S3464-118

1. Short title; table of contents 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. The table of contents for this Act is as follows:

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: The Director of the Institute shall— 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 subject to the availability of appropriations, make grants to, or enter into contracts with, public or nonprofit private entities to conduct such research. 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. 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. 447E.Endemic fungal diseases(a)In generalThe 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)ReportsThe 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 appropriationsIn 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 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— to provide expertise and to review all efforts within the Department of Health and Human Services related to fungal disease in the United States; to help ensure interagency coordination and minimize overlap with respect to such disease; and to examine research priorities with respect to such disease. The Working Group shall— make recommendations to the Secretary, including an updated strategy related to development of therapeutics and vaccines for endemic fungal diseases, that shall— take into account ongoing fungal disease research, including for animals, that may be adapted for human use; 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 include recommendations for congressional action to spur additional research and product development for fungal diseases; and 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. The members of the Working Group shall represent a diversity of scientific disciplines and shall be composed of the following members: Seven Federal members, consisting of one or more representatives of each of the following: The Office of the Assistant Secretary for Health, who shall serve as Chair. The Food and Drug Administration. The Centers for Disease Control and Prevention. The National Institutes of Health, who shall serve as Vice Chair. Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate. Seven non-Federal public members, consisting of representatives of the following categories: Physicians, veterinarians, and other medical providers with experience in diagnosing and treating endemic fungal disease. Scientists or researchers with expertise in endemic fungal disease. Patients who have been diagnosed with an endemic fungal disease and family members or caregivers of such patients, as applicable. Nonprofit organizations that advocate for patients with respect to endemic fungal disease. Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. The Working Group shall meet not less frequently than annually. 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— 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 make such report publicly available on the website of the Department of Health and Human Services. The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.). The Working Group under this section shall terminate 5 years after the date of enactment of this Act. 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— by redesignating subparagraph (S) as subparagraph (T); and by inserting after subparagraph (R) the following: Coccidioidomycosis. (S)Coccidioidomycosis..