; (II) reckless misconduct; (III) gross negligence relative to the applicable standard of care and practice with respect to the administration or dispensing of such investigational drug; or (IV) an intentional tort under applicable State law. (ii) The requirements described in this clause are the requirements under subsection (b) or (c) of section 561, including— (I) 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); (II) ensuring that the informed consent requirements of part 50 of title 21, Code of the Federal Regulations (or any successor regulations) are met; and (III) ensuring that review by an institutional review board is obtained in a manner consistent with the requirements of part 56 of title 21, Code of the Federal Regulations (or any successor regulations). (2) Determination not to provide drug No manufacturer, sponsor, licensed physician, clinical investigator, or hospital shall be liable for determining not to provide access to an investigational drug under this section or for discontinuing any such access that it initially determined to provide. (3) Limitation (A) In general Except as set forth in paragraphs (1) and (2), nothing in this section shall be construed to modify or otherwise affect the right of any person to bring a private action against a manufacturer or sponsor (or their agent or representative), physician, clinical investigator, hospital, prescriber, dispenser, or other entity under any State or Federal product liability, tort, consumer protection, or warranty law. (B) Federal Government Nothing in this section shall be construed to modify or otherwise affect the authority of the Federal Government to bring suit under any Federal law. .