,,ii #aahth ,,congress #ast ,session ,s4 #acee ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bg1 #bjbc ,mr4 ,bennet 7for himself and ,mr4 ,young7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,pioneering ,antimicrobial ,subscriptions ,to ,end ,upsurging ,resistance ,act of #bjbc or the ,,pasteur ,act of #bjbc4 #b4 ,developing antimicrobial innovations ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,developing antimicrobial innovations #cii,,oo4 ,establishment of ,committee2 subscription model2 advisory group 7a7 ,in general ,not later than #fj days after the date of enactment of this part1 the ,secretary shall establish a ,committee on ,critical ,need ,antimicrobials and appoint members to the ,committee4 7b7 ,members 7#a7 ,in general ,the ,committee shall consist of at least one representative from each of the ,national ,institute of ,allergy and ,infectious ,diseases1 the ,centers for ,disease ,control and ,prevention1 the ,biomedical ,advanced ,research and ,development ,authority1 the ,food and ,drug ,administration1 the ,centers for ,medicare ,medicaid ,services1 the ,veterans ,health ,administration1 and the ,department of ,defense4 7#b7 ,chair ,the ,secretary shall appoint as the ,chair of the ,committee a non-voting1 independent member who may not be a member of the ,committee or from an organization represented under paragraph 7#a74 7#c7 ,consultation ,the ,secretary shall consult with the ,under ,secretary of ,veterans ,affairs for ,health and ,secretary of ,defense when appointing members from the ,veterans ,health ,administration and the ,department of ,defense4 7c7 ,duties ,not later than #a year after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 and in consultation with the ,critical ,need ,antimicrobials ,advisory ,group established under subsection 7g71 shall do the following3 7#a7 ,develop a list of infections for which new antimicrobial drug development is needed1 taking into account organisms1 sites of infection1 and type of infections for which there is an unmet medical need1 findings from the most recent report entitled ,antibiotic ,resistance ,threats in the ,united ,states issued by the ,centers for ,disease ,control and ,prevention1 or an anticipated unmet medical need1 including a potential global health security threat4 ,for the list developed under this paragraph1 the ,secretary1 in collaboration with the ,committee1 may use the infection list in such most recent ,antibiotic ,resistance ,threats in the ,united ,states report for up to #c years following the date of enactment of this part and subsequently update the list under this paragraph in accordance with subsection 7e74 7#b7 ,develop regulations1 for purposes of subsection 7d71 outlining favored characteristics of critical need antimicrobial drugs1 that are evidence based1 clinically focused1 and designed to treat the infections described in paragraph 7#a71 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 7f7 or section #cii,,oo-#b4 ,the favored characteristics shall be weighed for purposes of such monetary value of the subscription contract such that meeting certain characteristics1 or meeting more than one such characteristic1 increases the monetary value of the subscription contract4 ,such favored characteristics of an antimicrobial drug shall include-- 7,a7 treating infections on the list under paragraph 7#a72 7,b7 improving clinical outcomes for patients with multi-drug-resistant infections2 7,c7 being a first-approved antimicrobial drug that has the potential to address1 or has the evidence of addressing1 unmet medical needs for the treatment of a serious or life-threatening infection1 and1 to a lesser extent1 second and third drugs that treat such infections2 7,d7 route of administration1 especially through oral administration2 7,e7 7i7 containing no active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that has been approved in any other application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or intending to be the subject of a new biological product license application under section #cea7;a72 7ii7 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 section #eje of such ,act or licensed under section #cea1 including reduced toxicity2 or 7iii7 not being affected by cross-resistance to any antimicrobial drug approved under such section #eje or licensed under such section #cea2 7,f7 addressing a multi-drug resistant infection through a novel chemical scaffold or mechanism of action2 7,g7 having received a transitional subscription contract under subsection 7f72 and 7,h7 any other characteristic the ,committee or the ,critical ,need ,antimicrobial ,advisory ,group established under subsection 7g7 determines necessary4 7d7 ,regulations 7#a7 ,in general ,not later than #ah months after the appointment of the initial members of the ,committee1 the ,secretary shall issue proposed regulations which shall include-- 7,a7 a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section #cii,,oo-#a2 7,b7 how subscription contracts under section #cii,,oo-#b shall be established and paid2 7,c7 the favored characteristics under subsection 7c77#b71 how such characteristics