[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2333 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2333
To reauthorize certain programs under the Public Health Service Act
with respect to public health security and all-hazards preparedness and
response, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 18, 2023
Mr. Casey (for himself, Mr. Romney, Mr. Sanders, and Mr. Cassidy)
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 Public Health Service Act
with respect to public health security and all-hazards preparedness and
response, and for other purposes.
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 Response Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--STATE AND LOCAL READINESS AND RESPONSE
Sec. 101. Temporary reassignment of State and local personnel during a
public health emergency.
Sec. 102. Public Health Emergency Preparedness program.
Sec. 103. Improving and enhancing participation of EMS organizations in
the hospital preparedness program.
Sec. 104. Improving medical readiness and response capabilities.
Sec. 105. Pilot program to support State medical stockpiles.
Sec. 106. Enhancing domestic wastewater surveillance for pathogen
detection.
Sec. 107. Reauthorization of Mosquito Abatement for Safety and Health
program.
TITLE II--FEDERAL PLANNING AND COORDINATION
Sec. 201. All-Hazards Emergency Preparedness and Response.
Sec. 202. National Health Security Strategy.
Sec. 203. Improving development and distribution of diagnostic tests.
Sec. 204. Pilot program for public health data availability.
Sec. 205. Combating antimicrobial resistance.
Sec. 206. Strategic National Stockpile and material threats.
Sec. 207. Medical countermeasures for viral threats with pandemic
potential.
Sec. 208. Public Health Emergency Medical Countermeasures Enterprise.
Sec. 209. Strengthening public health communication.
Sec. 210. Fellowship and training programs.
Sec. 211. Assessment of COVID-19 mitigation policies.
TITLE III--ADDRESSING THE NEEDS OF ALL INDIVIDUALS
Sec. 301. Transition of certain countermeasures between compensation
programs.
Sec. 302. Accelerating injury compensation program administration and
ensuring program integrity.
Sec. 303. Compensation for injuries relating to the public health
emergency caused by SARS-CoV-2.
Sec. 304. Review of regulations.
Sec. 305. Supporting individuals with disabilities, older adults, and
other at-risk individuals during emergency
responses.
Sec. 306. National advisory committees.
Sec. 307. Research and coordination of activities concerning the long-
term health effects of SARS-CoV-2
infection.
Sec. 308. National Academies study on prizes.
TITLE IV--STRENGTHENING BIOSECURITY
Sec. 401. Treatment of genetic variants and synthetic products of
select agents and toxins.
Sec. 402. Establishment of no-fault reporting system.
Sec. 403. Evaluation of the Federal Select Agent Program and related
policies.
Sec. 404. Supporting research and laboratory surge capacity.
Sec. 405. Gene synthesis.
Sec. 406. Limitation related to countries of concern conducting certain
research.
Sec. 407. Assessment of artificial intelligence threats to health
security.
TITLE V--PREVENTING DRUG SHORTAGES
Sec. 501. Improving notification procedures in case of increased demand
for critical drugs.
Sec. 502. Reporting on supply chains.
Sec. 503. Reporting on use of new authorities and requirements with
respect to drug shortages.
TITLE VI--ADDITIONAL REAUTHORIZATIONS AND TECHNICAL AMENDMENTS
Sec. 601. Medical countermeasure priority review voucher.
Sec. 602. Epidemic Intelligence Service loan repayment program.
Sec. 603. Vaccine tracking and distribution.
Sec. 604. Regional health care emergency preparedness and response
systems.
Sec. 605. Emergency system for advance registration of volunteer health
professional.
Sec. 606. Limited antitrust exemption.
Sec. 607. Trauma care.
Sec. 608. Military and civilian partnership for trauma readiness.
Sec. 609. National Disaster Medical System.
Sec. 610. Volunteer Medical Reserve Corps.
Sec. 611. Epidemiology-laboratory capacity grants.
Sec. 612. Veterans Affairs.
Sec. 613. Technical amendments.
TITLE I--STATE AND LOCAL READINESS AND RESPONSE
SEC. 101. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL DURING A
PUBLIC HEALTH EMERGENCY.
Section 319(e) of the Public Health Service Act (42 U.S.C. 247d(e))
is amended--
(1) in paragraph (1), by striking ``such Governor or tribal
organization's designee'' and inserting ``the designee of the
Governor or Tribal organization, or the State or Tribal health
official'';
(2) in paragraph (2)(B)--
(A) in the matter preceding clause (i), by striking
``tribal organization'' and inserting ``Tribal
organization, or the State or Tribal health official'';
and
(B) in clause (v), by striking ``tribal
organization'' and inserting ``Tribal organization or
State or Tribal health official'';
(3) in paragraph (6)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``Reauthorization Act of
2013'' and inserting ``and Response Act''; and
(ii) by striking ``appropriate committees
of the Congress'' and inserting ``Committee on
Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce
of the House of Representatives''; and
(B) in subparagraph (A), by inserting ``, including
requests from State or Tribal health officials'' before
the semicolon;
(4) in paragraph (7)(A), by striking ``tribal
organization'' and inserting ``Tribal organization''; and
(5) in paragraph (8), by striking ``2023'' and inserting
``2028''.
SEC. 102. PUBLIC HEALTH EMERGENCY PREPAREDNESS PROGRAM.
Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a)
is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A)(ii), by striking
``influenza'' and inserting ``response planning''; and
(B) in subparagraph (H), by inserting ``, such as
community-based organizations, including faith-based
organizations, and other public and private entities''
after ``stakeholders'';
(2) in subsection (g)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by inserting ``and the ability of
each entity receiving an award under subsection (a) to
respond to all-hazards threats'' before the period at
the end of the first sentence;
(B) in paragraph (2)--
(i) in the paragraph heading, by striking
``influenza'' and inserting ``response''; and
(ii) in subparagraph (A)--
(I) by striking ``to pandemic
influenza'' and inserting ``to a
pathogen causing a pandemic, including
pandemic influenza''; and
(II) by striking ``such pandemic
influenza'' and inserting ``such
pandemic response'';
(C) in paragraph (5)--
(i) in the paragraph heading, by striking
``influenza'' and inserting ``pandemic
response'';
(ii) in the matter preceding subparagraph
(A), by striking ``2019'' and inserting
``2025'';
(iii) in clause (i), by striking ``2018''
and inserting ``2024''; and
(iv) in subparagraph (B), by striking
``pandemic influenza'' and inserting ``a
pathogen causing a pandemic''; and
(D) in paragraph (6)--
(i) in subparagraph (A), in the matter
preceding clause (i), by striking ``The amounts
described in this paragraph are the following
amounts that are payable to an entity for
activities described in this section of section
319C-2'' and inserting ``The Secretary shall
withhold from an entity pursuant to paragraph
(5) for noncompliance with the requirements of
this section or section 319C-2 as follows'';
and
(ii) in subparagraph (B), by inserting
``with respect to the requirements of this
section or section 319C-2'' after ``paragraph
(5)''; and
(3) in subsection (h)--
(A) in paragraph (1)(A), by striking ``$685,000,000
for each of fiscal years 2019 through 2023'' and
inserting ``$735,000,000 for each of fiscal years 2024
through 2028'';
(B) in paragraph (4)--
(i) in subparagraph (A), by striking ``For
fiscal year 2027, the Secretary'' and inserting
``The Secretary''; and
(ii) in subparagraph (D), by striking ``for
fiscal year 2026''; and
(C) in paragraph (5)(A), by striking ``For fiscal
year 2007, the Secretary'' and inserting ``The
Secretary''.
SEC. 103. IMPROVING AND ENHANCING PARTICIPATION OF EMS ORGANIZATIONS IN
THE HOSPITAL PREPAREDNESS PROGRAM.
(a) Increasing Participation by EMS in the Hospital Preparedness
Program.--Section 319C-2 of the Public Health Service Act (42 U.S.C.
247d-3b) is amended--
(1) in subsection (b)(1)(A)--
(A) in clause (iii)(III), by striking ``; and'' and
inserting semicolon; and
(B) by striking clause (iv) and inserting the
following:
``(iv) one or more emergency medical
service organizations; and
``(v) to the extent practicable, one or
more emergency management organizations; and'';
and
(2) in subsection (g)(1)--
(A) by striking the heading and inserting:
``(1) Local response capabilities.--
``(A) Program coordination.--'';
(B) by striking ``extent practicable, ensure'' and
inserting the following: ``extent practicable--
``(i) ensure'';
(C) by striking the period and inserting ``; and'';
and
(D) by adding at the end the following:
``(ii) seek to increase participation of
eligible entities described in subsection
(b)(1)(A) with lower participation rates
relative to coalitions of other eligible
entities, such as coalitions that include
emergency medical services organizations and
health care facilities in underserved areas.''.
(b) Preferences.--Section 319C-2(d)(1)(A)(iii) of the Public Health
Service Act (42 U.S.C. 247d-3b(d)(1)(A)(iii)) is amended by striking
``subsection (b)(1)(A)(ii)'' and inserting ``clauses (ii) and (iv) of
subsection (b)(1)(A)''.
SEC. 104. IMPROVING MEDICAL READINESS AND RESPONSE CAPABILITIES.
Section 319C-2 of the Public Health Service Act (42 U.S.C. 247d-3b)
is amended--
(1) in subsection (b)(2)--
(A) in subparagraph (A), by striking ``and'' at the
end;
(B) in subparagraph (B), by striking the period and
inserting ``; and''; and
(C) by inserting at the end the following:
``(C) designate a lead entity to administer such award and
support coordination between entities described in this
subsection.'';
(2) in subsection (g)(1), as amended by section 102(a)(2),
by adding at the end the following:
``(B) Regional operations.--An eligible entity
shall establish and maintain, or leverage an existing,
capability to enable coordination of regional medical
operations, which may include systems to facilitate
information sharing and coordination, within a
coalition described under subsection (b)(1)(A) and, as
appropriate, between multiple coalitions that are in
close geographic proximity to each other.''; and
(3) in subsection (j)(1)--
(A) in subparagraph (A), by striking ``2019 through
2023'' and inserting ``2024 through 2028''; and
(B) in subparagraph (B)(iii), by striking ``2023''
and inserting ``2028''.
SEC. 105. PILOT PROGRAM TO SUPPORT STATE MEDICAL STOCKPILES.
(a) In General.--Section 319F-2(i) of the Public Health Service Act
(42 U.S.C. 247d-6b(i)) is amended--
(1) in paragraph (2)(B)(i)--
(A) in subclause (I), by striking ``and 2024'' and
inserting ``through 2025''; and
(B) in subclause (II), by striking ``2025'' and
inserting ``2026'';
(2) in paragraph (4)--
(A) in subparagraph (G), by striking ``; and'' at
the end and inserting a semicolon;
(B) by redesignating subparagraph (H) as
subparagraph (I);
(C) by inserting after subparagraph (G) the
following:
``(H) facilitate the sharing of best practices
between States within a consortia of States in receipt
of funding related to establishing and maintaining a
stockpile of medical products; and''; and
(D) in subparagraph (I), as so redesignated, by
striking ``State efforts'' and inserting ``State or
regional efforts'';
(3) by redesignating paragraphs (5) through (9) as
paragraphs (6) through (10), respectively;
(4) by inserting after paragraph (4) the following:
``(5) Coordination.--An entity in receipt of an award under
paragraph (1), in carrying out the activities under this
subsection, shall coordinate with appropriate health care
entities, health officials, and emergency management officials
within the jurisdiction of such State or States.''; and
(5) in paragraph (10), as so redesignated, by striking
``$3,500,000,000 for each of fiscal years 2023 and 2024'' and
inserting ``such sums as may be necessary for each of fiscal
years 2024 through 2028''.
