S.Amdt. 6052

1. Adds SEC. __. DEVELOPING ANTIMICROBIAL INNOVATIONS wherever appropriate

   Adds a section

   Inserted: SEC. __. DEVELOPING ANTIMICROBIAL INNOVATIONS.

   Inserted: Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:

   Inserted: "PART W--DEVELOPING ANTIMICROBIAL INNOVATIONS

   Inserted: "SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY GROUP.

   Inserted: "(a) In General.--Not later than 60 days after the date of enactment of this part, the Secretary shall establish a Committee on Critical Need Antimicrobials and appoint members to the Committee.

   Inserted: "(b) Members.--

   Inserted: "(1) In general.--The Committee shall consist of at least one representative from each of the National Institute of Allergy and Infectious Diseases, the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Veterans Health Administration, and the Department of Defense.

   Inserted: "(2) Chair.--The Secretary shall appoint one of the members of the Committee to serve as the Chair of the Committee.

   Inserted: "(c) Duties.--Not later than 1 year after the appointment of all initial members of the Committee, the Secretary, in collaboration with the Committee, and in consultation with the Critical Need Antimicrobials Advisory Group established under subsection (g), shall do the following:

   Inserted: "(1) Develop a list of infections and patient types for which new antimicrobial drug development is needed, taking into account patient factors, organisms, sites of infection, and type of infections for which there is an unmet medical need, findings from the most recent report entitled 'Antibiotic Resistance Threats in the United States' issued by the Centers for Disease Control and Prevention, or an anticipated unmet medical need, including a potential global health security threat. For the list developed under this paragraph, the Secretary, in collaboration with the Committee, may use the infection list in such most recent report for up to 3 years following the date of enactment of this part and subsequently update the list under this paragraph in accordance with subsection (e).

   Inserted: "(2) Develop regulations, in accordance with subsection (d), outlining favored characteristics of critical need antimicrobial drugs, that are evidence based, clinically focused, and designed to improve patient outcomes in treating the infections described in paragraph (1), and establishing criteria for how each such characteristic or combinations of multiple characteristics will adjust the monetary value of a subscription contract awarded under subsection (f) or section 399OO-2. The favored characteristics shall be weighed for purposes of such monetary value such that meeting certain characteristics, or meeting more than one such characteristic, increases the monetary value. Such favored characteristics of an antimicrobial drug shall include--

   Inserted: "(A) treating infections and patients on the list under paragraph (1);

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   Inserted: "(B) improving clinical and patient outcomes for patients with multi-drug-resistant infections;

   Inserted: "(C) being a first-approved antimicrobial drug that has the evidence of addressing unmet medical needs for the treatment of a serious or life-threatening infection, and, to a lesser extent, second and third drugs that treat such infections;

   Inserted: "(D) route of administration, especially through oral administration;

   Inserted: "(E)(i) containing no active moiety (as defined by the Secretary 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 or intending to be the subject of a new biological product license application under section 351(a);

   Inserted: "(ii) being a member of a new class of drugs with a novel target and novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under section 505 of such Act or licensed under section 351, including reduced toxicity;

   Inserted: "(iii) not being affected by cross-resistance to any antimicrobial drug approved under such section 505 or licensed under such section 351;

   Inserted: "(F) improving patient outcomes for an infection through a novel chemical scaffold or mechanism of action;

   Inserted: "(G) having received a transitional subscription contract under subsection (f); and

   Inserted: "(H) any other characteristic the Secretary, in collaboration with the Committee, determines necessary.

   Inserted: "(d) Regulations.--

   Inserted: "(1) In general.--Not later than 1 year after the appointment of the initial members of the Committee, the Secretary shall issue proposed regulations which shall include--

   Inserted: "(A) a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section 399OO-1;

   Inserted: "(B) how subscription contracts under such section shall be established and paid;

   Inserted: "(C) the favored characteristics under subsection (c)(2), how such characteristics will be weighed, and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug; and

   Inserted: "(D) other elements of the subscription contract process, in accordance with this part.