will be weighed1 and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug2 and 7,d7 other elements of the subscription contract process1 in accordance with this part4 7#b7 ,development of final regulations ,before finalizing the regulations under paragraph 7#a71 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 #aej days after such date of issuance4 ,the ,secretary shall finalize and publish such regulations not later than #aej days after the close of such period of public comment and meetings4 7#c7 ,committee recommendations ,in issuing regulations under this subsection1 the ,secretary shall consider the recommendations of the ,committee under subsection 7c77#b74 7e7 ,list of infections ,the ,secretary1 in collaboration with the ,committee1 shall update the list of infections under subsection 7c77#a7 at least every #b years following the development of the initial list under that subsection4 7f7 ,transitional subscription contracts 7#a7 ,in general ,not earlier than #cj days after the date of enactment of this part and ending on the date that the ,secretary finalizes the regulations under subsection 7d71 the ,secretary may use up to #aj percent of the amount appropriated under section #cii,,oo-#d7;a7 to engage in transitional subscription contracts of up to #e years in length with antimicrobial developers1 as determined by the ,secretary1 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 ,prevention1 and may include antimicrobial drugs that are qualified infectious disease products 7as defined in section #eje;,e7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 innovative biological products1 or innovative drugs that achieve improved clinical outcomes4 ,such a contract may authorize the contractor to use funds made available under the contract for completion of postmarketing clinical studies1 manufacturing1 and other preclinical and clinical efforts4 7#b7 ,requirements 7,a7 ,in general ,the ,secretary1 through the office described in paragraph 7#d71 may enter into a contract under paragraph 7#a7-- 7i7 if the ,secretary determines that the antimicrobial drug is intended to treat an infection for which there is an unmet clinical need1 an anticipated clinical need1 or drug resistance2 7ii7 subject to terms including-- 7,i7 that the ,secretary shall cease any payment installments under a transitional subscription contract if the sponsor does not-- 7aa7 ensure commercial availability of the antimicrobial drug within #cj days of receiving first payment under the contract2 7bb7 identify1 track1 and publicly report drug resistance data1 and trends using available data related to the antimicrobial drug2 7cc7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7dd7 submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists1 which such plan may be consistent with the ,stewardship and ,access ,plan 7,,sap7 ,development ,guide 7#bjba72 7ee7 subject to subparagraph 7,b71 ensure a reliable drug supply chain1 thus leading to an interruption of the supply of the antimicrobial drug in the ,united ,states for more than #fj days2 or 7ff7 make meaningful progress toward completion of ,food and ,drug ,administration-required postmarketing studies1 including such studies that are evidence based2 and 7,,ii7 other terms as determined by the ,secretary2 and 7iii7 if-- 7,i7 a phase #c clinical study has been initiated for the antimicrobial drug2 or 7,,ii7 the antimicrobial drug has been approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea7;a74 7,b7 ,waiver ,the requirement under subparagraph 7,a77ii77,i77ee7 may be waived in the case that an emergency prohibits access to a reliable drug supply chain4 7#c7 ,transitional guidance ,not later than #abj days after the appointment of the initial members of the ,committee1 the ,secretary shall issue1 in consultation with the ,committee1 transitional guidance outlining the characteristics of antimicrobial drugs that are eligible for transitional subscription contracts under paragraph 7#a71 the requirements to enter into a transitional subscription contract under paragraph 7#b71 and the process by which drug developers can enter into transitional subscription contracts with the ,secretary under this subsection4 7#d7 ,payment office and mechanism ,not later than #cj days after the date of enactment of this part1 the ,secretary shall establish within the ,administration for ,strategic ,preparedness and ,response an office to manage the transitional subscription contracts1 including eligibility1 requirements1 and contract amounts1 during the period described in paragraph 7#a74 7g7 ,critical need antimicrobial advisory group 7#a7 ,in general ,not later than #cj days after the appointment of all initial members of the ,committee1 the ,secretary1 in collaboration with the ,committee1 shall establish a ,critical ,need ,antimicrobial ,advisory ,group 7referred to in this subsection as the ,advisory ,group7 and appoint members to the ,advisory ,group4 7#b7 ,members ,the members of the ,advisory ,group shall include-- 7,a7 not fewer than #f individuals who are-- 7i7 infectious disease specialists2 or 7ii7 other health experts with expertise in researching