[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3219 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 3219
To protect against seasonal and pandemic influenza, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 2, 2023
Ms. Baldwin (for herself, Ms. Klobuchar, Mr. Blumenthal, and Ms. Smith)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To protect against seasonal and pandemic influenza, 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.
This Act may be cited as the ``Protecting America from Seasonal and
Pandemic Influenza Act of 2023'' or the ``Influenza Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Influenza occurs seasonally each year, and, throughout
history, has caused devastating pandemics. The 1918 influenza
pandemic killed an estimated 675,000 people in the United
States.
(2) In an average season, influenza results in 12,000 to
52,000 deaths in the United States, including over 100
pediatric deaths. Additionally, influenza causes hundreds of
thousands of hospitalizations and millions of illnesses.
(3) The Council of Economic Advisors issued a report in
2019 estimating that seasonal influenza costs the United States
approximately $361,000,000,000 per year, and that an influenza
pandemic has the potential to cause up to $3,790,000,000,000 in
losses. This report was issued prior to the COVID-19 pandemic,
which will cost the United States an estimated
$16,000,000,000,000.
(4) Most funding for pandemic influenza preparedness up
until fiscal year 2018 was derived from supplemental
appropriations that dated back to the 2009 H1N1 pandemic.
(5) Centers for Disease Control and Prevention (referred to
in this section as the ``CDC'') studies of influenza
hospitalization rates by race and ethnicity during 10 influenza
seasons from 2009 to 2019 showed that individuals from racial
and ethnic minority groups are at higher risk for being
hospitalized with influenza.
(6) The COVID-19 pandemic response has been built on the
pandemic influenza response ecosystem.
(7) Strategies that increase seasonal influenza vaccination
rates will also improve pandemic readiness.
(8) The National Influenza Vaccine Modernization Strategy
of 2020-2030 of the Department of Health and Human Services
should be implemented as quickly as possible to ensure the
Nation's vaccine enterprise is highly responsive, flexible,
scalable, and effective at reducing the impact of seasonal and
pandemic influenza viruses.
(9) Influenza surveillance has been improved significantly
through advances in next-generation gene sequencing tools to
analyze circulating influenza viruses. The technology allows
the CDC to study more influenza viruses faster and in more
detail, and to monitor genetic changes in influenza viruses to
better understand and improve the effectiveness of influenza
vaccines.
(10) Influenza diagnosis and surveillance has improved
significantly through advances in influenza testing. Timely
infection control and prevention strategies would be
significantly bolstered by accurate and readily accessible at-
home diagnostic tests. Rapid diagnostics can improve access for
underserved populations and allow for better antibiotic
stewardship.
(11) Vaccine hesitancy in the United States has reached a
tipping point where it is adversely affecting public health.
Misinformation is widely available on social media, and
traditional sources of information on the value and efficacy of
vaccines are not trusted by many people of the United States,
especially those who are vaccine hesitant.
(12) Support for vaccine communication, outreach, and
administration across public health and health care settings is
critical to drive demand of influenza vaccines, treatments, and
medical countermeasures and ensure equitable uptake of such
innovations.
SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA VACCINE, THERAPEUTICS,
AND DIAGNOSTICS DEVELOPMENT, MANUFACTURING, AND SUPPLY
CHAIN.
(a) Timely Delivery of First Doses of Finished Influenza Vaccine.--
(1) National goal.--It is a national goal for the United
States to have, not later than 3 years after the date of
enactment of this Act, the capacity to deliver first doses of
finished influenza vaccine within 12 weeks of emergence of an
influenza strain with pandemic potential.
(2) Plan.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Assistant Secretary for
Preparedness and Response and the Director of the Biomedical
Advanced Research and Development Authority, shall publish a
plan to achieve the goal specified in paragraph (1).
(b) Universal Influenza Vaccine.--
(1) National goal.--It is a national goal for the United
States to have developed a universal influenza vaccine, not
later than 10 years after the date of enactment of this Act.
