Sec. 4. Definitions
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In this Act: The term biological product has the meaning given such term in section 351 of the Public Health Service Act (42 U.S.C. 262). The term drug has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). The term dual use product means a product that is a qualifying treatment for HIV/AIDS and that has a significant use for other diseases. The term Fund means the Prize Fund for HIV/AIDS established under section 7. The term market clearance means the approval of an application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or the approval of a biologics license application under subsection
(a)of section 351 of the Public Health Service Act (42 U.S.C. 262). The term qualifying treatment for HIV/AIDS means an antiretrovial drug, biological product, vaccine, or other treatment primarily used for HIV/AIDS that has been certified as a qualifying product by the Secretary of Health and Human Services, for purposes of the Prize Fund for HIV/AIDS.
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