Bill Summary
The "Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2026" (PASTEUR Act) seeks to amend the Public Health Service Act by establishing a comprehensive program designed to address the growing threat of antimicrobial resistance. The Act focuses on fostering the development of innovative antimicrobial drugs that target urgent and serious pathogens, while ensuring their availability through a structured contracting process with drug sponsors.
Key components of the legislation include:
1. **Contracting Framework**: The Secretary of Health and Human Services is authorized to enter into contracts with sponsors of eligible antimicrobial drugs that meet specific criteria, including targeting pathogens identified by the CDC as urgent threats. The application process for these contracts includes a scoring system to evaluate the drugs based on their potential contributions to public health and innovation.
2. **Incentives for Development**: Sponsors may receive annual payments between $75 million and $300 million over a contract duration of up to ten years, provided they meet certain requirements such as ensuring commercial availability and monitoring resistance data. Payments can be adjusted based on sales revenue, and may be terminated if sponsors fail to comply with contract conditions.
3. **Advisory Group**: The Act establishes a Critical Need Antimicrobial Advisory Group to provide expert guidance on antimicrobial resistance and drug use. This group will be composed of various qualified professionals and patient advocates, ensuring integrity and transparency in its operations.
4. **Promoting Responsible Use**: The legislation also includes initiatives to encourage appropriate antimicrobial use in healthcare settings through grant programs aimed at improving antibiotic stewardship, particularly in underserved areas and outpatient facilities. Additionally, it mandates enhanced surveillance and reporting of antimicrobial use and resistance trends to inform public health strategies.
Overall, the PASTEUR Act aims to revitalize the development pipeline for critical antimicrobials, promote their responsible use, and bolster efforts to combat antimicrobial resistance, thereby safeguarding public health.
Possible Impacts
Here are three examples of how people will be affected by the "Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2026" (PASTEUR Act):
1. **Improved Access to Effective Treatments**: Patients suffering from serious infections caused by resistant pathogens will benefit significantly from the availability of new antimicrobial drugs developed under the PASTEUR Act. The legislation facilitates the development of innovative treatments targeting urgent threats identified by the CDC, ensuring that effective options are accessible when traditional antibiotics fail. This could lead to better health outcomes and potentially save lives for individuals facing critical infections.
2. **Enhanced Antibiotic Stewardship in Healthcare Facilities**: Healthcare providers will see increased support for implementing antibiotic stewardship programs designed to promote the responsible use of antimicrobials. Facilities, particularly those lacking existing programs or located in rural areas, will receive grants to adopt practices that prevent misuse of antibiotics, ultimately leading to a reduction in resistance and improved patient care. This focused effort will not only enhance the quality of healthcare but also reduce the long-term burden of antimicrobial resistance on the healthcare system.
3. **Informed Public and Improved Surveillance**: The establishment of comprehensive monitoring and reporting systems will provide the public and healthcare professionals with valuable information about antimicrobial use and resistance patterns. By making data publicly available, the legislation encourages a more informed approach to treatment decisions and fosters awareness of the importance of combating resistance. This transparency will empower patients to engage in discussions about their treatment options and the necessity of responsible antimicrobial use, contributing to a culture of accountability in healthcare.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7352 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 7352
To amend the Public Health Service Act to establish a program to
develop innovative antimicrobial drugs targeting the most challenging
pathogens and most threatening infections, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 4, 2026
Mr. Carter of Georgia (for himself, Mr. Peters, Mr. Langworthy, Mr.
Levin, and Mr. Carey) introduced the following bill; which was referred
to the Committee on Energy and Commerce, and in addition to the
Committee on 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 amend the Public Health Service Act to establish a program to
develop innovative antimicrobial drugs targeting the most challenging
pathogens and most threatening infections, 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 ``Pioneering Antimicrobial
Subscriptions To End Upsurging Resistance Act of 2026'' or the
``PASTEUR Act of 2026''.
