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 is listed under ICR 202311-0910-012.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
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	Information collection
FINAL RULE: Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigation	Information collection
Requests for Discretionary Certificates of Confidntiality	Other-Statutory Authority
Reporting associated with 21 CFR parts 50 and 56	Information collection
Disclosures associated with 21 CFR parts 50 and 56	Information collection

All Historical Document Collections

Historical document collections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

OMB Details

Recordkeeping associated with 21 CFR parts 50 and 56

Federal Enterprise Architecture: Health - Consumer Health and Safety