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Home , April 19, Samidorphan

20284 Federal Register / Vol. 86, No. 73 / Monday, 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: , 2021. substance 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: , 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 ) 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 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)- 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- distribute, reverse distribute, dispense, management and processing system is a antagonist with a weak 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

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antagonist, a class of drugs with no comments on the proposal on or before Regulatory Analyses abuse potential. 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 , 2015. Support 557. The CSA sets forth the criteria for On , 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 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 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 warranting the 811(c). Both DEA and HHS analyses are samidorphan when combined with application of E.O. 13132. The rule does available in their entirety in the public olanzapine has the potential to improve not have substantial direct effects on the docket of this rule (Docket Number the safety profile of olanzapine by States, on the relationship between the DEA–665) at http://www.regulations.gov mitigating the weight gain associated Federal government and the States, or under ‘‘Supporting and Related with olanzapine treatment without the distribution of power and Material.’’ altering its antipsychotic efficacy. This responsibilities among the various commenter agreed with DEA’s levels of government. Determination To Decontrol conclusion that samidorphan lacks Samidorphan abuse or dependence potential and Executive Order 13175 After a review of the available data, stated that samidorphan and its salts This rule does not have tribal including the scientific and medical should be removed from the CSA implications warranting the application evaluation and the recommendation to schedules. This commenter further of E.O. 13175. This rule does not have decontrol samidorphan from HHS, the mentioned that the samidorphan and substantial direct effects on one or more Acting Administrator of DEA published olanzapine combination product, which Indian tribes, on the relationship in the Federal Register a notice of is currently under review by FDA for between the Federal government and proposed rulemaking (NPRM) entitled marketing approval, is an important Indian tribes, or on the distribution of ‘‘Schedules of Controlled Substances: new therapeutic option for patients and power and responsibilities between the Removal of Samidorphan from Control’’ any delay in its availability for Federal government and Indian tribes. which proposed removal of therapeutic use would negatively affect samidorphan and its salts from the stakeholders, and therefore this final Regulatory Flexibility Act schedules of the CSA. 85 FR 79450, rule should be made effective The Acting Administrator, in , 2020. The proposed rule immediately. accordance with the Regulatory provided an opportunity for interested DEA Response: DEA appreciates the Flexibility Act (5 U.S.C. 601–612) persons to file a request for a hearing in comments in support of this (RFA), has reviewed this rule and by accordance with DEA regulations by rulemaking. approving it certifies that it will not have a significant economic impact on , 2021. No requests for such Scheduling Conclusion a hearing were received by DEA. The a substantial number of small entities. NPRM also provided an opportunity for Based on the consideration of all The purpose of this rule is to remove interested persons to submit written comments, the scientific and medical samidorphan from the list of schedules evaluation and accompanying of the CSA. This action removes 1 As discussed in a memorandum of recommendation of HHS, and based on regulatory controls and administrative, understanding entered into by the Food and Drug DEA’s consideration of its own eight- civil, and criminal sanctions applicable Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency factor analysis, the Acting to controlled substances for handlers within the HHS in carrying out the Secretary’s Administrator finds that these facts and and proposed handlers of samidorphan. scheduling responsibilities under the CSA, with the all relevant data demonstrate that Accordingly, it has the potential for concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. samidorphan does not meet the some economic impact in the form of The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the requirements for inclusion in any cost savings. authority to make domestic drug scheduling schedule, and will be removed from This rule will affect all persons who recommendations. 58 FR 35460, 1, 1993. control under the CSA. would handle, or propose to handle,

