,i #aafth ,,congress #ast ,session ,h4 ,r4 #cgig ,,in ,,the ,,house ,,of ,,representatives ,july #ag1 #bjai,mr4 ,blumenauer 7for himself1 ,mr4 ,harris1 ,ms4 ,lofgren1 ,mr4 ,griffith1 ,mr4 ,bishop of ,utah1 and ,mrs4 ,dingell7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend the ,controlled ,substances ,act to make marijuana accessible for use by qualified marijuana researchers for medical purposes1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,marijuana ,research ,act of #bjai4 #b4 ,production and supply 7a7 ,in general ,the ,secretary of ,health and ,human ,services-- 7#a7 until the date on which the ,secretary determines that manufacturers and distributors 7other than the ,federal ,government7 can ensure a sufficient supply of marijuana for qualified marijuana researchers intended for medical research1 shall-- 7,a7 continue to produce marijuana through the ,national ,institute on ,drug ,abuse 7,,nida7 ,drug ,supply ,program2 and 7,b7 offer for sale immature marijuana plants and the seeds of marijuana-- 7i7 to all qualified marijuana researchers who submit a request for such plants or seeds to engage in research pursuant to the section #cjc7;f77#c7 of the ,controlled ,substances ,act1 as amended by section #c2 and 7ii7 in quantities sufficient to produce an adequate supply of marijuana for such research2 and 7#b7 beyond the date specified in paragraph 7#a71 may1 at the ,secretary's discretion1 continue to so produce and supply marijuana4 7b7 ,requirement ,to verify registration ,before supplying marijuana to any person through the ,national ,institute on ,drug ,abuse ,drug ,supply ,program1 the ,secretary of ,health and ,human ,services shall-- 7#a7 require the person to submit documentation demonstrating that the person is a qualified marijuana researcher seeking to conduct research pursuant to section #cjc7;f77#c7 of the ,controlled ,substances ,act1 as amended by section #c2 and 7#b7 not later than #cj days after receipt of such documentation1 review such documentation and verify that the marijuana will be used for such research 7and for no other purpose authorized pursuant to this ,act74 7c7 ,guidelines on production ,the ,commissioner of ,food and ,drugs1 in consultation with the ,director of the ,national ,institute on ,drug ,abuse1 shall-- 7#a7 not later than #ahj days after the date of enactment of this ,act1 issue guidelines on the production of marijuana by qualified marijuana researchers pursuant to subsection 7a77#a77;,b72 and 7#b7 encourage researchers and manufacturers that are authorized to produce or manufacture marijuana pursuant to section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc71 as amended by this ,act1 to comply with such guidelines to the extent applicable4 7d7 ,definition ,in this section3 7#a7 ,the term immature marijuana plant means a marijuana plant with no observable flowers or buds4 7#b7 ,the term qualified medical marijuana researcher means a researcher who is registered to conduct research with marijuana under section #cjc7;f77#c7 of the ,controlled ,substances ,act1 as amended by section #c4 #c4 ,facilitating marijuana research 7a7 ,in general ,section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is amended-- 7#a7 by redesignating paragraphs 7#a7 through 7#e7 as subparagraphs 7,a7 through 7,e71 respectively2 7#b7 by striking 7f7 ,the ,attorney ,general and inserting 7f77#a7 ,the ,attorney ,general2 7#c7 by striking ,registration applications and inserting the following3 7#b7 ,registration applications 2 7#d7 in paragraph 7#b71 as so designated1 by striking schedule ,i each place that term appears and inserting schedule ,i1 except marijuana12 7#e7 by striking ,article #g and inserting the following3 7#d7 ,article #g 2 and 7#f7 by inserting before paragraph 7#d71 as so designated1 the following3 7#c7 7,a7 ,the ,attorney ,general shall register a practitioner to conduct research with marijuana if-- 7i7 the applicant is authorized to dispense1 or conduct research with respect to1 controlled substances in schedules ,,ii1 ,,iii1 ,,iv1 and ,v under the laws of the ,state in which the applicant practices2 7ii7 the applicant is only using marijuana manufactured by a person registered under subsection 7l72 7iii7 the applicant's research protocol-- 7,i7 has been reviewed and allowed by-- 7aa7 the ,secretary under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772 or 7bb7 the ,national ,institutes of ,health or another ,federal agency that funds scientific research2 or 7,,ii7 in the case of nonhuman research that is not federally funded1 has been voluntarily submitted by the applicant to1 and approved by1 the ,national ,institutes of ,health2 and 7iv7 the applicant has demonstrated that there are effective procedures in place to adequately safeguard against diversion of the marijuana from legitimate medical or scientific use1 in accordance with subparagraph 7,e74 7,b7 ,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 interest4 ,in determining the public interest1 the following factors shall be considered3 7i7 ,the applicant's experience in dispensing1 or conducting research with respect to1 controlled substances4 7ii7 ,the applicant's conviction record under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of controlled substances4 7iii7 ,compliance with applicable ,state or local laws relating to controlled substance misuse or diversion4 7,c7 ,not later than #ij days after the date of enactment of the ,medical ,marijuana ,research ,act of #bjai1 for purposes of subparagraph 7,a77ii77,,ii71 the ,national ,institutes of ,health shall establish a process that-- 7i7 allows a researcher to voluntarily submit the research protocol of the researcher for review and approval2 and 7ii7 