{"description":"Documents matching 'compliance statutory governing conduct nonclinical'","count":125,"total_pages":7,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=compliance+statutory+governing+conduct+nonclinical&format=json&page=2","results":[{"title":"Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Processes and Practices Applicable to Bioresearch Monitoring Inspections.\" This final guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA's Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The guidance covers the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.","document_number":"2025-23404","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23404/processes-and-practices-applicable-to-bioresearch-monitoring-inspections-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23404.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23404.pdf?1766065521","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"submitted to the Agency in support of regulatory decision-making, as well as to provide for protection of the rights, safety, and welfare of human and animal trial participants involved in FDA-regulated research. The program assesses <span class=\"match\">compliance</span> with <span class=\"match\">statutory</span> requirements and FDA's regulations <span class=\"match\">governing</span> the <span class=\"match\">conduct</span> of <span class=\"match\">nonclinical</span> and clinical studies, and applicable postmarketing activities. \n FDA also is confirming that the following two guidances will be withdrawn upon publication of this guidance, as their substance is superseded by this final guidance"},{"title":"Regulatory Agenda","type":"Notice","abstract":"The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.","document_number":"2025-18328","html_url":"https://www.federalregister.gov/documents/2025/09/22/2025-18328/regulatory-agenda","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-22/pdf/2025-18328.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18328.pdf?1758285918","publication_date":"2025-09-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"PRACTICE FOR <span class=\"match\">NONCLINICAL</span> LABORATORY STUDIES [0910-AJ01] \n Legal Authority: 21 U.S.C. 371 \n Abstract: The Food and Drug Administration (FDA) is proposing to: (1) Amend the regulations for Good Laboratory Practice (21 CFR part 58) to require a modern quality system for <span class=\"match\">conducting</span> <span class=\"match\">nonclinical</span> laboratory studies when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA; (2) to provide an opportunity for a hearing prior to disqualification of certain persons involved in the <span class=\"match\">conduct</span> of a nonclinical"},{"title":"Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Processes and Practices Applicable to Bioresearch Monitoring Inspections.\" The draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA's Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals. The draft guidance is intended to cover the following: the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct.","document_number":"2024-12319","html_url":"https://www.federalregister.gov/documents/2024/06/05/2024-12319/processes-and-practices-applicable-to-bioresearch-monitoring-inspections-draft-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-05/pdf/2024-12319.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-12319.pdf?1717505121","publication_date":"2024-06-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Agency in support of regulatory decision-making, as well as to provide for protection of the rights, safety, and welfare of human trial participants and animal subjects involved in FDA-regulated research. The program assesses <span class=\"match\">compliance</span> with <span class=\"match\">statutory</span> requirements and FDA's regulations <span class=\"match\">governing</span> the <span class=\"match\">conduct</span> of <span class=\"match\">nonclinical</span> and clinical studies, and applicable postmarketing activities. \n FDA also is announcing that the following two guidances will be withdrawn upon finalization of this guidance, as their substance is superseded by this draft guidance"},{"title":"Requirements Related to the Mental Health Parity and Addiction Equity Act","type":"Rule","abstract":"This document sets forth final rules amending regulations implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and adding new regulations implementing the nonquantitative treatment limitation (NQTL) comparative analyses requirements under MHPAEA, as amended by the Consolidated Appropriations Act, 2021 (CAA, 2021). Specifically, these final rules amend the existing NQTL standard to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from using NQTLs that place greater restrictions on access to mental health and substance use disorder benefits as compared to medical/surgical benefits. As part of these changes, these final rules require plans and issuers to collect and evaluate relevant data in a manner reasonably designed to assess the impact of NQTLs on relevant outcomes related to access to mental health and substance use disorder benefits and medical/surgical benefits and to take reasonable action, as necessary, to address material differences in access to mental health or substance use disorder benefits as compared to medical/surgical benefits. These final rules also amend existing examples and add new examples on the