; and (B) the provision of such eligible investigational drug occurs in compliance with the applicable requirements set forth in sections 312.7 and 312.8(d)(1) of title 21, Code of Federal Regulations (or any successor regulations) that apply to investigational drugs, subject to paragraph (5). (3) Notification The condition specified in this paragraph, with respect to an eligible investigational drug referred to in paragraph (1), is that the sponsor of such eligible investigational drug notifies the Secretary of the provision of such eligible investigational drug for use by an eligible patient pursuant to this section. Such notification shall be submitted within 7 business days of the provision of such eligible investigational drug as correspondence to the investigational new drug application described in subsection (a)(2). (4) Adverse event reporting The condition specified in this paragraph, with respect to an eligible investigational drug referred to in paragraph (1), is that the sponsor or manufacturer of such eligible investigational drug has required, as a condition of providing the drug to a physician for use by an eligible patient pursuant to this section, that such physician will immediately report to such sponsor or manufacturer any serious adverse events, as such term is defined in section 312.32 of title 21, Code of Federal Regulations (or any successor regulations), associated with the use of the eligible investigational drug by the eligible patient. (5) Application For purposes of this section, the requirements set forth in sections 312.7 and 312.8(d)(1) of title 21 of the Code of Federal Regulations (or any successor regulations) are deemed to apply to any person who manufactures, distributes, prescribes, dispenses, introduces or delivers for introduction into interstate commerce, or provides to an eligible patient an eligible investigational drug pursuant to this section. (c) Use of clinical outcomes (1) In general Notwithstanding any other provision of this Act, the Public Health Service Act, or