; or (B) the sponsor requests use of such outcomes. (2) Limitation If the Secretary makes a determination under paragraph (1)(A), the Secretary shall provide written notice of such determination to the sponsor, including a public health justification for such determination, and such notice shall be made part of the administrative record. Such determination shall not be delegated below the director of the agency center that is charged with the premarket review of the eligible investigational drug. (d) Reporting The manufacturer or sponsor of an eligible investigational drug that provides an eligible investigational drug pursuant to this section shall post on the same publicly available internet website used by the manufacturer for purposes of section 561A(b) an annual summary of any provision by the manufacturer or sponsor of an eligible investigational drug under this section. The summary shall include the number of requests received, the number of requests granted, the number of patients treated, the therapeutic area of the drug made available, and any known or suspected 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. (e) Rule of construction Nothing in this section shall be construed as limiting the authority of the Secretary to require manufacturers or sponsors of investigational drugs to review and report information relevant to the safety of such investigational drug obtained or otherwise received by the sponsor pursuant to part 312 of title 21, Code of Federal Regulations (or successor regulations). . (b) No liability Section 561B of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), 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