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Federal Register / Vol. 86, No. 51 / Thursday, March 18, 2021 / Proposed Rules
Posting of Public Comments
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Please note that all comments received in response to this docket are considered part of the public record.
They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration DEA for public inspection online at http
www.regulations.gov. Such information includes personal identifying information such as your name, address, etc. voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information such as your name, address, etc. as part of your comment, but do not want it to be made publicly available, you must include the phrase PERSONAL IDENTIFYING
INFORMATION in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase CONFIDENTIAL BUSINESS
INFORMATION in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available.
Comments posted to http
www.regulations.gov may include any personal identifying information such as name, address, and phone number included in the text of your electronic submission that is not identified as directed above as confidential.
An electronic copy of this document and supplemental information to this proposed rule are available at http
www.regulations.gov for easy reference.
Request for Hearing or Waiver of Participation in a Hearing Pursuant to 21 U.S.C. 811a, this action is a formal rulemaking on the record after opportunity for a hearing.
Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act, 5 U.S.C.
551559. 21 CFR 1308.411308.45; 21

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CFR part 1316, subpart D. Interested persons may file requests for hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44a or b, and include a statement of interest in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested persons position on the matters of fact and law involved in any hearing as set forth in 21 CFR
1308.44c.
All requests for a hearing and waivers of participation must be sent to DEA
using the address information provided above.
Legal Authority The Controlled Substances Act CSA
provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General delegated to the Administrator of DEA pursuant to 28
CFR 0.100 on his own motion. 21
U.S.C. 811a. This proposed action is supported by a recommendation from the Acting Assistant Secretary for Health of U.S. Department of Health and Human Services HHS Acting Assistant Secretary and an evaluation of all other relevant data by DEA. If finalized, this action would make permanent the existing temporary regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl.
Background On February 6, 2018, pursuant to 21
U.S.C. 811h1, the then-Acting Administrator of DEA published an order in the Federal Register 83 FR
5188 temporarily placing fentanylrelated substances, as defined in that order, in schedule I of the CSA upon finding that these substances pose an imminent hazard to the public safety.
As discussed below in Factor 3, the four substances named in this proposed rule fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl meet the existing definition of fentanyl-related substances as they are not otherwise controlled in any other schedule i.e., not included under another Administration Controlled
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Substance Code Number and are structurally related to fentanyl by one or more of the five modifications listed under the definition.
That temporary order was effective upon the date of publication. Pursuant to 21 U.S.C. 811h2, the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the four specific substances already covered by that order, was set to expire on February 6, 2020. However, as explained in DEAs April 10, 2020, correcting amendment 85 FR 20155, Congress overrode and extended that expiration date until May 6, 2021, by enacting on February 6, 2020
the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act Pub. L. 116
114, sec. 2, 134 Stat. 103. By operation of law, the temporary control of fentanyl-related substances, which includes these four covered substances, will remain in effect until May 6, 2021, unless DEA permanently places them in schedule I prior to May 6, 2021. As discussed in the above Legal Authority section, proceedings under 21 U.S.C.
811a may be initiated by the Administrator of DEA on his own motion.
The Acting Administrator, on his own motion, is initiating proceedings to permanently schedule the following four fentanyl-related substances:
Fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl. DEA gathered the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for 16
fentanyl-related substances the four that are the subject of this proposed rule as well as 12 other fentanyl-related substances 1. On April 3, and October 2, 2019, the then-Acting Administrator submitted this data to the Assistant Secretary for Health of HHS, and requested that HHS provide DEA with a scientific and medical evaluation and a scheduling recommendation for these 16 fentanyl-related substances, in accordance with 21 U.S.C. 811b and c. On July 2, 2020, HHS provided DEA
with a scientific and medical evaluation and scheduling recommendation for 11
1 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-phenyl fentanyl, b-methyl fentanyl, benzodioxole fentanyl, crotonyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetylfentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.

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