S 3386 — End Tuberculosis Now Act of 2022

In order to achieve by 2035 the goals of the Political Declaration of the High-Level Meeting of the General Assembly on the Fight Against Tuberculosis, adopted by the United Nations General Assembly October 10, 2018, and of the World Health Organization End TB Strategy, adopted by the World Health Assembly in 2014, new and existing tools must be developed and madescaled-up. available.

(3) OverMore than \1/3\ of people who become ill with TB may be undiagnosed or misdiagnosed, resulting in unnecessary illness, communicable infections, and increased mortality.

(4) Since March 2020, the COVID-19 pandemic has severely disrupted TB responses in low- and middle-income countries, stalling and reversing years of progress made against TB,TB. with detection dropping by 50 percent and an estimated 1,000,000 fewer people will be diagnosed and enrolled on TB treatment.

(5)According In May 2020, a modeling study conducted by the Stop Tuberculosis Partnership (referred to in this Act as the ``StopWorld TBHealth Partnership'')Organization, infrom collaboration2019 with the United States Agency for International Development (referred to in2020-- this(A) Act as ``USAID'') and partners estimated that a 3-month global lockdowndetection followed by a protracted 10-month restoration could lead to an additional 6,300,000 cases of TB betweendropped 2020by and18 andpercent; an additional 1,400,000 TB deaths during this period, causing a setback of at least 5 to 8 years in the fight against TB.

(6)(B) Findingsan releasedestimated by1,300,000 thefewer Stoppeople TBwere Partnershipdiagnosed on March 18, 2021, found that TB diagnosis and enrolmentenrolled on treatment in declined by an estimated total of 1,000,000 cases in 9 countries that collectively represent 60 percent of the global TB caseload,treatment; pushing the TB response back to 2008 levels in terms of people diagnosed and treated.

(7)and Failure(C) toin properlysome diagnosecountries, and treat TB cancase leadnotifications todropped deathby andup can exacerbate antimicrobial resistance, a key contributor to rising41 casespercent, ofsetting multi-drug-resistantprogress tuberculosis,back andby extensivelyup drug-resistantto tuberculosis,12 andyears. increasing the probability of the introduction of resistant TB into new geographic areas.

(8)(5) TBFailure programsto haveproperly playeddiagnose aand centraltreat roleTB incan respondinglead to COVID-19,death, includingcan throughexacerbate leveragingantimicrobial theresistance expertise(a ofkey medicalcontributor staffto withrising expertisecases inof multi-drug-resistant TB and lungextensively diseases,drug-resistant theTB), repurposingand ofcan TBincrease hospitals, and the useprobability of the TBintroduction rapidof molecularresistant testingTB platformsinto andnew X-Raygeographic equipmentareas. for multiple purposes, including COVID-19.

(9)(6) With sufficient resourcing, TB programprograms expertise,have infectionplayed control,a laboratorycentral capacity,role activein caseresponding findingto andCOVID-19, contactincluding investigation,through canleveraging servethe asexpertise aof platformmedical forstaff respiratorywith pandemicexpertise responsein againstTB existing and newlung infectiousdiseases, respiratorythe diseaserepurposing withoutof suchTB ahospitals, responseand necessitating the disruptionuse of ongoingthe TB programsrapid molecular testing platforms and activities.x-ray equipment for multiple purposes, including the treatment of COVID-19.

(10)(7) Globally,With onlysufficient aboutresourcing, \1/2\TB ofprogram theexpertise, $13,000,000,000infection requiredcontrol, annuallylaboratory outlinedcapacity, inactive thecase Stopfinding, TBand Partnership'scontact Globalinvestigation Plancan toserve Endas TBplatforms for tuberculosisrespiratory prevention,pandemic diagnosis,response against existing and treatmentnew isinfectious currentlyrespiratory available.disease without disrupting ongoing TB programs and activities.

(11)(8) AnGlobally, estimatedonly additionalabout $3,500,000,000\1/2\ willof bethe needed$13,000,000,000 duringrequired 2021annually, foras TBoutlined programs in countriesthe eligibleStop forTB Partnership's Global FundPlan for AIDS, Tuberculosis, and Malaria programming to recoverEnd fromTB, theis negativecurrently impactsavailable. of COVID-19, with a total annual gap of at least $8,000,000,000 for TB diagnosis, prevention, and treatment in such countries.

