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) introduced the following bill; which was referred to the Committee on Energy 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 within the jurisdiction of the committee concerned 

A BILL 

To protect against seasonal and pandemic influenza, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting America 

5 from Seasonal and Pandemic Influenza Act of 2023’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds the following: 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 5846 IH

1 (1) Influenza occurs seasonally each year, and 

2 throughout history has caused devastating 

3 pandemics. The 1918 influenza pandemic killed an 

4 estimated 675,000 Americans. 

5 (2) In an average season, influenza results in 

6 12,000 to 52,000 deaths in the United States, in7 cluding over 100 pediatric deaths. Additionally, in8 fluenza causes hundreds of thousands of hospitaliza9 tions and millions of illnesses. 

10 (3) The Council of Economic Advisors issued a 

11 report in 2019 estimating that seasonal influenza 

12 costs the United States approximately 

13 $361,000,000,000 per year, and that an influenza 

14 pandemic has the potential to cause up to 

15 $3,790,000,000,000 in losses. This report was 

16 issued prior to the COVID–19 pandemic, which will 

17 cost the United States an estimated 

18 $16,000,000,000,000. 

19 (4) Most funding for pandemic influenza pre20 paredness up until fiscal year 2018 was derived from 

21 supplemental appropriations that dated back to the 

22 2009 H1N1 pandemic. 

23 (5) Centers for Disease Control and Prevention 

24 (in this preamble referred to as the ‘‘CDC’’) studies 

25 of influenza hospitalization rates by race and ethVerDate Sep 11 2014 00:04 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5846.IH H5846

kjohnson on DSK7ZCZBW3PROD with $$_JOB
3 

•HR 5846 IH

1 nicity during 10 influenza seasons from 2009 to 

2 2019 showed that people from racial and ethnic mi3 nority groups are at higher risk for being hospital4 ized with influenza. 

5 (6) The COVID–19 pandemic response has 

6 been built on the pandemic influenza response eco7 system. 

8 (7) Strategies that increase seasonal influenza 

9 vaccination rates will also improve pandemic readi10 ness. 

11 (8) The National Influenza Vaccine Moderniza12 tion Strategy of 2020–2030 of the Department of 

13 Health and Human Services should be implemented 

14 as quickly as possible to ensure the Nation’s vaccine 

15 enterprise is highly responsive, flexible, scalable, and 

16 effective at reducing the impact of seasonal and pan17 demic influenza viruses. 

18 (9) Influenza surveillance has been improved 

19 significantly over the last several years by deploying 

20 next-generation gene sequencing tools to analyze cir21 culating influenza viruses. The technology allows the 

22 CDC to study more influenza viruses faster and in 

23 more detail, and to monitor genetic changes in influ24 enza viruses to better understand and improve the 

25 effectiveness of influenza vaccines. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
4 

•HR 5846 IH

1 (10) Influenza diagnosis and surveillance has 

2 improved significantly over the last several years by 

3 advances in influenza testing. Timely infection con4 trol and prevention strategies would be significantly 

5 bolstered by accurate and readily accessible at-home 

6 diagnostic tests. Rapid diagnostics can improve ac7 cess for underserved populations and allow for better 

8 antibiotic stewardship. 

9 (11) Vaccine hesitancy in the United States has 

10 reached a tipping point where it is adversely affect11 ing public health. Misinformation is widely available 

12 on social media, and traditional sources of informa13 tion on the value and efficacy of vaccines are not 

14 trusted by many Americans, especially those who are 

15 vaccine hesitant. 

16 (12) Support for vaccine communication, out17 reach, and administration across public health and 

18 health care settings is critical to drive demand of in19 fluenza vaccines, treatments, and medical counter20 measures and ensure equitable uptake of these inno21 vations. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
5 

•HR 5846 IH

1 SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA 

2 VACCINE, THERAPEUTICS, AND DIAGNOSTICS 

3 DEVELOPMENT, MANUFACTURING, AND SUP4 PLY CHAIN. 

5 (a) TIMELY DELIVERY OF FIRST DOSES OF FIN6 ISHED INFLUENZA VACCINE.— 

7 (1) NATIONAL GOAL.—It is a national goal for 

8 the United States, not later than 3 years after the 

9 date of enactment of this Act, to have the capacity 

10 to deliver first doses of finished influenza vaccine 

11 within 12 weeks of emergence of an influenza strain 

12 with pandemic potential. 

