OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Orphan Drug Requirements: 21 CFR 316

OMB 0910-0167 ยท 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 Drug Requirements: 21 CFR 316 expires 2027-01-31 and is listed under ICR 202504-0910-005.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 4035 FDA Orphan Drug Designation Request FormForm and Instruction
0167 Orphan Drugs Part 316 SSA 2026.docxSupporting Statement A
83C_0167_Executive Order 14168_Form FDA 4035.docxJustification for No Material/Nonsubstantive Change
Orphan Drug Requirements Form and Instruction
Orphan Drug Requirements Other-Guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202609-0910-004 Extension without change of a currently approved collection 2026-09-21
202504-0910-005 No material or nonsubstantive change to a currently approved collection 2025-05-05
202312-0910-005 Extension without change of a currently approved collection 2023-12-19 Approved without change
202011-0910-012 Revision of a currently approved collection 2020-12-29
201711-0910-007 Revision of a currently approved collection 2017-12-19 Approved without change
201408-0910-001 Revision of a currently approved collection 2014-10-27 Approved without change
201106-0910-010 Extension without change of a currently approved collection 2011-06-29 Approved without change
201105-0910-005 Extension without change of a currently approved collection 2011-05-19 Improperly submitted and continue
200805-0910-004 Extension without change of a currently approved collection 2008-05-13 Approved without change
200711-0910-001 Revision of a currently approved collection 2007-11-09 Approved without change
200707-0910-002 Extension without change of a currently approved collection 2007-07-02 Approved without change
200405-0910-004 Extension without change of a currently approved collection 2004-05-28 Approved without change
200105-0910-001 Extension without change of a currently approved collection 2001-05-01 Approved without change
199805-0910-002 Reinstatement without change of a previously approved collection 1998-05-11 Approved without change
199302-0910-004 Reinstatement with change of a previously approved collection 1993-02-16 Approved without change
198907-0910-008 Reinstatement with change of a previously approved collection 1989-07-21 Approved without change
198406-0910-004 Reinstatement with change of a previously approved collection 1984-06-01 Approved without change
198405-0910-001 Reinstatement with change of a previously approved collection 1984-05-09 Approved without change
198308-0910-001 New collection (Request for a new OMB Control Number) 1983-08-29 Approved without change