public health emergency or potential public health
emergency under paragraph (1);
``(D) strengthen biosurveillance capabilities and
laboratory capacity to identify, collect, and analyze
information on such public health emergency or
potential public health emergency, including the
systems under section 319D;
``(E) support initial emergency operations and
assets related to preparation and deployment of
intermittent disaster response personnel expenses under
section 2812, and the Medical Reserve Corps under
section 2813; and
``(F) other activities, as the Secretary determines
applicable and appropriate.''; and
(D) by inserting after paragraph (3), as so
redesignated, the following:
``(4) Review.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Secretary, in
coordination with the Assistant Secretary for Preparedness and
Response, shall conduct a review of the Fund under this
section, and provide recommendations to the Committee on
Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives on policies to improve such Fund for the uses
described in paragraph (2).
``(5) GAO report.--Not later than 4 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, the Comptroller General of
the United States shall conduct a review of the Fund under this
section, including the uses and the resources available in the
Fund.''; and
(2) in subsection (c)--
(A) by inserting ``rapidly respond to public health
emergencies or potential public health emergencies
and'' after ``used to''; and
(B) by striking ``section.'' and inserting ``Act or
funds otherwise provided for emergency response.''.
SEC. 206. IMPROVING PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS BY
PUBLIC HEALTH EMERGENCY VOLUNTEERS.
Section 319I (42 U.S.C. 247d-7b) is amended:
(1) in subsection (a), by adding at the end the following:
``Such health care professionals may include members of the
National Disaster Medical System, members of the Medical
Reserve Corps, and individual health care professionals.'';
(2) in subsection (i) by adding at the end ``In order to
inform the development of such mechanisms by States, the
Secretary shall make available information and material
provided by States that have developed mechanisms to waive the
application of licensing requirements to applicable health
professionals seeking to provide medical services during a
public health emergency. Such information shall be made
publicly available in a manner that does not jeopardize
national security.''; and
(3) in subsection (k) by striking ``$2014 through 2018''
and inserting ``2019 through 2023''.
TITLE III--REACHING ALL COMMUNITIES
SEC. 301. STRENGTHENING AND ASSESSING THE EMERGENCY RESPONSE WORKFORCE.
(a) National Disaster Medical System.--Clause (ii) of section
2812(a)(3)(A) (42 U.S.C. 300hh-11(a)(3)(A)) is amended to read as
follows:
``(ii) be present at locations, and for
limited periods of time, specified by the
Secretary on the basis that the Secretary has
determined that a location is at risk of a
public health emergency during the time
specified, or there is a significant potential
for a public health emergency.''.
(b) Volunteer Medical Reserve Corps.--Section 2813(a) (42 U.S.C. 42
U.S.C. 300hh-15(a)) is amended by striking the second sentence and
inserting ``The Secretary may appoint a Director to head the Corps and
oversee the activities of the Corps chapters that exist at the State,
local, and tribal levels.''
(c) Review of the National Disaster Medical System.--Section
2812(b)(2) (42 U.S.C. 300hh-11(b)(2)) is amended to read as follows:
``(2) Joint review and medical surge capacity strategic
plan.--
``(A) Review.--Not later than 180 days after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018, the
Secretary, in coordination with the Secretary of
Homeland Security, the Secretary of Defense, and the
Secretary of Veterans Affairs, shall conduct a joint
review of the National Disaster Medical System. Such
review shall include--
``(i) an evaluation of medical surge
capacity, as described in section 2803(a);
``(ii) an assessment of the available
workforce of the intermittent disaster response
personnel described in subsection (c);
``(iii) the capacity of the workforce
described in clause (ii) to respond to all
hazards, including capacity to simultaneously
respond to multiple public health emergencies
and the capacity to respond to a nationwide
public health emergency;
``(iv) the effectiveness of efforts to
recruit, retain, and train such workforce; and
``(v) gaps that may exist in such workforce
and recommendations for addressing such gaps.
``(B) Updates.--As part of the National Health
Security Strategy under section 2802, the Secretary
shall update the findings from the review under
subparagraph (A) and provide recommendations to modify
the policies of the National Disaster Medical System as
necessary.''.
(d) Notification of NDMS Shortage.--Section 2812(c) (42 U.S.C.
300hh-11(c)) is amended by adding at the end the following:
``(3) Service benefit.--Individuals appointed to serve
under this subsection shall be considered public safety
officers under part L of title I of the Omnibus Crime Control
and Safe Streets Act of 1968. The Secretary shall provide
notification to eligible individuals of any effect such
designation may have on other benefits for which such
individuals are eligible, including benefits from private
entities.
``(4) Notification.--Not later than 30 days after the date
on which the Secretary determines the number of intermittent
disaster response personnel of such System is insufficient to
address a public health emergency or potential public health
emergency, the Secretary shall submit to the congressional
committees of jurisdiction a notification detailing the impact
such shortage could have on meeting public health needs and
emergency medical personnel needs during a public health
emergency, and any identified measures to address such
shortage.
