Federal Register Vol 86 No 211 Thursday November 4 2021 Rules and Regulations Issued in Des Moines Washington on October 28 2021 B G Chew Acting Group Manager Operations Support Group Western Service Center FR Doc 2021–23980 Filed 11–3–21 8 45 am BILLING CODE 4910–13–P DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 744 Docket No 211019–0210 RIN 0694–AI64 Addition of Certain Entities to the Entity List Bureau of Industry and Security Commerce ACTION Final rule AGENCY ERC Entity List Decisions Additions to the Entity List This final rule amends the Export Administration Regulations EAR by adding four entities to the Entity List These four entities have been determined by the U S Government to be acting contrary to the foreign policy and national security interests of the United States and will be listed on the Entity List under the destinations of Israel Russia and Singapore SUMMARY This rule is effective November 4 2021 FOR FURTHER INFORMATION CONTACT Chair End-User Review Committee Office of the Assistant Secretary for Export Administration Bureau of Industry and Security Department of Commerce Phone 202 482–5991 Email ERC@bis doc gov SUPPLEMENTARY INFORMATION DATES Background lotter on DSK11XQN23PROD with RULES1 Entity List The Entity List supplement no 4 to part 744 of the EAR identifies entities for which there is reasonable cause to believe based on specific and articulable facts that the entities have been involved are involved or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States The EAR 15 CFR parts 730–774 impose additional license requirements on and limit the availability of most license exceptions for exports reexports and transfers in-country to listed entities The license review policy for each listed entity is identified in the ‘‘License Review Policy’’ column on the Entity List and the impact on the availability VerDate Sep 11 2014 16 17 Nov 03 2021 Jkt 256001 of license exceptions is described in the relevant Federal Register document adding entities to the Entity List Bureau of Industry and Security BIS places entities on the Entity List pursuant to part 744 Control Policy End-User and End-Use Based and part 746 Embargoes and Other Special Controls of the EAR The End-User Review Committee ERC composed of representatives of the Departments of Commerce Chair State Defense Energy and where appropriate the Treasury makes all decisions regarding additions to removals from or other modifications to the Entity List The ERC makes all decisions to add an entry to the Entity List by majority vote and makes all decisions to remove or modify an entry by unanimous vote This rule implements the decision of the ERC to add four entities to the Entity List The four entities are added based on § 744 11 License requirements that apply to entities acting contrary to the national security or foreign policy interests of the United States of the EAR The four entities are located in Israel Russia and Singapore The ERC determined that NSO Group and Candiru be added to the Entity List based on § 744 11 b of the EAR Entities for which there is reasonable cause to believe based on specific and articulated facts that the entity has been involved is involved or poses a significant risk of being or becoming involved in activities that are contrary to the national security or foreign policy interests of the United States and those acting on behalf of such entities Specifically investigative information has shown that the Israeli companies NSO Group and Candiru developed and supplied spyware to foreign governments that used this tool to maliciously target government officials journalists businesspeople activists academics and embassy workers The ERC determined that Positive Technologies located in Russia and Computer Security Initiative Consultancy PTE LTD located in Singapore be added to the Entity List based on their engagement in activities counter to U S national security Specifically these entities traffic in cyber exploits used to gain access to information systems threatening the privacy and security of individuals and organizations worldwide Pursuant to § 744 11 b of the EAR the ERC determined that the conduct of the above-described four entities raises PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 60759 sufficient concerns that prior review via the imposition of a license requirement for exports reexports or transfers incountry of all items subject to the EAR involving these four entities and the possible issuance of license denials or the possible imposition of license conditions on shipments to these entities will enhance BIS’s ability to prevent violations of the EAR or otherwise protect U S national security or foreign policy interests In addition the ERC also determined that no license exceptions should be available for exports reexports or transfers incountry to the persons being added to the Entity List in this rule The ERC imposed a license review policy of a presumption of denial for these four entities The acronym ‘‘a k a ’’ which is an abbreviation of ‘also known as ’ is used in entries on the Entity List to identify aliases thereby assisting exporters reexporters and