; or (II) if the biological product has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety, purity, or potency reasons; and (ii) a notice of the removal shall be published in the Federal Register. . 332. Review and report on types of information to be listed Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services shall— (1) solicit public comment regarding the type of information, if any, that should be added to or removed from the list required by paragraph (9) of section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ), as added by section 331; and (2) transmit to Congress an evaluation of such comments, including any recommendations about the types of information that should be added to or removed from the list. E Orange Book 341. Orange Book (a) Submission of patent information for brand name drugs Paragraph (1) of section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) is amended to read as follows: (b) (1) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (A) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (B) a full list of the articles used as components of such drug; (C) a full statement of the composition of such drug; (D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (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