(12)(9) OnAccording Septemberto 26,estimates 2018,by the UnitedGlobal NationsFund convenedfor theAIDS, first High-Level Meeting of the General Assembly on the Fight Against Tuberculosis, atand whichMalaria, 120an countries--additional (A)$3,500,000,000 signedwas aneeded Politicalduring Declaration2021 to accelerate progress against TB, including commitments to increase funding for TB controlprograms andin researcheligible andcountries developmentin programs,order and ambitious goals to successfullyrecover treat 40,000,000 people with tuberculosis and prevent at least 30,000,000 from becomingthe illnegative withimpacts TBof betweenCOVID-19. 2018 and 2022;

and(10) (B)On committedSeptember to26, ``ending2018, the epidemicUnited inNations allconvened countries,the andfirst pledge[d]High-Level toMeeting provideof leadershipthe andGeneral toAssembly workon togetherthe Fight Against Tuberculosis, during which 120 countries-- (A) signed a Political Declaration to accelerate ourprogress nationalagainst TB, including through commitments to increase funding for TB prevention, diagnosis, treatment, and globalresearch collectiveand actions,development investmentsprograms, and innovationsto urgentlyset ambitious goals to fightsuccessfully thistreat preventable40,000,000 people with active TB and treatableprevent disease,''at asleast reflected30,000,000 infrom Unitedbecoming Nationsill Generalwith AssemblyTB Resolutionbetween A/RES/73/3.2018 and 2022;

(13)and The(B) Unitedcommitted Statesto Government``ending continuesthe toepidemic bein aall leadcountries, funderand ofpledge[d] globalto TBprovide researchleadership and development,to contributingwork 44together percentto ofaccelerate theour totalnational $901,000,000and in global fundingcollective inactions, 2019,investments and caninnovations catalyzeurgently moreto investmentsfight fromthis otherpreventable countries.and treatable disease'', as reflected in United Nations General Assembly Resolution 73/3.

(14)(11) WorkingThe withUnited governmentsStates andGovernment partnerscontinues aroundto thebe world,a thelead TBfunder effortsof byglobal USAIDTB haveresearch savedand 60,000,000development, lives,contributing demonstrating44 percent of the effectivenesstotal of$915,000,000 Unitedin Statesglobal programsfunding in 2020, and activities.can catalyze more investments from other countries.

(15)(12) OnWorking Septemberwith 26,governments 2018,and thepartners USAIDaround Administrator announced a new performance-based Global Accelerator to End TB, aimed at catalyzing investments to meet the targetworld, setUSAID's byTB theprogramming Unitedhas Nationssaved High-Levelan Meetingestimated on66,000,000 tuberculosislives, of treating 40,000,000 people with the disease by 2022, further demonstrating the criticaleffectiveness roleof that United States leadershipprograms and assistanceactivities playsagainst in the fightillness. to eliminate TB.

(16)(13) ItOn isSeptember essential26, to2018, ensurethe thatUSAID effortsAdministrator amongannounced Uniteda Statesnew Governmentperformance-based agencies,Global partnerAccelerator nations,to internationalEnd organizations,TB, nongovernmentalaimed organizations,at thecatalyzing privateinvestments sector,to andmeet otherthe actorstreatment aretarget complementaryset andby notthe duplicativeUnited inNations orderHigh-Level toMeeting, achievefurther demonstrating the goalcritical ofrole endingthat theUnited TBStates epidemicleadership and assistance plays in allthe countries.fight to eliminate TB.

(14) It is essential to ensure that efforts among United States Government agencies, partner nations, international organizations, nongovernmental organizations, the private sector, and other actors are complementary and not duplicative in order to achieve the goal of ending the TB epidemic in all countries.

``SECTION``SEC. 104B.

104B.

``(1) CongressThe recognizesinternational thespread continuingof challengetuberculosis of(referred theto internationalin spreadthis ofsection tuberculosis,as `TB') and the deadly impact of theTB's continued existence ofconstitutes TB.a continuing challenge.

``(2) Additional tools and resources are required to effectively diagnose, prevent, and treat tuberculosis.TB.

``(3) Effectively resourced tuberculosisTB programs can serve as a critical platform for respiratorypreventing pandemicand responseresponding againstto existingfuture and new infectious respiratory disease.disease pandemics.

``(b) Policy.--ItPolicy.-- ``(1) In general.--It is a major objective of the foreign assistance program of the United States to help end the globalTB tuberculosispublic pandemichealth emergency through actionsaccelerated actions-- ``(A) to support the diagnosis and treatment of all adults and children with all forms of tuberculosis,TB; and to prevent new tuberculosis infections in adults and children.

