,,ii #aagth ,,congress #b;d ,session ,s4 #cdih ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #ac 7legislative day1 ,january #aj71 #bjbb,mr4 ,kelly 7for himself1 ,ms4 ,sinema1 and ,mrs4 ,feinstein7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to support endemic fungal disease research1 incentivize fungal vaccine development1 discover new antifungal therapies and diagnostics1 and for other purposes4 #a4 ,short title 7a7 ,in general ,this ,act may be cited as the ,finding ,orphan-disease ,remedies ,with ,antifungal ,research and ,development ,act of #bjbb or the ,,forward ,act of #bjbb4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,continuing support for research on endemic fungal diseases4,sec4 #c4 ,endemic fungal disease working group4,sec4 #d4 ,,fda guidance for industry on development of diagnostics and antifungal drugs and vaccines for ,valley ,fever4,sec4 #e4 ,priority review2 fast track product4,sec4 #f4 ,priority review vouchers for products for prevention or treatment of endemic fungal diseases4,sec4 #g4 ,combating antimicrobial resistance biopharmaceutical accelerator program4 #b4 ,continuing support for research on endemic fungal diseases ,the ,public ,health ,service ,act is amended by inserting after section #ddg;,c of such ,act 7#db ,u4,s4,c4 #bhe;f-#d7 the following new section3 #ddg;,d4 ,endemic fungal diseases 7a7 ,in general ,the ,director of the ,institute shall-- 7#a7 continue to conduct or support epidemiological1 basic1 translational1 and clinical research related to endemic fungal diseases1 including coccidioidomycosis 7commonly known as and referred to in this section as ,valley ,fever72 and 7#b7 subject to the availability of appropriations1 make grants to1 or enter into contracts with1 public or nonprofit private entities to conduct such research4 7b7 ,reports ,the ,director of the ,institute shall ensure that each triennial report under section #djc includes information on actions undertaken by the ,national ,institutes of ,health to carry out subsection 7a7 with respect to endemic fungal diseases1 including ,valley ,fever4 7c7 ,authorization of appropriations ,in addition to other amounts available for the purposes of carrying out this section1 there is authorized to be appropriated to carry out this section #bj1jjj1jjj for each of fiscal years #bjbb through #bjbf for such purpose4 4 #c4 ,endemic fungal disease working group 7a7 ,establishment ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish a working group1 to be known as the ,endemic ,fungal ,disease ,working ,group 7referred to in this section as the ,working ,group71 comprised of representatives of appropriate ,federal agencies and other non-,federal entities-- 7#a7 to provide expertise and to review all efforts within the ,department of ,health and ,human ,services related to endemic fungal disease2 7#b7 to help ensure interagency coordination and minimize overlap with respect to such disease2 and 7#c7 to examine research priorities with respect to such disease4 7b7 ,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-- 7,a7 ongoing endemic fungal disease research1 including research related to causes1 prevention1 treatment1 surveillance1 diagnosis1 diagnostics1 duration of illness1 and intervention for individuals with an endemic fungal disease2 7,b7 advances made pursuant to such research2 7,c7 the impact of viral respiratory illnesses1 including ,,covid-#ai1 and fungal lung diseases and pneumonias2 7,d7 ,federal activities related to endemic fungal disease1 including-- 7i7 epidemiological activities related to endemic fungal disease2 and 7ii7 basic1 clinical1 and translational endemic fungal disease research related to the pathogenesis1 prevention1 diagnosis1 and treatment of endemic fungal disease2 7,e7 gaps in endemic fungal disease research described in subparagraph 7,d77ii72 7,f7 the ,working ,group's meetings required under subsection 7d72 and 7,g7 the comments received by the ,working ,group2 7#b7 make recommendations to the ,secretary1 including a proposed strategy related to development of therapeutics and vaccines1 regarding any appropriate changes or improvements to such activities described in paragraph 7#a72 and 7#c7 in implementing this subsection1 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 7c7 ,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 7,a7 ,the ,office of the ,assistant ,secretary for ,health4 7,b7 ,the ,food and ,drug ,administration4 7,c7 ,the ,centers for ,disease ,control and ,prevention4 7,d7 ,the ,national ,institutes of ,health4 7,e7 ,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 7,a7 ,physicians and other medical providers with experience in diagnosing and treating endemic fungal disease4 7,b7 ,scientists or researchers with expertise4 7,c7 ,patients and their family members4 7,d7 ,nonprofit organizations that advocate for patients with respect to endemic fungal