Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews with entities that submit a Request for Designation (RFD) or pre-RFD, an Investigational New Drug (IND) application or pre-IND request, or a New Drug Application (NDA) or Biologics License Application (BLA) for a combination product to FDA.