13 (2) PLAN.—Not later than 6 months after the 

14 date of enactment of this Act, the Secretary of 

15 Health and Human Services, the Assistant Secretary 

16 for Preparedness and Response, and the Director of 

17 the Biomedical Advanced Research and Development 

18 Authority shall publish a plan to achieve the goal 

19 specified in paragraph (1). 

20 (b) UNIVERSAL INFLUENZA VACCINE.— 

21 (1) NATIONAL GOAL.—It is a national goal for 

22 the United States, not later than 10 years after the 

23 date of enactment of this Act, to have developed a 

24 universal influenza vaccine. 

25 (2) PLAN.— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
6 

•HR 5846 IH

1 (A) PUBLICATION.—Not later than 1 year 

2 after the date of enactment of this Act, the Sec3 retary of Health and Human Services, the Di4 rector of the National Institutes of Health, and 

5 the Director of the Biomedical Advanced Re6 search and Development Authority shall publish 

7 a plan to achieve the goal specified in para8 graph (1) in partnership with vaccine manufac9 turers. 

10 (B) INTERIM SUPPORT.—The plan under 

11 subparagraph (A) shall include provisions, as 

12 necessary to achieve such goal, for support over 

13 the period of 5 years following the publication 

14 of such plan of the following: 

15 (i) Incremental vaccine efficacy im16 provements. 

17 (ii) The research workforce. 

18 (c) STRENGTHENING THE VACCINE SUPPLY

19 CHAIN.— 

20 (1) PUBLIC-PRIVATE PARTNERSHIPS.— 

21 (A) IN GENERAL.—The Secretary of 

22 Health and Human Services shall— 

23 (i) establish public-private partner24 ships to strengthen the domestic vaccine 

25 supply chain; and 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
7 

•HR 5846 IH

1 (ii) evaluate the capabilities, capacity, 

2 and utilization of such partnerships, in3 cluding by assessing and testing relevant 

4 logistical and interoperable technology with 

5 stakeholders in the supply chain. 

6 (B) DOMESTIC VACCINE SUPPLY CHAIN.— 

7 For purposes of this paragraph, the term ‘‘do8 mestic vaccine supply chain’’ includes the full 

9 domestic supply chain, including— 

10 (i) production of ingredients and man11 ufacturing and distribution of finished vac12 cines; 

13 (ii) fill-finish capacity; and 

14 (iii) the supply chain of ancillary sup15 plies such as needles and syringes. 

16 (2) EVALUATION OF USING DPA.—The Sec17 retary of Health and Human Services, in coordina18 tion with the Administrator of the Federal Emer19 gency Management Agency and the Secretary of De20 fense, shall— 

21 (A) evaluate the use of the Defense Pro22 duction Act of 1950 (50 U.S.C. 4501 et seq.) 

23 for COVID–19 pandemic response; 

24 (B) not later than 1 year after the date of 

25 enactment of this Act, complete such evaluation 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
8 

•HR 5846 IH

1 and submit a report to the Congress on the re2 sults of such evaluation; and 

3 (C) include in such report— 

4 (i) recommendations on using the De5 fense Production Act of 1950 (50 U.S.C. 

6 4501 et seq.) for building domestic capac7 ity to respond to an influenza pandemic; 

8 and 

9 (ii) input from external stakeholders. 

10 (d) NATIONAL INFLUENZA VACCINE MODERNIZA11 TION STRATEGY.—The Secretary of Health and Human 

12 Services shall— 

13 (1) implement the portions of the National In14 fluenza Vaccine Modernization Strategy 2020–2030 

15 that are within the authority of the Department of 

16 Health and Human Services to carry out (under 

17 other applicable provisions of law); and 

18 (2) by June 15 each calendar year through 

19 2030, submit to the Congress a report on such im20 plementation. 

21 (e) ASSISTANT SECRETARY FOR PREPAREDNESS AND

22 RESPONSE.—Section 2811 of the Public Health Service 

23 Act (42 U.S.C. 300hh–10) is amended— 

24 (1) in subsection (b)— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
9 

•HR 5846 IH

1 (A) in paragraph (3), by inserting ‘‘, in2 cluding the pandemic influenza medical counter3 measures program under paragraphs (2)(E) 

4 and (4)(H) of section 319L(c)’’ after ‘‘qualified 

5 pandemic or epidemic products (as defined in 

6 section 319F–3)’’; and 

7 (B) in paragraph (7), by inserting ‘‘, in8 cluding through the pandemic influenza medical 

9 countermeasures program under paragraphs 

10 (2)(E) and (4)(H) of section 319L(c)’’ after 

11 ‘‘for each such threat’’; and 

12 (2) in subsection (d)(2)— 

13 (A) in subparagraph (J), by striking ‘‘and’’ 

14 at the end; 

15 (B) by redesignating subparagraph (K) as 

16 subparagraph (L); and 

17 (C) by inserting after subparagraph (J) 

18 the following: 

19 ‘‘(K) evaluate progress with respect to im20 plementing the National Influenza Vaccine 

21 Modernization Strategy, issued in June 2020, 

22 or any successor strategy; and’’. 