(b) GAO Report.--Section 2409(b) of the PREVENT Pandemics Act
(Public Law 117-328) is amended--
(1) in paragraph (2), by striking ``; and'' and inserting a
semicolon;
(2) in paragraph (3), by striking the period and inserting
``; and''; and
(3) by adding at the end the following:
``(4) the impact of any regional stockpiling approaches
carried out under such subsection (i)(1) of section 319F-2 of
the Public Health Service Act (42 U.S.C. 247d-6b).''.
SEC. 106. ENHANCING DOMESTIC WASTEWATER SURVEILLANCE FOR PATHOGEN
DETECTION.
(a) In General.--Subtitle C of title XXVIII of the Public Health
Service Act (42 U.S.C. 300hh-31 et seq.) is amended by adding at the
end the following:
``SEC. 2827. WASTEWATER SURVEILLANCE FOR PATHOGEN DETECTION.
``(a) Wastewater Surveillance System.--The Secretary, acting
through the Director of the Centers for Disease Control and Prevention
and in coordination with other Federal departments and agencies, shall
award grants, contracts, or cooperative agreements to eligible entities
to establish, maintain, or improve activities related to the detection
and monitoring of infectious diseases through wastewater for public
health emergency preparedness and response purposes.
``(b) Eligible Entities.--To be eligible to receive an award under
this section, an entity shall--
``(1) be a State, Tribal, or local health department, or a
partnership between such a health department and other public
and private entities; and
``(2) submit to the Secretary an application at such time,
in such manner, and containing such information as the
Secretary may reasonably require, which shall include--
``(A) a description of activities proposed to be
carried out pursuant to an award under subsection (a);
``(B) factors such entity proposes to use to select
wastewater sampling sites;
``(C) a plan for responding, as appropriate, to
findings from such wastewater sampling, consistent with
applicable plans developed by such entity pursuant to
section 319C-1;
``(D) a plan to sustain such wastewater
surveillance activities described in such application
following the conclusion of the award period; and
``(E) any additional information the Secretary may
require.
``(c) Consideration.--In making awards under subsection (a), the
Secretary may give priority to eligible entities that have submitted an
application that--
``(1) details plans to provide public access to data
generated through such wastewater surveillance activities in a
manner that enables comparison to such data generated by other
recipients of an award under subsection (a); and
``(2) provides an assessment of community needs related to
ongoing infectious disease monitoring, including burden of
infectious diseases that can be detected in wastewater and
availability of other forms of infectious disease surveillance.
``(d) Use of Funds.--An eligible entity shall, as appropriate, use
amounts awarded under this section to--
``(1) establish, or enhance existing, capacity and
capabilities to conduct wastewater sampling, testing, and
related analysis;
``(2) conduct wastewater surveillance, as appropriate, at
individual facilities, institutions, and locations in rural
areas, in which there is an increased risk of infectious
disease outbreaks, or areas in which wastewater is not treated
through the relevant local utility of the jurisdiction; and
``(3) implement projects that use evidence-based or
promising practices to conduct wastewater surveillance
activities.
``(e) Partnerships.--In carrying out activities under this section,
eligible entities shall identify opportunities to partner with other
public or private entities to leverage relevant capabilities maintained
by such entities, as appropriate and consistent with this section.
``(f) Technical Assistance.--The Secretary, in consultation with
the heads of other applicable Federal agencies and departments, as
appropriate, shall provide technical assistance to recipients of awards
under this section to facilitate the planning, development, and
implementation of activities described in subsection (d).
``(g) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated such sums as may be necessary
for each of fiscal years 2024 through 2028.''.
(b) Wastewater Surveillance Research.--
(1) In general.--The Secretary of Health and Human Services
(in this subsection referred to as the ``Secretary'') shall
continue to conduct or support research on the use of
wastewater surveillance to detect and monitor emerging
infectious diseases, which may include--
(A) research to improve the efficiency of
wastewater sample collection and analysis and increase
the sensitivity and specificity of wastewater testing
methods; and
(B) implementation and development of evidence-
based practices to facilitate the estimation of
population-level data within a community.
(2) Non-duplication of effort.--The Secretary shall ensure
that activities carried out under this subsection do not
unnecessarily duplicate efforts of other agencies and offices
within the Department of Health and Human Services related to
wastewater surveillance.
SEC. 107. REAUTHORIZATION OF MOSQUITO ABATEMENT FOR SAFETY AND HEALTH
PROGRAM.
Section 317S of the Public Health Service Act (42 U.S.C. 247b-21)
is amended--
(1) in subsection (a)(3)(A), by striking ``subsection
(b)(3)'' and inserting ``subsection (b)(4)'';
(2) in subsection (b)--
(A) by redesignating paragraphs (3) through (6) as
paragraphs (4) through (7), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Considerations.--The Secretary may consider the use
of innovative and novel technology for mosquito prevention and
control in making grants under paragraph (1).'';
(3) by amending subsection (d) to read as follows:
``(d) Uses of Funds.--Amounts appropriated under subsection (f) may
be used by the Secretary to provide training and technical assistance
with respect to the planning, development, and operation of assessments
and plans under subsection (a) and control programs under subsection
(b). The Secretary may provide such training and technical assistance
directly or through awards of grants or contracts to public and private
entities.''; and
(4) in subsection (f)(1), by striking ``2019 through 2023''
and inserting ``2024 through 2028''.
TITLE II--FEDERAL PLANNING AND COORDINATION
SEC. 201. ALL-HAZARDS EMERGENCY PREPAREDNESS AND RESPONSE.
Section 2811 of the Public Health Service Act (42 U.S.C. 300hh-10)
is amended--
(1) in subsection (b)--
(A) in paragraph (3)--
(i) by striking ``Oversee advanced'' and
inserting the following:
``(A) In general.--Oversee advanced''; and
(ii) by adding at the end following:
``(B) Development of requirements.--Lead the
development and approval, and, on a routine basis, the
review and update, of requirements for such
countermeasures and products, including related
capabilities, to inform the advanced research,
development, procurement, and replenishment decisions
of the Department of Health and Human Services.'';
(B) in paragraph (4)--
(i) in subparagraph (F)--
(I) in the matter preceding clause
(i), by striking ``and in consultation
with the Secretary of Homeland
Security,''; and
(II) in clause (i), by inserting
``enhance'' after ``capabilities and'';
and
(ii) in subparagraph (G)--
(I) in clause (i), by striking
``based on'' and inserting ``based on--
'';
(II) in clause (ii), by striking
``; and'' at the end and inserting a
semicolon;
(III) in clause (iii), by striking
the period and inserting ``; and''; and
(IV) by adding at the end the
following:
``(iv) that include, as appropriate,
participation by relevant industry, academia,
professional societies, and other
stakeholders.'';
(iii) in subparagraph (H)--
(I) by inserting ``and the Director
of the Office of Pandemic Preparedness
and Response'' after ``Security
Affairs''; and
(II) by inserting ``and medical
product and supply capacity planning
pursuant to subparagraph (J), including
discussion of any relevant identified
supply chain vulnerabilities'' before
the period at the end;
(iv) in subparagraph (I), by inserting
``the Director of the Office of Pandemic
Preparedness and Response Policy,'' after
``Security Affairs,''; and
(v) in subparagraph (J)(i), in the matter
preceding subclause (I), by inserting
``(including ancillary medical supplies and
components of medical products, such as active
pharmaceutical ingredients, key starting
materials, and medical device components)''
after ``supply needs''; and
(C) in paragraph (7)--
(i) in the matter preceding subparagraph
(A), by inserting ``and the requirements
developed pursuant to paragraph (3)(B)'' after
``subsection (d)'';
(ii) by redesignating subparagraphs (E) and
(F) as subparagraphs (F) and (G), respectively;
and
(iii) by inserting after subparagraph (D)
the following:
``(E) include a professional judgment of
anticipated budget needs for each future fiscal year
accounted for in such plan to account for the full
range of anticipated medical countermeasure needs and
life-cycle costs to address such priorities and
requirements;'';
(2) in subsection (d)--
(A) by amending paragraph (1) to read as follows:
``(1) In general.--Not later than March 15, 2020, and
biennially thereafter, the Assistant Secretary for Preparedness
and Response shall develop and 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 coordinated strategy for medical
countermeasures to address chemical, biological, radiological,
and nuclear threats, informed by the requirements developed
pursuant to subsection (b)(3)(B). Not later than 180 days after
the submission of such strategy to such committees, the
Assistant Secretary for Preparedness and Response shall submit
an accompanying implementation plan to such committees. In
developing such a strategy and plan, the Assistant Secretary
for Preparedness and Response shall consult with the Public
Health Emergency Medical Countermeasures Enterprise established
under section 2811-1.''; and
(B) in paragraph (2), in the matter preceding
subparagraph (A), by inserting ``strategy and'' before
``plan''; and
(3) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by inserting ``, including an
emerging infectious disease,'' after ``any such
agent''; and
(B) in paragraph (2)(A), by striking ``$250,000,000
for each of fiscal years 2019 through 2023'' and
inserting ``$335,000,000 for each of fiscal years 2024
through 2028''.
SEC. 202. NATIONAL HEALTH SECURITY STRATEGY.
Section 2802 of the Public Health Service Act is amended--
(1) in subsection (a)(3)--
(A) by striking ``In 2022, the'' and inserting
``The''; and
(B) by inserting ``, maintaining, and sustaining''
after ``establishing''; and
(2) in subsection (b)--
(A) in paragraph (2)--
(i) in subparagraph (A), by inserting
``that support interagency coordination and
availability of information, as appropriate''
before the period;
(ii) in subparagraph (B), by inserting
``rapid testing,'' after ``and supplies,'';
(B) in paragraph (3)--
(i) in subparagraph (C), by inserting ``and
current capacity of facilities within such
systems, as applicable'' before the period;
(ii) in subparagraph (D), by inserting
``and other medical products and medical
supplies directly related to responding to
chemical, biological, radiological, or nuclear
threats, including emerging infectious
diseases, and incidents covered by the National
Response Framework, as applicable and
consistent with the activities carried out
under section 2811(b)(4)(J)'' before the
period; and
(iii) by adding at the end the following:
``(H) Supporting the availability of blood and
blood products with respect to public health
emergencies.'';
(C) in paragraph (5), by inserting ``applicable
federally-funded activities and'' after ``(including'';
(D) in paragraph (8)--
(i) in subparagraph (A), by inserting
``public health and medical'' before
``activities''; and
(ii) in subparagraph (B), by striking
``familiarity with'' and inserting
``understanding of, and coordination
between,'';
(E) by redesignating paragraphs (9) and (10) as
paragraphs (10) and (12), respectively;
(F) by inserting after paragraph (8) the following:
``(9) Other settings.--Supporting Federal, State, local,
and Tribal coordination and planning with respect to facilities
in which there is an increased risk of infectious disease
outbreaks, including such facilities that address the needs of
at-risk individuals, in the event of a public health emergency
declared under section 319.'';
(G) by inserting after subparagraph (10), as so
redesignated, the following:
``(11) Other hazards.--Assessing current and potential
health security threats from natural disasters or other extreme
weather events with respect to public health and medical
preparedness and response.''; and
(H) by striking ``tribal'' each place it appears
and inserting ``Tribal''.
SEC. 203. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC TESTS.
Section 319B of the Public Health Service Act (42 U.S.C. 247d-2) is
amended to read as follows:
``SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBUTION OF DIAGNOSTIC
TESTS.
