; and (II) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption under 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ). (iv) The applicant will transfer or sell any marihuana manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. (v) The applicant has completed the application and review process under subsection (a) for the bulk manufacture of controlled substances in schedule I. (vi) The applicant has established and begun operation of a process for storage and handling of controlled substances in schedule I, including for inventory control and monitoring security in accordance with section 105 of the Cannabidiol and Marihuana Research Expansion Act . (vii) The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marihuana, if that State requires such a license. (C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under subparagraph (A)(ii) with respect to an application, the Attorney General shall approve or deny the application. (2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant. ; (3) in subsection (h)(2), as so redesignated, by striking subsection (f) each place it appears and inserting subsection (g) ; (4) in subsection (j)(1), as so redesignated, by striking subsection (d) and inserting subsection (e) ; and (5) in subsection (k), as so redesignated, by striking subsection (f) each place it appears and inserting subsection (g) . (b) Technical and conforming amendments (1) The Controlled Substances Act ( 21 U.S.C. 801 et seq.) is amended— (A) in section 102 ( 21 U.S.C. 802 )— (i) in paragraph (16)(B)— (I) in clause (i), by striking or at the end; (II) by redesignating clause (ii) as (iii)