provides a researcher described in clause 7i7 with a decision not less than #cj days after the date on which the research protocol is submitted4 7,d7 7i7 ,not later than #fj days after the date on which the ,attorney ,general receives a complete application for registration under this paragraph1 the ,attorney ,general shall approve or deny the application4 7ii7 ,for purposes of clause 7i71 an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under subparagraph 7,a7 are satisfied4 7iii7 ,in the case of a denial under clause 7i71 the ,attorney ,general shall provide a written explanation of the basis for the denial and a description of any curative steps that may be taken for such request to be approved4 7,e7 7i7 ,a researcher registered under this paragraph shall store marijuana to be used in research in a securely locked1 substantially constructed cabinet4 7ii7 ,except as provided in clause 7i71 any security measures required by the ,attorney ,general for practitioners conducting research with marijuana pursuant to a registration under this paragraph shall be consistent with the security measures for practitioners conducting research on other controlled substances in schedule ,,ii that have a similar risk of diversion and abuse4 7,f7 7i7 ,if the ,attorney ,general grants an application for registration under this paragraph1 the applicant may amend or supplement the research protocol without reapplying if the applicant does not-- 7,i7 change the type of drug1 the source of the drug1 or the conditions under which the drug is stored1 tracked1 or administered2 or 7,,ii7 otherwise increase the risk of diversion4 7ii7 ,if an applicant amends or supplements the research protocol or initiates research on a new research protocol under clause 7i71 the applicant shall1 in order to renew the registration under this paragraph1 provide notice to the ,attorney ,general of the amended or supplemented research protocol or any new research protocol in the applicant's renewal materials4 7iii7 7,i7 ,if an applicant amends or supplements a research protocol and the amendment or supplement involves a change to the type of drug1 the source of the drug1 or conditions under which the drug is stored1 tracked1 or administered or otherwise increases the risk of diversion1 the applicant shall provide notice to the ,attorney ,general not later than #cj days before proceeding on such amended or supplemental research or new research protocol1 as the case may be4 7,,ii7 ,if the ,attorney ,general does not object during the #cj-;day period following a notification under subclause 7,i71 the applicant may proceed with the amended or supplemental research or new research protocol4 7iv7 ,the ,attorney ,general may object to an amended or supplemental protocol or a new research protocol under clause 7i7 or 7iii7 only if additional security measures are needed to safeguard against diversion or abuse4 7,g7 ,if marijuana or a compound of marijuana is listed on a schedule other than schedule ,i1 the provisions of paragraphs 7#a71 7#b71 and 7#d7 that apply to research with a controlled substance in the applicable schedule shall apply to research with marijuana or that compound1 as applicable1 in lieu of the provisions of subparagraphs 7,a7 through 7,g7 of this paragraph4 4 7b7 ,conforming amendment ,section #ajb7af7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7af77 is amended by inserting or marijuana after ,the term marihuana4 #d4 ,manufacture and distribution of marijuana for use in legitimate1 medical research ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc71 as amended by section #c1 is further amended by adding at the end the following3 7l7 ,registration of persons ,to manufacture and distribute marijuana for use in legitimate1 medical research 7#a7 ,registration of manufacturers ,beginning not later than the day that is #a year after the date of enactment of the ,medical ,marijuana ,research ,act of #bjai1 the ,attorney ,general shall register an applicant to manufacture marijuana to the extent the marijuana will be used exclusively by qualified marijuana researchers for research pursuant to subsection 7f77#c71 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 ,in determining the public interest1 the ,attorney ,general shall-- 7,a7 take into consideration-- 7i7 maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical1 scientific1 or research channels2 7ii7 compliance with applicable ,state and local laws relating to controlled substance misuse and diversion2 and 7iii7 prior conviction record of the applicant under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of such substances2 and 7,b7 not take into consideration any factors other than the factors listed in subparagraph 7,a74 7#b7 ,registration of distributors ,beginning not later than the day that is #a year after the date of enactment of the ,medical ,marijuana ,research ,act of #bjai1 the ,attorney ,general shall register an applicant to distribute marijuana that is intended to be used exclusively by qualified medical marijuana researchers for research pursuant to subsection 7f77#c71 unless the ,attorney ,general determines that the issuance of such registration is inconsistent with the public interest4 7#c7 ,public interest ,in determining the public interest under paragraph 7#b71 the ,attorney ,general shall-- 7,a7 take into consideration-- 7i7 maintenance of effective controls against diversion of marijuana and any controlled substance compounded therefrom into other than legitimate medical1 scientific1 or research channels2 7ii7 compliance with applicable ,state and local law2 7iii7 prior conviction record of the applicant under ,federal or ,state laws relating to the manufacture1 distribution1 or