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samidorphan. Samidorphan is not Government Agency Plan nor any other , 6b-naltrexol, naltrexone, and currently available or marketed in any action is required under provisions of samidorphan, and their respective salts, country. Due to the wide variety of UMRA. but including the following: unidentifiable and unquantifiable Paperwork Reduction Act * * * * * variables that potentially could influence the distribution and This action does not impose a new D. Christopher Evans, dispensing rates, if any, of samidorphan, collection of information requirement Acting Administrator. DEA is unable to determine the number under the Paperwork Reduction Act, 44 [FR Doc. 2021–07884 Filed 4–16–21; 8:45 am] of entities and small entities which U.S.C. 3501–3521. This action would BILLING CODE 4410–09–P might handle samidorphan. In some not impose recordkeeping or reporting instances where a controlled requirements on State or local pharmaceutical drug is removed from governments, individuals, businesses, or the schedules of the CSA, DEA is able organizations. An agency may not DEPARTMENT OF STATE to quantify the estimated number of conduct or sponsor, and a person is not affected entities and small entities required to respond to, a collection of 22 CFR Part 62 because the handling of the drug is information unless it displays a expected to be limited to DEA currently valid OMB control number. [Public Notice: 10818] registrants even after removal from the Congressional Review Act schedules. In such instances, DEA’s RIN 1400–AF03 knowledge of its registrant population This rule is not a major rule as forms the basis for estimating the defined by section 804 of the Small Change to Certification Authority for number of affected entities and small Business Regulatory Enforcement the Alien Physician Category of the entities. However, DEA does not have a Fairness Act of 1996 (Congressional Exchange Visitor Program basis to estimate whether samidorphan Review Act (CRA)). This rule will not AGENCY: Department of State. is expected to be handled by persons result in: an annual effect on the who hold DEA registrations, by persons economy of $100 million or more; a ACTION: Final rule. who are not currently registered with major increase in costs or prices for SUMMARY: The Department of State DEA to handle controlled substances, or consumers, individual industries, (Department) is changing the both. Therefore, DEA is unable to Federal, State, or local government certification authority for alien estimate the number of entities and agencies, or geographic regions; or physicians from the American Board of small entities who plan to handle significant adverse effects on Medical Specialties (ABMS) to the samidorphan. competition, employment, investment, Although DEA does not have a productivity, innovation, or on the Accreditation Council for Graduate reliable basis to estimate the number of ability of United States-based Medical Education (ACGME). affected entities and quantify the companies to compete with foreign- DATES: This rule is effective , economic impact of this final rule, a based companies in domestic and 2021. qualitative analysis indicates that this export markets. However, pursuant to FOR FURTHER INFORMATION CONTACT: G. rule is likely to result in some cost the CRA, DEA is submitting a copy of Kevin Saba, Director, Office of Policy savings. Any person planning to handle this final rule to both Houses of and Program Support, Office of Private samidorphan will realize cost savings in Congress and to the Comptroller Sector Exchange, Bureau of Educational the form of saved DEA registration fees, General. and Cultural Affairs, U.S. Department of and the elimination of physical security, List of Subjects in 21 CFR Part 1308 State, SA–4E, 2201 C Street NW, recordkeeping, and reporting Washington, DC 20522; email at requirements. Because of these factors, Administrative practice and [email protected]; or, (202) 634– DEA projects that this rule will not procedure, Drug traffic control, 4710. result in a significant economic impact Reporting and recordkeeping on a substantial number of small requirements. SUPPLEMENTARY INFORMATION: In 22 CFR entities. For the reasons set out above, 21 CFR 62.27(e)(1) and (e)(4)(i), there is a part 1308 is amended to read as follows: reference to the ‘‘American Board of Administrative Procedure Act Medical Specialties’’ (ABMS). These DEA finds that good cause exists for PART 1308—SCHEDULES OF provisions, last amended in 1993, state adopting this rule as a final rule with an CONTROLLED SUBSTANCES that ABMS will perform certain immediate effective date under 5 U.S.C. certification functions for the Secretary ■ 553(d) because this final rule relieves a 1. The authority citation for 21 CFR of State. restriction. part 1308 continues to read as follows: ABMS no longer produces the Authority: 21 U.S.C. 811, 812, 871(b), publication, Marquis Who’s Who, Unfunded Mandates Reform Act of 1995 956(b) unless otherwise noted. referenced in 22 CFR part 62. On the basis of information contained ■ 2. In § 1308.12, revise paragraph (b)(1) Furthermore, ABMS has confirmed that in the RFA section above, DEA has introductory text to read as follows: it is also no longer the appropriate determined and certifies pursuant to the organization to comment on programs of Unfunded Mandates Reform Act of 1995 § 1308.12 Schedule II. graduate medical education. The (UMRA), 2 U.S.C. 1501 et seq., that this * * * * * Department has confirmed that the action would not result in any federal (b) * * * Accreditation Council for Graduate mandate that may result ‘‘in the (1) Opium and , and any salt, Medical Education (ACGME) has expenditure by State, local, and tribal compound, derivative, or preparation of responsibility to accredit and recognize governments, in the aggregate, or by the opium or opiate excluding institutions offering programs of private sector, of $100 million or more apomorphine, -derived graduate medical education, and is (adjusted for inflation) in any one , , , replacing the reference to the ABMS year. . . .’’ Therefore, neither a Small , , , with the ACGME in § 62.27.

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