,i #aaeth ,,congress #b;d ,session ,h4 ,r4 #fefb ,,in ,,the ,,house ,,of ,,representatives ,july #bf1 #bjah,mr4 ,mc,carthy 7for himself1 ,mr4 ,schweikert1 ,ms4 ,bass1 ,ms4 ,sinema1 and ,ms4 ,mc,sally7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to support endemic orphan fungal disease research1 incentivize ,valley ,fever vaccine development1 discover new antifungal therapies and diagnostics1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,in general ,this ,act may be cited as the ,finding ,orphan-disease ,remedies ,with ,antifungal ,research and ,development ,act of #bjah or the ,,forward ,act of #bjah4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,findings4 ,sec4 #c4 ,continuing support for research on endemic orphan fungal diseases4 ,sec4 #d4 ,endemic orphan fungal disease ,federal-,state match pilot program4 ,sec4 #e4 ,,fda guidance for industry on development of diagnostics and antifungal drugs and vaccines for ,valley ,fever4 ,sec4 #f4 ,including antifungal biological products as qualified infectious disease products4 ,sec4 #g4 ,priority review to encourage treatments for endemic orphan fungal diseases4 ,sec4 #h4 ,including antifungal products in the ,,carb-,x program4 ,sec4 #i4 ,blockchain pilot program for hospital data security for coccidioidomycosis research4 #b4 ,findings ,congress finds the following3 7#a7 ,worldwide fungal infections1 such as candidiasis1 cryptococcosis1 and aspergillosis1 often pose fatal opportunistic threats to immunologically impaired persons4 7#b7 ,endemic fungal infections1 such as histoplasmosis1 coccidioidomycosis1 and blastomycosis1 occur in certain geographic regions worldwide1 including in the ,united ,states1 and are acquired through exposure to the environment4 7#c7 ,because the endemic mycoses referred to in paragraph 7#b7 are regional1 such endemic mycoses do not receive the same amount of resources as mycoses of worldwide distribution1 even though within the regions in which they are endemic such strains pose significant public health threats4 7#d7 ,coccidioidomycosis1 also known as ,valley ,fever1 is a fungal infection acquired by the inhalation of spores of certain fungi primarily found in the soil endemic to the ,american ,southwest1 including in ,arizona1 ,california1 ,nevada1 ,new ,mexico1 ,texas1 ,utah1 and ,washington4 7#e7 ,according to the ,morbidity and ,mortality ,weekly ,report issued by the ,centers for ,disease ,control and ,prevention and dated ,august #aa1 #bjag-- 7,a7 #ig percent of the all reported cases of ,valley ,fever occurred in ,california and ,arizona2 7,b7 individuals at increased risk for severe ,valley ,fever include persons of ,african or ,filipino descent1 pregnant women1 adults in older age groups1 and other individuals with weakened immune systems2 7,c7 the overall incident rate of ,valley ,fever peaked in #bjaa and again in #bjaf2 7,d7 in ,california1 the ,valley ,fever incident rate for #bjaf was the highest recorded to date1 with #db percent of cases reported coming from ,kern ,county2 and 7,e7 the reason for increases in ,valley ,fever cases reported in ,california in #bjaf is not known4 7#f7 ,valley ,fever illness ranges from influenza-like symptoms to life-threatening when the infection spreads to other parts of the body1 including the brain4 7#g7 ,the overall estimated impact of ,valley ,fever is less than #bjj1jjj people in the ,united ,states1 with roughly #bjj deaths each year and over #aa1jjj new cases identified in #bjaf4 ,the estimated economic impact to the ,united ,states is at least #ejj1jjj1jjj from hospital1 outpatient1 and lost productivity costs4 7#h7 ,in the past #fj years1 only #d classes of antifungal compounds have been approved by the ,food and ,drug ,administration for treatment for all fungal infections4 7#i7 ,existing antifungal therapies often do not cure the fungal infection involved because1 similar to how bacteria have become resistant to antibiotic therapies1 some fungi no longer respond to the current limited antifungal therapies that are designed to treat them4 7#aj7 ,coccidioides1 the cause of ,valley ,fever1 is not cured by any available drug4 7#aa7 ,although antibiotic-resistant bacterial infections are a widely recognized public health threat1 less is known about the effects of antifungal resistance and the burden of drug-resistant fungal infections4 7#ab7 ,fungal infections are a rising threat to public health and the resistance to current antifungal therapies will only complicate the ,nation's response in the event of a public health emergency4 #c4 ,continuing support for research on endemic orphan fungal diseases 7a7 ,in general ,subtitle ,f of title ,,ii of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended by inserting after section #bjfb 7#db ,u4,s4,c4 #bhds7 the following new section3 #bjfb;,a4 ,endemic orphan fungal diseases 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall continue to conduct or support epidemiological1 basic1 translational1 and clinical research related to endemic orphan fungal diseases1 including coccidioidomycosis 7commonly known as and referred to in this section as ,valley ,fever74 7b7 ,reports ,the ,secretary shall ensure that each triennial report under section #djc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7 