disease4 7,e7 ,other individuals whose expertise is determined by the ,secretary to be beneficial to the functioning of the ,working ,group4 7d7 ,meetings ,the ,working ,group shall meet annually4 7e7 ,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 subsection 7g71 the ,working ,group shall-- 7#a7 submit a report on its activities under subsection 7b77#a7 and any recommendations under paragraph 7b77#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 website of the ,department of ,health and ,human ,services4 7f7 ,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 7g7 ,sunset ,the ,working ,group under this section shall terminate #e years after the date of enactment of this ,act4 7h7 ,endemic fungal disease defined ,in this section1 the term endemic fungal disease means blastomycosis1 coccidioidomycosis1 histoplasmosis1 and sparotrichosis4 #d4 ,,fda guidance for industry on development of diagnostics and antifungal drugs and vaccines for ,valley ,fever 7a7 ,draft guidance ,not later than #b years after the date of 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 ,final guidance ,not later than #ah months after the close of the public comment period on the draft guidance issued pursuant to subsection 7a71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall finalize the draft guidance4 7c7 ,workshops2 good guidance practices ,in developing and issuing the guidance required by this section1 the ,secretary of ,health and ,human ,services shall hold at least #b public workshops4 #e4 ,priority review2 fast track product 7a7 ,priority review 7#a7 ,in general ,section #ebd;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is amended by striking then the ,secretary shall give priority review to the first application submitted for approval for such drug under section #eje7;b7 and inserting or if the drug is a biological product intended to treat coccidioidomycosis1 then the ,secretary shall give priority review to the first application submitted for approval for such drug under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act4 7#b7 ,applicability ,the amendment made by paragraph 7#a7 applies only to any application submitted under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 on or after the date of enactment of this ,act4 7b7 ,fast track product ,section #ejf7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;b77#a77 is amended by striking or if the ,secretary designates the drug as a qualified infectious disease product under section #eje;,e7d7 and inserting 1 if the ,secretary designates the drug as a qualified infectious disease product under section #eje;,e7d71 or if the drug is a biological product intended to treat coccidioidomycosis4 #f4 ,priority review vouchers for products for prevention or treatment of endemic fungal diseases ,section #ebd7;a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a77#c77 is amended-- 7#a7 by redesignating subparagraph 7,s7 as subparagraph 7,t72 and 7#b7 by inserting after subparagraph 7,r7 the following3 7,s7 ,coccidioidomycosis4 4 #g4 ,combating antimicrobial resistance biopharmaceutical accelerator program ,paragraph 7#d7 of section #cai,l7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77 is amended by adding at the end the following3 7,g7 ,combating antimicrobial resistance biopharmaceutical accelerator program 7i7 ,in general ,the ,secretary1 acting through the ,director of ,,barda1 shall implement strategic initiatives1 to be known as the ,combating ,antimicrobial ,resistance ,biopharmaceutical ,accelerator ,program1 including by building on existing programs and by awarding contracts1 grants1 and cooperative agreements1 or entering into other transactions-- 7,i7 to optimize the use of antimicrobials in human and animal health settings2 7,,ii7 to support innovative candidate products in preclinical and clinical development that reduce antimicrobial resistance2 and 7,,iii7 to support research with respect to infection prevention and control to slow the spread of resistant bacteria1 fungi1 and viruses4 7ii7 ,references ,except as otherwise specified1 any reference to the ,combating ,antibiotic ,resistant ,bacteria ,biopharmaceutical ,accelerator or the ,,carb-,x program in any statute1 ,executive order1 rule1 regulation1 directive1 or other ,federal document is deemed to be a reference to the ,combating ,antimicrobial ,resistance ,biopharmaceutical ,accelerator ,program under this subparagraph4 7iii7 ,authorization of appropriations 7,i7 ,in general ,to carry out the program under clause 7i71 there is authorized to be appropriated #ejj1jjj1jjj for the period of fiscal years #bjbb through #bjbf1 to remain available until expended4 7,,ii7 ,requirement ,of the amounts made available to carry out the program under clause 7i7 for the period of fiscal years #bjbb through #bjbf1 not less than #aj percent shall be used to support antifungal product development4 4