norml01 - Page 16
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g Id_ at 1323. Surely, the notice provided herer which was con-
i siderably less informative than that given in McLouth, was also
inadequate° Had DEA informed the public in advance that it
I intended to adopt a multi-factor FDCA-based test for determining
whether a substance has an accepted medical use in treatment, it
I is likely that many more persons would have participated in the
i proceedings. The notices informed the public that DEA was con-
sidering controlling MDMA and rescheduling marijuana; they did
I not indicate that at the same time the agency would promulgate a
generally applicable rule defining the "characteristics '_ of a
i substance that has an _accepted medical use in treatment in the
i United States. '_ Se__e J.Ao 50_
The Administrator's adoption of FDA rules is also vul-
g nerable on this ground° While those regulations were duly
promulgated by the FDA after notice and an opportunity for public
comments nothing in the notices would haws alerted a reader that
i those same regulations would be applied by the Administrator in
determining whether a drug has an accepted medical use in treat-
i ment within the meaning of the CSAo See New Drug and Antibiotic
Requlations, 47 Fed. Reg. 46_622 (Oct° 19, 1982); Pro_sed New
i Druq_ Antibiotic_and Biologic Drug Product Requlations, 48 Fed°
l Reg. 26,720 (June 9_ 1983).
Respondent's fall-back argument is that any procedural
i error was harmless_ because Petitioners did not describe
'_specific evidence that they would have otherwise produced."
Resp. Br_ at 26. Assuming Respondent is correct in suggesting
i that the Administrator's standard is a rule, McLouth Steel
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