SEC. 2. PURPOSE.
The purpose of this Act is to ensure the availability of
antimicrobials to--
(1) stimulate a new age of research, development, and
market access to lifesaving medicines;
(2) ensure the appropriate use of lifesaving medicines;
(3) maintain the highest medical care standards for
American patients;
(4) promote national health system preparedness; and
(5) defend the United States and its military.
SEC. 3. DEVELOPING ANTIMICROBIAL INNOVATIONS.
Title III of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by adding at the end the following:
``PART X--U.S. NOVEL ANTIMICROBIAL SUPPLY CONTRACTS
``SEC. 399PP. CONTRACT APPLICATION, AWARD, AND IMPLEMENTATION.
``(a) In General.--The Secretary may enter into contracts with
sponsors of eligible antimicrobials for the purpose of ensuring the
availability of such eligible antimicrobials.
``(b) Eligible Antimicrobial.--To be eligible for a contract under
this section, an antimicrobial drug shall--
``(1) treat a pathogen--
``(A) included as an `urgent' or `serious' threat
in the most recent Antibiotic Resistance Threats in the
United States report published by the Centers for
Disease Control and Prevention; or
``(B) that the Secretary has determined appropriate
in consultation with the Advisory Group established
under section 399PP-1; and
``(2) address an unmet medical need.
``(c) Applications.--
``(1) Submission.--To be eligible to enter into a contract
under this section, a sponsor of an eligible antimicrobial
shall submit to the Secretary an application not later than 2
years after the date on which the eligible antimicrobial is--
``(A) approved under section 505(c) of the Federal
Food, Drug, and Cosmetic Act (including in accordance
with section 506(h) of such Act); or
``(B) licensed under section 351(a) of this Act.
``(2) Contents.--An application submitted under paragraph
(1) with respect to an eligible antimicrobial--
``(A) shall include--
``(i) appropriate information to determine
the score of the eligible antimicrobial in
accordance with the methodology established
under subsection (d); and
``(ii) such other information as the
Secretary determines appropriate; and
``(B) is not required to include information
relating to pricing or research and development costs
of the eligible antimicrobial.
``(3) Review.--Not later than 90 days after the date on
which the Secretary receives an application under this
subsection with respect to an eligible antimicrobial (including
a revised application under paragraph (4)), the Secretary
shall--
``(A) review the application;
``(B) if the eligible antimicrobial's score is
below the minimum scoring threshold described in
subsection (d)(1)(B), deny the application; and
``(C) if the eligible antimicrobial's score meets
or exceeds such minimum scoring threshold, approve the
application and calculate annual payments for the
contract under subsection (f).
``(4) Revised applications.--Beginning 1 year after the
denial of an application with respect to an eligible
antimicrobial under paragraph (3), and not more frequently than
once every 2 years thereafter, the sponsor of the eligible
antimicrobial may submit to the Secretary a revised application
for the eligible antimicrobial with additional information that
may materially affect the eligible antimicrobial's score under
subsection (d).
``(d) Scoring.--
``(1) In general.--Not later than 270 days after the date
of enactment of this part, the Secretary, in consultation with
the Advisory Group established under section 399PP-1, the
Assistant Secretary for Preparedness and Response, the Director
of the Biomedical Advanced Research and Development Authority,
and the Commissioner of Food and Drugs, shall promulgate
regulations, after the consideration of comments received in
response to a public request for information and a public
hearing, establishing--
``(A) a quantitative scoring methodology for
eligible antimicrobials for which applications are
submitted under this section; and
``(B) a minimum scoring threshold that the score of
an eligible antimicrobial under paragraph (2) must meet
or exceed in order for the sponsor of such eligible
antimicrobial to enter into a contract under this
section.
