Search Results for keywords:"annual reports"

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 Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.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 Securities and Exchange Commission (SEC) is requesting an extension for collecting certain information using Form 1-K, as required under the Paperwork Reduction Act. Form 1-K is mandatory for Tier 2 issuers who conduct offerings under Regulation A and need to file annual reports. There are about 353 issuers that file this form each year, and preparing it requires around 600 hours. The public can submit comments on this information request from December 12, 2024, to January 13, 2025.

The Securities and Exchange Commission has approved an amendment proposed by the Public Company Accounting Oversight Board (PCAOB) which allows a firm’s registration to be withdrawn if it fails to file required annual reports and pay fees for two consecutive years. This new rule aims to help the PCAOB keep an accurate list of active firms and improve how they manage their resources, ensuring regulations are more efficient. The amendment provides steps for notifying firms of their delinquency, offering them a chance to remain registered. Additionally, the amendment will apply to audits of Emerging Growth Companies to ensure consistent protection of investor interests.

The Veterans Health Administration is seeking comments on a proposed information collection related to Nonprofit Research and Education Corporations (NPCs) by March 5, 2025. This involves various forms used for annual reports, audit remediation, internal control, and operational oversight, which help monitor the NPCs' operations and financial health. The Veterans Affairs Department uses this data for oversight, ensuring NPCs address any audit issues and improve their operations. The total expected burden for this data collection is 858 hours annually, affecting not-for-profit organizations.

The Securities and Exchange Commission (SEC) has requested an extension for a previously approved information collection related to Form 40-F, as required by the Paperwork Reduction Act. This form is used by certain Canadian companies to register securities or submit annual reports in accordance with the Securities Exchange Act. The SEC estimates that responding to this form takes approximately 431.42 hours, and an average of 175 responses are submitted annually. The public is invited to comment on this request by visiting a specified website or by sending an email by April 21, 2025.

The Federal Highway Administration (FHWA) is asking for public feedback on their intention to resume a previously approved information collection. This information collection, linked to the Moving Ahead for Progress in the 21st Century Act, requires federal agencies to provide annual reports on property acquisition activities. It involves 56 respondents and is set to occur annually, with an estimated 5-hour burden per response. Public comments are welcome until February 3, 2025, particularly on the necessity and efficiency of this data collection process.

The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications because the companies responsible for these drugs repeatedly failed to submit the required annual reports. The FDA had previously offered these companies the chance for a hearing, but they did not respond, which meant they gave up that opportunity and any arguments about the legal status of the drugs. As a result, these drug approvals will no longer be valid starting February 23, 2021.