transferors in identifying entities on the Entity List For the reasons described above this final rule adds the following four entities to the Entity List and includes where appropriate aliases Israel • Candiru and • NSO Group Russia • Positive Technologies Singapore • Computer Security Initiative Consultancy PTE LTD Savings Clause Shipments of items removed from eligibility for a License Exception or export reexport or transfer in-country without a license NLR as a result of this regulatory action that were en route aboard a carrier to a port of export reexport or transfer in-country on November 4 2021 pursuant to actual orders for export reexport or transfer in-country to or within a foreign destination may proceed to that destination under the previous eligibility for a License Exception or export reexport or transfer in-country without a license NLR Export Control Reform Act of 2018 On August 13 2018 the President signed into law the John S McCain National Defense Authorization Act for Fiscal Year 2019 which included the Export Control Reform Act of 2018 ECRA 50 U S C 4801–4852 ECRA provides the legal basis for BIS’s principal authorities and serves as the authority under which BIS issues this rule E FR FM 04NOR1 SGM 04NOR1 60760 Federal Register Vol 86 No 211 Thursday November 4 2021 Rules and Regulations Rulemaking Requirements 1 Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and if regulation is necessary to select regulatory approaches that maximize net benefits including potential economic environmental public health and safety effects distributive impacts and equity Executive Order 13563 emphasizes the importance of quantifying both costs and benefits of reducing costs of harmonizing rules and of promoting flexibility This rule has been determined to be not significant for purposes of Executive Order 12866 2 Notwithstanding any other provision of law no person is required to respond to or be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 44 U S C 3501 et seq PRA unless that collection of information displays a currently valid Office of Management and Budget OMB Control Number This regulation involves collections previously approved by OMB under control number 0694–0088 Simplified Network Application Processing System which includes among other things license applications and commodity classification and carries a burden Country ISRAEL lotter on DSK11XQN23PROD with RULES1 List of Subjects in 15 CFR Part 744 Exports Reporting and recordkeeping requirements Terrorism RUSSIA 16 17 Nov 03 2021 Jkt 256001 PO 00000 2 Supplement No 4 to part 744 is amended ■ a Under ISRAEL by adding in alphabetical order entries for ‘‘Candiru’’ and ‘‘NSO Group’’ ■ b Under RUSSIA by adding in alphabetical order an entry for ‘‘Positive Technologies’’ and ■ c Under SINGAPORE by adding in alphabetical order an entry for ‘‘Computer Security Initiative Consultancy PTE LTD ’’ The additions read as follows ■ Federal Register citation All items subject to the EAR See § 744 11 of the EAR Presumption of denial 86 FR INSERT FR PAGE NUMBER November 4 2021 All items subject to the EAR See § 744 11 of the EAR Presumption of denial 86 FR INSERT FR PAGE NUMBER November 4 2021 Positive Technologies 8 Preobrzhenskaya Square Moscow Russia 107061 Authority 50 U S C 4801–4852 50 U S C 4601 et seq 50 U S C 1701 et seq 22 U S C 3201 et seq 42 U S C 2139a 22 U S C 7201 et seq 22 U S C 7210 E O 12058 43 FR 20947 3 CFR 1978 Comp p 179 E O 12851 58 FR 33181 3 CFR 1993 Comp p 608 E O 12938 59 FR 59099 3 CFR 1994 Comp p 950 E O 13026 61 FR 58767 3 CFR 1996 Comp p 228 E O 13099 63 FR 45167 3 CFR 1998 Comp p 208 E O 13222 66 FR 44025 3 CFR 2001 Comp p 783 E O 13224 66 FR 49079 3 CFR 2001 Comp p 786 Notice of September 15 2021 86 FR 52069 September 17 2021 Notice of November 12 2020 85 FR 72897 November 13 2020 License review policy Candiru a k a the following seven aliases —Candiru Ltd —DF Associates Ltd —Grindavik Solutions Ltd —Taveta Ltd —Saito Tech Ltd —Greenwick Solutions and —Tabatha Ltd 21 Haarbaa Tel Aviv-Yafo Israel 6473921 NSO Group 22 Galgalei Haplada Herzliya Tel Aviv-Yafo Israel 4672222 1 The authority citation for 15 CFR part 744 is revised to read as follows ■ License requirement PART 744— AMENDED Supplement No 4 to Part 744—Entity List Accordingly part 744 of the Export Administration Regulations 15 CFR parts 730–774 is amended as follows Entity VerDate Sep 11 2014 estimate of 29 6 minutes for a manual or electronic submission for a total burden estimate of 31 835 hours Total burden hours associated with the PRA and OMB control number 0694–0088 are not expected to increase as a result of this rule 3 This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132 4 Pursuant to section 1762 of ECRA this action is exempt from the Administrative Procedure Act 5 U S C 553 requirements for notice of proposed rulemaking opportunity for public participation and delay in effective date 5 Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U S C 553 or by any other law the analytical requirements of the Regulatory Flexibility Act 5 U S C 601 et seq are not applicable Accordingly no regulatory flexibility analysis is required and