II 

116TH CONGRESS 

1ST SESSION S. 1567 

To support endemic fungal disease research, incentivize fungal vaccine development, 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, Education, 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) IN GENERAL.—This Act may be cited as the 

5 ‘‘Finding Orphan-disease Remedies With Antifungal Re6 search and Development Act of 2019’’ or the ‘‘FOR7 WARD Act of 2019’’. 

8 (b) TABLE OF CONTENTS.—The table of contents for 

9 this Act is as follows: 


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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 endemic 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. 

1 SEC. 2. CONTINUING SUPPORT FOR RESEARCH ON EN2 DEMIC FUNGAL DISEASES. 

3 The Public Health Service Act is amended by insert4 ing after section 320A of such Act (42 U.S.C. 247d–8) 

5 the following new section: 

6 ‘‘SEC. 320B. ENDEMIC FUNGAL DISEASES. 

7 ‘‘(a) IN GENERAL.—The Secretary shall continue to 

8 conduct or support epidemiological, basic, translational, 

9 and clinical research related to endemic fungal diseases, 

10 including coccidioidomycosis (commonly known as and re11 ferred to in this section as ‘Valley Fever’). 

12 ‘‘(b) REPORTS.—The Secretary shall ensure that 

13 each triennial report under section 403 includes informa14 tion on actions undertaken by the National Institutes of 

15 Health to carry out subsection (a) with respect to endemic 

16 fungal diseases, including Valley Fever. 

17 ‘‘(c) ENDEMIC FUNGAL DISEASE WORKING

18 GROUP.— 

19 ‘‘(1) ESTABLISHMENT.—The Secretary shall es20 tablish a working group, to be known as the EnVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 demic Fungal Disease Working Group (referred to 

2 in this section as the ‘Working Group’), comprised 

3 of representatives of appropriate Federal agencies 

4 and other non-Federal entities— 

5 ‘‘(A) to provide expertise and to review all 

6 efforts within the Department of Health and 

7 Human Services related to endemic fungal dis8 ease; 

9 ‘‘(B) to help ensure interagency coordina10 tion and minimize overlap with respect to such 

11 disease; and 

12 ‘‘(C) to examine research priorities with re13 spect to such disease. 

14 ‘‘(2) RESPONSIBILITIES.—The Working Group 

15 shall— 

16 ‘‘(A) not later than 2 years after the date 

17 of enactment of the FORWARD Act of 2019, 

18 develop or update a summary of— 

19 ‘‘(i) ongoing endemic fungal disease 

20 research, including research related to 

21 causes, prevention, treatment, surveillance, 

22 diagnosis, diagnostics, duration of illness, 

23 and intervention for individuals with an 

24 endemic fungal disease; 


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1 ‘‘(ii) advances made pursuant to such 

2 research; 

3 ‘‘(iii) Federal activities related to en4 demic fungal disease, including— 

5 ‘‘(I) epidemiological activities re6 lated to endemic fungal disease; and 

7 ‘‘(II) basic, clinical, and 

8 translational endemic fungal disease 

9 research related to the pathogenesis, 

10 prevention, diagnosis, and treatment 

11 of endemic fungal disease; 

12 ‘‘(iv) gaps in endemic fungal disease 

13 research described in clause (iii)(II); 

14 ‘‘(v) the Working Group’s meetings 

15 required under paragraph (4); and 

16 ‘‘(vi) the comments received by the 

17 Working Group; 

18 ‘‘(B) make recommendations to the Sec19 retary regarding any appropriate changes or 

20 improvements to such activities and research; 

21 and 

22 ‘‘(C) solicit input from States, localities, 

23 and nongovernmental entities, including organi24 zations representing patients, health care pro25 viders, researchers, and industry regarding sciVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 entific advances, research questions, and sur2 veillance activities. 

3 ‘‘(3) MEMBERSHIP.—The members of the 

4 Working Group shall represent a diversity of sci5 entific disciplines and views and shall be composed 

6 of the following members: 

7 ‘‘(A) FEDERAL MEMBERS.—Seven Federal 

8 members, consisting of one or more representa9 tives of each of the following: 

10 ‘‘(i) The Office of the Assistant Sec11 retary for Health. 

12 ‘‘(ii) The Food and Drug Administra13 tion. 

14 ‘‘(iii) The Centers for Disease Control 

15 and Prevention. 

16 ‘‘(iv) The National Institutes of 

17 Health. 

18 ‘‘(v) Such other agencies and offices 

19 of the Department of Health and Human 

20 Services as the Secretary determines ap21 propriate. 

22 ‘‘(B) NON-FEDERAL PUBLIC MEMBERS.— 

23 Seven non-Federal public members, consisting 

24 of representatives of the following categories: 


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1 ‘‘(i) Physicians and other medical pro2 viders with experience in diagnosing and 

3 treating endemic fungal disease. 