In all countries in which the United States Government has established development programs, particularly in countries with the highest burden of tuberculosis and other``(B) countries with high rates of tuberculosis, it is the policy of the United States-- ``(1) to supportprevent thenew objectives of the World Health Organization End TB Strategy,infections includingfrom goals--occurring. ``(A) to reduce by 95 percent tuberculosis deaths by 2035;

``(B)``(2) Support for global plans and objectives.--In countries in which the United States Government has established foreign assistance programs under this Act, particularly in countries with the highest burden of TB and other countries with high rates of infection and transmission of TB, it is the policy of the United States-- ``(A) to reducesupport bythe 90objectives percentof the tuberculosisWorld incidenceHealth rateOrganization End TB Strategy, including its goals-- ``(i) to reduce TB deaths by 95 percent by 2035;

and``(ii) ``(C) to reduce by 100 percent the numberTB ofincidence familiesrate facingby catastrophicpercent health costs due to tuberculosis by 2035;

``(2)and ``(iii) to supportreduce the Stopnumber TBof Partnership'sfamilies Globalfacing Plancatastrophic tohealth Endcosts TBdue 2018-2022, and any follow up plan, including support for-- ``(A) developing and using innovative new technologies and therapies to increaseTB activeby casepercent findingby to2035; rapidly diagnose and treat children and adults with all forms of tuberculosis, alleviate suffering, and ensure tuberculosis treatment completion;

``(B) providingto diagnosissupport andthe treatmentStop withTB thePartnership's goalGlobal ofPlan successfullyto treatingEnd 40,000,000TB people2023-2030, withincluding tuberculosis by 2022,providing includingsupport 3,500,000for-- children,``(i) developing and 1,500,000using peopleinnovative withnew drug-resistanttechnologies tuberculosisand intherapies supportto ofincrease theactive targetcase setfinding byand therapidly Politicaldiagnose Declarationand oftreat thechildren High-Leveland Meetingadults with all forms of theTB, Generalalleviate Assemblysuffering, onand theensure FightTB Againsttreatment Tuberculosis;completion;

``(C)``(ii) diagnosingexpanding diagnosis and treatingtreatment latentin tuberculosisline infection,with inthe supportgoals ofestablished by the globalPolitical goalDeclaration of providingthe preventiveHigh-Level therapyMeeting toof atthe leastGeneral 30,000,000Assembly people,on includingthe 4,000,000Fight childrenAgainst underTuberculosis, 5including-- years``(I) ofsuccessfully age,treating 20,000,00040,000,000 householdpeople contactswith ofactive peopleTB affected by tuberculosis,2023, including 3,500,000 children, and 6,000,0001,500,000 people living with HIV,drug-resistant byTB; 2022;

``(D)and ensuring``(II) highdiagnosing qualityand treating latent tuberculosis careinfection, byin closingsupport gapsof inthe careglobal cascades,goal implementingof continuousproviding qualitypreventive improvementtherapy to at allleast levels30,000,000 people by 2023, including 4,000,000 children younger than 5 years of care,age, 20,000,000 household contacts of people affected by TB, and providing6,000,000 patientpeople support;living with HIV;

and``(iii) ``(E)ensuring sustainablyhigh-quality procuringTB tuberculosiscare commoditiesby toclosing avoidgaps interruptions in supply,care thecascades, procurementimplementing ofcontinuous commoditiesquality ofimprovement unknownat quality,all orlevels payment of excessivecare, commodityand costsproviding inrelated countriespatient impactedsupport; by tuberculosis;

and ``(3)``(iv) tosustainable ensureprocurements thatof UnitedTB Statescommodities fundingto supportsavoid activitiesinterruptions thatin simultaneouslysupply, emphasize-- ``(A) the developmentprocurement of comprehensivecommodities person-of centeredunknown programs,quality, includingor diagnosis,payment treatment,of andexcessive preventioncommodity strategiescosts toin ensurecountries that--impacted ``(i)by allTB; people sick with tuberculosis receive quality diagnosis and treatment through active case finding;

and``(C) ``(ii)ensure, peopleto atthe highgreatest riskextent forpracticable, tuberculosisthat infectionUnited areStates foundfunding supports activities that simultaneously emphasize-- ``(i) the development of comprehensive person-centered programs, including diagnosis, treatment, and treatedprevention strategies to ensure that-- ``(I) all people sick with preventiveTB therapiesreceive inquality adiagnosis timelyand manner;treatment through active case finding;

``(B)and robust``(II) tuberculosispeople infectionat controlhigh practicesrisk for TB infection are implementedfound inand alltreated congregatewith settings,preventive includingtherapies hospitalsin anda prisons;timely manner;

``(C)``(ii) therobust deploymentTB ofinfection diagnosticcontrol andpractices treatmentare capacity--implemented ``(i) in areasall withcongregate thesettings, highestincluding tuberculosishospitals burdens;and prisons;

and``(iii) ``(ii)the fordeployment highlyof at-riskdiagnostic and impoverishedtreatment populations,capacity-- including``(I) patientin support;areas with the highest TB burdens;

``(D) program monitoring and evaluation``(II) basedfor onhighly criticalat-risk tuberculosisand indicators,impoverished populations, including indicators relating to infection control, the numbers of patients accessing tuberculosis treatment, along with patient support services,services; and preventative therapy for those at risk, including all close contacts, and treatment outcomes for all forms of tuberculosis;

