[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5846 Introduced in House (IH)]
<DOC>
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. Barragan, 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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protecting America from Seasonal and
Pandemic Influenza Act of 2023''.
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) Influenza diagnosis and surveillance has improved
significantly over the last several years by advances in
influenza testing. Timely infection control and prevention
strategies would be significantly bolstered by accurate and
readily accessible at-home diagnostic tests. Rapid diagnostics
can improve access for underserved populations and allow for
better antibiotic stewardship.
(11) Vaccine hesitancy in the United States has reached a
tipping point where it is adversely affecting public health.
Misinformation is widely available on social media, and
traditional sources of information on the value and efficacy of
vaccines are not trusted by many Americans, especially those
who are vaccine hesitant.
(12) Support for vaccine communication, outreach, and
administration across public health and health care settings is
critical to drive demand of influenza vaccines, treatments, and
medical countermeasures and ensure equitable uptake of these
innovations.
SEC. 3. STRENGTHENING AND DIVERSIFYING INFLUENZA VACCINE, THERAPEUTICS,
AND DIAGNOSTICS DEVELOPMENT, MANUFACTURING, AND SUPPLY
CHAIN.
(a) Timely Delivery of First Doses of Finished Influenza Vaccine.--
(1) National goal.--It is a national goal for the United
States, 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--
(i) establish public-private partnerships
to strengthen the domestic vaccine supply
chain; and
(ii) evaluate the capabilities, capacity,
and utilization of such partnerships, including
by assessing and testing relevant logistical
and interoperable technology with stakeholders
in the supply chain.
(B) Domestic vaccine supply chain.--For purposes of
this paragraph, the term ``domestic vaccine supply
chain'' includes the full domestic supply chain,
including--
(i) production of ingredients and
manufacturing and distribution of finished
vaccines;
(ii) fill-finish capacity; and
(iii) the supply chain of ancillary
supplies such as needles and syringes.
(2) Evaluation of using dpa.--The Secretary of Health and
Human Services, in coordination with the Administrator of the
Federal Emergency Management Agency and the Secretary of
Defense, shall--
(A) evaluate the use of the Defense Production Act
of 1950 (50 U.S.C. 4501 et seq.) for COVID-19 pandemic
response;
(B) not later than 1 year after the date of
enactment of this Act, complete such evaluation and
submit a report to 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)(H) 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)(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
implementing the National Influenza Vaccine
Modernization Strategy, issued in June 2020, or any
successor strategy; and''.
(f) Biomedical Advanced Research and Development Authority.--
(1) Preparedness activities.--Section 319L(c) of the Public
Health Service Act (42 U.S.C. 247d-7e(c)) is amended--
(A) in paragraph (2)--
(i) in subparagraph (C), by striking
``and'' at the end;
(ii) in subparagraph (D), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end of the
following:
``(E) supporting pandemic influenza countermeasure
preparedness.''; and
(B) in paragraph (4), by adding at the end of the
following:
``(H) Pandemic influenza medical countermeasures
program.--In carrying out paragraph (2)(E), the
Secretary shall establish and implement a program
that--
``(i) supports research and development
activities for qualified pandemic or epidemic
products (as defined in section 319F-3),
including by--
``(I) developing innovative
technologies to enhance rapid response
to pandemic influenza threats;
``(II) developing influenza
vaccines with potential universal
vaccination capability;
``(III) developing enhanced
influenza vaccines with longer lasting
broad spectrum protective immunity
against a wider range of antigenically
divergent influenza strains;
``(IV) developing alternative
vaccine delivery approaches;
``(V) developing novel small- and
large-molecule novel influenza
antivirals, monoclonal antibodies, and
other products that provide better
influenza treatment and prevention;
``(VI) developing innovative
technologies to enhance rapid diagnosis
of influenza; and
``(VII) implementing the National
Influenza Vaccine Modernization
Strategy, issued in June 2020, or any
successor strategy;
``(ii) ensures readiness to respond to
qualified pandemic and epidemic threats,
including by--
``(I) supporting development and
manufacturing of influenza virus seeds,
clinical trial lots, and stockpiles of
novel influenza strains;
``(II) supporting the stockpile of
influenza antivirals through
diversifying and replenishing the
existing stockpile of influenza
antivirals;
``(III) supporting manufacturing
and fill-finish rapid response
infrastructure;
``(IV) supporting the stockpile of
influenza testing equipment and
supplies; and
``(V) testing and evaluating
pandemic threat rapid response
capabilities through regular
preparedness drills with key public and
private sector partners that examine
the range of activities (including
production and clinical testing of
influenza diagnostics, vaccines, and
therapeutics) required to effectively
respond to novel threats; and
``(iii) builds, sustains, and replenishes
qualified pandemic and epidemic stockpiles of
bulk antigen and adjuvant material, including
by--
``(I) annually testing the potency
and shelflife potential of all existing
pandemic and epidemic stockpiles held
by the Department of Health and Human
Services; and
``(II) developing, and
disseminating to key public and private
sector partners, a life cycle
management plan.''.
