II 118th CONGRESS 1st Session S. 3464 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. Short title; table of contents (a) In general This Act may be cited as the Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2023 or the FORWARD Act of 2023 . (b) Table of contents The table of contents for this Act is as follows: 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. 2. Continuing support for research on endemic fungal diseases The Public Health Service Act is amended by inserting after section 447D of such Act ( 42 U.S.C. 285f–5 ) the following new section: 447E. Endemic fungal diseases (a) In general The Director of the Institute shall— (1) continue to conduct or support basic, translational, and clinical research related to fungal diseases found in the United States, including coccidioidomycosis (commonly known as and referred to in this section as Valley Fever ); and (2) subject to the availability of appropriations, make grants to, or enter into contracts with, public or nonprofit private entities to conduct such research. (b) Reports The Director of the Institute shall ensure that each triennial report under section 403 includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to such fungal diseases, including coccidioidomycosis. (c) Authorization of appropriations In addition to other amounts available for the purposes of carrying out this section, there is authorized to be appropriated to carry out this section $20,000,000 for each of fiscal years 2024 through 2028 for such purpose. . 3. Endemic fungal disease working group (a) Establishment The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall establish a working group, to be known as the Endemic Fungal Disease Working Group (referred to in this section as the Working Group ), comprised of representatives of appropriate Federal agencies and other non-Federal entities— (1) to provide expertise and to review all efforts within the Department of Health and Human Services related to fungal disease in the United States; (2) to help ensure interagency coordination and minimize overlap with respect to such disease; and (3) to examine research priorities with respect to such disease. (b) Duties The Working Group shall— (1) make recommendations to the Secretary, including an updated strategy related to development of therapeutics and vaccines for endemic fungal diseases, that shall— (A) take into account ongoing fungal disease research, including for animals, that may be adapted for human use; (B) identify gaps in endemic fungal disease research, including basic, clinical, and translational research related to the pathogenesis, prevention, diagnosis, and treatment of such diseases; and (C) include recommendations for congressional action to spur additional research and product development for fungal diseases; and (2) in implementing this subsection, solicit input from States, Tribes, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, and surveillance activities. (c) Membership The members of the Working Group shall represent a diversity of scientific disciplines and shall be composed of the following members: (1) Federal members Seven Federal members, consisting of one or more representatives of each of the following: (A) The Office of the Assistant Secretary for Health, who shall serve as Chair. (B) The Food and Drug Administration. (C) The Centers for Disease Control and Prevention. (D) The National Institutes of Health, who shall serve as Vice Chair. (E) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate. (2) Non-Federal public members Seven non-Federal public members, consisting of representatives of the following categories: (A) Physicians, veterinarians, and other medical providers with experience in diagnosing and treating endemic fungal disease. (B) Scientists or researchers with expertise in endemic fungal disease. (C) Patients who have been diagnosed with an endemic fungal disease and family members or caregivers of such patients, as applicable. (D) Nonprofit organizations that advocate for patients with respect to endemic fungal disease. (E) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. (d) Meetings The Working Group shall meet not less frequently than annually. (e) Reporting Not later than 1 year after the date of enactment of this Act, and annually thereafter until termination of the Working Group pursuant to subsection (g), the Secretary shall— (1) submit a report on recommendations received under subsection (b)(1) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and (2) make such report publicly available on the website of the Department of Health and Human Services. (f) Applicability of FACA The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.). (g) Sunset The Working Group under this section shall terminate 5 years after the date of enactment of this Act. (h) Endemic fungal disease defined In this section, the term endemic fungal disease means blastomycosis, coccidioidomycosis, histoplasmosis, and sparotrichosis. 4. Expanding tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(3) ) is amended— (1) by redesignating subparagraph (S) as subparagraph (T); and (2) by inserting after subparagraph (R) the following: (S) Coccidioidomycosis. . 5. Combating antimicrobial resistance biopharmaceutical accelerator program Paragraph (4) of section 319L(c) of the Public Health Service Act (42 U.S.C. 247d–7e(c)) is amended by adding at the end the following: (H) Combating antimicrobial resistance biopharmaceutical accelerator program (i) In general The Secretary, acting through the Director of BARDA, shall implement strategic initiatives, to be known as the Combating Antimicrobial Resistance Biopharmaceutical Accelerator Program, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions— (I) to optimize the use of antimicrobials in human health settings; (II) to support innovative candidate products in preclinical and clinical development that reduce antimicrobial resistance; and (III) to support research with respect to infection prevention and control to slow the spread of resistant bacteria, fungi, and viruses. (ii) References Except as otherwise specified, any reference to the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator or the CARB-X program in any statute, Executive order, rule, regulation, directive, or other Federal document is deemed to be a reference to the Combating Antimicrobial Resistance Biopharmaceutical Accelerator Program under this subparagraph. (iii) Authorization of appropriations (I) In general To carry out the program under clause (i), there is authorized to be appropriated $500,000,000 for the period of fiscal years 2024 through 2028, to remain available until expended. (II) Requirement Of the amounts made available to carry out the program under clause (i) for the period of fiscal years 2024 through 2028, not less than 20 percent shall be used to support antifungal product development. .