antimicrobial resistance1 health economics1 or commercializing antimicrobial drugs2 and 7,b7 not fewer than #e patient advocates4 7#c7 ,chair ,the ,secretary shall appoint as ,chair of the ,advisory ,group a non-voting1 independent member who may not be a member represented under paragraph 7#b74 7#d7 ,conflicts of interest ,in appointing members under paragraph 7#b7 and a ,chair under paragraph 7#c71 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 development4 7#e7 ,applicability of ,,faca ,except as otherwise provided in this subsection1 the ,federal ,advisory ,committee ,act shall apply to the ,advisory ,group4 #cii,,oo-#a4 ,designation of antimicrobial drug as critical need antimicrobial drug 7a7 ,in general 7#a7 ,submission of request ,the sponsor of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 for an antimicrobial drug may request that the ,secretary designate the drug as a critical need antimicrobial4 ,a request for such designation may be submitted after the ,secretary grants for such drug an investigational new drug exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c71 and shall be submitted not later than #e years after the date of approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea7;a74 7#b7 ,content of request ,a request under paragraph 7#a7 shall include information1 such as clinical1 preclinical1 and postmarketing data1 a list of the favorable characteristics described in section #cii,,oo7c77#b71 and any other material that the ,secretary in consultation with the ,committee requires4 7#c7 ,review by secretary ,the ,secretary shall promptly review all requests for designation submitted under this subsection1 assess all required application components1 and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development4 ,after review1 the ,secretary shall approve or deny each request for designation not later than #ij days after receiving a request4 ,if the ,secretary approves a request1 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 application4 7#d7 ,length of designation period ,a designation granted under this section shall be in effect for a period of #aj years after the date that the designation is approved1 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 #cii,,oo7c77#a74 7#e7 ,subsequent reviews ,not earlier than #b years after a designation approval or denial under paragraph 7#c71 the sponsor may request a subsequent review to re-evaluate the value of a contract to include any new information4 7b7 ,development of designated drugs ,if a critical need antimicrobial designation is granted during clinical development of an antimicrobial drug1 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 identified under section #cii,,oo7c77#b74 7c7 ,appropriate use of critical need antimicrobial 7#a7 ,in general ,the sponsor of an antimicrobial drug that receives designation under subsection 7a7 shall1 within #ij days of such designation1 submit to the ,secretary a plan for appropriate use of diagnostics1 in order for the ,secretary and ,committee to consider such plan in developing clinical guidelines4 ,an appropriate use plan-- 7,a7 shall include-- 7i7 the appropriate use of the drug2 and 7ii7 the appropriate use of diagnostic tools1 where available1 or a plan to coordinate development of diagnostic tools as necessary2 and 7,b7 may be developed in partnership with the ,secretary1 infectious disease experts1 diagnostic experts or developers1 laboratory experts1 or another entity4 7#b7 ,consultation ,the ,secretary shall consult with relevant professional societies and the ,critical ,need ,antimicrobial ,advisory ,group established under section #cii,,oo7g7 to ensure that clinical guidelines issued by the ,secretary under paragraph 7#c71 with respect to an antimicrobial drug designated under subsection 7a71 includes the use of appropriate diagnostic approaches1 taking into consideration the diagnostic plan submitted by a sponsor under paragraph 7#a74 #cii,,oo-#b4 ,establishment of ,subscription ,contract ,office2 subscription contracts 7a7 ,subscription contract office 7#a7 ,in general ,not later than #ahj days after the date of enactment of this part1 the ,secretary shall establish within the ,administration for ,strategic ,preparedness and ,response an office1 to be known as the ,subscription ,contract ,office1 the head of which shall be the ,director 7referred to in this section as the ,director74 7#b7 ,purpose ,the purpose of the ,office established under paragraph 7#a7 shall be to manage the establishment and payment of subscription contracts awarded under this section1 including eligibility1 requirements1 and contract amounts4 7b7 ,application for a subscription contract 7#a7 ,submission of applications ,after approval under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea7;a71 the sponsor of an antimicrobial drug designated as a critical need antimicrobial under section #cii,,oo-#a may submit an application for a subscription contract to the ,director1 under a procedure established by the ,director4 7#b7 ,review of applications ,the ,director1 in consultation with the ,committee1 shall-- 7,a7 review all applications for subscription