none has been prepared All items subject to the EAR See § 744 11 of the EAR Frm 00008 Fmt 4700 Sfmt 4700 Presumption of denial E FR FM 04NOR1 SGM 04NOR1 86 FR INSERT FR PAGE NUMBER November 4 2021 60761 Federal Register Vol 86 No 211 Thursday November 4 2021 Rules and Regulations Country SINGAPORE BILLING CODE 3510–33–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Docket No DEA–631 Schedules of Controlled Substances Placement of Isotonitazene in Schedule I Drug Enforcement Administration Department of Justice ACTION Final amendment final order AGENCY With the issuance of this final order the Administrator of the Drug Enforcement Administration is permanently placing N N-diethyl-2- 2 4-isopropoxybenzyl -5-nitro-1Hbenzimidazol-1-yl ethan-1-amine commonly known as isotonitazene 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 within the specific chemical designation in schedule I of the Controlled Substances Act This scheduling action discharges the United States’ obligations under the Single Convention on Narcotic Drugs 1961 This action continues to impose the regulatory controls and administrative civil and criminal sanctions applicable to schedule I controlled substances on persons who handle manufacture distribute import export engage in research or conduct instructional activities with or possess or propose to handle isotonitazene DATES Effective December 6 2021 lotter on DSK11XQN23PROD with RULES1 SUMMARY 16 17 Nov 03 2021 Jkt 256001 86 FR INSERT FR PAGE NUMBER November 4 2021 Background On August 20 2020 DEA issued a temporary scheduling order placing isotonitazene N N-diethyl-2- 2- 4isopropoxybenzyl -5-nitro-1Hbenzimidazol-1-yl ethan-1-amine in Frm 00009 Legal Authority The United States is a party to the 1961 United Nations Single Convention on Narcotic Drugs Single Convention March 30 1961 18 U S T 1407 570 U N T S 151 as amended by the 1972 Protocol Article 3 paragraph 7 of the Single Convention requires that if the Commission on Narcotic Drugs Commission adds a substance to one of the schedules of such Convention and the United States receives notification of such scheduling decision from the Secretary-General of the United Nations Secretary-General the United States as a signatory Member State is obligated to control the substance under its national drug control legislation Under 21 U S C 811 d 1 if control of a substance is required ‘‘by United States obligations under international treaties conventions or protocols in effect on October 27 1970 ’’ the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations without regard to the findings required by 21 U S C 811 a or 812 b and without regard to the procedures prescribed by 21 U S C 811 a and b The Attorney General has delegated scheduling authority under 21 U S C 811 to the Administrator of the Drug Enforcement Administration Administrator of DEA or Administrator 28 CFR 0 100 PO 00000 Terrence L Boos Drug and Chemical Evaluation Section Diversion Control Division Drug Enforcement Administration Telephone 571 362– 3249 SUPPLEMENTARY INFORMATION FR Doc 2021–24123 Filed 11–3–21 8 45 am Federal Register citation Presumption of denial FOR FURTHER INFORMATION CONTACT Matthew S Borman Deputy Assistant Secretary for Export Administration VerDate Sep 11 2014 All items subject to the EAR See § 744 11 of the EAR License review policy Computer Security Initiative Consultancy PTE LTD a k a the following alias —COSEINC 102F Pasir Panjang Rd #08–02 Citilink Warehouse Complex Singapore 118530 License requirement Entity Fmt 4700 Sfmt 4700 schedule I of the Controlled Substances Act CSA 85 FR 51342 That order was based on findings by the Acting Administrator of DEA Acting Administrator that the temporary scheduling of this substance was necessary to avoid an imminent hazard to the public safety the order was codified at 21 CFR 1308 11 h 48 In November 2020 the DirectorGeneral of the World Health Organization recommended to the Secretary-General that isotonitazene be placed in Schedule I of the Single Convention as this substance has an opioid mechanism of action and similarity to drugs that are controlled in Schedule I of the Single Convention i e isotonitazene is similar to drugs such as morphine and fentanyl and has dependence and abuse potential On June 10 2021 the Secretary-General advised the Secretary of State of the United States by letter that during its 64th session in April 2021 the Commission voted to place isotonitazene in Schedule I of the Single Convention CND Apr 64 1 Isotonitazene As discussed in the background section isotonitazene is temporarily controlled in schedule I of the CSA upon the Acting Administrator’s finding it poses imminent hazard to the public safety Isotonitazene has a pharmacological profile similar to etonitazene schedule I fentanyl schedule II and other schedule I and II synthetic opioids that act as muopioid receptor agonists Because of the pharmacological similarities of isotonitazene to etonitazene a potent mu-opioid agonist the use of isotonitazene presents a high risk of abuse and has negatively affected users and communities The abuse of isotonitazene has been associated with E FR FM 04NOR1 SGM 04NOR1