Federal Register - June 10, 2021

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Fuente: Federal Register

30772

Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules and Regulations
contains a stage 7 port, P/N 2614M30P01, with a port casting serial number S/N listed in Table 1 in Planning Information, Paragraph 3.A., of CFM Service Bulletin SB
LEAP1A7200042101A930AD, Issue 001, dated October 22, 2020.
d Subject Joint Aircraft System Component JASC
Code 7250, Turbine Section.
e Unsafe Condition This AD was prompted by a report of a manufacturing quality escape found during inspection of an HPT case. The FAA is issuing this AD to prevent failure of the HPT
case. The unsafe condition, if not addressed, could result in failure of the HPT case, uncontained rotor release, damage to the engine, and damage to the airplane.
f Compliance Comply with this AD within the compliance times specified, unless already done.
g Required Actions Before the HPT case exceeds the cycles since new limit in Table 1, Planning Information, Paragraph 3.A., of CFM SB
LEAP1A7200042101A930AD, Issue 001, dated October 22, 2020, or during the next piece part exposure, whichever occurs first after the effective date of this AD, remove the affected HPT case from service and replace with a part eligible for installation.

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h Definitions For the purpose of this AD:
1 A part eligible for installation is an HPT
case, P/N 2668M94G01, that contains a stage 7 port, P/N 2614M30P01, with an S/N that is not listed in Table 1 in Planning Information, Paragraph 3.A., of CFM SB
LEAP1A7200042101A930AD, Issue 001, dated October 22, 2020.
2 Piece-part exposure is when the HPT
case is removed from the engine and fully disassembled.
i Alternative Methods of Compliance AMOCs 1 The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in Related Information. You may email your request to: ANE-AD-AMOC@
faa.gov.
2 Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/
certificate holding district office.
j Related Information For more information about this AD, contact Christopher McGuire, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781
2387120; fax: 781 2387199; email:
Chris.McGuire@faa.gov.

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k Material Incorporated by Reference 1 The Director of the Federal Register approved the incorporation by reference IBR of the service information listed in this paragraph under 5 U.S.C. 552a and 1 CFR
part 51.
2 You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
i CFM Service Bulletin LEAP1A7200
042101A930AD, Issue 001, dated October 22, 2020.
ii Reserved 3 For CFM service information identified in this AD, contact CFM International, S.A., Aviation Operations Center, 1 Neumann Way, M/D Room 285, Cincinnati, OH 45125;
phone: 877 4323272; email:
aviation.fleetsupport@ge.com.
4 You may view this service information at FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781 2387759.
5 You may view this service information that is incorporated by reference at the National Archives and Records Administration NARA. For information on the availability of this material at NARA, email: fedreg.legal@nara.gov, or go to:
https www.archives.gov/federal-register/cfr/
ibr-locations.html.
Issued on May 21, 2021.
Lance T. Gant, Director, Compliance & Airworthiness Division, Aircraft Certification Service.
FR Doc. 202112137 Filed 6921; 8:45 am BILLING CODE 491013P

DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA715

Schedules of Controlled Substances:
Placement of Oliceridine in Schedule II
Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
AGENCY:

This final rule adopts, with a change as mentioned below, an interim final rule with request for comments published in the Federal Register on October 30, 2020, placing oliceridine, N3-methoxythiophen-2-ylmethyl29R-9-pyridin-2-yl-6oxaspiro4.5decan-9-ylethylamine fumarate, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule II of the Controlled Substances Act. In response to an error in the chemical name of oliceridine as noted by one of the commenters to the interim final rule, the Drug Enforcement
SUMMARY:

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Administration makes a correction to the above mentioned chemical name of oliceridine by removing the word fumarate to read as N-3methoxythiophen-2-ylmethyl2-9R9-pyridin-2-yl-6-oxaspiro4.5decan-9ylethylamine. This change clarifies the control of oliceridine free base and its salts, to include the fumarate salt, by definition.
DATES: Effective July 12, 2021.
FOR FURTHER INFORMATION CONTACT: Dr.
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: 571 362
3249.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority On October 30, 2020, the Drug Enforcement Administration DEA, pursuant to 21 U.S.C. 811j, published an interim final rule IFR to place oliceridine including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, a medication approved recently by the Food and Drug Administration FDA for medical use as an intravenous drug for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate, in schedule II of the Controlled Substances Act CSA. 85 FR
68749. The IFR provided an opportunity for interested persons to submit comments, as well as file a request for hearing or waiver of hearing, on or before November 30, 2020. DEA
received three comments and did not receive any requests for hearing or waiver of hearing.
Comments Received In response to the IFR, DEA received three comments. The submissions were from individuals or anonymous commenters. One commenter suggested that oliceridine be placed in schedule III
rather than schedule II, one commenter had a statement on the controlled name, and the third commenter discussed another substance entirely that was unrelated to oliceridine. As such, the third comment was outside the scope of this current scheduling action.
Comment: One commenter suggested that oliceridine be placed in schedule III
of the CSA, rather than schedule II. The commenter mentioned that placement of oliceridine in schedule II will limit its medical applications and limit access to the drug due to schedule II
manufacturing quotas. The commenter stated that oliceridine has the potential
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Federal Register - June 10, 2021

TítuloFederal Register

PaísEstados Unidos de América

Fecha10/06/2021

Nro. de páginas341

Nro. de ediciones7798

Primera edición14/03/1936

Ultima edición18/06/2026

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