``(a) Framework.--The Secretary shall develop, make publicly
available not later than 1 year after the date of enactment of the
Pandemic and All-Hazards Preparedness and Response Act, and update not
less frequently than every 3 years thereafter, a strategic framework
for the rapid development, validation, authorization, manufacture,
procurement, and distribution of diagnostic tests, and for rapid
scaling of testing capacity, in response to chemical, biological,
radiological, or nuclear threats, including infectious diseases for
which a public health emergency is declared under section 319, or that
has significant potential to cause such a public health emergency. Such
strategic framework shall take into consideration--
``(1) domestic capacity, including any such capacity
established through partnerships with public and private
entities pursuant to subsection (c), to support the
development, validation, authorization, manufacture,
procurement, and distribution of tests;
``(2) novel technologies and platforms that may be used to
improve testing capabilities, including high-throughput
laboratory diagnostics, and point-of-care diagnostics, and any
such technologies to improve the accessibility of such tests,
and facilitate the development and manufacture of diagnostic
tests;
``(3) medical supply needs related to testing, including
diagnostic testing, equipment, supplies, and component parts,
and any potential vulnerabilities related to the availability
of such medical supplies and related planning, consistent with
section 2811(b)(4)(J);
``(4) strategies for the rapid and efficient distribution
of tests locally, regionally, or nationwide and scaling
laboratory testing capacity; and
``(5) assessing such strategies through drills and
operational exercises carried out under section 2811(b)(4)(G),
as appropriate.
``(b) Coordination.--To inform the development and update of the
framework under subsection (a), and in carrying out activities to
implement such framework, the Secretary shall coordinate with industry,
States, local governmental entities, Indian Tribes and Tribal
organizations, and other relevant public and private entities.
``(c) Capacity Building.--The Secretary may contract with public
and private entities, as appropriate, to increase domestic capacity in
the rapid development, validation, authorization, manufacture,
procurement, and distribution of diagnostic tests, as appropriate, to
State, local, and Tribal health departments and other appropriate
entities for immediate public health response activities to address an
infectious disease with respect to which a public health emergency is
declared under section 319, or that has significant potential to cause
such a public health emergency.''.
SEC. 204. PILOT PROGRAM FOR PUBLIC HEALTH DATA AVAILABILITY.
(a) Situational Awareness System.--Section 319D of the Public
Health Service Act (42 U.S.C. 247d-4) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by inserting ``, and
facilitate the leveraging of relevant public health
data across the Department of Health and Human
Services'' after ``extent practicable''; and
(B) in paragraph (2)--
(i) in subparagraph (A)--
(I) by striking ``among agencies''
and inserting ``among, and direct
communication between, agencies'';
(II) by inserting ``the sharing of
information from applicable public
health data systems,'' after
``Technology),''; and
(III) by striking ``; and'' at the
end and inserting a semicolon;
(ii) in subparagraph (B), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following:
``(C) facilitate communication, including
bidirectional communication or other means of
communication, to enable timely information sharing
with State, local, and Tribal public health officials,
between agencies and offices of the Department of
Health and Human Services, and with health care
providers, as applicable and appropriate.'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) by striking ``, the Secretary may'' and
inserting ``and support the near real-time
public availability of data, as appropriate,
pursuant to section 319D-2, the Secretary shall
establish a pilot program to''; and
(ii) by striking ``, in collaboration with
appropriate'' and inserting ``. Such States or
consortia of States shall carry out such
activities in collaboration with appropriate
stakeholders, such as health information
exchanges, laboratory information systems,'';
(B) in paragraph (2)(A), by inserting ``pursuant to
paragraph (3)'' after ``may require'';
(C) by striking paragraph (6);
(D) by redesignating paragraphs (3) through (5) as
paragraphs (4) through (6), respectively;
(E) by inserting after paragraph (2) the following:
``(3) Data plan.--For purposes of this subsection, the
Secretary shall develop a plan for data elements to be reported
to the Secretary pertaining to potentially catastrophic
infectious disease outbreaks, in such form and manner and at
such timing and frequency as determined by the Secretary. When
developing the plan under this subsection, the Secretary
shall--
``(A) align with the standards and implementation
specifications adopted by the Secretary under section
3004, where applicable, and update, as necessary and
consistent with applicable requirements of subsection
(b)(3) and section 2823, uniform standards for
applicable entities to report data elements;
``(B) consider the use of technologies that enable
fast bulk exchange of data; and
``(C) ensure the data elements reported under this
subsection and made publicly available pursuant to
section 319D-2 are made available consistent with
applicable Federal and State privacy law, at a
minimum.''; and
(F) in paragraph (4), as so redesignated--
(i) in subparagraph (A), by striking
``emergencies;'' and inserting ``emergencies,
including such diseases recommended by the
National Public Health Data Board established
under section 319D-2; and'';
(ii) in subparagraph (B), by striking ``;
and'' and inserting a period; and
(iii) by striking subparagraph (C); and
(3) in subsection (h)--
(A) in paragraph (1), by striking ``2022 and 2023''
and inserting ``2024 through 2028''; and
(B) in paragraph (2), by striking ``2022 and 2023''
and inserting ``2024 through 2028''.
(b) Data Selection and Access.--Title III of the Public Health
Service Act (42 U.S.C. 241 et seq.) is amended by inserting after
section 319D-1 the following:
``SEC. 319D-2. PUBLIC HEALTH DATA PILOT PROGRAM.
``(a) In General.--The Secretary shall--
``(1) establish and maintain a near real-time, open source,
public-facing, and publicly available website to provide
deidentified, aggregated data on potentially catastrophic
disease outbreaks, in accordance with subsection (b); and
``(2) collect the data elements pertaining to such diseases
recommended pursuant to subsection (b)(1)(B), using existing
processes or any new processes established pursuant to section
319D(d).
``(b) National Public Health Data Board.--
``(1) In general.--The Secretary shall establish a National
Public Health Data Board to advise, and make recommendations to
the Secretary with respect to potentially catastrophic
infectious diseases appropriate for inclusion in the public
health situational awareness system pilot program established
pursuant to section 319D(d) and the website established under
subsection (a)(1).
``(2) Membership.--The Board established under paragraph
(1) shall consist of the following members:
``(A) Federal members.--The following Federal
members:
``(i) The Secretary of Health and Human
Services.
``(ii) The Secretary of Defense.
``(iii) The Secretary of Veterans Affairs.
``(iv) The National Coordinator for Health
Information Technology.
``(v) The Director of the National
Institutes of Health.
``(vi) The Director of the Centers for
Disease Control and Prevention.
``(vii) The Assistant Secretary for
Preparedness and Response.
``(viii) The Director of the Indian Health
Service.
``(ix) The Administrator of the Centers for
Medicare & Medicaid Services.
``(x) The Commissioner of Food and Drugs.
``(xi) Such other heads of departments,
agencies, and offices as the Secretary
determines appropriate.
``(B) Non-federal members.--Such other individuals
appointed by the Secretary--
``(i) who have relevant public health,
medical, or scientific expertise, including--
``(I) individuals with expertise or
experience in--
``(aa) State, local, or
Tribal health data systems or
practices; or
``(bb) health data
standards and technology
systems, which may include
hospital, pharmacy, laboratory
information systems and health
information exchanges; and
``(II) representatives of national
public health organizations; and
``(ii) individuals with such other specific
expertise as the Secretary determines
appropriate.
``(c) Rule of Construction.--Nothing in this section shall be
construed to alter existing obligations under regulations promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996, and this section shall be applied in a
manner that is consistent with applicable Federal and State privacy
law, at a minimum.
``(d) Nonduplication of Efforts.--The Secretary shall ensure that
the activities carried out by the Board under this section do not
duplicate the efforts of other Federal advisory committees that advise
and make recommendations to the Secretary.
``(e) Sunset.--This section shall cease to have force or effect on
September 30, 2028.''.
SEC. 205. COMBATING ANTIMICROBIAL RESISTANCE.
Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is
amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting ``and
activities'' after ``Federal programs'';
(B) in paragraph (2)--
(i) by striking ``public health
constituencies, manufacturers, veterinary and
medical professional societies and others'' and
inserting ``the Advisory Council described in
subsection (b) and relevant public and private
entities''; and
(ii) by inserting ``, pursuant to paragraph
(4),'' after ``comprehensive plan'';
(C) by amending paragraph (3) to read as follow:
``(3) Agenda.--The task force described in paragraph (1)
shall consider factors the Secretary considers appropriate,
including factors to--
``(A) slow the emergence of resistant bacteria and
fungi and prevent the spread of resistant infections;
``(B) strengthen activities to combat resistance
with respect to zoonotic diseases;
``(C) advance development and use of rapid and
innovative capabilities, including diagnostic tests,
for identification and characterization of resistant
bacteria and fungi;
``(D) accelerate basic and applied research and
development for new antibiotics, antifungals, and other
related therapeutics and vaccines; and
``(E) support international collaboration and
capacities for antimicrobial-resistance prevention,
detection, and control.'';
(D) by redesignating paragraph (4) as paragraph
(5); and
(E) by inserting after paragraph (3) the following:
``(4) Action plan.--Not later than October 1, 2025, and
every 5 years thereafter, the task force described in paragraph
(1) shall develop and submit 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 a plan regarding Federal programs and
activities to combat antimicrobial resistance, including
measurable outcomes, as appropriate, informed by the agenda
described in paragraph (3) and input provided by the Advisory
Council described in subsection (b) and other relevant
stakeholders provided pursuant to paragraph (2).'';
(2) by redesignating subsections (b) through (o) as
subsections (c) through (p), respectively;
(3) by inserting after subsection (a) the following:
``(b) Advisory Council.--
``(1) In general.--The Secretary may continue the
Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria, referred to in this subsection as the `Advisory
Council'.
``(2) Duties.--The Advisory Council shall advise and
provide information and recommendations to the Secretary,
acting through the Task Force established under subsection (a),
regarding Federal programs and activities intended to reduce or
combat antimicrobial-resistant bacteria or fungi that may
present a public health threat and improve capabilities to
prevent, diagnose, mitigate, or treat such resistance. Such
advice, information, and recommendations may be related to
improving Federal efforts related to factors described in
subsection (a)(3) and other topics related to antimicrobial
resistance, as appropriate.
``(3) Meetings and coordination.--
``(A) Meetings.--The Advisory Council shall meet
not less than biannually and, to the extent
practicable, in coordination with meetings of the task
force established under subsection (a).
``(B) Coordination.--The Advisory Council shall, to
the greatest extent practicable, coordinate activities
carried out by the Council with the task force
established under subsection (a).
``(4) FACA.--Chapter 10 of title 5, United States Code,
shall apply to the activities and duties of the Advisory
Council.''; and
(4) in subsection (n), as so redesignated, by striking
``(f) through (j)'' and inserting ``(g) through (k)''.
SEC. 206. STRATEGIC NATIONAL STOCKPILE AND MATERIAL THREATS.
Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b)
is amended--
(1) in subsection (a)--
(A) in paragraph (2)(B)(i), by striking subclause
(IV) and inserting the following:
``(IV) the emergency health
security threat or threats such
countermeasure procurement is intended
to address, including--
``(aa) whether such
procurement is consistent with
meeting emergency health
security needs associated with
such threat or threats; and
``(bb) in the case of a
countermeasure that addresses a
biological agent, whether such
agent has an increased
likelihood to become resistant
to, more resistant to, or
evade, such countermeasure
relative to other available
medical countermeasures;''; and
(B) in paragraph (3)--
(i) in subparagraph (B), by striking ``are
followed, regularly reviewed, and updated with
respect to such stockpile'' and inserting
``with respect to such stockpile are followed,
regularly reviewed, and updated to reflect best
practices'';
(ii) by redesignating subparagraphs (H)
through (K) as subparagraphs (I) through (L),
respectively; and
(iii) by inserting after subparagraph (G)
the following:
``(H) utilize tools to enable the timely and
accurate tracking, including the location and
geographic distribution and utilization, of the
contents of the stockpile throughout the deployment of
such contents;'';
(2) in subsection (c)(2)(C)--
(A) by striking ``promptly''; and
(B) by inserting ``, not later than 60 days after
such determination'';
(3) in subsection (f)(1), by striking ``$610,000,000 for
each of fiscal years 2019 through 2021, and $750,000,000 for
each of fiscal years 2022 and 2023'' and inserting
``$965,000,000 for each of fiscal years 2024 through 2028'';
and
(4) in subsection (g)(1), by striking ``2019 through 2028''
and inserting ``2024 through 2033''.
