II 

118TH CONGRESS 

1ST SESSION S. 3464 

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 

DECEMBER 12, 2023 

Mr. KELLY (for himself 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 2023’’ or the ‘‘FOR7 WARD Act of 2023’’. 

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 working group. 

Sec. 4. Expanding tropical disease product priority review voucher program to 

encourage prevention and treatment of coccidioidomycosis. 

Sec. 5. 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 447D of such Act (42 U.S.C. 285f–5) 

5 the following new section: 

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

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

8 shall— 

9 ‘‘(1) continue to conduct or support basic, 

10 translational, and clinical research related to fungal 

11 diseases found in the United States, including coc12 cidioidomycosis (commonly known as and referred to 

13 in 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 

21 Institutes of Health to carry out subsection (a) with reVerDate Sep 11 2014 03:06 Dec 28, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3464.IS S3464

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1 spect to such fungal diseases, including coccidioidomy2 cosis. 

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 2024 through 2028 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 fungal disease in the United States; 

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) DUTIES.—The Working Group shall— 

24 (1) make recommendations to the Secretary, in25 cluding an updated strategy related to development 


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1 of therapeutics and vaccines for endemic fungal dis2 eases, that shall— 

3 (A) take into account ongoing fungal dis4 ease research, including for animals, that may 

5 be adapted for human use; 

6 (B) identify gaps in endemic fungal disease 

7 research, including basic, clinical, and 

8 translational research related to the patho9 genesis, prevention, diagnosis, and treatment of 

10 such diseases; and 

11 (C) include recommendations for congres12 sional action to spur additional research and 

13 product development for fungal diseases; and 

14 (2) in implementing this subsection, solicit 

15 input from States, Tribes, localities, and nongovern16 mental entities, including organizations representing 

17 patients, health care providers, researchers, and in18 dustry regarding scientific advances, research ques19 tions, and surveillance activities. 

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

21 Group shall represent a diversity of scientific disciplines 

22 and shall be composed of the following members: 

23 (1) FEDERAL MEMBERS.—Seven Federal mem24 bers, consisting of one or more representatives of 

25 each of the following: 


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1 (A) The Office of the Assistant Secretary 

2 for Health, who shall serve as Chair. 

3 (B) The Food and Drug Administration. 

4 (C) The Centers for Disease Control and 

5 Prevention. 

6 (D) The National Institutes of Health, who 

7 shall serve as Vice Chair. 

8 (E) Such other agencies and offices of the 

9 Department of Health and Human Services as 

10 the Secretary determines appropriate. 

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

12 non-Federal public members, consisting of represent13 atives of the following categories: 

14 (A) Physicians, veterinarians, and other 

15 medical providers with experience in diagnosing 

16 and treating endemic fungal disease. 

17 (B) Scientists or researchers with expertise 

18 in endemic fungal disease. 

19 (C) Patients who have been diagnosed with 

20 an endemic fungal disease and family members 

21 or caregivers of such patients, as applicable. 

22 (D) Nonprofit organizations that advocate 

23 for patients with respect to endemic fungal dis24 ease. 


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1 (E) Other individuals whose expertise is 

2 determined by the Secretary to be beneficial to 

3 the functioning of the Working Group. 

4 (d) MEETINGS.—The Working Group shall meet not 

5 less frequently than annually. 

6 (e) REPORTING.—Not later than 1 year after the 

7 date of enactment of this Act, and annually thereafter 

8 until termination of the Working Group pursuant to sub9 section (g), the Secretary shall— 

10 (1) submit a report on recommendations re11 ceived under subsection (b)(1) to the Committee on 

12 Health, Education, Labor, and Pensions of the Sen13 ate and the Committee on Energy and Commerce of 

14 the House of Representatives; and 

15 (2) make such report publicly available on the 

16 website of the Department of Health and Human 

17 Services. 

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

19 shall be treated as an advisory committee subject to the 

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

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

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

23 Act. 

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

25 section, the term ‘‘endemic fungal disease’’ means blastoVerDate Sep 11 2014 03:06 Dec 28, 2023 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3464.IS S3464

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1 mycosis, coccidioidomycosis, histoplasmosis, and 

2 sparotrichosis. 

3 SEC. 4. EXPANDING TROPICAL DISEASE PRODUCT PRI4 ORITY REVIEW VOUCHER PROGRAM TO EN5 COURAGE PREVENTION AND TREATMENT OF 

6 COCCIDIOIDOMYCOSIS. 

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

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

9 (1) by redesignating subparagraph (S) as sub10 paragraph (T); and 

11 (2) by inserting after subparagraph (R) the fol12 lowing: 

13 ‘‘(S) Coccidioidomycosis.’’. 

14 SEC. 5. COMBATING ANTIMICROBIAL RESISTANCE BIO15 PHARMACEUTICAL ACCELERATOR PROGRAM. 

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

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

18 by adding at the end the following: 

19 ‘‘(H) COMBATING ANTIMICROBIAL RESIST20 ANCE BIOPHARMACEUTICAL ACCELERATOR PRO21 GRAM.— 

22 ‘‘(i) IN GENERAL.—The Secretary, 

23 acting through the Director of BARDA, 

24 shall implement strategic initiatives, to be 

25 known as the Combating Antimicrobial ReVerDate Sep 11 2014 03:06 Dec 28, 2023 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3464.IS S3464

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1 sistance Biopharmaceutical Accelerator 

2 Program, including by building on existing 

3 programs and by awarding contracts, 

4 grants, and cooperative agreements, or en5 tering into other transactions— 

6 ‘‘(I) to optimize the use of 

7 antimicrobials in human health set8 tings; 

9 ‘‘(II) to support innovative can10 didate products in preclinical and clin11 ical development that reduce anti12 microbial resistance; and 

13 ‘‘(III) to support research with 

14 respect to infection prevention and 

15 control to slow the spread of resistant 

16 bacteria, fungi, and viruses. 

17 ‘‘(ii) REFERENCES.—Except as other18 wise specified, any reference to the Com19 bating Antibiotic Resistant Bacteria Bio20 pharmaceutical Accelerator or the CARB21 X program in any statute, Executive order, 

22 rule, regulation, directive, or other Federal 

23 document is deemed to be a reference to 

24 the Combating Antimicrobial Resistance 


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1 Biopharmaceutical Accelerator Program 

2 under this subparagraph. 

3 ‘‘(iii) AUTHORIZATION OF APPROPRIA4 TIONS.— 

5 ‘‘(I) IN GENERAL.—To carry out 

6 the program under clause (i), there is 

7 authorized to be appropriated 

8 $500,000,000 for the period of fiscal 

9 years 2024 through 2028, to remain 

10 available until expended. 

11 ‘‘(II) REQUIREMENT.—Of the 

12 amounts made available to carry out 

13 the program under clause (i) for the 

14 period of fiscal years 2024 through 

15 2028, not less than 20 percent shall 

16 be used to support antifungal product 

17 development.’’. 

Æ 


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