3 new federal notices

New in the Federal Register

Rules, proposed rules, and notices from the FDA and USDA that touch food, labels, and organic.

• Notice · Health and Human Services Department Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

  The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

• Notice · Health and Human Services Department Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0

  The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation...

• Notice · Health and Human Services Department Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments

  The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public...

Summaries are the agencies' own words. Read the full document before you act on it.