application of the rules for NQTLs to clarify and illustrate the requirements of MHPAEA. Additionally, these final rules set forth the content requirements for NQTL comparative analyses and specify how plans and issuers must make these comparative analyses available to the Department of the Treasury (Treasury), the Department of Labor (DOL), and the Department of Health and Human Services (HHS) (collectively, the Departments), as well as to an applicable State authority, and to participants, beneficiaries, and enrollees. Finally, HHS finalizes regulatory amendments to implement the sunset provision for self-funded non-Federal governmental plan elections to opt out of compliance with MHPAEA, as adopted in the Consolidated Appropriations Act, 2023 (CAA, 2023).","document_number":"2024-20612","html_url":"https://www.federalregister.gov/documents/2024/09/23/2024-20612/requirements-related-to-the-mental-health-parity-and-addiction-equity-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-23/pdf/2024-20612.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20612.pdf?1726258517","publication_date":"2024-09-23","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"},{"raw_name":"Internal Revenue Service","name":"Internal Revenue Service","id":254,"url":"https://www.federalregister.gov/agencies/internal-revenue-service","json_url":"https://www.federalregister.gov/api/v1/agencies/254","parent_id":497,"slug":"internal-revenue-service"},{"raw_name":"DEPARTMENT OF LABOR","name":"Labor Department","id":271,"url":"https://www.federalregister.gov/agencies/labor-department","json_url":"https://www.federalregister.gov/api/v1/agencies/271","parent_id":null,"slug":"labor-department"},{"raw_name":"Employee Benefits Security Administration","name":"Employee Benefits Security Administration","id":131,"url":"https://www.federalregister.gov/agencies/employee-benefits-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/131","parent_id":271,"slug":"employee-benefits-security-administration"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"136(c)(4)(iii) are intended to give particular meaning to the <span class=\"match\">statutory</span> language with respect to an NQTL itself, which, in these final rules, also requires <span class=\"match\">compliance</span>, in operation, with the design and application requirements under 26 CFR 54.9812-1(c)(4)(i), 29 CFR 2590.712(c)(4)(i), and 45 CFR 146.136(c)(4)(i). The Departments agree with commenters who noted that these requirements will promote transparency and <span class=\"match\">compliance</span> with MHPAEA, that such information is critical to assessing an NQTL's <span class=\"match\">compliance</span> with the statute, and that requiring plans and issuers"},{"title":"Regulatory Agenda","type":"Proposed Rule","abstract":"The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.","document_number":"2024-16451","html_url":"https://www.federalregister.gov/documents/2024/08/16/2024-16451/regulatory-agenda","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-16/pdf/2024-16451.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-16451.pdf?1723725919","publication_date":"2024-08-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Silver Spring, MD 20993, \n Phone: \n 877 287-1373, \n Email: ctpregulations@fda.hhs.gov. \n \n \n RIN: \n 0910-AI05\n \n 74. <span class=\"match\">Conduct</span> of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies [0910-AI57] \n \n Legal Authority: \n 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262\n \n \n Abstract: \n FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA's study <span class=\"match\">conduct</span> expectations for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies"},{"title":"Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons","type":"Rule","abstract":"The Department of Justice is issuing a final rule to implement Executive Order 14117 of February 28, 2024 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government- Related Data by Countries of Concern), by prohibiting and restricting certain data transactions with certain countries or persons.","document_number":"2024-31486","html_url":"https://www.federalregister.gov/documents/2025/01/08/2024-31486/preventing-access-to-us-sensitive-personal-data-and-government-related-data-by-countries-of-concern","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-01-08/pdf/2024-31486.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31486.pdf?1735911918","publication_date":"2025-01-08","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"}],"excerpts":"“facilitate or otherwise relate to <span class=\"match\">compliance</span>” with Federal law or other regulatory obligation. This commenter noted that some financial institutions may institute <span class=\"match\">compliance</span> programs that go beyond what is specifically required by Federal law in order to help ensure <span class=\"match\">compliance</span> with such laws or other regulatory obligations. \n The Department appreciates that some financial institutions may impose internal rules and requirements that are stricter than those established by Federal law in order to help ensure <span class=\"match\">compliance</span>. The commenter's suggestion to extend"},{"title":"Schedules of Controlled Substances: Rescheduling of Marijuana","type":"Proposed Rule","abstract":"The Department of Justice (\"DOJ\") proposes to transfer marijuana from schedule I of the Controlled Substances Act (\"CSA\") to schedule III of the CSA, consistent with the view of the Department of Health and Human Services (\"HHS\") that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of \"marijuana\" would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (\"FDCA\"). DOJ is soliciting comments on this proposal.","document_number":"2024-11137","html_url":"https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-21/pdf/2024-11137.