includes information on actions undertaken by the ,national ,institutes of ,health to carry out subsection 7a7 with respect to endemic orphan fungal diseases1 including ,valley ,fever4 7c7 ,valley ,fever ,working ,group 7#a7 ,establishment ,the ,secretary shall establish a working group1 to be known as the ,valley ,fever ,working ,group 7referred to in this section as the ,working ,group71 comprised of representatives of appropriate ,federal agencies and other non-,federal entities1 to provide expertise and to review all efforts within the ,department of ,health and ,human ,services related to ,valley ,fever1 to help ensure interagency coordination and minimize overlap1 and to examine research priorities4 7#b7 ,responsibilities ,the ,working ,group shall-- 7,a7 not later than #b years after the date of enactment of this ,act1 develop or update a summary of-- 7i7 ongoing ,valley ,fever research1 including research related to causes1 prevention1 treatment1 surveillance1 diagnosis1 diagnostics1 duration of illness1 and intervention for individuals with ,valley ,fever2 7ii7 advances made pursuant to such research2 7iii7 ,federal activities related to ,valley ,fever1 including-- 7,i7 epidemiological activities related to ,valley ,fever2 and 7,,ii7 basic1 clinical1 and translational ,valley ,fever research related to the pathogenesis1 prevention1 diagnosis1 and treatment of ,valley ,fever2 7iv7 gaps in ,valley ,fever research described in clause 7iii77,,ii72 7v7 the ,working ,group's meetings required under paragraph 7#d72 and 7vi7 the comments received by the ,working ,group2 7,b7 make recommendations to the ,secretary regarding any appropriate changes or improvements to such activities and research2 and 7,c7 solicit input from ,states1 localities1 and nongovernmental entities1 including organizations representing patients1 health care providers1 researchers1 and industry regarding scientific advances1 research questions1 and surveillance activities4 7#c7 ,membership ,the members of the ,working ,group shall represent a diversity of scientific disciplines and views and shall be composed of the following members3 7,a7 ,federal members ,seven ,federal members1 consisting of one or more representatives of each of the following3 7i7 ,the ,office of the ,assistant ,secretary for ,health4 7ii7 ,the ,food and ,drug ,administration4 7iii7 ,the ,centers for ,disease ,control and ,prevention4 7iv7 ,the ,national ,institutes of ,health4 7v7 ,such other agencies and offices of the ,department of ,health and ,human ,services as the ,secretary determines appropriate4 7,b7 ,non-,federal public members ,seven non-,federal public members1 consisting of representatives of the following categories3 7i7 ,physicians and other medical providers with experience in diagnosing and treating ,valley ,fever4 7ii7 ,scientists or researchers with expertise4 7iii7 ,patients and their family members4 7iv7 ,nonprofit organizations that advocate for patients with respect to ,valley ,fever4 7v7 ,other individuals whose expertise is determined by the ,secretary to be beneficial to the functioning of the ,working ,group4 7#d7 ,meetings ,the ,working ,group shall meet annually4 7#e7 ,reporting ,not later than #b years after the date of enactment of this ,act1 and every #b years thereafter until termination of the ,working ,group pursuant to paragraph 7#g71 the ,working ,group shall-- 7,a7 submit a report on its activities under paragraph 7#b77;,a7 and any recommendations under paragraph 7#b77;,b7 to the ,secretary1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 and 7,b7 make such report publicly available on the internet website of the ,department of ,health and ,human ,services4 7#f7 ,applicability of ,,faca ,the ,working ,group shall be treated as an advisory committee subject to the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app474 7#g7 ,sunset ,the ,working ,group under this section shall terminate #e years after the date of enactment of this ,act4 7d7 ,endemic orphan fungal disease defined ,the term endemic orphan fungal disease has the meaning given such term in section #ebi;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 7b7 ,conforming table of contents amendment ,section #a7;b7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended in the table of contents1 by inserting after the item relating to section #bjfb the following3 ,sec4 #bjfb;,a4 ,endemic orphan fungal diseases4 4 #d4 ,endemic orphan fungal disease ,federal-,state match pilot program 7a7 ,in general ,for each of fiscal years #bjai through #bjbd1 the ,secretary of ,health and ,human ,services shall1 subject to the availability of appropriations1 award grants through a competitive process to eligible entities to conduct research with respect to endemic orphan fungal diseases1 including coccidioidomycosis4 7b7 ,eligibility ,an entity eligible to receive a grant under this section is a ,state or local public hospital1 an institution of higher education 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja771 or a nonprofit organization that has been provided funds from ,state or local government sources for epidemiological1 basic1 translational1 and clinical research on endemic orphan fungal diseases during the #c-year period ending