23 (f) BIOMEDICAL ADVANCED RESEARCH AND DEVEL24 OPMENT AUTHORITY.— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
10 

•HR 5846 IH

1 (1) PREPAREDNESS ACTIVITIES.—Section 

2 319L(c) of the Public Health Service Act (42 U.S.C. 

3 247d–7e(c)) is amended— 

4 (A) in paragraph (2)— 

5 (i) in subparagraph (C), by striking 

6 ‘‘and’’ at the end; 

7 (ii) in subparagraph (D), by striking 

8 the period at the end and inserting ‘‘; 

9 and’’; and 

10 (iii) by adding at the end of the fol11 lowing: 

12 ‘‘(E) supporting pandemic influenza coun13 termeasure preparedness.’’; and 

14 (B) in paragraph (4), by adding at the end 

15 of the following: 

16 ‘‘(H) PANDEMIC INFLUENZA MEDICAL

17 COUNTERMEASURES PROGRAM.—In carrying 

18 out paragraph (2)(E), the Secretary shall estab19 lish and implement a program that— 

20 ‘‘(i) supports research and develop21 ment activities for qualified pandemic or 

22 epidemic products (as defined in section 

23 319F–3), including by— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
11 

•HR 5846 IH

1 ‘‘(I) developing innovative tech2 nologies to enhance rapid response to 

3 pandemic influenza threats; 

4 ‘‘(II) developing influenza vac5 cines with potential universal vaccina6 tion capability; 

7 ‘‘(III) developing enhanced influ8 enza vaccines with longer lasting 

9 broad spectrum protective immunity 

10 against a wider range of antigenically 

11 divergent influenza strains; 

12 ‘‘(IV) developing alternative vac13 cine delivery approaches; 

14 ‘‘(V) developing novel small- and 

15 large-molecule novel influenza 

16 antivirals, monoclonal antibodies, and 

17 other products that provide better in18 fluenza treatment and prevention; 

19 ‘‘(VI) developing innovative tech20 nologies to enhance rapid diagnosis of 

21 influenza; and 

22 ‘‘(VII) implementing the Na23 tional Influenza Vaccine Moderniza24 tion Strategy, issued in June 2020, or 

25 any successor strategy; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
12 

•HR 5846 IH

1 ‘‘(ii) ensures readiness to respond to 

2 qualified pandemic and epidemic threats, 

3 including by— 

4 ‘‘(I) supporting development and 

5 manufacturing of influenza virus 

6 seeds, clinical trial lots, and stockpiles 

7 of novel influenza strains; 

8 ‘‘(II) supporting the stockpile of 

9 influenza antivirals through diversi10 fying and replenishing the existing 

11 stockpile of influenza antivirals; 

12 ‘‘(III) supporting manufacturing 

13 and fill-finish rapid response infra14 structure; 

15 ‘‘(IV) supporting the stockpile of 

16 influenza testing equipment and sup17 plies; and 

18 ‘‘(V) testing and evaluating pan19 demic threat rapid response capabili20 ties through regular preparedness 

21 drills with key public and private sec22 tor partners that examine the range 

23 of activities (including production and 

24 clinical testing of influenza 

25 diagnostics, vaccines, and theraVerDate Sep 11 2014 00:04 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5846.IH H5846

kjohnson on DSK7ZCZBW3PROD with $$_JOB
13 

•HR 5846 IH

1 peutics) required to effectively re2 spond to novel threats; and 

3 ‘‘(iii) builds, sustains, and replenishes 

4 qualified pandemic and epidemic stockpiles 

5 of bulk antigen and adjuvant material, in6 cluding by— 

7 ‘‘(I) annually testing the potency 

8 and shelflife potential of all existing 

9 pandemic and epidemic stockpiles held 

10 by the Department of Health and 

11 Human Services; and 

12 ‘‘(II) developing, and dissemi13 nating to key public and private sector 

14 partners, a life cycle management 

15 plan.’’. 