``(E)``(iv) trainingprogram monitoring and engagementevaluation ofbased healthon carecritical workersTB onindicators, theincluding useindicators ofrelating newto diagnosticinfection toolscontrol, andthe therapiesnumbers asof theypatients becomeaccessing available,TB treatment and increasedpatient support forservices, trainingand frontlinepreventative healththerapy carefor workersthose toat supportrisk, expandedincluding tuberculosisall activeclose casecontacts, finding,and contacttreatment tracingoutcomes andfor patientall support;forms of TB;

``(F)``(v) coordinationtraining withand domesticengagement agenciesof andhealth organizationscare workers on anthe aggressiveuse researchof agendanew todiagnostic developtools vaccinesand therapies as wellthey asbecome newavailable, toolsand increased support for training frontline health care workers to diagnose,support treat,expanded TB active case finding, contact tracing, and preventpatient tuberculosissupport globally;services;

``(G)``(vi) linkagescoordination with thedomestic privateagencies sectorand on--organizations ``(i)to support an aggressive research andagenda developmentto ofdevelop avaccines vaccine,as andwell onas new tools forto diagnosisdiagnose, treat, and treatmentprevent ofTB tuberculosis;globally;

``(ii)``(vii) improvinglinkages currentwith the private sector on-- ``(I) research and development of a vaccine, and on new tools for diagnosis and treatment of tuberculosis;TB;

and``(II) ``(iii)improving trainingcurrent healthcaretools professionalsfor ondiagnosis useand treatment of theTB, newestincluding andtelehealth mostsolutions effectivefor diagnosticprevention and therapeutictreatment; tools;

``(H)and the``(III) reductiontraining ofhealthcare barriersprofessionals toon care,use includingof stigmathe andnewest treatment and diagnosismost costs,effective through--diagnostic ``(i)and trainingtherapeutic fortools; health workers;

``(ii)``(viii) sensitizingthe reduction of policybarriers makers;to care, including stigma and treatment and diagnosis costs, including through-- ``(I) training health workers;

``(iii)``(II) requirementssensitizing forpolicy accessmakers; and affordability provisions in all grants and funding agreements;

``(iv)``(III) educationrequiring andthat empowermentall campaignsrelevant forgrants tuberculosisand patientsfunding regardingagreements localinclude tuberculosisaccess services;and affordability provisions;

``(v)``(IV) monitoringsupporting barrierseducation toand accessingempowerment tuberculosiscampaigns for TB patients regarding local TB services;

and``(V) ``(vi)monitoring increasedbarriers supportto foraccessing patient-ledTB andservices; community-led tuberculosis outreach efforts;

and ``(I)``(VI) increasing support for country-level,patient-led sustainable accountability mechanisms and capacitycommunity-led toTB measureoutreach progressefforts; and ensure that commitments made by governments and relevant stakeholders are met.

and ``(ix) support for country-level, sustainable accountability mechanisms and capacity to measure progress and ensure that commitments made by governments and relevant stakeholders are met.

``(2) End tb strategy.--The term `End TB Strategy' means the strategy to eliminate tuberculosisTB that was approved by the World Health Assembly in May 2014, and is described in The`The End TB Strategy:

Global strategyStrategy and targetsTargets for tuberculosisTuberculosis prevention,Prevention, careCare and controlControl afterAfter 2015.2015'.

``(3) Global alliance for tuberculosis drug development.-- The term `Global Alliance for Tuberculosis Drug Development' means the public-private partnership that bring together leaders in health, science, philanthropy, and private industry to devise new approaches to tuberculosis.TB.

``(4) Global tuberculosis drug facility.--The term `Global Tuberculosis Drug Facility' means the initiative of the Stop Tuberculosis Partnership to increase access to the most advanced, affordable, quality-assured tuberculosisTB drugs and diagnostics.

``(5) MDR-TB.--The term `MDR-TB' means multi-drug-resistant tuberculosis.TB.

``(6) Stop tuberculosis partnership.--The term `Stop Tuberculosis Partnership' means the partnership of the1,600 Unitedorganizations Nations(including Officeinternational forand Projecttechnical Services,organizations, donorsgovernment programs, research and funding agencies, foundations, nongovernmental organizations, civil society and community groups, and the private sector), donors, including the United States, high tuberculosisTB burden countries, multilateral agencies, and nongovernmental and technical agenciesagencies, which is governed by the Stop TB Partnership Coordinating Board and hosted by a United Nations entity, committed to short- and long-term measures required to control and eventually eliminate tuberculosisTB as a public health problem in the world.

``(7) XDR-TB.--The term `XDR-TB' means extensively drug- resistant tuberculosis.TB.

