19 Sep 2025

🌍FDA Environmental Impact Requirements for Business Applications

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$$ - High

The regulatory text involves compliance and regulatory requirements related to environmental impact assessments for businesses regulated by the FDA, which directly affects how they conduct operations and product approvals. Companies must prepare and submit detailed environmental documentation as part of their application processes.

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