📄FDA Notice
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with our generic drug user fee program.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The proposed information collection related to the Generic Drug User Fee Program outlines compliance and regulatory requirements for businesses in the pharmaceutical sector, making it crucial for stakeholders that must respond by March 2025.