16 (g) AUTHORIZATION OF APPROPRIATIONS.—Section 

17 319L(d) of the Public Health Service Act (42 U.S.C. 

18 247d–7e(d)) is amended by adding at the end the fol19 lowing: 

20 ‘‘(3) PANDEMIC INFLUENZA.—To carry out this 

21 section and section 2811 with respect to pandemic 

22 influenza, in addition to amounts authorized to be 

23 appropriated by paragraph (2) and any amounts au24 thorized to be appropriated by section 2811, there is 

25 authorized to be appropriated $335,000,000 for each 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
14 

•HR 5846 IH

1 of the fiscal years 2024 through 2028, to remain 

2 available until expended.’’. 

3 SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE 

4 OF NEW TECHNOLOGIES TO DETECT, PRE5 VENT, AND RESPOND TO INFLUENZA. 

6 (a) SENSE OF CONGRESS.—It is the sense of Con7 gress that the Centers for Disease Control and Prevention 

8 should support interoperable immunization information 

9 systems that enable bidirectional data exchange among 

10 States, localities, and community immunization providers. 

11 (b) PRIORITIZING INFLUENZA, INFLUENZA COM12 BINATION, AND PATHOGEN AGNOSTIC TOOLS.— 

13 (1) NIH.—The Director of the National Insti14 tutes of Health may conduct or support basic re15 search prioritizing the development of— 

16 (A) agnostic tools to detect influenza and 

17 other pathogens; and 

18 (B) technologies that automate sample 

19 preparation for such tools. 

20 (2) BARDA.—The Director of the Biomedical 

21 Advanced Research and Development Authority may 

22 conduct or support advanced development of novel 

23 sequencing modalities prioritizing tools described in 

24 paragraph (1)(A) and technologies described in 

25 paragraph (1)(B). 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
15 

•HR 5846 IH

1 (c) DEVELOPMENT OF POINT-OF-CARE AND SELF2 TESTING DIAGNOSTICS.—The Director of the Biomedical 

3 Advanced Research and Development Authority, in col4 laboration with the Director of the Centers for Disease 

5 Control and Prevention, the Director of the National Insti6 tutes of Health, and the Commissioner of Food and 

7 Drugs, may conduct or support development of rapid, ac8 curate, easily accessible, self-administrable diagnostic tests 

9 that are readable at the point of care or at home. 

10 (d) INCORPORATING DIAGNOSTICS SUPPLY CHAIN

11 RESILIENCY INTO INFLUENZA PANDEMIC PLANNING.— 

12 The Assistant Secretary for Preparedness and Response, 

13 in collaboration with the Commissioner of Food and 

14 Drugs, the Director of the Centers for Disease Control 

15 and Prevention, the Secretary of Commerce, and the Sec16 retary of Transportation, shall— 

17 (1) incorporate diagnostics supply chain resil18 iency into influenza pandemic planning that sup19 ports a health care system that tests to treat and 

20 bolsters testing and vaccine delivery supply chains; 

21 and 

22 (2) not later than 1 year after the date of en23 actment of this Act, publish a plan for rapidly ex24 panding public and private diagnostic testing capac25 ity (including at clinical laboratories, at public 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
16 

•HR 5846 IH

1 health department laboratories, and by means of 

2 self-testing) in an influenza pandemic, including ad3 dressing transportation infrastructure, the need for 

4 sterilization, and sourcing critical raw materials, 

5 components, and parts. 

6 (e) SCALING UP PROPHYLACTIC INFLUENZA ANTI7 BODY PRODUCTS THAT ADDRESS GAPS IN COVERAGE.— 

8 The Director of the Biomedical Advanced Research and 

9 Development Authority may conduct or support preventive 

10 approaches, including those still in preclinical and clinical 

11 stages, to rapidly scale up preexposure prophylactic influ12 enza antibody products that address influenza infection. 

13 (f) MODERNIZING POTENCY ASSAYS.—The Commis14 sioner of Food and Drugs shall work with vaccine manu15 facturers to modernize potency assays across a variety of 

16 manufacturing technologies so as to reduce by 6 weeks 

17 the period required to first evaluate new vaccine can18 didates during a pandemic. 

