I 
118TH CONGRESS 
1ST SESSION H. R. 5846 
To protect against seasonal and pandemic influenza, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 29, 2023 
Mr. LARSEN of Washington (for himself, Ms. BARRAGA´N, Mr. BERA, Ms. 
NORTON, Ms. ROSS, Mr. CARBAJAL, and Mr. TORRES of New York) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committees on Financial 
Services, and the Budget, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned 
A BILL 
To protect against seasonal and pandemic influenza, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
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(1) Influenza occurs seasonally each year, and 
throughout 
history 
has 
caused 
devastating 
pandemics. The 1918 influenza pandemic killed an 
estimated 675,000 Americans. 
(2) In an average season, influenza results in 
12,000 to 52,000 deaths in the United States, in-
cluding over 100 pediatric deaths. Additionally, in-
fluenza causes hundreds of thousands of hospitaliza-
tions 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 pre-
paredness 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 
(in this preamble referred to as the ‘‘CDC’’) studies 
of influenza hospitalization rates by race and eth-
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nicity during 10 influenza seasons from 2009 to 
2019 showed that people from racial and ethnic mi-
nority groups are at higher risk for being hospital-
ized with influenza. 
(6) The COVID–19 pandemic response has 
been built on the pandemic influenza response eco-
system. 
(7) Strategies that increase seasonal influenza 
vaccination rates will also improve pandemic readi-
ness. 
(8) The National Influenza Vaccine Moderniza-
tion 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 pan-
demic influenza viruses. 
(9) Influenza surveillance has been improved 
significantly over the last several years by deploying 
next-generation gene sequencing tools to analyze cir-
culating influenza viruses. The technology allows the 
CDC to study more influenza viruses faster and in 
more detail, and to monitor genetic changes in influ-
enza viruses to better understand and improve the 
effectiveness of influenza vaccines. 
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(10) Influenza diagnosis and surveillance has 
improved significantly over the last several years by 
advances in influenza testing. Timely infection con-
trol and prevention strategies would be significantly 
bolstered by accurate and readily accessible at-home 
diagnostic tests. Rapid diagnostics can improve ac-
cess 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 affect-
ing public health. Misinformation is widely available 
on social media, and traditional sources of informa-
tion on the value and efficacy of vaccines are not 
trusted by many Americans, especially those who are 
vaccine hesitant. 
(12) Support for vaccine communication, out-
reach, and administration across public health and 
health care settings is critical to drive demand of in-
fluenza vaccines, treatments, and medical counter-
measures and ensure equitable uptake of these inno-
vations. 
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SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA 
VACCINE, THERAPEUTICS, AND DIAGNOSTICS 
DEVELOPMENT, MANUFACTURING, AND SUP-
PLY CHAIN. 
(a) TIMELY DELIVERY OF FIRST DOSES OF FIN-
ISHED INFLUENZA VACCINE.— 
(1) NATIONAL GOAL.—It is a national goal for 
the United States, not later than 3 years after the 
date of enactment of this Act, to have 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, 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, not later than 10 years after the 
date of enactment of this Act, to have developed a 
universal influenza vaccine. 
(2) PLAN.— 
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(A) PUBLICATION.—Not later than 1 year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services, the Di-
rector of the National Institutes of Health, and 
the Director of the Biomedical Advanced Re-
search and Development Authority shall publish 
a plan to achieve the goal specified in para-
graph (1) in partnership with vaccine manufac-
turers. 
(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 im-
provements. 
(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 partner-
ships to strengthen the domestic vaccine 
supply chain; and 
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(ii) evaluate the capabilities, capacity, 
and utilization of such partnerships, in-
cluding 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 ‘‘do-
mestic vaccine supply chain’’ includes the full 
domestic supply chain, including— 
(i) production of ingredients and man-
ufacturing and distribution of finished vac-
cines; 
(ii) fill-finish capacity; and 
(iii) the supply chain of ancillary sup-
plies such as needles and syringes. 
(2) EVALUATION
OF
USING
DPA.—The Sec-
retary of Health and Human Services, in coordina-
tion with the Administrator of the Federal Emer-
gency Management Agency and the Secretary of De-
fense, shall— 
(A) evaluate the use of the Defense Pro-
duction 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 
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and submit a report to the Congress on the re-
sults of such evaluation; and 
(C) include in such report— 
(i) recommendations on using the De-
fense Production Act of 1950 (50 U.S.C. 
4501 et seq.) for building domestic capac-
ity to respond to an influenza pandemic; 
and 
(ii) input from external stakeholders. 