``(d) Authorization.--To carry out this section, the President is authorized, consistent with section 104(c), to furnish assistance, on such terms and conditions as the President may determine, for the prevention, treatment, control, and elimination of tuberculosis.TB.

``(e) Goals.--In consultation with the appropriate congressional committees, the President shall establish goals, based on the policy and indicators described in subsection (b), forfor-- ``(1) United States tuberculosisTB programs to detect, curecure, and prevent all forms of tuberculosisTB globally for the period between 2023 and 2030 that isare aligned with the End TB Strategy's 2030 targets,targets byand updating the UnitedUSAID's StatesGlobal Government Tuberculosis (TB) Strategy (2015-2019)2023- and2030; the National Action Plan for Combating Multidrug-Resistant Tuberculosis.

``(f) Coordination.-- ``(1) In general.--In carrying out this section, the President shall coordinate with the World Health Organization, the Stop TB Partnership, the Global Fund to Fight AIDS, Tuberculosis, and Malaria,``(2) andupdating other organizations with respect to the developmentNational andAction implementationPlan offor aCombating comprehensiveMultidrug-Resistant globalTuberculosis. tuberculosis response program.

``(2)``(f) BilateralCoordination.-- assistance.--In``(1) providingIn bilateralgeneral.--In assistancecarrying underout this section, the President,President actingshall throughcoordinate with the AdministratorWorld ofHealth Organization, the UnitedStop StatesTB AgencyPartnership, forthe InternationalGlobal Development,Fund shall--to ``(A)Fight catalyzeAIDS, supportTuberculosis, for research and developmentMalaria, of new tools to prevent, diagnose, treat, and controlother tuberculosisorganizations worldwide,with particularlyrespect to reduce the incidencedevelopment of, and mortalityimplementation from,of alla formscomprehensive ofglobal drug-TB resistantresponse tuberculosis;program.

``(B)``(2) ensureBilateral assistance.--In providing bilateral assistance under this section, the President, acting through the Administrator of the United States programsAgency andfor activitiesInternational aimedDevelopment, atshall-- reaching``(A) thosecatalyze infectedsupport withfor tuberculosisresearch provideand qualitydevelopment diagnosisof andnew treatment,tools to prevent, diagnose, treat, and reachcontrol thoseTB atworldwide, highparticularly riskto withreduce preventivethe therapy;incidence of, and mortality from, all forms of drug-resistant TB;

and``(B) ``(C) ensure coordination among relevant United States Governmentprograms agencies, including the Centers for Disease Control and Prevention,activities thefocus Nationalon Institutesfinding ofindividuals Health,with theactive BiomedicalTB Advanceddisease Research and Developmentprovide Authority,quality thediagnosis Food and Drugtreatment, Administration,including thethrough Nationaldigital Sciencehealth Foundation,solutions, the Department of Defense (through its Congressionally Directed Medical Research Program), and otherreaching Federalthose agenciesat thathigh engagerisk inwith internationalpreventive tuberculosistherapy; activities to ensure accountability and transparency, reduce duplication of efforts and ensure appropriate integration and coordination of tuberculosis services into other United States-supported health programs.

``(g)and Priority``(C) Toensure Endcoordination TBamong Strategy.--Inrelevant furnishingUnited assistanceStates underGovernment subsectionagencies, (d),including the PresidentDepartment shallof giveState, prioritythe to--Centers ``(1)for buildingDisease Control and strengtheningPrevention, tuberculosisthe programsNational toInstitutes diagnoseof Health, the Biomedical Advanced Research and treatDevelopment allAuthority, peoplethe sickFood withand TB,Drug Administration, the National Science Foundation, the Department of Defense (through its Congressionally Directed Medical Research Programs), and ensuringother everyonerelevant whoFederal isdepartments sickand withagencies tuberculosisthat haveengage accessin international TB activities-- ``(i) to qualityensure diagnosisaccountability and treatment;transparency;

``(2)``(ii) direct,to high-qualityreduce integratedduplication services for all forms of tuberculosis,efforts; as described by the World Health Organization, which call for the coordination of active case finding, treatment of all forms of tuberculosis disease and infection, patient support, and tuberculosis prevention;

``(3)and individuals``(iii) co-infectedto withensure HIVappropriate andintegration other co- morbidities, and othercoordination individualsof withTB tuberculosisservices whointo mayother beUnited atStates-supported riskhealth ofprograms. stigma;

``(4)``(g) strengtheningPriority theTo capacityEnd ofTB healthStrategy.--In systemsfurnishing toassistance detect,under prevent,subsection and(d), treatthe tuberculosis,President includingshall MDR-TBprioritize-- and``(1) XDR-TB,building asand describedstrengthening inTB theprograms-- International``(A) Standardsto forincrease Tuberculosisthe Care,diagnosis and thetreatment latestof internationaleveryone guidancewho relatedis tosick tuberculosis;with TB;