``(5) Certain appointments.--
``(A) In general.--If the Secretary determines that
the number of intermittent disaster response personnel
within the National Disaster Medical System under this
section is insufficient to address a public health
emergency or potential public health emergency, the
Secretary may appoint candidates directly to personnel
positions for intermittent disaster response within
such system. The Secretary shall provide updates on the
number of vacant or unfilled positions within such
system to the congressional committees of jurisdiction
each quarter for which this authority is in effect.
``(B) Sunset.--The authority under this paragraph
shall expire on September 30, 2021.''.
(e) Public Safety Officer Benefits.--Section 1204(9) of title I of
the Omnibus Crime Control and Safe Streets Act of 1968 (34 U.S.C.
10284(9)) is amended--
(1) in subparagraph (C)(ii), by striking ``or'' at the end;
(2) in subparagraph (D), by striking the period and
inserting ``; or''; and
(3) by inserting after subparagraph (D) the following:
``(E) an individual appointed to the National
Disaster Medical System under section 2812 of the
Public Health Service Act (42 U.S.C. 300hh-11) who is
performing official duties of the Department of Health
and Human Services, if those official duties are
related to responding to a public health emergency or
potential public health emergency, or other activities
for which the Secretary of Health and Human Services
has activated such National Disaster Medical System.''.
(f) National Disaster Medical System Authorization of
Appropriations.--Section 2812(g) (42 U.S.C. 300hh-11(g)) is amended by
striking ``$52,700,000 for each of fiscal years 2014 through 2018'' and
inserting ``$57,400,000 for each of fiscal years 2019 through 2023''.
(g) Medical Reserve Corps Authorization of Appropriations.--Section
2813(i) (42 U.S.C. 300hh-15(i)) is amended by striking ``2014 through
2018'' and inserting ``2019 through 2023''.
SEC. 302. HEALTH SYSTEM INFRASTRUCTURE TO IMPROVE PREPAREDNESS AND
RESPONSE.
(a) Coordination of Preparedness.--Section 2811(b)(5) (42 U.S.C.
300hh-10(b)(5)) is amended by adding at the end the following: ``Such
logistical support shall include working with other relevant Federal,
State, local, tribal, and territorial public health officials and
private sector partners to identify the critical infrastructure assets,
systems, and networks needed for the proper functioning of the health
care and public health sectors that need to be maintained through any
emergency or disaster, including entities capable of assisting with,
responding to, and mitigating the effect of a public health emergency,
including an emergency under section 319, an emergency or major
disaster under the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, or the National Emergencies Act, including by
establishing methods to exchange critical information and deliver
products consumed or used to preserve, protect, or sustain life,
health, or safety, and sharing of specialized expertise.''.
(b) Manufacturing Capacity.--Section 2811(d)(2)(C) (42 U.S.C.
300hh-10(d)(2)(C)) is amended by inserting ``, and ancillary medical
supplies to assist with the utilization of such products,'' after
``products''.
SEC. 303. CONSIDERATIONS FOR AT-RISK INDIVIDUALS.
(a) At-Risk Individuals in the National Health Security Strategy.--
Section 2802(b)(4)(B) (42 U.S.C. 300hh-1(b)(4)(B)) is amended--
(1) by striking ``this section and sections 319C-1, 319F,
and 319L,'' and inserting ``this Act''; and
(2) by striking ``special'' and inserting ``access or
functional''.
(b) Countermeasure Considerations.--Section 319L(c)(6) (42 U.S.C.
247d-7e(c)(6)) is amended--
(1) by striking ``elderly'' and inserting ``senior
citizens''; and
(2) by inserting ``with relevant characteristics that
warrant consideration during the process of researching and
developing such countermeasures and products'' before the
period.
SEC. 304. IMPROVING EMERGENCY PREPAREDNESS AND RESPONSE CONSIDERATIONS
FOR CHILDREN.
Part B of title III (42 U.S.C. 243 et seq.) is amended by inserting
after section 319D the following:
``SEC. 319D-1. CHILDREN'S PREPAREDNESS UNIT.
``(a) Enhancing Emergency Preparedness for Children.--The
Secretary, acting through the Director of the Centers for Disease
Control and Prevention (referred to in this subsection as the
`Director'), shall maintain an internal team of experts, to be known as
the Children's Preparedness Unit (referred to in this subsection as the
`Unit'), to work collaboratively to provide guidance on the
considerations for, and the specific needs of, children before, during,
and after public health emergencies. The Unit shall inform the Director
regarding emergency preparedness and response efforts pertaining to
children at the Centers for Disease Control and Prevention.
``(b) Expertise.--The team described in subsection (a) shall
include one or more pediatricians, which may be a developmental-
behavior pediatrician, and may also include behavioral scientists,
child psychologists, epidemiologists, biostatisticians, health
communications staff, and individuals with other areas of expertise, as
the Secretary determines appropriate.