dispensing of such substances2 and 7iv7 past experience in the distribution of controlled substances1 and the existence in the establishment of effective controls against diversion2 and 7,b7 not take into consideration any factors other than the factors listed in subparagraph 7,a74 7#d7 ,no limit on number of manufacturers and distributors ,notwithstanding any other provision of law1 the ,attorney ,general shall not impose or implement any limit on the number of persons eligible to be registered to manufacture or distribute marijuana pursuant to paragraph 7#a7 or 7#b74 7#e7 ,requirement to verify use for legitimate1 medical research ,as a condition on registration under this section to manufacture or distribute marijuana1 the ,attorney ,general shall require the registrant-- 7,a7 to require any person to whom the marijuana will be supplied to submit documentation demonstrating that the marijuana will be used exclusively by qualified medical marijuana researchers for research pursuant to subsection 7f77#c72 7,b7 in the case of distribution1 to complete1 with respect to that distribution1 the ,,dea ,controlled substance order form 7,,dea #bbb7 7or a successor form7 and the ,,dea ,certificate of ,registration 7,,dea ,form #bbc7 7or a successor form7 and to upload such forms to the system used by the ,drug ,enforcement ,agency for such distribution2 7,c7 to include in the labeling of any marijuana so manufactured or distributed-- 7i7 the following statement3 ,this material is for medical and scientific research purposes only42 and 7ii7 the name of the requestor of the marijuana2 and 7,d7 not later than #cj days after receipt of such documentation1 and before supplying the marijuana to such person1 to review such documentation and verify that the marijuana will be so used4 7#f7 ,timing ,not later than #cj days after receipt of a request for registration under this subsection to manufacture or distribute marijuana1 the ,attorney ,general shall-- 7,a7 grant or deny the request2 and 7,b7 in the case of a denial1 provide a written explanation of the basis for the denial and a description of any curative steps that may be taken for such request to be approved4 7#g7 ,deemed approval ,if the ,attorney ,general fails to grant or deny a request for registration under this subsection to manufacture or distribute marijuana within the #cj-;day period referred to in paragraph 7#e71 such request is deemed approved4 7#h7 ,definition ,for purposes of this subsection1 the term qualified medical marijuana researcher means a researcher who is registered to conduct research with marijuana under subsection 7f77#c74 4 #e4 ,termination of interdisciplinary review process for non-,,nih-funded researchers ,the ,secretary of ,health and ,human ,services may not-- 7#a7 reinstate the ,public ,health ,service interdisciplinary review process described in the guidance entitled ,guidance on ,procedures for the ,provision of ,marijuana for ,medical ,research 7issued on ,may #ba1 #aiii72 or 7#b7 create an additional review of scientific protocols that is only conducted for research on marijuana other than the review of research protocols performed at the request of a researcher conducting nonhuman research that is not federally funded1 in accordance with section #cjc7;f77#c77;,a77ii77,,ii7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77#c77;,a77ii77,,ii771 as amended by section #c4 #f4 ,consideration of results of research ,immediately upon the approval by the ,food and ,drug ,administration of an application for a marijuana-based drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 and 7irrespective of whether any such approval is granted7 not later than the date that is #e years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall-- 7#a7 conduct a review of existing medical and other research with respect to marijuana2 7#b7 submit a report to the ,congress on the results of such review2 and 7#c7 include in such report whether1 taking into consideration the factors listed in section #bja7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;c771 as well as any potential for medical benefits1 any gaps in research1 and any impacts of ,federal restrictions and policy on research1 marijuana should be transferred to a schedule other than schedule ,i 7if marijuana has not been so transferred already74 #g4 ,no production quotas for marijuana grown for legitimate1 scientific research ,section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7 is amended by adding at the end the following3 7j7 ,the ,attorney ,general may only establish a quota for production of marijuana that is manufactured and distributed in accordance with the ,medical ,marijuana ,research ,act of #bjai that meets the changing medical1 scientific1 and industrial needs for marijuana 7as defined by the ,national ,institute on ,drug ,abuse74 4 #h4 ,article #bh of the ,single ,convention on ,narcotic ,drugs ,article #bh of the ,single ,convention on ,narcotic ,drugs shall not be construed to prohibit1 or impose additional restrictions upon1 research involving marijuana1 or the manufacture1 distribution1 or dispensing of marijuana1 that is conducted in accordance with the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 this ,act1 and the amendments made by this ,act4 #i4 ,no interference by ,department of ,justice ,the ,attorney ,general of the ,united ,states1 and any officer or employee of the ,department of ,justice1 shall not interfere with the production1 distribution1 and sale of marijuana in accordance with this ,act and the amendments made by this ,act4 #aj4 ,definition ,in this ,act1 the term marijuana has the meaning given to the term marihuana in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74