Wednesday, April 18, 2001 Part II Department of Justice Drug Enforcement Agency Denial of Petition; Notice VerDate 11<MAY>2000 16:06 Apr 17, 2001 Jkt 194001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\18APN2.SGM pfrm08 PsN: 18APN2 20038 Federal Register / Vol. 66, No. 75 / Wednesday, April 18, 2001 / Notices DEPARTMENT OF JUSTICE Congress may be amended by the Attorney DEA.2 Also attached is a document prepared General in rulemaking proceedings by DEA that specifies other data relevant to Drug Enforcement Administration prescribed by the Administrative Procedure your petition that DEA considered. Act. 21 U.S.C. 811(a). The Attorney General C. Basis for Denial of Your Petition: The Notice of Denial of Petition has delegated this authority to the Evidence Demonstrates That Marijuana Does Administrator of DEA. 28 CFR 0.100. Have A High Potential For Abuse By letter dated March 20, 2001, the As you have done, any interested party Your petition rests on your contention that Drug Enforcement Administration may petition the Administrator to initiate marijuana does not have a ‘‘high potential for rulemaking proceedings to reschedule a (DEA) denied a petition to initiate abuse’’ commensurate with schedule I or II rulemaking proceedings to reschedule controlled substance. 21 U.S.C. 811(a); 21 of the CSA. The Assistant Secretary has marijuana. Because DEA believes that CFR 1308.43(a). Before initiating such concluded, based on current scientific and this matter is of particular interest to proceedings, the Administrator must gather medical evidence, that marijuana does have members of the public, the agency is the necessary data and request from the a high potential for abuse commensurate publishing below the letter sent to the Secretary of HHS a scientific and medical with schedule I. The additional data gathered evaluation and recommendation as to by DEA likewise reveals that marijuana has petitioner (denying the petition), along whether the controlled substance should be with the supporting documentation that a high potential for abuse. Indeed, when the rescheduled as the petitioner proposes. 21 HHS evaluation is viewed in combination was attached to the letter. U.S.C. 811(b); 21 CFR 1308.43(d). The with the additional data gathered by DEA, Dated: March 28, 2001. Secretary has delegated this function to the the evidence overwhelmingly leads to the 1 Donnie R. Marshall, Assistant Secretary for Health. conclusion that marijuana has a high The recommendations of the Assistant Administrator. potential for abuse. Secretary are binding on the Administrator Accordingly, there is no statutory basis for U.S. Department of Justice, with respect to scientific and medical DEA to grant your petition to initiate Drug Enforcement Administration, matters. Id. If the Administrator determines rulemaking proceedings to reschedule Washington, D.C. 20537 that the evaluations and recommendations of marijuana. For this reason alone, your the Assistant Secretary and ‘‘all other petition must be denied. March 20, 2001. relevant data’’ constitute substantial evidence D. A Schedule I Drug With a High Potential Jon Gettman: that the drug that is the subject of the petition For Abuse and No Currently Accepted Dear Mr. Gettman: On July 10, 1995, you should be subject to lesser control or Medical Use or Safety for Use Must Remain petitioned the Drug Enforcement removed entirely from the schedules, he shall Classified In Schedule I Administration (DEA) to initiate rulemaking initiate rulemaking proceedings to proceedings under the rescheduling reschedule the drug or remove it from the DEA’s denial of your petition is based provisions of the Controlled Substances Act schedules as the evidence dictates. 21 U.S.C. exclusively on the scientific and medical (CSA). Specifically, you petitioned DEA to 811(b); 21 CFR 1308.43(e). In making such a findings of HHS, with which DEA concurs, propose rules, pursuant to 21 U.S.C. 811(a), determination, the Administrator must that lead to the conclusion that marijuana has that would amend the schedules of consider eight factors: a high potential for abuse. Nonetheless, controlled substances with respect to the (1) The drug’s actual or relative potential independent of this scientific and medical following controlled substances: marijuana; for abuse; basis for denying your petition, there is a tetrahydrocannabinols; dronabinol; and (2) Scientific evidence of its logical flaw in your proposal that should be nabilone. Although you grouped these pharmacological effect, if known; noted. substances together in your petition, the (3) The state of current scientific You do not assert in your petition that scheduling analysis differs for each. To avoid knowledge regarding the drug; marijuana has a currently accepted medical confusion, DEA is providing you with a (4) Its history and current pattern of abuse; use in treatment in the United States or that separate response for each of the controlled (5) The scope, duration, and