Sec. 704. Antifungal research and development
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Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) of antifungal therapies designed to treat coccidioidomycosis (commonly known as Valley Fever).
Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance. To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Secretary of Health and Human Services shall hold a public workshop.
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