(g) Authorization of Appropriations.--Section 319L(d) of the Public
Health Service Act (42 U.S.C. 247d-7e(d)) is amended by adding at the
end the following:
``(3) Pandemic influenza.--To carry out this section and
section 2811 with respect to pandemic influenza, in addition to
amounts authorized to be appropriated by paragraph (2) and any
amounts authorized to be appropriated by section 2811, there is
authorized to be appropriated $335,000,000 for each of the
fiscal years 2024 through 2028, to remain available until
expended.''.
SEC. 4. PROMOTING INNOVATIVE APPROACHES AND USE OF NEW TECHNOLOGIES TO
DETECT, PREVENT, AND RESPOND TO INFLUENZA.
(a) Sense of Congress.--It is the sense of Congress that the
Centers for Disease Control and Prevention should support interoperable
immunization information systems that enable bidirectional data
exchange among States, localities, and community immunization
providers.
(b) Prioritizing Influenza, Influenza Combination, and Pathogen
Agnostic Tools.--
(1) NIH.--The Director of the National Institutes of Health
may conduct or support basic research prioritizing the
development of--
(A) agnostic tools to detect influenza and other
pathogens; and
(B) technologies that automate sample preparation
for such tools.
(2) BARDA.--The Director of the Biomedical Advanced
Research and Development Authority may conduct or support
advanced development of novel sequencing modalities
prioritizing tools described in paragraph (1)(A) and
technologies described in paragraph (1)(B).
(c) Development of Point-of-Care and Self-Testing Diagnostics.--The
Director of the Biomedical Advanced Research and Development Authority,
in collaboration with the Director of the Centers for Disease Control
and Prevention, the Director of the National Institutes of Health, and
the Commissioner of Food and Drugs, may conduct or support development
of rapid, accurate, easily accessible, self-administrable diagnostic
tests that are readable at the point of care or at home.
(d) Incorporating Diagnostics Supply Chain Resiliency Into
Influenza Pandemic Planning.--The Assistant Secretary for Preparedness
and Response, in collaboration with the Commissioner of Food and Drugs,
the Director of the Centers for Disease Control and Prevention, the
Secretary of Commerce, and the Secretary of Transportation, shall--
(1) incorporate diagnostics supply chain resiliency into
influenza pandemic planning that supports a health care system
that tests to treat and bolsters testing and vaccine delivery
supply chains; and
(2) not later than 1 year after the date of enactment of
this Act, publish a plan for rapidly expanding public and
private diagnostic testing capacity (including at clinical
laboratories, at public health department laboratories, and by
means of self-testing) in an influenza pandemic, including
addressing transportation infrastructure, the need for
sterilization, and sourcing critical raw materials, components,
and parts.
(e) 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 preventive
approaches, including those still in preclinical and clinical stages,
to rapidly scale up preexposure prophylactic influenza antibody
products that address influenza infection.
(f) 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.
(g) 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.
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 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.--
(1) In general.--The Secretary of Health and Human Services
shall create partnerships to address misinformation and
disinformation with respect to influenza vaccines.
(2) Requirements.--The partnerships under paragraph (1)
shall--
(A) build on lessons learned from COVID-19; and
(B) allow for dissemination of best practices and
lessons learned between partnering organizations.
(3) Members.--The members of the partnerships under
paragraph (1) shall include representatives of organizations
with experience working with vulnerable populations,
including--
(A) individuals with chronic health conditions;
(B) older Americans;
(C) parents of young children;
(D) pregnant people;
(E) Tribal communities; and
(F) racial and ethnic minorities.
(4) Conferring with partnering organizations.--The
Secretary of Health and Human Services shall confer with
organizations represented in partnerships under paragraph (1)--
(A) in advance of each seasonal influenza season,
on messaging and communications; and
(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 report to the Congress on the partnerships
created, and activities conducted, under this section.
(d) Communications Public-Private Partnership.--
(1) In general.--Not later than six months after the date
of enactment of this Act, the Secretary of Health and Human
Services shall implement 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 independent,
nongovernmental, nonprofit entity;
(B) focus on individuals with chronic illness 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);
(C) support behavioral research around sources of
vaccine hesitancy; and
(D) develop and implement a targeted, multimodal
communications campaign, using internet platforms,
television, and nontraditional 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 paragraph (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 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, including
addressing barriers to vaccinations, therapeutics, and
diagnostics in the point-of-care and at-home self-
testing settings.
