; 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 an essential device to make by a specified date any labeling change regarding the expiration period that the Secretary determines to be appropriate based on the data and information required to be submitted under this section 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. . (b) Civil monetary penalty Section 303(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f) ) is amended by adding at the end the following: (10) Civil monetary penalty with respect to extended shelf life dates for essential devices If the manufacturer of a device subject to notification requirements under section 506J violates section 506K by failing to submit data and information as required under section 506K(b)(1), failing to conduct or submit the results of studies as required under section 506K(b)(3), or failing to make a labeling change as required under section 506K(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. . (c) Emergency use eligible products Subparagraph (A) of section 564A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3a(a)(1)) is amended to read as follows: (A) is approved or cleared under this chapter, otherwise listed as a device pursuant to section 510(j), conditionally approved under section 571, or licensed under section 351 of the Public Health Service Act