``(c) Duties.--The team described in subsection (a) may--
``(1) assist State, local, tribal, and territorial
emergency planning and response activities related to children,
which may include developing, identifying, and sharing best
practices;
``(2) provide technical assistance, training, and
consultation to Federal, State, local, tribal, and territorial
public health officials to improve preparedness and response
capabilities with respect to the needs of children, including
providing such technical assistance, training, and consultation
to eligible entities in order to support the achievement of
measurable evidence-based benchmarks and objective standards
applicable to sections 319C-1 and 319C-2;
``(3) improve the utilization of methods to incorporate the
needs of children in planning for and responding to a public
health emergency, including public awareness of such methods;
``(4) coordinate with, and improve, public-private
partnerships, such as health care coalitions pursuant to
sections 319C-2 and 319C-3, to address gaps and inefficiencies
in emergency preparedness and response efforts for children;
``(5) provide expertise and input during the development of
guidance and clinical recommendations to address the needs of
children when preparing for, and responding to, public health
emergencies; and
``(6) carry out other duties related to preparedness and
response activities for children, as the Secretary determines
appropriate.''.
SEC. 305. REAUTHORIZING THE NATIONAL ADVISORY COMMITTEE ON CHILDREN AND
DISASTERS.
Section 2811A (42 U.S.C. 300hh-10a) is amended--
(1) in subsection (b)(2), by inserting ``, mental and
behavioral,'' after ``medical'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``15'' and
inserting ``25''; and
(B) by striking paragraph (2) and inserting the
following:
``(2) Required non-federal members.--The Secretary, in
consultation with such other heads of Federal agencies as may
be appropriate, shall appoint to the Advisory Committee under
paragraph (1) at least 13 individuals to perform the duties
described in subsections (b) and (c), including--
``(A) at least 2 non-Federal professionals with
expertise in pediatric medical disaster planning,
preparedness, response, or recovery;
``(B) at least 2 representatives from State, local,
tribal, or territorial agencies with expertise in
pediatric disaster planning, preparedness, response, or
recovery;
``(C) at least 4 members representing health care
professionals, which may include members with expertise
in pediatric emergency medicine; pediatric trauma,
critical care, or surgery; the treatment of pediatric
patients affected by chemical, biological,
radiological, or nuclear agents and emerging infectious
diseases; pediatric mental or behavioral health related
to children affected by a public health emergency; or
pediatric primary care; and
``(D) other members as the Secretary determines
appropriate, of whom--
``(i) at least one such member shall
represent a children's hospital;
``(ii) at least one such member shall be an
individual with expertise in schools or child
care settings;
``(iii) at least one such member shall be
an individual with expertise in children and
youth with special health care needs; and
``(iv) at least one such member shall be an
individual with expertise in the needs of
parents or family caregivers, including the
parents or caregivers of children with
disabilities.''.
``(3) Federal members.--The Advisory Committee under
paragraph (1) shall include the following Federal members or
their designees:
``(A) The Assistant Secretary for Preparedness and
Response.
``(B) The Director of the Biomedical Advanced
Research and Development Authority.
``(C) The Director of the Centers for Disease
Control and Prevention.
``(D) The Commissioner of Food and Drugs.
``(E) The Director of the National Institutes of
Health.
``(F) The Assistant Secretary of the Administration
for Children and Families.
``(G) The Administrator of the Health Resources and
Services Administration.
``(H) The Administrator of the Federal Emergency
Management Agency.
``(I) The Administrator of the Administration for
Community Living.
``(J) The Secretary of Education.
``(K) Representatives from such Federal agencies
(such as the Substance Abuse and Mental Health Services
Administration and the Department of Homeland Security)
as the Secretary determines appropriate to fulfill the
duties of the Advisory Committee under subsections (b)
and (c).''.
``(4) Term of appointment.--Each member of the Advisory
Committee appointed under paragraph (2) shall serve for a term
of 3 years, except that the Secretary may adjust the terms of
the Advisory Committee appointees serving on the date of
enactment of the Pandemic and All-Hazards Preparedness and
Advancing Innovation Act of 2018, or appointees who are
initially appointed after such date of enactment, in order to
provide for a staggered term of appointment for all members.
``(5) Consecutive appointments; maximum terms.--A member
appointed under paragraph (2) may serve not more than 3 terms
on the Advisory Committee, and not more than 2 of which may be
served consecutively.'';
(3) in subsection (e), by adding at the end ``At least one
meeting per year shall be an in-person meeting.''; and
(4) in subsection (f) by striking ``2018'' and inserting
``2023''.
SEC. 306. GUIDANCE FOR PARTICIPATION IN EXERCISES AND DRILLS.
Not later than 2 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue final guidance
regarding the participation of State, local, tribal, and territorial
public health department or agency personnel funded in whole or in part
through programs authorized under this Act in drills and operational
exercises in order to identify, inform, and address the gaps in and
policies related to all-hazards medical and public health preparedness
and response, which may include drills and operational exercises that
incorporate medical surge capacity planning, medical countermeasure
distribution and administration, and preparing for and responding to
identified threats for that region. The Secretary shall consult with
the Department of Homeland Security, the Department of Defense, the
Department of Veterans Affairs, and other applicable Federal
departments and agencies as necessary and appropriate in the
development of such guidance. The Secretary shall make the guidance
available on the internet website of the Department of Health and Human
Services.
