Pub. L. 117-328, div. FF, tit. III, subtit. B, ch. 1, sec. 3211

ANTIFUNGAL RESEARCH AND DEVELOPMENT.

EnactedYear: 2022Length: 145 wordsOfficial source
SEC. 3211. ANTIFUNGAL RESEARCH AND DEVELOPMENT.(a) Draft Guidance.—Not later than 3 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensure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). (b) Final Guidance.—Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant 136 STAT. 5826 to subsection (a), the Secretary, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance. (c) Workshop.—To assist entities developing preventive vaccines for fungal infections and coccidioidomycosis, the Secretary shall hold a public workshop.
Pub. L. 117-328, div. FF, tit. III, subtit. B, ch. 1, sec. 3211: ANTIFUNGAL RESEARCH AND DEVELOPMENT. | Justis AI