I 

116TH CONGRESS 

1ST SESSION H. R. 2858 

To support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 21, 2019 

Mr. MCCARTHY (for himself, Mr. SCHWEIKERT, Ms. BASS, and Mr. STANTON) 

introduced the following bill; which was referred to the Committee on Energy and Commerce 

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 19:13 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2858.IH H2858

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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 transla8 tional endemic fungal disease research 

9 related to the pathogenesis, preven10 tion, diagnosis, and treatment of en11 demic 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 19:13 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2858.IH H2858

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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 sporotri17 chosis.’’. 

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 19:13 Jun 06, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2858.IH H2858

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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, translation16 al, and clinical research on endemic fungal diseases. 

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 (3) that contains such other information as the 

25 Secretary may require. 


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

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

3 the amount of funds received from State or local govern4 ment sources for the research that is the subject of the 

5 grant. 

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

7 section, the term ‘‘endemic fungal disease’’ means blasto8 mycosis, coccidioidomycosis, histoplasmosis, and sporotri9 chosis. 

10 (f) AUTHORIZATION OF APPROPRIATIONS.—There is 

11 authorized to be appropriated to carry out this section 

12 $8,000,000 for each of fiscal years 2021 through 2025, 

13 to remain available until expended. 

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

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

16 SEC. 4. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT 

17 OF DIAGNOSTICS AND ANTIFUNGAL DRUGS 

18 AND VACCINES FOR VALLEY FEVER. 

19 (a) DRAFT GUIDANCE.—Not later than 2 years after 

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

21 Health and Human Services, acting through the Commis22 sioner of Food and Drugs, shall issue draft guidance for 

23 industry for the purposes of assisting entities seeking ap24 proval under the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 301 et seq.) or licensure under section 351 


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

2 antifungal therapies, diagnostics, or vaccines, specifically 

3 therapies, diagnostics, and vaccines designed to diagnose, 

4 treat, or prevent coccidioidomycosis (commonly known as 

5 Valley Fever). 

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

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

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

9 of Health and Human Services, acting through the Com10 missioner of Food and Drugs, shall finalize the draft guid11 ance. 

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

13 developing and issuing the guidance required by this sec14 tion, the Secretary of Health and Human Services shall 

15 hold at least 2 public workshops. 

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

17 (a) PRIORITY REVIEW.— 

18 (1) IN GENERAL.—Section 524A(a) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

20 360n–1(a)) is amended by striking ‘‘then the Sec21 retary shall give priority review to the first applica22 tion submitted for approval for such drug under sec23 tion 505(b)’’ and inserting ‘‘or if the drug is a bio24 logical product intended to treat blastomycosis, coc25 cidioidomycosis, histoplasmosis, or sporotrichosis, 


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1 then the Secretary shall give priority review to the 

2 first application submitted for approval for such 

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

4 351(a) of the Public Health Service Act’’. 

5 (2) APPLICABILITY.—The amendment made by 

6 paragraph (1) applies to an application submitted 

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

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

9 submitted on or after the date of enactment of this 

10 Act. 

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

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

13 356(b)(1)) is amended by striking ‘‘or if the Secretary 

14 designates the drug as a qualified infectious disease prod15 uct under section 505E(d)’’ and inserting ‘‘if the Sec16 retary designates the drug as a qualified infectious disease 

17 product under section 505E(d), or if the drug is a biologi18 cal product intended to treat blastomycosis, coccidioidomy19 cosis, histoplasmosis, or sporotrichosis’’. 

20 SEC. 6. PRIORITY REVIEW VOUCHERS FOR PRODUCTS FOR 

21 PREVENTION OR TREATMENT OF ENDEMIC 

22 FUNGAL DISEASES. 

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

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


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1 (1) by redesignating subparagraph (S) as sub2 paragraph (T); and 

3 (2) by inserting after subparagraph (R) the fol4 lowing: 

5 ‘‘(S) Blastomycosis, coccidioidomycosis, 

6 histoplasmosis, and sporotrichosis.’’. 

7 SEC. 7. ESTABLISHMENT OF ANTIFUNGAL RESISTANCE RE8 SEARCH PROGRAM MODELED ON THE CARB– 

9 X PROGRAM. 

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

11 Human Services, acting through the Director of the Bio12 medical Advanced Research and Development Authority, 

13 shall carry out a program, modeled on the Combating An14 tibiotic Resistant Bacteria Accelerator program of the De15 partment of Health and Human Services (commonly re16 ferred to as ‘‘CARB–X’’), for research with respect to 

17 antifungal resistance, including therapies, diagnostics, and 

18 vaccines, including for coccidioidomycosis. 

