Federal Register/Vol. 86, No. 73/Monday, April 19, 2021/Rules
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20284 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations PART 892—RADIOLOGY DEVICES include semi-automated measurements based upon its potential for abuse, its or time-series measurements. currently accepted medical use in ■ 10. The authority citation for part 892 * * * * * treatment in the United States, and the continues to read as follows: degree of dependence the drug or other Dated: April 8, 2021. substance may cause. 21 U.S.C. 812. The Authority: 21 U.S.C. 351, 360, 360c, 360e, Janet Woodcock, 360j, 360l, 371. initial schedules of controlled Acting Commissioner of Food and Drugs. substances established by Congress are ■ 11. Amend § 892.2010 by revising Dated: April 13, 2021. found at 21 U.S.C. 812(c) and the paragraph (a) to read as follows: Xavier Becerra, current list of scheduled substances is § 892.2010 Medical image storage device. Secretary, Department of Health and Human published at 21 CFR part 1308. Services. (a) Identification: A medical image Pursuant to 21 U.S.C. 811(a)(2), the [FR Doc. 2021–07860 Filed 4–16–21; 8:45 am] storage device is a hardware device that Attorney General may, by rule, ‘‘remove provides electronic storage and retrieval BILLING CODE 4164–01–P any drug or other substance from the functions for medical images. Examples schedules if he finds that the drug or include electronic hardware devices other substance does not meet the employing magnetic and optical discs, DEPARTMENT OF JUSTICE requirements for inclusion in any magnetic tapes, and digital memory. schedule.’’ The Attorney General has Drug Enforcement Administration delegated scheduling authority under 21 * * * * * U.S.C. 811 to the Acting Administrator ■ 12. Amend § 892.2020 by revising 21 CFR Part 1308 of the Drug Enforcement Administration paragraph (a) to read as follows: [Docket No. DEA–665] (DEA). 28 CFR 0.100. § 892.2020 Medical image communications The CSA provides that proceedings device. Schedules of Controlled Substances: for the issuance, amendment, or repeal Removal of Samidorphan From Control of the scheduling of any drug or other (a) Identification. A medical image substance may be initiated by the communications device provides AGENCY: Drug Enforcement Attorney General on the petition of any electronic transfer of medical image data Administration, Department of Justice. interested party. 21 U.S.C. 811(a)(3). between medical devices. It may ACTION: Final rule. This action was initiated by one petition include a physical communications to remove samidorphan from the list of SUMMARY: With the issuance of this final medium, modems, and interfaces. It scheduled controlled substances of the rule, the Acting Administrator of the may provide simple image review CSA, and is supported by, inter alia, a Drug Enforcement Administration software functionality for medical image recommendation from the Assistant removes samidorphan (3-carboxamido- processing and manipulation, such as Secretary of the HHS and an evaluation 4-hydroxy naltrexone) and its salts from grayscale window and level, zoom and of all relevant data by DEA. This action the schedules of the Controlled pan, user delineated geometric removes the regulatory controls and Substances Act. This scheduling action measurements, compression, or user administrative, civil, and criminal is pursuant to the Controlled Substances added image annotations. The device sanctions applicable to controlled Act which requires that such actions be does not perform advanced image substances, including those specific to made on the record after opportunity for processing or complex quantitative schedule II controlled substances, on a hearing through formal rulemaking. functions. This does not include persons who handle or propose to Prior to the effective date of this rule, electronic transfer of medical image handle samidorphan. software functions. samidorphan was a schedule II * * * * * controlled substance because it can be Background derived from opium alkaloids. This Samidorphan (3-carboxamido-4- ■ 13. Amend § 892.2050 by revising the action removes the regulatory controls hydroxy naltrexone), is a chemical section heading and paragraph (a) to and administrative, civil, and criminal entity that is structurally similar to read as follows: sanctions applicable to controlled naltrexone, a mu (m)-opioid receptor substances, including those specific to § 892.2050 Medical image management antagonist. Samidorphan (other schedule II controlled substances, on and processing system. developmental code names: RDC–0313 persons who handle (manufacture, (a) Identification. A medical image or ALKS 33) is a mu-opioid receptor distribute, reverse