; (ii) life-sustaining; or (iii) intended for use in the prevention or treatment of a debilitating disease or condition in humans or animals, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act. (2) Medical countermeasure The term medical countermeasure means a countermeasure as defined in section 565(a). (e) Confidentiality Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. . (b) Prohibited act Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 3503(a)(1)(A) of division FF of Public Law 117–328 , is amended by inserting at the end the following new subsection: (jjj) The failure to comply with any order issued under section 506M. . (c) Penalties Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended by inserting at the end the following: (9) If a manufacturer of a life-saving drug fails to submit data and information as required under section 506M(b)(1), fails to conduct or submit the data and information generated by studies as required under section 506M(b)(2), or fails to make a labeling change as required under section 506M(c), such manufacturer shall be subject to a civil penalty of not more than $10,000 for the first day on which the violation occurs and not more than $10,000 for each subsequent day on which the violation is not corrected. . B Drug origin transparency 511. Enhanced drug manufacturing amount information reporting (a) In general Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j)(3) ) is amended— (1) in subparagraph (A), by adding or (2) after paragraph (1)