on the date of the enactment of this ,act4 7c7 ,application ,an entity seeking a grant under this section shall submit an application to the ,secretary-- 7#a7 in such form and manner as the ,secretary shall prescribe2 7#b7 that contains a certification that the entity has received the funds described in subsection 7b7 and that specifies the amount of such funds2 and 7#c7 that contains such other information as the ,secretary may require4 7d7 ,amount of grant ,the amount of a grant under this section shall equal 7to the extent practicable7 the amount of funds received from ,state or local government sources for the research that is the subject of the grant4 7e7 ,endemic orphan fungal disease defined ,the term endemic orphan fungal disease has the meaning given such term in section #ebi;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #g4 7f7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #h1jjj1jjj for each of fiscal years #bjai through #bjbd1 to remain available until expended4 7g7 ,sunset ,the ,secretary may not award grants under this section on or after ,october #a1 #bjbd4 #e4 ,,fda guidance for industry on development of diagnostics and antifungal drugs and vaccines for ,valley ,fever 7a7 ,in general ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue draft guidance for industry for the purposes of assisting entities seeking approval under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 of antifungal therapies1 diagnostics1 or vaccines1 specifically therapies1 diagnostics1 and vaccines designed to diagnose1 treat1 or prevent coccidioidomycosis 7commonly known as ,valley ,fever74 7b7 ,consultation ,in developing the draft guidance under subsection 7a71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall consult with institutions of higher education 7as defined in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja771 researchers1 and other relevant stakeholders4 7c7 ,final guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall finalize the draft guidance issued under subsection 7a7 not later than #b years after the date of the enactment of this ,act4 #f4 ,including antifungal biological products as qualified infectious disease products 7a7 ,in general ,section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 7or1 pursuant to section #cea of the ,public ,health ,service ,act1 in the case of an antifungal biological product7 after pursuant to section #eje for a drug2 and 7,b7 by striking or the #g-year period described in section #ebg1 and inserting the #g-year period described in section #ebg1 or1 in the case of an antifungal biological product1 the #ab-year period under section #cea7k7 of the ,public ,health ,service ,act12 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by inserting or1 in the case of an antifungal biological product1 section #cea7;a7 of the ,public ,health ,service ,act after #eje7;b72 and 7,b7 in paragraph 7#b71 by inserting or1 in the case of an antifungal biological product1 section #cea of the ,public ,health ,service ,act after #eje2 7#c7 in subsection 7d77#a7 by inserting or1 in the case of an antifungal biological product1 section #cea7;a7 of the ,public ,health ,service ,act after #eje7;b72 and 7#d7 in subsection 7g71 in the matter preceding paragraph 7#a7-- 7,a7 by inserting 7including antifungal biological products7 after antifungal drug2 and 7,b7 by inserting or prevent after treat4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply with respect to applications for the approval of biological products under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 submitted on or after the date of the enactment of this ,act4 7c7 ,updated guidance ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall update ,qualified ,infectious ,disease ,product ,designation ,questions and ,answers ,guidance for ,industry issued in ,january #bjah1 to implement the amendments made by subsection 7a74 #g4 ,priority review to encourage treatments for endemic orphan fungal diseases ,subchapter ,b of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is amended by adding at the end the following new section3 #ebi;,b4 ,priority review to encourage treatments for endemic orphan fungal diseases 7a7 ,definitions ,in this section3 7#a7 ,endemic orphan fungal disease ,the term endemic orphan fungal disease means a disease1 such as coccidioidomycosis1 that-- 7,a7 is caused by a fungus2 7,b7 primarily occurs in certain limited geographic regions2 and 7,c7 is a rare disease or condition 7as that term is defined in section #ebf7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7a77#b7774 7#b7 ,endemic orphan fungal disease drug application ,the term endemic orphan fungal disease drug application means an application that-- 7,a7 is a human drug application for a drug intended for use-- 7i7 to prevent or treat harm from an endemic orphan fungal disease2 or 7ii7 to cure an endemic orphan fungal disease2 7,b7 the ,secretary determines eligible for priority review2 7,c7 is approved after the date of enactment of this section2 and 7,d7 is for a human drug1 no active ingredient 7including any ester or salt of the active ingredient7 of which has been approved in any other application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act4 7#c7 ,human