4 ‘‘(ii) Scientists or researchers with ex5 pertise. 

6 ‘‘(iii) Patients and their family mem7 bers. 

8 ‘‘(iv) Nonprofit organizations that ad9 vocate for patients with respect to endemic 

10 fungal disease. 

11 ‘‘(v) Other individuals whose expertise 

12 is determined by the Secretary to be bene13 ficial to the functioning of the Working 

14 Group. 

15 ‘‘(4) MEETINGS.—The Working Group shall 

16 meet annually. 

17 ‘‘(5) REPORTING.—Not later than 2 years after 

18 the date of enactment of the FORWARD Act of 

19 2019, and every 2 years thereafter until termination 

20 of the Working Group pursuant to paragraph (7), 

21 the Working Group shall— 

22 ‘‘(A) submit a report on its activities under 

23 paragraph (2)(A) and any recommendations 

24 under paragraph (2)(B) to the Secretary, the 

25 Committee on Energy and Commerce of the 


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1 House of Representatives, and the Committee 

2 on Health, Education, Labor, and Pensions of 

3 the Senate; and 

4 ‘‘(B) make such report publicly available 

5 on the internet website of the Department of 

6 Health and Human Services. 

7 ‘‘(6) APPLICABILITY OF FACA.—The Working 

8 Group shall be treated as an advisory committee 

9 subject to the Federal Advisory Committee Act (5 

10 U.S.C. App.). 

11 ‘‘(7) SUNSET.—The Working Group under this 

12 section shall terminate 5 years after the date of en13 actment of the FORWARD Act of 2019. 

14 ‘‘(d) ENDEMIC FUNGAL DISEASE DEFINED.—In this 

15 section, the term ‘endemic fungal disease’ means blasto16 mycosis, coccidioidomycosis, histoplasmosis, and 

17 sparotrichosis.’’. 

18 SEC. 3. ENDEMIC FUNGAL DISEASE FEDERAL-STATE 

19 MATCH PILOT PROGRAM. 

20 (a) IN GENERAL.— 

21 (1) GRANTS.—For each of fiscal years 2021 

22 through 2025, the Secretary of Health and Human 

23 Services shall, subject to the availability of appro24 priations, award grants through a competitive proc25 ess to eligible entities to conduct research with reVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 spect to endemic fungal diseases, including coccidioi2 domycosis. 

3 (2) PEER REVIEW.—Any research supported 

4 under this section shall be subject to peer review in 

5 accordance with the requirements applicable to re6 search supported by the National Institutes of 

7 Health under section 492 of the Public Health Serv8 ice Act (42 U.S.C. 289a). 

9 (b) ELIGIBILITY.—An entity eligible to receive a 

10 grant under this section is a State or local public hospital, 

11 an institution of higher education (as defined in section 

12 101 of the Higher Education Act of 1965 (20 U.S.C. 

13 1001)), a public health department, or a nonprofit organi14 zation that has been provided funds from State or local 

15 government sources for epidemiological, basic, 

16 translational, and clinical research on endemic fungal dis17 eases. 

18 (c) APPLICATION.—An entity seeking a grant under 

19 this section shall submit an application to the Secretary— 

20 (1) in such form and manner as the Secretary 

21 shall prescribe; 

22 (2) that contains a certification that the entity 

23 has received the funds described in subsection (b) 

24 and that specifies the amount of such funds; and 


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1 (3) that contains such other information as the 

2 Secretary may require. 

3 (d) AMOUNT OF GRANT.—The amount of a grant 

4 under this section shall equal (to the extent practicable) 

5 the amount of funds received from State or local govern6 ment sources for the research that is the subject of the 

7 grant. 

8 (e) ENDEMIC FUNGAL DISEASE DEFINED.—In this 

9 section, the term ‘‘endemic fungal disease’’ means blasto10 mycosis, coccidioidomycosis, histoplasmosis, and 

11 sporotrichosis. 

12 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

13 authorized to be appropriated to carry out this section 

14 $8,000,000 for each of fiscal years 2021 through 2025, 

15 to remain available until expended. 

16 (g) SUNSET.—The Secretary may not award grants 

17 under this section on or after October 1, 2025. 