significance of marijuana has an accepted safety for use substances that you proposed be abuse; under medical supervision. Indeed, the HHS rescheduled. This letter responds to your (6) What, if any, risk there is to the public scientific and medical evaluation reaffirms petition to reschedule marijuana. health; expressly that marijuana has no currently accepted medical use in treatment in the Summary (7) The drug’s psychic or physiological dependence liability; and United States and a lack of accepted safety You requested that DEA remove marijuana (8) Whether the drug is an immediate for use under medical supervision. from schedule I based on your assertion that precursor of a substance already controlled Nor do you dispute that marijuana is a drug of abuse. That is, you do not contend ‘‘there is no scientific evidence that [it has] under the CSA. sufficient abuse potential to warrant schedule that marijuana has no potential for abuse I or II status under the [CSA].’’ In accordance 21 USC 811(c). such that it should be removed entirely from with the CSA rescheduling provisions, DEA In this case, you submitted your petition by the CSA schedules. Rather, your contention gathered the necessary data and forwarded letter dated March 10, 1995. After gathering is that marijuana has less than a ‘‘high that information and your petition to the the necessary data, DEA referred the petition potential for abuse’’ commensurate with Department of Health and Human Services to HHS on December 17, 1997, and requested schedules I and II and, therefore, it cannot be (HHS) for a scientific and medical evaluation from HHS a scientific and medical evaluation classified in either of these two schedules. and scheduling recommendation. HHS and scheduling recommendation. HHS Congress established only one schedule— concluded that marijuana does have a high forwarded its scientific and medical schedule I—for drugs of abuse with ‘‘no potential for abuse and therefore evaluation and scheduling recommendation currently accepted medical use in treatment recommended that marijuana remain in to DEA on January 17, 2001. in the United States’’ and ‘‘lack of accepted schedule I. Based on the HHS evaluation and B. HHS Scientific and Medical Evaluation safety for use * * * under medical all other relevant data, DEA has concluded and Other Relevant Data Considered by DEA supervision.’’ 21 USC 812(b). To be classified that there is no substantial evidence that in schedules II through V, a drug of abuse Attached to this letter is the scientific and marijuana should be removed from schedule medical evaluation and scheduling I. Accordingly, your petition to initiate 2 recommendation that HHS submitted to To avoid confusion, those parts of the HHS rulemaking proceedings to reschedule document that are not relevant to your petition with marijuana is hereby denied. respect to marijuana (i.e., those parts that are 1 As set for in a memorandum of understanding relevant only to the scheduling of Detailed Explanation entered in to by HHS, the Food and Drug tetrahydrocannabinols, dronabinol, or nabilone) A. Statutory Requirements and Procedural Administration (FDA), and the National Institute on have been redacted from the attachment. The HHS History Drug Abuse (NIDA), FDA acts as the lead agency evaluation of these other substances will be within HHS in carrying out the Secretary’s addressed when DEA responds (in separate letters) The CSA provides that the schedules of scheduling responsibilities under the CAS, with the to your petitions with respect to these other controlled substances established by concurrence of NIDA. 50 FR 9518 (1985). substances. VerDate 11<MAY>2000 11:15 Apr 17, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\FR\FM\18APN2.SGM pfrm01 PsN: 18APN2 Federal Register / Vol. 66, No. 75 / Wednesday, April 18, 2001 / Notices 20039 must have a ‘‘currently accepted medical use placement in schedules III through V since it CSA. In December 1997, the DEA in treatment in the United States.’’ 3 Id. This has no currently accepted medical use in Administrator requested that the is why the CSA allows practitioners to treatment in the United States—a Department of Health and Human prescribe only those controlled substances determination that is reaffirmed by HHS in that are listed in schedules II through V. 21 the attached medical and scientific Services (DHHS) develop scientific and USC 829. Drugs listed in schedule I, by evaluation. medical evaluations and contrast, may not be prescribed for patient For the foregoing reasons, your petition to recommendations as to the proper use; they may only be dispensed by reschedule marijuana cannot be granted scheduling of the substances at issue, practitioners who are conducting FDA- under the CSA and is, therefore, denied. pursuant to 21 U.S.C. 811(b). approved research and have obtained a Sincerely, schedule I research registration from DEA. 21 This document responds to the USC 823(f); 21 CFR 5.10(a)(9), 1301.18, Donnie R.