[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9476 Introduced in House (IH)]

<DOC>






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. Barragan) 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 
consideration 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 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 2022''.

SEC. 2. FINDINGS.

    The 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 Americans.
            (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 (in this 
        preamble referred to as the ``CDC'') studies of influenza 
        hospitalization rates by race and ethnicity during 10 influenza 
        seasons from 2009 to 2019 showed that people 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 
        over the last several years by deploying 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) 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 Americans, especially those 
        who are vaccine hesitant.
            (11) 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 these 
        innovations.

SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA VACCINE 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, 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.--
                    (A) Publication.--Not later than 1 year after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services, 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 establish public-private partnerships to 
                strengthen the domestic vaccine 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 the 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 
        the 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)(G) of section 319L(c)'' 
                after ``qualified pandemic or epidemic products (as 
                defined in section 319F-3)''; and
                    (B) in paragraph (7), by inserting ``, including 
                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:
                    ``(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:
                    ``(G) 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 novel small- and 
                                large-molecule novel influenza 
                                antivirals, monoclonal antibodies, and 
                                other products that provide better 
                                influenza treatment and prevention; and
                                    ``(V) 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 needed to meet the goals 
                                of the National Influenza Vaccine 
                                Modernization Strategy, issued in June 
                                2020, or any successor strategy; and
                                    ``(IV) 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 vaccines) 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 shelf life 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 $382,000,000 for each of the 
        fiscal years 2023 through 2027, to remain available until 
        expended.''.

SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE OF NEW TECHNOLOGIES TO 
              DETECT, PREVENT, 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 institutions, and other private 
        entities to expand genomic sequencing.
            (2) Sources of data.--The sequencing supported pursuant to 
        paragraph (1) may rely on multiple sources of data, including 
        human, animal, plant, and environmental data necessary to track 
        zoonotic diseases.
    (b) Centers of Excellence in Genomic Epidemiology.--The Director of 
the Centers for Disease Control 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 institutions to improve genomic 
        epidemiology, including through the conduct or support of 
        research.
    (c) 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.
    (d) Prioritizing Influenza 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).
    (e) Development of Point-of-Person 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, 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 resiliency into 
        influenza pandemic planning; 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 
        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 Prevention shall carry out activities to provide for the 
coordination of the integration of data and results from point-of-
person diagnostic tests in local, State, and Federal health databases.
    (h) Scaling up Prophylactic Influenza Antibody Products That 
Address Gaps in Coverage.--The Director of the Biomedical Advanced 
Research and Development Authority may conduct or support novel 
preventive 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 Commissioner of Food and Drugs 
shall work with vaccine manufacturers 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 candidates 
during a pandemic.
    (j) Improved Influenza Therapeutics.--The Director of the 
Biomedical Advanced Research and Development Authority may conduct or 
support improved influenza therapeutics that--
            (1) are more broadly protective; and
            (2) meet the needs of high-risk and high-exposure 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 strengthen and diversify the public health and 
health care workforce so as to ensure the capacity of such workforce to 
effectuate advances pursuant to subsections (a) through (j).

SEC. 5. INCREASING INFLUENZA VACCINE AND THERAPEUTICS ACCESS AND 
              COVERAGE ACROSS ALL POPULATIONS.

    (a) Annual Report on Public Communication Strategy.--The Director 
of the Centers for Disease Control 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 
effectiveness of vaccines.
    (b) Sense of Congress.--It is the sense of Congress 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 vaccine safety and effectiveness 
over multiple influenza seasons.
    (c) Addressing Misinformation and Disinformation.--The Secretary of 
Health and Human Services shall create partnerships to address 
misinformation and disinformation with respect to influenza vaccines.
    (d) Communications Public-Private Partnership.--The Secretary of 
Health and Human Services may provide for the establishment of a 
communications public-private partnership initiative for increasing 
vaccine confidence that--
            (1) includes an independent, nongovernmental, nonprofit 
        entity;
            (2) supports behavioral research evaluating individual 
        behavior analysis and influence;
            (3) identifies and targets vaccine hesitant individuals; 
        and
            (4) provides information on vaccine safety and 
        effectiveness.
    (e) Incorporating Health Equity Into Seasonal and Pandemic 
Influenza Planning and Response.--The Director of the Centers for 
Disease Control and Prevention and the Assistant Secretary for 
Preparedness and Response shall--
            (1) incorporate health equity into the seasonal and 
        pandemic influenza planning and response programs overseen by 
        such officials; and
            (2) in so doing--
                    (A) emphasize the inclusion of all populations; and
                    (B) include strategies to reach communities of 
                color, communities with lower socioeconomic status, 
                seniors, and individuals with disabilities.
    (f) Report on Lessons Learned From COVID-19 Federal Retail Pharmacy 
Program.--Not later than 6 months after the date of enactment of this 
Act, the Secretary of Health and Human Services shall--
            (1) submit a report to the Congress on lessons learned from 
        the COVID-19 Federal Retail Pharmacy Program; and
            (2) identify positive aspects of such Program that could be 
        applied with respect to influenza.
    (g) Creating Administration Pathways.--The Secretary of Health and 
Human Services may award grants to States to create administration 
pathways for pharmacy personnel to administer influenza vaccines, in 
order to increase vaccination rates for adults and children.
    (h) Strategic National Stockpile.--The Secretary of Health and 
Human Services shall incorporate into the Strategic National Stockpile 
under section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-
6b) products needed to respond to pandemic influenza, including 
through--
            (1) dynamic management of aging antivirals; and
            (2) diversification of stockpiled products.
    (i) Monitoring and Distributing Influenza Antiviral Supplies.--The 
Secretary of Health and Human Services shall--
            (1) monitor influenza antiviral supplies throughout the 
        country; and
            (2) establish a process, to be used in pandemic situations, 
        to distribute products rapidly and effectively to areas of 
        urgent need in close coordination with manufacturers and State 
        and local health officials.
    (j) Plan for Ensuring Access to Appropriate Influenza Therapeutics 
and Prophylaxis.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall publish a plan for ensuring access to 
        appropriate influenza therapeutics and prophylaxis for--
                    (A) high-risk patients, such as nursing home and 
                pediatric patients; and
                    (B) high-exposure patients, such as first 
                responders and health care workers.
            (2) Communications efforts.--The plan required by paragraph 
        (1) shall include communications efforts to educate the public 
        about the benefits of early use of influenza therapeutics and 
        prophylaxis.