19 (g) IMPROVED INFLUENZA THERAPEUTICS.—The 

20 Director of the Biomedical Advanced Research and Devel21 opment Authority may conduct or support improved influ22 enza therapeutics that— 

23 (1) are more broadly protective; and 

24 (2) meet the needs of high-risk and high-expo25 sure patients. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
17 

•HR 5846 IH

1 SEC. 5. INCREASING INFLUENZA VACCINE, THERAPEUTICS, 

2 AND TESTING ACCESS AND COVERAGE 

3 ACROSS ALL POPULATIONS. 

4 (a) ANNUAL REPORT ON PUBLIC COMMUNICATION

5 STRATEGY.—The Director of the Centers for Disease Con6 trol and Prevention shall submit an annual report to the 

7 Congress on the public communication strategy of the 

8 Centers to increase public confidence in the safety and ef9 fectiveness of vaccines. 

10 (b) SENSE OF CONGRESS.—It is the sense of Con11 gress that the National Institutes of Health, the Director 

12 of the Centers for Disease Control and Prevention, the 

13 Secretary of Defense, the Secretary of Veterans Affairs, 

14 the Administrator of the Centers for Medicare & Medicaid 

15 Services, and the Commissioner of Food and Drugs should 

16 support research using large data sets from multiple 

17 sources of health data to further support and evaluate vac18 cine safety and effectiveness over multiple influenza sea19 sons. 

20 (c) ADDRESSING MISINFORMATION AND

21 DISINFORMATION.— 

22 (1) IN GENERAL.—The Secretary of Health and 

23 Human Services shall create partnerships to address 

24 misinformation and disinformation with respect to 

25 influenza vaccines. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
18 

•HR 5846 IH

1 (2) REQUIREMENTS.—The partnerships under 

2 paragraph (1) shall— 

3 (A) build on lessons learned from COVID– 

4 19; and 

5 (B) allow for dissemination of best prac6 tices and lessons learned between partnering or7 ganizations. 

8 (3) MEMBERS.—The members of the partner9 ships under paragraph (1) shall include representa10 tives of organizations with experience working with 

11 vulnerable populations, including— 

12 (A) individuals with chronic health condi13 tions; 

14 (B) older Americans; 

15 (C) parents of young children; 

16 (D) pregnant people; 

17 (E) Tribal communities; and 

18 (F) racial and ethnic minorities. 

19 (4) CONFERRING WITH PARTNERING ORGANIZA20 TIONS.—The Secretary of Health and Human Serv21 ices shall confer with organizations represented in 

22 partnerships under paragraph (1)— 

23 (A) in advance of each seasonal influenza 

24 season, on messaging and communications; and 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
19 

•HR 5846 IH

1 (B) at the end of each seasonal influenza 

2 season, on best practices and lessons learned. 

3 (5) REPORT TO CONGRESS.—Not later than one 

4 year after the date of enactment of this Act, the 

5 Secretary of Health and Human Services shall re6 port to the Congress on the partnerships created, 

7 and activities conducted, under this section. 

8 (d) COMMUNICATIONS PUBLIC-PRIVATE PARTNER9 SHIP.— 

10 (1) IN GENERAL.—Not later than six months 

11 after the date of enactment of this Act, the Sec12 retary of Health and Human Services shall imple13 ment a targeted demonstration project that provides 

14 for the establishment of a communications public15 private partnership initiative for increasing vaccine 

16 confidence. 

17 (2) REQUIREMENTS.—The demonstration 

18 project under paragraph (1) shall— 

19 (A) be implemented through an inde20 pendent, nongovernmental, nonprofit entity; 

21 (B) focus on individuals with chronic ill22 ness or other comorbidities who tend to have 

23 worse clinical outcomes from influenza (such as 

24 individuals with heart disease or diabetes, and 

25 racial and ethnic minorities); 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
20 

•HR 5846 IH

1 (C) support behavioral research around 

2 sources of vaccine hesitancy; and 

3 (D) develop and implement a targeted, 

4 multimodal communications campaign, using 

5 internet platforms, television, and nontradi6 tional targeted social media and community 

7 outreach in an effort to reach individuals who 

8 may be especially vaccine hesitant. 