   Inserted: "(2) Development of final regulations.--Before finalizing the regulations under paragraph (1), the Secretary shall solicit public comment and hold public meetings for the period beginning on the date on which the proposed regulations are issued and ending on the date that is 120 days after such date of issuance. The Secretary shall finalize and publish such regulations not later than 120 days after the close of such period of public comment and meetings.

   Inserted: "(3) Subscription contract office.--Not later than 6 months after the date of enactment of this part, the Secretary shall propose an agency or office in the Department of Health and Human Services to manage the establishment and payment of subscription contracts awarded under section 399OO-2, including eligibility, requirements, and contract amounts. The Secretary shall solicit public comment and finalize the agency or office no later than 45 days following the proposed agency or office. Such agency or office shall be referred to as the 'Subscription Contract Office'.

   Inserted: "(e) List of Infections and Patient Types.--The Secretary, in collaboration with the Committee, shall update the list of infections and patient types under subsection (c)(1) at least every 2 years.

   Inserted: "(f) Transitional Subscription Contracts.--

   Inserted: "(1) In general.--Not earlier than 30 days after the date of enactment of this part and ending on the date that the Secretary finalizes the subscription contract regulations under subsection (d), the Secretary may use up to $1,000,000,000 of the amount appropriated under section 399OO-4(a) to engage in transitional subscription contracts of up to 3 years in length with antimicrobial developers, as determined by the Secretary, that have developed antimicrobial drugs treating infections listed in the most recent report entitled 'Antibiotic Resistance Threats in the United States' issued by the Centers for Disease Control and Prevention, and may include antimicrobial drugs that are qualified infectious disease products (as defined in section 505E(g) of the Federal Food, Drug, and Cosmetic Act), innovative biological products, or innovative drugs that achieve improved clinical and patient outcomes through immunomodulation. Such a contract may authorize the contractor to use funds made available under the contract for completion of postmarketing clinical studies, manufacturing, and other preclinical and clinical efforts.

   Inserted: "(2) Requirements.--

   Inserted: "(A) In general.--The Secretary, through the office described in paragraph (4), may enter into a contract under paragraph (1)--

   Inserted: "(i) if the Secretary determines that the antimicrobial drug is intended to treat an infection and improves patient outcomes for which there is an unmet clinical need, an anticipated clinical need, or drug resistance;

   Inserted: "(ii) subject to terms including--

   Inserted: "(I) that the Secretary shall cease any payment installments under a transitional subscription contract if the sponsor does not--

   Inserted: "(aa) ensure commercial and Federal availability of the antimicrobial drug within 30 days of receiving first payment under the contract;

   Inserted: "(bb) identify, track, and publicly report drug resistance data, patient outcomes, and trends using available data related to the antimicrobial drug;

   Inserted: "(cc) develop and implement education and communications strategies, including communications for individuals with limited English proficiency and individuals with disabilities, for health care professionals and patients about appropriate use of the antimicrobial drug;

   Inserted: "(dd) submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists, which such plan may be consistent with the Stewardship and Access Plan (SAP) Development Guide (2021);

   Inserted: "(ee) subject to subparagraph (B), ensure a reliable drug supply chain, thus leading to an interruption of the supply of the antimicrobial drug in the United States for more than 60 days; or

   Inserted: "(ff) make meaningful progress toward completion of Food and Drug Administration-required postmarketing studies, including such studies that are evidence based; and

   Inserted: "(II) other terms as determined by the Secretary; and

   Inserted: "(iii) if--

   Inserted: "(I) a phase 3 clinical study has been initiated for the antimicrobial drug; or

   Inserted: "(II) the antimicrobial drug has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensed under section 351(a).

   Inserted: "(B) Waiver.--The requirement under subparagraph (A)(ii)(I)(ee) may be waived in the case that an emergency prohibits access to a reliable drug supply chain.