(d) NATIONAL INFLUENZA VACCINE MODERNIZA-
TION STRATEGY.—The Secretary of Health and Human 
Services shall— 
(1) implement the portions of the National In-
fluenza 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 the Congress a report on such im-
plementation. 
(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)— 
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(A) in paragraph (3), by inserting ‘‘, in-
cluding the pandemic influenza medical counter-
measures 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), by inserting ‘‘, in-
cluding 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), 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 im-
plementing the National Influenza Vaccine 
Modernization Strategy, issued in June 2020, 
or any successor strategy; and’’. 
(f) BIOMEDICAL ADVANCED RESEARCH AND DEVEL-
OPMENT AUTHORITY.— 
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(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 fol-
lowing: 
‘‘(E) supporting pandemic influenza coun-
termeasure 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 estab-
lish and implement a program that— 
‘‘(i) supports research and develop-
ment activities for qualified pandemic or 
epidemic products (as defined in section 
319F–3), including by— 
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‘‘(I) developing innovative tech-
nologies to enhance rapid response to 
pandemic influenza threats; 
‘‘(II) developing influenza vac-
cines with potential universal vaccina-
tion capability; 
‘‘(III) developing enhanced influ-
enza vaccines with longer lasting 
broad spectrum protective immunity 
against a wider range of antigenically 
divergent influenza strains; 
‘‘(IV) developing alternative vac-
cine delivery approaches; 
‘‘(V) developing novel small- and 
large-molecule 
novel 
influenza 
antivirals, monoclonal antibodies, and 
other products that provide better in-
fluenza treatment and prevention; 
‘‘(VI) developing innovative tech-
nologies to enhance rapid diagnosis of 
influenza; and 
‘‘(VII) implementing the Na-
tional Influenza Vaccine Moderniza-
tion Strategy, issued in June 2020, or 
any successor strategy; 
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‘‘(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 diversi-
fying and replenishing the existing 
stockpile of influenza antivirals; 
‘‘(III) supporting manufacturing 
and fill-finish rapid response infra-
structure; 
‘‘(IV) supporting the stockpile of 
influenza testing equipment and sup-
plies; and 
‘‘(V) testing and evaluating pan-
demic threat rapid response capabili-
ties through regular preparedness 
drills with key public and private sec-
tor partners that examine the range 
of activities (including production and 
clinical 
testing 
of 
influenza 
diagnostics, 
vaccines, 
and 
thera-
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peutics) required to effectively re-
spond to novel threats; and 
‘‘(iii) builds, sustains, and replenishes 
qualified pandemic and epidemic stockpiles 
of bulk antigen and adjuvant material, in-
cluding 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 dissemi-
nating 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 fol-
lowing: 
‘‘(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 au-
thorized to be appropriated by section 2811, there is 
authorized to be appropriated $335,000,000 for each 
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of the fiscal years 2024 through 2028, to remain 
available until expended.’’. 
SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE 
OF NEW TECHNOLOGIES TO DETECT, PRE-
VENT, AND RESPOND TO INFLUENZA. 
(a) SENSE OF CONGRESS.—It is the sense of Con-
gress 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 COM-
BINATION, AND PATHOGEN AGNOSTIC TOOLS.— 
(1) NIH.—The Director of the National Insti-
tutes of Health may conduct or support basic re-
search 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). 
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(c) DEVELOPMENT OF POINT-OF-CARE AND SELF- 
TESTING DIAGNOSTICS.—The Director of the Biomedical 
Advanced Research and Development Authority, in col-
laboration with the Director of the Centers for Disease 
Control and Prevention, the Director of the National Insti-
tutes of Health, and the Commissioner of Food and 
Drugs, may conduct or support development of rapid, ac-
curate, 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 Sec-
retary of Transportation, shall— 
(1) incorporate diagnostics supply chain resil-
iency into influenza pandemic planning that sup-
ports 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 en-
actment of this Act, publish a plan for rapidly ex-
panding public and private diagnostic testing capac-
ity (including at clinical laboratories, at public 
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health department laboratories, and by means of 
self-testing) in an influenza pandemic, including ad-
dressing transportation infrastructure, the need for 
sterilization, and sourcing critical raw materials, 
components, and parts. 
(e) SCALING UP PROPHYLACTIC INFLUENZA ANTI-
BODY PRODUCTS THAT ADDRESS GAPS IN COVERAGE.— 
The Director of the Biomedical Advanced Research and 
Development Authority may conduct or support preventive 
approaches, including those still in preclinical and clinical 
stages, to rapidly scale up preexposure prophylactic influ-
enza antibody products that address influenza infection. 
(f) MODERNIZING POTENCY ASSAYS.—The Commis-
sioner of Food and Drugs shall work with vaccine manu-
facturers to modernize potency assays across a variety of 
manufacturing technologies so as to reduce by 6 weeks 
the period required to first evaluate new vaccine can-
didates during a pandemic. 
(g) IMPROVED INFLUENZA THERAPEUTICS.—The 
Director of the Biomedical Advanced Research and Devel-
opment Authority may conduct or support improved influ-
enza therapeutics that— 
(1) are more broadly protective; and 
(2) meet the needs of high-risk and high-expo-
sure patients. 
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SEC. 5. INCREASING INFLUENZA VACCINE, THERAPEUTICS, 
AND 
TESTING 
ACCESS 
AND 
COVERAGE 
ACROSS ALL POPULATIONS. 
(a) ANNUAL REPORT ON PUBLIC COMMUNICATION 
STRATEGY.—The Director of the Centers for Disease Con-
trol and Prevention shall submit an annual report to the 
Congress on the public communication strategy of the 
Centers to increase public confidence in the safety and ef-
fectiveness of vaccines. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that the National Institutes of Health, the Director 
of the Centers for Disease Control and Prevention, the 
Secretary of Defense, the Secretary of Veterans Affairs, 
the Administrator of the Centers for Medicare & Medicaid 
Services, and the Commissioner of Food and Drugs should 
support research using large data sets from multiple 
sources of health data to further support and evaluate vac-
cine safety and effectiveness over multiple influenza sea-
sons. 
(c) 
ADDRESSING
MISINFORMATION
AND 
DISINFORMATION.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall create partnerships to address 
misinformation and disinformation with respect to 
influenza vaccines. 
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(2) REQUIREMENTS.—The partnerships under 
paragraph (1) shall— 
(A) build on lessons learned from COVID– 
19; and 
(B) allow for dissemination of best prac-
tices and lessons learned between partnering or-
ganizations. 
(3) MEMBERS.—The members of the partner-
ships under paragraph (1) shall include representa-
tives of organizations with experience working with 
vulnerable populations, including— 
(A) individuals with chronic health condi-
tions; 
(B) older Americans; 
(C) parents of young children; 
(D) pregnant people; 
(E) Tribal communities; and 
(F) racial and ethnic minorities. 
(4) CONFERRING WITH PARTNERING ORGANIZA-
TIONS.—The Secretary of Health and Human Serv-
ices shall confer with organizations represented in 
partnerships under paragraph (1)— 
(A) in advance of each seasonal influenza 
season, on messaging and communications; and 
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(B) at the end of each seasonal influenza 
season, on best practices and lessons learned. 
(5) REPORT TO CONGRESS.—Not later than one 
year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall re-
port to the Congress on the partnerships created, 
and activities conducted, under this section. 
(d) COMMUNICATIONS PUBLIC-PRIVATE PARTNER-
SHIP.— 
(1) IN GENERAL.—Not later than six months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall imple-
ment a targeted demonstration project that provides 
for the establishment of a communications public- 
private partnership initiative for increasing vaccine 
confidence. 
(2) 
REQUIREMENTS.—The 
demonstration 
project under paragraph (1) shall— 
(A) be implemented through an inde-
pendent, nongovernmental, nonprofit entity; 
(B) focus on individuals with chronic ill-
ness or other comorbidities who tend to have 
worse clinical outcomes from influenza (such as 
individuals with heart disease or diabetes, and 
racial and ethnic minorities); 
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(C) support behavioral research around 
sources of vaccine hesitancy; and 
(D) develop and implement a targeted, 
multimodal communications campaign, using 
internet platforms, television, and nontradi-
tional targeted social media and community 
outreach in an effort to reach individuals who 
may be especially vaccine hesitant. 
(3) REPORT.—Not later than six months after 
completion of the demonstration project under para-
graph (1), the Secretary of Health and Human 
Services shall— 
(A) prepare a report on the demonstration 
project, including an evaluation of the project’s 
methods, findings, and results; and 
(B) make such report publicly available on 
the website of the Department of Health and 
Human Services. 
(e) INCORPORATING HEALTH EQUITY INTO SEA-
SONAL AND PANDEMIC INFLUENZA PLANNING AND RE-
SPONSE.—The Director of the Centers for Disease Control 
and Prevention and the Assistant Secretary for Prepared-
ness and Response shall— 
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