9 (3) REPORT.—Not later than six months after 

10 completion of the demonstration project under para11 graph (1), the Secretary of Health and Human 

12 Services shall— 

13 (A) prepare a report on the demonstration 

14 project, including an evaluation of the project’s 

15 methods, findings, and results; and 

16 (B) make such report publicly available on 

17 the website of the Department of Health and 

18 Human Services. 

19 (e) INCORPORATING HEALTH EQUITY INTO SEA20 SONAL AND PANDEMIC INFLUENZA PLANNING AND RE21 SPONSE.—The Director of the Centers for Disease Control 

22 and Prevention and the Assistant Secretary for Prepared23 ness and Response shall— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
21 

•HR 5846 IH

1 (1) incorporate health equity into the seasonal 

2 and pandemic influenza planning and response pro3 grams overseen by such officials; and 

4 (2) in so doing— 

5 (A) emphasize the inclusion of all popu6 lations; and 

7 (B) include strategies to reach commu8 nities of color, communities with lower socio9 economic status, seniors, and individuals with 

10 disabilities, including addressing barriers to 

11 vaccinations, therapeutics, and diagnostics in 

12 the point-of-care and at-home self-testing set13 tings. 

14 (f) EXPANDING ACCESS TO INFLUENZA TREATMENT

15 AND ADOPTING LESSONS LEARNED FROM COVID–19 

16 FEDERAL RETAIL PHARMACY PROGRAM.— 

17 (1) REPORT.—Not later than 6 months after 

18 the date of enactment of this Act, the Secretary of 

19 Health and Human Services shall submit a report to 

20 the Congress on lessons learned from the COVID– 

21 19 Federal Retail Pharmacy Program, including as22 pects of the program that could be applied with re23 spect to multianalyte tests that target COVID–19 as 

24 well as influenza and other upper respiratory vi25 ruses. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
22 

•HR 5846 IH

1 (2) DEMONSTRATION PROJECT.— 

2 (A) IN GENERAL.—Not later than one year 

3 after the date of enactment of this Act, the Sec4 retary of Health and Human Services shall ini5 tiate an influenza test-to-treat demonstration 

6 project that builds on the test-to-treat model 

7 employed for COVID–19. 

8 (B) LENGTH; LOCATIONS.—This dem9 onstration project under subparagraph (A) shall 

10 run for the length of one seasonal influenza 

11 season and be based in one or more of the fol12 lowing locations: 

13 (i) Facilities that serve vulnerable 

14 populations, such as populations who are 

15 in long-term care facilities, are 65 years of 

16 age or older, may have other medical con17 ditions, and will be in unavoidable close 

18 contact with others. 

19 (ii) Federal health care facilities that 

20 serve at-risk and vulnerable communities, 

21 such as Indian Health Service clinics, Fed22 erally qualified health centers (as defined 

23 in section 1861(aa) of the Social Security 

24 Act (42 U.S.C. 1395x(aa))), and facilities 

25 of the Department of Veterans Affairs. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
23 

•HR 5846 IH

1 (iii) Existing COVID–19 test-to-treat 

2 sites at retail pharmacies, potentially in 

3 specific geographic areas with historically 

4 high mortality from influenza. 

5 (iv) Other appropriate locations iden6 tified by the Secretary of Health and 

7 Human Services, in consultation with ex8 ternal stakeholder organizations, to test 

9 the operational feasibility and impact of in10 fluenza test-to-treat programs. 

11 (3) REPORT.—Not later than six months after 

12 completion of the demonstration project, the Sec13 retary of Health and Human Services shall— 

14 (A) prepare a report on the demonstration 

15 project under paragraph (1), including an eval16 uation of the project’s methods, findings, and 

17 results; and 

18 (B) make such report publicly available on 

19 the website of the Department of Health and 

20 Human Services. 

21 (g) CREATING ADMINISTRATION PATHWAYS.—The 

22 Secretary of Health and Human Services may award 

23 grants to States to create administration pathways for 

24 pharmacy personnel to administer influenza vaccines, 

25 tests, and therapeutics, in order to increase vaccination, 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
24 

•HR 5846 IH

1 testing, and relevant treatment as needed for adults and 

2 children. 

3 (h) STRATEGIC NATIONAL STOCKPILE.—The Sec4 retary of Health and Human Services shall incorporate 

5 into the Strategic National Stockpile under section 319F– 

6 2 of the Public Health Service Act (42 U.S.C. 247d–6b) 

7 products needed to respond to pandemic influenza, includ8 ing through— 

9 (1) dynamic management of antivirals; 

10 (2) vendor-managed inventory of testing equip11 ment and supplies; 

12 (3) replenishment of aging antivirals, testing 

13 equipment, supplies, and other products; and 

14 (4) diversification of stockpiled products. 

