Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions-Accelerated Approval of Drugs and Biologics
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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 This notice solicits comments on information collection relating to the draft guidance, "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics."
Abstract as published in the Federal Register.
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