FORWARD Act of 2019

II 116TH CONGRESS 1ST SESSION S. 1567 To support endemic fungal disease research, incentivize fungal vaccine devel- opment, discover new antifungal therapies and diagnostics, and for other purposes. IN THE SENATE OF THE UNITED STATES MAY 21, 2019 Ms. MCSALLY (for herself and Ms. SINEMA) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) IN GENERAL.—This Act may be cited as the 4 ‘‘Finding Orphan-disease Remedies With Antifungal Re- 5 search and Development Act of 2019’’ or the ‘‘FOR- 6 WARD Act of 2019’’. 7 (b) TABLE OF CONTENTS.—The table of contents for 8 this Act is as follows: 9 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 2 •S 1567 IS Sec. 1. Short title; table of contents. Sec. 2. Continuing support for research on endemic fungal diseases. Sec. 3. Endemic fungal disease Federal-State match pilot program. Sec. 4. FDA guidance for industry on development of diagnostics and antifungal drugs and vaccines for Valley Fever. Sec. 5. Priority review; fast track product. Sec. 6. Priority review vouchers for products for prevention or treatment of en- demic fungal diseases. Sec. 7. Establishment of antifungal resistance research program modeled on the CARB–X program. Sec. 8. Blockchain pilot program for hospital data security for endemic fungal disease research. SEC. 2. CONTINUING SUPPORT FOR RESEARCH ON EN- 1 DEMIC FUNGAL DISEASES. 2 The Public Health Service Act is amended by insert- 3 ing after section 320A of such Act (42 U.S.C. 247d–8) 4 the following new section: 5 ‘‘SEC. 320B. ENDEMIC FUNGAL DISEASES. 6 ‘‘(a) IN GENERAL.—The Secretary shall continue to 7 conduct or support epidemiological, basic, translational, 8 and clinical research related to endemic fungal diseases, 9 including coccidioidomycosis (commonly known as and re- 10 ferred to in this section as ‘Valley Fever’). 11 ‘‘(b) REPORTS.—The Secretary shall ensure that 12 each triennial report under section 403 includes informa- 13 tion on actions undertaken by the National Institutes of 14 Health to carry out subsection (a) with respect to endemic 15 fungal diseases, including Valley Fever. 16 ‘‘(c) ENDEMIC FUNGAL DISEASE WORKING 17 GROUP.— 18 ‘‘(1) ESTABLISHMENT.—The Secretary shall es- 19 tablish a working group, to be known as the En- 20 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 3 •S 1567 IS demic Fungal Disease Working Group (referred to 1 in this section as the ‘Working Group’), comprised 2 of representatives of appropriate Federal agencies 3 and other non-Federal entities— 4 ‘‘(A) to provide expertise and to review all 5 efforts within the Department of Health and 6 Human Services related to endemic fungal dis- 7 ease; 8 ‘‘(B) to help ensure interagency coordina- 9 tion and minimize overlap with respect to such 10 disease; and 11 ‘‘(C) to examine research priorities with re- 12 spect to such disease. 13 ‘‘(2) RESPONSIBILITIES.—The Working Group 14 shall— 15 ‘‘(A) not later than 2 years after the date 16 of enactment of the FORWARD Act of 2019, 17 develop or update a summary of— 18 ‘‘(i) ongoing endemic fungal disease 19 research, including research related to 20 causes, prevention, treatment, surveillance, 21 diagnosis, diagnostics, duration of illness, 22 and intervention for individuals with an 23 endemic fungal disease; 24 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 4 •S 1567 IS ‘‘(ii) advances made pursuant to such 1 research; 2 ‘‘(iii) Federal activities related to en- 3 demic fungal disease, including— 4 ‘‘(I) epidemiological activities re- 5 lated to endemic fungal disease; and 6 ‘‘(II) basic, clinical, and 7 translational endemic fungal disease 8 research related to the pathogenesis, 9 prevention, diagnosis, and treatment 10 of endemic fungal disease; 11 ‘‘(iv) gaps in endemic fungal disease 12 research described in clause (iii)(II); 13 ‘‘(v) the Working Group’s meetings 14 required under paragraph (4); and 15 ‘‘(vi) the comments received by the 16 Working Group; 17 ‘‘(B) make recommendations to the Sec- 18 retary regarding any appropriate changes or 19 improvements to such activities and research; 20 and 21 ‘‘(C) solicit input from States, localities, 22 and nongovernmental entities, including organi- 23 zations representing patients, health care pro- 24 viders, researchers, and industry regarding sci- 25 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 5 •S 1567 IS entific advances, research questions, and sur- 1 veillance activities. 2 ‘‘(3) MEMBERSHIP.