contracts under paragraph 7#a7 and assess all required application components2 7,b7 determine the extent to which the critical need antimicrobial drug covered by the application meets the favored characteristics identified under section #cii,,oo7c77#b72 and 7,c7 deny any application for a drug that does not meet the minimum number and kind of favored characteristics needed for the drug to be designated as a critical need antimicrobial based on the regulations issue under section #cii,,oo7d74 7c7 ,requirements ,as a condition of entering into a subscription contract under this section1 the sponsor of the critical need antimicrobial drug covered by the application shall agree to-- 7#a7 ensure commercial availability of the antimicrobial drug within #cj days of receiving first payment under the contract1 and sufficient supply for susceptibility device manufacturers2 7#b7 identify1 track1 and publicly report drug resistance data1 and trends using available data related to the antimicrobial drug2 7#c7 develop and implement education and communications strategies1 including communications for individuals with limited ,english proficiency and individuals with disabilities1 for health care professionals and patients about appropriate use of the antimicrobial drug2 7#d7 submit an appropriate use assessment to the ,secretary1 the ,committee1 the ,administrator of the ,food and ,drug ,administration1 and the ,director of the ,centers for ,disease ,control and ,prevention every #b years regarding use of the antimicrobial drug1 including how the drug is being marketed2 7#e7 submit a plan for registering the drug in additional countries where an unmet medical need exists2 7#f7 ensure a reliable drug supply chain1 where any interruption to the supply chain will not last for more than #fj days in the ,united ,states2 7#g7 complete any postmarketing studies required by the ,food and ,drug ,administration in a timely manner2 7#h7 produce the drug at a reasonable volume determined with the ,director to ensure patient access to the drug2 7#i7 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 into1 or contamination of1 the environment by antimicrobial agents or products as a result of the manufacturing process2 and 7#aj7 abide by such other terms as the ,director may require4 7d7 ,monetary value 7#a7 ,in general ,the ,director1 in consultation with the ,committee1 shall assign a monetary value to each subscription contract under this section based on the regulations developed under section #cii,,oo7d74 7#b7 ,considerations ,in assigning a monetary value to a subscription contract under paragraph 7#a71 the ,director shall take into account the favored characteristic or combination of favored characteristics of the drug covered by the contract1 as determined by the ,director1 in consultation with the ,committee1 under subsection 7b77#b77;,b74 7e7 ,amount of contracts 7#a7 ,in general ,a subscription contract under this section shall be for the sale to the ,secretary of any quantity of the antimicrobial drug covered by the contract needed over the term of the contract1 at a price agreed on by the sponsor and the ,director1 based on the monetary value assigned to the contract under subsection 7d74 7#b7 ,minimum and maximum amount ,the total projected amount to be paid by the ,director under a subscription contract under this section shall be not less than #gej1jjj1jjj and not more than #c1jjj1jjj1jjj1 adjusted for inflation4 7f7 ,term 7#a7 ,initial term ,the initial term of a subscription contract under this section shall be-- 7,a7 not less than #e years2 and 7,b7 not greater than the greater of-- 7i7 #aj years2 and 7ii7 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 ,states1 as listed in the publication of the ,food and ,drug ,administration entitled ,approved ,drug ,products with ,therapeutic ,equivalence ,evaluations4 7#b7 ,effect ,a subscription contract shall remain in effect for the period described in paragraph 7#a7 even if the infection treated by the antimicrobial drug covered by the subscription contract is later removed from the list of infections under section #cii,,oo7c77#a74 7#c7 ,extension of contracts ,the ,director may extend a subscription contract with a sponsor under this subsection beyond the initial contract period4 ,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 #be1jjj1jjj per year4 ,all other terms of an extended contract shall be the same as the terms of the initial contract4 ,the total amount of funding used on such contract extensions shall be no more than #a1jjj1jjj1jjj1 and shall be allocated from the amount made available under section #cii,,oo-#d7;a74 7#d7 ,modification of contracts ,the ,director or sponsor1 #a year after the start of the contract period under this subsection and every #b years thereafter1 may request a modification of the amount of the contract based on information that adjusts favored characteristics in section #cii,,oo7c77#b74 7g7 ,payments 7#a7 ,in general ,not later than #ahj days after the date on which a subscription contract is granted under subsection 7a71 the ,director shall provide payments for drugs purchased under the contract in installments