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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 316 - Orphan Drugs |
| Subpart A - General Provisions |
| § 316.1 - Scope of this part. |
| § 316.2 - Purpose. |
| § 316.3 - Definitions. |
| § 316.4 - Address for submissions. |
| Subpart B - Written Recommendations for Investigations of Orphan Drugs |
| § 316.10 - Content and format of a request for written recommendations. |
| § 316.12 - Providing written recommendations. |
| § 316.14 - Refusal to provide written recommendations. |
| 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. |
| Subpart D - Orphan-drug Exclusive Approval |
| § 316.31 - Scope of orphan-drug exclusive approval. |
| § 316.34 - FDA recognition of exclusive approval. |
| § 316.36 - Insufficient quantities of orphan drugs. |
| Subpart E - Open Protocols for Investigations |
| § 316.40 - Treatment use of a designated orphan drug. |
| Subpart F - Availability of Information |
| § 316.50 - Guidance documents. |
| § 316.52 - Availability for public disclosure of data and information in requests and applications. |