II 

117TH CONGRESS 

2D SESSION S. 3498 

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 

JANUARY 13 (legislative day, JANUARY 10), 2022 

Mr. KELLY (for himself, Ms. SINEMA, and Mrs. FEINSTEIN) 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. 

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

5 ‘‘Finding Orphan-disease Remedies With Antifungal Re6 search and Development Act of 2022’’ or the ‘‘FOR7 WARD Act of 2022’’. 

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

9 this Act is as follows: 


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Sec. 1. Short title. 

Sec. 2. Continuing support for research on endemic fungal diseases. 

Sec. 3. Endemic fungal disease working group. 

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. Combating antimicrobial resistance biopharmaceutical accelerator program. 

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 447C of such Act (42 U.S.C. 285f–4) 

5 the following new section: 

6 ‘‘SEC. 447D. ENDEMIC FUNGAL DISEASES. 

7 ‘‘(a) IN GENERAL.—The Director of the Institute 

8 shall— 

9 ‘‘(1) continue to conduct or support epidemio10 logical, basic, translational, and clinical research re11 lated to endemic fungal diseases, including coccidioi12 domycosis (commonly known as and referred to in 

13 this section as ‘Valley Fever’); and 

14 ‘‘(2) subject to the availability of appropria15 tions, make grants to, or enter into contracts with, 

16 public or nonprofit private entities to conduct such 

17 research. 

18 ‘‘(b) REPORTS.—The Director of the Institute shall 

19 ensure that each triennial report under section 403 in20 cludes information on actions undertaken by the National 


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1 Institutes of Health to carry out subsection (a) with re2 spect to endemic fungal diseases, including Valley Fever. 

3 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In ad4 dition to other amounts available for the purposes of car5 rying out this section, there is authorized to be appro6 priated to carry out this section $20,000,000 for each of 

7 fiscal years 2022 through 2026 for such purpose.’’. 

8 SEC. 3. ENDEMIC FUNGAL DISEASE WORKING GROUP. 

9 (a) ESTABLISHMENT.—The Secretary of Health and 

10 Human Services (referred to in this section as the ‘‘Sec11 retary’’) shall establish a working group, to be known as 

12 the Endemic Fungal Disease Working Group (referred to 

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

14 representatives of appropriate Federal agencies and other 

15 non-Federal entities— 

16 (1) to provide expertise and to review all efforts 

17 within the Department of Health and Human Serv18 ices related to endemic fungal disease; 

19 (2) to help ensure interagency coordination and 

20 minimize overlap with respect to such disease; and 

21 (3) to examine research priorities with respect 

22 to such disease. 

23 (b) RESPONSIBILITIES.—The Working Group shall— 


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1 (1) not later than 2 years after the date of en2 actment of this Act, develop or update a summary 

3 of— 

4 (A) ongoing endemic fungal disease re5 search, including research related to causes, 

6 prevention, treatment, surveillance, diagnosis, 

7 diagnostics, duration of illness, and intervention 

8 for individuals with an endemic fungal disease; 

9 (B) advances made pursuant to such re10 search; 

11 (C) the impact of viral respiratory ill12 nesses, including COVID–19, and fungal lung 

13 diseases and pneumonias; 

14 (D) Federal activities related to endemic 

15 fungal disease, including— 

16 (i) epidemiological activities related to 

17 endemic fungal disease; and 

18 (ii) basic, clinical, and translational 

19 endemic fungal disease research related to 

20 the pathogenesis, prevention, diagnosis, 

21 and treatment of endemic fungal disease; 

22 (E) gaps in endemic fungal disease re23 search described in subparagraph (D)(ii); 

24 (F) the Working Group’s meetings re25 quired under subsection (d); and 


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1 (G) the comments received by the Working 

2 Group; 

3 (2) make recommendations to the Secretary, in4 cluding a proposed strategy related to development 

5 of therapeutics and vaccines, regarding any appro6 priate changes or improvements to such activities de7 scribed in paragraph (1); and 

8 (3) in implementing this subsection, solicit 

9 input from States, localities, and nongovernmental 

10 entities, including organizations representing pa11 tients, health care providers, researchers, and indus12 try regarding scientific advances, research questions, 

13 and surveillance activities. 

14 (c) MEMBERSHIP.—The members of the Working 

15 Group shall represent a diversity of scientific disciplines 

16 and views and shall be composed of the following mem17 bers: 

18 (1) FEDERAL MEMBERS.—Seven Federal mem19 bers, consisting of one or more representatives of 

20 each of the following: 

21 (A) The Office of the Assistant Secretary 

22 for Health. 

23 (B) The Food and Drug Administration. 

24 (C) The Centers for Disease Control and 

25 Prevention. 


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1 (D) The National Institutes of Health. 

2 (E) Such other agencies and offices of the 

3 Department of Health and Human Services as 

4 the Secretary determines appropriate. 

5 (2) NON-FEDERAL PUBLIC MEMBERS.—Seven 

6 non-Federal public members, consisting of represent7 atives of the following categories: 

8 (A) Physicians and other medical providers 

9 with experience in diagnosing and treating en10 demic fungal disease. 

11 (B) Scientists or researchers with exper12 tise. 

13 (C) Patients and their family members. 

14 (D) Nonprofit organizations that advocate 

15 for patients with respect to endemic fungal dis16 ease. 

17 (E) Other individuals whose expertise is 

18 determined by the Secretary to be beneficial to 

19 the functioning of the Working Group. 

20 (d) MEETINGS.—The Working Group shall meet an21 nually. 

