OMB control number

Orphan Drugs

OMB 0910-0167 · HHS/FDA.

OMB 0910-0167

This information is required to support implementation and administration of the Orphan Drug Act and FDA regulations found in 21 CFR part 316. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the applicable statutes and regulations.

The latest form for Orphan Drugs expires 2027-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
83C_0167_Executive Order 14168_Form FDA 4035.docx Justification for No Material/Nonsubstantive Change
0167 Orphan Drugs Part 316 SSA 2023.docx Supporting Statement A
Orphan Drug Requirements Other-Guidance

All Historical Document Collections

202504-0910-005	No material or nonsubstantive change to a currently approved collection	2025-05-05
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