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-11137.pdf?1715958912","publication_date":"2024-05-21","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"excerpts":" The ALJ will have all powers necessary to <span class=\"match\">conduct</span> a fair hearing, to take all necessary action to avoid delay, and to maintain order. \n Id. \n The ALJ's authorities include the power to hold conferences to simplify or determine the issues in the hearing or to consider other matters that may aid in the expeditious disposition of the hearing; require parties to state their position in writing; sign and issue subpoenas to compel the production of documents and materials to the extent necessary to <span class=\"match\">conduct</span> the hearing; examine witnesses and direct witnesses"},{"title":"Regulatory Agenda","type":"Proposed Rule","abstract":"The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.","document_number":"2023-14544","html_url":"https://www.federalregister.gov/documents/2023/07/27/2023-14544/regulatory-agenda","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-07-27/pdf/2023-14544.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-14544.pdf?1690375514","publication_date":"2023-07-27","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Silver Spring, MD 20993, \n Phone: \n 877 287-1373, \n Email: ctpregulations@fda.hhs.gov \n .\n \n \n RIN: \n 0910-AI05\n \n 74. <span class=\"match\">Conduct</span> of Analytical and Clinical Pharmacology, Bioavailability, and Bioequivalence Studies [0910-AI57] \n \n Legal Authority: \n 21 U.S.C. 355; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262\n \n \n Abstract: \n FDA is proposing to amend 21 CFR 320, in certain parts, and establish a new 21 CFR 321 to clarify FDA's study <span class=\"match\">conduct</span> expectations for clinical pharmacology, and clinical and analytical bioavailability (BA) and bioequivalence (BE) studies"},{"title":"Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality","type":"Rule","abstract":"This final rule will advance CMS's efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The final rule addresses standards for timely access to care and States' monitoring and enforcement efforts, reduces State burdens for implementing some State directed payments (SDPs) and certain quality reporting requirements, adds new standards that will apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and that specify the scope and nature of ILOSs, specifies medical loss ratio (MLR) requirements, and establishes a quality rating system for Medicaid and CHIP managed care plans.","document_number":"2024-08085","html_url":"https://www.federalregister.gov/documents/2024/05/10/2024-08085/medicaid-program-medicaid-and-childrens-health-insurance-program-chip-managed-care-access-finance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-10/pdf/2024-08085.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08085.pdf?1713816918","publication_date":"2024-05-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"§ 438.358(c)(5) could be used to <span class=\"match\">conduct</span> the secret shopper surveys proposed at § 438.68(f) and for secret shopper surveys <span class=\"match\">conducted</span> for MCOs, States may be able to receive enhanced Federal financial participation (FFP), pursuant to § 438.370. \n Secret shopper surveys can be <span class=\"match\">conducted</span> in many ways, using varying levels of complexity and gathering a wide range of information. We wanted to give States flexibility to design their secret shopper surveys to produce results that not only validate managed care plans' <span class=\"match\">compliance</span> with provider directory data"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization","type":"Rule","abstract":"This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); updates and makes changes to requirements for certain quality programs; and makes other policy- related changes. We are also finalizing the provisions of the interim final action with comment period regarding the changes to the FY 2025 IPPS rates due to the court decision in Bridgeport Hosp. v. Becerra. Lastly, it finalizes certain updates to the ONC Health Information Technology (IT) Certification Program.","document_number":"2025-14681","html_url":"https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-ipps-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-04/pdf/2025-14681.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14681.pdf?1753992911","publication_date":"2025-08-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"reconsideration if they believe that the finding of non-<span class=\"match\">compliance</span> is erroneous, or if they were non-compliant, they have a valid and justifiable excuse for this non-<span class=\"match\">compliance</span> (78 FR 50886). We further stated that, after we review the request for reconsideration, we may reverse our initial finding of non-<span class=\"match\">compliance</span> if: (1) the LTCH provides proof of <span class=\"match\">compliance</span> with all requirements during the reporting period; or (2) the LTCH provides adequate proof of a valid or justifiable excuse for non-<span class=\"match\">compliance</span> if the LTCH was not able to comply with requirements"},{"title":"Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)","type":"Rule","abstract":"This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.","document_number":"2024-07105","html_url":"https://www.federalregister.gov/documents/2024/04/23/2024-07105/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-23/pdf/2024-07105.