15 (i) MONITORING AND DISTRIBUTING INFLUENZA

16 ANTIVIRAL SUPPLIES.—The Secretary of Health and 

17 Human Services shall— 

18 (1) monitor influenza antiviral supplies 

19 throughout the country and publicly report chal20 lenges in availability in any region, State, county, or 

21 metropolitan area; and 

22 (2) establish a process, to be used in the case 

23 of a pandemic or during times when influenza 

24 antiviral supply availability is challenged, to ensure 

25 rapid and effective distribution of products to areas 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
25 

•HR 5846 IH

1 of urgent need in close coordination with manufac2 turers, distributors, and State and local health offi3 cials. 

4 (j) PLAN FOR ENSURING ACCESS TO APPROPRIATE

5 INFLUENZA THERAPEUTICS, PREEXPOSURE PROPHY6 LAXIS, AND DIAGNOSTICS.— 

7 (1) IN GENERAL.—Not later than 1 year after 

8 the date of enactment of this Act, the Secretary of 

9 Health and Human Services shall publish a plan for 

10 ensuring access to appropriate influenza thera11 peutics, preexposure prophylaxis influenza antibody 

12 products, and influenza diagnostics, including during 

13 times when availability is challenged in certain re14 gions or localities, for— 

15 (A) high-risk patients, such as nursing 

16 home and pediatric patients; 

17 (B) high-exposure patients, such as first 

18 responders and health care workers; and 

19 (C) low-income individuals, individuals cov20 ered by Medicaid, uninsured individuals, Tribal 

21 communities, and other underserved popu22 lations. 

23 (2) COMMUNICATIONS EFFORTS.—The plan re24 quired by paragraph (1) shall include communica25 tions efforts to educate the public about the benefits 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
26 

•HR 5846 IH

1 of early use of influenza diagnostics, therapeutics, 

2 and preexposure prophylaxis products. 

3 (k) GAO REVIEW ON TRANSFERRING COVID–19 

4 TECHNOLOGIES.— 

5 (1) IN GENERAL.—Not later than six months 

6 after the date of enactment of this Act, the Comp7 troller General of the United States shall conduct a 

8 review of the technology and systems utilized by the 

9 Centers for Disease Control and Prevention, the Ad10 ministration for Strategic Preparedness and Re11 sponse, Operation Warp Speed, the Countermeasure 

12 Acceleration Group, H–CORE, and other current 

13 and historical departments and agencies involved in 

14 the COVID–19 response for surveillance and track15 ing of COVID–19 cases, treatments, and vaccines, 

16 with particular focus on— 

17 (A) disease surveillance; 

18 (B) vaccine surveillance; and 

19 (C) vaccine effectiveness. 

20 (2) SCOPE.—The review under paragraph (1) 

21 shall include— 

22 (A) assessment of which technology and 

23 systems can be applied to, or can be altered to 

24 apply to, influenza and other infectious dis25 eases; and 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
27 

•HR 5846 IH

1 (B) formulation of recommendations for 

2 applying and altering technologies and systems 

3 as described in subparagraph (A). 

4 (3) REPORT BY HHS TO CONGRESS.—Not later 

5 than 30 days after completion of the review required 

6 by paragraph (1), the Secretary of Health and 

7 Human Services shall submit a report to the Con8 gress on the timeline and actions necessary to imple9 ment the recommendations formulated under para10 graph (2)(B). 

11 SEC. 6. AUTHORIZING SUSTAINABLE FUNDING FOR THE IN12 FLUENZA ECOSYSTEM. 

13 (a) INFLUENZA PLANNING AND RESPONSE PRO14 GRAM.—There is authorized to be appropriated 

15 $231,000,000 for fiscal year 2024 and each subsequent 

16 fiscal year for programs and activities of the Centers for 

17 Disease Control and Prevention relating to influenza plan18 ning and response. 

19 (b) STRATEGIC NATIONAL STOCKPILE.—There is au20 thorized to be appropriated $965,000,000 for fiscal year 

21 2024 and each subsequent fiscal year for the Strategic 

22 National Stockpile under section 319F–2 of the Public 

23 Health Service Act (42 U.S.C. 247d–6b). 

24 (c) HOSPITAL PREPAREDNESS PROGRAM.—There is 

25 authorized to be appropriated $305,000,000 for fiscal year 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
28 

•HR 5846 IH

1 2024 and each subsequent fiscal year for Hospital Pre2 paredness Program of the Assistant Secretary for Pre3 paredness and Response. 

