Publication of Venezuela Sanctions Regulations Web General License 5P

III. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910–0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910–0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. List of Subjects in 21 CFR Part 876 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows: PART 876—GASTROENTEROLOGY￾UROLOGY DEVICES ■ 1. The authority citation for part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. ■ 2. Add § 876.4330 to subpart E to read as follows: § 876.4330 Endoscopic pancreatic debridement device. (a) Identification. An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of debridement of walled off pancreatic necrosis and all adverse events. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate the sterility of the patient￾contacting components of the device. (4) The patient-contacting components of the device must be demonstrated to be non-pyrogenic. (5) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (6) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Testing of rotational speeds and vacuum pressure; (ii) Functional testing including testing with all device components and the ability to torque the device; and (iii) Functional testing in a relevant tissue model to demonstrate the ability to resect and remove tissue. (7) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (8) Software verification, validation, and hazard analysis must be performed. (9) Training must be provided so that upon completion of the training program, the user can resect and remove tissue of interest while preserving non￾target tissue. (10) Labeling must include the following: (i) A summary of the clinical performance testing conducted with the device; (ii) Instructions for use, including the creation of a conduit for passage of endoscope and device into a walled off pancreatic necrotic cavity; (iii) Unless clinical performance data demonstrates that it can be removed or modified, a boxed warning stating that the device should not be used in patients with known or suspected pancreatic cancer; (iv) The recommended training for safe use of the device; and (v) A shelf life for any sterile components. Dated: September 4, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–20248 Filed 9–6–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Office of Foreign Assets Control 31 CFR Part 591 Publication of Venezuela Sanctions Regulations Web General License 5P AGENCY: Office of Foreign Assets Control, Treasury. ACTION: Publication of 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 Venezuela Sanctions Regulations: GL 5P, which was previously made available on OFAC’s website. DATES: GL 5P was issued on August 12, 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 12, 2024, OFAC issued GL 5P to authorize certain transactions otherwise prohibited by the Venezuela Sanctions Regulations (VSR), 31 CFR part 591. GL 5P was made available on OFAC’s website (https:// ofac.treasury.gov) when it was issued. GL 5P supersedes GL 5O, which was issued on April 15, 2024. The text of GL 5P is provided below. OFFICE OF FOREIGN ASSETS CONTROL Venezuela Sanctions Regulations 31 CFR Part 591 GENERAL LICENSE NO. 5P Authorizing Certain Transactions Related to the Petro´leos de Venezuela, S.A. 2020 8.5 Percent Bond on or After November 12, 2024 (a) Except as provided in paragraph (b) of this general license, on or after

November 12, 2024, all transactions related to, the provision of financing for, and other dealings in the Petro´leos de Venezuela, S.A. 2020 8.5 Percent Bond that would be prohibited by subsection l(a)(iii) of Executive Order (E.O.) 13835 of May 21, 2018, as amended by E.O. 13857 of January 25, 2019, and incorporated into the Venezuela Sanctions Regulations, 31 CFR part 591 (the VSR), are authorized. (b) This general license does not authorize any transactions or activities otherwise prohibited by the VSR, or any other part of 31 CFR chapter V. (c) Effective August 12, 2024, General License No. 5O, dated April 15, 2024, is replaced and superseded in its entirety by this General License No. 5P. Lisa M. Palluconi, Acting Director Office of Foreign Assets Control. Dated: August 12, 2024. Lisa M. Palluconi, Acting Director, Office of Foreign Assets Control. [FR Doc. 2024–20224 Filed 9–6–24; 8:45 am] BILLING CODE 4810–AL–P