SEC. 207. MEDICAL COUNTERMEASURES FOR VIRAL THREATS WITH PANDEMIC
POTENTIAL.
Section 319L of the Public Health Service Act (42 U.S.C. 247d-7e)
is amended--
(1) in subsection (c)(4)--
(A) in subparagraph (D), by amending clause (iii)
to read as follows:
``(iii) conduct research to promote
strategic initiatives, such as--
``(I) rapid diagnostics;
``(II) broad spectrum
antimicrobials;
``(III) medical countermeasures for
virus families that have significant
potential to cause a pandemic,
including such countermeasures that
take either pathogen-specific or broad
spectrum approaches; and
``(IV) technologies to improve the
production and use of medical
countermeasures, which may include
vaccine-manufacturing technologies,
dose-sparing technologies, efficacy-
increasing technologies, platform
technologies, technologies to
administer countermeasures, and
technologies to improve storage and
transportation of countermeasures.'';
and
(B) in subparagraph (F), by amending clause (ii) to
read as follows:
``(ii) threats that--
``(I)(aa) consistently exist or
continually circulate and have a
significant potential to become a
pandemic, such as pandemic influenza;
or
``(bb) include priority virus
families and other viral pathogens with
a significant potential to cause a
pandemic; and
``(II) 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);'';
(2) in subsection (d)(2), by striking ``$611,700,000 for
each of fiscal years 2019 through 2023'' and inserting
``$950,000,000 for each of fiscal years 2024 through 2028'';
and
(3) in subsection (e)(1), by amending subparagraph (D) to
read as follows:
``(D) Sunset.--This paragraph shall cease to have
force or effect after September 30, 2028.''.
SEC. 208. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE.
Section 2811-1(c) of the Public Health Service Act (42 U.S.C.
300hh-10a(c)) is amended--
(1) in paragraph (1)--
(A) by redesignating subparagraph (D) as
subparagraph (E); and
(B) by inserting after subparagraph (C) the
following:
``(D) Assist the Secretary in developing strategies
for appropriate and evidence-based allocation and
distribution of countermeasures to jurisdictions, in a
manner that supports the availability and use of such
countermeasures, for public health and medical
preparedness and response needs.'';
(2) in paragraph (2), by striking ``, as appropriate''; and
(3) by adding at the end the following:
``(3) Information sharing.--The Secretary shall, as
appropriate and in a manner that does not compromise national
security, share information related to recommendations made and
strategies developed under subparagraphs (A) and (C) of
paragraph (1) with relevant stakeholders, including industry
and State, local, and Tribal public health departments.''.
SEC. 209. STRENGTHENING PUBLIC HEALTH COMMUNICATION.
(a) Public Health Communications Advisory Committee.--The Secretary
of Health and Human Services (referred to in this section as the
``Secretary'') shall establish an advisory committee to be known as the
Public Health Communications Advisory Committee (referred to in this
subsection as the ``Advisory Committee'').
(b) Duties.--The Advisory Committee shall make recommendations to
the Secretary and report on--
(1) critical aspects of communication and dissemination of
scientific and evidence-based public health information during
public health emergencies;
(2) research from relevant external stakeholders related to
evidence-based or evidence-informed strategies and best
practices to effectively communicate and disseminate such
information; and
(3) strategies to improve communication and dissemination
of scientific and evidence-based public health information to
the public and to improve communication between Federal, State,
local, and Tribal health officials.
(c) Composition.--The Advisory Committee shall be composed of--
(1) appropriate Federal officials, appointed by the
Secretary, who shall serve as nonvoting members; and
(2) individuals, appointed by the Secretary, representing a
variety of States and rural and urban areas, and each of whom
that has--
(A) expertise in public health, including
individuals with experience in State, local, and Tribal
health departments, medicine, communications, related
technology, psychology, mental health and substance use
disorders, national security;
(B) experience in leading community outreach; or
(C) expertise in other areas, as the Secretary
determines appropriate.
(d) Dissemination.--The Secretary shall review the recommendations
of the Advisory Committee and, not later than 180 days after receipt of
the report under subsection (b), 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
describing any actions planned by the Secretary related to this
section.
(e) Termination.--The Advisory Committee shall terminate 2 years
after the date of enactment of this Act.
SEC. 210. FELLOWSHIP AND TRAINING PROGRAMS.
Section 317G of the Public Health Service Act (42 U.S.C. 247b-8) is
amended--
(1) by striking ``The Secretary,'' and inserting the
following:
``(a) In General.--The Secretary,''; and
(2) by adding at the end the following:
``(b) Noncompetitive Conversion.--
``(1) In general.--The Secretary may noncompetitively
convert an individual who has completed an epidemiology,
surveillance, or laboratory fellowship or training program
under subsection (a) to a career-conditional appointment
without regard to the provisions of subchapter I of chapter 33
of title 5, United States Code, provided that individual meets
qualification requirements for the appointment.''.
SEC. 211. ASSESSMENT OF COVID-19 MITIGATION POLICIES.
(a) GAO Study.--The Comptroller General of the United States shall
conduct a study on the economic impact and health outcomes associated
with the response to the COVID-19 pandemic in the United States. Such
study shall include--
(1) a summary of strategies used by local governmental
entities, States, and the Federal Government to contain and
mitigate the spread of COVID-19 during the public health
emergency declared under section 319 of the Public Health
Service Act (42 U.S.C. 247d) on January 31, 2020, including--
(A) limitations on large gatherings of people;
(B) the closure of schools, businesses, houses of
worship, and other facilities;
(C) masking policies;
(D) testing policies; and
(E) vaccination policies;
(2) an analysis and review of the scientific evidence
related to the effectiveness of such strategies in preventing
or mitigating the spread of COVID-19, including estimates of
the burden of disease and death that were avoided through such
interventions;
(3) an analysis and review of the economic and health
impacts of such strategies, including impacts related to mental
and physical health and student learning loss; and
(4) an accounting of Federal funding used to implement such
strategies.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Comptroller General of the United States shall submit
a report on the study under subsection (a) to the Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives. Such report shall
include recommendations based on the findings of the study conducted
under subsection (a) regarding the impact of such strategies during the
COVID-19 public health emergency, including how to improve future
responses.
TITLE III--ADDRESSING THE NEEDS OF ALL INDIVIDUALS
SEC. 301. TRANSITION OF CERTAIN COUNTERMEASURES BETWEEN COMPENSATION
PROGRAMS.
(a) Treatment of Certain Ineligible Requests Related to COVID-19
Countermeasures.--
(1) Requests initially submitted under cicp.--
(A) In general.--In the case of a request for
compensation submitted under section 319F-4 of the
Public Health Service Act (42 U.S.C. 247d-6e) for an
injury or death related to a COVID-19 vaccine that the
Secretary determines to be ineligible pursuant to
subparagraph (B) of such section 319F-4(b)(4), as added
by subsection (b)(1), the Secretary shall, not later
than 30 days after such determination, notify the
individual submitting the request of such
determination.
(B) Submission of petition.--An individual who
receives a notification described in subparagraph (A)
shall be eligible to submit a petition to the United
States Court of Federal Claims under section 2111 of
the Public Health Service Act (42 U.S.C. 300aa-11) with
respect to the same vaccine administration claimed in
the request submitted under section 319F-4 of such Act
(42 U.S.C. 247d-6e), provided that such petition is
submitted not later than the later of--
(i) 1 year after receiving such
notification under subparagraph (A); or
(ii) the last date on which the individual
otherwise would be eligible to submit a
petition relating to such injury, as specified
in section 2116 of the Public Health Service
Act (42 U.S.C. 300aa-16).
(C) Eligibility.--To be eligible to submit a
petition in accordance with subparagraph (B), the
petitioner shall have submitted the request for
compensation under section 319F-4 of the Public Health
Service Act that was determined to be ineligible not
later than the deadline for filing a petition under
section 2116 of the Public Health Service Act (42
U.S.C. 300aa-16) that applies with respect to the
administration of such vaccine.
(2) Requests initially submitted under vicp.--
(A) In general.--If a special master determines
that--
(i) a petition submitted under section 2111
of the Public Health Service Act (42 U.S.C.
300aa-11) related to a COVID-19 vaccine is
ineligible for the National Vaccine Injury
Compensation Program under subtitle 2 of title
XXI of the Public Health Service Act (42 U.S.C.
300aa-10 et seq.) because it relates to a
vaccine administered at a time when the vaccine
was not included in the Vaccine Injury Table
under section 2114 of such Act (42 U.S.C.
300aa-14); and
(ii) the vaccine was administered when it
was a covered countermeasure subject to a
declaration under section 319F-3(b) of such Act
(42 U.S.C. 247d-6d(b)),
the special master shall, not later than 30 days after
such determination, notify the petitioner of such
determination.
(B) Submission of request.--An individual who
receives a notification described in subparagraph (A)
shall be eligible to submit a request for compensation
under section 319F-4(b) of the Public Health Service
Act (42 U.S.C. 247d-6e) with respect to the same
vaccine administration claimed in the petition
submitted under section 2111 of such Act--
(i) not later than 1 year after receiving
such notification; or
(ii) in the case that the notification is
issued after judicial review of the petition
under subsection (e) or (f) of section 2112 of
such Act (42 U.S.C. 300aa-12), not later than 1
year after the decision of the United States
Court of Federal Claim or the mandate is issued
by the United States Court of Appeals for the
Federal Circuit pursuant to such subsection (e)
or (f).
(C) Eligibility.--To be eligible to submit a
request for compensation in accordance with
subparagraph (B), the individual submitting the request
shall have submitted the petition under section 2111 of
the Public Health Service Act (42 U.S.C. 300aa-11) that
was determined to be ineligible not later than one year
after the date of administration of the vaccine.
(b) Changes to Certain Programs.--
(1) CICP.--Section 319F-4 of the Public Health Service Act
(42 U.S.C. 247d-6e) is amended--
(A) in subsection (b)(4)--
(i) by striking ``Except as provided'' and
inserting the following:
``(A) In general.--Except as provided''; and
(ii) by adding at the end the following:
``(B) Exclusion of injuries caused by vaccines on
the vaccine injury table.--Notwithstanding any other
provision of this section, no individual may be
eligible for compensation under this section with
respect to a vaccine that, at the time it was
administered, was included in the Vaccine Injury Table
under section 2114.''; and
(B) in subsection (d)(3)--
(i) by striking ``This section'' and
inserting the following:
``(A) In general.--This section''; and
(ii) by adding at the end the following:
``(B) Exhaustion of remedies.--A covered individual
shall not be considered to have exhausted remedies as
described in paragraph (1), nor be eligible to seek
remedy under section 319F-3(d), unless such individual
has provided to the Secretary all supporting
documentation necessary to facilitate the
determinations required under subsection (b)(4).''.