   Inserted: "(3) Transitional guidance.--Not later than 120 days after the appointment of the initial members of the Committee, the Secretary shall issue, in consultation with the Committee, transitional guidance outlining the antimicrobial drugs that are eligible for transitional subscription contracts under paragraph (1), the requirements to enter into a transitional subscription contract under paragraph (2), and the process by which drug developers can enter into transitional subscription contracts with the Secretary under this subsection.

   Inserted: "(4) Payment office and mechanism.--Not later than 30 days after the date of enactment of this part, the Secretary shall determine the agency or office in the Department of Health and Human Services that will manage the transitional subscription contracts, including eligibility, requirements, and contract amounts, during the period described in paragraph (1).

   Inserted: "(g) Critical Need Antimicrobial Advisory Group.--

   Inserted: "(1) In general.--Not later than 30 days after the appointment of all initial members of the Committee, the Secretary, in collaboration with the Committee, shall establish a Critical Need Antimicrobial Advisory Group (referred to in this subsection as the 'Advisory Group') and appoint members to the Advisory Group.

   Inserted: "(2) Members.--The members of the Advisory Group shall include--

   Inserted: "(A) not fewer than 6 individuals who are--

   Inserted: "(i) infectious disease specialists; or

   Inserted: "(ii) other health experts with expertise in researching antimicrobial resistance, health economics, or commercializing antimicrobial drugs; and

   Inserted: "(B) not fewer than 5 patient advocates.

   Inserted: "(3) Chair.--The Secretary shall appoint one of the members of the Advisory Group to serve as the Chair.

   Inserted: "(4) Conflicts of interest.--In appointing members under paragraph (2), the Secretary shall ensure that no member receives compensation in any manner from a commercial or for-profit entity that develops antimicrobials or that might benefit from antimicrobial development.

   Inserted: "(5) Applicability of faca.--Except as otherwise provided in this subsection, the Federal Advisory Committee Act shall apply to the Advisory Group.

   Inserted: "SEC. 399O-1. CRITICAL NEED ANTIMICROBIAL DRUG APPLICATION AND PAYMENT THROUGH SUBSCRIPTION CONTRACTS.

   Inserted: "(a) In General.--

   Inserted: "(1) Submission of request.--The sponsor of an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) for an antimicrobial drug may request that the Secretary designate the drug as a critical need antimicrobial. A request for such designation may be submitted after the Secretary grants for such drug an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3), and shall be submitted not later than 5 years after the date of approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensure under section 351(a).

   Inserted: "(2) Content of request.--A request under paragraph (1) shall include information, such as clinical, preclinical and postmarketing data, evidence of patient outcomes, a list of the favorable characteristics described in section 399OO(c)(2), and any other material that the Secretary in consultation with the Committee requires.

   Inserted: "(3) Review by secretary.--The Secretary shall promptly review all requests for designation submitted under this subsection, assess all required application components, and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development. After review, the Secretary shall approve or deny each request for designation not later than 90 days after receiving a request. If the Secretary approves a request, it shall publish the value of the contract that the critical need antimicrobial developer would be eligible to receive if such developer successfully demonstrates that the drug meets the maximum value of the favored characteristics listed in the application.

   Inserted: "(4) Length of designation period.--A designation granted under this section shall be in effect for a period of 10 years after the date that the designation is approved, and shall remain in effect for such period even if the infection treated by such drug is later removed from the list of infections under section 399OO(c)(1).

   Inserted: "(5) Subsequent reviews.--No sooner than 2 years after a designation approval or denial under subsection (3), the sponsor may request a subsequent review to re-evaluate the value of a contract to include any new information.

   Inserted: "(b) Development of Designated Drugs.--If a critical need antimicrobial designation is granted during clinical development of an antimicrobial drug, the Secretary may work with the sponsor to maximize the opportunity for the sponsor to successfully demonstrate that the antimicrobial drug possesses the favored characteristics of high-monetary valued products identified under section 399OO(c)(2).

