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 ! _ Fede_l Register / VoL 5_, No. _ / Tuesday, October 14, 19_ / Rules and Regu]at|ons 365_
 , _adu©ted "on the record after After studying briefs submitted by the _TDMA to willing subjects in
 oppori_ity for a hearing" as required participants, the _ud_e issued e uncontrolled0 nonresearch studies end
 _by _I U_SoC. 811(a) and in accordan_ recommended decision on that issue, would not have done so if such a
 ...... |wRb the Administrative Ptoced_ces AcL dated june 1. 1985. He reco_ende_ procedure was _safe. Final|y, w|th
 _5 U_C. _ end 557. first, that the language of the Act was regard to the issue of abuse potential,
 ']_s authority and criteria for such that a subst_ce with e potential the judse found that the Agency did not
 dsssityL_8 substances into schedules for abuse less than a "high" potential° meet its burden in establishing that
 _r the Controtled Substances Act is and having no currently accepted MDMA has a high potential for abuse.
 |omd _t 21 U.S.C 811+ This section of medical use L_ treatment0 cennot be On june it, 13 and 7A0 I988,
 the Act sets forth the standards by placed in any of the five schedule_o respectiveiy+ David Joranson. counsel
 which the Attorney Genera| and the Alternatively, the judge recommend_:l for DEA, and two counsel for Hoffmen-
 _etary of the Department of Hea|th that suoh • substance should be p_aced LaRoche, LaCe filed exceptions to the
 _d Humar_ Services are to evaluate in either Sched_e IIL _V or V, Option and Recommendations of the
 _bstances for control decontrol or depending upon its degree of potentte_ Administrative Law _udge. In reply,
 m_sh_tulir_o The Secretary of DHH$ is for abuse. _n a letter to the Grtnspoor_ Greet, et aL _leda Response
 _srged with maidn8 scientific and Administrative Law jt_dge, dated to the exceptions on June _, 198_. and
 medical evaluations, including scientific October _019_5o the Administrator also moved to strike potions of the
 _vidence of a substance's advised that he had decided not to issue Government's exceptions alleging the
 phsrmacolo_dcal effects, the state of a final agency ruling os that initia_ ruling Government's use of the term "bias"
 ...... sue'rent scientific knowledge regard_J_8 until he had received the entL_ r_corct a_ with respect to the Administrative Law
 the conclusiot_ of the _ase, luke's opinion was prejudicial
 the dcu8 or other substance, what risk During the course of the hearing, on Additional|y, they flied a motion for the
 there is to the public healtL_ _e psychic _u/y _. _985, in a_ independent action by opportunity for oral presentation te the
 or physiological dependence liability of the Administrator of DFJ_. MD_ was Admi_i_tratoro On July 24, !988, the
 • _ dzu8, and whether the substance _ pieced into Schedule _ of the CSA Administrative Law judge certified end
 s_ L_ediate precursor of a substance pursuant to the emergency scheduling transmitted the record to the
 already controlled under _te Act, The provisions of _1 U.S.C. 81'I (h)(1)0 Administrator of DF.,A. The record
 Attorney General must consider those following e determination by the included the Opinion and
 items presented by the Secrete W. and in Administrator that this action wee P_ecommendatlons of the Admisistrative
 edition must consider the actual or necessary to avoid an imminent h_ard Law judge, the findings of fact and
 sleeve potential for abuse of the to the public safety° 50 FR _3118. conclusions of law proposed by all
 substance, the history and current On May _ I_, the jure issued _s panics, the exceptions filed by the
 _tter_ of abuse, and the scope, Opinion and _ecommendations
 parties, the response to those exceptions
 d_zation and significance of abuse, regarding the scheduling of _'_MA_ The and motions filed by Grinspoen. Greet0
 _MA was not a controlled substance° judge recommended _at Nff)MA be st aL, all of the exhibits and affidavits,
 It had net been approved for marketing pieced is Sched_e Ill of the CSA_ He and all of the Lraascripts of the hearing
 i_ the United States by the Food and reached this conclusion after fu_dL_
 Dins A_:ht_f_t_stratlor_ that I_)MA has a currently accepted _e_sio_,
 Fo|lowin_ preheating procedures, medical use in treatment in the U_ted On August 11, _88, the Adminis_eter
 lhere remained five parfies_ includ_ Steres, that Iv_DMA does not lacc_ granted the motion to s_ke portions of
 the Agency, participating in the hearing accepted safety for use _uder _edlcal the Government exceptions, filed by
 _e'_r,esso The participants were the eupeP_ston, and that _t has _ess th_ e_ Grl_speon, Greer, et eL, and ordered the
 Agency staff; George Greet, M.Do, Lanier high potential for abuse. Goveznmant to refile its exceptions
 G_espoon0 M.D., Thomas B. Roberts, Co,earning the _ssue of "aceepted without use of the term "bias" with
 Ph.D, end james Bakelar_ McNei_ab_ inc. _edical use", the judge refused to respect to the Administrative Law
 and Hoffma_-_Roche, _c.; Lyn B. accup_ the Agency's ar_umem that L_ • Judge_s opinion. The Achui_strator also
 _mstein, Esq.; and David _ joransom oh'uS or other substance beir_ denied the motion for the opportunity
 Five hearing sessions, comprornisir_ considered for scheduling is not for oral presentation to him filed by
 ains hearing days, beginning on approved for marketing in the United Grinspoon, Greet, et aL On August _,
 _:ebmary _10 198So and culminating o_ States under the Federal Food. Drug and _80_ the Government refiled its
 November _, _985, were conducted Cosmetic Act, _ U.S.C. _, et _o, then exceptiona,
 before the Administrative Law JuGs: it has no °'accepted medical use" He The Adm_Istrator bus carefully
 the testLmony of 33 witnesses was heard concluded that "accepted medical use" reviewed the entire record in this matter
 _d _ exhibits were reoeived _nto i_ determined by what i_ actuary go_ and hereby issues this final rule as
 _,_ce. on _ffthin the health care community, prescribed by 21 CFR _3ISo07. The
 At a p_liminary prehearing Using thin standard, the judge fo_d Administrator declines to accept the
 that. based on the tesLtmony of a _commendations of the Administrative
 _terenca on February l, 1985, the
 relatively small _oup of psychletr_ts Law judge and farads that there is
 Ad_i_atlve Law Judge detertRIRsd and psychotherapists who have used substantial evidence in the record to
 _t one of the issues identified
 MDb_.P_ in treatment of hu_a_ _Lnd _uppo_t the decision that MDMA be
 Im_ented a purely legal question which found it to have certain desirable placed in Schedule _ as a halluclnoge_c
 ___t be decided without the need of effects. MDMA had an accepted mec_cai controlled substance. The Adm_istrator
 sty _'{dence end in advance of the use in treatment in the United States. _nds, consistent with his decision that:
 sth_ issues _ the case. The issue was: With regard to the issue of "accepted _. A new drug application (NDA) must
 Assuming that a substemce has a pote_tial safety for use", the judge concluded that be approved by the Food and Dru_
 abuse and hu no currently accepted MDMA does not lack accepted safety Administration prior to the marketing of
 use in tz_atment in the U_t_d States. tot use because the same _roup of a new drt_ in the United States. The
 _n _h_ subs_an_ be placed _n any schedule psychlat_sts and psychotherapists NDA generally consists of data
 _n Sch_tds I? mentioned above have administered collected dr_n_ the pro.clinical and
 ' i