SEC. 6. AUTHORIZING SUSTAINABLE FUNDING FOR THE INFLUENZA ECOSYSTEM.

    (a) Influenza Planning and Response Program.--There is authorized 
to be appropriated $251,000,000 for fiscal year 2025 and each 
subsequent fiscal year for programs and activities of the Centers for 
Disease Control and Prevention relating to influenza planning and 
response.
    (b) Strategic National Stockpile.--There is authorized to be 
appropriated $1,657,000,000 for fiscal year 2023 and each subsequent 
fiscal year for the Strategic National Stockpile under section 319F-2 
of the Public Health Service Act (42 U.S.C. 247d-6b).
    (c) Hospital Preparedness Program.--There is authorized to be 
appropriated $474,000,000 for fiscal year 2023 and each subsequent 
fiscal year for Hospital Preparedness Program of the Assistant 
Secretary for Preparedness and Response.
    (d) Universal Flu Vaccine Research.--There is authorized to be 
appropriated $260,000,000 for fiscal year 2023 and each subsequent 
fiscal year for research of the National Institutes of Health to 
develop a universal flu vaccine.
    (e) Immunization Program.--There is authorized to be appropriated 
$1,130,000,000 for fiscal year 2023 and each subsequent fiscal year for 
the immunization program of the Centers for Disease Control and 
Prevention under section 317 of the Public Health Service Act (42 
U.S.C. 247b).
    (f) Public Health Emergency Preparedness Program.--There is 
authorized to be appropriated $824,000,000 for fiscal year 2023 and 
each subsequent fiscal year for the Public Health Emergency 
Preparedness Program of the Centers for Disease Control and Prevention.
    (g) Infectious Disease Rapid Response Reserve Fund.--There is 
authorized to be appropriated $35,000,000 for fiscal year 2023 and each 
subsequent fiscal year for the Infectious Disease Rapid Response 
Reserve Fund of the Centers for Disease Control and Prevention.
    (h) Data Modernization Initiative.--There is authorized to be 
appropriated $250,000,000 for fiscal year 2023 and each subsequent 
fiscal year for the Public Health Data Modernization Initiative of the 
Centers for Disease Control and Prevention.
    (i) Health Defense Operations Budget Matters.--
            (1) Designation.--Section 251(b)(2) of the Balanced Budget 
        and Emergency Deficit Control Act of 1985 (2 U.S.C. 901(b)(2)) 
        is amended by adding at the end the following:
                    ``(F) Health defense operations.--(i) If, for any 
                fiscal year, appropriations for discretionary accounts 
                are enacted that the Congress designates in statute on 
                an account by account basis as being for health defense 
                operations, then the adjustment for that fiscal year 
                shall be the total of such appropriations for that 
                fiscal year.
                    ``(ii) Any report or explanatory statement 
                accompanying an appropriations Act that contains an 
                account with amounts that are designated as being for 
                health defense operations pursuant to clause (i) shall 
                specify each program, project, or activity that will be 
                funded by such amounts, and a specific dollar amount 
                provided for each such program, project, or 
                activity.''.
            (2) Professional bypass budget.--Title IV of the Public 
        Health Service Act (42 U.S.C. 281 et seq.) is amended by 
        inserting after section 402B the following:

``SEC. 402C. HEALTH DEFENSE OPERATIONS PROFESSIONAL BYPASS BUDGET.

    ``(a) In General.--For fiscal year 2024 and each fiscal year 
thereafter, the Director of the Centers for Disease Control and 
Prevention, the Director of the National Institutes of Health, and the 
Assistant Secretary for Preparedness and Response shall prepare and 
submit directly to the President for review and transmittal to 
Congress, after reasonable opportunity for comment, but without change, 
by the Secretary of Health and Human Services, an annual budget 
estimate (including an estimate of the number and type of personnel 
needs for the Institutes) for amounts to be designated as being for 
health defense operations pursuant to subparagraph (F) of section 
251(b)(2) of the Balanced Budget and Emergency Deficit Control Act of 
1985.
    ``(b) Programs, Projects, and Activities.--Any budget estimate 
submitted pursuant to subsection (a) by the Director shall include any 
program, project, or activity that received funds designated under such 
subparagraph (F) for the fiscal year during which such budget is 
submitted, except that the Director may modify the programs, projects, 
or activities contained in such budget estimate as circumstances 
warrant.''.
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