[Congressional Record Volume 168, Number 158 (Thursday, September 29, 2022)]
[Senate]
[Pages S5583-S5587]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 6052. Mr. BENNET (for himself and Mr. Young) submitted an 
amendment intended to be proposed to amendment SA 5499 submitted by Mr. 
Reed (for himself and Mr. Inhofe) and intended to be proposed to the 
bill H.R. 7900, to authorize appropriations for fiscal year 2023 for 
military activities of the Department of Defense, for military 
construction, and for defense activities of the Department of Energy, 
to prescribe military personnel strengths for such fiscal year, and for 
other purposes; which was ordered to lie on the table; as follows:

        At the appropriate place, insert the following:

     SEC. __. 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 W--DEVELOPING ANTIMICROBIAL INNOVATIONS

     ``SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; 
                   ADVISORY GROUP.

       ``(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.
       ``(b) Members.--
       ``(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.
       ``(2) Chair.--The Secretary shall appoint one of the 
     members of the Committee to serve as the Chair of the 
     Committee.
       ``(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:
       ``(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

[[Page S5584]]

     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).
       ``(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--
       ``(A) treating infections and patients on the list under 
     paragraph (1);
       ``(B) improving clinical and patient outcomes for patients 
     with multi-drug-resistant infections;
       ``(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;
       ``(D) route of administration, especially through oral 
     administration;
       ``(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);
       ``(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;
       ``(iii) not being affected by cross-resistance to any 
     antimicrobial drug approved under such section 505 or 
     licensed under such section 351;
       ``(F) improving patient outcomes for an infection through a 
     novel chemical scaffold or mechanism of action;
       ``(G) having received a transitional subscription contract 
     under subsection (f); and
       ``(H) any other characteristic the Secretary, in 
     collaboration with the Committee, determines necessary.
       ``(d) Regulations.--
       ``(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--
       ``(A) a process by which the sponsors can apply for an 
     antimicrobial drug to become a critical need antimicrobial 
     drug under section 399OO-1;
       ``(B) how subscription contracts under such section shall 
     be established and paid;
       ``(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
       ``(D) other elements of the subscription contract process, 
     in accordance with this part.
       ``(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.
       ``(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'.
       ``(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.
       ``(f) Transitional Subscription Contracts.--
       ``(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.
       ``(2) Requirements.--
       ``(A) In general.--The Secretary, through the office 
     described in paragraph (4), may enter into a contract under 
     paragraph (1)--
       ``(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;
       ``(ii) subject to terms including--

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

       ``(aa) ensure commercial and Federal availability of the 
     antimicrobial drug within 30 days of receiving first payment 
     under the contract;
       ``(bb) identify, track, and publicly report drug resistance 
     data, patient outcomes, and trends using available data 
     related to the antimicrobial drug;
       ``(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;
       ``(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);
       ``(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
       ``(ff) make meaningful progress toward completion of Food 
     and Drug Administration-required postmarketing studies, 
     including such studies that are evidence based; and

       ``(II) other terms as determined by the Secretary; and

       ``(iii) if--

       ``(I) a phase 3 clinical study has been initiated for the 
     antimicrobial drug; or
       ``(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).

       ``(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.
       ``(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.
       ``(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).
       ``(g) Critical Need Antimicrobial Advisory Group.--
       ``(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.
       ``(2) Members.--The members of the Advisory Group shall 
     include--
       ``(A) not fewer than 6 individuals who are--
       ``(i) infectious disease specialists; or
       ``(ii) other health experts with expertise in researching 
     antimicrobial resistance, health economics, or 
     commercializing antimicrobial drugs; and
       ``(B) not fewer than 5 patient advocates.
       ``(3) Chair.--The Secretary shall appoint one of the 
     members of the Advisory Group to serve as the Chair.
       ``(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.
       ``(5) Applicability of faca.--Except as otherwise provided 
     in this subsection, the Federal Advisory Committee Act shall 
     apply to the Advisory Group.