drug application ,the term human drug application has the meaning given such term in section #gce7a74 7#d7 ,priority review ,the term priority review1 with respect to a human drug application1 means review and action by the ,secretary on such application not later than #f months after receipt by the ,secretary of such application1 as described in the ,manual of ,policies and ,procedures in the ,food and ,drug ,administration and goals identified in the letters described in section #aja7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act4 7#e7 ,priority review voucher ,the term priority review voucher means a voucher issued by the ,secretary to the sponsor of an endemic orphan fungal disease drug application that entitles the holder of such voucher to priority review of a single human drug application submitted under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act after the date of approval of the endemic orphan fungal disease drug application4 7b7 ,priority ,review ,voucher 7#a7 ,in general ,the ,secretary shall award a priority review voucher to the sponsor of an endemic orphan fungal disease drug application upon approval by the ,secretary of such endemic orphan fungal disease drug application4 7#b7 ,transferability ,the sponsor of a endemic orphan fungal disease drug application that receives a priority review voucher under this section may transfer 7including by sale7 the entitlement to such voucher to a sponsor of a human drug for which an application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act will be submitted after the date of the approval of the endemic orphan fungal disease drug application4 ,there is no limit on the number of times a priority review voucher may be transferred before such voucher is used4 7#c7 ,notification 7,a7 ,in general ,the sponsor of a human drug application shall notify the ,secretary not later than #ij calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application1 including the date on which the sponsor intends to submit the application4 ,such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section4 7,b7 ,transfer after notice ,the sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph 7,a7 may transfer the voucher after such notification is provided1 if such sponsor has not yet submitted the human drug application described in the notification4 7c7 ,priority ,review ,user ,fee 7#a7 ,in general ,the ,secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the ,secretary a fee determined under paragraph 7#b74 ,such fee shall be in addition to any fee required to be submitted by the sponsor under chapter ,,vii4 7#b7 ,fee amount ,the amount of the priority review user fee shall be determined each fiscal year by the ,secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year4 7#c7 ,annual fee setting ,the ,secretary shall establish1 before the beginning of each fiscal year beginning after ,september #cj1 #bjai1 for that fiscal year1 the amount of the priority review user fee4 7#d7 ,payment 7,a7 ,in general ,the priority review user fee required by this subsection shall be due upon the submission of a human drug application under section #eje7;b77#a7 or section #cea7;a7 of the ,public ,health ,service ,act for which the priority review voucher is used4 7,b7 ,complete application ,an application described under subparagraph 7,a7 for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the ,secretary's procedures for paying such fees4 7,c7 ,no waivers1 exemptions1 reductions1 or refunds ,the ,secretary may not grant a waiver1 exemption1 reduction1 or refund of any fees due and payable under this section4 7#e7 ,offsetting collections ,fees collected pursuant to this subsection for any fiscal year-- 7,a7 shall be deposited and credited as offsetting collections to the account providing appropriations to the ,food and ,drug ,administration2 and 7,b7 shall not be collected for any fiscal year except to the extent provided in advance in appropriation ,acts4 7d7 ,notice of ,issuance of ,voucher and ,approval of ,products ,under ,voucher ,the ,secretary shall publish a notice in the ,federal ,register and on the ,internet website of the ,food and ,drug ,administration not later than #cj calendar days after the occurrence of each of the following3 7#a7 ,the ,secretary issues a priority review voucher under this section4 7#b7 ,the ,secretary approves a drug pursuant to an application submitted under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act for which the sponsor of the application used a priority review voucher issued under this section4 7e7 ,eligibility for ,other ,programs ,nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program1 including under this ,act1 except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this ,act with respect to such drug4 7f7 ,relation to ,other ,provisions ,the provisions of this section shall supplement1 not supplant1 any other provisions of this ,act or the ,public ,health ,service ,act that encourage the development of medical countermeasures4 7g7 ,sunset ,the ,secretary may not award any priority review vouchers under subsection 7b7 after ,october #a1 #bjbd4 4 #h4 ,including antifungal products in the ,,carb-,x program 7a7 ,in general ,the ,secretary of ,health and ,human ,services