established by the ,director1 in consultation with the sponsor of the antimicrobial drug and in accordance with subsection 7j74 7#b7 ,timing of payments ,the ,director-- 7,a7 may make payments under paragraph 7#a7 in equal annual installments2 and 7,b7 shall not make such payments more frequently than twice per year4 7#c7 ,option ,the sponsor shall have the option to receive #ej percent of the payment amount due in the last year of the contract during the first year of the contract in order to offset costs of establishing manufacturing capacity4 7#d7 ,funding ,payments under this subsection shall be allocated from the amount made available under section #cii,,oo-#d7;a74 7#e7 ,adjustment ,in the case of an antimicrobial drug that received a transitional subscription contract under section #cii,,oo7f71 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 #cii,,oo7f7 for such drug4 7h7 ,use of contract funds ,funds received by the sponsor under a subscription contract under this section shall be used-- 7#a7 to meet the requirements described in subsection 7c72 and 7#b7 to support the completion of postmarketing clinical studies1 manufacturing1 other preclinical and clinical activities1 or other activities agreed to by the ,director and sponsor in the contract4 7i7 ,contracts for generic and biosimilar versions ,notwithstanding any other provision of this part1 the ,director 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 section4 ,such contracts shall be awarded in accordance with a procedure1 including for determining the terms and amounts of such contracts1 established by the ,director4 7j7 ,antimicrobial drug sponsor revenue limitations 7#a7 ,requirement 7,a7 ,in general ,with respect to a payment installment under a subscription contract entered into under this section1 the net revenue from sales of the applicable antimicrobial drug for beneficiaries or enrollees in ,federal health care programs during the period covered by the payment installment shall be subtracted from the payment installment4 7,b7 ,payment ,the amount calculated under subparagraph 7,a7 shall be paid by the ,secretary to the relevant ,federal health care program 7or its trust fund7 at the time of the applicable installment payment4 7,c7 ,coordination ,the ,director shall coordinate with the relevant agencies of the ,federal ,government1 including the ,centers for ,medicare and ,medicaid ,services1 to carry out this subsection in a manner that ensures minimal disruption to how a health care provider currently acquires applicable antimicrobial drugs4 7#b7 ,regulations 7,a7 ,in general ,to carry out this subsection1 the ,secretary shall promulgate regulations to identify the ,federal health care programs applicable under this section1 including ,medicare part ,a and ,medicaid1 and to establish the methodology and data collection requirements necessary to calculate the amount under paragraph 7#a77;,a74 7,b7 ,methodology ,any methodology established for the collection of data and calculation of the amount under paragraph 7#a77;,a7 shall take into account any legally mandated or voluntary discounts and rebates provided by the manufacturer of the applicable antimicrobial drug to the ,federal health care programs that pay for such drug1 on the condition that the ,secretary may presume that discounts not described in subclauses 7,i7 and 7,,ii7 of subparagraph 7,c77ii7 are captured in the price determined under subparagraph 7,c77i77,,ii74 7,c7 ,estimating annual net revenue 7i7 ,in general ,in determining the net revenue from sales of the applicable antimicrobial drug for beneficiaries or enrollees in ,federal health care programs for the purpose of calculating the amount under paragraph 7#a77;,a71 the ,secretary shall determine such net revenue amount by multiplying-- 7,i7 the total number of billing units of such antimicrobial drugs reported under the process described in subparagraph 7,d77ii7 for the applicable payment installment period2 by 7,,ii7 the average sales price 7as defined in section #ahdg;,a7c7 of the ,social ,security ,act71 the average manufacturer price 7as defined in section #aibg7k77#a7 of the ,social ,security ,act71 or another pricing metric used in ,federal health care programs1 for such antimicrobial drugs4 7ii7 ,requirement ,the ,secretary shall adjust the amount determined under clause 7i77,,ii7 to account for-- 7,i7 rebates1 discounts1 add-on payments1 or other adjustments provided under-- 7aa7 section #cdj;,b2 or 7bb7 section #aibg of the ,social ,security ,act2 or 7,,ii7 negotiated price concessions described in section #ahfj;,d-#b7;d77#a77;,b7 of the ,social ,security ,act that are not captured in the applicable price4 7,d7 ,coding 7i7 ,in general ,in promulgating regulations under subparagraph 7,a71 the ,secretary shall1 as appropriate1 establish and assign codes1 under existing or new coding systems1 to identify units of the applicable antimicrobial drug for beneficiaries or enrollees in ,federal health care programs4 7ii7 ,coding use requirements ,in promulgating regulations under subparagraph 7,a71 the ,secretary shall require hospitals 7or other providers or suppliers7 that administer