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-07105.pdf?1712265021","publication_date":"2024-04-23","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"by MA organizations and their TPMOs. \n Through routine oversight and monitoring, CMS may take <span class=\"match\">compliance</span> actions if it determines that an MA organization is out of <span class=\"match\">compliance</span> with the terms of its contract with CMS. Based on an assessment of the circumstances surrounding non-<span class=\"match\">compliance</span>, CMS may issue a <span class=\"match\">compliance</span> action such as a notice of non-<span class=\"match\">compliance</span>, warning letter, or corrective action plan. As described in § 422.504(m)(3), a notice of non-<span class=\"match\">compliance</span> may be issued for any failure to comply with the requirements of the MA organization's current"},{"title":"Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability","type":"Proposed Rule","abstract":"This proposed rule seeks to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information through proposals for: standards adoption; adoption of certification criteria to advance public health data exchange; expanded uses of certified application programming interfaces, such as for electronic prior authorization, patient access, care management, and care coordination; and information sharing under the information blocking regulations. It proposes to establish a new baseline version of the United States Core Data for Interoperability. The proposed rule would update the ONC Health IT Certification Program to enhance interoperability and optimize certification processes to reduce burden and costs. The proposed rule would also implement certain provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA), which would support the reliability, privacy, security, and trust within TEFCA.","document_number":"2024-14975","html_url":"https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-08-05/pdf/2024-14975.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14975.pdf?1721825115","publication_date":"2024-08-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"in monitoring and encouraging developers' <span class=\"match\">compliance</span> with certain 45 CFR 170 subpart D requirements over the past three years, and pursuant to the authority in PHSA \n \n section 3001(c)(5)(E) to “encourage <span class=\"match\">compliance</span> with the conditions of certification,” we now propose new ONC-ACB PoPC requirements in § 170.523 to encourage and support developers' <span class=\"match\">compliance</span> with Maintenance of Certification requirements in § 170.402 and 170.404. In parallel, we propose to update ONC-ACBs' responsibilities for <span class=\"match\">conducting</span> reactive surveillance in accordance with § 170"},{"title":"Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality","type":"Proposed Rule","abstract":"This proposed rule would advance CMS' efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The proposed rule would specifically address standards for timely access to care and States' monitoring and enforcement efforts, reduce burden for some State directed payments and certain quality reporting requirements, add new standards that would apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and specify the scope and nature of ILOS, specify medical loss ratio (MLR) requirements, and establish a quality rating system for Medicaid and CHIP managed care plans.","document_number":"2023-08961","html_url":"https://www.federalregister.gov/documents/2023/05/03/2023-08961/medicaid-program-medicaid-and-childrens-health-insurance-program-chip-managed-care-access-finance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-03/pdf/2023-08961.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-08961.pdf?1682626517","publication_date":"2023-05-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"independent entity (\n such as those described in section 1852(e)(4) \n ) or that has an external review <span class=\"match\">conducted</span> under section 1852(e)(3) of the Act, the external review activities <span class=\"match\">conducted</span> under subparagraph (A) with respect to the organization shall not be duplicative of review activities <span class=\"match\">conducted</span> as part of the accreditation process or the external review <span class=\"match\">conducted</span> under such section (\n emphasis added \n ). Section 1852(e)(4) of the Act is the <span class=\"match\">statutory</span> basis for PAOs to obtain MA deeming authority from CMS. We do not read this provision as requiring"},{"title":"Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction","type":"Rule","abstract":"This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy- related changes. This final rule also revises our regulations on the counting of days associated with individuals eligible for certain benefits provided by section 1115 demonstrations in the Medicaid fraction of a hospital's disproportionate patient percentage (DPP) used in the disproportionate share hospital (DSH) calculation.","document_number":"2023-16252","html_url":"https://www.federalregister.gov/documents/2023/08/28/2023-16252/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-28/pdf/2023-16252.