Search Results for keywords:"hearing request"

The Securities and Exchange Commission (SEC) has published a notice regarding an application for an order under the Investment Company Act of 1940. The order would grant exemptions from certain sections of the Act and a rule under it, allowing ActiveShares ETFs to issue and redeem shares in large batches, and facilitate market transactions at negotiated prices. The application involves the ActiveShares ETF Trust, Legg Mason Partners Fund Advisor, LLC, and Legg Mason Investor Services, LLC, seeking relief consistent with a prior order. The SEC will issue the order unless someone requests a hearing by February 8, 2021, by contacting the SEC via email.

Leading Pharma LLC has applied to register as an importer of controlled substances. This application is for research and development purposes, aiming toward creating a new pharmaceutical product that is pending approval by the Food and Drug Administration (FDA). Interested parties can submit comments or request a hearing regarding this application, with a deadline of January 17, 2025. The Drug Enforcement Administration (DEA) will approve the application only if it meets specific legal criteria.

Sigma Aldrich Research Biochemicals Inc. has applied to the Drug Enforcement Administration to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances for use as reference standards only, and no other uses are approved under this registration. The public can submit comments or objections electronically regarding this application until May 12, 2025, through the Federal eRulemaking Portal. Additionally, requests for a hearing on the application must also be made by this date.

The Food and Drug Administration (FDA) is proposing to reject the new drug application from Vanda Pharmaceuticals for TRADIPITANT capsules, intended to treat nausea in gastroparesis. The application was found lacking as it did not provide substantial evidence of the drug’s effectiveness and safety based on submitted studies and data. Vanda has the option to request a hearing to contest this decision, though they must address all the identified deficiencies. If no hearing request is filed, or if it is not deemed substantial, the FDA will officially deny the application.

In a notice from the Securities and Exchange Commission (SEC), an application was submitted under the Investment Company Act of 1940. The applicants, including Privacore PCAAM Alternative Income Fund and others, are seeking exemptions to allow certain investment companies to issue multiple share classes with asset-based distribution or service fees and early withdrawal charges. A hearing on the application may occur if requested by December 23, 2024. Public comments and hearing requests can be submitted via email, and further information is available on the SEC's EDGAR system.

The Drug Enforcement Administration (DEA) has announced that the Research Triangle Institute has applied to become a bulk manufacturer of certain controlled substances. The institute intends to produce these substances synthetically for research purposes and to provide analytical reference standards. Interested parties can submit electronic comments or objections regarding this registration by June 17, 2025, and can request a hearing by the same date. Comments are to be submitted through the Federal eRulemaking Portal at regulations.gov.

Sigma Aldrich Research Biochemicals, Inc. has applied to the Drug Enforcement Administration (DEA) to become registered as a bulk manufacturer of controlled substances. The public is invited to submit comments or objections and request a hearing by April 26, 2021. The application was submitted on December 17, 2020, and aims to manufacture reference standards of certain controlled substances. Comments should be sent to the DEA at the address provided in the notice.

Groff Hemplex LLC has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The company plans to use these substances for its own purposes and to sell them to approved research investigators. The public can submit comments or objections electronically by April 28, 2025, and also request a hearing on this application by the same date. This application process follows the regulations set by the DEA under 21 CFR 1301.33(a).

S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

Siemens Healthcare Diagnostics Inc. has submitted an application to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. The company intends to use these substances to produce products that are exempt from DEA regulations. Individuals or existing registered manufacturers can express their support or objections in writing by March 15, 2021, or request a hearing regarding this application by the same date.