Search Results for citation:"90 FR 12162"

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Search Results: citation:"90 FR 12162"

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  • 2025-04115 — Information Collection; Application/Permit for Use of Space in Public Buildings and Grounds, GSA Form 3453
    Type:Notice
    Citation:90 FR 12162
    Reading Time:about 2 minutes

    The General Services Administration (GSA) is inviting public comments on a proposal to extend the use of GSA Form 3453, which is needed to request the use of public space in federal buildings and on federal grounds for various activities. The proposal is part of the Paperwork Reduction Act process, which requires the Regulatory Secretariat Division to seek approval from the Office of Management and Budget (OMB). People can submit comments and suggestions regarding this proposal, especially about its necessity and accuracy, until May 13, 2025. For further details, individuals can contact Ms. Karen Handsfield at the GSA.

    Simple Explanation

    GSA wants to keep using a special form that people need to fill out when they want to use spaces in public buildings, like for events, and they are asking for everyone's thoughts and ideas until May 2025.

  • 2025-04101 — Sage Therapeutics, Inc.; Withdrawal of Approval of a New Drug Application for ZULRESSO (Brexanolone) Solution, 100 Milligrams/20 Milliliters
    Type:Notice
    Citation:90 FR 12162
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has decided to withdraw its approval of the new drug application (NDA) for ZULRESSO (brexanolone) solution, which was previously held by Sage Therapeutics, Inc. This decision comes after Sage Therapeutics informed the FDA that the drug is no longer being sold and requested the withdrawal. The withdrawal of approval is effective as of April 14, 2025. It is important to note that any remaining ZULRESSO products can still be used until they are sold out, expire, or become unusable after the withdrawal date.

    Simple Explanation

    The FDA has stopped approving ZULRESSO, a special liquid medicine used by Sage Therapeutics, because it's not being sold anymore. Sage told the FDA this, and any leftover ZULRESSO can still be used until it's all gone or goes bad.