Subpart C—Designation of an Orphan Drug

Sections

• 316.20
  § 316.20 Content and format of a request for orphan-drug designation.
• 316.21
  § 316.21 Verification of orphan-drug status.
• 316.22
  § 316.22 Permanent-resident agent for foreign sponsor.
• 316.23
  § 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
• 316.24
  § 316.24 Deficiency letters and granting orphan-drug designation.
• 316.25
  § 316.25 Refusal to grant orphan-drug designation.
• 316.26
  § 316.26 Amendment to orphan-drug designation.
• 316.27
  § 316.27 Change in ownership of orphan-drug designation.
• 316.28
  § 316.28 Publication of orphan-drug designations.
• 316.29
  § 316.29 Revocation of orphan-drug designation.
• 316.30
  § 316.30 Annual reports of holder of orphan-drug designation.