📦FDA Export Notification and Recordkeeping Requirements Overview
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Notification and Recordkeeping Requirements
Summary
The Food and Drug Administration (FDA, Agency, or we) 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 notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
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The document details regulatory requirements for exporters regarding notification and recordkeeping under FDA guidelines, impacting compliance for businesses dealing with human drugs, devices, and food products. Non-compliance could lead to penalties and operational interruptions.