TITLE IV--PRIORITIZING A THREAT-BASED APPROACH
SEC. 401. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.
Section 2811(b) (42 U.S.C. 300hh-10(b)) is amended--
(1) in the matter preceding paragraph (1) by inserting
``utilize experience related to public health emergency
preparedness and response, biodefense, medical countermeasures,
and other relevant topics to'' after ``shall''; and
(2) in paragraph (4) by adding at the end the following:
``(I) Threat awareness.--Coordinate with the
Director of the Centers for Disease Control and
Prevention, the Director of National Intelligence, the
Secretary of Homeland Security, the Assistant to the
President for National Security Affairs, the Secretary
of Defense, and other relevant Federal officials, to
maintain a current assessment of national security
threats and inform preparedness and response
capabilities based on the range of the threats that
have the potential to result in a public health
emergency.''.
SEC. 402. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.
(a) In General.--Title XXVIII is amended by inserting after section
2811 (42 U.S.C. 300hh-10) the following:
``SEC. 2811-1. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES
ENTERPRISE.
``(a) In General.--The Secretary shall establish the Public Health
Emergency Medical Countermeasures Enterprise (referred to in this
section as the `PHEMCE'). The Assistant Secretary for Preparedness and
Response shall serve as chair of the PHEMCE.
``(b) Members.--The PHEMCE shall include each of the following
members, or the designee of such members:
``(1) The Assistant Secretary for Preparedness and
Response.
``(2) The Director of the Centers for Disease Control and
Prevention.
``(3) The Director of the National Institutes of Health.
``(4) The Commissioner of Food and Drugs.
``(5) The Secretary of Defense.
``(6) The Secretary of Homeland Security.
``(7) The Secretary of Agriculture.
``(8) The Secretary of Veterans Affairs.
``(9) Representatives of any other Federal agency, which
may include the Director of the Biomedical Advanced Research
and Development Authority, and the Director of the Strategic
National Stockpile, as the Secretary determines appropriate.
``(c) Functions.--
``(1) In general.--The functions of the PHEMCE shall
include the following:
``(A) Establish a process pursuant to section
2811(d)(2)(B) to make recommendations to the Secretary
regarding the prioritization of research, development,
and procurement of countermeasures, as defined in
section 319F-2(c), based on the health security needs
of the United States. Such recommendations shall be
informed by the National Health Security Strategy
pursuant to section 2802, the Strategic National
Stockpile review required under section 319F-2(a)(2),
the countermeasures budget plan pursuant to section
2811(b)(7), and an assessment of current national
security threats, including chemical, biological,
radiological and nuclear threats, including emerging
infectious diseases. In the event that members of the
PHEMCE do not agree upon a recommendation, the
Secretary shall provide a determination regarding such
recommendation.
``(B) Identify national health security needs,
including gaps in public health preparedness and
response related to countermeasures and challenges to
addressing such needs (including any regulatory
challenges), and provide for alignment of
countermeasure procurement with recommendations under
subparagraph (A).
``(C) Develop strategies related to logistics,
deployment, distribution, dispensing, and use of
countermeasures that may be applicable to the
activities of the strategic national stockpile under
section 319F-2(a).
``(D) Provide consultation for the development of
the strategy and implementation plan under section
2811(d).
``(2) Input.--In carrying out subparagraphs (B) and (C) of
paragraph (1), the PHEMCE shall solicit and consider input from
State, local, tribal, and territorial public health
departments, as appropriate.''.
(b) Public Health Emergency Medical Countermeasures Enterprise
Strategy and Implementation Plan.--Section 2811(d)(1) (42 U.S.C. 300hh-
10(d)(1)) is amended--
(1) by striking ``Not later than 180 days after the date of
enactment of this subsection, and every year thereafter'' and
inserting ``Not later than March 15, 2020, and biennially
thereafter''; and
(2) by striking ``Director of Biomedical'' and all that
follows through ``Food and Drugs'' and inserting ``Public
Health Emergency Medical Countermeasures Enterprise established
under section 2811-1''.
SEC. 403. STRATEGIC NATIONAL STOCKPILE.