``(5) research and development``(B) ofto innovativeensure diagnostics,that drugsuch therapies,individuals andhave vaccines,access andto program-basedquality operationaldiagnosis research;and treatment;

``(6)``(2) thedirect, Stophigh-quality Tuberculosisintegrated Partnership'sservices Globalfor Drugall Facility,forms andof TB, as described by the GlobalWorld AllianceHealth Organization, which call for Tuberculosisthe Drugcoordination Development,of andactive othercase organizationsfinding, promotingtreatment theof developmentall forms of newTB productsdisease and drugsinfection, forpatient tuberculosis;support, and TB prevention;

and``(3) ``(7)treating ensuringindividuals tuberculosisco-infected programswith canHIV serveand asother keyco-morbidities, platformsand forother supportingindividuals nationalwith respiratoryTB pandemicwho responsemay againstbe existingat andrisk newof infectiousstigma; respiratory disease.

``(h)``(4) Assistancestrengthening for the Worldcapacity Health Organization and the Stop Tuberculosis Partnership.--In carrying out this section, the President, acting through the Administrator of thehealth Unitedsystems States Agency for International Development, is authorized to providedetect, increasedprevent, resources to the World Health Organization and thetreat StopTB, Tuberculosisincluding PartnershipMDR-TB to improve the capacity of countries with high burdens or rates of tuberculosis and otherXDR-TB, affectedas countriesdescribed toin implement the Endlatest TBinternational Strategy,guidance therelated Stop TB Global Plan to EndTB; TB, their own national strategies and plans, other global efforts to control MDR-TB and XDR- TB.

``(i)``(5) Annualresearching Report on Tuberculosis Activities.--Not later than December 15 of each year until the goals specified in subsection (b)(1) are met, the President shall submit an annual report to the appropriate congressional committees that describes United States foreign assistance to control tuberculosis and thedeveloping impactinnovative ofdiagnostics, suchdrug efforts,therapies, including-- ``(1) the number of individuals with active tuberculosis disease that were diagnosed and treated,vaccines, including the rate of treatment completion and theprogram-based numberresearch; receiving patient support;

``(2)``(6) thesupport numberfor ofthe personsStop withTuberculosis MDR-TBPartnership's andGlobal XDR-TBDrug thatFacility, werethe diagnosedGlobal andAlliance treated,for includingTuberculosis theDrug rateDevelopment, ofand completion,other inorganizations countriespromoting receivingthe Uniteddevelopment Statesof bilateralnew foreignproducts assistanceand drugs for tuberculosisTB; control programs;

``(3)and the``(7) numbersensuring ofthat peopleTB trainedprograms bycan theserve Unitedas Stateskey Governmentplatforms infor tuberculosissupporting surveillancenational respiratory pandemic response against existing and control;new infectious respiratory disease.

``(4)``(h) Assistance for the numberWorld Health Organization and the Stop Tuberculosis Partnership.--In carrying out this section, the President, acting through the Administrator of individualsthe withUnited activeStates TBAgency diseasefor identifiedInternational asDevelopment, ais resultauthorized-- ``(1) to provide resources to the World Health Organization and the Stop Tuberculosis Partnership to improve the capacity of engagementcountries with thehigh privateburdens sectoror rates of TB and other nongovernmentalaffected partnerscountries into countriesimplement receivingthe UnitedEnd StatesTB bilateralStrategy, foreignthe assistanceStop forTB tuberculosisGlobal Plan to End TB, their own national strategies and plans, other global efforts to control programs;MDR-TB and XDR-TB;

``(5)and a``(2) descriptionto ofleverage the collaborationcontributions and coordination of Unitedother Statesdonors anti-tuberculosisfor efforts with the Worldactivities Healthdescribed Organization,in theparagraph Stop(1). TB Partnership, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and other major public and private entities;

``(6)``(i) aAnnual descriptionReport on TB Activities.--Not later than December 15 of each year until the collaborationearlier andof coordinationthe amongdate on which the Unitedgoals Statesspecified Agencyin forsubsection International(b)(2)(A) Developmentare andmet otheror Unitedthe Stateslast agencies,day includingof 2035, the CentersPresident forshall Diseasesubmit Controlan andannual Preventionreport to the appropriate congressional committees that describes United States foreign assistance to control TB and the Officeimpact of such efforts, including-- ``(1) the Globalnumber AIDSof Coordinator,individuals forwith active TB disease that were diagnosed and treated, including the purposesrate of combatingtreatment tuberculosis;completion and the number receiving patient support;

``(7)``(2) the constraintsnumber onof implementationpersons ofwith programsMDR-TB posedand byXDR-TB healththat workforcewere shortages,diagnosed healthand systemtreated, limitations,including otherthe componentsrate of successfulcompletion, implementation,in andcountries strategiesreceiving toUnited addressStates suchbilateral constraints;foreign assistance for TB control programs;