``(2) Methodology.--An eligible antimicrobial shall receive
a score, calculated by points awarded based on criteria
developed in consultation with the Advisory Group established
under section 399PP-1 within the following three categories,
with a weighting assigned to each criterion established under
such categories and a greater number of points resulting in a
higher score:
``(A) Category i.--The eligible antimicrobial's
major contributions to patient care, including--
``(i) improving clinical outcomes for
patients with multi-drug-resistant infections;
``(ii) improved dose frequency;
``(iii) reduced toxicity;
``(iv) reductions in adverse events; and
``(v) benefits from the eligible
antimicrobial's route of administration,
especially through oral administration or more
than one administration method.
``(B) Category ii.--The innovative characteristics
of the eligible antimicrobial, including--
``(i) being a first-approved antimicrobial
drug that has the potential to address, or has
the evidence of addressing, unmet medical needs
for the treatment of a serious or life-
threatening infection, or, to a lesser extent,
second and third drugs that treat such
infection;
``(ii) containing no active moiety (as
defined in section 314.3 of title 21, Code of
Federal Regulations (or any successor
regulations)) that has been approved in any
other application under section 505(b) of the
Federal Food, Drug, and Cosmetic Act and
containing no active ingredient licensed in any
other biological product license application
under section 351(a) of this Act;
``(iii) being a member of a new class of
drugs with a novel target or novel mode of
action that are distinctly different from the
target or mode of any antimicrobial drug
approved under such section 505(b) or licensed
under such section 351(a); and
``(iv) addressing a multi-drug resistant
infection through a novel chemical scaffold or
mode of action.
``(C) Category iii.--The benefit of the eligible
antimicrobial to health systems and public health,
including--
``(i) not being affected by cross-
resistance to one or more antimicrobials
approved under such section 505(b) or licensed
under such section 351(a);
``(ii) manufacturing capabilities within
the United States;
``(iii) improved product stability and
storage;
``(iv) increased activity against
resistance mechanisms; and
``(v) reduction of the economic or
population burden of antimicrobial resistance
in the United States.
``(e) Contract Requirements.--As a condition of entering into a
contract under this section with respect to an eligible antimicrobial,
the sponsor of the eligible antimicrobial shall--
``(1) beginning on the date that is 30 days after the
sponsor receives its first payment under the contract and for
the remainder of the contract term, ensure--
``(A) the commercial availability of the eligible
antimicrobial in the United States; and
``(B) sufficient supply of the eligible
antimicrobial for antimicrobial susceptibility test
device manufacturers;
``(2) identify, track, and publicly report drug resistance
data and trends using available data related to the eligible
antimicrobial, including the use of data collected by the
Secretary under section 399PP-2(c);
``(3) develop and implement education and communications
strategies for health care professionals and patients
concerning the appropriate use of the eligible antimicrobial,
such as--
``(A) information from labeling approved by the
Food and Drug Administration; and
``(B) communications for individuals with limited
English proficiency and individuals with disabilities;
``(4) submit to the Secretary a plan regarding the
appropriate use of the eligible antimicrobial, including best
practices for antimicrobial stewardship and a general
description of how the product will be marketed. The
appropriate use plan may include a plan to collect data on the
impact of diagnostics, antimicrobial stewardship programs, and
other appropriate use efforts on patient outcomes and health-
care costs;
``(5) upon the request of the Secretary, submit to the
Secretary a plan for registering the eligible antimicrobial in
countries other than the United States where an unmet medical
need exists;
``(6) undertake efforts to ensure a reliable drug supply
chain, including, in the event of the Food and Drug
Administration determining that a shortage exists for the
eligible antimicrobial, not later than 30 days after such
determination submitting to the Secretary a plan to address
such shortage;
``(7) beginning on the date that is 30 days after the
sponsor receives its first payment under the contract and for
the remainder of the contract term, manufacture the eligible
antimicrobial drug at a volume that reasonably ensures the
availability of sufficient quantities of the drug to meet the
needs of individuals with the disease or condition for which
the eligible antimicrobial is approved in the United States;
``(8) abide by manufacturing and environmental best
practices for the control of discharge of antimicrobial active
pharmaceutical ingredients and other antimicrobial agents or
products, including the antibiotic manufacturing standard
developed by the AMR Industry Alliance (as described in the
report titled `Minimizing risk of developing antibiotic
resistance and aquatic ecotoxicity in the environment resulting
from the manufacturing of human antibiotics' published in May
2025) or seeking a sustainability certification from BSI
Standards Limited; and
``(9) abide by such other terms as the Secretary may
require under the contract.