18 SEC. 4. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT 

19 OF DIAGNOSTICS AND ANTIFUNGAL DRUGS 

20 AND VACCINES FOR VALLEY FEVER. 

21 (a) DRAFT GUIDANCE.—Not later than 2 years after 

22 the date of the enactment of this Act, the Secretary of 

23 Health and Human Services, acting through the Commis24 sioner of Food and Drugs, shall issue draft guidance for 

25 industry for the purposes of assisting entities seeking apVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 proval under the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 301 et seq.) or licensure under section 351 

3 of the Public Health Service Act (42 U.S.C. 262) of 

4 antifungal therapies, diagnostics, or vaccines, specifically 

5 therapies, diagnostics, and vaccines designed to diagnose, 

6 treat, or prevent coccidioidomycosis (commonly known as 

7 Valley Fever). 

8 (b) FINAL GUIDANCE.—Not later than 18 months 

9 after the close of the public comment period on the draft 

10 guidance issued pursuant to subsection (a), the Secretary 

11 of Health and Human Services, acting through the Com12 missioner of Food and Drugs, shall finalize the draft guid13 ance. 

14 (c) WORKSHOPS; GOOD GUIDANCE PRACTICES.—In 

15 developing and issuing the guidance required by this sec16 tion, the Secretary of Health and Human Services shall 

17 hold at least 2 public workshops. 

18 SEC. 5. PRIORITY REVIEW; FAST TRACK PRODUCT. 

19 (a) PRIORITY REVIEW.— 

20 (1) IN GENERAL.—Section 524A(a) of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

22 360n–1(a)) is amended by striking ‘‘then the Sec23 retary shall give priority review to the first applica24 tion submitted for approval for such drug under sec25 tion 505(b)’’ and inserting ‘‘or if the drug is a bioVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 logical product intended to treat blastomycosis, coc2 cidioidomycosis, histoplasmosis, or sporotrichosis, 

3 then the Secretary shall give priority review to the 

4 first application submitted for approval for such 

5 drug under section 505(b) of this Act or section 

6 351(a) of the Public Health Service Act’’. 

7 (2) APPLICABILITY.—The amendment made by 

8 paragraph (1) applies to an application submitted 

9 under section 351(a) of the Public Health Service 

10 Act (42 U.S.C. 262(a)) only if such application is 

11 submitted on or after the date of enactment of this 

12 Act. 

13 (b) FAST TRACK PRODUCT.—Section 506(b)(1) of 

14 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 356(b)(1)) is amended by striking ‘‘or if the Secretary 

16 designates the drug as a qualified infectious disease prod17 uct under section 505E(d)’’ and inserting ‘‘, if the Sec18 retary designates the drug as a qualified infectious disease 

19 product under section 505E(d), or if the drug is a biologi20 cal product intended to treat blastomycosis, coccidioidomy21 cosis, histoplasmosis, or sporotrichosis’’. 


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1 SEC. 6. PRIORITY REVIEW VOUCHERS FOR PRODUCTS FOR 

2 PREVENTION OR TREATMENT OF ENDEMIC 

3 FUNGAL DISEASES. 

4 Section 524(a)(3) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360n(a)(3)) is amended— 

6 (1) by redesignating subparagraph (S) as sub7 paragraph (T); and 

8 (2) by inserting after subparagraph (R) the fol9 lowing: 

10 ‘‘(S) Blastomycosis, coccidioidomycosis, 

11 histoplasmosis, and sporotrichosis.’’. 

12 SEC. 7. ESTABLISHMENT OF ANTIFUNGAL RESISTANCE RE13 SEARCH PROGRAM MODELED ON THE CARB– 

14 X PROGRAM. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services, acting through the Director of the Bio17 medical Advanced Research and Development Authority, 

18 shall carry out a program, modeled on the Combating An19 tibiotic Resistant Bacteria Accelerator program of the De20 partment of Health and Human Services (commonly re21 ferred to as ‘‘CARB–X’’), for research with respect to 

22 antifungal resistance, including therapies, diagnostics, and 

23 vaccines, including for coccidioidomycosis. 

24 (b) AUTHORIZATION OF APPROPRIATIONS.—There is 

25 authorized to be appropriated to carry out subsection (a) 


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1 $10,000,000 for each of fiscal years 2021 through 2025, 

2 to remain available until expended. 