applicable antimicrobial drugs in the inpatient or outpatient setting to report on their claims to such ,federal health care programs the billing units of such antimicrobial drugs used in the care of beneficiaries or enrollees in each ,federal health care program1 regardless of whether payment for those units are separately reimbursed4 7#c7 ,definitions ,in this subsection3 7,a7 ,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 7a74 7,b7 ,federal health care program ,the term ,federal health care program has the meaning given such term in section #aabh;,b7f7 of the ,social ,security ,act1 except that1 for purposes of this subsection1 such term includes the health insurance program under chapter #hi of title #e1 ,united ,states ,code4 7k7 ,failure ,to adhere to terms ,the ,secretary shall cease any payment installments under a contract under this section if-- 7#a7 the sponsor-- 7,a7 permanently withdraws the antimicrobial drug from the market in the ,united ,states2 7,b7 fails to meet the requirements described in subsection 7c72 or 7,c7 does not complete a postmarket study required by the ,food and ,drug ,administration during the term of the contract2 7#b7 the annual international and private insurance market revenues with respect to an antimicrobial drug 7not counting any subscription revenues from any source pursuant to a contract under this section or other international or private entities7 exceed #e times the average annual amount of the subscription contract paid by the ,secretary as certified by the sponsor annually2 or 7#c7 if the total revenue of the sponsor from government programs that pay for drugs subject to a contract agreement entered into pursuant to this section for a year exceeds the amount of the subscription contract paid by the ,secretary for that year4 7l7 ,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 section4 7m7 ,effect ,nothing in this section permits the ,secretary to use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly1 disabled1 or terminally ill individual as of lower value than extending the life of an individual who is younger1 nondisabled1 or not terminally ill in determining the value of an antimicrobial drug or a subscription contract 7or a transitional subscription contract71 including in such a way that would limit patient access4 #cii,,oo-#c4 ,encouraging appropriate use of antimicrobials and combating resistance 7a7 ,establishment of health facility grant program 7#a7 ,in general ,not later than #a year after the date of enactment of this part1 the ,secretary shall establish a grant program under the ,centers for ,disease ,control and ,prevention to support hospital1 skilled nursing facility1 and other health care facility efforts-- 7,a7 to judiciously use antimicrobial drugs1 such as by establishing or implementing appropriate use programs1 including infectious disease telehealth programs1 using appropriate diagnostic tools1 partnering with academic hospitals1 increasing health care-associated infection reporting and prevention efforts1 and monitoring antimicrobial resistance2 and 7,b7 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 program1 as specified by the ,secretary1 relating to antimicrobial drugs4 7#b7 ,prioritization ,in awarding grants under paragraph 7#a71 the ,secretary shall prioritize health care facilities without an existing program to judiciously use antimicrobial drugs1 subsection 7d7 hospitals 7as defined in subparagraph 7,b7 of section #ahhf7;d77#b7 of the ,social ,security ,act that are located in rural areas 7as defined in subparagraph 7,d7 of such section71 critical access hospitals 7as defined in section #ahfa7mm77#a7 of such ,act71 hospitals serving ,tribal populations1 and safety-net hospitals4 7b7 ,surveillance and reporting of antimicrobial use and resistance 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall use the ,national ,healthcare ,safety ,network and other appropriate surveillance systems to assess trends in antimicrobial resistance and antibiotic and antifungal use1 such as-- 7,a7 appropriate conditions and measures causally related to antimicrobial resistance1 including types of infections1 the source or body sites of infections1 the demographic information of patients with infections1 and infection onset in a community or hospital setting1 increased lengths of hospital stay1 increased costs1 and rates of mortality2 and 7,b7 changes in bacterial and fungal resistance to antimicrobial drugs1 including changes in percent resistance1 prevalence of antimicrobial-resistant infections1 rates of mortality1 and other such changes4 7#b7 ,antimicrobial use data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall obtain reliable and comparable human antibiotic and antifungal drug consumption data 7including1 as available and appropriate1 volume antimicrobial distribution data and antibiotic and antifungal use data1 including prescription data7 by ,state or metropolitan areas4 ,to accomplish this1 the ,centers for ,disease ,control and ,prevention may work with1 as appropriate1 ,federal departments and agencies 7including the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,department