Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

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The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.