; or (B) any information related to the clinical outcomes experienced by a terminally ill patient supplied an investigational drug or device pursuant to this section. (2) Exception Nothing in this subsection prevents the sponsor of a clinical trial from voluntarily disclosing, collecting, or reporting information to the Food and Drug Administration. (d) Definition of investigational drug or device In this section, the term investigational drug or device means a drug or device that— (1) has not yet been approved, licensed, or cleared for commercial distribution under section 505, 510(k), or 515 of this Act or section 351 of the Public Health Service Act, and cannot otherwise be lawfully marketed in the United States; and (2) is or has been the subject of one or more clinical trials. . 3. Liability protection The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) is amended by inserting after section 561A, as inserted by section 2 of this Act, the following: 561B. Liability protection Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device in accordance with section 561A shall not be liable in any action under Federal or State law for any loss, damage, or injury arising out of, relating to, or resulting from— (1) the design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or (2) the safety or effectiveness of the drug or device. .