OMB.report

Federal forms, ICRs, and supporting documents

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 is listed under ICR 202308-0910-020.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
CGMP for Blood and Blood Components: Reporting Requirements Information collection
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 Information collection

All Historical Document Collections

Historical document collections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

OMB Details

CGMP for Blood and Blood Components: Reporting Requirements

Federal Enterprise Architecture: Health - Consumer Health and Safety