``(f) Annual Payments.--
``(1) In general.--Pursuant to a contract entered into
under this section, the Secretary shall make annual payments to
the sponsor of an eligible antimicrobial for the duration of
the contract term. Such payments shall begin not later than 180
days after the date on which the Secretary approves the
contract.
``(2) Calculation system.--The Secretary, in consultation
with the Administrator of the Centers for Medicare & Medicaid
Services, shall promulgate regulations establishing a system
for the calculation of the annual payments described in
paragraph (1). Such system shall adhere to the following:
``(A) Minimum and maximum amount.--An annual
payment may not be less than $75,000,000 or more than
$300,000,000, adjusted on an annual basis in accordance
with the consumer price index for all urban consumers
(all items; United States city average).
``(B) Adjustment for net revenue.--The annual
payment shall be adjusted downward by the amount of net
revenue from sales in the United States of the eligible
antimicrobial during the previous 12-month period,
including any legally mandated or voluntary discounts
and rebates provided by the sponsor of the eligible
antimicrobial, such as volume discounts, prompt pay
discounts, cash discounts, free goods that are
contingent on any purchase requirement, chargebacks,
and rebates.
``(3) Disclosure of information.--The Secretary may require
the sponsor of an eligible antimicrobial to disclose to the
Secretary such information as the Secretary requires to
calculate an annual payment under this subsection.
Notwithstanding any other provision of law, such information
shall be kept confidential and may not be--
``(A) disclosed by the Secretary to any entity,
including other governmental or private parties, in a
form that reveals the identity of a specific
manufacturer or the prices charged for drugs by such
manufacturer; or
``(B) used by the Secretary for any purpose other
than calculating the annual payments under this
subsection.
``(4) Termination of payments.--The Secretary may cease
annual payments pursuant to a contract entered into under this
section if the Secretary determines that the sponsor of the
eligible antimicrobial subject to such contract--
``(A) permanently withdraws the eligible
antimicrobial from the market in the United States;
``(B) materially fails to meet one or more of the
requirements described in subsection (e) after notice
by the Secretary and an opportunity to correct; or
``(C) does not conduct with due diligence a
postmarket study required to be completed by the Food
and Drug Administration during the term of the
contract.
``(5) Rule of construction.--Nothing in this subsection
shall be construed as authorizing the Secretary--
``(A) to disclose any information that is a trade
secret or confidential information subject to section
552(b)(4) of title 5, United States Code, or section
1905 of title 18, United States Code; or
``(B) to use evidence from comparative clinical
effectiveness research in a manner that treats
extending the life of an elderly, disabled, or
terminally ill individual as of lower value than
extending the life of an individual who is younger,
nondisabled, or not terminally ill for the purposes of
calculating annual payments under this subsection,
including in such a way that would limit patient
access.
``(g) Contract Term.--
``(1) Length of term.--The term of a contract entered into
under this section shall end on the earlier of--
``(A) the date that is 10 years after the date on
which the contract is approved; and
``(B) the date on which the Secretary determines at
least one drug or biological product is--
``(i) approved or licensed (as
applicable)--
``(I) under section 505(j) of the
Federal Food, Drug, and Cosmetic Act,
using the contract antimicrobial as the
listed drug; or
``(II) under section 351(k) of the
Public Health Service Act, using the
contract antimicrobial as the reference
product; and
``(ii) marketed pursuant to such approval
or licensure.