(2) VICP.--Title XXI of the Public Health Service Act (42
U.S.C. 300aa-1 et seq.) is amended--
(A) in section 2111(a)(2)(A) (42 U.S.C. 300aa-
11(a)(2)(A)), in the matter preceding clause (i), by
inserting ``containing the information required under
subsection (c)'' after ``unless a petition'';
(B) in section 2112(d) (42 U.S.C. 300aa-12(d))--
(i) by adding at the end of paragraph (1)
the following: ``Such designation shall not
occur until the petitioner has filed all
materials required under section 2111(c).'';
and
(ii) in paragraph (3)(A)(ii), by striking
``the petition was filed'' and inserting ``on
which the chief special master makes the
designation pursuant to paragraph (1)'';
(C) in section 2114(e) (42 U.S.C. 300aa-14(e))--
(i) in paragraph (2), in the matter
preceding subparagraph (A), by striking ``2
years'' and inserting ``6 months''; and
(ii) by adding at the end the following:
``(4) Licensure requirement.--Notwithstanding paragraphs
(2) and (3), the Secretary may not revise the Vaccine Injury
Table to include a vaccine for which the Centers for Disease
Control and Prevention has issued a recommendation for routine
use in children or pregnant women until at least one
application for such vaccine has been approved under section
351. Upon such revision of the Vaccine Injury Table, all
vaccines to prevent the same infectious disease, including
vaccines authorized under emergency use pursuant to section 564
of the Federal Food, Drug, and Cosmetic Act, shall be
considered included in the Vaccine Injury Table.''; and
(D) in section 2116 (42 U.S.C. 300aa-16), by adding
at the end the following:
``(d) Clarification.--Notwithstanding subsections (a) and (b), an
injury or death related to a vaccine administered at a time when the
vaccine was a covered countermeasure subject to a declaration under
section 319F-3(b) shall not be eligible for compensation under the
Program.''.
SEC. 302. ACCELERATING INJURY COMPENSATION PROGRAM ADMINISTRATION AND
ENSURING PROGRAM INTEGRITY.
(a) In General.--Section 2112(c) of the Public Health Service Act
(42 U.S.C. 300aa12(c)) is amended--
(1) in paragraph (1), by striking ``not more than 8 special
masters'' and inserting ``not fewer than 10 special masters'';
and
(2) in paragraph (4)--
(A) by striking ``a term of 4 years'' and inserting
``an initial term of 4 years'';
(B) by striking the second and third sentences; and
(C) by adding at the end the following: ``An
individual appointed as special master may be
reappointed to serve one or more additional terms of up
to 8 years each, pursuant to paragraph (1), and subject
to termination under paragraphs (2) and (3).''.
(b) Petitions for Compensation.--Section 2111(a)(2)(A)(i) of the
Public Health Service Act (42 U.S.C. 300aa-11(a)(2)(A)(i)) is amended--
(1) in subclause (I), by striking ``, and'' and inserting a
semicolon;
(2) in subclause (II)--
(A) by moving the margin 2 ems to the right; and
(B) by striking ``, or'' and inserting ``; and'';
and
(3) by adding at the end the following:
``(III) the judgment described in subclause (I)
does not result from a petitioner's motion to dismiss
the case; or''.
(c) Compensation.--Section 2115(e)(1) of the Public Health Service
Act (42 U.S.C. 300aa-15(e)(1)) is amended by adding at the end the
following: ``When making a determination of good faith under this
paragraph, the special master or court may consider whether the
petitioner demonstrated an intention to obtain compensation on such
petition and was not merely seeking to satisfy the exhaustion
requirement under section 2121(b).''.
SEC. 303. COMPENSATION FOR INJURIES RELATING TO THE PUBLIC HEALTH
EMERGENCY CAUSED BY SARS-COV-2.
(a) In General.--With respect to claims filed under the
Countermeasure Injury Compensation Program (referred to in this section
as ``the Program'') under section 319F-4 of the Public Health Service
Act (42 U.S.C. 247d-6e) alleging a covered injury caused by the
administration or use of a covered countermeasure pursuant to a
declaration under section 319F-3(b) of such Act (42 U.S.C. 247d-6d(b))
relating to COVID-19, the following shall apply:
(1) Notwithstanding the filing deadline applicable under
section 319F-4, the claim shall be filed within 3 years of the
administration or use of the covered countermeasure, or one
year after enactment of this section, whichever is later, and,
if a claim filed under the Program with respect to such
administration or use was filed before the date of enactment of
this Act and denied on the basis of having not been filed
within the time period required under subsection (b)(4) of such
section 319F-4, such claim may be refiled pursuant to this
paragraph.
(2) With respect to a claim relating to the administration
of a COVID-19 vaccine, such a claim may be filed under the
Program only if the administration of such vaccine occurred
prior to the addition of the vaccine to the Vaccine Injury
Table under section 2114 of the Public Health Service Act (42
U.S.C. 300aa-14).
(3) Not later than 9 months after the date of enactment of
this section, the Secretary of Health and Human Services shall
promulgate a covered countermeasure injury table pursuant to
subsection (b)(5) of section 319F-4 of the Public Health
Service Act (42 U.S.C. 247d-6e(b)(5)).
(b) Professional Judgment Budget.--
(1) In general.--The Secretary of Health and Human
Services--
(A) in consultation with the Attorney General,
shall submit a budget outlining the resource needs for
each agency for purposes of carrying out the National
Vaccine Injury Compensation Program under subtitle 2 of
title XXI of such Act (42 U.S.C. 300aa-10 et seq.) for
fiscal years 2024 through 2028; and
(B) shall submit a budget outlining resource needs
for purposes of carrying out the Countermeasures Injury
Compensation Program under section 319F-4 of the Public
Health Service Act (42 U.S.C. 247d-6e) for fiscal years
2024 through 2028.
(2) Inclusions.--The budgets described in subparagraphs (A)
and (B) of paragraph (1) shall include estimates of both the
resources necessary to process current backlogs and each
program's ability to reduce processing times with respect to
such professional judgments.
(c) NASEM Report.--The Secretary of Health and Human Services shall
seek to enter into a contract with the National Academies of Sciences,
Engineering, and Medicine under which such National Academies shall
report, not later than 3 years after the date of enactment of this Act,
on the Countermeasure Injury Compensation Program under section 319F-4
of the Public Health Service Act (42 U.S.C. 247d-6e), including
recommendations to improve the administration of such program and
whether Congress should adjust the compensation payments available
under such program.
SEC. 304. REVIEW OF REGULATIONS.
The Secretary of Health and Human Services shall update
regulations, as needed for purposes of carrying out the amendments made
by sections 301 and 302.
SEC. 305. SUPPORTING INDIVIDUALS WITH DISABILITIES, OLDER ADULTS, AND
OTHER AT-RISK INDIVIDUALS DURING EMERGENCY RESPONSES.
(a) Technical Assistance Centers on At-Risk Individuals and
Disasters.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') may, through
grants, contracts, or cooperative agreements to eligible
entities, establish more than one research, training, and
technical assistance centers to provide appropriate
information, training, and technical assistance to States,
localities, Tribes, and other applicable entities related to
addressing the unique needs and considerations of at-risk
individuals, as defined in section 2802(b)(4) of the Public
Health Service Act (42 U.S.C. 300hh-1(b)(4)), in the event of a
public health emergency declared by the Secretary pursuant to
section 319 of the Public Health Service Act (42 U.S.C. 247d).
(2) Responsibilities of the centers.--The centers
established under paragraph (1) shall conduct activities for
the purpose of--
(A) developing, identifying, evaluating, and
disseminating evidence-based or evidence-informed
strategies to improve health and other related outcomes
for at-risk individuals related to public health
emergencies, including by addressing such unique needs
and considerations in carrying out public health and
medical activities to prepare for, respond to, and
recover from, such public health emergencies; and
(B) assisting applicable entities in the
implementation of such evidence-based strategies,
including through sub-grants, contracts, or cooperative
agreements.
(3) Priority.--In awarding grants for activities described
in this subsection, the Secretary shall give priority to
eligible entities with demonstrated expertise in, and ability
to carry out, the activities described in paragraph (2).
(4) Consultation.--In carrying out activities under
paragraph (2), the centers established under paragraph (1)
shall take into consideration relevant findings and
recommendations of, and, as appropriate, consult with, the
National Advisory Committee on Individuals with Disabilities
and Disasters established under section 2811C of the Public
Health Service Act (42 U.S.C. 300hh-10d), the National Advisory
Committee on Children and Disasters under section 2811A of such
Act (42 U.S.C. 300hh-10b), and the National Advisory Committee
on Seniors and Disasters under section 2811B of such Act (42
U.S.C. 300hh-10c).
(5) Reports.--Not later than 2 years after the date of
enactment of this Act and every 2 years thereafter, the
Secretary shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report
describing the activities carried out under this subsection
during the preceding 2 fiscal years.
(6) Sunset.--This subsection shall cease to have force or
effort on September 30, 2028.
(b) Crisis Standards of Care.--Not later than 2 years after the
date of enactment of this Act, the Secretary, acting through the
Director of the Office for Civil Rights of the Department of Health and
Human Services, shall issue guidance to States and localities on the
development or modification of State and local crisis standards of care
for use during the response to a public health emergency declared by
the governor of a State or by the Secretary under section 319 of the
Public Health Service Act (42 U.S.C. 247d), or a major disaster or
emergency declared by the President under section 401 or 501,
respectively, of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5170, 5191) to ensure that such standards of
care are consistent with the nondiscrimination requirements of section
504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), title II of the
Americans with Disabilities Act of 1990 (42 U.S.C. 12131 et seq.), and
the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.).
SEC. 306. NATIONAL ADVISORY COMMITTEES.
(a) National Advisory Committee on Children and Disasters.--Section
2811A of the Public Health Service Act (42 U.S.C. 300hh-10b) is
amended--
(1) in subsection (c)--
(A) by striking ``may provide advice'' and
inserting the following: ``may provide--
``(1) advice'';
(B) by striking the period and inserting ``; and'';
and
(C) by adding at the end the following:
``(2) recommendations to the Director of the Office of
Pandemic Preparedness and Response Policy and to Congress with
respect to the public health and emergency preparedness needs
of children.''; and
(2) in subsection (g), by striking ``2023'' and inserting
``2028''.
(b) National Advisory Committee on Seniors and Disasters.--Section
2811B of the Public Health Service Act (42 U.S.C. 300hh-10c) is
amended--
(1) in subsection (c)--
(A) by striking ``may provide advice'' and
inserting the following: ``may provide--
``(1) advice'';
(B) by striking the period and inserting ``; and'';
and
(C) by adding at the end the following:
``(2) recommendations to the Director of the Office of
Pandemic Preparedness and Response Policy and to Congress with
respect to the public health and emergency preparedness needs
of seniors.'';
(2) in subsection (d)--
(A) in paragraph (1), by striking ``17 members''
and inserting ``25 members''; and
(B) in paragraph (2)--
(i) in subparagraph (J), by striking ``2''
and inserting ``3'';
(ii) in subparagraph (K), by striking ``2''
and inserting ``3'';
(iii) by redesignating subparagraphs (K)
through (L) as subparagraphs (L) through (M),
respectively; and
(iv) by inserting after subparagraph (J)
the following:
``(K) At least 2 non-Federal health care
professionals with expertise in gerontology.''; and
(3) by amending subsection (g) to read as follows:
``(g) Sunset.--The Advisory Committee shall terminate on September
30, 2028.''.
