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Federal Register/Vol. 85, No. 167/Thursday, August 27, 2020

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Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Proposed Rules 52935 BIS does not seek to expand DATES: Comments must be submitted Drug Enforcement Administration, Attn: jurisdiction over technologies that are electronically or postmarked on or DEA Federal Register Representative/ not currently subject to the EAR, such before September 28, 2020. DPW, 8701 Morrissette Drive, as ‘‘fundamental research’’ described in Interested persons may file written Springfield, Virginia 22152. § 734.8 of the EAR. comments on this proposal in FOR FURTHER INFORMATION CONTACT: BIS will review public comments accordance with 21 CFR 1308.43(g). Scott A. Brinks, Regulatory Drafting and submitted in response to this ANPRM to Commenters should be aware that the Policy Support Section, Diversion help inform BIS and its interagency electronic Federal Docket Management Control Division, Drug Enforcement partners’ efforts to identify, reevaluate System will not accept comments after Administration; Mailing Address: 8701 and subsequently control foundational 11:59 p.m. Eastern Time on the last day Morrissette Drive, Springfield, Virginia technologies. This interagency process of the comment period. 22152; Telephone: (571) 362–8209. is expected to result in rules and Interested persons may file a request SUPPLEMENTARY INFORMATION: comment periods with new control for a hearing or waiver of hearing levels for items currently controlled for pursuant to 21 CFR 1308.44 and in Posting of Public Comments AT reasons on the CCL or new ECCNs accordance with 21 CFR 1316.45 and/or Please note that all comments on the CCL for technologies currently 1316.47, as applicable. Requests for a received in response to this docket are classified as EAR99. hearing and waivers of an opportunity considered part of the public record. OMB has determined that this action for a hearing or to participate in a They will, unless reasonable cause is is significant under Executive Order hearing must be received on or before given, be made available by the Drug 12866. September 28, 2020. Enforcement Administration (DEA) for Submission of Comments ADDRESSES: To ensure proper handling public inspection online at http:// of comments, please reference ‘‘Docket www.regulations.gov. Such information Comments should be submitted to BIS No. DEA–482’’ on all electronic and includes personal identifying as described in the ADDRESSES section of written correspondence, including any information (such as your name, this ANPRM by October 26, 2020. attachments. address, etc.) voluntarily submitted by Matthew S. Borman, • Electronic comments: The Drug the commenter. The Freedom of Deputy Assistant Secretary for Export Enforcement Administration (DEA) Information Act (FOIA) applies to all Administration. encourages that all comments be comments received. If you want to [FR Doc. 2020–18910 Filed 8–26–20; 8:45 am] submitted electronically through the submit personal identifying information Federal eRulemaking Portal which (such as your name, address, etc.) as BILLING CODE 3510–33–P provides the ability to type short part of your comment, but do not want comments directly into the comment it to be made publicly available, you field on the web page or attach a file for must include the phrase ‘‘PERSONAL DEPARTMENT OF JUSTICE lengthier comments. Please go to http:// IDENTIFYING INFORMATION’’ in the Drug Enforcement Administration www.regulations.gov and follow the first paragraph of your comment. You online instructions at that site for must also place all of the personal 21 CFR Part 1308 submitting comments. Upon completion identifying information you do not want of your submission you will receive a made publicly available in the first [Docket No. DEA–482] Comment Tracking Number for your paragraph of your comment and identify comment. Please be aware that what information you want redacted. Schedules of Controlled Substances: submitted comments are not If you want to submit confidential Placement of N-Ethylpentylone in instantaneously available for public business information as part of your Schedule I view on Regulations.gov. If you have comment, but do not want it to be made AGENCY: Drug Enforcement received a Comment Tracking Number, publicly available, you must include the Administration, Department of Justice. your comment has been successfully phrase ‘‘CONFIDENTIAL BUSINESS ACTION: Notice of proposed rulemaking. submitted and there is no need to INFORMATION’’ in the first paragraph resubmit the same comment. of your comment. You must also SUMMARY: The Drug Enforcement • Paper comments: Paper comments prominently identify the confidential Administration proposes placing 1-(1,3- that duplicate the electronic submission business information to be redacted benzodioxol-5-yl)-2- are not necessary. Should you wish to within the comment. (ethylamino)pentan-1-one (N- mail a paper comment, in lieu of an Comments containing personal ethylpentylone, ephylone) and its electronic comment, it should be sent identifying information or confidential