—The members of the 3 Working Group shall represent a diversity of sci- 4 entific disciplines and views and shall be composed 5 of the following members: 6 ‘‘(A) FEDERAL MEMBERS.—Seven Federal 7 members, consisting of one or more representa- 8 tives of each of the following: 9 ‘‘(i) The Office of the Assistant Sec- 10 retary for Health. 11 ‘‘(ii) The Food and Drug Administra- 12 tion. 13 ‘‘(iii) The Centers for Disease Control 14 and Prevention. 15 ‘‘(iv) The National Institutes of 16 Health. 17 ‘‘(v) Such other agencies and offices 18 of the Department of Health and Human 19 Services as the Secretary determines ap- 20 propriate. 21 ‘‘(B) NON-FEDERAL PUBLIC MEMBERS.— 22 Seven non-Federal public members, consisting 23 of representatives of the following categories: 24 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 6 •S 1567 IS ‘‘(i) Physicians and other medical pro- 1 viders with experience in diagnosing and 2 treating endemic fungal disease. 3 ‘‘(ii) Scientists or researchers with ex- 4 pertise. 5 ‘‘(iii) Patients and their family mem- 6 bers. 7 ‘‘(iv) Nonprofit organizations that ad- 8 vocate for patients with respect to endemic 9 fungal disease. 10 ‘‘(v) Other individuals whose expertise 11 is determined by the Secretary to be bene- 12 ficial to the functioning of the Working 13 Group. 14 ‘‘(4) MEETINGS.—The Working Group shall 15 meet annually. 16 ‘‘(5) REPORTING.—Not later than 2 years after 17 the date of enactment of the FORWARD Act of 18 2019, and every 2 years thereafter until termination 19 of the Working Group pursuant to paragraph (7), 20 the Working Group shall— 21 ‘‘(A) submit a report on its activities under 22 paragraph (2)(A) and any recommendations 23 under paragraph (2)(B) to the Secretary, the 24 Committee on Energy and Commerce of the 25 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 7 •S 1567 IS House of Representatives, and the Committee 1 on Health, Education, Labor, and Pensions of 2 the Senate; and 3 ‘‘(B) make such report publicly available 4 on the internet website of the Department of 5 Health and Human Services. 6 ‘‘(6) APPLICABILITY OF FACA.—The Working 7 Group shall be treated as an advisory committee 8 subject to the Federal Advisory Committee Act (5 9 U.S.C. App.). 10 ‘‘(7) SUNSET.—The Working Group under this 11 section shall terminate 5 years after the date of en- 12 actment of the FORWARD Act of 2019. 13 ‘‘(d) ENDEMIC FUNGAL DISEASE DEFINED.—In this 14 section, the term ‘endemic fungal disease’ means blasto- 15 mycosis, coccidioidomycosis, histoplasmosis, and 16 sparotrichosis.’’. 17 SEC. 3. ENDEMIC FUNGAL DISEASE FEDERAL-STATE 18 MATCH PILOT PROGRAM. 19 (a) IN GENERAL.— 20 (1) GRANTS.—For each of fiscal years 2021 21 through 2025, the Secretary of Health and Human 22 Services shall, subject to the availability of appro- 23 priations, award grants through a competitive proc- 24 ess to eligible entities to conduct research with re- 25 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 8 •S 1567 IS spect to endemic fungal diseases, including coccidioi- 1 domycosis. 2 (2) PEER REVIEW.—Any research supported 3 under this section shall be subject to peer review in 4 accordance with the requirements applicable to re- 5 search supported by the National Institutes of 6 Health under section 492 of the Public Health Serv- 7 ice Act (42 U.S.C. 289a). 8 (b) ELIGIBILITY.—An entity eligible to receive a 9 grant under this section is a State or local public hospital, 10 an institution of higher education (as defined in section 11 101 of the Higher Education Act of 1965 (20 U.S.C. 12 1001)), a public health department, or a nonprofit organi- 13 zation that has been provided funds from State or local 14 government sources for epidemiological, basic, 15 translational, and clinical research on endemic fungal dis- 16 eases. 17 (c) APPLICATION.—An entity seeking a grant under 18 this section shall submit an application to the Secretary— 19 (1) in such form and manner as the Secretary 20 shall prescribe; 21 (2) that contains a certification that the entity 22 has received the funds described in subsection (b) 23 and that specifies the amount of such funds; and 24 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 9 •S 1567 IS (3) that contains such other information as the 1 Secretary may require. 2 (d) AMOUNT OF GRANT.—The amount of a grant 3 under this section shall equal (to the extent practicable) 4 the amount of funds received from State or local govern- 5 ment sources for the research that is the subject of the 6 grant. 