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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i4
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 316
    PART 316—ORPHAN DRUGS
  5. subpart C
    Subpart C—Designation of an Orphan Drug

Subpart C. Subpart C—Designation of an Orphan Drug

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