Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Information on Pediatric Uses of Medical Devices

الملخص

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 associated with the requirement for submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose, or cure.