(c) National Advisory Committee on Individuals With Disabilities
and Disasters.--Section 2811C of the Public Health Service Act (42
U.S.C. 300hh-10d) is amended--
(1) by redesignating subsections (c) through (g) as
subsections (d) through (h), respectively;
(2) by inserting after subsection (b) the following:
``(c) Additional Duties.--The Advisory Committee may provide--
``(1) advice and recommendations to the Secretary and to
Congress with respect to individuals with disabilities and the
medical and public health grants and cooperative agreements as
applicable to preparedness and response activities under this
title and title III; and
``(2) recommendations to the Director of the Office of
Pandemic Preparedness and Response Policy and to Congress with
respect to the public health and emergency preparedness needs
of individuals with disabilities.'';
(3) in subsection (d), as so redesignated--
(A) in paragraph (1), by striking ``17 members''
and inserting ``25 members'';
(B) in paragraph (2)--
(i) by striking subparagraphs (K) through
(M); and
(ii) by inserting after subparagraph (J)
the following:
``(K) 15 non-Federal members (at least 4 of whom
shall be individuals with disabilities) from diverse
backgrounds, including the following:
``(i) One representative from each of the
following:
``(I) A nongovernmental
organization that provides disaster
preparedness and response services.
``(II) A community-based
organization that represents
individuals with multiple types of
disabilities.
``(III) A State-based organization
that represents individuals with
multiple types of disabilities.
``(IV) A national organization that
represents individuals with multiple
types of disabilities.
``(V) A national organization that
represents older adults.
``(VI) An organization that
provides relevant housing services,
including during the response to, and
recovery from, disasters.
``(VII) An organization that
represents disabled veterans.
``(ii) Four individuals with geographically
diverse expertise in emergency management.
``(iii) Two non-Federal health care
professionals with expertise in disability
accessibility before, during, and after
disasters, medical and mass care disaster
planning, preparedness, response, or
recovery.''; and
(C) by adding at the end the following:
``(3) Consideration.--In appointing members, including the
Chair, to the Committee under this subsection, the Secretary
may give consideration to disability status.''; and
(4) by amending subsection (h), as so redesignated, to read
as follows:
``(h) Sunset.--The Advisory Committee shall terminate on September
30, 2028.''.
SEC. 307. RESEARCH AND COORDINATION OF ACTIVITIES CONCERNING THE LONG-
TERM HEALTH EFFECTS OF SARS-COV-2 INFECTION.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall, as
appropriate--
(1) coordinate activities among relevant Federal
departments and agencies with respect to addressing the long-
term health effects of SARS-CoV-2 infection, which may include
conditions that arise as a result of such infection;
(2) continue to conduct or support basic, clinical,
epidemiological, behavioral, and translational research and
public health surveillance related to the pathogenesis,
prevention, diagnosis, and treatment of the long-term health
effects of SARS-CoV-2 infection and re-infection, which may
include conditions and any effects on development, cognition,
and neural structure and function that arise as a result of
such infection; and
(3) consistent with the findings of studies and research
under paragraph (1), in consultation with health and public
health professional associations, scientific and medical
researchers, and other relevant experts, develop and inform
recommendations, guidance, and educational materials on the
long-term effects of SARS-CoV-2 infection, which may include
conditions that arise as a result of such infection, and
provide such recommendations, guidance, and educational
materials to health care providers and the general public.
(b) Considerations.--In conducting or supporting research under
this section, the Secretary shall consider the diversity of research
participants or cohorts to ensure inclusion of a broad range of
participants, as applicable and appropriate.
(c) Additional Activities.--The Secretary may--
(1) acting through the Director of the Agency for
Healthcare Research and Quality, conduct or support research
related to--
(A) the improvement of health care delivery for
individuals experiencing long-term health effects of
SARS-CoV-2, which may include conditions that arise as
a result of such infection;
(B) the identification of any trends associated
with differences in diagnosis and treatment of the
long-term health effects of SARS-CoV-2 infection and
related conditions; and
(C) the development or identification of tools and
strategies to help health care entities and providers
care for such populations, which may include addressing
any differences identified pursuant to subparagraph
(B);
(2) publicly disseminate the results of such research; and
(3) establish a primary care technical assistance
initiative to convene primary care providers and organizations,
which may include support for continuing training and education
for such providers, as applicable and appropriate, in order to
collect and disseminate best practices related to the care of
individuals with long-term health effects of SARS-CoV-2
infection, which may include conditions that arise as a result
of such infection.
(d) Annual Reports.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter for the next 4 years,
the Secretary shall prepare and submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives regarding an
overview of the research conducted or supported under this section and
any relevant findings. Such reports may include information about how
the research and relevant findings under this section relate to other
research efforts supported by other public or private entities.
(e) Public Availability of Information.--In making information or
reports publicly available under this section, the Secretary shall take
into consideration the delivery of such information in a manner that
takes into account the range of communication needs of the intended
recipients, including at-risk individuals.
SEC. 308. NATIONAL ACADEMIES STUDY ON PRIZES.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary of Health and Human Services shall seek to
enter into an agreement with the National Academies of Sciences,
Engineering, and Medicine (referred to in this section as the
``National Academies'') to conduct a study to examine--
(1) alternative models for directly funding, or stimulating
investment in, biomedical research and development that delink
research and development costs from the prices of drugs,
including the progressive replacement of patents and regulatory
exclusivities on new drugs with a combination of expanded
support for research and innovation prizes to reward the
successful development of drugs or achievement of related
milestones;
(2) the dollar amount of innovation prizes for different
stages of research and development of different classes or
types of drugs, and total annual funding, that would be
necessary to stimulate investment sufficient to achieve such
successful drug development and related milestones;
(3) the relative effectiveness and efficiency of such
alternative models in stimulating innovation, compared to the
status quo that includes patents and regulatory exclusivities;
(4) strategies to implement such alternative models
described in paragraph (1), including a phased transition over
time; and
(5) the anticipated economic and societal impacts of such
alternative models, including an assessment of impact on--
(A) the number and variety of new drugs that would
be developed, approved, and marketed in the United
States, including such new drugs intended to prevent,
diagnose, or treat a rare disease or condition;
(B) the rate at which new drugs would be developed,
approved, and marketed in the United States;
(C) access to medication and health outcomes;
(D) average lifespan and disease burden in the
United States;
(E) the number of manufacturers that would be
seeking approval for a drug or bringing a drug to
market for the first time;
(F) Federal discretionary and mandatory spending;
and
(G) public and private insurance markets.
(b) Authorization of Appropriations.--To carry out this section,
there is authorized to be appropriated $3,000,000 for fiscal year 2024.
(c) Requirements.--In conducting the study pursuant to subsection
(a), the National Academies shall hold not fewer than 2 public
listening sessions to solicit feedback from interested parties,
including representatives of academia, professional societies, patient
advocates, public health organizations, relevant Federal departments
and agencies, drug developers, representatives of other relevant
industries, and subject matter experts.
(d) Report.--Not later than 2 years after the date of enactment of
this Act, the National Academies shall submit 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 a
report on the study conducted pursuant to subsection (a).
TITLE IV--STRENGTHENING BIOSECURITY
SEC. 401. TREATMENT OF GENETIC VARIANTS AND SYNTHETIC PRODUCTS OF
SELECT AGENTS AND TOXINS.
Section 351A(a)(1) of the Public Health Service Act (42 U.S.C.
262a(a)(1)) is amended by adding at the end the following:
``(C) Inclusions.--
``(i) In general.--For purposes of the list
under this paragraph, the following shall be
considered to be a biological agent or toxin
included on the list:
``(I) Any biological agent that
incorporates nucleic acids coding for a
virulence factor from a listed agent or
toxin.
``(II) Any biological agent or
toxin that is genetically homologous to
a listed agent or toxin with respect to
nucleotides coding for virulence
factors or toxicity.
``(III) Any biological agent or
toxin that is synthetically derived
with virulence or toxicity
characteristics of a listed agent or
toxin.
``(IV) Any nucleic acid that
encodes for components contributing to
pathogenicity, transmissibility, or
toxicity of a listed agent or toxin.
``(ii) Exemptions.--The Secretary may
exempt from inclusion on the list under this
paragraph any biological agent, toxin, or
nucleic acid described in clause (i), if such
agent, toxin, or nucleic acid does not meet the
criteria under subparagraph (B).''.
SEC. 402. ESTABLISHMENT OF NO-FAULT REPORTING SYSTEM.
Title III of the Public Health Service Act is amended by inserting
after section 351A (42 U.S.C. 262a) the following:
``SEC. 351B. NO-FAULT REPORTING SYSTEM.
``(a) Definitions.--In this section:
``(1) The term `listed agents and toxins' has the meaning
given the term in section 351A(l).
``(2) The term `reporting system' means the reporting
system established under subsection (b)(1).
``(b) Establishment.--
``(1) In general.--Not later than 3 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Response Act, the Secretary shall establish a confidential,
anonymous, voluntary, no-fault reporting system related to
accidents, near-accidents, or other safety incidents involving
biological agents and toxins, in order to support continuous
improvement and sharing of lessons learned related to such
incidents.
``(2) Availability.--The ability to submit reports on a
voluntary basis to the reporting system shall be made available
to individuals affiliated with laboratories located in the
United States, or at federally-funded entities outside the
United States, that conduct research involving biological
agents and toxins.
``(3) Data.--Not later than 2 years after the date of
enactment of the Pandemic and All-Hazards Preparedness and
Response Act, the Secretary shall publish a notice in the
Federal Register on plans for the reporting system, including--
``(A) data elements that will be included in the
submission of reports;
``(B) procedures and processes for the submission
of reports;
``(C) criteria for incidents that may be reported
to such system; and
``(D) procedures for privacy and anonymization.
``(4) Prototyping and testing.--The Secretary shall test
and prototype the reporting system for not less than 1 year
before finalizing the reporting system.
``(5) External feedback.--The Secretary shall seek feedback
on development of the reporting system from external
stakeholders, including prior to publication of the information
under paragraph (3) and prior to introduction of prototypes and
finalization of such system under paragraph (4).
``(c) FOIA.--
``(1) In general.--Information submitted to, or derived
from, the reporting system shall be exempt from disclosure
under section 552 of title 5, United States Code.
``(2) Applicability.--For purposes of paragraph (1), this
section shall be considered a statute described in section
552(b)(3)(B) of title 5, United States Code.
``(d) Prohibition on Use as Evidence.--Information submitted to, or
derived from, the reporting system shall not be used in any Federal or
State enforcement action or criminal prosecution.
``(e) Privacy; Disciplinary Action for Unauthorized Disclosure.--An
individual or entity that submits information to the reporting system
under subsection (b) shall not be required to provide their name.
``(f) Relationship to Other Reporting Systems.--The voluntary
reporting system established under this section shall supplement, and
not supplant, any other requirements to submit reports under any other
reporting system.''.
SEC. 403. EVALUATION OF THE FEDERAL SELECT AGENT PROGRAM AND RELATED
POLICIES.
(a) In General.--Not later than 4 years after the date of enactment
of this Act, the National Science Advisory Board for Biosecurity
(referred to in this section as the ``Board'') established pursuant to
section 404O of the Public Health Service Act (42 U.S.C. 283r) shall be
charged with assessing the framework for biosafety and biosecurity
oversight, particularly with respect to mitigating risks to the United
States population with respect to biological threats. The findings of
the Board shall address scientific advancements and integration of the
Program and other related Federal policies and frameworks for biosafety
and biosecurity. The findings of the Board shall be transmitted to the
President.
(b) Framework.--
(1) In general.--The recommendations developed under
subsection (a) shall include a proposed framework for an
integrated approach to the oversight of biological research
that raises significant biosafety and biosecurity concerns,
which may include proposals to harmonize and modernize relevant
Federal policies such as the following:
(A) The Federal Select Agent Program.
(B) Federal policies relating to dual-use research
of concern.
(C) Federal policies related to federally funded
research involving enhanced pathogens of pandemic
potential.
(D) The Biosafety in Microbiological and Biomedical
Laboratories Manual of the Department of Health and
Human Services, and other related guidance documents.
(E) The Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid Molecules of the
National Institutes of Health.
