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 5158 Fedora| Register / Vo|o 53, No, 34 / Monday, February 22° '19_,8 / Ru|es and ReRu]atiorts
 Counsel Federal Energy Regulatory controlled substance. This rute will Administrator's statutory authority to
 Commission, 625 North Capita! Street. impose the criminal and regulatory develop such a standard°
 NE., Washington, DC 20426, (202) 357- controla of Schedule t on the The Administrator conclud_ that
 8530. manufacture, distribution and further hearings are not necessary in
 Stmm.._MEN'rAMV _N$O_A_qO_ possession of MDMA. this matter since the record below is
 On january 2S. _98& the Commission _FFEC_Vl OA_: The effective date of extraordinarily complete and since all
 issued a Notice of OMB control nurRber this order is March 230 1988, the parties had the opportunity to
 in Order No. 4_, establishing a list for wt_ _'UR'rH=R _FORMAT_O_ ¢o_'rAcrr_ provide evidence and brief all the
 utilities to use in classifying certain Howard McC|ain, }r., ChieL Drug re!event issues, which included:
 property at nuclear power pIant_ aa Control Section. Drug Enforceraent What consititutes "currently accepted
 '=retirement unRs °° for accounting Administratlo_o I_5 _ Street NW.. medical use in treatment in the Un_¢ed
 purposes. (53 FR 25@3° _ano 2_. 1988). Washington. DC 20537. Telephone: (202} States" within the purview of 21 UoSoC
 This notice corrects the title shown on ¢33-_388. 812(b}?
 the prior notice° At 53 FR 2593, second Su_M_rt'_J_v _NFORMA_O_¢ On What constitutes °°accepled safety for
 column (page 11 of the Commission's October 14.19_ the Administrated • o_ use.., under medical supervision"
 _rder)o the title is revised to read: "List DEA, _otlowing rulem_king on the within the purview of 21 U.S.C. 812|b)?
 : of Property for Use in Accounting for the record which included a hearing be t_ore Does MDMA have a "currently
 Addition and Retirement of Reactor an Administrative Law _udge_ issued a accepted reed[cat use in treatment in the
 : Plant Equlpment," _na] rule placing MDMA into Schedule I United States °° within the purview of Z_
 l_i_ _o _hell, under the ControLled Substances Act° UoSoC. 812(b}?
 ActingS_cretary. {5_ FR 3655_} The effective date of this Is there a lack of °°accepted safety for
 lYE Dace _-3_s Filed Z-_:_=_; _:,_5 am_ rule was November '13, _988. _n thi_ fina_ use {of MDMAJ under medical
 s_u._ coos _z_.,_._ rule, the Administrator made firrdir.gs supervision" within the purview of 2_
 required by the statute. 2_ UoS.Co 8_:2_e), U,S_C. 8121b}?
 -" -" and concluded that MDMA met the The Administrator further concludes
 criteria for placement of substance:_ into ttmt since all parties have had ample
 DEPARTMENT OF JUSTICE Schedule L The Administrator found opportunity to be heard on these issues.
 that MDMA: (I} Had no currently there is no necessity to publish his
 Drug Enforc,m@nt Acimtn|s_tio_ accepted medical a_e in treatment in the conclusions as a proposed rule. but
 United States: {2) lacked accepted _;afety rather as a final rule.
 2'_ CFR P_ _ for use under medical supervision; _nd
 _ N¢. S,_,=,_ {3} had a high potential for abuse° Hnd_n$_
 On September _9, 11967, the United The Administrator adopts the
 Sche_t_es of Controil_a gu_s_¢_ States Court of Appeals for the First followin_ findings regarding °°accepted
 _ch@dgfin@ of 3,_ Circuit issued iis opinion on the Petition medical use in treatment _n the Uaited
 Methylened_oxymethamph_t_mtne for Review of the Order of the Drug States': and "accepted safety for use
 (MDMA) into Schedule ! of the Enforcement Administration. See_ under medical supervision" which were
 Costro_e¢_ Substances Act; Re_an_l Cc/_#poon v. Drag E_forcemen_ published as part of the original fins!
 Admi_Hstmt/or_. 828 Fo2d 8_Io The rule found at 51 FR 36552 (October 1,_.
 AOEeCY: Drug Enforcement mandate was issued on December 22, 11986}: L 2. 3, t, 5, 6. 7. 8, 11.1_o 13, 140 15,
 Administration, 1987, The Court fourtd that the _6. 4_0 _5, ,16, 47. These findings are
 _CtqO_: Final rule. Administrator applied an incorrect incorporated into this final rule ns
 ahmdard in determining _he meanin_ of though they were set out futly herein,
 summary: This is a fi_m[ rule p_at;_ng the the phrases "currently accepted med_ca| The Administrator further finds, based
 drug 3_,_- use in treatment in the United States '°
 upon the record in the proceedings
 methy_enedioxymethamphetam_ne and 'qack of accepted safety for use conducted before the Administrative
 {MDMA) into Schedule I of the under medley[ supervision. _° Specifically Law judge:
 Controlled Substances Act (CSA) , the Court stated that_
 _o]_owing a remand from the United A, The published scientific and
 States Court of Appeals for the First The Administrator erroneously _ppiied sn medtcal literature and the information
 Circuit° This rule will classify MDMA a_ in_eWr_t_on _f the "accepted medical _se in from the files of the Food and Drug
 _reatmen_ in _he United Stereo" _r_d
 a Schedule I hallucinogenic controlled "_ecep_ed _efety _cr _e.. , under medical Administration do not establish or
 substance and is the culmination of a supervision'" etSter_,a aff section 812_b_(1} _hat support claims of therapeutic use of
 formal rulemaking on the record directly conflicts with congressional intent, MDMA0 as an adjunct 'to psychotherapy,
 conducted before an Administrative We _herefo_ vacate the Adm_istrat_r'* in treatment in the United States.
 Law Judge of the Drug Enforcement determination that MDMA shouid be p|_ cad _o There are insu_fic_ent and
 Administration (DE,A). The original final _n Sehedui_ _ of the CgA and rem_nd the rsle inadequate studies and reports
 for fu_er consideration by the DEA. Ot_ _haracter_zing MDMA from a chemical
 ride placing MDMA in Sehed_._e I was remand, the Administrator wfl_ not be
 published on October 140 1986, with an permitted _o _res_ the sbzenee of FDA to×ieo_ogieal and pharmacological
 effective date of November 13, _9_6. (8"I interstate marketing approval as conclusive perspective to justify use of MDMA in
 FR 38552}. On review by the United evidence that MI3MA ha_ no currently humans.
 States Court of Appeals for the First _ccepted medical use and leeks accepted C. There were no published accounts
 Circuit the _|e was vacated and s.fely for use cruder medical super, islam. 8_ Of MDMA's pharmacology or toxicology
 remanded _o the Administrator for F._ _0 _o until 11973, when an animal study
 further findings. Following a review _f The Court did not provide any further conducted by the U.S. Army Chemical
 the record in this matter, the parameters for the Administrator in Corps was released° |t showed that the.
 Administrator concludes that MDMA reconsidering his declsio_ _tating that _t acute lethal doses of MDMA end MD,A
 should be classified as a Schedule _ would not Infrlnge on the were similar,

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