(a) Section 319F-2(a) (42 U.S.C. 247d-6b(a)) is amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(2) in paragraph (1)--
(A) by inserting ``and optimize'' after ``provide
for'';
(B) by inserting ``and, as informed by existing
recommendations of, or consultations with, the Public
Health Emergency Medical Countermeasure Enterprise
established under section 2811-1, make necessary
additions or modifications to the contents of such
stockpile or stockpiles based on the review conducted
under paragraph (2)'' before the period of the first
sentence; and
(C) by striking the second sentence;
(3) by inserting after paragraph (1) the following:
``(2) Threat-based review.--
``(A) In general.--The Secretary shall conduct a
biennial threat-based review (taking into account at-
risk individuals) of the contents of the stockpile
under paragraph (1), including non-pharmaceutical
supplies, and, in consultation with the Public Health
Emergency Medical Countermeasures Enterprise
established under section 2811-1, review contents
within the stockpile and assess whether such contents
are consistent with the recommendations made pursuant
to section 2811-1(c)(1)(A). Such review shall be
submitted biennially, beginning on March 15, 2019, to
the Committee on Health, Education, Labor, and Pensions
and the Committee on Appropriations of the Senate and
the Committee on Energy and Commerce and the Committee
on Appropriations of the House of Representatives, in a
manner that does not compromise national security.
``(B) Additions, modifications, and
replenishments.--Each biennial threat-based review
under subparagraph (A) shall, for each new or modified
countermeasure procurement or replenishment, provide--
``(i) information regarding--
``(I) the quantities of the
additional or modified countermeasure
procured for, or contracted to be
procured for, the stockpile;
``(II) planning considerations for
appropriate manufacturing capacity and
capability to meet the goals of such
additions or modifications (without
disclosing proprietary information),
including consideration of the effect
such additions or modifications may
have on the availability of such
products and ancillary medical supplies
in the health care system;
``(III) the presence or lack of a
commercial market for the
countermeasure at the time of
procurement;
``(IV) the emergency health
security threat or threats such
countermeasure procurement is intended
to address, including whether such
procurement is consistent with meeting
emergency health security needs
associated with such threat or threats;
``(V) an assessment of whether the
emergency health security threat or
threats described in subclause (IV)
could be addressed in a manner that
better utilizes the resources of the
stockpile and permits the greatest
possible increase in the level of
emergency preparedness to address such
threats;
``(VI) whether such countermeasure
is replenishing an expired
countermeasure, is a different
countermeasure with the same indication
that is replacing an expired
countermeasure, or is a new addition to
the stockpile;
``(VII) a description of how such
additions or modifications align with
the countermeasures budget plan as
required under section 2811(b)(7),
including expected life-cycle costs,
expenditures related to countermeasure
procurement to address the threat or
threats described in subclause (IV),
replenishment dates (including the
ability to extend the maximum shelf
life of a countermeasure), and the
manufacturing capacity required to
replenish such countermeasure; and
``(VIII) appropriate protocols and
processes for the deployment,
distribution, or dispensing of the
countermeasure at the State and local
level, including plans for relevant
capabilities of State and local
entities to dispense, distribute, and
administer the countermeasure; and
``(ii) an assurance that for each
countermeasure produced or replenished under
this subsection, the Secretary completed a
review addressing each item listed under this
subsection in advance of such procurement or
replenishment, which need not be provided in
advance of procurement.'';
(4) in paragraph (3), as so redesignated--
(A) in subparagraph (A), by inserting ``and the
Public Health Emergency Medical Countermeasures
Enterprise established under section 2811-1'' before
the semicolon;
(B) in subparagraph (C), by inserting ``, and the
availability, deployment, dispensing, and
administration of countermeasures'' before the
semicolon; and
(C) by amending subparagraph (E) to read as
follows:
``(E) devise plans for effective and timely supply-
chain management of the stockpile, in consultation with
the Director of the Centers for Disease Control and
Prevention, the Assistant Secretary for Preparedness
and Response, the Secretary of Transportation, the
Secretary of Homeland Security, the Secretary of
Veterans Affairs, and the heads of other appropriate
Federal agencies, State, local, tribal, and territorial
agencies, and the public and private health care
infrastructure, as applicable, taking into account the
manufacturing capacity and other available sources of
products and appropriate alternatives to supplies in
the stockpile''; and
(5) by adding at the end the following:
``(5) GAO report.--
``(A) In general.--Not later than 3 years after the
date of enactment of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018, and
every 5 years thereafter, the Comptroller General of
the United States shall conduct a review of any changes
to the contents or management of the stockpile since
January 1, 2015. Such review shall include--
``(i) an assessment of the
comprehensiveness and completeness of each
biennial threat-based review under paragraph
(2), including whether all newly procured or
replenished countermeasures within the
stockpile were described in each annual review,
and whether, consistent with paragraph (2)(B),
the Secretary conducted the necessary internal
review in advance of such procurement or
replenishment;
``(ii) an assessment of whether the
Secretary established health security and
science-based justifications, and a description
of such justifications for procurement
decisions related to health security needs with
respect to the identified threat, for additions
or modifications to the stockpile based on the
information provided in such reviews under
paragraph (2)(B), including whether such review
was conducted prior to procurement,
modification, or replenishment;
``(iii) an assessment of the plans
developed by the Secretary for the deployment,
distribution, and dispensing of countermeasures
procured, modified, or replenished under
paragraph (1), including whether such plans
were developed prior to procurement,
modification, or replenishment;
``(iv) an accounting of countermeasures
procured, modified, or replenished under
paragraph (1) that received advanced research
and development funding from the Biomedical
Advanced Research and Development Authority;
``(v) an analysis of how such procurement
decisions made progress towards meeting
emergency health security needs related to the
identified threats for countermeasures added,
modified, or replenished under paragraph (1);
``(vi) a description of the resources
expended related to the procurement of
countermeasures (including additions,
modifications, and replenishments) in the
stockpile, and how such expenditures relate to
the emergency health security needs of the
stockpile;
``(vii) an assessment of the extent to
which additions, modifications, and
replenishments reviewed under paragraph (2)
align with previous relevant reports or reviews
by the Secretary or the Comptroller General;
and
``(viii) with respect to any change in the
Federal organizational management of the
stockpile, an assessment and comparison of the
processes affected by such change, including
planning for potential countermeasure
deployment, distribution, or dispensing
capabilities and processes related to
procurement decisions, use of stockpiled
countermeasures, and use of resources for such
activities.