(2) Requirements for framework.--The framework proposed
under paragraph (1) shall--
(A) be developed in consultation with stakeholders
and experts from institutions of higher education,
industry, and other government agencies; and
(B) make recommendations related to mitigating any
identified risks associated with existing gaps in
oversight of such research, which may include research
that does not receive Federal funding, taking into
consideration any national security concerns, the
potential benefits of such research, considerations
related to the research community, transparency, and
public availability of information, and international
research collaboration.
(c) Reorganization.--In carrying out this section, the Board may
make recommendations related to the clarification of the authorities
and responsibilities of relevant Federal departments and agencies and
any necessary reorganization of such authorities and responsibilities
among such departments and agencies.
(d) Report.--Not later than 1 year after the issuance of
recommendations under subsection (a), the President 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,
and, as applicable, other appropriate committees of Congress, a report
that describes plans to consider and implement such recommendations,
including the identification of--
(1) any barriers to implementation; and
(2) any areas in which the President disagrees with the
findings or recommendations of the Board.
SEC. 404. SUPPORTING RESEARCH AND LABORATORY SURGE CAPACITY.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall make awards to
establish or maintain, as applicable, not fewer than 12 regional
biocontainment laboratories, for purposes of--
(1) conducting biomedical research to support public health
and medical preparedness for, and rapid response to, biological
agents, including emerging infectious diseases;
(2) ensuring the availability of surge capacity for
purposes of responding to such biological agents;
(3) supporting information-sharing between, and the
dissemination of findings to, researchers and other relevant
individuals to facilitate collaboration between industry and
academia; and
(4) providing, as appropriate and applicable, technical
assistance and training to researchers and other relevant
individuals to support the biomedical research workforce in
improving the management and mitigation of safety and security
risks in the conduct of research involving such biological
agents.
(b) Requirements.--As a condition of receiving a grant under this
section, a regional biocontainment laboratory shall agree--
(1) to such oversight activities as the Secretary
determines appropriate, including periodic meetings with
relevant officials of the Department of Health and Human
Services, facility inspections, and other activities as
necessary and appropriate to ensure compliance with the terms
and conditions of such award; and
(2) to report accidents, near-accidents, or other safety
incidents involving biological agents and toxins into the no-
fault reporting system established pursuant to section 351B of
the Public Health Service Act, as added by section 402.
(c) Board.--The Secretary shall establish a Board consisting of a
representative from each entity in receipt of an award under subsection
(a), which shall be headed by an executive committee of 3 members
elected upon an affirmative vote from a majority of such
representatives. The Board shall make recommendations to the Secretary
in administering awards under this section, for purposes of--
(1) improving the quality and consistency of applicable
procedures and practices within laboratories funded pursuant to
subsection (a); and
(2) ensuring coordination, as appropriate, of federally
funded activities carried out at such laboratories.
(d) Definition.--In this section, the term ``regional
biocontainment laboratory'' means a Biosafety or Animal Biosafety
Level-3 and Level-2 facility located at an institution in the United
States that is designated by the Secretary to carry out the activities
described in subsection (a).
(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $52,000,000 for each of fiscal
years 2024 through 2028.
(f) Administrative Expenses.--Of the amount available to carry out
this section for a fiscal year, the Secretary may use not more than 5
percent for the administrative expenses of carrying out this section,
including expenses related to carrying out subsection (c).
(g) Report to Congress.--Not later than 1 year after the date of
the enactment of this Act, and biannually thereafter, the Secretary, in
consultation with the heads of applicable Federal departments and
agencies shall report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives on--
(1) the activities and accomplishments of the regional
biocontainment laboratories;
(2) any published or disseminated research findings based
on research conducted in such laboratories in the applicable
year;
(3) oversight activities carried out by the Secretary
pursuant to subsection (b);
(4) activities undertaken by the Secretary to take into
consideration the capacity and capabilities of the network of
regional biocontainment laboratories in activities to prepare
for and respond to biological agents, which may include
leveraging such capacity and capabilities to support the
Laboratory Response Network, as applicable and appropriate;
(5) plans for the maintenance and sustainment of federally
funded activities conducted at the regional biocontainment
laboratories, consistent with the strategy required under
section 2312 of the PREVENT Pandemics Act (Public Law 117-328);
and
(6) activities undertaken by the Secretary to coordinate
with applicable agencies to ensure work carried out by such
facilities is prioritized and complementary to one another, and
avoiding unnecessary duplication.
SEC. 405. GENE SYNTHESIS.
(a) Guidance.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall update the Screening Framework
Guidance for Providers of Synthetic Double-Stranded DNA to account for
scientific and technological advancements with respect to mitigating
risk of unauthorized individuals or individuals with malicious intent
from using nucleic acid synthesis technologies to obtain biological
agents or toxins of concern. Such guidance shall include
recommendations related to--
(1) screening for sequences that the Secretary determines
may contribute to toxicity, pathogenicity, or virulence;
(2) screening and verification of the identity and
legitimacy of customers;
(3) the identification, evaluation, and use of appropriate
software or other tools to enable the screening described in
paragraphs (1) and (2);
(4) ensuring nucleic acid synthesis activities are carried
out in compliance with existing regulations under part 73 of
title 42, Code of Federal Regulations, part 331 of title 7,
Code of Federal Regulations, part 121 of title 9, Code of
Federal Regulations, and part 774 of title 15 Code of Federal
Regulations (or successor regulations);
(5) implementing appropriate safeguards, which may include
the use of such software or other tools, in gene synthesis
equipment to facilitate screening of nucleic acid sequences
and, as applicable, customers;
(6) maintaining records of customer orders, metadata, and
screening system or protocol performance in specified formats,
which may include standardized machine-readable and
interoperable data formats; and
(7) other recommendations as determined appropriate by the
Secretary.
(b) Sequences of Concern.--The Secretary shall maintain a public
docket to solicit recommendations on potential sequences of concern
and, in consultation with other Federal departments and agencies and
non-Federal experts, as appropriate, review and update, on a regular
basis, a list of sequences of concern to facilitate screening under
subsection (a)(1).
(c) Landscape Review.--The Secretary, in coordination with other
Federal departments and agencies, as appropriate, shall conduct a
landscape review of providers and manufacturers of gene synthesis
equipment, products, software, and other tools with the purpose of
understanding the number, types, and capabilities of products and
equipment that exist domestically and to inform the development of any
updates to the guidance under subsection (a).
(d) Technical Assistance.--The Secretary, in consultation with
other Federal departments and agencies, shall provide technical
assistance upon request of a gene synthesis provider, manufacturer of
gene synthesis equipment, or developer of software or other screening
tools to support implementation of the recommendations included in the
guidance under subsection (a).
(e) Definitions.--For purposes of this section:
(1) The term ``gene synthesis equipment'' means equipment
needed to produce gene synthesis products.
(2) The term ``gene synthesis product''--
(A) means custom single-stranded or double-stranded
DNA, or single-stranded or double-stranded RNA, which
has been chemically or enzymatically synthesized or
otherwise manufactured de novo and is of a length
exceeding the screening threshold, as determined by the
Secretary; and
(B) does not include--
(i) base chemical subunits, such as
individual nucleotides or nucleosides, or
oligonucleotides shorter than the screening
threshold typically used as polymerase chain
reaction primers, as determined by the
Secretary;
(ii) by-products generated during
sequencing that are not useful for assembly or
cloning, as determined by the Secretary; or
(iii) products generated from cloning or
assembling of existing gene or gene fragment
material, in circumstances in which the gene
synthesis provider has no access or notice to
the sequence design, as determined by the
Secretary.
(3) The term ``gene synthesis provider'' means an entity
that synthesizes and distributes gene synthesis products,
including bacteria, viruses, or fungi containing recombinant or
synthetic nucleic acid molecules, for delivery to a customer.
(4) The term ``manufacturers of gene synthesis equipment''
means an entity that produces and sells equipment for
synthesizing gene synthesis products.
SEC. 406. LIMITATION RELATED TO COUNTRIES OF CONCERN CONDUCTING CERTAIN
RESEARCH.
Section 2315(c) of the PREVENT Pandemics Act (Public Law 117-328)
is amended--
(1) in paragraph (1)--
(A) by inserting ``that may reasonably be
anticipated to involve the creation, transfer, and use
of enhanced pathogens of pandemic potential or
biological agents or toxins listed pursuant to section
351A(a)(1) if such research is'' after ``not fund
research''; and
(B) by striking ``, involving pathogens of pandemic
potential'' and all that follows through the period at
the end and inserting a period;
(2) in paragraph (2)--
(A) in the heading, by striking ``Conditions for
listing or suspending prohibition'' and inserting
``Limitations''; and
(B) in the matter preceding subparagraph (A)--
(i) by striking ``The Secretary'' and
inserting ``Beginning 5 years after an initial
determination of a country of concern, the
Director of National Intelligence or the
Secretary''; and
(ii) by inserting ``with respect to such
country of concern'' after ``paragraph (1)'';
and
(3) by adding at the end the following:
``(3) Clarification.--
``(A) In general.--The requirement of paragraph (1)
may be waived by the President for the duration of the
initial response to an outbreak of a novel emerging
infectious disease if the President determines that
such requirement impedes the ability of the Federal
Government to immediately respond to such outbreak.
``(B) Notification.--The President shall notify
Congress not later than 48 hours after exercising the
waiver under subparagraph (A), and shall provide
updates to Congress related to the use of such waiver
every 15 days thereafter.''.
SEC. 407. ASSESSMENT OF ARTIFICIAL INTELLIGENCE THREATS TO HEALTH
SECURITY.
(a) In General.--Not later than 45 days after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall seek to enter into a contract
with the National Academies of Sciences, Engineering, and Medicine
(referred to in this section as the ``National Academies'') to conduct
a study assessing the potential vulnerabilities to health security
presented by the current or prospective use or misuse of artificial
intelligence, including with respect to open-source artificial
intelligence models, such as large language models.
(b) Inclusions.--The study conducted pursuant to the contract under
subsection (a) shall include--
(1) an assessment of the potential vulnerabilities posed by
technical advancements in artificial intelligence to health
security, including any risks related to the development of,
enhancement of, or protection from, chemical, biological,
radiological, or nuclear threats;
(2) a description of roles, responsibilities, and
capabilities of agencies and offices of the Department of
Health and Human Services, and, as applicable and appropriate,
other Federal departments and agencies, with respect to the
identification and mitigation of such potential
vulnerabilities;
(3) a summary of any ongoing Federal activities related to
the identification, understanding, and mitigation of such
potential risks;
(4) the identification of any potential gaps, whether
current or anticipated, related to such roles,
responsibilities, and capabilities; and
(5) recommendations to improve Federal efforts to identify,
prepare for, and mitigate such potential vulnerabilities.
(c) Reports.--
(1) National academies report.--Not later than 2 years
after the date of the contract under subsection (a), the
National Academies 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
on the study conducted pursuant to subsection (a).
(2) HHS report.--Not later than 1 year after the issuance
of the report required under paragraph (1), the Secretary shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives a report detailing actions
taken to mitigate and monitor risks to health security posed by
misuse of artificial intelligence, as detailed in the report
under paragraph (1).
TITLE V--PREVENTING DRUG SHORTAGES
SEC. 501. IMPROVING NOTIFICATION PROCEDURES IN CASE OF INCREASED DEMAND
FOR CRITICAL DRUGS.