(f) Expanding Access to Influenza Treatment and Adopting Lessons
Learned From COVID-19 Federal Retail Pharmacy Program.--
(1) Report.--Not later than 6 months after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit a report to the Congress on lessons
learned from the COVID-19 Federal Retail Pharmacy Program,
including aspects of the program that could be applied with
respect to multianalyte tests that target COVID-19 as well as
influenza and other upper respiratory viruses.
(2) Demonstration project.--
(A) In general.--Not later than one year after the
date of enactment of this Act, the Secretary of Health
and Human Services shall initiate an influenza test-to-
treat demonstration project that builds on the test-to-
treat model employed for COVID-19.
(B) Length; locations.--This demonstration project
under subparagraph (A) shall run for the length of one
seasonal influenza season and be based in one or more
of the following locations:
(i) Facilities that serve vulnerable
populations, such as populations who are in
long-term care facilities, are 65 years of age
or older, may have other medical conditions,
and will be in unavoidable close contact with
others.
(ii) Federal health care facilities that
serve at-risk and vulnerable communities, such
as Indian Health Service clinics, Federally
qualified health centers (as defined in section
1861(aa) of the Social Security Act (42 U.S.C.
1395x(aa))), and facilities of the Department
of Veterans Affairs.
(iii) Existing COVID-19 test-to-treat sites
at retail pharmacies, potentially in specific
geographic areas with historically high
mortality from influenza.
(iv) Other appropriate locations identified
by the Secretary of Health and Human Services,
in consultation with external stakeholder
organizations, to test the operational
feasibility and impact of influenza test-to-
treat programs.
(3) Report.--Not later than six months after completion of
the demonstration project, the Secretary of Health and Human
Services shall--
(A) prepare a report on the demonstration project
under paragraph (1), 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.
(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,
tests, and therapeutics, in order to increase vaccination, testing, and
relevant treatment as needed 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 antivirals;
(2) vendor-managed inventory of testing equipment and
supplies;
(3) replenishment of aging antivirals, testing equipment,
supplies, and other products; and
(4) 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 publicly report challenges in availability in any
region, State, county, or metropolitan area; and
(2) establish a process, to be used in the case of a
pandemic or during times when influenza antiviral supply
availability is challenged, to ensure rapid and effective
distribution of products to areas of urgent need in close
coordination with manufacturers, distributors, and State and
local health officials.
(j) Plan for Ensuring Access to Appropriate Influenza Therapeutics,
Preexposure Prophylaxis, and Diagnostics.--
(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, preexposure prophylaxis
influenza antibody products, and influenza diagnostics,
including during times when availability is challenged in
certain regions or localities, for--
(A) high-risk patients, such as nursing home and
pediatric patients;
(B) high-exposure patients, such as first
responders and health care workers; and
(C) low-income individuals, individuals covered by
Medicaid, uninsured individuals, Tribal communities,
and other underserved populations.
(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 diagnostics,
therapeutics, and preexposure prophylaxis products.
(k) GAO Review on Transferring COVID-19 Technologies.--
(1) In general.--Not later than six months after the date
of enactment of this Act, the Comptroller General of the United
States shall conduct a review of the technology and systems
utilized by the Centers for Disease Control and Prevention, the
Administration for Strategic Preparedness and Response,
Operation Warp Speed, the Countermeasure Acceleration Group, H-
CORE, and other current and historical departments and agencies
involved in the COVID-19 response for surveillance and tracking
of COVID-19 cases, treatments, and vaccines, with particular
focus on--
(A) disease surveillance;
(B) vaccine surveillance; and
(C) vaccine effectiveness.
(2) Scope.--The review under paragraph (1) shall include--
(A) assessment of which technology and systems can
be applied to, or can be altered to apply to, influenza
and other infectious diseases; and
(B) formulation of recommendations for applying and
altering technologies and systems as described in
subparagraph (A).
(3) Report by hhs to congress.--Not later than 30 days
after completion of the review required by paragraph (1), the
Secretary of Health and Human Services shall submit a report to
the Congress on the timeline and actions necessary to implement
the recommendations formulated under paragraph (2)(B).
SEC. 6. AUTHORIZING SUSTAINABLE FUNDING FOR THE INFLUENZA ECOSYSTEM.
(a) Influenza Planning and Response Program.--There is authorized
to be appropriated $231,000,000 for fiscal year 2024 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 $965,000,000 for fiscal year 2024 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 $305,000,000 for fiscal year 2024 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 $270,000,000 for fiscal year 2024 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
$682,000,000 for fiscal year 2024 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 $735,000,000 for fiscal year 2024 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 2024 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 $175,000,000 for fiscal year 2024 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:
``(H) 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 2025 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 (H) 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 (H) 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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