⚕️Proposed Collection
Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Products
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 activities related to emergency use authorization for medical products.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document involves proposed information collection regarding Emergency Use Authorizations for medical products, triggering compliance and regulatory requirements for businesses in the healthcare sector. Companies may need to adjust their operations to meet new data collection standards and public comment on these processes, indicating financial and operational implications.