``(8)``(3) athe breakdownnumber of expenditurespeople fortrained patientby servicesthe supportingUnited TBStates diagnosis,Government treatment, and prevention, including procurement of drugs and other commodities, drug management, training in diagnosis and treatment, health systems strengthening that directly impacts provision of TB services,surveillance and research;control;

and``(4) ``(9) for each country receiving bilateral United States assistance for the purposenumber of tuberculosisindividuals prevention,with treatment,active andTB control--disease ``(A)identified as a descriptionresult of progressengagement towith adopt and implement the mostprivate recentsector Worldand Healthother Organizationnongovernmental guidelinespartners toin improvecountries diagnosis,receiving treatment,United andStates preventionbilateral offoreign tuberculosisassistance for adultsTB andcontrol children,programs; disaggregated by sex, including the proportion of health facilities that have adopted the latest World Health Organization guidelines on strengthening surveillance systems and preventative, diagnostic, and therapeutic methods, including the use of rapid diagnostic tests and orally administered tuberculosis treatment regimens;

``(B)``(5) thea numberdescription of adultsthe collaboration and childrencoordination receivingof tuberculosisUnited preventiveStates therapy,anti-TB includingefforts people with HIVthe andWorld allHealth closeOrganization, contacts,the disaggregatedStop byTB sexPartnership, and,the asGlobal possible,Fund incometo orFight wealthAIDS, quintile,Tuberculosis and theMalaria, establishmentand ofother effectivemajor tuberculosispublic infection control in all relevant congregant settings, including hospitals, clinics, and prisons;private entities;

``(C)``(6) a description of progressthe incollaboration implementingand measurescoordination toamong reducethe tuberculosisUnited incidence,States includingAgency actions--for ``(i)International toDevelopment expandand activeother caseUnited findingStates departments and contactagencies, tracingincluding tothe identifyCenters for Disease Control and reachPrevention vulnerableand groups;the Office of the Global AIDS Coordinator, for the purposes of combating TB;

and``(7) ``(ii)the toconstraints expandon tuberculosisimplementation preventiveof therapy,programs engagementposed ofby thehealth privateworkforce sector,shortages, health system limitations, barriers to digital health implementation, other challenges to successful implementation, and diagnosticstrategies capacity;to address such constraints;

``(D)``(8) a descriptionbreakdown of progressexpenditures tofor expandpatient diagnosis,services prevention,supporting andTB treatmentdiagnosis, fortreatment, alland formsprevention, of tuberculosis, including inprocurement pregnantof women,drugs children, and other high-riskcommodities, individualsdrug andmanagement, groupstraining atin greaterdiagnosis riskand oftreatment, TB,health includingsystems migrants,strengthening prisoners,that miners,directly peopleimpacts exposedthe toprovision silica,of andTB peopleservices, livingand withresearch; HIV/ AIDS, disaggregated by sex;

``(E)and ``(9) for each country, and when practicable, each project site receiving bilateral United States assistance for the ratepurpose of successfulTB completionprevention, treatment, and control-- ``(A) a description of tuberculosisprogress treatmenttoward the adoption and implementation of the most recent World Health Organization guidelines to improve diagnosis, treatment, and prevention of TB for adults and children, disaggregated by sex, including the proportion of health facilities that have adopted the latest World Health Organization guidelines on strengthening monitoring systems and preventative, diagnostic, and therapeutic methods, including the numberuse of individualsrapid receivingdiagnostic supporttests forand orally administered TB treatment completion;regimens;

``(F)``(B) the number of people,individuals disaggregatedscreened by sex, receiving treatment for MDR-TB,TB thedisease proportionand of those treated with the latestnumber regimensevaluated endorsedfor byTB theinfection Worldusing Healthactive Organization,case anyfinding factorsoutside impeding scale up of suchhealth treatment,facilities; and a description of progress to expand community-based MDR-TB care;

``(G)``(C) athe descriptionnumber of tuberculosisindividuals commoditywith procurementactive challenges,TB disease that were diagnosed and treated, including shortages,the stockouts,rate orof failedtreatment tenderscompletion forand tuberculosisthe drugsnumber orreceiving otherpatient commodities;support;

``(H)``(D) the proportionnumber of healthadults facilitiesand children, including people with specimenHIV referraland linkagesclose tocontacts, GeneXpertwho testingare sites,evaluated for TB infection, the number of adults and tochildren referencestarted labson treatment for secondTB lineinfection, drugand resistancethe testing,number of adults and achildren descriptioncompleting ofsuch thetreatment, turnarounddisaggregated timeby forsex testand, results;as possible, income or wealth quintile;