7 (e) ENDEMIC FUNGAL DISEASE DEFINED.—In this 8 section, the term ‘‘endemic fungal disease’’ means blasto- 9 mycosis, coccidioidomycosis, histoplasmosis, and 10 sporotrichosis. 11 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 12 authorized to be appropriated to carry out this section 13 $8,000,000 for each of fiscal years 2021 through 2025, 14 to remain available until expended. 15 (g) SUNSET.—The Secretary may not award grants 16 under this section on or after October 1, 2025. 17 SEC. 4. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT 18 OF DIAGNOSTICS AND ANTIFUNGAL DRUGS 19 AND VACCINES FOR VALLEY FEVER. 20 (a) DRAFT GUIDANCE.—Not later than 2 years after 21 the date of the enactment of this Act, the Secretary of 22 Health and Human Services, acting through the Commis- 23 sioner of Food and Drugs, shall issue draft guidance for 24 industry for the purposes of assisting entities seeking ap- 25 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 10 •S 1567 IS proval under the Federal Food, Drug, and Cosmetic Act 1 (21 U.S.C. 301 et seq.) or licensure under section 351 2 of the Public Health Service Act (42 U.S.C. 262) of 3 antifungal therapies, diagnostics, or vaccines, specifically 4 therapies, diagnostics, and vaccines designed to diagnose, 5 treat, or prevent coccidioidomycosis (commonly known as 6 Valley Fever). 7 (b) FINAL GUIDANCE.—Not later than 18 months 8 after the close of the public comment period on the draft 9 guidance issued pursuant to subsection (a), the Secretary 10 of Health and Human Services, acting through the Com- 11 missioner of Food and Drugs, shall finalize the draft guid- 12 ance. 13 (c) WORKSHOPS; GOOD GUIDANCE PRACTICES.—In 14 developing and issuing the guidance required by this sec- 15 tion, the Secretary of Health and Human Services shall 16 hold at least 2 public workshops. 17 SEC. 5. PRIORITY REVIEW; FAST TRACK PRODUCT. 18 (a) PRIORITY REVIEW.— 19 (1) IN GENERAL.—Section 524A(a) of the Fed- 20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 21 360n–1(a)) is amended by striking ‘‘then the Sec- 22 retary shall give priority review to the first applica- 23 tion submitted for approval for such drug under sec- 24 tion 505(b)’’ and inserting ‘‘or if the drug is a bio- 25 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 11 •S 1567 IS logical product intended to treat blastomycosis, coc- 1 cidioidomycosis, histoplasmosis, or sporotrichosis, 2 then the Secretary shall give priority review to the 3 first application submitted for approval for such 4 drug under section 505(b) of this Act or section 5 351(a) of the Public Health Service Act’’. 6 (2) APPLICABILITY.—The amendment made by 7 paragraph (1) applies to an application submitted 8 under section 351(a) of the Public Health Service 9 Act (42 U.S.C. 262(a)) only if such application is 10 submitted on or after the date of enactment of this 11 Act. 12 (b) FAST TRACK PRODUCT.—Section 506(b)(1) of 13 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 14 356(b)(1)) is amended by striking ‘‘or if the Secretary 15 designates the drug as a qualified infectious disease prod- 16 uct under section 505E(d)’’ and inserting ‘‘, if the Sec- 17 retary designates the drug as a qualified infectious disease 18 product under section 505E(d), or if the drug is a biologi- 19 cal product intended to treat blastomycosis, coccidioidomy- 20 cosis, histoplasmosis, or sporotrichosis’’. 21 VerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567 kjohnson on DSK79L0C42 with BILLS 12 •S 1567 IS SEC. 6. PRIORITY REVIEW VOUCHERS FOR PRODUCTS FOR 1 PREVENTION OR TREATMENT OF ENDEMIC 2 FUNGAL DISEASES. 3 Section 524(a)(3) of the Federal Food, Drug, and 4 Cosmetic Act (21 U.S.C. 360n(a)(3)) is amended— 5 (1) by redesignating subparagraph (S) as sub- 6 paragraph (T); and 7 (2) by inserting after subparagraph (R) the fol- 8 lowing: 9 ‘‘(S) Blastomycosis, coccidioidomycosis, 10 histoplasmosis, and sporotrichosis.’’. 11 SEC. 7. ESTABLISHMENT OF ANTIFUNGAL RESISTANCE RE- 12 SEARCH PROGRAM MODELED ON THE CARB– 13 X PROGRAM. 14 (a) IN GENERAL.—The Secretary of Health and 15 Human Services, acting through the Director of the Bio- 16 medical Advanced Research and Development Authority, 17 shall carry out a program, modeled on the Combating An- 18 tibiotic Resistant Bacteria Accelerator program of the De- 19 partment of Health and Human Services [Text truncated for display. Full text available on Congress.gov.]