   Inserted: "(c) Appropriate Use of Critical Need Antimicrobial.--

   Inserted: "(1) In general.--The sponsor of an antimicrobial drug that receives designation under subsection (a) shall within 90 days of such designation, submit to the Secretary a plan for appropriate use of diagnostics, in order for the Secretary and Committee to consider such plan in developing clinical guidelines. An appropriate use plan--

   Inserted: "(A) shall include--

   Inserted: "(i) the appropriate use of the drug; and

   Inserted: "(ii) the appropriate use of diagnostic tools, where available, such as diagnostic testing for biomarkers related to antimicrobial-resistant pathogens and demonstrating improved infection diagnosis and benefit with the drug, or other targeted diagnostic approaches, to inform use of the drug; and

   Inserted: "(B) may be developed in partnership with the Secretary, infectious disease experts, diagnostic experts or developers, laboratory experts, or another entity.

   Inserted: "(2) Consultation.--The Secretary shall consult with relevant professional societies and the Critical Need Antimicrobial Advisory Group established under section 399OO(g) to ensure that clinical guidelines issued by the Secretary under paragraph (3), with respect to an antimicrobial drug designated under subsection (a), includes the use of appropriate diagnostic approaches, taking into consideration the diagnostic plan submitted by a sponsor under paragraph (1).

   Inserted: "(3) Publication of clinical guidelines.--Not later than 1 year after the Secretary makes the first designation under subsection (a), and not less than every 3 years thereafter, the Secretary shall publish clinical guidelines in consultation with relevant professional societies with respect to each antimicrobial drug that has been approved or licensed as described in subsection (a)(1) and that has been designated under subsection (a), which guidelines shall set forth the evidence-based recommendations for prescribing the drug, in accordance with the evidence in submissions of the sponsor under paragraph (1) and after consultation under paragraph (2), as appropriate.

   Inserted: "SEC. 399O-2. SUBSCRIPTION CONTRACTS.

   Inserted: "(a) Application for a Subscription Contract.--

   Inserted: "(1) Submission of applications.--After approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensure under section 351(a), the sponsor of an antimicrobial drug designated as a critical need antimicrobial under section 399OO-1 may submit an application for a subscription contract with the Secretary, under a procedure established by the Secretary.

   Inserted: "(2) Review of applications.--The Secretary shall, in consultation with the Committee--

   Inserted: "(A) review all applications for subscription contracts under paragraph (1) and assess all required application components;

   Inserted: "(B) determine the extent to which the critical need antimicrobial meets the favored characteristics identified under section 399OO(c)(2), and deny any application for a drug that meets none of such characteristics; and

   Inserted: "(C) assign a monetary value to the contract based on the regulations developed under section 399OO(d).

   Inserted: "(b) Criteria.--To qualify for a subscription contract under this section, the sponsor of an antimicrobial drug designated as a critical need antimicrobial shall agree to--

   Inserted: "(1) ensure commercial and Federal availability of the antimicrobial drug within 30 days of receiving first payment under the contract, and sufficient supply for susceptibility device manufacturers;

   Inserted: "(2) identify, track, and publicly report drug resistance data, patient outcomes, and trends using available data related to the antimicrobial drug;

   Inserted: "(3) develop and implement education and communications strategies, including communications for individuals with limited English proficiency and individuals with disabilities, for health care professionals and patients about appropriate use of the antimicrobial drug;

   Inserted: "(4) submit an appropriate use assessment to the Secretary, Committee, Food and Drug Administration, and Centers for Disease Control and Prevention every 2 years regarding use of the antimicrobial drug, including how the drug is being marketed;

   Inserted: "(5) submit a plan for registering the drug in additional countries where an unmet medical need exists;

   Inserted: "(6) ensure a reliable drug supply chain, where any interruption to the supply chain will not last for more than 60 days in the United States;

   Inserted: "(7) complete any postmarketing studies required by the Food and Drug Administration in a timely manner;

   Inserted: "(8) produce the drug at a reasonable volume determined with the Secretary to ensure patient access to the drug;

   Inserted: "(9) price the drug at a price that is not lower than a comparable generic drug;

   Inserted: "(10) abide by the manufacturing and environmental best practices in the supply chain for the control of discharge of antimicrobial active pharmaceutical ingredients to ensure minimal discharge into, or contamination of, the environment by antimicrobial agents or products as a result of the manufacturing process; and

   Inserted: "(11) abide by other terms as the Secretary may require.

