; or (II) an individual involved in a program of the Department. (ii) Unapproved products The Secretary may accept a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) as part of a gift, bequest, or devise under this paragraph only if such drug or device is— (I) a drug that is approved under section 505 of such Act, that meets the requirements for marketing under section 505G of such Act, or that is licensed under section 351 of this Act; (II) a device that is approved under section 515 of the Federal Food, Drug, and Cosmetic Act, that is classified under section 513(f)(2) of such Act, that is licensed under section 351 of this Act, that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or for which a report is not required under such section 510(k); (III) authorized for emergency use in accordance with section 564 or 564A of the Federal Food, Drug, and Cosmetic Act or prepositioned for use in accordance with section 564B of such Act; (IV) authorized for investigational use under section 505, 512, or 520 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act; (V) determined by the Commissioner of Food and Drugs to be appropriate for use, without approval, licensure, authorization, or clearance, to respond to a shortage or potential shortage situation; or (VI) a respiratory protective device approved and determined to be a priority, as described in section 319F–3(i)(1)(D) of this Act. (C) Report (i) In general The Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate an annual report disclosing— (I) any gift, bequest, or devise that was accepted under this paragraph during the year covered by the report; (II) how the gifts, bequests, and devises contribute to the mission of the stockpile