``(I)``(E) the numberestablishment of peopleeffective trainedTB byinfection thecontrol Unitedin Statesall Governmentrelevant tocongregant deliversettings, high-qualityincluding tuberculosishospitals, surveillance,clinics, laboratory services, prevention, treatment, and care;prisons;

``(J)``(F) a description of howprogress supportedin activitiesimplementing aremeasures coordinatedto with--reduce TB incidence, including actions-- ``(i) countryto nationalexpand TBactive planscase finding and strategies;contact tracing to reach vulnerable groups;

and ``(ii) tuberculosis control efforts supported by the Global Fund to Fightexpand AIDS,TB Tuberculosis,preventive andtherapy, Malaria,engagement andof other international assistance funds, including in the areasprivate ofsector, program development and implementation;diagnostic capacity;

and``(G) ``(K)a fordescription the first 3 years of theprogress reportto requiredexpand underdiagnosis, thisprevention, subsection,and atreatment sectionfor thatall describesforms the progress in recovering from the negative impact of COVID-19TB, on tuberculosis, including whetherin therepregnant haswomen, beenchildren, theand developmentindividuals and implementationgroups ofat agreater comprehensiverisk plan to ensure tuberculosis activities recover from diversion of resources,TB, theincluding continuedmigrants, useprisoners, ofminers, bidirectionalpeople TB-COVIDexposed testing,to silica, and progresspeople onliving increasedwith diagnosisHIV/AIDS, anddisaggregated treatmentby ofsex; active tuberculosis.

``(j)``(H) Annual Report on Tuberculosis Research and Development.--The President, acting through the Administratorrate of thesuccessful Unitedcompletion States Agency for International Development, and in coordination with the National Institutes of Health,TB thetreatment Centers for Diseaseadults Control and Prevention,children, thedisaggregated Biomedicalby Advancedsex, Research and Development Authority, the Foodnumber and Drug Administration, the National Science Foundation, and the Office of theindividuals Globalreceiving AIDSsupport Coordinator, shall submit an annual report to Congress that-- ``(1) describes current progress and challenges to the development of new tools for thetreatment purposecompletion; of tuberculosis prevention, treatment, and control;

``(2)``(I) identifiesthe criticalnumber gapsof andpeople, emergingdisaggregated prioritiesby sex, receiving treatment for researchMDR-TB, andthe development,proportion includingof forthose rapidtreated andwith point-of-carethe diagnostics,latest shortenedregimens treatmentsendorsed andby preventionthe methods,World Health Organization, factors impeding scale up of such treatment, and vaccines;a description of progress to expand community-based MDR-TB care;

``(J) a description of TB commodity procurement challenges, including shortages, stockouts, or failed tenders for TB drugs or other commodities;

``(K) the proportion of health facilities with specimen referral linkages to quality diagnostic networks, including established testing sites and reference labs, to ensure maximum access and referral for second line drug resistance testing, and a description of the turnaround time for test results;

``(L) the number of people trained by the United States Government to deliver high-quality TB diagnostic, preventative, monitoring, treatment, and care services;

``(M) a description of how supported activities are coordinated with-- ``(i) country national TB plans and strategies;

and ``(ii) TB control efforts supported by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and other international assistance programs and funds, including in the areas of program development and implementation;

and ``(N) for the first 3 years of the report required under this subsection, a description of the progress in recovering from the negative impact of COVID-19 on TB, including-- ``(i) whether there has been the development and implementation of a comprehensive plan to recover TB activities from diversion of resources;

``(ii) the continued use of bidirectional TB-COVID testing;

and ``(iii) progress on increased diagnosis and treatment of active TB.

``(j) Annual Report on TB Research and Development.--The President, acting through the Administrator of the United States Agency for International Development, and in coordination with the National Institutes of Health, the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, the National Science Foundation, and the Office of the Global AIDS Coordinator, shall submit an annual report to the appropriate congressional committees that-- ``(1) describes the current progress and challenges to the development of new tools for the purpose of TB prevention, treatment, and control;

``(2) identifies critical gaps and emerging priorities for research and development, including for rapid and point-of-care diagnostics, shortened treatments and prevention methods, telehealth solutions for prevention and treatment, and vaccines;

``(k) Evaluation Report.--Not later than 2 years after the date of the enactment of the End Tuberculosis Now Act of 2021,2022, and every 5 years thereafter until 2036,the last day of 2035, the Comptroller General of the United States shall submit a report to the appropriate congressional committees that evaluates the performance and impact on tuberculosisTB prevention, diagnosis, treatment, and care efforts that are supported by United States bilateral assistance funding, including recommendations for improving such programs.''.

<all>Calendar No.

601 117th CONGRESS 2d Session S.

3386 _______________________________________________________________________ A BILL To prevent, treat, and cure tuberculosis globally.

_______________________________________________________________________ December 7, 2022 Reported with an amendment