19 (b) AUTHORIZATION OF APPROPRIATIONS.—There is 

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

21 $10,000,000 for each of fiscal years 2021 through 2025, 

22 to remain available until expended. 


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1 SEC. 8. BLOCKCHAIN PILOT PROGRAM FOR HOSPITAL 

2 DATA SECURITY FOR ENDEMIC FUNGAL DIS3 EASE RESEARCH. 

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

5 (42 U.S.C. 281 et seq.) is amended by adding at the end 

6 the following new section: 

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

8 DATA SECURITY FOR ENDEMIC FUNGAL DIS9 EASE RESEARCH. 

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

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

12 auditable research on endemic fungal disease. In carrying 

13 out such program, the Director of NIH shall— 

14 ‘‘(1) award a grant to an eligible entity to in15 stall a blockchain on the servers of, or otherwise pro16 vide blockchain services to, the National Institutes of 

17 Health, and provide support with respect to such a 

18 blockchain, which shall contain public, unalterable 

19 data which includes every query made through the 

20 procedure established under subsection (c), as well 

21 as the identity of the individual who asked such a 

22 question, without disclosing the results of such que23 ries; 

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

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

26 hospitals qualified software; and 


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

2 such hospital with respect to such qualified 

3 software or any associated service; 

4 ‘‘(3) provide to such qualified hospitals any nec5 essary hardware in accordance with subsection (e); 

6 and 

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

8 cybersecurity of such qualified hospitals by attempt9 ing to attack simulated data on the servers of such 

10 hospitals. 

11 ‘‘(b) ELIGIBLE ENTITIES; APPLICATION.—The Di12 rector of NIH shall determine whether an entity is eligible 

13 to receive a grant under this section and shall select hos14 pitals to be qualified hospitals for purposes of this section. 

15 An entity seeking a grant under this section, and a hos16 pital seeking to be so selected, shall submit to the Director 

17 of NIH an application in such form and manner and con18 taining such information as the Director of NIH may 

19 specify. 

20 ‘‘(c) DATA QUERIES.—The Director of NIH shall es21 tablish, for purposes of allowing researchers to process 

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

23 section, a procedure to determine— 

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


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

2 such servers; and 

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

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

5 servers’ data is required to ensure privacy. 

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

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

8 Director of NIH shall publish in the Federal Register a 

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

10 and (4) of subsection (a). 

11 ‘‘(e) PROVISION OF SERVERS.— 

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

13 in carrying out subsection (a)(3), provide to quali14 fied hospitals hardware, including computer servers, 

15 sufficient to support qualified software. 

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

17 of a computer server under paragraph (1), a quali18 fied hospital shall agree not to use the qualified soft19 ware on the server to store data from patients of the 

20 hospital until the Director of NIH determines that 

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

22 determined that simulated data used in such soft23 ware could not be extracted from the hospital’s serv24 ers. 

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


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

2 uses a distributed digital ledger of cryptographically 

3 signed transactions that are grouped into blocks, 

4 each of which— 

5 ‘‘(A) is cryptographically linked to the pre6 vious block after validation and undergoing a 

7 consensus decision; and 

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

9 any older blocks more difficult to modify and is 

10 replicated across all copies of the ledger within 

11 the relevant network, with any conflicts in such 

12 blocks resolved automatically using established 

13 rules. 

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

15 blastomycosis, coccidioidomycosis, histoplasmosis, 

16 and sporotrichosis. 

17 ‘‘(3) The term ‘qualified hospital’ means a hos18 pital that is located in a region in which endemic 

19 fungal disease is endemic. 

20 ‘‘(4) The term ‘qualified software’ means soft21 ware that uses secure multiparty encrypted com22 puting to allow researchers to perform computations 

23 on encrypted data supplied by qualified hospitals. 

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

25 computing’ means a form of cryptography in which 


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1 parties can jointly compute a function of inputs 

2 while keeping those inputs private from each other, 

3 and from all other parties, such as multiparty homo4 morphic encryption, threshold encryption, and secure 

5 multiparty computation. 

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

7 is authorized to be appropriated to carry out this section 

8 $5,000,000 for fiscal year 2021, to remain available until 

9 expended.’’. 

Æ 


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