; and (3) other evidence as the Secretary may determine. (d) Applications under sections 505(b)(2) and 505(j) (1) In general A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug, whether derived from investigations or studies required under this section or derived from other sources, when the omitted information is protected by patent or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(B). (2) Labeling Notwithstanding clauses (iii) and (iv) of section 505(j)(5)(B), the Secretary may require that the labeling of a drug approved under section 505(j) that omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug include a statement of any appropriate contraindications, warnings, or precautions related to the disparity that the Secretary considers necessary. . (b) Enforcement Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: (ee) If it is a drug and the holder of the approved application under section 505 or license under section 351 of the Public Health Service Act for the drug has failed to complete the investigations or studies, or comply with any other requirement, of section 505G. . (c) Drug fees Section 736(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h ) is amended by adding after are required the following: , including supplements required under section 505G . 111. Improving health data regarding Native Hawaiians and other Pacific Islanders Part B of title III of the Public Health Service Act ( 42 U.S.C. 243 et seq.) is amended by inserting after section 317U, as added, the following: 317V. Native Hawaiian and other Pacific