; (E) such samples of such drug and of the articles used as components thereof as the Secretary may require; (F) specimens of the labeling proposed to be used for such drug; (G) any assessments required under section 505B; and (H) patent information, with respect to each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug, and consistent with the following requirements: (i) The applicant shall file with the application the patent number and the expiration date of— (I) any patent which claims the drug for which the applicant submitted the application and is a drug substance (including active ingredient) patent or a drug product (including formulation and composition) patent; and (II) any patent which claims the method of using such drug. (ii) If an application is filed under this subsection for a drug and a patent of the type described in clause (i) which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include such patent information. Upon approval of the application, the Secretary shall publish the information submitted under subparagraph (H). The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by subparagraph (A). . (b) Conforming changes to requirements for subsequent submission of patent information Section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(7) ) is amended— (1) by inserting after the patent number and the expiration date of any patent which the following: fulfills the criteria in subsection (b) and