Search Results for keywords:"regulatory notice"

The Food and Drug Administration (FDA) is withdrawing approval for two abbreviated new drug applications (ANDAs) from Flamingo Pharmaceuticals Ltd. This decision is because the company has consistently failed to submit the necessary annual reports for these drug applications. Despite being given a chance for a hearing, the company did not respond, resulting in a waiver of their hearing opportunity and any claims about the drug's legal status. Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.

The Federal Reserve System has announced that several individuals and groups have applied to acquire shares of banks or bank holding companies under the Change in Bank Control Act. These applications are being reviewed based on specific factors outlined in the law. The public can inspect the details of these applications and submit comments until March 12, 2021. Families and individuals from Missouri and Kansas are among the applicants aiming to retain or acquire control over various banking institutions.

The Maritime Administration (MARAD) of the U.S. Department of Transportation is inviting public comments on a request concerning the coastwise endorsement eligibility of the SEA CZAR, a foreign-built vessel intended to offer passenger charters in the Pacific Northwest. The vessel will operate from Tacoma to the Canadian border, including the San Juan Islands and Lake Washington. MARAD seeks feedback on how this could impact U.S. vessel builders or businesses using U.S.-flag vessels, and comments can be submitted via various methods until January 6, 2025. If adverse effects are determined, MARAD may deny the endorsement.

The Food and Drug Administration (FDA) is removing its approval for eight different abbreviated new drug applications (ANDAs), as the companies that made these drugs informed the FDA that the drugs are no longer being sold. The companies asked the FDA to cancel these approvals, and the FDA has agreed to do so as of April 14, 2025. Even though approval is being withdrawn, the decision does not prevent the companies from filing new applications in the future if desired. Also, any existing drugs from the list that are still in stock after this date can be sold until they run out, expire, or otherwise become unsuitable.

The Internal Revenue Service (IRS) is requesting comments from the public and other federal agencies about continuing information collections related to the repeal of the bonding requirement for low-income housing tax credit recapture, as outlined by the Paperwork Reduction Act of 1995. The comment period is open until May 5, 2025, and inputs are sought on the necessity, burden, and potential improvements to these collections. This notice also clarifies that the IRS is not making any changes to the current paperwork burden for this collection. Kerry L. Dennis, a Tax Analyst at the IRS, approved this request.

ANR Pipeline Company has filed a notice with the Federal Energy Regulatory Commission (FERC) seeking approval to increase the pressure limit of its gas pipeline in Acadia Parish, Louisiana. This involves raising the Maximum Allowable Operating Pressure (MAOP) from 858 psig to 1,050 psig. Public participation is encouraged through filing protests, motions to intervene, or comments on the proposal by April 5, 2021. More details can be accessed on FERC's website or by contacting them directly for assistance.

The Federal Maritime Commission has announced the filing of new shipping agreements under the Shipping Act of 1984. These agreements involve several international shipping companies, and the Notice outlines changes like title adjustments and the removal of a company from one agreement, and a scope expansion in another. Interested parties can view the agreements online or contact the Commission for more information, and they have the opportunity to submit comments regarding the agreements within a specific timeframe. The proposed changes will take effect in February 2025.

The Animal and Plant Health Inspection Service (APHIS) is proposing to classify Canada as Level I for both bovine tuberculosis and brucellosis, based on evaluations they have prepared. This proposal is open for public review and comment until April 26, 2021. The evaluations and additional information are available for public access on the Regulations.gov website or can be viewed at the USDA's reading room in Washington, DC. After considering any comments received, APHIS will announce the final decision regarding Canada's classification in a future notice.

The Financial Industry Regulatory Authority, Inc. (FINRA) has filed a proposed rule change with the Securities and Exchange Commission to extend the implementation date of certain amendments to their Rule 4210, which concerns margin requirements, to October 26, 2021. These amendments, related to specific types of financial transactions, have been postponed to allow further consultation with industry participants and regulators to avoid disruption to the market. The change is immediate and does not involve any alterations to the wording of FINRA rules. Public comments are invited regarding this proposed extension.

The Postal Regulatory Commission has published a notice about the Postal Service's filing regarding a negotiated service agreement. This filing concerns possible changes to the Competitive product list, either by adding a new agreement or modifying an existing one. The public is invited to submit comments by December 11, 2024, through the Commission's online system or by contacting the General Counsel for advice on other methods of submission. The notice also specifies details about public proceedings for reviewing these requests, including docket numbers, filing titles, and the representatives assigned to these proceedings.