   Inserted: "(c) Amount and Terms of Contracts.--

   Inserted: "(1) Amounts.--A subscription contract under this section shall be for the sale to the Secretary of any quantity of the antimicrobial drug needed over the term of the contract under paragraph (2), at an agreed upon price, for a total projected amount determined by the Secretary that is not less than $750,000,000 and not more than $3,000,000,000, adjusted for inflation, accounting for the favored characteristic or combination of favored characteristics of the drug, including improved patient outcomes, as determined by the Secretary, in consultation with the Committee, under subsection (a)(2), and shall be allocated from the amount made available under section 399OO-4(a). Not later than 6 months after the subscription contract is granted under subsection (a), the Secretary shall provide payments for purchased drugs in installments established by the Secretary in consultation with the sponsor of the antimicrobial drug and in accordance with subsection (d)(3). Funds received by the sponsor shall be used to support criteria qualification under subsection (b), the completion of postmarketing clinical studies, manufacturing, other preclinical and clinical activities, or other activities agreed to by the Secretary and sponsor in the contract.

   Inserted: "(2) Terms.--

   Inserted: "(A) Initial term.--The initial term of a contract under this subsection shall be no less than 5 years or greater than the greater of 10 years or the remaining period of time during which the sponsor has patent protections or a remaining exclusivity period with respect to the antimicrobial drug in the United States, as listed in the publication of the Food and Drug Administration entitled 'Approved Drug Products with Therapeutic Equivalence Evaluations'. Payments may be in equal annual installments with the option to redeem 50 percent of the last year's reimbursement in year 1 of the contract in order to offset costs of establishing manufacturing capacity, or another subscription arrangement to which the Secretary and sponsor agree. Subscription contracts shall remain in effect for such period even if the infection treated by such antimicrobial drug is later removed from the list of infections under section 399OO(c)(1).

   Inserted: "(B) Extension of contracts.--The Secretary may extend a subscription contract with a sponsor under this subsection beyond the initial contract period. A single contract extension may be in effect not later than the date on which all periods of exclusivity granted by the Food and Drug Administration expire and shall be in an amount not to exceed $25,000,000 per year. All other terms of an extended contract shall be the same as the terms of the initial contract. The total amount of funding used on such contract extensions shall be no more than $1,000,000,000, and shall be allocated from the amount made available under section 399OO-4.

   Inserted: "(C) Modification of contracts.--The Secretary or sponsor, 1 year after the start of the contract period under this subsection and every 2 years thereafter, may request a modification of the amount of the contract based on information that adjusts favored characteristics in section 399OO(c)(2).

   Inserted: "(3) Adjustment.--In the case of an antimicrobial drug that received a transitional subscription contract under section 399OO(f), the amount of a subscription contract for such drug under this section shall be reduced by the amount of the transitional subscription contract under such section 399OO(f) for such drug.

   Inserted: "(4) Contracts for generic and biosimilar versions.--Notwithstanding any other provision in this part, the Secretary may award a subscription contract under this section to a manufacturer of a generic or biosimilar version of an antimicrobial drug for which a subscription contract has been awarded under this section. Such contracts shall be awarded in accordance with a procedure, including for determining the terms and amounts of such contracts, established by the Secretary.

