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 -: _j_ FFede_l°R_t_ter / V_L'S:L No/1_ ] Tuesday, Ocfober' 14. I'0_ / RUles arid R_uldtloh_
 By the Commlssion. similar to those produced by MDA._ and accepted medical use in treatment in the
 S_dzl_ _ Hollbl, {5) has been associated with raedica_ United States. Some ot the responding
 As_s/$t_nt_ct_tory. emergencies as reported by the Drug physician and psychiatrists reported
 Deled: October _ 19_ Abuse Warning Network (DAWN)o having used i_ in their practices with
 _FR Dec. 80,,.23089 Filed 1_0-_: 8:45 am I In accordance with the p_vJsions of what they felt were positive results.
 U.S_Co 8:H(h}, the DF.,A Adm,i_istrator Many disputed the Agency's concept of
 scum co_ _o._.M
 requested a scientific and medical "currently accepted medical use."
 _ " evaluation of the relevant information Several stated that the highly
 DEPARTMENT OF JUST|CE and a _chedu_ing recommendation for restrictive scheduling which was
 3,_-methy_enedioxymethamphetamine contemplated would effectively end
 D_Jg E_forCamerlt Ad_|at_sti¢_ _rom the Assistant Secretary for Health. presently onsoing research and
 On _une 0, 19a_, the Admlnistr_to_ of the _clentific expetimentationo Some felt
 _'_ CFR Part _3_ D_'_,_ F. nforcement Administration that the costs involved in obtaining art
 _ceived a letter from the As_i_tant Investisat_onal New Drug permit from
 _¢¢ket No. _l_._l Sec_tary for Health, acting on beha|_ of _he Food and D_g Administration to
 the Secretary of the Depa_ment of conduct human research with a
 Schedules o_ Cos_¢! Subs_¢¢_ Health and Htunan Services, st:stiRS that Schedule I drug would be prohibitive to,
 S_h_cluil_g Of 3,4,. 3,_me_ylenedioxyme_ampbetamine shy individual researcher. Another
 Methy_ssedtoxymatha_phst_mt_e (_V_A| has a high potential for abuse stated that it would be unreatistic to
 {MDMA) into Scheclule _ of the and presents a significant risk to the believe that any pharmaceutical
 Controlled Subst_rcea Act pubtic health, and recommending that it company would develop the drug,
 £_cw Drug Enforcement should be placed into Schedu|e I of _a Several felt that DEA did not beve
 Administration, ]ustlCSo Controlled Substances AcL sufficient information regarding the
 ACW_O_¢ Final rule. On _sly 27, I_6_, the Administrator of present and potentiel uses of this drug
 the Drug Enforcement Administration, and urged that the proposed schedulir_,_
 statuary: This is a _nal rule p_ci_g the baaed upon a review of _nvesti_etions action be delayed until DFr;A had the
 drug 3,_o by the Drug BrJorcement Administration opportunity to consider additional
 melhylenedio×ymethamphetamina and rely_g on the scientific and medical studies and report_ of e×per_mentatlo_
 (MDMA} into Schedule _ of the evaluation and the recommendation of and research,
 Controlled Substances Act (CSA). the Secretary of Health and H_:man A few of the writers questioned the
 MDMA will be classified as a _r_tces in accordance with _ UoS.C
 finding of high abuse potential as a
 hail_cinogenic controlled substance. 8_I(c}, issued a Notice of Proposed basis for placement into Schedule L
 This action was initiate_ following the Rulemaking to amend § 13_o11 of Title
 Drug Enforcement Adminlatration's 2_ of the Code of Federal Re_lations by While most of them acknow!edged that
 there is some evidence of unsupervised
 (DEA} review of the abuse and illicit p|ac_n8 MDMA in Schedule I a_ a use of NfDMA, they felt the reported
 trafficking of _/A. The Assistant hallucinogenic controlled substance. 40 instances of abuse were not sufficient _
 .... Secretary for Health° Department of FIR 302_0. _DMA was not, _t that time, number to warrant the conclusion that _i_
 Health and Human Services (DHHS), a controlled substance.
 supported DFEA°s position that tha The Notice of Propoeed Rulemaking is a substance with a high potential fop
 substance be placed Int_ Schedule | of allowed sixty days for inte_sted parties abuse° Others stated that a potential f_
 the CSA. The effect of _is rule is to to submit comments, oblectio_ or abuse had not led DEA to place oertai_
 other substances into Schedule L A fe_:_
 impose the criminal sanctions and requests for_ heating.
 regulatory controls of Schedule l'on th_ Sixteen comments w_ rec_',ved in believed that there may be _ome
 m_nufac_ure, dlstr_bution and response to the notice, _ven of which confusion of this substance with a_ot_',_
 which is known to be abused, MDA, a_
 possession of MDMA, requested a hearing,
 These comments and requests for that the differences betweer_ the two
 o_v_ The effective date of this order is hearing came from a vatie|y of should be closely examined° A number
 November 13, 19_. physicians, counselors, instructors and of the writers were not opposed to the
 SU_Wr_tRY tNFO_M_Y_: On others in medical or health care _elated placement of MDMA into one of the
 March 13. 1984, the Administrator of the professions, as well as from former schedules under the CSA, but believed
 Drug Enforcement Administration subjects of experimental studies that Schedule I was not the appropriate;
 submitted information relevant to the Invol_n8 the use and effects of MDMA. schedule.
 abuse potential and illicit traftfickin_ of All of the persons or entities _ha_ On November 13, 19_, _e Deputy
 3.4omethylened|oxymethampheta_ine submitted comments and/or requests for Adminls_rator of DEA referred the
 [MDMA} to the Assistant Secretary for hearing opposed the proposed matter to the Agency's Administrative
 Health, Department of Health and placement of the substance into Law Judse, Francis L Young_ to cond_:_!
 Human Services. Briefly, the Information Schedule L DEA was urged by many to a hea_n_ for tha purpose of _ceivin_
 documented that 3,4- delay _his proposed action until after factual evidence and expert opinion
 methylenedloxymethsmphetamlne, additional research _uld be completed, regardln_ the proposed schedul_ o_
 trafficked on the street as MDNLA or Most felt that preliminary _sage and MDMA. Judge Young was directed _o
 °'Ecstasy": (_ _s an analog of the studies had shown MD_A to h_ve report to the Administrator of DEA his
 Schedule I controlled substance, 3,_ enormous potential value a_ an adjunct findings end recommended conclueio_
 methylenedio×yemphetamlne (MDA), (2) to psychotherapy0 as an analgesic and in on the appropriate scheduling action to
 has no legitimate medlcal use or the trea_J'nent of problems of drag be taken with respect to MDMA and o_
 manufacturer in the United States, (3) addiction, the question of whether e drug which
 has been clandestinely synthesized end Most of the writers vigorously hae potential for abuse but no curre_t_y
 encotmtered in the illicit drug trefflc_ (4) oblectsd to one of DF.A's _tated bases accepted medic_l use in treatment c_
 _'sdur.ss _ttmu|aut and for the proposed scheduling, that being lawfully be placed in any schedule ofl_
 pe_chotomimetic effects _ _,msns the finding that MDIVLat had no currently than Schedule L The proceeding was

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