3 SEC. 8. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL 

4 DATA SECURITY FOR ENDEMIC FUNGAL DIS5 EASE RESEARCH. 

6 Part A of title IV of the Public Health Service Act 

7 (42 U.S.C. 281 et seq.) is amended by adding at the end 

8 the following new section: 

9 ‘‘SEC. 404O. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL 

10 DATA SECURITY FOR ENDEMIC FUNGAL DIS11 EASE RESEARCH. 

12 ‘‘(a) IN GENERAL.—The Director of NIH shall carry 

13 out a pilot program to conduct, support, and facilitate 

14 auditable research on endemic fungal disease. In carrying 

15 out such program, the Director of NIH shall— 

16 ‘‘(1) award a grant to an eligible entity to in17 stall a blockchain on the servers of, or otherwise pro18 vide blockchain services to, the National Institutes of 

19 Health, and provide support with respect to such a 

20 blockchain, which shall contain public, unalterable 

21 data which includes every query made through the 

22 procedure established under subsection (c), as well 

23 as the identity of the individual who asked such a 

24 question, without disclosing the results of such que25 ries; 


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1 ‘‘(2) award a grant to an eligible entity— 

2 ‘‘(A) to provide to not less than 3 qualified 

3 hospitals qualified software; and 

4 ‘‘(B) to provide customer service to each 

5 such hospital with respect to such qualified 

6 software or any associated service; 

7 ‘‘(3) provide to such qualified hospitals any nec8 essary hardware in accordance with subsection (e); 

9 and 

10 ‘‘(4) award grants to eligible entities to test the 

11 cybersecurity of such qualified hospitals by attempt12 ing to attack simulated data on the servers of such 

13 hospitals. 

14 ‘‘(b) ELIGIBLE ENTITIES; APPLICATION.—The Di15 rector of NIH shall determine whether an entity is eligible 

16 to receive a grant under this section and shall select hos17 pitals to be qualified hospitals for purposes of this section. 

18 An entity seeking a grant under this section, and a hos19 pital seeking to be so selected, shall submit to the Director 

20 of NIH an application in such form and manner and con21 taining such information as the Director of NIH may 

22 specify. 

23 ‘‘(c) DATA QUERIES.—The Director of NIH shall es24 tablish, for purposes of allowing researchers to process 


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1 data from a qualified hospital’s servers pursuant to this 

2 section, a procedure to determine— 

3 ‘‘(1) who can ask queries of the servers; 

4 ‘‘(2) which data the hospital must include on 

5 such servers; and 

6 ‘‘(3) which questions may be asked of such 

7 servers, and what form of de-identification of the 

8 servers’ data is required to ensure privacy. 

9 ‘‘(d) REQUEST FOR PROPOSALS.—Not later than 90 

10 days after the date of the enactment of this section, the 

11 Director of NIH shall publish in the Federal Register a 

12 request for proposals for grants under paragraphs (1), (2), 

13 and (4) of subsection (a). 

14 ‘‘(e) PROVISION OF SERVERS.— 

15 ‘‘(1) IN GENERAL.—The Director of NIH shall, 

16 in carrying out subsection (a)(3), provide to quali17 fied hospitals hardware, including computer servers, 

18 sufficient to support qualified software. 

19 ‘‘(2) CONDITION.—As a condition on the receipt 

20 of a computer server under paragraph (1), a quali21 fied hospital shall agree not to use the qualified soft22 ware on the server to store data from patients of the 

23 hospital until the Director of NIH determines that 

24 testing performed pursuant to subsection (a)(4) has 

25 determined that simulated data used in such softVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 ware could not be extracted from the hospital’s serv2 ers. 

3 ‘‘(f) DEFINITIONS.—In this section: 

4 ‘‘(1) The term ‘blockchain’ means software that 

5 uses a distributed digital ledger of cryptographically 

6 signed transactions that are grouped into blocks, 

7 each of which— 

8 ‘‘(A) is cryptographically linked to the pre9 vious block after validation and undergoing a 

10 consensus decision; and 

11 ‘‘(B) when added as a new block, makes 

12 any older blocks more difficult to modify and is 

13 replicated across all copies of the ledger within 

14 the relevant network, with any conflicts in such 

15 blocks resolved automatically using established 

16 rules. 

17 ‘‘(2) The term ‘endemic fungal disease’ means 

18 blastomycosis, coccidioidomycosis, histoplasmosis, 

19 and sporotrichosis. 

20 ‘‘(3) The term ‘qualified hospital’ means a hos21 pital that is located in a region in which endemic 

22 fungal disease is endemic. 

23 ‘‘(4) The term ‘qualified software’ means soft24 ware that uses secure multiparty encrypted comVerDate Sep 11 2014 01:55 May 30, 2019 Jkt 089200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S1567.IS S1567

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1 puting to allow researchers to perform computations 

2 on encrypted data supplied by qualified hospitals. 

3 ‘‘(5) The term ‘secure multiparty encrypted 

4 computing’ means a form of cryptography in which 

5 parties can jointly compute a function of inputs 

6 while keeping those inputs private from each other, 

7 and from all other parties, such as multiparty homo8 morphic encryption, threshold encryption, and secure 

9 multiparty computation. 

10 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

11 is authorized to be appropriated to carry out this section 

12 $5,000,000 for fiscal year 2021, to remain available until 

13 expended.’’. 

Æ 


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