21 CFR 316.24 - Granting orphan-drug designation.

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There is 1 rule appearing in the Federal Register for 21 CFR 316. View below or at eCFR (GPOAccess)
§ 316.24 Granting orphan-drug designation.
(a) FDA will grant the request for orphan-drug designation if none of the reasons described in § 316.25 for requiring or permitting refusal to grant such a request applies.
(b) When a request for orphan-drug designation is granted, FDA will notify the sponsor in writing and will publicize the orphan-drug designation in accordance with § 316.28.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2013-06-12; vol. 78 # 113 - Wednesday, June 12, 2013
    1. 78 FR 35117 - Orphan Drug Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 12, 2013.
      21 CFR Part 316

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 316 after this date.

  • 2013-06-12; vol. 78 # 113 - Wednesday, June 12, 2013
    1. 78 FR 35117 - Orphan Drug Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective August 12, 2013.
      21 CFR Part 316