Sec. 103. APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH

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## SEC. 103 APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH ###

(a)In General Section 303 of the Controlled Substances Act (21 U.S.C. 823), as amended by sections 101 and 102 of this Act, is further amended— ####

(1)by redesignating subsections

(c)through

(k)as subsections

(d)through (l), respectively; ####

(2)by inserting after subsection

(b)the following: > > ### “(c) > > > ####

(1)> > > #####

(A)> > As it relates to applications to manufacture marijuana for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this Act to manufacture marijuana to supply appropriately registered researchers in the United States, the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— > > > ###### “(i) > > approve the application; or > > > ###### “(ii) > > request supplemental information. > > > ##### “(B) > > For purposes of subparagraph (A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following: > > > ###### “(i) > > The requirements designated in the notice in the Federal Register are satisfied. > > > ###### “(ii) > > The requirements under this Act are satisfied. > > > ###### “(iii) > > The applicant will limit the transfer and sale of any marijuana manufactured under this subsection— > > > ###### “(I) > > to researchers who are registered under this Act to conduct research with controlled substances in schedule I; 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 marijuana 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 Medical Marijuana and Cannabidiol Research Expansion Act. > > > ###### “(vii) > > The applicant is licensed by each State in which the applicant will conduct operations under this subsection, to manufacture marijuana, 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 (52)(B)— ######

(I)by striking “303(f)” each place it appears and inserting “303(g)”; and ######

(II)in clause (i), by striking “(d), or (e)” and inserting “(e), or (f)”; and ######

(ii)in paragraph (54), by striking “303(f)” each place it appears and inserting “303(g)”; #####

(B)in section 302(g)(5)(A)(iii)(I)(bb) (21 U.S.C. 822(g)(5)(A)(iii)(I)(bb)), by striking “303(f)” and inserting “303(g)”; #####

(C)in section 304 (21 U.S.C. 824), by striking “303(g)(1)” each place it appears and inserting “303(h)(1)”; #####

(D)in section 307(d)(2) (21 U.S.C. 827(d)(2)), by striking “303(f)” and inserting “303(g)”; #####

(E)in section 309A(a)(2) (21 U.S.C. 829a(a)(2)), in the matter preceding subparagraph (A), by striking “303(g)(2)” and inserting “303(h)(2)”; #####

(F)in section 311(h) (21 U.S.C. 831(h)), by striking “303(f)” each place it appears and inserting “303(g)”; #####

(G)in section 401(h)(2) (21 U.S.C. 841(h)(2)), by striking “303(f)” each place it appears and inserting “303(g)”; #####

(H)in section 403(c)(2)(B) (21 U.S.C. 843(c)(2)(B)), by striking “303(f)” and inserting “303(g)”; and #####

(I)in section 512(c)(1) (21 U.S.C. 882(c)(1)) by striking “303(f)” and inserting “303(g)”. ####

(2)Section 1008(c) of the Controlled Substances Import and Export Act (21 U.S.C. 958(c)) is amended— #####

(A)in paragraph (1), by striking “303(d)” and inserting “303(e)”; and #####

(B)in paragraph (2)(B), by striking “303(h)” and inserting “303(i)”. ####

(3)Title V of the Public Health Service Act (42 U.S.C. 290aa et seq.) is amended— #####

(A)in section 520E-4(c) (42 U.S.C. 290bb-36d(c)), by striking “303(g)(2)(B)” and inserting “303(h)(2)(B)”; and #####

(B)in section 544(a)(3) (42 U.S.C. 290dd-3(a)(3)), by striking “303(g)” and inserting “303(h)”. ####

(4)Title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) is amended— #####

(A)in section 1833(bb)(3)(B) (42 U.S.C. 1395l(bb)(3)(B)), by striking “303(g)” and inserting “303(h)”; #####

(B)in section 1834(o)(3)(C)(ii) (42 U.S.C. 1395m(o)(3)(C)(ii)), by striking “303(g)” and inserting “303(h)”; and #####

(C)in section 1866F(c)(3)(C) (42 U.S.C. 1395cc-6(c)(3)(C)), by striking “303(g)” and inserting “303(h)”. ####

(5)Section 1903(aa)(2)(C)(ii) of the Social Security Act (42 U.S.C. 1396b(aa)(2)(C)(ii)) is amended by striking “303(g)” each place it appears and inserting “303(h)”.

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