OMB control number

Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

OMB 0910-0116 · HHS/FDA.

OMB 0910-0116

This information collection supports implementation of statutory and regulatory requirements that govern blood and blood components. All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). FDA administers the information collection to prevent the introduction, transmission, or spread of communicable diseases through blood or blood components.

The latest form for Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback" expires 2026-10-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
CGMP for Blood and Blood Components: Reporting Requirements
Annual reporting of released unsuitable units Other-Agency Guidance
FDA recommended notifications relating to blood donations and donor suitability determinations Other-Agency Guidance
CGMP for Blood and Blood Components: 3rd Party Disclosures Other-Agency Guidance
CGMP for Blood and Blood Components: Recordkeeping Requirements

All Historical Document Collections

202308-0910-020 Approved without change	Revision of a currently approved collection	2023-08-30
202307-0910-004 Approved without change	Revision of a currently approved collection	2023-07-26
202106-0910-004 Approved without change	Revision of a currently approved collection	2021-06-28
201908-0910-003 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-08-08
201812-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-12-11
201804-0910-014 Approved without change	Revision of a currently approved collection	2018-04-18
201503-0910-004 Approved without change	Extension without change of a currently approved collection	2015-03-11
201201-0910-001 Approved with change	Extension without change of a currently approved collection	2012-01-03
200811-0910-006 Approved with change	Revision of a currently approved collection	2008-11-20
200510-0910-006 Approved without change	Extension without change of a currently approved collection	2005-10-26
200210-0910-003 Approved without change	Extension without change of a currently approved collection	2002-10-10
200009-0910-012 Approved without change	Extension without change of a currently approved collection	2000-09-28
199712-0910-004 Approved without change	Reinstatement with change of a previously approved collection	1997-12-15
199303-0910-004 Approved without change	Reinstatement with change of a previously approved collection	1993-03-09
198601-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1986-01-28
198408-0910-009 Approved without change	Revision of a currently approved collection	1984-08-28
198311-0910-006 Approved without change	Revision of a currently approved collection	1983-11-25
198303-0910-011 Approved without change	Revision of a currently approved collection	1983-03-09
198101-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1981-01-08

OMB Details

CGMP for Blood and Blood Components: Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety