Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Reopening of Comment Period

Resumen

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. In the Federal Register of December 20, 2018, the Agency extended the comment period until February 13, 2019. The Agency is taking this action to reopen the comment period to allow interested persons additional time to submit comments due to technical issues with the Federal eRulemaking Portal (https://www.regulations.gov) on February 13, 2019.