💊FDA Determines SYNDROS Not Withdrawn, Opens Doors for Generics
The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.
Learn More🌍Impact of NEPA Procedures Rescission on Business and Compliance
This interim final rule rescinds DON's regulations implementing the National Environmental Policy Act (NEPA), because the Council on Environmental Quality's (CEQ) NEPA regulations, which they were meant to supplement, have been rescinded, and because the DoD is promulgating Department-wide NEPA procedures that will guide the Navy's NEPA process. In addition, this interim final rule requests comments on this action.
Learn More💰SEC Considers Staking Proposal for Bitwise Ethereum ETF
The Securities and Exchange Commission is evaluating a proposed rule change by NYSE Arca to amend regulations governing the listing of the Bitwise Ethereum ETF, specifically to allow staking of ether. This order initiates proceedings to determine if the change meets federal securities standards, inviting public comments and feedback on the proposal.
Learn More🥗FDA Notice on Information Collection for Communication Effectiveness
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection entitled "Generic Clearance for Quick Turnaround Testing of Communication Effectiveness."
Learn More🧪FDA Notice
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Learn More📄FDA Information Collection Activities and Approvals Summary
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More📈Proposed NYSE Rule Changes on Trading Halts Impact Businesses
The New York Stock Exchange (NYSE) filed proposed rule changes to amend its regulations on trading halts, intending to merge existing rules for clarity and consistency across self-regulatory organizations. The changes aim to enhance regulatory oversight for trading activities in response to operational or regulatory disruptions, thus promoting orderly market conditions.
Learn More📋CMS Notice on Proposed Information Collection Activities
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More📈Nasdaq Proposal for Generic Listing of Multi-Class ETFs Under Review
The SEC has extended the review period for Nasdaq's proposed rule change to adopt Rule 5703, which would allow the generic listing and trading of Multi-Class Exchange-Traded Fund Shares. The extension aims to provide adequate time for the Commission to consider the proposal and related issues before making a decision.
Learn More📑Change Order Accounting Regulation; Implications for Contractors
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division has submitted to OMB a request to review and approve an extension and revision of a previously approved information collection requirement regarding change order accounting and notification of changes.
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