OMB control number

Protection of Human Subjects and Institutional Review Boards

OMB 0910-0130 · HHS/FDA.

OMB 0910-0130

The information collection supports implementation of statutory and regulatory requirements pertaining to the rights and welfare of human subjects involved in FDA-regulated research, and applicable to Institutional Review Boards that oversee such research.

The latest form for Protection of Human Subjects and Institutional Review Boards expires 2026-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
IRB Waiver FRIA -- 11-27-23.docx Supplementary Document
Minimal Risk Final Rule SSA Fall 2023 RIN AH52 CLEAN.docx Supporting Statement A
Recordkeeping associated with 21 CFR parts 50 and 56
FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation
Requests for Discretionary Certificates of Confidntiality Other-Statutory Authority
Reporting associated with 21 CFR parts 50 and 56
Disclosures associated with 21 CFR parts 50 and 56

All Historical Document Collections

202311-0910-012 Approved without change	Revision of a currently approved collection	2023-11-27
202301-0910-012 Approved with change	Revision of a currently approved collection	2023-01-24
201912-0910-008 Approved without change	Revision of a currently approved collection	2020-01-15
201704-0910-001 Approved without change	Extension without change of a currently approved collection	2017-04-25
201403-0910-007 Approved without change	Extension without change of a currently approved collection	2014-03-20
201012-0910-005 Approved without change	Extension without change of a currently approved collection	2010-12-27
200711-0910-003 Approved without change	Extension without change of a currently approved collection	2007-11-19
200408-0910-002 Approved without change	Extension without change of a currently approved collection	2004-08-12
200108-0910-001 Approved without change	Extension without change of a currently approved collection	2001-08-10
199808-0910-004 Approved without change	Extension without change of a currently approved collection	1998-08-21
199501-0910-003 Approved without change	Reinstatement without change of a previously approved collection	1995-01-27
199104-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1991-04-12
198711-0910-004 Approved without change	Revision of a currently approved collection	1987-11-18
198608-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1986-08-01
198307-0910-008 Approved without change	Revision of a currently approved collection	1983-07-28
198107-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1981-07-17

OMB Details

Recordkeeping associated with 21 CFR parts 50 and 56

Federal Enterprise Architecture: Health - Consumer Health and Safety