2024-09-06 | 2024-19919Added · Updated
The Department of the Treasury’s Office of Foreign Assets Control published General License 101 to authorize specific transactions otherwise prohibited by sanctions against Belarus and Russia. This license permits the provision of goods, technology, or services necessary for civil aviation safety and the wind-down of transactions involving certain blocked entities, including Aviakompaniya Belkanto LLC and Aviakompaniya Rada LLC. The authorization is valid through September 10, 2024, and explicitly excludes transactions involving other blocked persons or those prohibited under specific Executive Order directives.
evaluate the solute removal profile and document all adverse events. (2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Ultrafiltration; (ii) Blood and dialysate pressure drop; (iii) Clearance rates; (iv) Sieving coefficients; (v) Mechanical hemolysis; (vi) Structural integrity; (vii) Blood compartment integrity; (viii) Volume of the blood compartment; and (ix) Endotoxin retention of the dialyzer membrane. (3) The tissue-contacting components of the device must be demonstrated to be biocompatible. Biocompatibility evaluation must include a chemical analysis of the dialyzer membrane. (4) Performance data must demonstrate the sterility of the patientcontacting components of the device. (5) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (7) Device labeling must include: (i) Shelf life; (ii) Storage conditions; (iii) Instructions for the preparation of the hemodialyzer, initiation of dialysis, troubleshooting, and discontinuance of dialysis; (iv) Membrane surface area, priming (blood) volume, maximum transmembrane pressure, maximum blood flow and maximum dialysate rate for each model; (v) A non-pyrogenic statement; (vi) A summary of the in vitro performance data, provided in tabular form; and (vii) A summary of the clinical performance data. Dated: August 30, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–20081 Filed 9–5–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Parts 548 and 587 Publication of Belarus Sanctions Regulations and Russian Harmful Foreign Activities Sanctions Regulations Web General License 101 AGENCY: Office of Foreign Assets Control, Treasury. ACTION: Publication of a web general license. SUMMARY: The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing one general license (GL) issued pursuant to the Belarus Sanctions Regulations and Russian Harmful Foreign Activities Sanctions Regulations: GL 101 which was previously made available on OFAC’s website. DATES: GL 101 was issued on August 9, 2024. See SUPPLEMENTARY INFORMATION for additional relevant dates. FOR FURTHER INFORMATION CONTACT: OFAC: Assistant Director for Licensing, 202–622–2480; Assistant Director for Regulatory Affairs, 202–622–4855; or Assistant Director for Compliance, 202– 622–2490. SUPPLEMENTARY INFORMATION: Electronic Availability This document and additional information concerning OFAC are available on OFAC’s website: https:// ofac.treasury.gov. Background On August 9, 2024, OFAC issued GL 101 to authorize certain transactions otherwise prohibited by the Belarus Sanctions Regulations, 31 CFR part 548, and the Russian Harmful Foreign Activities Sanctions Regulations, 31 CFR part 587. The GL was made available on OFAC’s website (https:// ofac.treasury.gov) when it was issued and has an expiration date of September 10, 2024. The text of this GLs is provided below. OFFICE OF FOREIGN ASSETS CONTROL Belarus Sanctions Regulations 31 CFR Part 548 Russian Harmful Foreign Activities Sanctions Regulations 31 CFR Part 587 GENERAL LICENSE NO. 101 Authorizing Civil Aviation Safety and Wind Down Transactions Involving Certain Entities Blocked on August 9, 2024 (a) Except as provided in paragraph (c) of this general license, all transactions prohibited by the Belarus Sanctions Regulations, 31 CFR part 548 (BSR), and Executive Order (E.O.) 14024, that are ordinarily incident and necessary to the provision, exportation, or reexportation of goods, technology, or services to ensure the safety of civil aviation involving one or more of the following blocked entities (collectively, the ‘‘Blocked Entities’’) are authorized through 12:01 a.m. eastern daylight time, September 10, 2024, provided that the goods, technology, or services that are provided, exported, or reexported are for use on aircraft operated solely for civil aviation purposes: (1) Aviakompaniya Belkanto LLC; (2) Aviakompaniya Rada LLC; (3) UE RubiStar; or (4) Any entity in which one or more of the above persons owns, directly or indirectly, individually or in the aggregate, a 50 percent or greater interest. (b) Except as provided in paragraph (c) of this general license, all transactions prohibited by the BSR or E.O. 14024 that are ordinarily incident and necessary to the wind down of any transaction involving any of the Blocked Entities are authorized through 12:01 a.m. eastern daylight time, September 10, 2024, provided that any payment to a Blocked Entity is made into a blocked account in accordance with the BSR and the Russian Harmful Foreign Activities Sanctions Regulations, 31 CFR part 587 (RuHSR). (c) This general license does not authorize: (1) Any transactions otherwise prohibited by the BSR or the RuHSR, including transactions involving any person blocked pursuant to the BSR or the RuHSR other than the Blocked Entities, unless separately authorized; (2) Any transactions prohibited by Directive 2 under E.O. 14024, Prohibitions Related to Correspondent or PayableThrough Accounts and Processing of Transactions Involving Certain Foreign Financial Institutions; or (3) Any transactions prohibited by Directive 4 under E.O. 14024, Prohibitions Related to Transactions Involving the Central Bank of the Russian Federation, the National Wealth Fund of the Russian Federation, and the Ministry of Finance of the Russian Federation. Note to General License 101. Nothing in this general license relieves any person from compliance with any other Federal laws or requirements of other Federal agencies, including export, reexport, and transfer (incountry) licensing requirements maintained by the Department of Commerce’s Bureau of
Industry and Security under the Export Administration Regulations, 15 CFR parts 730–774. Lawrence M. Scheinert Acting Deputy Director, Office of Foreign Assets Control. Dated: August 9, 2024 Lisa M. Palluconi, Acting Director, Office of Foreign Assets Control. [FR Doc. 2024–19919 Filed 9–5–24; 8:45 am] BILLING CODE 4810–AL–P
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