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-16252.pdf?1690920924","publication_date":"2023-08-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"neutral” payment rate under the LTCH PPS for discharges that do not meet the <span class=\"match\">statutory</span> criteria for exclusion beginning in FY 2016. For cost reporting periods beginning on or after October 1, 2015, discharges that do not meet certain <span class=\"match\">statutory</span> criteria for exclusion are paid based on the site neutral payment rate. Discharges that do meet the <span class=\"match\">statutory</span> criteria continue to receive payment based on the LTCH PPS standard Federal payment rate. For more information on the <span class=\"match\">statutory</span> requirements of the Pathway for SGR Reform Act of 2013, we refer readers"},{"title":"Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Proposed Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction","type":"Proposed Rule","abstract":"This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these systems. In this proposed rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. This proposed rule also would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We also propose to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). We propose to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. We also seek comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, we propose to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, we propose a technical correction to the Rural Emergency Hospital Conditions of Participation.","document_number":"2023-14768","html_url":"https://www.federalregister.gov/documents/2023/07/31/2023-14768/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-07-31/pdf/2023-14768.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-14768.pdf?1689279319","publication_date":"2023-07-31","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"},{"raw_name":"Office of the Secretary"}],"excerpts":"Prescription Drug Plan program audits \n 636 \n \n and <span class=\"match\">compliance</span> actions,\n 637 \n \n and the FDA which provides the public access to an online, searchable dashboard of <span class=\"match\">compliance</span> actions, including warning letters.\n 638 \n \n \n \n \n 635 \n  \n https://www.hrsa.gov/opa/program-integrity/fy-22-audit-results. \n \n \n \n \n 636 \n  \n https://www.cms.gov/medicare/<span class=\"match\">compliance</span>-and-audits/part-c-and-part-d-<span class=\"match\">compliance</span>-and-audits/programaudits. \n \n \n \n \n 637 \n  \n https://www.cms.gov/Medicare/<span class=\"match\">Compliance</span>-and-Audits/Part-C-and-Part-D-<span class=\"match\">Compliance</span>-and-Audits/PartCandPartDComplianceActions"},{"title":"Medical Device De Novo Classification Process","type":"Rule","abstract":"The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to requests for De Novo classification (\"De Novo request\") and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The final rule implements the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and modified by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act).","document_number":"2021-21677","html_url":"https://www.federalregister.gov/documents/2021/10/05/2021-21677/medical-device-de-novo-classification-process","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21677.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-21677.pdf?1633351544","publication_date":"2021-10-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"was not <span class=\"match\">conducted</span> in <span class=\"match\">compliance</span> with those regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with these requirements does not justify failure to provide information on a relevant clinical investigation. \n (B) For clinical investigations <span class=\"match\">conducted</span> in the United States, a statement that each investigation was <span class=\"match\">conducted</span> in <span class=\"match\">compliance</span> with part 812 of this chapter concerning sponsors of clinical investigations and clinical investigators, or if the investigation was not <span class=\"match\">conducted</span> in <span class=\"match\">compliance</span> with those"},{"title":"Ending the HIV/HCV Epidemics in Indian Country: A Program for American Indian/Alaska Native Tribes and Urban Indian Communities","type":"Notice","abstract":null,"document_number":"2022-08250","html_url":"https://www.federalregister.gov/documents/2022/04/18/2022-08250/ending-the-hivhcv-epidemics-in-indian-country-a-program-for-american-indianalaska-native-tribes-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-04-18/pdf/2022-08250.