shall1 in carrying out the ,combating ,antibiotic ,resistant ,bacteria ,accelerator program of the ,department of ,health and ,human ,services 7commonly referred to as ,,carb-,x71 conduct research with respect to antifungal resistance1 including therapies1 diagnostics1 and vaccines1 including for coccidioidomycosis4 7b7 ,authorization of appropriations ,there are authorized to be appropriated to the ,biodefense ,medical ,countermeasure ,development ,fund established under section #cai,l7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7d77 to carry out subsection 7a7 #aj1jjj1jjj for each of fiscal years #bjai through #bjbd1 to remain available until expended4 #i4 ,blockchain pilot program for hospital data security for coccidioidomycosis research ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following new section3 #djd,o4 ,blockchain pilot program for hospital data security for coccidioidomycosis research 7a7 ,in general ,the ,director of ,,nih shall carry out a pilot program to conduct1 support1 and facilitate auditable research on coccidioidomycosis 7commonly referred to as ,valley ,fever74 ,in carrying out such program1 the ,director shall-- 7#a7 award a grant to an eligible entity to install a blockchain on the servers of1 or otherwise provide blockchain services to1 the ,national ,institutes of ,health1 and provide support with respect to such a blockchain1 which shall contain public1 unalterable data which includes every query made through the procedure established under subsection 7c71 as well as the identity of the individual who asked such a question1 without disclosing the results of such queries2 7#b7 award a grant to an eligible entity-- 7,a7 to provide to not less than #c qualified hospitals qualified software2 and 7,b7 to provide customer service to each such hospital with respect to such qualified software or any associated service2 7#c7 provide to such qualified hospitals any necessary hardware in accordance with subsection 7e72 and 7#d7 award grants to eligible entities to test the cybersecurity of such qualified hospitals by attempting to attack simulated data on the servers of such hospitals4 7b7 ,eligible entities2 application ,the ,director of ,,nih shall determine whether an entity is eligible to receive a grant under this section and shall select hospitals to be qualified hospitals for purposes of this section4 ,an entity seeking a grant under this section1 and a hospital seeking to be so selected1 shall submit to the ,director of ,,nih an application in such form and manner and containing such information as the ,director of ,,nih may specify4 7c7 ,data queries ,the ,director of ,,nih shall establish1 for purposes of allowing researchers to process data from a qualified hospital's servers pursuant to this section1 a procedure to determine-- 7#a7 who can ask queries of the servers2 7#b7 which data the hospital must include on such servers2 and 7#c7 which questions may be asked of such servers1 and what form of de-identification of the servers' data is required to ensure privacy4 7d7 ,request for proposals ,not later than #ij days after the date of the enactment of this section1 the ,director of ,,nih shall publish in the ,federal ,register a request for proposals for grants under paragraphs 7#a71 7#b71 and 7#d7 of subsection 7a74 7e7 ,provision of servers 7#a7 ,in general ,the ,director of ,,nih shall1 in carrying out subsection 7a77#c71 provide to qualified hospitals hardware1 including computer servers1 sufficient to support qualified software4 7#b7 ,condition ,as a condition on the receipt of a computer server under paragraph 7#a71 a qualified hospital shall agree not to use the qualified software on the server to store data from patients of the hospital until the ,director of ,,nih determines that testing performed pursuant to subsection 7a77#d7 has determined that simulated data used in such software could not be extracted from the hospital's servers4 7f7 ,definitions ,in this section3 7#a7 ,the term blockchain means software that uses a distributed digital ledger of cryptographically signed transactions that are grouped into blocks1 each of which-- 7,a7 is cryptographically linked to the previous block after validation and undergoing a consensus decision2 and 7,b7 when added as a new block1 makes any older blocks more difficult to modify and is replicated across all copies of the ledger within the relevant network1 with any conflicts in such blocks resolved automatically using established rules4 7#b7 ,the term qualified hospital means a hospital that is located in a region in which coccidioidomycosis is endemic4 7#c7 ,the term qualified software means software that uses secure multiparty encrypted computing to allow researchers to perform computations on encrypted data supplied by qualified hospitals4 7#d7 ,the term secure multiparty encrypted computing means a form of cryptography in which parties can jointly compute a function of inputs while keeping those inputs private from each other1 and from all other parties1 such as multiparty homomorphic encryption1 threshold encryption1 and secure multiparty computation4 7g7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section #e1jjj1jjj for fiscal year #bjbj1 to remain available until expended4 4