optical, positional, and geometric via regular or express mail to: Drug business information identified as isomers, salts, and salts of isomers Enforcement Administration, Attn: DEA directed above will be made publicly whenever the existence of such salts, Federal Register Representative/DPW, available in redacted form. If a comment isomers, and salts of isomers is possible, 8701 Morrissette Drive, Springfield, has so much confidential business in schedule I of the Controlled Virginia 22152. information that it cannot be effectively Substances Act. If finalized, this action • Hearing requests: All requests for a redacted, all or part of that comment would make permanent the existing hearing and waivers of participation may not be made publicly available. regulatory controls and administrative, must be sent to: Drug Enforcement Comments posted to http:// civil, and criminal sanctions applicable Administration, Attn: Administrator, www.regulations.gov may include any to schedule I controlled substances on 8701 Morrissette Drive, Springfield, personal identifying information (such persons who handle (manufacture, Virginia 22152. All requests for hearing as name, address, and phone number) distribute, reverse distribute, import, and waivers of participation should also included in the text of your electronic export, engage in research, conduct be sent to: (1) Drug Enforcement submission that is not identified as instructional activities or chemical Administration, Attn: Hearing Clerk/ directed above as confidential. analysis, or possess), or propose to ALJ, 8701 Morrissette Drive, An electronic copy of this document handle N-ethylpentylone. Springfield, Virginia 22152; and (2) and supplemental information to this VerDate Sep<11>2014 16:33 Aug 26, 2020 Jkt 250001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\27AUP1.SGM 27AUP1 khammond on DSKJM1Z7X2PROD with PROPOSALS 52936 Federal Register / Vol. 85, No. 167 / Thursday, August 27, 2020 / Proposed Rules proposed rule are available at http:// who handles or proposes to handle N- medical evidence, on July 15, 2020, the www.regulations.gov for easy reference. ethylpentylone. Assistant Secretary submitted to the Acting Administrator HHS’s scientific Request for Hearing or Waiver of Background and medical evaluations for this Participation in Hearing On August 31, 2018, DEA published substance. Upon receipt of the scientific Pursuant to 21 U.S.C. 811(a), this an order in the Federal Register and medical evaluation and scheduling action is a formal rulemaking ‘‘on the amending 21 CFR 1308.11(h) to recommendation from HHS, DEA record after opportunity for a hearing.’’ temporarily place 1-(1,3-benzodioxol-5- reviewed the documents and all other Such proceedings are conducted yl)-2-(ethylamino)pentan-1-one (N- relevant data, and conducted its own pursuant to the provisions of the ethylpentylone, ephylone) in schedule I eight-factor analysis of the abuse Administrative Procedure Act, 5 U.S.C. of the CSA pursuant to the temporary potential of N-ethylpentylone in 551–559. 21 CFR 1308.41–1308.45; 21 scheduling provisions of 21 U.S.C. accordance with 21 U.S.C. 811(c). CFR part 1316, subpart D. Interested 811(h). 83 FR 44474. That temporary persons may file requests for hearing or scheduling order was effective on the Proposed Determination To Schedule notices of intent to participate in a date of publication, and was based on N-Ethylpentylone hearing in conformity with the findings by the former Acting As discussed in the background requirements of 21 CFR 1308.44(a) or Administrator of DEA that the section, the Acting Administrator is (b), and include a statement of interest temporary scheduling of this synthetic initiating proceedings, pursuant to 21 in the proceeding and the objections or cathinone was necessary to avoid an U.S.C. 811(a)(1), to add N- issues, if any, concerning which the imminent hazard to the public safety ethylpentylone permanently to schedule person desires to be heard. Any pursuant to section 811(h)(1). Section I. DEA has reviewed the scientific and interested person may file a waiver of an 811(h)(2) provides that the temporary medical evaluation and scheduling opportunity for a hearing or to control of this substance expire two recommendation, received from HHS, participate in a hearing together with a years from the effective date of the and all other relevant data and written statement regarding the scheduling order, which was August 31, conducted its own eight-factor analysis interested person’s position on the 2020. However, this same provision also of the abuse potential of N- matters of fact and law involved in any provides that, during the pendency of ethylpentylone pursuant to 21 U.S.C. hearing as set forth in 21 CFR proceedings under 21 U.S.C. 811(a)(1) 811(c). Included below is a brief 1308.44(c). for the permanent scheduling of the summary of each factor as analyzed by All requests for a hearing and waivers substance, the temporary scheduling of HHS and DEA, and as considered by of participation must be sent to DEA that substance can be extended for up to DEA in its proposed scheduling action.
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