``(B) Submission.--Not later than 6 months after
completing a classified version of the review under
subparagraph (A), the Comptroller General shall submit
an unclassified version of the review to the
appropriate committees of Congress.''.
(b) Authorization of Appropriations, Strategic National
Stockpile.--Section 319F-2(f)(1) (42 U.S.C. 247d-6b(f)(1)) is amended
by striking ``$533,800,000 for each of fiscal years 2014 through 2018''
and inserting ``$610,000,000 for each of fiscal years 2019 through
2023''.
SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL RESISTANCE,
AND OTHER SIGNIFICANT THREATS.
Section 319L(c)(4) (247d-7e(c)(4)) is amended by adding at the end
the following:
``(F) Strategic initiatives.--The Secretary, acting
through the Director of BARDA, may implement strategic
initiatives, including by building on existing
programs, supporting innovative candidate products in
preclinical and clinical development, to address
priority, naturally occurring and man-made threats
that, as determined by the Secretary, pose a
significant level of risk to national security based on
the characteristics of a chemical, biological,
radiological or nuclear threat, or existing
capabilities to respond to such a threat (including
medical response and treatment capabilities and
manufacturing infrastructure). Such initiatives shall
accelerate and support the advanced research,
development, and procurement of, countermeasures and
products, as applicable, to address areas including--
``(i) chemical, biological, radiological,
or nuclear threats, including emerging
infectious diseases, for which insufficient
approved, licensed, or authorized
countermeasures exist, or for which such
threat, or the result of an exposure to such
threat, may become resistant to countermeasures
or existing countermeasures may be rendered
ineffective;
``(ii) threats that consistently exist or
continually circulate and have significant
potential to become a pandemic, such as
pandemic influenza, which may include the
advanced research and development,
manufacturing, and appropriate stockpiling of
qualified pandemic or epidemic products, and
products, technologies, or processes to support
the advanced research and development of such
countermeasures (including multiuse platform
technologies for diagnostics, vaccines, and
therapeutics; virus seeds; clinical trial lots;
novel virus strains; and antigen and adjuvant
material); and
``(iii) threats that may result primarily
or secondarily from a chemical, biological,
radiological, or nuclear agent, or emerging
infectious disease, and which may present
increased treatment complications such as the
occurrence of resistance to available
countermeasures or potential countermeasures,
including antimicrobial resistant pathogens.''.
SEC. 405. REPORTING ON THE FEDERAL SELECT AGENT PROGRAM.
Section 351A(k) (42 U.S.C. 262a) 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 Pandemic and All-Hazards
Preparedness and Advancing Innovation Act of 2018, the
Secretary shall provide an update to the appropriate
committees of Congress on the implementation of
recommendations of the Federal Experts Security
Advisory Panel concerning the select agent program.
``(B) Continued updates.--The Secretary shall
provide status updates at 6-month intervals following
the submission of the update under subparagraph (A)
until the recommendations described in such
subparagraph are fully implemented, or a justification
is provided for the delay in, or lack of,
implementation.''.
TITLE V--INCREASING COMMUNICATION IN MEDICAL COUNTERMEASURE ADVANCED
RESEARCH 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 of each year'' and inserting ``March 15, 2020 and
every 2 years thereafter'';
(2) by striking subparagraph (A) and inserting the
following:
``(A) include consideration of the entire medical
countermeasures enterprise, including--
``(i) basic research and advanced research
and development;
``(ii) approval, clearance, licensure, and
authorized uses of products;
``(iii) procurement, stockpiling,
maintenance, and potential replenishment
(including manufacturing capabilities) of all
products in the Strategic National Stockpile;
and
``(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 development;''.
(3) by redesignating subparagraphs (D) and (E) as
subparagraphs (E) and (F), respectively;
(4) by inserting after subparagraph (C), the following:
``(D) identify the full range of anticipated
medical countermeasure needs related to research and
development, procurement, and stockpiling, including
the potential need for indications, dosing, and
administration technologies, and other countermeasure
needs as applicable and appropriate;''; and
(5) in subparagraph (E), as so redesignated, by striking
``March 15 of each year'' and inserting ``March 15, 2020, and
every 2 years thereafter''.