of ,homeland ,security1 the ,bureau of ,prisons1 the ,indian ,health ,service1 and the ,centers for ,medicare ,medicaid ,services71 private vendors1 health care organizations1 pharmacy benefit managers1 and other entities4 7#c7 ,antimicrobial resistance trend data ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall intensify and expand efforts to collect antimicrobial resistance 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 care1 including1 as appropriate1 acute care hospitals1 dialysis facilities1 nursing homes1 ambulatory surgical centers1 and other ambulatory health care settings in which antimicrobial drugs are routinely prescribed4 ,the ,secretary shall seek to collect such data from electronic medication administration reports and laboratory systems to produce the reports described in paragraph 7#d74 7#d7 ,public availability of data ,beginning on the date that is #b years after the date of enactment of this part1 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall1 for the purposes of improving the monitoring of important trends in antimicrobial use and resistance1 and1 as appropriate1 patient outcomes in relation to antimicrobial resistance-- 7,a7 make the data described under this subsection publicly available through reports and web updates issued on a regular basis that is not less than annually2 and 7,b7 examine opportunities to make such data available in near real time4 7c7 ,publication of clinical guidelines ,not later than #a year after the date the ,secretary makes the first designation under section #cii,,oo-#a7;a71 and not less than every #c years thereafter1 the ,secretary shall publish at least one update to clinical guidelines in consultation with relevant professional societies4 ,as appropriate1 guideline updates shall include each antimicrobial drug that has been approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea7;a7 and that has been designated under section #cii,,oo-#a7;a71 which guidelines shall set forth the evidence-based recommendations for prescribing the drug for the relevant infection time1 in accordance with the available evidence after consultation under section #cii,,oo-#a7;c77#b71 as appropriate4 7d7 ,funding ,the ,secretary may use not more than #e percent of the amounts appropriated under section #cii,,oo-#d7;a7 to carry out this section4 #cii,,oo-#d4 ,appropriations 7a7 ,in general ,to carry out this part1 there are hereby appropriated to the ,secretary1 out of amounts in the ,treasury not otherwise appropriated1 #f1jjj1jjj1jjj for fiscal year #bjbd1 to remain available until expended4 7b7 ,emergency designation 7#a7 ,in general ,the amounts provided by this section are designated as an emergency requirement pursuant to section #d7;g7 of the ,statutory ,pay-,as-,you-,go ,act of #bjaj4 7#b7 ,designation in senate ,in the ,senate1 this section is designated as an emergency requirement pursuant to section #daab7;a7 of ,h4 ,con4 ,res4 #ga 7#aaeth ,congress71 the concurrent resolution on the budget for fiscal year #bjah4 #cii,,oo-#e4 ,studies and reports 7a7 ,in general ,not later than #f years after the date of enactment of this part1 the ,comptroller ,general of the ,united ,states shall complete a study on the effectiveness of this part in developing priority antimicrobial drugs4 ,such study shall examine the indications for1 usage of1 development of resistance with respect to1 and private and societal value of critical need antimicrobial drugs1 and the impact of the programs under this part on markets of critical need antimicrobial drugs4 ,the ,comptroller ,general shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on the findings of such study4 7b7 ,antibiotic use in the ,united ,states2 annual reports ,the ,director of the ,centers for ,disease ,control and ,prevention shall1 each year1 update the report entitled ,antibiotic ,use in the ,united ,states to include updated information on progress and opportunities with respect to data1 programs1 and resources for prescribers to promote appropriate use of antimicrobial drugs4 7c7 ,report on antimicrobial prophylactics ,not later than #c years after the date of enactment of this part1 the ,director of the ,centers for ,disease ,control and ,prevention shall publish a report on antimicrobial prophylactics4 #cii,,oo-#f4 ,definitions ,in this part-- 7#a7 the term antimicrobial drug-- 7,a7 means1 subject to subparagraph 7,b71 a product that is-- 7i7 a drug that directly inhibits replication of or kills bacteria or fungi1 or acts on the substances produced by such bacteria or fungi1 relevant to the proposed indication at concentrations likely to be attainable in humans to achieve the intended therapeutic effect2 or 7ii7 a biological product that acts directly on bacteria or fungi or on the substances produced by such bacteria or fungi2 and 7,b7 does not include-- 7i7 a drug that achieves the effect described by subparagraph 7,a77i7 only at a concentration that cannot reasonably be studied in humans because of its anticipated toxicity2 or 7ii7 a vaccine2 and 7#b7 the term ,committee means the ,committee on ,critical ,need ,antimicrobials established under section #cii,,oo7a74 4