is amended by adding at the end the following: (f) Liability (1) Alleged acts or omissions (A) Manufacturer or sponsor No manufacturer or sponsor (or their agent or representative) of an investigational drug shall be liable for any alleged act or omission related to the provision of such drug to a single patient or small group of patients for treatment use in accordance with subsection (b) or (c) of section 561 or the provision of an eligible investigational drug to an eligible patient in accordance with this section, including, with respect to the provision of an investigational drug under section 561 or an eligible investigational drug under this section, the reporting of safety information, from clinical trials or any other source, as required by section 312.32 of title 21, Code of Federal Regulations (or any successor regulations). (B) Physician, clinical investigator, or hospital (i) No licensed physician, clinical investigator, or hospital shall be liable for any alleged act or omission related to the provision of an investigational drug to a single patient or small group of patients for treatment use in accordance with subsection (b) or (c) of section 561, as described in clause (ii), or the provision of an eligible investigational drug to an eligible patient in accordance with this section, unless such act or omission constitutes on the part of such physician, clinical investigator, or hospital with respect to such investigational drug or eligible investigational drug— (I) willful or criminal misconduct