SEC. 502. MATERIAL THREAT AND MEDICAL COUNTERMEASURE 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 Homeland 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 Security
and Government Affairs of the Senate and the Committee on Energy and
Commerce and the Committee on Homeland Security of the House of
Representatives''.
(b) Contracting Communications.--
(1) Contract duration.--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 Secretary shall notify the vendor
within 90 days of a determination by the Secretary to renew
such contract.''.
(2) Expedited authorities.--Section 319L(c)(5)(B)(i) (42
U.S.C. 247d-7e(c)(5)(B)(i)) is amended by adding at the end the
following: ``Upon award, extension, or termination of any such
contract, grant, cooperative agreement, and other transaction,
the Secretary shall provide a written notification to the
receiving entity that includes a justification for such award,
extension, or termination.''.
SEC. 503. AVAILABILITY OF REGULATORY MANAGEMENT PLANS.
Section 565(f) of the Federal Food, Drug, and Cosmetic 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 following:
``(3) Publication.--The Secretary shall make available on
the internet website of the Food and Drug Administration
information regarding regulatory management plans, including--
``(A) the process by which an applicant may submit
a request for a regulatory management plan;
``(B) the timeframe by which the Secretary is
required to respond to such request;
``(C) the information required for the submission
of such request;
``(D) a description of the types of development
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 inserting
``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 ``paragraph (4)(A)''.
SEC. 504. THE BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY
AND THE BIOSHIELD 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 ``$3,500,000,000 for
the period of fiscal years 2019 through 2023, to remain
available until expended''; and
(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''.
TITLE VI--ADVANCING TECHNOLOGIES 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'' inserting ``platform
technologies, technologies to administer countermeasures, technologies
to improve storage, and transportation of countermeasures''.
SEC. 602. MEDICAL COUNTERMEASURE MASTER FILES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 565A
the following:
``SEC. 565B. MEDICAL COUNTERMEASURE MASTER FILES.
``(a) Purpose.--The purpose of this section is to support and
accelerate the development or manufacture of security countermeasures,
qualified countermeasures, and qualified pandemic or epidemic products
by facilitating and encouraging submission of data and information to
support such products to master files, and through clarifying the
authority to cross-reference to data and information previously
submitted to the Secretary.
``(b) Applicability of Reference.--
``(1) In general.--A person may submit data and information
to the Secretary with the intent to reference, or to authorize,
in writing, another person to reference, such data or
information, in accordance with subsections (d) and (e) of
section 314.420 of title 21, Code of Federal Regulations (or
any successor regulations), to support a medical countermeasure
submission (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.
``(2) Master file holder.--In this section, the term
`master file holder' means a person who submits data and
information to the Secretary with the intent to reference or
authorize to reference such data or information to support a
medical countermeasure submission, as described in paragraph
(1).
``(c) Medical Countermeasure Master File Content.--
``(1) In general.--A master file under this section may
include information to support and accelerate--
``(A) the development of medical countermeasure
submissions to support the approval, licensure,
classification, clearance, conditional approval, or
authorization of one or more security countermeasures,
qualified countermeasures, or qualified pandemic or
epidemic products; and
``(B) the manufacture of security countermeasures,
qualified countermeasures, or qualified 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 updated during the time such
master file is referenced for a medical countermeasure
submission.
``(d) Sponsor Reference.--
``(1) In general.--Each incorporation of information or
data contained in a master file by reference shall describe the
incorporated material in a manner in which the Secretary
determines appropriate and that permits the review of such
information without necessitating resubmission of such
information or data. Master files shall be submitted in an
electronic format in accordance with section 745A and as
specified in applicable guidance.
``(2) Reference by a master file holder.--A master file
holder that is the sponsor of a 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 person.--A sponsor of a
medical countermeasure submission may, where the Secretary
determines appropriate, incorporate by reference all or part of
the contents of a medical countermeasure master file, if the
master file holder authorizes the incorporation in writing.
``(e) Acknowledgement of Master File by the Secretary.--The
Secretary shall provide the master file holder with a written
notification indicating that the Secretary has reviewed and relied upon
specified information or data within a master file and the purposes for
which such information or data was incorporated by reference if the
Secretary has reviewed and relied upon such specified information or
data to support the approval, classification, 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 master file for which such written notification was
provided in additional applications, as applicable and appropriate and
upon the request of the master file holder so notified in writing or by
an authorized person of such holder.
``(f) Rules of Construction.--Nothing in this section shall be
construed to--
``(1) alter the authority of the Secretary to approve,
license, classify, clear, conditionally approve, or authorize
drugs, biological products, or devices pursuant to this Act or
section 351 of the Public Health Service Act (as authorized
prior to 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; or
``(2) alter the authority of the Secretary under this Act
or the Public Health Service Act to determine the types of
information or data 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
product, or device submitted under sections 505(i), 505(b),
505(j), 512(b)(1), 512(b)(2), 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
requirements associated with such reference.
