Notice 14 Mar 2025 compliance, healthcare, regulation, government, health, legal

⚖️Overview of HHS Office of General Counsel's Organization and Authority

This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.

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Notice 14 Mar 2025 compliance, regulatory, immigration, non-profit, accreditation, legal

📋Information Collection Activities for Non-Attorney Representatives

The Executive Office for Immigration Review (EOIR), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

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Notice 13 Mar 2025 compliance, fda, debarment, pharmaceutical, drug regulation, importation, legal

🚫FDA Debars Alnashir Punjani for 5 Years

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Alnashir Alibhai Punjani for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Punjani was convicted of one felony count under Federal law for conspiracy to deliver and introduce unapproved drugs. The factual basis supporting Mr. Punjani's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Punjani was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 10, 2024 (30 days after receipt of the notice), Mr. Punjani had not responded. Mr. Punjani's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 13 Mar 2025 compliance, fda, debarment, health, sanctions, drug regulation, legal

⚖️Implications of John Kosolcharoen's FDA Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring John Warrington Kosolcharoen from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application (BLA). FDA bases this order on a finding that Mr. Kosolcharoen was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kosolcharoen was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 26, 2024 (30 days after receipt of the notice), Mr. Kosolcharoen has not responded. Mr. Kosolcharoen's failure to respond and request a hearing constitutes a waiver of Mr. Kosolcharoen's right to a hearing concerning this matter.

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Notice 13 Mar 2025 compliance, regulation, fda, debarment, pharmaceutical, drug importation, legal

⚖️FDA Debarment Order Against Jonathan Corbett Cosie

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jonathan Corbett Cosie for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Cosie was convicted of two felony counts under Federal law for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead. The factual basis supporting Mr. Cosie's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Cosie was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 6, 2025 (30 days after receipt of the notice), Mr. Cosie had not responded. Mr. Cosie's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 11 Mar 2025 compliance, regulation, financial, business, legal, patent, trademark, usp

📑USPTO Information Collection on Practitioner Conduct and Discipline

The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on the extension and revision of an existing information collection: 0651- 0017 (Practitioner Conduct and Discipline). The purpose of this notice is to allow 60 days for public comments preceding submission of the information collection to the Office of Management and Budget (OMB).

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Notice 7 Mar 2025 regulation, health, business, compensation, legal, vaccine

💉National Vaccine Injury Compensation Program Notice for Businesses

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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Notice 7 Mar 2025 compliance, business regulation, research, antitrust, legal, consortium

📜Notice on R Consortium Membership Changes by DOJ Antitrust Division

The Department of Justice's Antitrust Division issued a notice regarding changes in membership within the R Consortium, Inc. This notice outlines the addition of new members and its implications for antitrust provisions under the National Cooperative Research and Production Act, emphasizing compliance requirements for participating businesses.

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Notice 27 Feb 2025 compliance, sec, regulation, business governance, legal, securities laws

⚖️SEC Notice on Reporting Evidence of Material Violations

The Securities and Exchange Commission seeks comments on the reinstatement of an information collection requirement for attorneys regarding material violations by issuers. This involves compliance protocols, potentially impacting governance procedures and the ethical conduct of legal professionals within the securities field.

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Notice 18 Feb 2025 compliance, sec, regulation, securities, financial services, legal

🔒SEC Closed Meeting Notification

The Securities and Exchange Commission announces a closed meeting on critical regulatory issues, including discussions on injunctive actions and administrative proceedings. Such meetings may lead to significant decisions impacting businesses linked to compliance and enforcement actions, with potential repercussions in the financial sector and beyond.

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