``(2) Effect.--A contract shall remain in effect for the
term described in paragraph (1) even if the pathogen treated by
the eligible antimicrobial is later removed from the Antibiotic
Resistance Threats in the United States report described in
subsection (b)(1)(A).
``(h) Other Government Participation.--The Secretary shall make
efforts to increase the participation of other governmental bodies in
offering financial incentives to create commercial access to new and
novel antimicrobials that are similar to the contracts under this
section.
``(i) Authority Vested in the Secretary.--The authority vested in
the Secretary by this section to enter into contracts may be performed
without regard to such provisions of law or regulations relating to the
making, performance, amendment, or modification of contracts of the
United States, as the Secretary may determine to be inconsistent with
the furtherance of the purposes of this part.
``SEC. 399PP-1. CRITICAL NEED ANTIMICROBIAL ADVISORY GROUP.
``(a) In General.--Not later than 60 days after the date of
enactment of this part, the Secretary shall establish a Critical Need
Antimicrobial Advisory Group (referred to in this part as the `Advisory
Group') and appoint its members.
``(b) Members.--The Advisory Group shall be composed of 15 members,
to be appointed by the Secretary as follows:
``(1) 4 individuals who are physicians board-certified in
infectious diseases.
``(2) 4 individuals who are experts with demonstrated
expertise in antimicrobial resistance, health economics, or
research and development or commercialization of antimicrobial
drugs.
``(3) 4 individuals to serve as patient advocates, who are
well versed in antimicrobial treatment or resistance, either as
patients themselves or as caretakers.
``(4) 3 additional individuals who meet the qualifications
specified in paragraph (1), (2), or (3).
``(c) Chair.--In addition to the members appointed under subsection
(b), the Secretary shall appoint 1 individual to serve as a non-voting
Chair of the Advisory Group. Such individual shall meet the
qualifications specified in paragraph (1), (2), or (3) of subsection
(b).
``(d) Conflicts of Interest.--In appointing members under
subsection (b) and a Chair under subsection (c), the Secretary shall
ensure that no member (including the Chair) receives during the
individual's term of service with the Advisory Group compensation in
any manner from a commercial or for-profit entity that develops or
intends to develop antimicrobial drugs. In implementing the
requirements of this part, the Secretary shall prohibit Advisory Group
members (including the Chair) from participating in any particular
Advisory Group matter that will have a direct and predictable effect on
their financial interests.
``(e) Applicability of FACA.--
``(1) In general.--Except as otherwise provided in this
section, chapter 10 of title 5, United States Code (commonly
referred to as the `Federal Advisory Committee Act') shall
apply to the Advisory Group.
``(2) Termination.--Section 1013 of such title (relating to
the termination of advisory committees) shall not apply to the
Advisory Group.
``SEC. 399PP-2. ENCOURAGING APPROPRIATE USE OF ANTIMICROBIALS AND
COMBATING RESISTANCE.
``(a) Health Facility Grant Program.--
``(1) In general.--Not later than 1 year after the date of
enactment of this part, the Secretary, acting through the
Director of the Centers for Disease Control and Prevention (in
this subsection referred to as the `Secretary'), shall
establish a grant program to support hospital, skilled nursing
facility, and other health care facility efforts--
``(A) to judiciously use antimicrobial drugs, such
as by establishing or implementing appropriate use
programs, including infectious disease telehealth
programs, using appropriate diagnostic tools,
partnering with academic hospitals, increasing health
care-associated infection reporting and prevention
efforts, and monitoring antimicrobial resistance; and
``(B) to participate in the National Healthcare
Safety Network Antimicrobial Use and Resistance Module
or the Emerging Infections Program Healthcare-
Associated Infections Community Interface activity of
the Centers for Disease Control and Prevention, as
specified by the Secretary, relating to antimicrobial
drugs.