   Inserted: "(d) Annual Antimicrobial Drug Sponsor Revenue Limitations.--

   Inserted: "(1) In general.--Pursuant to a contract entered into under this section, during the term of such a contract, the annual net revenue from sales of the applicable antimicrobial drug for beneficiaries or enrollees in Federal health care programs shall be subtracted from the annual payment installments determined in the subscription contract. The Secretary shall coordinate with the relevant agencies of the Federal Government to carry out this subsection in a manner that ensures minimal disruption to how a health care provider currently acquires applicable antimicrobial drugs.

   Inserted: "(2) Regulations.--To carry out this subsection, the Secretary shall promulgate regulations to identify the Federal health care programs applicable under this section and to establish the methodology and data collection requirements necessary to determine the amount to be subtracted from any contract. Any methodology established for the collection of data and calculation of the amount to be subtracted from any contract shall take into account any legally mandated or voluntary discounts and rebates provided by the manufacturer of the applicable antimicrobial drug to the government programs that pay for such drugs subject to a contract agreement entered into pursuant to subsection (c)(2).

   Inserted: "(3) Definitions.--In this subsection:

   Inserted: "(A) Applicable antimicrobial drug.--The term 'applicable antimicrobial drug' means an antimicrobial drug for which the sponsor of such drug receives a subscription contract under subsection (a).

   Inserted: "(B) Federal health care program.--The term 'Federal health care program' has the meaning given such term in section 1128B(f) of the Social Security Act, except that, for purposes of this subsection, such term includes the health insurance program under chapter 89 of title 5, United States Code.

   Inserted: "(e) Failure To Adhere to Terms.--The Secretary shall cease any payment installments under a contract under this section if--

   Inserted: "(1) the sponsor--

   Inserted: "(A) permanently withdraws the antimicrobial drug from the market in the United States;

   Inserted: "(B) fails to meet criteria under subsection (b); or

   Inserted: "(C) does not complete a postmarket study required by the Food and Drug Administration during the length of the term of the contract;

   Inserted: "(2) the annual international and private insurance market revenues with respect to an antimicrobial drug (not counting any subscription revenues from any source pursuant to a contract under this section or other international or private entities) exceed 5 times the average annual amount of the subscription contract paid by the Secretary as certified by the sponsor annually; or

   Inserted: "(3) if the total revenue of the sponsor from government programs that pay for drugs subject to a contract agreement entered into pursuant to subsection (c)(2), for a year exceeds the amount of the subscription contract paid by the Secretary for that year.

   Inserted: "(f) Private Payer and International Payer Participation.--The Secretary shall make efforts to increase the participation of domestic private payors and international payors in subscription contracts or other types of value-based arrangements that are similar to the subscription contracts authorized under this section.

   Inserted: "SEC. 399O-3. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS, COMBATING RESISTANCE, AND IMPROVING PATIENT OUTCOMES.

   Inserted: "(a) Establishment of Health Facility Grant Program.--

   Inserted: "(1) In general.--Not later than 1 year after the date of enactment of this part, the Secretary and the Director of the Centers for Disease Control and Prevention shall coordinate with the Administrator of the Health Resources and Services Administration, the Administrator of the Centers for Medicare & Medicaid Services, the National Coordinator for Health Information Technology, and other relevant agencies, to establish a grant program under the Centers for Disease Control and Prevention to support hospital, skilled nursing facility, and other inpatient facility efforts--

   Inserted: "(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 monitoring antimicrobial resistance and patient outcomes; and

   Inserted: "(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 or a similar reporting program, as specified by the Secretary, relating to antimicrobial drugs.

   Inserted: "(2) Prioritization.--In awarding grants under paragraph (1), the Secretary shall prioritize hospitals or skilled nursing facilities without an existing program to judiciously use antimicrobial drugs, subsection (d) hospitals (as defined in subparagraph (B) of section 1886(d)(2) of the Social Security Act that are located in rural areas (as defined in subparagraph (D) of such section), critical access hospitals (as defined in section 1861(mm)(1) of such Act), hospitals serving Tribal-populations, and safety-net hospitals.

   Inserted: "(3) Funding.--Of the amounts appropriated under section 399OO-4, the Secretary shall reserve $500,000,000 to carry out this subsection.

