Orphan Drugs

OMB 0910-0167

This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.

The latest form for Orphan Drugs expires 2021-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0167 Orphan Drugs Part 316 SSA 2023.docx Supporting Statement A
Orphan Drug Requirements Other-Guidance

All Historical Document Collections

202312-0910-005 Approved without change	Extension without change of a currently approved collection	2023-12-19
202011-0910-012	Revision of a currently approved collection	2020-12-29
201711-0910-007 Approved without change	Revision of a currently approved collection	2017-12-19
201408-0910-001 Approved without change	Revision of a currently approved collection	2014-10-27
201106-0910-010 Approved without change	Extension without change of a currently approved collection	2011-06-29
201105-0910-005 Improperly submitted and continue	Extension without change of a currently approved collection	2011-05-19
200805-0910-004 Approved without change	Extension without change of a currently approved collection	2008-05-13
200711-0910-001 Approved without change	Revision of a currently approved collection	2007-11-09
200707-0910-002 Approved without change	Extension without change of a currently approved collection	2007-07-02
200405-0910-004 Approved without change	Extension without change of a currently approved collection	2004-05-28
200105-0910-001 Approved without change	Extension without change of a currently approved collection	2001-05-01
199805-0910-002 Approved without change	Reinstatement without change of a previously approved collection	1998-05-11
199302-0910-004 Approved without change	Reinstatement with change of a previously approved collection	1993-02-16
198907-0910-008 Approved without change	Reinstatement with change of a previously approved collection	1989-07-21
198406-0910-004 Approved without change	Reinstatement with change of a previously approved collection	1984-06-01
198405-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1984-05-09
198308-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1983-08-29

OMB Details

Written recommendations; content and format of a request, the providing of; refusal to provide

Federal Enterprise Architecture: Health - Consumer Health and Safety