This Act may be cited as the “Medical Marijuana Research Act”.

(a) Production and supply.—The Secretary of Health and Human Services—

(1) until the date on which the Secretary determines that manufacturers and distributors (other than the Federal Government) can ensure a sufficient supply of marijuana (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by section 8) intended for research by qualified marijuana researchers registered pursuant to paragraph (3) of section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)), as added by section 3, shall—

(A) continue, through grants, contracts, or cooperative agreements, to produce marijuana through the National Institute on Drug Abuse Drug Supply Program;

(B) not later than one year after the date of enactment of this Act, act jointly with the Attorney General of the United States to establish and implement a specialized process for manufacturers and distributors, notwithstanding the registration requirements of section 303 of such Act (21 U.S.C. 823), to supply qualified marijuana researchers with marijuana products—

(i) available through State-authorized marijuana programs; and

(ii) consistent with the guidance issued under subsection (c); and

(C) not later than 60 days after the date of enactment of this Act, jointly convene with the Attorney General a meeting to initiate the development of the specialized process described in subparagraph (B); and

(2) beyond the date specified in paragraph (1), may, at the Secretary’s discretion, continue—

(A) through grants, contracts, or cooperative agreements, to so produce marijuana; and

(B) to implement such specialized process.

(b) Requirement to verify registration.—Before supplying marijuana to any person through the National Institute on Drug Abuse Drug Supply Program or through implementation of the specialized process established under subsection (a)(1)(B), the Secretary of Health and Human Services shall—

(1) require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section 303(f)(3) of the Controlled Substances Act, as added by subsection (d) of this section, or a manufacturer duly registered under section 303(l) of the Controlled Substances Act, as added by section 3 of this Act; and

(2) not later than 60 days after receipt of such documentation, review such documentation and verify that the marijuana will be used for such research (and for no other purpose authorized pursuant to this Act or the amendments made by this Act).

(c) Guidance on Use of State-authorized marijuana programs.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance related to marijuana from State-authorized marijuana programs for research.

(d) Research.—Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended—

(1) by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively;

(2) by striking “(f) The Attorney General” and inserting “(f)(1) The Attorney General”;

(3) by striking “Registration applications” and inserting the following:

“(2) Registration applications”;

(4) in paragraph (2), as so designated, by striking “schedule I” each place that term appears and inserting “schedule I, except marijuana,”;

(5) by striking “Article 7” and inserting the following:

“(4) Article 7”; and

(6) by inserting before paragraph (4), as so designated, the following:

“(3) (A) The Attorney General shall register the applicant to conduct research with marijuana if—

“(i) the applicant is authorized to dispense, or conduct research with respect to, controlled substances in schedule I, II, III, IV, or V;

“(ii) the applicant is compliant with, and authorized to conduct the activities described in clause (i) under, the laws of the State in which the applicant practices; and

“(iii) in the case of an applicant pursuing clinical research, the applicant’s clinical research protocol has been reviewed and authorized to proceed by the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act.

“(B) An applicant registered under subparagraph (A) shall be referred to in this section as a ‘qualified marijuana researcher’.

“(C) (i) Not later than 60 days after the date on which the Attorney General receives a complete application for registration under this paragraph, the Attorney General shall approve or deny the application.

“(ii) For purposes of clause (i), an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under subparagraph (A) are satisfied.

“(iii) In the case of a denial under clause (i), the Attorney General shall provide a written explanation of the basis for the denial.

“(D) The Attorney General shall grant an application for registration under this paragraph unless the Attorney General determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered:

“(i) The applicant’s experience in dispensing, or conducting research with respect to, controlled substances.

“(ii) The applicant’s conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

“(iii) Compliance with applicable State or local laws relating to controlled substance misuse or diversion.

“(iv) Such other conduct which may threaten the public health and safety.

“(E) (i) A qualified marijuana researcher shall store marijuana to be used in research in a securely locked, substantially constructed cabinet.

“(ii) Except as provided in clause (i), any security measures required by the Attorney General for applicants conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for applicants conducting research on other controlled substances in schedule II that have a similar risk of diversion and abuse.

“(F) (i) If the Attorney General grants an application for registration under this paragraph, the applicant may amend or supplement the research protocol and proceed with the research under such amended or supplemented protocol, without additional review or approval by the Attorney General or the Secretary of Health and Human Services if the applicant does not change the type of marijuana, the source of the marijuana, or the conditions under which the marijuana is stored, tracked, or administered.

“(ii) If an applicant amends or supplements the research protocol or initiates research on a new research protocol under clause (i), the applicant shall, in order to renew the registration under this paragraph, provide notice to the Attorney General of the amended or supplemented research protocol or any new research protocol in the applicant’s renewal materials.

“(iii) (I) If an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of marijuana, the source of the marijuana, or conditions under which the marijuana is stored, tracked, or administered, the applicant shall provide notice to the Attorney General not later than 30 days before proceeding on such amended or supplemental research or new research protocol, as the case may be.

“(II) If the Attorney General does not object during the 30-day period following a notification under subclause (I), the applicant may proceed with the amended or supplemental research or new research protocol.

“(iv) The Attorney General may object to an amended or supplemental protocol or a new research protocol under clause (i) or (iii) only if additional security measures are needed to safeguard against diversion or abuse.

“(G) If marijuana is listed on a schedule other than schedule I, the provisions of paragraphs (1), (2), and (4) that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound, as applicable, in lieu of the provisions of subparagraphs (A) through (F) of this paragraph.

“(H) Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 505(i) of the Federal Food, Drug, and Cosmetic Act or over requirements related to research protocols, including changes in—

“(i) the method of administration of marijuana;

“(ii) the dosing of marijuana; and

“(iii) the number of individuals or patients involved in research.”.

Section 303 of the Controlled Substances Act (21 U.S.C. 823), as amended by section 2, is further amended by adding at the end the following:

The Secretary of Health and Human Services may not—

Immediately upon the approval by the Food and Drug Administration of an application for a drug that contains marijuana (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by section 8 of this Act) under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and (irrespective of whether any such approval is granted) not later than the date that is 5 years after the date of enactment of this Act, the Secretary of Health and Human Services shall—

Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended by adding at the end the following:

Article 28 of the Single Convention on Narcotic Drugs shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act (21 U.S.C. 801 et seq.), this Act, and the amendments made by this Act.

(a) Qualified marijuana researcher.—In this Act, the term “qualified marijuana researcher” has the meaning given the term in section 303(f)(3) of the Controlled Substances Act, as added by section 2(d) of this Act.

(b) Updating term.—Section 102(16) of the Controlled Substances Act (21 U.S.C. 802(16)) is amended—

(1) in subparagraph (A), by striking “the term ‘marihuana’ means” and inserting “the terms ‘marihuana’ and ‘marijuana’ mean”; and

(2) in subparagraph (B), by striking “The term ‘marihuana’ does not” and inserting “The terms ‘marihuana’ and ‘marijuana’ do not”.

The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled “Budgetary Effects of PAYGO Legislation” for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.