``(g) Definitions.--In this section:
``(1) The term `medical countermeasure submission' means an
investigational new drug application under section 505(i), a
new drug application under section 505(b), or an abbreviated
new drug application 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 biological
product license application under section 351(k) of the Public
Health Service Act, a new animal drug application under section
512(b)(1) or abbreviated new animal drug application under
section 512(b)(2), an application for conditional approval of a
new animal drug under 571, an investigational 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 device under section 510(k), or request for an
emergency use authorization under section 564 to support--
``(A) the approval, licensure, classification,
clearance, conditional approval, or authorization of a
security countermeasure, qualified countermeasure, or
qualified pandemic or epidemic product; or
``(B) a new indication to an approved security
countermeasure, qualified countermeasure, or qualified
pandemic or epidemic product.
``(2) The terms `qualified countermeasure', `security
countermeasure', and `qualified pandemic or epidemic product'
have the meanings given such terms in sections 319F-1, 319F-2,
and 319F-3, respectively, of the Public Health Service Act.''.
(b) Stakeholder Input.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), 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 developing 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 technologies
to support and accelerate the development or manufacture of security
countermeasures, qualified countermeasures, and qualified pandemic or
epidemic products, including through the reliance on cross-referenced
data and information contained within master files and submissions
previously submitted to the Secretary as set forth in section 565B of
the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
(c) Guidance.--Not later than 2 years after the after the date of
enactment of this Act, the Secretary, acting through the Commissioner
of Food and Drugs, shall publish 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 (a) 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
accelerate the development or manufacture of security countermeasures,
qualified countermeasures, 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. 603. ANIMAL RULE REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study on the application of the requirements under section
565(d) of the of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-4(d)) (referred to in this section as the ``animal rule'') as a
component of medical countermeasure advanced development under the
Biomedical Advanced Research and Development Authority and regulatory
review by the Food and Drug Administration. In conducting such study,
the Comptroller General shall examine the following:
(1) The extent to which advanced development and review of
a medical countermeasure are coordinated between the Biomedical
Advanced Research and Development Authority and the Food and
Drug Administration, including activities facilitate
appropriate and efficient design of studies to support
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 Development Under the Animal Rule Guidance
for Industry'' (issued in October 2015), to resolve
discrepancies in the design of adequate and well-controlled
efficacy studies conducted in animal models related to the
provision of substantial evidence of effectiveness for the
product approved, licensed, or authorized 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 flexibilities 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 decisionmaking with respect to
medical countermeasures.
(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), 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 advancing,
reviewing, and procuring medical countermeasures, including the
Office of the Assistant Secretary for Preparedness and
Response, the Biomedical Advanced Research and Development
Authority, 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, and 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 recommendations to improve the application and
consistency of the requirements 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 development 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.
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.--Section 319A(e) (42 U.S.C.
247d-1(e)) is amended by striking ``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) Public Disclosure Exemption.--Section 319L(e)(1)(C) (42 U.S.C.
247d-7e(e)(1)(C)) is amended by striking ``12'' and inserting ``17''.
(f) Limited Antitrust Exemption.--
(1) In general.--Section 405 of the Pandemic and All-
Hazards Preparedness Act (42 U.S.C. 247d-6a note) is amended--
(A) by redesignating such section as section 319L-
1;
(B) transferring such section to the Public Health
Service Act (42 U.S.C. 201 et seq.), to appear after
section 319L of such Act (42 U.S.C. 247d-7e);
(C) in subsection (a)(1)--
(i) by striking ``Secretary of Health and
Human Services (referred to in this subsection
as the `Secretary')'' and inserting
``Secretary'';
(ii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6b)) (as amended by
this Act'';
(iii) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6a)) (as amended by
this Act''; and
(iv) by striking ``of the Public Health
Service Act (42 U.S.C. 247d-6d)''; and
(D) in subsection (b), by striking ``12-year'' and
inserting ``17-year''.
(2) Effective date.--The amendment made by paragraph (1)(D)
shall take effect as if enacted on December 17, 2012.
(3) 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.
SEC. 702. 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 inserting ``section 319F(e)''; and
(2) in section 319K(a) (42 U.S.C. 247d-7d(a)), by striking
``section 319F(h)(4)'' and inserting ``section 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 ``individuals,,'' and
inserting ``individuals,''; and
(2) in subparagraph (F), by striking ``make satisfactory
annual improvement and describe'' and inserting ``makes
satisfactory annual improvement and describes''.
(c) Federal Food, Drug, and Cosmetic Act.--The Federal Food, Drug,
and Cosmetic Act is amended--
(1) in section 564A(e)(2)(A) (21 U.S.C. 360bbb-
3a(e)(2)(A)), by striking ``subsection (a)(1)(C)(i)'' and
inserting ``subsection (a)(1)(C)''; and
(2) in section 564B(2)(C) (21 U.S.C. 360bbb-3b(2)(C)), by
inserting ``or section 564A''.
<all>