``(2) Prioritization.--In awarding grants under paragraph
(1), the Secretary shall prioritize health care facilities
without an existing program to judiciously use antimicrobial
drugs, subsection (d) hospitals (as defined in section
1886(d)(1)(B) of the Social Security Act) that are located in
rural areas (as defined in section 1886(d)(2)(D) of such Act),
critical access hospitals (as defined in section 1861(mm)(1) of
such Act), hospitals serving Tribal populations, and safety-net
hospitals.
``(3) Standards for use of grant funds.--In implementing or
expanding an antibiotic stewardship program, an entity
receiving a grant under paragraph (1) shall adhere to
nationally recognized guidelines and best practices, including
adequate staffing, for improving antibiotic use.
``(b) Antimicrobial Stewardship Pilot Program for Outpatient
Facilities.--
``(1) Antimicrobial stewardship pilot program for
outpatient facilities.--Not later than 2 years after the date
of enactment of this part, the Secretary, in consultation with
the Director of the Centers for Disease Control and Prevention
and the Administrator of the Centers for Medicare & Medicaid
Services (in this subsection referred to as the `Secretary'),
shall establish a pilot program to make grants to entities to
implement or expand antibiotic stewardship programs in
outpatient facilities.
``(2) Implementation.--In developing the pilot program, the
Secretary shall consult with professional societies with
expertise in antibiotic stewardship.
``(3) Eligible entities.--To be eligible to receive a grant
under paragraph (1), an entity shall be--
``(A) a physician;
``(B) a hospital outpatient department;
``(C) an urgent care setting described in paragraph
(5)(A); or
``(D) a retail clinic described in paragraph
(5)(B).
``(4) Standards for use of grant funds.--In implementing or
expanding an antibiotic stewardship program through a grant
under this subsection, an entity shall adhere to nationally
recognized guidelines and best practices, including adequate
staffing, for improving antibiotic use.
``(5) Prioritization.--In awarding grants under paragraph
(1), the Secretary shall prioritize--
``(A) urgent care settings, such as facilities that
use Place of Service Code 20 for urgent care developed
by the Centers for Medicare & Medicaid Services (or any
successor code); and
``(B) retail clinics, meaning facilities that are
co-located with a pharmacy or other retail commercial
establishment, such as those that use Place of Service
Code 17 for walk-in retail health clinics developed by
the Centers for Medicare & Medicaid Services (or any
successor code).
``(6) Report.--Not later than 5 years after the date of
enactment of this part, the Secretary shall submit to Congress
a report on the impacts of the pilot program, including
recommendations for expanding antimicrobial stewardship to
additional outpatient settings.
``(c) Surveillance and Reporting of Antimicrobial Use and
Resistance.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall use the National Healthcare Safety Network and other
appropriate surveillance systems to collect data and assess
trends in antimicrobial resistance and antibiotic and
antifungal use, such as--
``(A) appropriate conditions and measures causally
related to antimicrobial resistance, including types of
infections, the source or body sites of infections, the
demographic information of patients with infections,
infection onset in a community or hospital setting,
increased lengths of hospital stay, increased costs,
and rates of mortality; and
``(B) changes in bacterial and fungal resistance to
antimicrobial drugs, including changes in percent
resistance, prevalence of antimicrobial-resistant
infections, rates of mortality, and other such changes.
``(2) Antimicrobial use data.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall obtain reliable and comparable human
antibiotic and antifungal drug consumption data (including, as
available and appropriate, volume antimicrobial distribution
data and antibiotic and antifungal use data, including
prescription data) by State or metropolitan areas. To
accomplish this, the Secretary may work with, as appropriate,
Federal departments and agencies (including the Department of
Veterans Affairs, the Department of Defense, the Department of
Homeland Security, the Bureau of Prisons, the Indian Health
Service, and the Centers for Medicare & Medicaid Services),
private vendors, health care organizations, pharmacy benefit
managers, and other entities.