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-08250.pdf?1650026730","publication_date":"2022-04-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Indian Health Service","name":"Indian Health Service","id":237,"url":"https://www.federalregister.gov/agencies/indian-health-service","json_url":"https://www.federalregister.gov/api/v1/agencies/237","parent_id":221,"slug":"indian-health-service"}],"excerpts":"evaluate each component as described under Recipient Activities (see Section V.1.B, Application Review Information, Evaluation Criteria, Project Objective(s), Work Plan, and Approach). \n B. The IHS will <span class=\"match\">conduct</span> site visits to recipient sites and/or coordinate recipient visits to IHS facilities to assess work plans and ensure data security, confirm <span class=\"match\">compliance</span> with applicable laws and regulations, assess program activities, and to resolve problems, as needed mutually. \n C. DCCS will provide a forum for outreach and education to advance this program's goals"},{"title":"Premarket Tobacco Product Applications and Recordkeeping Requirements","type":"Rule","abstract":"The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.","document_number":"2021-21011","html_url":"https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21011.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-21011.pdf?1633351525","publication_date":"2021-10-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"whether the investigation is a clinical investigation or a <span class=\"match\">nonclinical</span> laboratory investigation. For <span class=\"match\">nonclinical</span> laboratory investigations, an application must contain documentation demonstrating all actions taken to ensure the reliability of the study, including whether the investigation was <span class=\"match\">conducted</span> using good laboratory practices (GLPs), such as those specified in part 58 (21 CFR part 58). FDA considers GLPs to be those that support the quality, reliability, and integrity of <span class=\"match\">nonclinical</span> laboratory investigations. This requirement helps FDA determine"},{"title":"Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements","type":"Rule","abstract":"This final rule amends the safe harbors to the Federal anti- kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the Department of Health and Human Services' (HHS's) Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of \"remuneration\" added by the Bipartisan Budget Act of 2018 (Budget Act of 2018).","document_number":"2020-26072","html_url":"https://www.federalregister.gov/documents/2020/12/02/2020-26072/medicare-and-state-health-care-programs-fraud-and-abuse-revisions-to-safe-harbors-under-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-12-02/pdf/2020-26072.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-26072.pdf?1605907821","publication_date":"2020-12-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of Inspector General"}],"excerpts":"OIG requires a VBE to have a <span class=\"match\">compliance</span> program, OIG should permit the VBE to meet such a requirement by: (i) Developing a <span class=\"match\">compliance</span> program specific to the VBE and its VBE participants, (ii) adopting an existing <span class=\"match\">compliance</span> program held by one of the VBE participants, or (iii) requiring an attestation from each VBE participant that it has a <span class=\"match\">compliance</span> program and <span class=\"match\">conducts</span> annual <span class=\"match\">compliance</span> reviews. Another commenter recommended that OIG provide model <span class=\"match\">compliance</span> provisions that could be included in agreements between parties in a VBE. \n \n Response:"},{"title":"Program of Comprehensive Assistance for Family Caregivers Improvements and Amendments Under the VA MISSION Act of 2018","type":"Rule","abstract":"The Department of Veterans Affairs (VA) adopts as final, with changes, a proposed rule to revise its regulations that govern VA's Program of Comprehensive Assistance for Family Caregivers (PCAFC). This final rule makes improvements to PCAFC and updates the regulations to comply with the recent enactment of the VA MISSION Act of 2018, which made changes to the program's authorizing statute. This final rule allows PCAFC to better address the needs of veterans of all eras and standardize the program to focus on eligible veterans with moderate and severe needs.","document_number":"2020-15931","html_url":"https://www.federalregister.gov/documents/2020/07/31/2020-15931/program-of-comprehensive-assistance-for-family-caregivers-improvements-and-amendments-under-the-va","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-31/pdf/2020-15931.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15931.pdf?1596113119","publication_date":"2020-07-31","agencies":[{"raw_name":"DEPARTMENT OF VETERANS AFFAIRS","name":"Veterans Affairs Department","id":520,"url":"https://www.federalregister.gov/agencies/veterans-affairs-department","json_url":"https://www.federalregister.gov/api/v1/agencies/520","parent_id":null,"slug":"veterans-affairs-department"}],"excerpts":"§ 71.20(a)(4). We make no changes based on this comment. \n § 71.25 Approval and Designation of Primary and Secondary Family Caregivers \n \n Several commenters questioned how VA will <span class=\"match\">conduct</span> eligibility assessments, including who will <span class=\"match\">conduct</span> these assessments and requested additional information. Specifically, commenters asserted VA needs to identify who will <span class=\"match\">conduct</span> eligibility assessments and have limitations on who this may be. One commenter questioned how VA will ensure standardization for eligibility assessments and \n \n reassessments. One commenter"}]}