; and (B) submit to the Secretary the results, data, and information generated by such studies when available. (c) Labeling The Secretary may issue an order requiring the manufacturer of a life-saving drug to, by a specified date, make any labeling change regarding the expiration date that the Secretary determines to be appropriate based on the data and information required to be submitted under this section in accordance with labeling requirements under subparts F and G of part 211 of title 21, Code of Federal Regulations (or any successor regulations) or any other data and information available to the Secretary. (d) 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. (e) Definition In this section, the term life-saving drug means a drug described in section 506C(a). . (b) Civil monetary penalty Section 303(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(b) ) is amended by adding at the end the following: (9) (A) If a manufacturer fails to submit data and information as required under section 506C–2(b)(1), fails to conduct or submit the results, data, and information generated by studies as required under section 506C–2(b)(3), or fails to make a labeling change as required under section 506C–2(c), such manufacturer shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation. (B) If a violation described in subparagraph (A) is not corrected within the 30-day period following notification by the Secretary of a violation described in subparagraph (A), the manufacturer shall, in addition to any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected. . 3. Reporting on increases in demand for a drug (a) In