1 May 2025

🧪FDA Notice on Reagents for Detection of Specific Novel Influenza A Viruses

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses

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 the information collection associated with Agency guidance on reagents for detection of specific novel influenza A viruses.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

$$ - Med

The notice involves a proposed information collection requirement on reagents for the detection of novel influenza A viruses, which may have compliance implications for businesses in the medical device sector. Companies will need to assess their reporting processes to align with FDA guidance and could foresee operational changes or resource reallocations.

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