(a) In General.--Section 506C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356c) is amended--
(1) in the section heading, by striking ``discontinuance or
interruption in the production of life-saving drugs'' and
inserting ``notification of issues affecting domestic supply of
critical drugs'';
(2) by striking subsections (a), (b), and (c), and
inserting the following:
``(a) Notification Required.--
``(1) In general.--A manufacturer of a covered drug shall
notify the Secretary, in accordance with subsection (b), of--
``(A)(i) a permanent discontinuance in the
manufacture of the drug or an interruption of the
manufacture of the drug that is likely to lead to a
meaningful disruption in the supply of such drug in the
United States;
``(ii) a permanent discontinuance in the
manufacture of an active pharmaceutical ingredient of
such drug, or an interruption in the manufacture of an
active pharmaceutical ingredient of such drug that is
likely to lead to a meaningful disruption in the supply
of the active pharmaceutical ingredient of such drug;
or
``(iii) any other circumstance, such as an increase
in demand or export restriction, that is likely to
leave the manufacturer unable to meet demand for the
drug without a meaningful shortfall or delay; and
``(B) the reasons for such discontinuance,
interruption, or other circumstance, if known.
``(2) Contents.--Notification under this subsection with
respect to a covered drug shall include--
``(A) with respect to the reasons for the
discontinuation, interruption, or other circumstance
described in paragraph (1)(A)(iii), if an active
pharmaceutical ingredient is a reason for, or risk
factor in, such discontinuation, interruption, or other
circumstance, the source of the active pharmaceutical
ingredient and any alternative sources for the active
pharmaceutical ingredient known to the manufacturer;
``(B) whether any associated device used for
preparation or administration included in the drug is a
reason for, or a risk factor in, such discontinuation,
interruption, or other circumstance described in
paragraph (1)(A)(iii);
``(C) the expected duration of the interruption;
and
``(D) such other information as the Secretary may
require.
``(b) Timing.--A notice required under subsection (a) shall be
submitted to the Secretary--
``(1) at least 6 months prior to the date of the
discontinuance or interruption;
``(2) in the case of such a notice with respect to a
circumstance described in subsection (a)(1)(A)(iii), as soon as
practicable, or not later than 10 business days after the onset
of the circumstance; or
``(3) if compliance with paragraph (1) or (2) is not
possible, as soon as practicable.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute, through such means as the Secretary
determines appropriate, information on the discontinuance or
interruption of the manufacture of, or other circumstance described in
subsection (a)(1)(A)(iii) that is likely to lead to a shortage or
meaningful disruption in the supply of, covered drugs to appropriate
organizations, including physician, health provider, and patient
organizations, as described in section 506E.'';
(3) in subsection (g), in the matter preceding paragraph
(1), by striking ``drug described in subsection (a)'' and
inserting ``covered drug''; and
(4) in subsection (j), by striking ``drug described in
subsection (a)'' and inserting ``covered drug''.
(b) Definitions.--Paragraph (1) of section 506C(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended to read as
follows:
``(1) the term `covered drug' means a drug that is intended
for human use and that--
``(A) is--
``(i) life-supporting;
``(ii) life-sustaining; or
``(iii) intended for use in the prevention
or treatment of a debilitating disease or
condition, including any such drug used in
emergency medical care or during surgery or any
such drug that is critical to the public health
during a public health emergency declared by
the Secretary under section 319 of the Public
Health Service Act;
``(B) is not a radio pharmaceutical drug product or
any other product as designated by the Secretary; and
``(C) is not a biological product (as defined in
section 351(i) of the Public Health Service Act),
unless otherwise provided by the Secretary in the
regulations promulgated under subsection (i);''.
SEC. 502. REPORTING ON SUPPLY CHAINS.
Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(j)(3)(A)) is amended--
(1) by inserting ``, and the names and unique facility
identifiers of the manufacturers of the active pharmaceutical
ingredients such person used for the manufacture, preparation,
propagation, compounding, or processing of such drug, and the
amount of such drug manufactured, prepared, propagated,
compounded, or processed using each such active pharmaceutical
ingredient from each such manufacturer'' before the period at
the end of the first sentence; and
(2) by inserting after the first sentence the following:
``In addition to the reporting required under the preceding
sentence, the Secretary may receive voluntary submissions of
such information at more frequent intervals.''.
SEC. 503. REPORTING ON USE OF NEW AUTHORITIES AND REQUIREMENTS WITH
RESPECT TO DRUG SHORTAGES.
Not later than 90 days after the date of enactment of this Act, the
Secretary of Health and Human Services (referred to in this section as
the ``Secretary'') shall report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives on--
(1) the extent to which the Secretary has implemented the
authorities and requirements under sections 506C(g), 506C(j),
506E(d), 510(j)(3), and 704(b)(2) (21 U.S.C. 356c(g), 356c(j),
356e(d), 360(j)(3), 374(b)(2)) of the Federal Food, Drug, and
Cosmetic Act, as amended by section 3111 and 3112 of the
Coronavirus Aid, Relief, and Economic Security Act (Public Law
116-136), including--
(A) specific examples of uses of such authorities
and requirements; and
(B) an assessment of the extent to which such
authorities and requirements have helped mitigate drug
shortages; and
(2) the status of the guidance documents that the Secretary
intends to issue with respect to reporting and risk management
plan requirements applicable to manufacturers of drugs and
active pharmaceutical ingredients, pursuant to the amendments
made to section 506C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356c) by subsections (a) and (b) of section 3112
of the Coronavirus Aid, Relief, and Economic Security Act
(Public Law 116-136).
TITLE VI--ADDITIONAL REAUTHORIZATIONS AND TECHNICAL AMENDMENTS
SEC. 601. MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER.
Section 565A(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4a) is amended by striking ``2023'' and inserting
``2028''.
SEC. 602. EPIDEMIC INTELLIGENCE SERVICE LOAN REPAYMENT PROGRAM.
Section 317F(c)(2) of the Public Health Service Act (42 U.S.C.
247b-7(c)(2)) is amended by striking ``2019 through 2023'' and
inserting ``2024 through 2028''.
SEC. 603. VACCINE TRACKING AND DISTRIBUTION.
Section 319A(e) of the Public Health Service Act (42 U.S.C. 247d-
1(e)) is amended by striking ``2019 through 2023'' and inserting ``2024
through 2028''.
SEC. 604. REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE
SYSTEMS.
Section 319C-3(e)(2) of the Public Health Service Act (42 U.S.C.
247d-3c(e)(2)) is amended by striking ``2023'' and inserting ``2028''.
SEC. 605. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF VOLUNTEER HEALTH
PROFESSIONAL.
Section 319I(k) of the Public Health Service Act (42 U.S.C. 247d-
7b(k)) is amended by striking ``2019 through 2023'' and inserting
``2024 through 2028''.
SEC. 606. LIMITED ANTITRUST EXEMPTION.
Section 319L-1(b) of the Public Health Service Act (42 U.S.C. 247d-
7f(b)) is amended by striking ``at the end of the 17-year period that
begins on the date of enactment of this Act'' and inserting ``on
September 30, 2028''.
SEC. 607. TRAUMA CARE.
Section 1232(a) of the Public Health Service Act (42 U.S.C. 300d-
32(a)) is amended by striking ``$24,000,000 for each of fiscal years
2023 through 2027'' and inserting ``$39,000,000 for each of fiscal
years 2024 through 2028''.
SEC. 608. MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS.
Section 1291(g) of the Public Health Service Act (42 U.S.C. 300d-
91(g)) is amended by striking ``2019 through 2023'' and inserting
``2024 through 2028''.
SEC. 609. NATIONAL DISASTER MEDICAL SYSTEM.
(a) In General.--Section 2812 of the Public Health Service Act (42
U.S.C. 300hh-11) is amended--
(1) in subsection (c)(4)(B), by striking ``2023'' and
inserting ``2028''; and
(2) in subsection (g), by striking ``$57,400,000 for each
of fiscal years 2019 through 2023'' and inserting ``$65,900,000
for each of fiscal years 2024 through 2028''.
(b) Repeal of Sunset.--
(1) In general.--Section 301(d)(3) of the Pandemic and All-
Hazards Preparedness and Advancing Innovation Act of 2019
(Public Law 116-22; 34 U.S.C. 10284 note) is repealed.
(2) Effective date.-- Paragraph (1) shall take effect as if
enacted on September 30, 2021.
SEC. 610. VOLUNTEER MEDICAL RESERVE CORPS.
Section 2813(i) of the Public Health Service Act (42 U.S.C. 300hh-
15(i)) is amended by striking ``2019 through 2023'' and inserting
``2024 through 2028''.
SEC. 611. EPIDEMIOLOGY-LABORATORY CAPACITY GRANTS.
Section 2821(b) of the Public Health Service Act (42 U.S.C. 300hh-
31(b)) is amended, in the matter preceding paragraph (1), by striking
``2019 through 2023'' and inserting ``2024 through 2028''.
SEC. 612. VETERANS AFFAIRS.
Section 8117(g) of title 38, United States Code is amended by
striking ``2019 through 2023'' and inserting ``2024 through 2028''.
SEC. 613. TECHNICAL AMENDMENTS.
(a) Title XXI of the Public Health Service Act (42 U.S.C. 300aa-1
et seq.) is amended--
(1) in section 2105(b), by striking ``, 2103, and 2104''
each place it appears and inserting ``and 2103'';
(2) in section 2110(b), by striking ``the program'' and
inserting ``The Program'';
(3) in section 2111(a)--
(A) in paragraph (6), by striking ``1988 for'' and
inserting ``1988, for''; and
(B) in paragraph (10), by striking ``United States
Claims Court'' and inserting ``United States Court of
Federal Claims'';
(4) in section 2112--
(A) in subsection (c)(6)(A), by striking ``United
States Claims Courts'' and inserting ``United States
Court of Federal Claims''; and
(B) in subsection (f)--
(i) by striking ``United States Claims
Court on'' and inserting ``United States Court
of Federal Claims on''; and
(ii) by striking ``United States Claims
Court's judgment'' and inserting ``judgment of
the United States Court of Federal Claims'';
(5) in section 2115(b)(3), by striking ``subsection (e)''
and inserting ``subsection (e))'';
(6) in section 2117--
(A) in the section heading, by striking
``subrogration'' and inserting ``subrogation''; and
(B) in subsection (a), by striking ``subrograted''
and inserting ``subrogated''; and
(7) in section 2127--
(A) in subsection (b)(1), by inserting ``and
Prevention'' before the period; and
(B) in subsection (c), by striking ``Committee on
Labor and Human Resources'' and inserting ``Committee
on Health, Education, Labor, and Pensions''.
(b) Section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d) is amended--
(1) in subsection (c)(5)(B)(ii)(I), by striking ``chapter
5'' and inserting ``chapter V''; and
(2) in subsection (i)(7)--
(A) by striking ``321(g)(1))'' and inserting
``321(g)(1)))''; and
(B) by striking ``321(h))'' and inserting
``321(h)))''.
(c) Section 319F-4 of the Public Health Service Act (42 U.S.C.
247d-6e) is amended--
(1) in subsection (b)(1), by striking ``under 319F-3(b)''
and inserting ``under section 319F-3(b)''; and
(2) in subsection (d)(5), by striking ``under subsection
(a) the Secretary determines that a covered individual
qualifies for compensation'' and inserting ``a covered
individual is determined under subsection (a) to be eligible
for compensation under this section''.
(d) Part C of title II of the Public Health Service Act (42 U.S.C.
239 et seq.) is amended--
(1) in section 261(a)(2)(A), by striking ``specialities''
and inserting ``specialties'';
(2) in section 265(c)(5), by striking ``involves'' and
inserting ``involved'';
(3) in section 266(b)(3)(B)(ii), by striking ``to with
respect to an eligible'' and inserting ``with respect to an
eligible''; and
(4) in section 267(b), by striking ``such Act'' and
inserting ``such part''.
(e) Section 351A(e)(7)(B)(ii) is amended by striking ``judical''
and inserting ``judicial''.
<all>