distribute, dispense, management and processing system is a antagonist with a weak partial agonist conduct research, import, export, or device that provides one or more activity at the kappa- and delta-opioid conduct chemical analysis) or propose capabilities relating to the review and receptors. According to HHS, products to handle samidorphan. digital processing of medical images for containing samidorphan are currently the purposes of interpretation by a DATES: Effective April 19, 2021. being developed for medical use. trained practitioner of disease detection, FOR FURTHER INFORMATION CONTACT: Samidorphan is currently controlled in diagnosis, or patient management. The Terrence L. Boos, Drug & Chemical schedule II of the CSA, as defined in 21 software components may provide Evaluation Section, Diversion Control CFR 1308.12(b)(l), because it can be advanced or complex image processing Division, Drug Enforcement derived from opium alkaloids. On April functions for image manipulation, Administration; Mailing Address: 8701 14, 2014, DEA received a petition to enhancement, or quantification that are Morrissette Drive, Springfield, Virginia initiate proceedings to amend 21 CFR intended for use in the interpretation 22152; Telephone: (571) 362–3261. 1308.12(b)(1) so as to decontrol and analysis of medical images. SUPPLEMENTARY INFORMATION: samidorphan from schedule II of the Advanced image manipulation CSA. The petition complied with the functions may include image Legal Authority requirements of 21 CFR 1308.43(b) and segmentation, multimodality image Under the Controlled Substances Act was accepted for filing. The petitioner registration, or 3D visualization. (CSA), each controlled substance is contended that samidorphan has been Complex quantitative functions may classified into one of five schedules characterized as an opioid receptor VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\19APR1.SGM 19APR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations 20285 antagonist, a class of drugs with no comments on the proposal on or before Regulatory Analyses abuse potential. January 11, 2021. Executive Orders 12866 and 13563 DEA and HHS Eight Factor Analyses Comments Received In accordance with 21 U.S.C. 811(a), Pursuant to 21 U.S.C. 811(b), DEA DEA received two comments on the this scheduling action is subject to gathered the necessary data on proposed rule to remove samidorphan formal rulemaking procedures done ‘‘on samidorphan and forwarded the data, from control. Both commenters the record after opportunity for a the sponsor’s petition, and a request for supported decontrol of samidorphan. hearing,’’ which are conducted pursuant scheduling recommendation on to the provisions of 5 U.S.C. 556 and samidorphan to HHS on April 24, 2015. Support 557. The CSA sets forth the criteria for On January 9, 2020, DEA received One commenter, a psychiatrist, scheduling a drug or other substance. from HHS a scientific and medical clinical investigator and pain Such actions are exempt from review by evaluation (dated December 19, 2019) management expert, who participated as the Office of Management and Budget conducted by the Food and Drug a principal investigator in clinical trials (OMB) pursuant to section 3(d)(1) of 1 Administration (FDA) entitled ‘‘Basis that examined the safety and efficacy of Executive Order (E.O.) 12866 and the for the Recommendation to Remove samidorphan and olanzapine principles reaffirmed in E.O. 13563. Samidorphan (3-Carboxamido-4- combination product, stated that Executive Order 12988 Hydroxy Naltrexone) and its Salts from samidorphan counters weight gain All Schedules of Control Under the associated with clinical use of This regulation meets the applicable Controlled Substances Act’’ and a olanzapine as antipsychotic medication standards set forth in sections 3(a) and scheduling recommendation. Following and this combination product offers 3(b)(2) of E.O. 12988 Civil Justice consideration of the eight factors and significant advancement relative to Reform to eliminate drafting errors and findings related to the substance’s abuse olanzapine alone, and thus supported ambiguity, minimize litigation, provide potential, legitimate medical use, and this scheduling action. a clear legal standard for affected dependence liability, HHS Another commenter, on behalf of the conduct, and promote simplification recommended that samidorphan and its and burden reduction. salts be removed from all schedules of sponsor of a samidorphan and control of the CSA. In response, DEA olanzapine combination drug product Executive Order 13132 conducted its own eight factor analysis currently under review by FDA for This rulemaking does not have of samidorphan pursuant to 21 U.S.C. marketing approval, stated that federalism implications