4 (d) UNIVERSAL FLU VACCINE RESEARCH.—There is 

5 authorized to be appropriated $270,000,000 for fiscal year 

6 2024 and each subsequent fiscal year for research of the 

7 National Institutes of Health to develop a universal flu 

8 vaccine. 

9 (e) IMMUNIZATION PROGRAM.—There is authorized 

10 to be appropriated $682,000,000 for fiscal year 2024 and 

11 each subsequent fiscal year for the immunization program 

12 of the Centers for Disease Control and Prevention under 

13 section 317 of the Public Health Service Act (42 U.S.C. 

14 247b). 

15 (f) PUBLIC HEALTH EMERGENCY PREPAREDNESS

16 PROGRAM.—There is authorized to be appropriated 

17 $735,000,000 for fiscal year 2024 and each subsequent 

18 fiscal year for the Public Health Emergency Preparedness 

19 Program of the Centers for Disease Control and Preven20 tion. 

21 (g) INFECTIOUS DISEASE RAPID RESPONSE RE22 SERVE FUND.—There is authorized to be appropriated 

23 $35,000,000 for fiscal year 2024 and each subsequent fis24 cal year for the Infectious Disease Rapid Response ReVerDate Sep 11 2014 00:04 Oct 05, 2023 Jkt 049200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H5846.IH H5846

kjohnson on DSK7ZCZBW3PROD with $$_JOB
29 

•HR 5846 IH

1 serve Fund of the Centers for Disease Control and Preven2 tion. 

3 (h) DATA MODERNIZATION INITIATIVE.—There is 

4 authorized to be appropriated $175,000,000 for fiscal year 

5 2024 and each subsequent fiscal year for the Public 

6 Health Data Modernization Initiative of the Centers for 

7 Disease Control and Prevention. 

8 (i) HEALTH DEFENSE OPERATIONS BUDGET MAT9 TERS.— 

10 (1) DESIGNATION.—Section 251(b)(2) of the 

11 Balanced Budget and Emergency Deficit Control 

12 Act of 1985 (2 U.S.C. 901(b)(2)) is amended by 

13 adding at the end the following: 

14 ‘‘(H) HEALTH DEFENSE OPERATIONS.—(i) 

15 If, for any fiscal year, appropriations for discre16 tionary accounts are enacted that the Congress 

17 designates in statute on an account-by-account 

18 basis as being for health defense operations, 

19 then the adjustment for that fiscal year shall be 

20 the total of such appropriations for that fiscal 

21 year. 

22 ‘‘(ii) Any report or explanatory statement 

23 accompanying an appropriations Act that con24 tains an account with amounts that are des25 ignated as being for health defense operations 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
30 

•HR 5846 IH

1 pursuant to clause (i) shall specify each pro2 gram, project, or activity that will be funded by 

3 such amounts, and a specific dollar amount pro4 vided for each such program, project, or activ5 ity.’’. 

6 (2) PROFESSIONAL BYPASS BUDGET.—Title IV 

7 of the Public Health Service Act (42 U.S.C. 281 et 

8 seq.) is amended by inserting after section 402B the 

9 following: 

10 ‘‘SEC. 402C. HEALTH DEFENSE OPERATIONS PROFES11 SIONAL BYPASS BUDGET. 

12 ‘‘(a) IN GENERAL.—For fiscal year 2025 and each 

13 fiscal year thereafter, the Director of the Centers for Dis14 ease Control and Prevention, the Director of the National 

15 Institutes of Health, and the Assistant Secretary for Pre16 paredness and Response shall prepare and submit directly 

17 to the President for review and transmittal to Congress, 

18 after reasonable opportunity for comment, but without 

19 change, by the Secretary of Health and Human Services, 

20 an annual budget estimate (including an estimate of the 

21 number and type of personnel needs for the Institutes) 

22 for amounts to be designated as being for health defense 

23 operations pursuant to subparagraph (H) of section 

24 251(b)(2) of the Balanced Budget and Emergency Deficit 

25 Control Act of 1985. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
31 

•HR 5846 IH

1 ‘‘(b) PROGRAMS, PROJECTS, AND ACTIVITIES.—Any 

2 budget estimate submitted pursuant to subsection (a) by 

3 the Director shall include any program, project, or activity 

4 that received funds designated under such subparagraph 

5 (H) for the fiscal year during which such budget is sub6 mitted, except that the Director may modify the programs, 

7 projects, or activities contained in such budget estimate 

8 as circumstances warrant.’’. 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB