I 
117TH CONGRESS 
2D SESSION 
H. R. 9476 
To protect against seasonal and pandemic influenza, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 8, 2022 
Mr. LARSEN of Washington (for himself, Ms. ROSS, Mr. BERA, Ms. NORTON, 
Mr. CARBAJAL, and Ms. BARRAGA´N) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committees on the Budget, and Financial Services, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within 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 2022’’. 
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) 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. 
(11) 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. 
SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA 
VACCINE DEVELOPMENT, MANUFACTURING, 
AND SUPPLY 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. 
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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 establish pub-
lic-private partnerships to strengthen the do-
mestic vaccine 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-
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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 
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 
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(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)— 
(A) in paragraph (3), by inserting ‘‘, in-
cluding the pandemic influenza medical counter-
measures program under paragraphs (2)(E) 
and (4)(G) 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)(G) 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: 
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‘‘(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.— 
(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: 
‘‘(G) 
PANDEMIC
INFLUENZA
MEDICAL 
COUNTERMEASURES
PROGRAM.—In 
carrying 
out paragraph (2)(E), the Secretary shall estab-
lish and implement a program that— 
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‘‘(i) supports research and develop-
ment activities for qualified pandemic or 
epidemic products (as defined in section 
319F–3), including by— 
‘‘(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 novel small- and 
large-molecule 
novel 
influenza 
antivirals, monoclonal antibodies, and 
other products that provide better in-
fluenza treatment and prevention; and 
‘‘(V) implementing the National 
Influenza 
Vaccine 
Modernization 
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 needed to meet the goals of 
the National Influenza Vaccine Mod-
ernization Strategy, issued in June 
2020, or any successor strategy; and 
‘‘(IV) 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 vaccines) 
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required to effectively respond 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 shelf life 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 $382,000,000 for each 
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of the fiscal years 2023 through 2027, to remain 
available until expended.’’. 
SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE 
OF NEW TECHNOLOGIES TO DETECT, PRE-
VENT, AND RESPOND TO INFLUENZA. 
(a) EXPANDED GENOMIC SEQUENCING.— 
(1) GRANTS.—The Director of the Centers for 
Disease Control and Prevention may award grants 
to State and local laboratories, academic research in-
stitutions, and other private entities to expand 
genomic sequencing. 
(2) SOURCES OF DATA.—The sequencing sup-
ported pursuant to paragraph (1) may rely on mul-
tiple sources of data, including human, animal, 
plant, and environmental data necessary to track 
zoonotic diseases. 
(b) CENTERS OF EXCELLENCE IN GENOMIC EPIDE-
MIOLOGY.—The Director of the Centers for Disease Con-
trol and Prevention may— 
(1) designate Centers of Excellence in Genomic 
Epidemiology; and 
(2) award grants to such Centers of Excellence 
to establish and implement partnerships between 
State and local health departments and academic in-
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stitutions to improve genomic epidemiology, includ-
ing through the conduct or support of research. 
(c) 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. 
(d) PRIORITIZING INFLUENZA AND PATHOGEN AG-
NOSTIC 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). 
(e) 
DEVELOPMENT
OF
POINT-OF-PERSON 
DIAGNOSTICS.—The Director of the Biomedical Advanced 
Research and Development Authority, in collaboration 
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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, and readable point-of-person 
diagnostic tests. 
(f) 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 
and the Director of the Centers for Disease Control and 
Prevention, shall— 
(1) incorporate diagnostics supply chain resil-
iency into influenza pandemic planning; 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 
health department laboratories, and by means of 
self-testing) in an influenza pandemic. 
(g) COORDINATING THE INTEGRATION OF POINT-OF- 
PERSON DIAGNOSTIC TEST RESULTS IN DATABASES.— 
The Director of the Centers for Disease Control and Pre-
vention shall carry out activities to provide for the coordi-
nation of the integration of data and results from point- 
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of-person diagnostic tests in local, State, and Federal 
health databases. 
(h) 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 novel pre-
ventive approaches, including those still in preclinical and 
clinical stages, to rapidly scale up prophylactic influenza 
antibody products that address gaps in vaccine coverage. 
(i) 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. 
(j) IMPROVED INFLUENZA THERAPEUTICS.—The Di-
rector of the Biomedical Advanced Research and Develop-
ment 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. 
(k) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and 
Human Services shall submit to the Congress a plan to 
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