(2) Plan.--
(A) Publication.--Not later than 1 year after the
date of enactment of this Act, the Secretary of Health
and Human Services, acting through the Director of the
National Institutes of Health and the Director of the
Biomedical Advanced Research and Development Authority,
shall publish a plan to achieve the goal specified in
paragraph (1) in partnership with vaccine
manufacturers.
(B) Interim support.--The plan under subparagraph
(A) shall include provisions, as necessary to achieve
such goal, for support over the period of 5 years
following the publication of such plan of the
following:
(i) Incremental vaccine efficacy
improvements.
(ii) The research workforce.
(c) Strengthening the Vaccine Supply Chain.--
(1) Public-private partnerships.--
(A) In general.--The Secretary of Health and Human
Services shall--
(i) establish public-private partnerships
to strengthen the domestic vaccine supply
chain; and
(ii) evaluate the capabilities, capacity,
and utilization of such partnerships, including
by assessing and testing relevant logistical
and interoperable technology with stakeholders
in the supply chain.
(B) Domestic vaccine supply chain.--For purposes of
this paragraph, the term ``domestic vaccine supply
chain'' includes the full domestic supply chain,
including--
(i) production of ingredients and
manufacturing and distribution of finished
vaccines;
(ii) fill-finish capacity; and
(iii) the supply chain of ancillary
supplies such as needles and syringes.
(2) Evaluation of using dpa.--The Secretary of Health and
Human Services, in coordination with the Administrator of the
Federal Emergency Management Agency and the Secretary of
Defense, shall--
(A) evaluate the use of the Defense Production Act
of 1950 (50 U.S.C. 4501 et seq.) for COVID-19 pandemic
response;
(B) not later than 1 year after the date of
enactment of this Act, complete such evaluation and
submit a report to Congress on the results of such
evaluation; and
(C) include in such report--
(i) recommendations on using the Defense
Production Act of 1950 (50 U.S.C. 4501 et seq.)
for building domestic capacity to respond to an
influenza pandemic; and
(ii) input from external stakeholders.
(d) National Influenza Vaccine Modernization Strategy.--The
Secretary of Health and Human Services shall--
(1) implement the portions of the National Influenza
Vaccine Modernization Strategy 2020-2030 that are within the
authority of the Department of Health and Human Services to
carry out (under other applicable provisions of law); and
(2) by June 15 each calendar year through 2030, submit to
Congress a report on such implementation.
(e) Assistant Secretary for 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), by inserting ``, including
the pandemic influenza medical countermeasures program
under paragraphs (2)(E) and (4)(H) of section 319L(c)''
after ``qualified pandemic or epidemic products (as
defined in section 319F-3)''; and
(B) in paragraph (7), in the matter preceding
subparagraph (A), by inserting ``, including through
the pandemic influenza medical countermeasures program
under paragraphs (2)(E) and (4)(H) of section 319L(c)''
after ``for each such threat''; and
(2) in subsection (d)(2)--
(A) in subparagraph (J)(v), by striking ``and'' at
the end;
(B) by redesignating subparagraph (K) as
subparagraph (L); and
(C) by inserting after subparagraph (J) the
following:
``(K) evaluate progress with respect to
implementing the National Influenza Vaccine
Modernization Strategy, issued in June 2020, or any
successor strategy; and''.