22 (e) REPORTING.—Not later than 2 years after the 

23 date of enactment of this Act, and every 2 years thereafter 

24 until termination of the Working Group pursuant to sub25 section (g), the Working Group shall— 


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1 (1) submit a report on its activities under sub2 section (b)(1) and any recommendations under para3 graph (b)(2) to the Secretary, the Committee on En4 ergy and Commerce of the House of Representa5 tives, and the Committee on Health, Education, 

6 Labor, and Pensions of the Senate; and 

7 (2) make such report publicly available on the 

8 website of the Department of Health and Human 

9 Services. 

10 (f) APPLICABILITY OF FACA.—The Working Group 

11 shall be treated as an advisory committee subject to the 

12 Federal Advisory Committee Act (5 U.S.C. App.). 

13 (g) SUNSET.—The Working Group under this section 

14 shall terminate 5 years after the date of enactment of this 

15 Act. 

16 (h) ENDEMIC FUNGAL DISEASE DEFINED.—In this 

17 section, the term ‘‘endemic fungal disease’’ means blasto18 mycosis, coccidioidomycosis, histoplasmosis, and 

19 sparotrichosis. 

20 SEC. 4. FDA GUIDANCE FOR INDUSTRY ON DEVELOPMENT 

21 OF DIAGNOSTICS AND ANTIFUNGAL DRUGS 

22 AND VACCINES FOR VALLEY FEVER. 

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

24 the date of enactment of this Act, the Secretary of Health 

25 and Human Services, acting through the Commissioner of 


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1 Food and Drugs, shall issue draft guidance for industry 

2 for the purposes of assisting entities seeking approval 

3 under the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 301 et seq.) or licensure under section 351 of the 

5 Public Health Service Act (42 U.S.C. 262) of antifungal 

6 therapies, diagnostics, or vaccines, specifically therapies, 

7 diagnostics, and vaccines designed to diagnose, treat, or 

8 prevent coccidioidomycosis (commonly known as Valley 

9 Fever). 

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

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

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

13 of Health and Human Services, acting through the Com14 missioner of Food and Drugs, shall finalize the draft guid15 ance. 

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

17 developing and issuing the guidance required by this sec18 tion, the Secretary of Health and Human Services shall 

19 hold at least 2 public workshops. 

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

21 (a) PRIORITY REVIEW.— 

22 (1) IN GENERAL.—Section 524A(a) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

24 360n–1(a)) is amended by striking ‘‘then the Sec25 retary shall give priority review to the first applicaVerDate Sep 11 2014 03:59 Jan 14, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3498.IS S3498

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1 tion submitted for approval for such drug under sec2 tion 505(b)’’ and inserting ‘‘or if the drug is a bio3 logical product intended to treat coccidioidomycosis, 

4 then the Secretary shall give priority review to the 

5 first application submitted for approval for such 

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

7 351(a) of the Public Health Service Act’’. 

8 (2) APPLICABILITY.—The amendment made by 

9 paragraph (1) applies only to any application sub10 mitted under section 351(a) of the Public Health 

11 Service Act (42 U.S.C. 262(a)) on or after the date 

12 of enactment of this 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 coccidioidomycosis’’. 

21 SEC. 6. PRIORITY REVIEW VOUCHERS FOR PRODUCTS FOR 

22 PREVENTION OR TREATMENT OF ENDEMIC 

23 FUNGAL DISEASES. 

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

25 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) Coccidioidomycosis.’’. 

6 SEC. 7. COMBATING ANTIMICROBIAL RESISTANCE BIO7 PHARMACEUTICAL ACCELERATOR PROGRAM. 

8 Paragraph (4) of section 319L(c) of the Public 

9 Health Service Act (42 U.S.C. 247d–7e(c)) is amended 

10 by adding at the end the following: 

11 ‘‘(G) COMBATING ANTIMICROBIAL RESIST12 ANCE BIOPHARMACEUTICAL ACCELERATOR PRO13 GRAM.— 

14 ‘‘(i) IN GENERAL.—The Secretary, 

15 acting through the Director of BARDA, 

16 shall implement strategic initiatives, to be 

17 known as the Combating Antimicrobial Re18 sistance Biopharmaceutical Accelerator 

19 Program, including by building on existing 

20 programs and by awarding contracts, 

21 grants, and cooperative agreements, or en22 tering into other transactions— 

23 ‘‘(I) to optimize the use of 

24 antimicrobials in human and animal 

25 health settings; 


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1 ‘‘(II) to support innovative can2 didate products in preclinical and clin3 ical development that reduce anti4 microbial resistance; and 

5 ‘‘(III) to support research with 

6 respect to infection prevention and 

7 control to slow the spread of resistant 

8 bacteria, fungi, and viruses. 

9 ‘‘(ii) REFERENCES.—Except as other10 wise specified, any reference to the Com11 bating Antibiotic Resistant Bacteria Bio12 pharmaceutical Accelerator or the CARB13 X program in any statute, Executive order, 

14 rule, regulation, directive, or other Federal 

15 document is deemed to be a reference to 

16 the Combating Antimicrobial Resistance 

17 Biopharmaceutical Accelerator Program 

18 under this subparagraph. 

19 ‘‘(iii) AUTHORIZATION OF APPROPRIA20 TIONS.— 

21 ‘‘(I) IN GENERAL.—To carry out 

22 the program under clause (i), there is 

23 authorized to be appropriated 

24 $500,000,000 for the period of fiscal 


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1 years 2022 through 2026, to remain 

2 available until expended. 

3 ‘‘(II) REQUIREMENT.—Of the 

4 amounts made available to carry out 

5 the program under clause (i) for the 

6 period of fiscal years 2022 through 

7 2026, not less than 10 percent shall 

8 be used to support antifungal product 

9 development.’’. 

Æ 


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