REGULATIONS
Rulings
AD/CVD
Notices
HTSUS
U.S. Code
Regs
More
Ports
About
Updates
Apps
Larger font
Smaller font
SEARCH
Sort by Rank
Titles Ascending
Titles Descending
10 per page
25 Result/page
50 Result/page
Regulations last checked for updates: May 23, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 316
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.
authority:
21 U.S.C. 360aa
,
360bb
,
360cc
,
360dd
,
371
source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
.list_box li,p,.cm-search-info,.cm-search-detail,.abt span,.expand-collapse_top
Get the CustomsMobile app!