``(3) Antimicrobial resistance trend data.--The Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, shall intensify and expand efforts to collect
antimicrobial resistance data and encourage adoption of the
Antimicrobial Use and Resistance Module or other appropriate
module within the National Healthcare Safety Network and other
appropriate surveillance systems among all health care
facilities across the continuum of care, including, as
appropriate, acute care hospitals, dialysis facilities, nursing
homes, ambulatory surgical centers, and other ambulatory health
care settings in which antimicrobial drugs are routinely
prescribed. The Secretary shall seek to collect such data from
electronic medication administration reports and laboratory
systems to produce the reports described in paragraph (5).
``(4) Diagnostics data.--The Secretary shall collect data
on tests used to diagnose and inform the appropriate treatment
of infections in health care settings. This includes data on
the implementation of diagnostic stewardship to ensure the
appropriate use of a diagnostic test before a treatment is
prescribed, and the use of diagnostics in monitoring and
tracking infectious diseases. The Secretary shall collect data
on the use of diagnostic tests through the National Healthcare
Safety Network (in this paragraph referred to as the `NHSN')
Antimicrobial Use and Resistance Module or other appropriate
NHSN module. These efforts shall be implemented in
collaboration with external stakeholders, including infectious
disease professional societies, patient advocacy organizations,
health care systems and professionals, and the diagnostics
industry.
``(5) Public availability of data.--Beginning on the date
that is 2 years after the date of enactment of this part, the
Secretary shall, for the purposes of improving the monitoring
of important trends in antimicrobial use and resistance, and,
as appropriate, patient outcomes in relation to antimicrobial
resistance--
``(A) make the data described in paragraphs (1)
through (4) publicly available through reports and web
updates issued on a regular basis that is not less than
annually; and
``(B) examine opportunities to make such data
available in near real time.
``SEC. 399PP-3. DEFINITIONS.
``In this part:
``(1) Antimicrobial drug.--The term `antimicrobial drug'--
``(A) means--
``(i) a drug that directly inhibits
replication of or kills bacteria or fungi, or
acts on the substances produced by such
bacteria or fungi, relevant to the proposed
indication at concentrations likely to be
attainable in humans to achieve the intended
therapeutic effect; and
``(ii) a biological product that acts
directly on bacteria or fungi or on the
substances produced by such bacteria or fungi;
and
``(B) does not include--
``(i) a drug that achieves the effect
described in subparagraph (A)(i) only at a
concentration that cannot reasonably be studied
in humans because of its anticipated toxicity;
or
``(ii) a vaccine.
``(2) Contract.--The term `contract' means a transaction
other than a procurement contract, grant, or a cooperative
agreement.
``(3) Contract antimicrobial.--The term `contract
antimicrobial' means an antimicrobial drug or biological
product for which a contract under this part is in effect.
``(4) Eligible antimicrobial.--The term `eligible
antimicrobial' means an antimicrobial drug or biological
product that satisfies the eligibility criteria described in
section 399PP(b).
``SEC. 399PP-4. APPROPRIATIONS.
``(a) In General.--To carry out this part, there is authorized to
be appropriated, and appropriated, to the Secretary, out of amounts in
the Treasury not otherwise appropriated, $6,000,000,000 for fiscal year
2026, to remain available until expended.
``(b) Allocation.--The Secretary may use not more than 6.5 percent
of the amounts appropriated under subsection (a) to carry out section
399PP-2.
``(c) Emergency Designation.--
``(1) In general.--The amounts provided by this section are
designated as an emergency requirement pursuant to section 4(g)
of the Statutory Pay-As-You-Go Act of 2010.
``(2) Designation in senate.--In the Senate, this section
is designated as an emergency requirement pursuant to section
4112(a) of H. Con. Res. 71 (115th Congress), the concurrent
resolution on the budget for fiscal year 2018.''.
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