(f) Biomedical Advanced Research and Development Authority.--
(1) Preparedness activities.--Section 319L(c) of the Public
Health Service Act (42 U.S.C. 247d-7e(c)) is amended--
(A) in paragraph (2)--
(i) in subparagraph (C), by striking
``and'' at the end;
(ii) in subparagraph (D), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end of the
following:
``(E) supporting pandemic influenza countermeasure
preparedness.''; and
(B) in paragraph (4), by adding at the end of the
following:
``(H) Pandemic influenza medical countermeasures
program.--In carrying out paragraph (2)(E), the
Secretary shall establish and implement a program
that--
``(i) supports research and development
activities for qualified pandemic or epidemic
products (as defined in section 319F-3),
including by--
``(I) developing innovative
technologies to enhance rapid response
to pandemic influenza threats;
``(II) developing influenza
vaccines with potential universal
vaccination capability;
``(III) developing enhanced
influenza vaccines with longer lasting
broad spectrum protective immunity
against a wider range of antigenically
divergent influenza strains;
``(IV) developing alternative
vaccine delivery approaches;
``(V) developing novel small- and
large-molecule novel influenza
antivirals, monoclonal antibodies, and
other products that provide better
influenza treatment and prevention;
``(VI) developing innovative
technologies to enhance rapid diagnosis
of influenza; and
``(VII) implementing the National
Influenza Vaccine Modernization
Strategy, issued in June 2020, or any
successor strategy;
``(ii) ensures readiness to respond to
qualified pandemic and epidemic threats,
including by--
``(I) supporting development and
manufacturing of influenza virus seeds,
clinical trial lots, and stockpiles of
novel influenza strains;
``(II) supporting the stockpile of
influenza antivirals through
diversifying and replenishing the
existing stockpile of influenza
antivirals;
``(III) supporting manufacturing
and fill-finish rapid response
infrastructure;
``(IV) supporting the stockpile of
influenza testing equipment and
supplies; and
``(V) testing and evaluating
pandemic threat rapid response
capabilities through regular
preparedness drills with key public and
private sector partners that examine
the range of activities (including
production and clinical testing of
influenza diagnostics, vaccines, and
therapeutics) required to effectively
respond to novel threats; and
``(iii) builds, sustains, and replenishes
qualified pandemic and epidemic stockpiles of
bulk antigen and adjuvant material, including
by--
``(I) annually testing the potency
and shelflife potential of all existing
pandemic and epidemic stockpiles held
by the Department of Health and Human
Services; and
``(II) developing, and
disseminating to key public and private
sector partners, a life cycle
management plan.''.
(g) Authorization of Appropriations.--Section 319L(d) of the Public
Health Service Act (42 U.S.C. 247d-7e(d)) is amended by adding at the
end the following:
``(3) Pandemic influenza.--To carry out this section and
section 2811 with respect to pandemic influenza, in addition to
amounts authorized to be appropriated by paragraph (2) and any
amounts authorized to be appropriated by section 2811, there is
authorized to be appropriated $335,000,000 for each of fiscal
years 2024 through 2028, to remain available until expended.''.
SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE OF NEW TECHNOLOGIES TO
DETECT, PREVENT, AND RESPOND TO INFLUENZA.
(a) Sense of Congress.--It is the sense of Congress that the
Centers for Disease Control and Prevention should support interoperable
immunization information systems that enable bidirectional data
exchange among States, localities, and community immunization
providers.
(b) Prioritizing Influenza, Influenza Combination, and Pathogen
Agnostic Tools.--
(1) NIH.--The Director of the National Institutes of Health
may conduct or support basic research prioritizing the
development of--
(A) agnostic tools to detect influenza and other
pathogens; and
(B) technologies that automate sample preparation
for such tools.
(2) BARDA.--The Director of the Biomedical Advanced
Research and Development Authority may conduct or support
advanced development of novel sequencing modalities
prioritizing tools described in paragraph (1)(A) and
technologies described in paragraph (1)(B).
(c) Development of Point-of-Care and Self-Testing Diagnostics.--The
Director of the Biomedical Advanced Research and Development Authority,
in collaboration with the Director of the Centers for Disease Control
and Prevention, the Director of the National Institutes of Health, and
the Commissioner of Food and Drugs, may conduct or support development
of rapid, accurate, easily accessible, self-administrable diagnostic
tests that are readable at the point of care or at home.
(d) Incorporating Diagnostics Supply Chain Resiliency Into
Influenza Pandemic Planning.--The Assistant Secretary for Preparedness
and Response, in collaboration with the Commissioner of Food and Drugs,
the Director of the Centers for Disease Control and Prevention, the
Secretary of Commerce, and the Secretary of Transportation, shall--
(1) incorporate diagnostics supply chain resiliency into
influenza pandemic planning that supports a health care system
that tests to treat and bolsters testing and vaccine delivery
supply chains; and
(2) not later than 1 year after the date of enactment of
this Act, publish a plan for rapidly expanding public and
private diagnostic testing capacity (including at clinical