   Inserted: "(b) Surveillance and Reporting of Antibiotic Use, Resistance, and Patient Outcomes.--

   Inserted: "(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 assess--

   Inserted: "(A) appropriate conditions, patient outcomes, and measures causally related to antibacterial resistance, including types of infections, the causes for infections, the types of patients with infections, and whether infections are acquired in a community or hospital setting, increased lengths of hospital stay, increased costs, and rates of mortality; and

   Inserted: "(B) changes in bacterial resistance to antimicrobial drugs in relation to patient outcomes, including changes in percent resistance, prevalence of antibiotic-resistant infections, rates of patient survival, patient symptoms and function in their daily lives, and other such changes.

   Inserted: "(2) Antibiotic use data.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall work with Federal 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 as appropriate to obtain reliable and comparable human antibiotic drug consumption data (including, as available and appropriate, volume antibiotic distribution data and antibiotic use data, including prescription data) by State or metropolitan areas.

   Inserted: "(3) Antibiotic resistance trend and patient outcomes data.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall intensify and expand efforts to collect antibiotic resistance and patient outcomes data and encourage adoption of the Antibiotic Use and Resistance Module within the National Healthcare Safety Network 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 (4).

   Inserted: "(4) Public availability of data.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, for the purposes of improving the monitoring of important trends in patient outcomes in relation to antibacterial resistance--

   Inserted: "(A) make the data derived from surveillance under this subsection publicly available through reports issued on a regular basis that is not less than annually; and

   Inserted: "(B) examine opportunities to make such data available in near real time.

   Inserted: "SEC. 399O-4. APPROPRIATIONS.

   Inserted: "(a) In General.--To carry out this part, there are hereby appropriated to the Secretary, out of amounts in the Treasury not otherwise appropriated, $6,000,000,000, for fiscal year 2023, to remain available until expended.

   Inserted: "(b) Emergency Designation.--

   Inserted: "(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.

   Inserted: "(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.

   Inserted: "SEC. 399O-5. STUDIES AND REPORTS.

   Inserted: "(a) In General.--Not later than 6 years after the date of enactment of this part, the Comptroller General of the United States shall complete a study on the effectiveness of this part in developing priority antimicrobial drugs and improving patient outcomes. Such study shall examine the indications for, usage of, development of resistance with respect to, and private and societal value of critical need antimicrobial drugs, and the impact of the programs under this part on patient outcomes and markets of critical need antimicrobial drugs. The Comptroller General shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the findings of such study.

   Inserted: "(b) Antibiotic Use in the United States; Annual Reports.--The Director of the Centers for Disease Control and Prevention shall, each year, update the report entitled 'Antibiotic Use in the United States' to include updated information on progress and opportunities with respect to data, programs, and resources for prescribers to promote appropriate use of antimicrobial drugs.

   Inserted: "(c) Report on Antimicrobial Prophylactics.--Not later than 3 years after the date of enactment of this part, the Director of the Centers for Disease Control and Prevention shall publish a report on antimicrobial prophylactics.

   Inserted: "SEC. 399O-6. DEFINITIONS.

   Inserted: "In this part--

   Inserted: "(1) the term 'antimicrobial drug'--

   Inserted: "(A) means, subject to subparagraph (B), a product that is--

   Inserted: "(i) a drug that directly inhibits replication of or kills bacteria or fungi relevant to the proposed indication at concentrations likely to be attainable in humans to achieve the intended therapeutic effect; or

   Inserted: "(ii) a biological product that acts directly on bacteria or fungi or on the substances produced by such bacteria or fungi; and

   Inserted: "(B) does not include--

   Inserted: "(i) a drug that achieves the effect described by subparagraph (A)(i) only at a concentration that cannot reasonably be studied in humans because of its anticipated toxicity; or

   Inserted: "(ii) a vaccine; and

   Inserted: "(2) the term 'Committee' means the Committee on Critical Need Antimicrobials established under section 399OO.".

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