[[Page S5585]]

  


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

       ``(a) In General.--
       ``(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).
       ``(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.
       ``(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.
       ``(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).
       ``(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.
       ``(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).
       ``(c) Appropriate Use of Critical Need Antimicrobial.--
       ``(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--
       ``(A) shall include--
       ``(i) the appropriate use of the drug; and
       ``(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
       ``(B) may be developed in partnership with the Secretary, 
     infectious disease experts, diagnostic experts or developers, 
     laboratory experts, or another entity.
       ``(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).
       ``(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.

     ``SEC. 399O-2. SUBSCRIPTION CONTRACTS.

       ``(a) Application for a Subscription Contract.--
       ``(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.
       ``(2) Review of applications.--The Secretary shall, in 
     consultation with the Committee--
       ``(A) review all applications for subscription contracts 
     under paragraph (1) and assess all required application 
     components;
       ``(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
       ``(C) assign a monetary value to the contract based on the 
     regulations developed under section 399OO(d).
       ``(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--
       ``(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;
       ``(2) identify, track, and publicly report drug resistance 
     data, patient outcomes, and trends using available data 
     related to the antimicrobial drug;
       ``(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;
       ``(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;
       ``(5) submit a plan for registering the drug in additional 
     countries where an unmet medical need exists;
       ``(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;
       ``(7) complete any postmarketing studies required by the 
     Food and Drug Administration in a timely manner;
       ``(8) produce the drug at a reasonable volume determined 
     with the Secretary to ensure patient access to the drug;
       ``(9) price the drug at a price that is not lower than a 
     comparable generic drug;
       ``(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
       ``(11) abide by other terms as the Secretary may require.
       ``(c) Amount and Terms of Contracts.--
       ``(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.
       ``(2) Terms.--
       ``(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).
       ``(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

[[Page S5586]]

     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.
       ``(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).
       ``(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.
       ``(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.
       ``(d) Annual Antimicrobial Drug Sponsor Revenue 
     Limitations.--
       ``(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.
       ``(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).
       ``(3) Definitions.--In this subsection:
       ``(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).
       ``(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.
       ``(e) Failure To Adhere to Terms.--The Secretary shall 
     cease any payment installments under a contract under this 
     section if--
       ``(1) the sponsor--
       ``(A) permanently withdraws the antimicrobial drug from the 
     market in the United States;
       ``(B) fails to meet criteria under subsection (b); or
       ``(C) does not complete a postmarket study required by the 
     Food and Drug Administration during the length of the term of 
     the contract;
       ``(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
       ``(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.
       ``(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.

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

       ``(a) Establishment of Health Facility Grant Program.--
       ``(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--
       ``(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
       ``(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.
       ``(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.
       ``(3) Funding.--Of the amounts appropriated under section 
     399OO-4, the Secretary shall reserve $500,000,000 to carry 
     out this subsection.
       ``(b) Surveillance and Reporting of Antibiotic Use, 
     Resistance, and Patient Outcomes.--
       ``(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--
       ``(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
       ``(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.
       ``(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.
       ``(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).
       ``(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--
       ``(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
       ``(B) examine opportunities to make such data available in 
     near real time.

     ``SEC. 399O-4. APPROPRIATIONS.

       ``(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.
       ``(b) 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

[[Page S5587]]

     concurrent resolution on the budget for fiscal year 2018.

     ``SEC. 399O-5. STUDIES AND REPORTS.

       ``(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.
       ``(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.
       ``(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.

     ``SEC. 399O-6. DEFINITIONS.

       ``In this part--
       ``(1) the term `antimicrobial drug'--
       ``(A) means, subject to subparagraph (B), a product that 
     is--
       ``(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
       ``(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 by 
     subparagraph (A)(i) only at a concentration that cannot 
     reasonably be studied in humans because of its anticipated 
     toxicity; or
       ``(ii) a vaccine; and
       ``(2) the term `Committee' means the Committee on Critical 
     Need Antimicrobials established under section 399OO.''.
                                 ______