Designation of drugs for rare diseases or conditions

The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— A designation of a drug under subsection (a) shall be subject to the condition that— Notice respecting the designation of a drug under subsection (a) shall be made available to the public. The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).